OBG Management

What is the most ominous manifestation of congenital parvovirus infection, and what is the cause of this abnormality?

Continue to the answer...

Hydrops fetalis is the most ominous complication of congenital parvovirus infection. The virus crosses the placenta and attacks red cell progenitor cells, resulting in an aplastic anemia. In addition, the virus may cause myocarditis that, in turn, may result in cardiac failure in the fetus.

What is the most ominous manifestation of congenital parvovirus infection, and what is the cause of this abnormality?

Continue to the answer...

Hydrops fetalis is the most ominous complication of congenital parvovirus infection. The virus crosses the placenta and attacks red cell progenitor cells, resulting in an aplastic anemia. In addition, the virus may cause myocarditis that, in turn, may result in cardiac failure in the fetus.

What is the most ominous manifestation of congenital parvovirus infection, and what is the cause of this abnormality?

Continue to the answer...

Hydrops fetalis is the most ominous complication of congenital parvovirus infection. The virus crosses the placenta and attacks red cell progenitor cells, resulting in an aplastic anemia. In addition, the virus may cause myocarditis that, in turn, may result in cardiac failure in the fetus.

What are the major complications of pyelonephritis in pregnancy?

Continue to the answer...

Pyelonephritis is an important cause of preterm labor, sepsis, and adult respiratory distress syndrome. Most cases of pyelonephritis develop as a result of an untreated or inadequately treated lower urinary tract infection.

What are the major complications of pyelonephritis in pregnancy?

Continue to the answer...

Pyelonephritis is an important cause of preterm labor, sepsis, and adult respiratory distress syndrome. Most cases of pyelonephritis develop as a result of an untreated or inadequately treated lower urinary tract infection.

What are the major complications of pyelonephritis in pregnancy?

Continue to the answer...

Pyelonephritis is an important cause of preterm labor, sepsis, and adult respiratory distress syndrome. Most cases of pyelonephritis develop as a result of an untreated or inadequately treated lower urinary tract infection.

Which major organisms cause urinary tract infections (UTIs) in women?

Continue to the answer...

The most common causative organism is Escherichia coli, which is responsible for approximately 70% of all UTIs. Klebsiella pneumoniae and Proteus species are the 2 other aerobic gram-negative bacilli that are common uropathogens. In addition, 3 gram-positive cocci are important: enterococci, Staphylococcus saprophyticus, and group B streptococcus.

Which major organisms cause urinary tract infections (UTIs) in women?

Continue to the answer...

The most common causative organism is Escherichia coli, which is responsible for approximately 70% of all UTIs. Klebsiella pneumoniae and Proteus species are the 2 other aerobic gram-negative bacilli that are common uropathogens. In addition, 3 gram-positive cocci are important: enterococci, Staphylococcus saprophyticus, and group B streptococcus.

Which major organisms cause urinary tract infections (UTIs) in women?

Continue to the answer...

The most common causative organism is Escherichia coli, which is responsible for approximately 70% of all UTIs. Klebsiella pneumoniae and Proteus species are the 2 other aerobic gram-negative bacilli that are common uropathogens. In addition, 3 gram-positive cocci are important: enterococci, Staphylococcus saprophyticus, and group B streptococcus.

What are the best tests for the diagnosis of congenital cytomegalovirus (CMV) infection?

Continue to the answer...

When congenital CMV is suspected, if the patient is at least 15 weeks’ gestation, an amniocentesis should be performed to test for CMV DNA in the amniotic fluid using polymerase chain reaction (PCR) methodology. If the initial test is negative, amniocentesis should be repeated in approximately 4 weeks. Coincident with amniocentesis, a detailed ultrasound examination should be performed to search for findings suggestive of fetal injury, such as growth restriction, microcephaly, periventricular calcifications, hepatosplenomegaly, echogenic bowel, and serous effusions in the pleural space or abdomen.

What are the best tests for the diagnosis of congenital cytomegalovirus (CMV) infection?

Continue to the answer...

When congenital CMV is suspected, if the patient is at least 15 weeks’ gestation, an amniocentesis should be performed to test for CMV DNA in the amniotic fluid using polymerase chain reaction (PCR) methodology. If the initial test is negative, amniocentesis should be repeated in approximately 4 weeks. Coincident with amniocentesis, a detailed ultrasound examination should be performed to search for findings suggestive of fetal injury, such as growth restriction, microcephaly, periventricular calcifications, hepatosplenomegaly, echogenic bowel, and serous effusions in the pleural space or abdomen.

What are the best tests for the diagnosis of congenital cytomegalovirus (CMV) infection?

Continue to the answer...

When congenital CMV is suspected, if the patient is at least 15 weeks’ gestation, an amniocentesis should be performed to test for CMV DNA in the amniotic fluid using polymerase chain reaction (PCR) methodology. If the initial test is negative, amniocentesis should be repeated in approximately 4 weeks. Coincident with amniocentesis, a detailed ultrasound examination should be performed to search for findings suggestive of fetal injury, such as growth restriction, microcephaly, periventricular calcifications, hepatosplenomegaly, echogenic bowel, and serous effusions in the pleural space or abdomen.

Texas Senate Bill 8 (SB8) is the most extreme antiabortion legislation currently in effect in the United States. SB8 was introduced by the Texas legislature on March 11, 2021, and signed into law by Governor Greg Abbott on May 19, 2021.¹ The law went into effect on September 1, 2021, despite an appeal to the US Supreme Court to block the law until the courts could weigh in on its constitutionality. The bill prohibits all abortion care in the state of Texas after cardiac activity has been identified, typically at 6 weeks’ gestational age. The majority of pregnant people may be unaware at that point that they are pregnant, particularly if their menstrual cycles are irregular.² An estimated 85% of abortions in Texas occur after the 6-week mark, leaving millions of Texans without the constitutionally protected rights assured to them in Roe v Wade.^3,4 This has and will disproportionately impact communities of color and low-income people seeking abortion care.

SB8 does not contain exceptions in case of a pregnancy that results from rape, sexual assault, or incest, but it does contain an exemption for abortion care because of a medical emergency, as approved by a physician. The physician is required to note the medical emergency in the patient’s chart, stating that the “medical emergency necessitated the abortion” and “prevented compliance” with SB8.⁵ In practice, this exception is so vague as to leave clinicians concerned that routine management of medical conditions and complications, as in ectopic pregnancy, places them at risk of legal action against them and their colleagues should they authorize abortion care.

In Texas, abortion restrictions are nothing new. Texas patients are already subject to a 2-trip requirement: Since 2011 they have been required to have a mandatory ultrasound in one visit and schedule a second visit, 24 hours later, for the procedure.⁶ As of 2003, Texas law also mandates that providers discuss with patients the medical risks, adoption alternatives, and developmental stages of the pregnancy.⁶ There are no medical indications for either of these laws, and their impact is to delay patient care. Unfortunately, laws such as these have been increasingly common in the past decade, with 106 abortion restrictions enacted in 2021 alone.^7,8

What is different about SB8?

SB8 is unique in that it deputizes private citizens to enforce the law. This represents a major change in the antichoice movement’s tactics, as previous bills have made violations a criminal offense. SB8 allows a citizen to sue anyone associated with abortion care, with a minimum penalty of $10,000. In practice, a citizen of another state, who has no connection to the patient receiving care, can sue under this Texas law.⁹ Anyone “aiding and abetting a violation” can be found liable for up to 4 years after the date of care, including, for example, a ride-hailing driver called to ferry the patient to the appointment, the health care team providing abortion care, or insurance companies covering the costs of care. In addition, anyone found guilty of “aiding and abetting” a violation of the bill is responsible for all costs and attorney fees associated with the civil case.^5,10

Furthermore, SB8 outlines defenses that cannot be used to preempt a finding of civil liability, including “ignorance or mistake of the law,” “belief of the law’s unconstitutionality,” and “consent of the [patient] to the abortion.”⁵ This additional layer of restriction makes it difficult to appeal the bill and convolutes an individual’s ability to challenge the law. The law also forbids the state (Texas), a state official, a court, or a district attorney from intervening on behalf of the law—upending typical courses of appeal. This legislation also complicates both federal and state intervention regarding SB8’s constitutionality, as the state has no role in enforcing the law as it is written.⁵

Continue to: What has been the response?...

What has been the response?

As expected, abortion foes reacted positively to SB8, while abortion advocates expressed outrage that the law went into effect. Many were additionally confused that the Supreme Court chose not to intervene to stay the law while the courts adjudicate its constitutionality, as is typical in other cases concerning abortion restrictions.¹¹

In a 5-4 ruling, the US Supreme Court allowed SB8 to take effect on September 1, issuing its decision on the “Shadow Docket.” As such, a decision was handed down on an expedited timeline in response to an emergency appeal without any oral arguments or a lengthy opinion explaining the ruling.^11,12 The majority delivered a brief, one-paragraph order summarizing their decision, explaining that their refusal to grant the injunction was not a commentary on the law’s constitutionality. The High Court stated that they could not initially comment on the law’s constitutionality before it went into effect, citing that per the law, the state had no role in enforcement, and at the time, no private actions had yet been brought under the law. Justice Sonia Sotomayor dissented, stating, “The Court’s order is stunning. Presented with an application to enjoin a flagrantly unconstitutional law engineered to prohibit women from exercising their constitutional rights and evade judicial scrutiny, a majority of Justices have opted to bury their heads in the sand.”¹³

Following the Supreme Court’s refusal to act, US Attorney General Merrick Garland commented that “the Justice Department was evaluating all options to protect the constitutional rights of women and other persons.” Just one week later, the US Department of Justice filed a lawsuit against the State of Texas, arguing that SB8 was unconstitutional under the Supremacy Clause (federal law takes precedence over state law) and the Fourteenth Amendment.^14,15

On October 6, in response to the Department of Justice’s challenge, District Judge Robert Pitman issued an injunction to prevent enforcement of SB8. In a 113-page ruling, Judge Pitman explained that “a person’s right under the Constitution to choose to obtain an abortion prior to fetal viability is well established.” Judge Pittman held SB8 unconstitutional, stating, “Women have been unlawfully prevented from exercising control over their lives in ways that are protected by the Constitution... Fully aware that depriving its citizens of this right by direct state action would be flagrantly unconstitutional, the State contrived an unprecedented and transparent statutory scheme to do just that.”¹⁶

Just 48 hours after the injunction issued by Judge Pitman, the Fifth Circuit Court of Appeals overturned the injunction, and SB8 went back into effect while litigation on its constitutionality proceeded.^2,17 The Fifth Circuit Court of Appeals is widely considered to be one of the most conservative courts in the country.¹⁸

On October 15, 2021, the Department of Justice appealed the Fifth Circuit Court’s decision and asked the US Supreme Court to intervene, requesting that the Court issue an emergency halt to the law.^19,20 On October 22, 2021, the Court declined to halt the law but scheduled oral arguments on the case for November 1, 2021. This is a stunningly fast briefing schedule for a case of such constitutional importance.

Given the legal back-and-forth, many clinicians are not providing abortion care in Texas as the litigation unfolds. SB8 permits retroactive enforcement, mandating that those “aiding and abetting” of abortion care may be civilly liable for up to 4 years after providing the care.⁵

Continue to: Potential outcomes, and what comes next...

Potential outcomes, and what comes next

Since the ascension of Justice Amy Coney Barrett to the High Court, there has been a nationwide increase in antiabortion legislation. Between January and July 2021, more than 90 abortion restrictions were passed, more restrictions in any single year since Roe v Wade was decided in 1973.⁸ In the past decade, more than 500 laws that restrict abortion have been passed across the United States, and studies indicate that 87% to 90% of American counties today are without a single abortion provider.^21,22 Abortion supporters are particularly concerned about the future of Roe v Wade, with a conservative Supreme Court set to hear the challenge to SB8 on November 1, 2021, followed by a second case from Mississippi challenging the constitutionality of a 15-week ban on abortion in Dobbs v Jackson Women’s Health Organization (read about this case in “Supreme Court Case: Dobbs v Jackson Women’s Health Organization: What you need to know,” at https://www.mdedge.com/obgyn/article/245853/practice-management/supreme-court-case-dobbs-v-jackson-womens-health).^23,24

At the time of this article writing, we do not know how the Supreme Court will rule on the variety of challenges to the right to privacy. That said, advocates believe it is safe to assume that the landscape of abortion access is likely to change dramatically in the coming year.

Action items: What can you do?

It is important to remember that not only does SB8 severely limit access to safe and legal abortion but also it makes pregnancy dangerous for all pregnant people in Texas and places doubt in providers’ minds on how to manage medical care for their patients.

On the federal level, many advocates are focusing on codifying the right to choose and protecting abortion care from medically unnecessary restrictions. The Women’s Health Protection Act of 2021 (WHPA) was introduced in the House of Representatives by Rep. Judy Chu (D-CA), Lois Frankel (D-FL), Ayanna Pressley (D-MA), and Veronica Escobar (D-TX), and it passed in the US House of Representatives in a 218-211 vote.²⁵ WHPA now awaits a vote in a deeply divided US Senate. Although WHPA has wide popular support—an estimated 61% of Americans support the legislation—its future is unclear in the Senate.²⁶ Currently, WHPA has 48 supporters, all Democrats. You can contact your legislators via the links below to encourage them to pass WHPA. If you have friends and colleagues in states in which the Senator does not support WHPA, forward these links and encourage them to sign on: 

• Equal Access to Abortion, Everywhere: https://actforwomen.org/take-action/
• Physicians for Reproductive Rights: https://secure.everyaction.com/p/MOuAyW7F3Ua-FmaGtGD4Kw2
• Center for Reproductive Rights: https://reproductiverights.org/whpa-take-action/

Many also are organizing a crowdfunding campaign to support abortion providers as well as legislative resources. Additional groups to donate specifically to SB8 efforts include²⁷:

• Equal Access to Abortion, Everywhere: https://actforwomen.org/whpa-faqs/
• Planned Parenthood of Greater Texas, Inc: https://www.plannedparenthood.org/planned-parenthood-greater-texas/senate-bill-8
• Texas Equal Access Fund: https://secure.everyaction.com/ztEh8Qeh80-k2k1Yuo5gTw2
• ActBlue Charities: https://secure.actblue.com/donate/txfunds

Furthermore, it is more important than ever to support work within states to support abortion rights. State-specific abortion advocacy groups and their efforts include:

• Avow Foundation for Abortion Access: https://avowtexas.org/support/
• Planned Parenthood of Greater Texas, Inc: https://www.plannedparenthood.org/planned-parenthood-greater-texas
• NARAL Pro-Choice Texas: https://prochoicetexas.org/
• Texas Abortion Access Network: https://txabortionaccessnetwork.org/

Texas Senate Bill 8 (SB8) is the most extreme antiabortion legislation currently in effect in the United States. SB8 was introduced by the Texas legislature on March 11, 2021, and signed into law by Governor Greg Abbott on May 19, 2021.¹ The law went into effect on September 1, 2021, despite an appeal to the US Supreme Court to block the law until the courts could weigh in on its constitutionality. The bill prohibits all abortion care in the state of Texas after cardiac activity has been identified, typically at 6 weeks’ gestational age. The majority of pregnant people may be unaware at that point that they are pregnant, particularly if their menstrual cycles are irregular.² An estimated 85% of abortions in Texas occur after the 6-week mark, leaving millions of Texans without the constitutionally protected rights assured to them in Roe v Wade.^3,4 This has and will disproportionately impact communities of color and low-income people seeking abortion care.

SB8 does not contain exceptions in case of a pregnancy that results from rape, sexual assault, or incest, but it does contain an exemption for abortion care because of a medical emergency, as approved by a physician. The physician is required to note the medical emergency in the patient’s chart, stating that the “medical emergency necessitated the abortion” and “prevented compliance” with SB8.⁵ In practice, this exception is so vague as to leave clinicians concerned that routine management of medical conditions and complications, as in ectopic pregnancy, places them at risk of legal action against them and their colleagues should they authorize abortion care.

In Texas, abortion restrictions are nothing new. Texas patients are already subject to a 2-trip requirement: Since 2011 they have been required to have a mandatory ultrasound in one visit and schedule a second visit, 24 hours later, for the procedure.⁶ As of 2003, Texas law also mandates that providers discuss with patients the medical risks, adoption alternatives, and developmental stages of the pregnancy.⁶ There are no medical indications for either of these laws, and their impact is to delay patient care. Unfortunately, laws such as these have been increasingly common in the past decade, with 106 abortion restrictions enacted in 2021 alone.^7,8

What is different about SB8?

SB8 is unique in that it deputizes private citizens to enforce the law. This represents a major change in the antichoice movement’s tactics, as previous bills have made violations a criminal offense. SB8 allows a citizen to sue anyone associated with abortion care, with a minimum penalty of $10,000. In practice, a citizen of another state, who has no connection to the patient receiving care, can sue under this Texas law.⁹ Anyone “aiding and abetting a violation” can be found liable for up to 4 years after the date of care, including, for example, a ride-hailing driver called to ferry the patient to the appointment, the health care team providing abortion care, or insurance companies covering the costs of care. In addition, anyone found guilty of “aiding and abetting” a violation of the bill is responsible for all costs and attorney fees associated with the civil case.^5,10

Furthermore, SB8 outlines defenses that cannot be used to preempt a finding of civil liability, including “ignorance or mistake of the law,” “belief of the law’s unconstitutionality,” and “consent of the [patient] to the abortion.”⁵ This additional layer of restriction makes it difficult to appeal the bill and convolutes an individual’s ability to challenge the law. The law also forbids the state (Texas), a state official, a court, or a district attorney from intervening on behalf of the law—upending typical courses of appeal. This legislation also complicates both federal and state intervention regarding SB8’s constitutionality, as the state has no role in enforcing the law as it is written.⁵

Continue to: What has been the response?...

What has been the response?

As expected, abortion foes reacted positively to SB8, while abortion advocates expressed outrage that the law went into effect. Many were additionally confused that the Supreme Court chose not to intervene to stay the law while the courts adjudicate its constitutionality, as is typical in other cases concerning abortion restrictions.¹¹

In a 5-4 ruling, the US Supreme Court allowed SB8 to take effect on September 1, issuing its decision on the “Shadow Docket.” As such, a decision was handed down on an expedited timeline in response to an emergency appeal without any oral arguments or a lengthy opinion explaining the ruling.^11,12 The majority delivered a brief, one-paragraph order summarizing their decision, explaining that their refusal to grant the injunction was not a commentary on the law’s constitutionality. The High Court stated that they could not initially comment on the law’s constitutionality before it went into effect, citing that per the law, the state had no role in enforcement, and at the time, no private actions had yet been brought under the law. Justice Sonia Sotomayor dissented, stating, “The Court’s order is stunning. Presented with an application to enjoin a flagrantly unconstitutional law engineered to prohibit women from exercising their constitutional rights and evade judicial scrutiny, a majority of Justices have opted to bury their heads in the sand.”¹³

Following the Supreme Court’s refusal to act, US Attorney General Merrick Garland commented that “the Justice Department was evaluating all options to protect the constitutional rights of women and other persons.” Just one week later, the US Department of Justice filed a lawsuit against the State of Texas, arguing that SB8 was unconstitutional under the Supremacy Clause (federal law takes precedence over state law) and the Fourteenth Amendment.^14,15

On October 6, in response to the Department of Justice’s challenge, District Judge Robert Pitman issued an injunction to prevent enforcement of SB8. In a 113-page ruling, Judge Pitman explained that “a person’s right under the Constitution to choose to obtain an abortion prior to fetal viability is well established.” Judge Pittman held SB8 unconstitutional, stating, “Women have been unlawfully prevented from exercising control over their lives in ways that are protected by the Constitution... Fully aware that depriving its citizens of this right by direct state action would be flagrantly unconstitutional, the State contrived an unprecedented and transparent statutory scheme to do just that.”¹⁶

Just 48 hours after the injunction issued by Judge Pitman, the Fifth Circuit Court of Appeals overturned the injunction, and SB8 went back into effect while litigation on its constitutionality proceeded.^2,17 The Fifth Circuit Court of Appeals is widely considered to be one of the most conservative courts in the country.¹⁸

On October 15, 2021, the Department of Justice appealed the Fifth Circuit Court’s decision and asked the US Supreme Court to intervene, requesting that the Court issue an emergency halt to the law.^19,20 On October 22, 2021, the Court declined to halt the law but scheduled oral arguments on the case for November 1, 2021. This is a stunningly fast briefing schedule for a case of such constitutional importance.

Given the legal back-and-forth, many clinicians are not providing abortion care in Texas as the litigation unfolds. SB8 permits retroactive enforcement, mandating that those “aiding and abetting” of abortion care may be civilly liable for up to 4 years after providing the care.⁵

Continue to: Potential outcomes, and what comes next...

Potential outcomes, and what comes next

Since the ascension of Justice Amy Coney Barrett to the High Court, there has been a nationwide increase in antiabortion legislation. Between January and July 2021, more than 90 abortion restrictions were passed, more restrictions in any single year since Roe v Wade was decided in 1973.⁸ In the past decade, more than 500 laws that restrict abortion have been passed across the United States, and studies indicate that 87% to 90% of American counties today are without a single abortion provider.^21,22 Abortion supporters are particularly concerned about the future of Roe v Wade, with a conservative Supreme Court set to hear the challenge to SB8 on November 1, 2021, followed by a second case from Mississippi challenging the constitutionality of a 15-week ban on abortion in Dobbs v Jackson Women’s Health Organization (read about this case in “Supreme Court Case: Dobbs v Jackson Women’s Health Organization: What you need to know,” at https://www.mdedge.com/obgyn/article/245853/practice-management/supreme-court-case-dobbs-v-jackson-womens-health).^23,24

At the time of this article writing, we do not know how the Supreme Court will rule on the variety of challenges to the right to privacy. That said, advocates believe it is safe to assume that the landscape of abortion access is likely to change dramatically in the coming year.

Action items: What can you do?

It is important to remember that not only does SB8 severely limit access to safe and legal abortion but also it makes pregnancy dangerous for all pregnant people in Texas and places doubt in providers’ minds on how to manage medical care for their patients.

On the federal level, many advocates are focusing on codifying the right to choose and protecting abortion care from medically unnecessary restrictions. The Women’s Health Protection Act of 2021 (WHPA) was introduced in the House of Representatives by Rep. Judy Chu (D-CA), Lois Frankel (D-FL), Ayanna Pressley (D-MA), and Veronica Escobar (D-TX), and it passed in the US House of Representatives in a 218-211 vote.²⁵ WHPA now awaits a vote in a deeply divided US Senate. Although WHPA has wide popular support—an estimated 61% of Americans support the legislation—its future is unclear in the Senate.²⁶ Currently, WHPA has 48 supporters, all Democrats. You can contact your legislators via the links below to encourage them to pass WHPA. If you have friends and colleagues in states in which the Senator does not support WHPA, forward these links and encourage them to sign on: 

• Equal Access to Abortion, Everywhere: https://actforwomen.org/take-action/
• Physicians for Reproductive Rights: https://secure.everyaction.com/p/MOuAyW7F3Ua-FmaGtGD4Kw2
• Center for Reproductive Rights: https://reproductiverights.org/whpa-take-action/

Many also are organizing a crowdfunding campaign to support abortion providers as well as legislative resources. Additional groups to donate specifically to SB8 efforts include²⁷:

• Equal Access to Abortion, Everywhere: https://actforwomen.org/whpa-faqs/
• Planned Parenthood of Greater Texas, Inc: https://www.plannedparenthood.org/planned-parenthood-greater-texas/senate-bill-8
• Texas Equal Access Fund: https://secure.everyaction.com/ztEh8Qeh80-k2k1Yuo5gTw2
• ActBlue Charities: https://secure.actblue.com/donate/txfunds

Furthermore, it is more important than ever to support work within states to support abortion rights. State-specific abortion advocacy groups and their efforts include:

• Avow Foundation for Abortion Access: https://avowtexas.org/support/
• Planned Parenthood of Greater Texas, Inc: https://www.plannedparenthood.org/planned-parenthood-greater-texas
• NARAL Pro-Choice Texas: https://prochoicetexas.org/
• Texas Abortion Access Network: https://txabortionaccessnetwork.org/

Texas Senate Bill 8 (SB8) is the most extreme antiabortion legislation currently in effect in the United States. SB8 was introduced by the Texas legislature on March 11, 2021, and signed into law by Governor Greg Abbott on May 19, 2021.¹ The law went into effect on September 1, 2021, despite an appeal to the US Supreme Court to block the law until the courts could weigh in on its constitutionality. The bill prohibits all abortion care in the state of Texas after cardiac activity has been identified, typically at 6 weeks’ gestational age. The majority of pregnant people may be unaware at that point that they are pregnant, particularly if their menstrual cycles are irregular.² An estimated 85% of abortions in Texas occur after the 6-week mark, leaving millions of Texans without the constitutionally protected rights assured to them in Roe v Wade.^3,4 This has and will disproportionately impact communities of color and low-income people seeking abortion care.

SB8 does not contain exceptions in case of a pregnancy that results from rape, sexual assault, or incest, but it does contain an exemption for abortion care because of a medical emergency, as approved by a physician. The physician is required to note the medical emergency in the patient’s chart, stating that the “medical emergency necessitated the abortion” and “prevented compliance” with SB8.⁵ In practice, this exception is so vague as to leave clinicians concerned that routine management of medical conditions and complications, as in ectopic pregnancy, places them at risk of legal action against them and their colleagues should they authorize abortion care.

In Texas, abortion restrictions are nothing new. Texas patients are already subject to a 2-trip requirement: Since 2011 they have been required to have a mandatory ultrasound in one visit and schedule a second visit, 24 hours later, for the procedure.⁶ As of 2003, Texas law also mandates that providers discuss with patients the medical risks, adoption alternatives, and developmental stages of the pregnancy.⁶ There are no medical indications for either of these laws, and their impact is to delay patient care. Unfortunately, laws such as these have been increasingly common in the past decade, with 106 abortion restrictions enacted in 2021 alone.^7,8

What is different about SB8?

SB8 is unique in that it deputizes private citizens to enforce the law. This represents a major change in the antichoice movement’s tactics, as previous bills have made violations a criminal offense. SB8 allows a citizen to sue anyone associated with abortion care, with a minimum penalty of $10,000. In practice, a citizen of another state, who has no connection to the patient receiving care, can sue under this Texas law.⁹ Anyone “aiding and abetting a violation” can be found liable for up to 4 years after the date of care, including, for example, a ride-hailing driver called to ferry the patient to the appointment, the health care team providing abortion care, or insurance companies covering the costs of care. In addition, anyone found guilty of “aiding and abetting” a violation of the bill is responsible for all costs and attorney fees associated with the civil case.^5,10

Furthermore, SB8 outlines defenses that cannot be used to preempt a finding of civil liability, including “ignorance or mistake of the law,” “belief of the law’s unconstitutionality,” and “consent of the [patient] to the abortion.”⁵ This additional layer of restriction makes it difficult to appeal the bill and convolutes an individual’s ability to challenge the law. The law also forbids the state (Texas), a state official, a court, or a district attorney from intervening on behalf of the law—upending typical courses of appeal. This legislation also complicates both federal and state intervention regarding SB8’s constitutionality, as the state has no role in enforcing the law as it is written.⁵

Continue to: What has been the response?...

What has been the response?

As expected, abortion foes reacted positively to SB8, while abortion advocates expressed outrage that the law went into effect. Many were additionally confused that the Supreme Court chose not to intervene to stay the law while the courts adjudicate its constitutionality, as is typical in other cases concerning abortion restrictions.¹¹

In a 5-4 ruling, the US Supreme Court allowed SB8 to take effect on September 1, issuing its decision on the “Shadow Docket.” As such, a decision was handed down on an expedited timeline in response to an emergency appeal without any oral arguments or a lengthy opinion explaining the ruling.^11,12 The majority delivered a brief, one-paragraph order summarizing their decision, explaining that their refusal to grant the injunction was not a commentary on the law’s constitutionality. The High Court stated that they could not initially comment on the law’s constitutionality before it went into effect, citing that per the law, the state had no role in enforcement, and at the time, no private actions had yet been brought under the law. Justice Sonia Sotomayor dissented, stating, “The Court’s order is stunning. Presented with an application to enjoin a flagrantly unconstitutional law engineered to prohibit women from exercising their constitutional rights and evade judicial scrutiny, a majority of Justices have opted to bury their heads in the sand.”¹³

Following the Supreme Court’s refusal to act, US Attorney General Merrick Garland commented that “the Justice Department was evaluating all options to protect the constitutional rights of women and other persons.” Just one week later, the US Department of Justice filed a lawsuit against the State of Texas, arguing that SB8 was unconstitutional under the Supremacy Clause (federal law takes precedence over state law) and the Fourteenth Amendment.^14,15

On October 6, in response to the Department of Justice’s challenge, District Judge Robert Pitman issued an injunction to prevent enforcement of SB8. In a 113-page ruling, Judge Pitman explained that “a person’s right under the Constitution to choose to obtain an abortion prior to fetal viability is well established.” Judge Pittman held SB8 unconstitutional, stating, “Women have been unlawfully prevented from exercising control over their lives in ways that are protected by the Constitution... Fully aware that depriving its citizens of this right by direct state action would be flagrantly unconstitutional, the State contrived an unprecedented and transparent statutory scheme to do just that.”¹⁶

Just 48 hours after the injunction issued by Judge Pitman, the Fifth Circuit Court of Appeals overturned the injunction, and SB8 went back into effect while litigation on its constitutionality proceeded.^2,17 The Fifth Circuit Court of Appeals is widely considered to be one of the most conservative courts in the country.¹⁸

On October 15, 2021, the Department of Justice appealed the Fifth Circuit Court’s decision and asked the US Supreme Court to intervene, requesting that the Court issue an emergency halt to the law.^19,20 On October 22, 2021, the Court declined to halt the law but scheduled oral arguments on the case for November 1, 2021. This is a stunningly fast briefing schedule for a case of such constitutional importance.

Given the legal back-and-forth, many clinicians are not providing abortion care in Texas as the litigation unfolds. SB8 permits retroactive enforcement, mandating that those “aiding and abetting” of abortion care may be civilly liable for up to 4 years after providing the care.⁵

Continue to: Potential outcomes, and what comes next...

Potential outcomes, and what comes next

Since the ascension of Justice Amy Coney Barrett to the High Court, there has been a nationwide increase in antiabortion legislation. Between January and July 2021, more than 90 abortion restrictions were passed, more restrictions in any single year since Roe v Wade was decided in 1973.⁸ In the past decade, more than 500 laws that restrict abortion have been passed across the United States, and studies indicate that 87% to 90% of American counties today are without a single abortion provider.^21,22 Abortion supporters are particularly concerned about the future of Roe v Wade, with a conservative Supreme Court set to hear the challenge to SB8 on November 1, 2021, followed by a second case from Mississippi challenging the constitutionality of a 15-week ban on abortion in Dobbs v Jackson Women’s Health Organization (read about this case in “Supreme Court Case: Dobbs v Jackson Women’s Health Organization: What you need to know,” at https://www.mdedge.com/obgyn/article/245853/practice-management/supreme-court-case-dobbs-v-jackson-womens-health).^23,24

At the time of this article writing, we do not know how the Supreme Court will rule on the variety of challenges to the right to privacy. That said, advocates believe it is safe to assume that the landscape of abortion access is likely to change dramatically in the coming year.

Action items: What can you do?

It is important to remember that not only does SB8 severely limit access to safe and legal abortion but also it makes pregnancy dangerous for all pregnant people in Texas and places doubt in providers’ minds on how to manage medical care for their patients.

On the federal level, many advocates are focusing on codifying the right to choose and protecting abortion care from medically unnecessary restrictions. The Women’s Health Protection Act of 2021 (WHPA) was introduced in the House of Representatives by Rep. Judy Chu (D-CA), Lois Frankel (D-FL), Ayanna Pressley (D-MA), and Veronica Escobar (D-TX), and it passed in the US House of Representatives in a 218-211 vote.²⁵ WHPA now awaits a vote in a deeply divided US Senate. Although WHPA has wide popular support—an estimated 61% of Americans support the legislation—its future is unclear in the Senate.²⁶ Currently, WHPA has 48 supporters, all Democrats. You can contact your legislators via the links below to encourage them to pass WHPA. If you have friends and colleagues in states in which the Senator does not support WHPA, forward these links and encourage them to sign on: 

• Equal Access to Abortion, Everywhere: https://actforwomen.org/take-action/
• Physicians for Reproductive Rights: https://secure.everyaction.com/p/MOuAyW7F3Ua-FmaGtGD4Kw2
• Center for Reproductive Rights: https://reproductiverights.org/whpa-take-action/

Many also are organizing a crowdfunding campaign to support abortion providers as well as legislative resources. Additional groups to donate specifically to SB8 efforts include²⁷:

• Equal Access to Abortion, Everywhere: https://actforwomen.org/whpa-faqs/
• Planned Parenthood of Greater Texas, Inc: https://www.plannedparenthood.org/planned-parenthood-greater-texas/senate-bill-8
• Texas Equal Access Fund: https://secure.everyaction.com/ztEh8Qeh80-k2k1Yuo5gTw2
• ActBlue Charities: https://secure.actblue.com/donate/txfunds

Furthermore, it is more important than ever to support work within states to support abortion rights. State-specific abortion advocacy groups and their efforts include:

• Avow Foundation for Abortion Access: https://avowtexas.org/support/
• Planned Parenthood of Greater Texas, Inc: https://www.plannedparenthood.org/planned-parenthood-greater-texas
• NARAL Pro-Choice Texas: https://prochoicetexas.org/
• Texas Abortion Access Network: https://txabortionaccessnetwork.org/

Uterine leiomyomas affect 70% to 80% of reproductive-age women. Interventions for symptomatic patients include myomectomy, hysterectomy, uterine artery embolization (UAE), and radiofrequency ablation (RFA). Several RFA devices exist on the market. One such device is the sonography-guided transcervical ablation of uterine fibroids (Sonata), which is unique in its transcervical approach that allows for incisionless treatment.¹ It can be used to treat fibroids classified as FIGO 1-6 with a radius up to 5 cm.¹ Postablative therapy outcomes at 1 and 2 years have been promising for total volume reduction (mean maximal volume reduction, 63.8%) and improvement in symptoms, including quality-of-life measures and amount of bleeding (95% reported reduction).^2,3

In our practice, we find this tool most helpful for medium-sized (3–5 cm) intramural fibroids and large type 2 fibroids.

In the accompanying video, we illustrate the steps for use of transcervical ultrasonographic RFA with Sonata treatment and demonstrate its impact on the uterus during simultaneous laparoscopy. We present a patient who underwent Sonata treatment for a 4-cm intramural fibroid and simultaneous laparoscopic myomectomy for a 4-cm pedunculated fibroid. This allowed for the unique ability to view the external effect on the uterus during Sonata use. We review the key surgical steps with this approach, including:

1. cervical dilation
2. introduction of the Sonata system
3. sonographic identification of the target fibroid
4. adjust size and shape of Smart Guide overlays
5. deploy the introducer
6. safety rotation check
7. deploy the needle electrodes
8. initiate RFA
9. withdraw needle electrodes and introducer.

RFA with Sonata treatment is a simple, minimally invasive therapeutic option for fibroids.

We hope that you find this video useful to your clinical practice.

>>DR. ARNOLD P. ADVINCULA AND COLLEAGUES

Vidyard Video

Uterine leiomyomas affect 70% to 80% of reproductive-age women. Interventions for symptomatic patients include myomectomy, hysterectomy, uterine artery embolization (UAE), and radiofrequency ablation (RFA). Several RFA devices exist on the market. One such device is the sonography-guided transcervical ablation of uterine fibroids (Sonata), which is unique in its transcervical approach that allows for incisionless treatment.¹ It can be used to treat fibroids classified as FIGO 1-6 with a radius up to 5 cm.¹ Postablative therapy outcomes at 1 and 2 years have been promising for total volume reduction (mean maximal volume reduction, 63.8%) and improvement in symptoms, including quality-of-life measures and amount of bleeding (95% reported reduction).^2,3

In our practice, we find this tool most helpful for medium-sized (3–5 cm) intramural fibroids and large type 2 fibroids.

In the accompanying video, we illustrate the steps for use of transcervical ultrasonographic RFA with Sonata treatment and demonstrate its impact on the uterus during simultaneous laparoscopy. We present a patient who underwent Sonata treatment for a 4-cm intramural fibroid and simultaneous laparoscopic myomectomy for a 4-cm pedunculated fibroid. This allowed for the unique ability to view the external effect on the uterus during Sonata use. We review the key surgical steps with this approach, including:

1. cervical dilation
2. introduction of the Sonata system
3. sonographic identification of the target fibroid
4. adjust size and shape of Smart Guide overlays
5. deploy the introducer
6. safety rotation check
7. deploy the needle electrodes
8. initiate RFA
9. withdraw needle electrodes and introducer.

RFA with Sonata treatment is a simple, minimally invasive therapeutic option for fibroids.

We hope that you find this video useful to your clinical practice.

>>DR. ARNOLD P. ADVINCULA AND COLLEAGUES

Vidyard Video

Uterine leiomyomas affect 70% to 80% of reproductive-age women. Interventions for symptomatic patients include myomectomy, hysterectomy, uterine artery embolization (UAE), and radiofrequency ablation (RFA). Several RFA devices exist on the market. One such device is the sonography-guided transcervical ablation of uterine fibroids (Sonata), which is unique in its transcervical approach that allows for incisionless treatment.¹ It can be used to treat fibroids classified as FIGO 1-6 with a radius up to 5 cm.¹ Postablative therapy outcomes at 1 and 2 years have been promising for total volume reduction (mean maximal volume reduction, 63.8%) and improvement in symptoms, including quality-of-life measures and amount of bleeding (95% reported reduction).^2,3

In our practice, we find this tool most helpful for medium-sized (3–5 cm) intramural fibroids and large type 2 fibroids.

In the accompanying video, we illustrate the steps for use of transcervical ultrasonographic RFA with Sonata treatment and demonstrate its impact on the uterus during simultaneous laparoscopy. We present a patient who underwent Sonata treatment for a 4-cm intramural fibroid and simultaneous laparoscopic myomectomy for a 4-cm pedunculated fibroid. This allowed for the unique ability to view the external effect on the uterus during Sonata use. We review the key surgical steps with this approach, including:

1. cervical dilation
2. introduction of the Sonata system
3. sonographic identification of the target fibroid
4. adjust size and shape of Smart Guide overlays
5. deploy the introducer
6. safety rotation check
7. deploy the needle electrodes
8. initiate RFA
9. withdraw needle electrodes and introducer.

RFA with Sonata treatment is a simple, minimally invasive therapeutic option for fibroids.

We hope that you find this video useful to your clinical practice.

>>DR. ARNOLD P. ADVINCULA AND COLLEAGUES

Vidyard Video

The Supreme Court’s usual processes were disrupted this term. The COVID-19 pandemic required audio hearings rather than in-person, and it resulted in a number of emergency legal appeals. As the Court began its regular sessions on October 5, 2020, there were only 8 justices—Justice Ruth Bader Ginsburg had passed away and Amy Coney Barrett had not yet been confirmed by the Senate. The Court decided many important cases this term, including dealing with the delivery of drugs to induce abortions, a Centers for Disease Control and Prevention (CDC) moratorium on housing evictions, yet another case on the Affordable Care Act, state laws concerning pharmacy benefit managers, and the Hologic and Minerva endometrial ablation systems patents. After considering these cases, we also will briefly look at other cases of general interest.

Abortion

Patient access to mifepristone

In May 2020, the American College of Obstetricians and Gynecologists (ACOG) was the named plaintiff in a lawsuit against the US Food and Drug Administration (FDA) regarding the drugs mifepristone and misoprostol that are used to induce medical abortions.¹ The case was filed by the American Civil Liberties Union on behalf of ACOG and others^2,3 and raised the issue of patients’ access to these medications. The basic claim of the case was that during the pandemic, the FDA’s regulation of mifepristone was unconstitutional in that they imposed an undue burden on the decision of women to have an abortion.⁴ (Although misoprostol is a part of the medical abortion regimen, it is not subject to special regulation and was not part of the litigation.)

The FDA regulation of mifepristone, begun in 2000 but modified since then, includes 3 elements to assure safe use:

• prescribers must have special training or certification
• the drug can be dispensed to patients only in a hospital, clinic, or medical office under the supervision of a certified health care provider (known as the “in-person dispensing requirement” because retail pharmacy or mail distribution are prohibited)
• the health care provider must review a “patient agreement form” with the patient and have the patient sign the consent form in the provider’s presence.⁵

The pandemic made fulfilling these requirements substantially more burdensome and difficult. The question was whether the FDA was constitutionally required to modify its regulations during a pandemic to take account of the undue burden of the regulation created by the pandemic. That is, the question was not whether the FDA could have or should have chosen to make the modification, but whether it was required to do so.

In July 2020, a federal district court in Maryland held that the FDA regulation was an unconstitutional burden on the abortion rights of women during the pandemic and issued a preliminary injunction to stop the FDA from enforcing the in-person dispensing and signature rules. The district judge applied the injunction to Maryland, but also made it a nationwide injunction. (The issue of district court nationwide injunctions is considered in, “District court ‘nationwide injunctions’”). 

The FDA asked the Fourth Circuit Court of Appeals to stay the enforcement of the injunction, which the appeals court denied. The FDA then appealed to the Supreme Court, asking it to stay the injunction. In October 2020, the Court announced that it was holding the FDA’s request “in abeyance” to allow the district court to consider a motion by the FDA to dissolve or change the injunction. It gave the district court 40 days in which to act. That decision by the Court was in the “Shadow Docket” (see sidebar on page XX), so the exact vote of the Court in October is not clear, but 2 Justices (Alito and Thomas) dissented and would have stayed the injunction.⁶ Over the next 40 days, the district court did not withdraw its nationwide injunction.

Thus, on January 12, 2021, the case was again before the Supreme Court, which let the FDA’s regulations regarding mifepristone remain in place by lifting the district court’s injunction. Most of the justices supporting the stay did not write to explain their decision, although their dissent in the earlier cases may have served that purpose. (Maryland was permitting many kinds of activity that were more risky than visiting a clinic—indoor dining, with open hair salons, gyms, and casinos.)⁷ Chief Justice Roberts wrote a concurrence to indicate that, in his view, the issue was not whether the FDA’s regulations placed an undue burden on a right to an abortion generally, but that “My view is that courts owe significant deference” to the public health authorities (here meaning the FDA). Justices Sotomayor and Kagan dissented, saying that the issue was the undue burden on women, given the difficulties of the pandemic, particularly going to medical facilities during the COVID-19 pandemic.⁸

The injunction, sought by ACOG and others, was issued by the district court and was in effect for several months before it was dissolved by the Supreme Court. Following the change in presidential administrations, in April 2021 the FDA announced that it was going to “exercise enforcement discretion with respect to the in-person dispensing requirement…during the COVID-19 public health emergency.”⁹

Continue to: The Texas abortion case...

The Texas abortion case

The Court, on September 1, 2021, declined to block a Texas abortion statute from taking effect.¹⁰ This law precludes abortions after a fetal heartbeat is present at about 6 weeks of gestation. The Fifth Circuit declined to grant an injunction delaying implementation of the Texas law, and the Court did not reverse that decision.

Over the years, a variety of states have placed limitations on abortion, and those almost always have been enjoined by federal courts before they went into effect. However, the Texas statute, which undoubtedly is unconstitutional, was creatively constructed to avoid an early injunction.¹¹ The statute does not allow state officials to enforce the new law, but rather it allows almost any private citizen to seek monetary damages from anyone performing an abortion or who “aids and abets” an abortion. Thus, it is difficult to tailor a lawsuit before this law is enforced. First, courts do not enjoin laws; they usually enjoin individuals from enforcing the law, and in this case it is difficult to know which individuals will be enforcing the laws and what their decisions might be. There also are some questions about the degree to which federal courts can enjoin state courts from deciding lawsuits under state law. For these procedural reasons, the majority of the Court found that those attacking the Texas law had not met their burden of showing that that they would win their case.

Even 3 of the dissenting justices said the defendants may be right that “existing doctrines preclude judicial intervention,” but that the consequences are such that the Court should delay the law until there is time for briefing and argument. The other 3 dissenting justices thought there would be ways of getting around the clever roadblock Texas had erected for the federal courts.

There has been some commentary that this case portends the abandonment of Roe v Wade and Casey,¹² but that conclusion does not seem warranted by this case. The Court has accepted a Mississippi abortion law to be heard next term.¹³ In addition, the Texas statute is likely to be back in federal court once a private individual has filed a claim for money from an abortion provider (and likely even before that).

COVID-19 cases

The Supreme Court decided several cases related to COVID-19, including adjustments to election procedures, church services, and CDC eviction moratoria. As a general matter early in the pandemic, the Court deferred to government authorities, generally upholding government actions. Chief Justice Roberts emphasized the importance of the Court deferring to government officials in emergencies. As the pandemic progressed into 2021, however, the Court became less and less sympathetic to government actions that were not consistent, permitted by existing law, or reasonably necessary. For example, regulations of churches that were inconsistent with the regulation of similar organizations were struck down.¹⁴

Among the most interesting of the summer 2021 cases was the CDC eviction moratorium that essentially prohibited landlords nationwide from evicting tenants for nonpayment of rent. When the challenges to these CDC regulations first reached the Court, the moratorium was about to expire; in a 5-4 decision, the Court did not enjoin the CDC from continuing that policy. Justice Kavanaugh (the fifth vote) warned that “clear and specific congressional authorization…would be necessary to extend the moratorium past July 31.”¹⁵ Despite telling the Court that the moratorium would expire on July 31, just 3 days after the expiration and without any congressional authorization, the CDC reinstated what was practically the same moratorium.¹⁶ On August 26, the Court struck down the reinstated regulation, probably by a 6-3 margin. (Because this case arose in the “Shadow Docket,” the vote of some justices is not certain).¹⁷

Continue to: The Affordable Care Act...

The Affordable Care Act

The Affordable Care Act was challenged in the Court for the third time.¹⁸ In this term’s case, several states argued that when Congress essentially eliminated the penalty/tax for not purchasing insurance coverage, there was no longer a constitutional basis for the individual mandate. With that centerpiece gone, they claimed, the whole statute should be declared unconstitutional.

Along with many other specialty groups, ACOG joined an amicus curiae brief sponsored by the American Medical Association (AMA).¹⁹ An amicus brief is one not filed by the parties to the case, but by organizations or individuals who have information that may be of use to the Court in considering the case. Among other things, the filing of an amicus brief indicates the interest of the organization in the outcome of the case. In this case, the crux of the amicus was that even if the individual mandate currently is not constitutional, the Court should sever that provision and retain the rest of the ACA.

Despite some wild predictions about what the Court might do, it did not decide any substantive issue. Rather, it found that none of the parties to the case had “standing” to challenge the constitutionality of the ACA. Therefore, in effect, the Court dismissed the case without deciding the substantive legal issues.
 

Pharmacy Benefit Managers

The powerful Pharmacy Benefit Managers (PBMs) are a hidden part of the health care system; however, in recent years there has been increasing regulatory attention paid to them. Some states have begun regulating aspects of PBMs. In this term, the Court considered an Arkansas law that sought to protect local pharmacies from PBM pricing practices.²⁰ The AMA filed an amicus brief in the case which made legal arguments, most of which had been made by the parties to the litigation.²¹

PBMs generally tell pharmacies how much they will reimburse the pharmacy for filling a prescription for a particular drug. In some instances, PBMs will set a reimbursement price that is lower than the wholesale price at which local pharmacies can purchase the drug. The Arkansas law prohibited PBMs in the state from reimbursing pharmacies for less than the wholesale cost the pharmacy paid for the drug.

The claim of the PBMs was that the Arkansas law violated the Employee Retirement Income Security Act (ERISA). In part, this act preempts state law that relates to fringe benefit plans. States have the authority to regulate insurance, but ERISA limits what they can do when the insurance relates to fringe benefits. The Court held that ERISA does not preempt the Arkansas law or similar state laws in other states. Because the state law was not preempted by the state law, the Arkansas regulation was upheld. The fact that this was a unanimous decision (8-0, because Justice Barrett was not on the Court when the case was heard) suggests that states may have leeway in additional regulations of PBMs, and it would not be surprising to see more of that state regulation in the future.

Continue to: Patent uncertainty...

Patent uncertainty

Csaba Truckai invented and patented the NovaSure System ablation device with a “moisture permeable” head. He sold his company and the related patents, which eventually were purchased by Hologic. Over time, Hologic added claims to the original patent. In the meantime, Truckai went on to invent another device, the Minerva Endometrial Ablation System (MEAS), which had a “moisture impermeable” head. (Note that the “Minerva Surgical, Inc.” involved in this case is not related to the company “Minerva Industries,” which some identified as a “patent troll.”)²²

Hologic sued Minerva, claiming that Truckai’s second device (MEAS) infringed on its patent for the first device (NovaSure). Truckai’s defense was that the patent on NovaSure was invalid. Hologic felt that since Truckai had obtained that patent and then sold it, it was improper for him now to claim it was invalid. There is a doctrine for that: assignor estoppel—the person who sold (assigned) the patent is prevented from later claiming it was invalid. The question in this case was whether assignor estoppel is part of the patent law of the United States. It is not in the patent statutes, so it is a court-determined part of the law.

In a 5-4 decision this Term, the Court held that assignor estoppel is recognized, but that it is narrow.²³ The Court identified several exceptions to assignor estoppel, notably for this case, including the situation in which the purchaser of the patent, after the purchase, returns to the Patent and Trademark Office to expand (amend) the patent’s claims. In that case, the seller could not be estopped by the amended terms of the patent. Minerva claimed that it was attacking the expanded patent that included changes made after it sold the patent. The Court, therefore, returned the case to the Federal Circuit to apply the principles it laid out about assignor estoppel.

Biotech and other fast-moving fields frequently have new technology building on slightly earlier technology. The current patent system often leaves uncertainty about who owns which part of a valid patent. This uncertainty is a drag on innovation, and the patent system is supposed to spur innovation. Assignor estoppel is likely to create additional complexity and uncertainty in some patents, which is regrettable.
 

Review of the Term

In addition to the other disruptions of the Term, during the first part of the Term, Amy Coney Barrett was not yet confirmed by the Senate, so there were only 8 justices until October 27. She did not participate in those cases that were heard before she joined the Court. The consensus is that the Court heard 67 cases: 57 were formally briefed and argued along with 8 summary reversals and 2 religious cases in the Shadow Docket. In my opinion, this undercounts both the number and the importance of the Shadow Docket cases, but the following data use the 67 case convention.²⁴

The Court was unanimous in 43% of the cases, including some of the most divisive issues. That unanimity reflects very narrow decisions. There were (by conventional count) only eight 5-4 opinions (12%), an unusually low number. Justice Kavanaugh is viewed as the “median” justice. He was in the majority in 97% of all cases. Chief Justice Roberts and Justice Barrett were in the majority 91%, and Justice Gorsuch 90%. As for the other justices, they were in the majority (all cases) most of the time: Justice Alito, 83%; Justice Thomas, 81%; Justice Breyer, 76%; Justice Kagan, 75%; and Justice Sotomayor, 69%. In “divided cases” (when unanimous cases are removed), the percentages are: Justice Kavanaugh, 95%; Chief Justice Roberts and Justice Barrett, 84%; Justice Gorsuch, 82%; Justice Alito, 70%; Justice Thomas, 66%; Justice Breyer, 58%; Justice Kagan, 55%; and Justice Sotomayor, 45%.

When the term began, many Court watchers expected a relatively uninteresting term, dealing with many technical legal details. In fact, it turned out to be more interesting and important than expected, even with narrow holdings in important cases. Part of the secret of the term was that a lot of the real action was in the Shadow Docket. The end of the term is sometimes the moment when a justice announces a plan to retire. Many commentators expected Justice Breyer might announce—he has been under pressure to do so, to allow President Biden to nominate and a Democratic Senate to confirm a progressive justice. However, he did not do so. It is possible that he will announce his retirement to be effective when his successor is confirmed, but that is pure speculation.
 

Continue to: Next Term...

Next Term

The next term began on Monday, October 4, 2021. With the considerable current activity in the Shadow Docket, there was not much of a summer break. The coming term looks extraordinary. The headline case is an abortion case from Mississippi, Dobbs v Jackson Women’s Health Organization.²⁵ The legal question is the constitutionality of Mississippi law that prohibits most abortions after 15 weeks of gestation. The Texas abortion law will also be back before the Court. As we saw this term, big cases may produce very narrow results, but this case has the potential for being a notable abortion decision.

In a different case the Court will decide whether a state attorney general can step in to defend an abortion law when the state health secretary does not do so.²⁶

The Court also has accepted 3 cases dealing with reimbursement for health services. One deals with whether or not the Department of Health and Human Services can set reimbursement rates without good survey data regarding costs,²⁷ another involves the calculation of additional payments for hospitals that serve a “disproportionate number of low-income patients,”²⁸ and the third whether state Medicaid programs can take funds from an injured beneficiary’s tort recovery to cover future Medicaid costs.²⁹

In other cases, the Court will review a gun control law from New York. The Court’s earlier Second Amendment cases involved guns in the home used for self-defense, but this case raises the question of whether a state can practically preclude “concealed-carry licenses.”³⁰ Many experts believe the Court will accept a case dealing with racial preferences in college admissions, perhaps the Harvard case in which the claim is discrimination against Asian Americans.³¹

The ACOG mifepristone case was interesting, in part because the federal district court issued a nationwide injunction against the Americans with Disabilities Act, enforcing its rules anywhere in the country. The effect of these orders is for a single district judge to create the “law of the land,” at least until that is reviewed—which can take months. The advantage of the nationwide injunction is that it avoids having to repeatedly litigate the same issues in multiple courts around the country. The downside is that plaintiffs can seek out a nonrepresentative judge or circuit and receive an injunction that would be granted by few other circuits. In addition, a nationwide injunction can apply to specific circumstances that are not before the court issuing the injunction. In the mifepristone case, for example, 10 states requested to intervene in the ACOG case. The court rejected the request, but the nationwide injunction applied to those states.¹

Although federal judges have had the authority to issue nationwide injunctions for years, they are becoming much more common. One reason is the ease of forum shopping noted earlier—organizations can cherry-pick district courts and circuits sympathetic to their views. Both left- and right-leaning organizations have learned this lesson, so left-leaning groups are likely to file in specific districts in the Ninth Circuit, and right-leaning groups to districts in the Fifth Circuit.

If the current trend of increasing nationwide injunctions continues, either the rules for the federal courts or congressional action may be required to reduce some of the abuses by both sides of the political spectrum.

The Supreme Court’s usual processes were disrupted this term. The COVID-19 pandemic required audio hearings rather than in-person, and it resulted in a number of emergency legal appeals. As the Court began its regular sessions on October 5, 2020, there were only 8 justices—Justice Ruth Bader Ginsburg had passed away and Amy Coney Barrett had not yet been confirmed by the Senate. The Court decided many important cases this term, including dealing with the delivery of drugs to induce abortions, a Centers for Disease Control and Prevention (CDC) moratorium on housing evictions, yet another case on the Affordable Care Act, state laws concerning pharmacy benefit managers, and the Hologic and Minerva endometrial ablation systems patents. After considering these cases, we also will briefly look at other cases of general interest.

Abortion

Patient access to mifepristone

In May 2020, the American College of Obstetricians and Gynecologists (ACOG) was the named plaintiff in a lawsuit against the US Food and Drug Administration (FDA) regarding the drugs mifepristone and misoprostol that are used to induce medical abortions.¹ The case was filed by the American Civil Liberties Union on behalf of ACOG and others^2,3 and raised the issue of patients’ access to these medications. The basic claim of the case was that during the pandemic, the FDA’s regulation of mifepristone was unconstitutional in that they imposed an undue burden on the decision of women to have an abortion.⁴ (Although misoprostol is a part of the medical abortion regimen, it is not subject to special regulation and was not part of the litigation.)

The FDA regulation of mifepristone, begun in 2000 but modified since then, includes 3 elements to assure safe use:

• prescribers must have special training or certification
• the drug can be dispensed to patients only in a hospital, clinic, or medical office under the supervision of a certified health care provider (known as the “in-person dispensing requirement” because retail pharmacy or mail distribution are prohibited)
• the health care provider must review a “patient agreement form” with the patient and have the patient sign the consent form in the provider’s presence.⁵

The pandemic made fulfilling these requirements substantially more burdensome and difficult. The question was whether the FDA was constitutionally required to modify its regulations during a pandemic to take account of the undue burden of the regulation created by the pandemic. That is, the question was not whether the FDA could have or should have chosen to make the modification, but whether it was required to do so.

In July 2020, a federal district court in Maryland held that the FDA regulation was an unconstitutional burden on the abortion rights of women during the pandemic and issued a preliminary injunction to stop the FDA from enforcing the in-person dispensing and signature rules. The district judge applied the injunction to Maryland, but also made it a nationwide injunction. (The issue of district court nationwide injunctions is considered in, “District court ‘nationwide injunctions’”). 

The FDA asked the Fourth Circuit Court of Appeals to stay the enforcement of the injunction, which the appeals court denied. The FDA then appealed to the Supreme Court, asking it to stay the injunction. In October 2020, the Court announced that it was holding the FDA’s request “in abeyance” to allow the district court to consider a motion by the FDA to dissolve or change the injunction. It gave the district court 40 days in which to act. That decision by the Court was in the “Shadow Docket” (see sidebar on page XX), so the exact vote of the Court in October is not clear, but 2 Justices (Alito and Thomas) dissented and would have stayed the injunction.⁶ Over the next 40 days, the district court did not withdraw its nationwide injunction.

Thus, on January 12, 2021, the case was again before the Supreme Court, which let the FDA’s regulations regarding mifepristone remain in place by lifting the district court’s injunction. Most of the justices supporting the stay did not write to explain their decision, although their dissent in the earlier cases may have served that purpose. (Maryland was permitting many kinds of activity that were more risky than visiting a clinic—indoor dining, with open hair salons, gyms, and casinos.)⁷ Chief Justice Roberts wrote a concurrence to indicate that, in his view, the issue was not whether the FDA’s regulations placed an undue burden on a right to an abortion generally, but that “My view is that courts owe significant deference” to the public health authorities (here meaning the FDA). Justices Sotomayor and Kagan dissented, saying that the issue was the undue burden on women, given the difficulties of the pandemic, particularly going to medical facilities during the COVID-19 pandemic.⁸

The injunction, sought by ACOG and others, was issued by the district court and was in effect for several months before it was dissolved by the Supreme Court. Following the change in presidential administrations, in April 2021 the FDA announced that it was going to “exercise enforcement discretion with respect to the in-person dispensing requirement…during the COVID-19 public health emergency.”⁹

Continue to: The Texas abortion case...

The Texas abortion case

The Court, on September 1, 2021, declined to block a Texas abortion statute from taking effect.¹⁰ This law precludes abortions after a fetal heartbeat is present at about 6 weeks of gestation. The Fifth Circuit declined to grant an injunction delaying implementation of the Texas law, and the Court did not reverse that decision.

Over the years, a variety of states have placed limitations on abortion, and those almost always have been enjoined by federal courts before they went into effect. However, the Texas statute, which undoubtedly is unconstitutional, was creatively constructed to avoid an early injunction.¹¹ The statute does not allow state officials to enforce the new law, but rather it allows almost any private citizen to seek monetary damages from anyone performing an abortion or who “aids and abets” an abortion. Thus, it is difficult to tailor a lawsuit before this law is enforced. First, courts do not enjoin laws; they usually enjoin individuals from enforcing the law, and in this case it is difficult to know which individuals will be enforcing the laws and what their decisions might be. There also are some questions about the degree to which federal courts can enjoin state courts from deciding lawsuits under state law. For these procedural reasons, the majority of the Court found that those attacking the Texas law had not met their burden of showing that that they would win their case.

Even 3 of the dissenting justices said the defendants may be right that “existing doctrines preclude judicial intervention,” but that the consequences are such that the Court should delay the law until there is time for briefing and argument. The other 3 dissenting justices thought there would be ways of getting around the clever roadblock Texas had erected for the federal courts.

There has been some commentary that this case portends the abandonment of Roe v Wade and Casey,¹² but that conclusion does not seem warranted by this case. The Court has accepted a Mississippi abortion law to be heard next term.¹³ In addition, the Texas statute is likely to be back in federal court once a private individual has filed a claim for money from an abortion provider (and likely even before that).

COVID-19 cases

The Supreme Court decided several cases related to COVID-19, including adjustments to election procedures, church services, and CDC eviction moratoria. As a general matter early in the pandemic, the Court deferred to government authorities, generally upholding government actions. Chief Justice Roberts emphasized the importance of the Court deferring to government officials in emergencies. As the pandemic progressed into 2021, however, the Court became less and less sympathetic to government actions that were not consistent, permitted by existing law, or reasonably necessary. For example, regulations of churches that were inconsistent with the regulation of similar organizations were struck down.¹⁴

Among the most interesting of the summer 2021 cases was the CDC eviction moratorium that essentially prohibited landlords nationwide from evicting tenants for nonpayment of rent. When the challenges to these CDC regulations first reached the Court, the moratorium was about to expire; in a 5-4 decision, the Court did not enjoin the CDC from continuing that policy. Justice Kavanaugh (the fifth vote) warned that “clear and specific congressional authorization…would be necessary to extend the moratorium past July 31.”¹⁵ Despite telling the Court that the moratorium would expire on July 31, just 3 days after the expiration and without any congressional authorization, the CDC reinstated what was practically the same moratorium.¹⁶ On August 26, the Court struck down the reinstated regulation, probably by a 6-3 margin. (Because this case arose in the “Shadow Docket,” the vote of some justices is not certain).¹⁷

Continue to: The Affordable Care Act...

The Affordable Care Act

The Affordable Care Act was challenged in the Court for the third time.¹⁸ In this term’s case, several states argued that when Congress essentially eliminated the penalty/tax for not purchasing insurance coverage, there was no longer a constitutional basis for the individual mandate. With that centerpiece gone, they claimed, the whole statute should be declared unconstitutional.

Along with many other specialty groups, ACOG joined an amicus curiae brief sponsored by the American Medical Association (AMA).¹⁹ An amicus brief is one not filed by the parties to the case, but by organizations or individuals who have information that may be of use to the Court in considering the case. Among other things, the filing of an amicus brief indicates the interest of the organization in the outcome of the case. In this case, the crux of the amicus was that even if the individual mandate currently is not constitutional, the Court should sever that provision and retain the rest of the ACA.

Despite some wild predictions about what the Court might do, it did not decide any substantive issue. Rather, it found that none of the parties to the case had “standing” to challenge the constitutionality of the ACA. Therefore, in effect, the Court dismissed the case without deciding the substantive legal issues.
 

Pharmacy Benefit Managers

The powerful Pharmacy Benefit Managers (PBMs) are a hidden part of the health care system; however, in recent years there has been increasing regulatory attention paid to them. Some states have begun regulating aspects of PBMs. In this term, the Court considered an Arkansas law that sought to protect local pharmacies from PBM pricing practices.²⁰ The AMA filed an amicus brief in the case which made legal arguments, most of which had been made by the parties to the litigation.²¹

PBMs generally tell pharmacies how much they will reimburse the pharmacy for filling a prescription for a particular drug. In some instances, PBMs will set a reimbursement price that is lower than the wholesale price at which local pharmacies can purchase the drug. The Arkansas law prohibited PBMs in the state from reimbursing pharmacies for less than the wholesale cost the pharmacy paid for the drug.

The claim of the PBMs was that the Arkansas law violated the Employee Retirement Income Security Act (ERISA). In part, this act preempts state law that relates to fringe benefit plans. States have the authority to regulate insurance, but ERISA limits what they can do when the insurance relates to fringe benefits. The Court held that ERISA does not preempt the Arkansas law or similar state laws in other states. Because the state law was not preempted by the state law, the Arkansas regulation was upheld. The fact that this was a unanimous decision (8-0, because Justice Barrett was not on the Court when the case was heard) suggests that states may have leeway in additional regulations of PBMs, and it would not be surprising to see more of that state regulation in the future.

Continue to: Patent uncertainty...

Patent uncertainty

Csaba Truckai invented and patented the NovaSure System ablation device with a “moisture permeable” head. He sold his company and the related patents, which eventually were purchased by Hologic. Over time, Hologic added claims to the original patent. In the meantime, Truckai went on to invent another device, the Minerva Endometrial Ablation System (MEAS), which had a “moisture impermeable” head. (Note that the “Minerva Surgical, Inc.” involved in this case is not related to the company “Minerva Industries,” which some identified as a “patent troll.”)²²

Hologic sued Minerva, claiming that Truckai’s second device (MEAS) infringed on its patent for the first device (NovaSure). Truckai’s defense was that the patent on NovaSure was invalid. Hologic felt that since Truckai had obtained that patent and then sold it, it was improper for him now to claim it was invalid. There is a doctrine for that: assignor estoppel—the person who sold (assigned) the patent is prevented from later claiming it was invalid. The question in this case was whether assignor estoppel is part of the patent law of the United States. It is not in the patent statutes, so it is a court-determined part of the law.

In a 5-4 decision this Term, the Court held that assignor estoppel is recognized, but that it is narrow.²³ The Court identified several exceptions to assignor estoppel, notably for this case, including the situation in which the purchaser of the patent, after the purchase, returns to the Patent and Trademark Office to expand (amend) the patent’s claims. In that case, the seller could not be estopped by the amended terms of the patent. Minerva claimed that it was attacking the expanded patent that included changes made after it sold the patent. The Court, therefore, returned the case to the Federal Circuit to apply the principles it laid out about assignor estoppel.

Biotech and other fast-moving fields frequently have new technology building on slightly earlier technology. The current patent system often leaves uncertainty about who owns which part of a valid patent. This uncertainty is a drag on innovation, and the patent system is supposed to spur innovation. Assignor estoppel is likely to create additional complexity and uncertainty in some patents, which is regrettable.
 

Review of the Term

In addition to the other disruptions of the Term, during the first part of the Term, Amy Coney Barrett was not yet confirmed by the Senate, so there were only 8 justices until October 27. She did not participate in those cases that were heard before she joined the Court. The consensus is that the Court heard 67 cases: 57 were formally briefed and argued along with 8 summary reversals and 2 religious cases in the Shadow Docket. In my opinion, this undercounts both the number and the importance of the Shadow Docket cases, but the following data use the 67 case convention.²⁴

The Court was unanimous in 43% of the cases, including some of the most divisive issues. That unanimity reflects very narrow decisions. There were (by conventional count) only eight 5-4 opinions (12%), an unusually low number. Justice Kavanaugh is viewed as the “median” justice. He was in the majority in 97% of all cases. Chief Justice Roberts and Justice Barrett were in the majority 91%, and Justice Gorsuch 90%. As for the other justices, they were in the majority (all cases) most of the time: Justice Alito, 83%; Justice Thomas, 81%; Justice Breyer, 76%; Justice Kagan, 75%; and Justice Sotomayor, 69%. In “divided cases” (when unanimous cases are removed), the percentages are: Justice Kavanaugh, 95%; Chief Justice Roberts and Justice Barrett, 84%; Justice Gorsuch, 82%; Justice Alito, 70%; Justice Thomas, 66%; Justice Breyer, 58%; Justice Kagan, 55%; and Justice Sotomayor, 45%.

When the term began, many Court watchers expected a relatively uninteresting term, dealing with many technical legal details. In fact, it turned out to be more interesting and important than expected, even with narrow holdings in important cases. Part of the secret of the term was that a lot of the real action was in the Shadow Docket. The end of the term is sometimes the moment when a justice announces a plan to retire. Many commentators expected Justice Breyer might announce—he has been under pressure to do so, to allow President Biden to nominate and a Democratic Senate to confirm a progressive justice. However, he did not do so. It is possible that he will announce his retirement to be effective when his successor is confirmed, but that is pure speculation.
 

Continue to: Next Term...

Next Term

The next term began on Monday, October 4, 2021. With the considerable current activity in the Shadow Docket, there was not much of a summer break. The coming term looks extraordinary. The headline case is an abortion case from Mississippi, Dobbs v Jackson Women’s Health Organization.²⁵ The legal question is the constitutionality of Mississippi law that prohibits most abortions after 15 weeks of gestation. The Texas abortion law will also be back before the Court. As we saw this term, big cases may produce very narrow results, but this case has the potential for being a notable abortion decision.

In a different case the Court will decide whether a state attorney general can step in to defend an abortion law when the state health secretary does not do so.²⁶

The Court also has accepted 3 cases dealing with reimbursement for health services. One deals with whether or not the Department of Health and Human Services can set reimbursement rates without good survey data regarding costs,²⁷ another involves the calculation of additional payments for hospitals that serve a “disproportionate number of low-income patients,”²⁸ and the third whether state Medicaid programs can take funds from an injured beneficiary’s tort recovery to cover future Medicaid costs.²⁹

In other cases, the Court will review a gun control law from New York. The Court’s earlier Second Amendment cases involved guns in the home used for self-defense, but this case raises the question of whether a state can practically preclude “concealed-carry licenses.”³⁰ Many experts believe the Court will accept a case dealing with racial preferences in college admissions, perhaps the Harvard case in which the claim is discrimination against Asian Americans.³¹

The ACOG mifepristone case was interesting, in part because the federal district court issued a nationwide injunction against the Americans with Disabilities Act, enforcing its rules anywhere in the country. The effect of these orders is for a single district judge to create the “law of the land,” at least until that is reviewed—which can take months. The advantage of the nationwide injunction is that it avoids having to repeatedly litigate the same issues in multiple courts around the country. The downside is that plaintiffs can seek out a nonrepresentative judge or circuit and receive an injunction that would be granted by few other circuits. In addition, a nationwide injunction can apply to specific circumstances that are not before the court issuing the injunction. In the mifepristone case, for example, 10 states requested to intervene in the ACOG case. The court rejected the request, but the nationwide injunction applied to those states.¹

Although federal judges have had the authority to issue nationwide injunctions for years, they are becoming much more common. One reason is the ease of forum shopping noted earlier—organizations can cherry-pick district courts and circuits sympathetic to their views. Both left- and right-leaning organizations have learned this lesson, so left-leaning groups are likely to file in specific districts in the Ninth Circuit, and right-leaning groups to districts in the Fifth Circuit.

If the current trend of increasing nationwide injunctions continues, either the rules for the federal courts or congressional action may be required to reduce some of the abuses by both sides of the political spectrum.

The Supreme Court’s usual processes were disrupted this term. The COVID-19 pandemic required audio hearings rather than in-person, and it resulted in a number of emergency legal appeals. As the Court began its regular sessions on October 5, 2020, there were only 8 justices—Justice Ruth Bader Ginsburg had passed away and Amy Coney Barrett had not yet been confirmed by the Senate. The Court decided many important cases this term, including dealing with the delivery of drugs to induce abortions, a Centers for Disease Control and Prevention (CDC) moratorium on housing evictions, yet another case on the Affordable Care Act, state laws concerning pharmacy benefit managers, and the Hologic and Minerva endometrial ablation systems patents. After considering these cases, we also will briefly look at other cases of general interest.

Abortion

Patient access to mifepristone

In May 2020, the American College of Obstetricians and Gynecologists (ACOG) was the named plaintiff in a lawsuit against the US Food and Drug Administration (FDA) regarding the drugs mifepristone and misoprostol that are used to induce medical abortions.¹ The case was filed by the American Civil Liberties Union on behalf of ACOG and others^2,3 and raised the issue of patients’ access to these medications. The basic claim of the case was that during the pandemic, the FDA’s regulation of mifepristone was unconstitutional in that they imposed an undue burden on the decision of women to have an abortion.⁴ (Although misoprostol is a part of the medical abortion regimen, it is not subject to special regulation and was not part of the litigation.)

The FDA regulation of mifepristone, begun in 2000 but modified since then, includes 3 elements to assure safe use:

• prescribers must have special training or certification
• the drug can be dispensed to patients only in a hospital, clinic, or medical office under the supervision of a certified health care provider (known as the “in-person dispensing requirement” because retail pharmacy or mail distribution are prohibited)
• the health care provider must review a “patient agreement form” with the patient and have the patient sign the consent form in the provider’s presence.⁵

The pandemic made fulfilling these requirements substantially more burdensome and difficult. The question was whether the FDA was constitutionally required to modify its regulations during a pandemic to take account of the undue burden of the regulation created by the pandemic. That is, the question was not whether the FDA could have or should have chosen to make the modification, but whether it was required to do so.

In July 2020, a federal district court in Maryland held that the FDA regulation was an unconstitutional burden on the abortion rights of women during the pandemic and issued a preliminary injunction to stop the FDA from enforcing the in-person dispensing and signature rules. The district judge applied the injunction to Maryland, but also made it a nationwide injunction. (The issue of district court nationwide injunctions is considered in, “District court ‘nationwide injunctions’”). 

The FDA asked the Fourth Circuit Court of Appeals to stay the enforcement of the injunction, which the appeals court denied. The FDA then appealed to the Supreme Court, asking it to stay the injunction. In October 2020, the Court announced that it was holding the FDA’s request “in abeyance” to allow the district court to consider a motion by the FDA to dissolve or change the injunction. It gave the district court 40 days in which to act. That decision by the Court was in the “Shadow Docket” (see sidebar on page XX), so the exact vote of the Court in October is not clear, but 2 Justices (Alito and Thomas) dissented and would have stayed the injunction.⁶ Over the next 40 days, the district court did not withdraw its nationwide injunction.

Thus, on January 12, 2021, the case was again before the Supreme Court, which let the FDA’s regulations regarding mifepristone remain in place by lifting the district court’s injunction. Most of the justices supporting the stay did not write to explain their decision, although their dissent in the earlier cases may have served that purpose. (Maryland was permitting many kinds of activity that were more risky than visiting a clinic—indoor dining, with open hair salons, gyms, and casinos.)⁷ Chief Justice Roberts wrote a concurrence to indicate that, in his view, the issue was not whether the FDA’s regulations placed an undue burden on a right to an abortion generally, but that “My view is that courts owe significant deference” to the public health authorities (here meaning the FDA). Justices Sotomayor and Kagan dissented, saying that the issue was the undue burden on women, given the difficulties of the pandemic, particularly going to medical facilities during the COVID-19 pandemic.⁸

The injunction, sought by ACOG and others, was issued by the district court and was in effect for several months before it was dissolved by the Supreme Court. Following the change in presidential administrations, in April 2021 the FDA announced that it was going to “exercise enforcement discretion with respect to the in-person dispensing requirement…during the COVID-19 public health emergency.”⁹

Continue to: The Texas abortion case...

The Texas abortion case

The Court, on September 1, 2021, declined to block a Texas abortion statute from taking effect.¹⁰ This law precludes abortions after a fetal heartbeat is present at about 6 weeks of gestation. The Fifth Circuit declined to grant an injunction delaying implementation of the Texas law, and the Court did not reverse that decision.

Over the years, a variety of states have placed limitations on abortion, and those almost always have been enjoined by federal courts before they went into effect. However, the Texas statute, which undoubtedly is unconstitutional, was creatively constructed to avoid an early injunction.¹¹ The statute does not allow state officials to enforce the new law, but rather it allows almost any private citizen to seek monetary damages from anyone performing an abortion or who “aids and abets” an abortion. Thus, it is difficult to tailor a lawsuit before this law is enforced. First, courts do not enjoin laws; they usually enjoin individuals from enforcing the law, and in this case it is difficult to know which individuals will be enforcing the laws and what their decisions might be. There also are some questions about the degree to which federal courts can enjoin state courts from deciding lawsuits under state law. For these procedural reasons, the majority of the Court found that those attacking the Texas law had not met their burden of showing that that they would win their case.

Even 3 of the dissenting justices said the defendants may be right that “existing doctrines preclude judicial intervention,” but that the consequences are such that the Court should delay the law until there is time for briefing and argument. The other 3 dissenting justices thought there would be ways of getting around the clever roadblock Texas had erected for the federal courts.

There has been some commentary that this case portends the abandonment of Roe v Wade and Casey,¹² but that conclusion does not seem warranted by this case. The Court has accepted a Mississippi abortion law to be heard next term.¹³ In addition, the Texas statute is likely to be back in federal court once a private individual has filed a claim for money from an abortion provider (and likely even before that).

COVID-19 cases

The Supreme Court decided several cases related to COVID-19, including adjustments to election procedures, church services, and CDC eviction moratoria. As a general matter early in the pandemic, the Court deferred to government authorities, generally upholding government actions. Chief Justice Roberts emphasized the importance of the Court deferring to government officials in emergencies. As the pandemic progressed into 2021, however, the Court became less and less sympathetic to government actions that were not consistent, permitted by existing law, or reasonably necessary. For example, regulations of churches that were inconsistent with the regulation of similar organizations were struck down.¹⁴

Among the most interesting of the summer 2021 cases was the CDC eviction moratorium that essentially prohibited landlords nationwide from evicting tenants for nonpayment of rent. When the challenges to these CDC regulations first reached the Court, the moratorium was about to expire; in a 5-4 decision, the Court did not enjoin the CDC from continuing that policy. Justice Kavanaugh (the fifth vote) warned that “clear and specific congressional authorization…would be necessary to extend the moratorium past July 31.”¹⁵ Despite telling the Court that the moratorium would expire on July 31, just 3 days after the expiration and without any congressional authorization, the CDC reinstated what was practically the same moratorium.¹⁶ On August 26, the Court struck down the reinstated regulation, probably by a 6-3 margin. (Because this case arose in the “Shadow Docket,” the vote of some justices is not certain).¹⁷

Continue to: The Affordable Care Act...

The Affordable Care Act

The Affordable Care Act was challenged in the Court for the third time.¹⁸ In this term’s case, several states argued that when Congress essentially eliminated the penalty/tax for not purchasing insurance coverage, there was no longer a constitutional basis for the individual mandate. With that centerpiece gone, they claimed, the whole statute should be declared unconstitutional.

Along with many other specialty groups, ACOG joined an amicus curiae brief sponsored by the American Medical Association (AMA).¹⁹ An amicus brief is one not filed by the parties to the case, but by organizations or individuals who have information that may be of use to the Court in considering the case. Among other things, the filing of an amicus brief indicates the interest of the organization in the outcome of the case. In this case, the crux of the amicus was that even if the individual mandate currently is not constitutional, the Court should sever that provision and retain the rest of the ACA.

Despite some wild predictions about what the Court might do, it did not decide any substantive issue. Rather, it found that none of the parties to the case had “standing” to challenge the constitutionality of the ACA. Therefore, in effect, the Court dismissed the case without deciding the substantive legal issues.
 

Pharmacy Benefit Managers

The powerful Pharmacy Benefit Managers (PBMs) are a hidden part of the health care system; however, in recent years there has been increasing regulatory attention paid to them. Some states have begun regulating aspects of PBMs. In this term, the Court considered an Arkansas law that sought to protect local pharmacies from PBM pricing practices.²⁰ The AMA filed an amicus brief in the case which made legal arguments, most of which had been made by the parties to the litigation.²¹

PBMs generally tell pharmacies how much they will reimburse the pharmacy for filling a prescription for a particular drug. In some instances, PBMs will set a reimbursement price that is lower than the wholesale price at which local pharmacies can purchase the drug. The Arkansas law prohibited PBMs in the state from reimbursing pharmacies for less than the wholesale cost the pharmacy paid for the drug.

The claim of the PBMs was that the Arkansas law violated the Employee Retirement Income Security Act (ERISA). In part, this act preempts state law that relates to fringe benefit plans. States have the authority to regulate insurance, but ERISA limits what they can do when the insurance relates to fringe benefits. The Court held that ERISA does not preempt the Arkansas law or similar state laws in other states. Because the state law was not preempted by the state law, the Arkansas regulation was upheld. The fact that this was a unanimous decision (8-0, because Justice Barrett was not on the Court when the case was heard) suggests that states may have leeway in additional regulations of PBMs, and it would not be surprising to see more of that state regulation in the future.

Continue to: Patent uncertainty...

Patent uncertainty

Csaba Truckai invented and patented the NovaSure System ablation device with a “moisture permeable” head. He sold his company and the related patents, which eventually were purchased by Hologic. Over time, Hologic added claims to the original patent. In the meantime, Truckai went on to invent another device, the Minerva Endometrial Ablation System (MEAS), which had a “moisture impermeable” head. (Note that the “Minerva Surgical, Inc.” involved in this case is not related to the company “Minerva Industries,” which some identified as a “patent troll.”)²²

Hologic sued Minerva, claiming that Truckai’s second device (MEAS) infringed on its patent for the first device (NovaSure). Truckai’s defense was that the patent on NovaSure was invalid. Hologic felt that since Truckai had obtained that patent and then sold it, it was improper for him now to claim it was invalid. There is a doctrine for that: assignor estoppel—the person who sold (assigned) the patent is prevented from later claiming it was invalid. The question in this case was whether assignor estoppel is part of the patent law of the United States. It is not in the patent statutes, so it is a court-determined part of the law.

In a 5-4 decision this Term, the Court held that assignor estoppel is recognized, but that it is narrow.²³ The Court identified several exceptions to assignor estoppel, notably for this case, including the situation in which the purchaser of the patent, after the purchase, returns to the Patent and Trademark Office to expand (amend) the patent’s claims. In that case, the seller could not be estopped by the amended terms of the patent. Minerva claimed that it was attacking the expanded patent that included changes made after it sold the patent. The Court, therefore, returned the case to the Federal Circuit to apply the principles it laid out about assignor estoppel.

Biotech and other fast-moving fields frequently have new technology building on slightly earlier technology. The current patent system often leaves uncertainty about who owns which part of a valid patent. This uncertainty is a drag on innovation, and the patent system is supposed to spur innovation. Assignor estoppel is likely to create additional complexity and uncertainty in some patents, which is regrettable.
 

Review of the Term

In addition to the other disruptions of the Term, during the first part of the Term, Amy Coney Barrett was not yet confirmed by the Senate, so there were only 8 justices until October 27. She did not participate in those cases that were heard before she joined the Court. The consensus is that the Court heard 67 cases: 57 were formally briefed and argued along with 8 summary reversals and 2 religious cases in the Shadow Docket. In my opinion, this undercounts both the number and the importance of the Shadow Docket cases, but the following data use the 67 case convention.²⁴

The Court was unanimous in 43% of the cases, including some of the most divisive issues. That unanimity reflects very narrow decisions. There were (by conventional count) only eight 5-4 opinions (12%), an unusually low number. Justice Kavanaugh is viewed as the “median” justice. He was in the majority in 97% of all cases. Chief Justice Roberts and Justice Barrett were in the majority 91%, and Justice Gorsuch 90%. As for the other justices, they were in the majority (all cases) most of the time: Justice Alito, 83%; Justice Thomas, 81%; Justice Breyer, 76%; Justice Kagan, 75%; and Justice Sotomayor, 69%. In “divided cases” (when unanimous cases are removed), the percentages are: Justice Kavanaugh, 95%; Chief Justice Roberts and Justice Barrett, 84%; Justice Gorsuch, 82%; Justice Alito, 70%; Justice Thomas, 66%; Justice Breyer, 58%; Justice Kagan, 55%; and Justice Sotomayor, 45%.

When the term began, many Court watchers expected a relatively uninteresting term, dealing with many technical legal details. In fact, it turned out to be more interesting and important than expected, even with narrow holdings in important cases. Part of the secret of the term was that a lot of the real action was in the Shadow Docket. The end of the term is sometimes the moment when a justice announces a plan to retire. Many commentators expected Justice Breyer might announce—he has been under pressure to do so, to allow President Biden to nominate and a Democratic Senate to confirm a progressive justice. However, he did not do so. It is possible that he will announce his retirement to be effective when his successor is confirmed, but that is pure speculation.
 

Continue to: Next Term...

Next Term

The next term began on Monday, October 4, 2021. With the considerable current activity in the Shadow Docket, there was not much of a summer break. The coming term looks extraordinary. The headline case is an abortion case from Mississippi, Dobbs v Jackson Women’s Health Organization.²⁵ The legal question is the constitutionality of Mississippi law that prohibits most abortions after 15 weeks of gestation. The Texas abortion law will also be back before the Court. As we saw this term, big cases may produce very narrow results, but this case has the potential for being a notable abortion decision.

In a different case the Court will decide whether a state attorney general can step in to defend an abortion law when the state health secretary does not do so.²⁶

The Court also has accepted 3 cases dealing with reimbursement for health services. One deals with whether or not the Department of Health and Human Services can set reimbursement rates without good survey data regarding costs,²⁷ another involves the calculation of additional payments for hospitals that serve a “disproportionate number of low-income patients,”²⁸ and the third whether state Medicaid programs can take funds from an injured beneficiary’s tort recovery to cover future Medicaid costs.²⁹

In other cases, the Court will review a gun control law from New York. The Court’s earlier Second Amendment cases involved guns in the home used for self-defense, but this case raises the question of whether a state can practically preclude “concealed-carry licenses.”³⁰ Many experts believe the Court will accept a case dealing with racial preferences in college admissions, perhaps the Harvard case in which the claim is discrimination against Asian Americans.³¹

The ACOG mifepristone case was interesting, in part because the federal district court issued a nationwide injunction against the Americans with Disabilities Act, enforcing its rules anywhere in the country. The effect of these orders is for a single district judge to create the “law of the land,” at least until that is reviewed—which can take months. The advantage of the nationwide injunction is that it avoids having to repeatedly litigate the same issues in multiple courts around the country. The downside is that plaintiffs can seek out a nonrepresentative judge or circuit and receive an injunction that would be granted by few other circuits. In addition, a nationwide injunction can apply to specific circumstances that are not before the court issuing the injunction. In the mifepristone case, for example, 10 states requested to intervene in the ACOG case. The court rejected the request, but the nationwide injunction applied to those states.¹

Although federal judges have had the authority to issue nationwide injunctions for years, they are becoming much more common. One reason is the ease of forum shopping noted earlier—organizations can cherry-pick district courts and circuits sympathetic to their views. Both left- and right-leaning organizations have learned this lesson, so left-leaning groups are likely to file in specific districts in the Ninth Circuit, and right-leaning groups to districts in the Fifth Circuit.

If the current trend of increasing nationwide injunctions continues, either the rules for the federal courts or congressional action may be required to reduce some of the abuses by both sides of the political spectrum.