Oral Contraception and Medical Liability

Question: Oral contraceptives are prescription drugs sold with highly specific manufacturer instructions on how and when to take them, because the sequence of pill ingestion is critical to their anovulatory efficacy.

Suppose a manufacturing mishap resulted in improper labeling and sequencing of the pills, and some women, relying on the product, became pregnant. In a lawsuit against the manufacturer, which of the following choices is best?

A. This is a case of product liability.

B. Affected plaintiffs should consider filing a class-action lawsuit.

C. Mothers can sue for wrongful pregnancy.

D. Children can sue for wrongful life.

E. All are possible legal causes of action.

Answer: E. This hypothetical is adapted from a recent report that the use of mispackaged oral contraceptives had resulted in more than 100 women becoming pregnant. The prescription drugs, available in blister packs, were erroneously sequenced such that the daily use of active or inactive drug was asynchronous with the woman’s ovulatory cycle, thus foiling the drug’s pregnancy prevention efficacy.

Typically, each packet of oral contraceptives comes with 28 days’ worth of color-coded pills, with the first 21 containing the active principle to inhibit ovulation, followed by 7 inert pills. Each monthly pack begins with the same strict pill sequence.

In 2011, the manufacturer of several brands of oral contraceptives recalled half a million such packs when it was discovered that some of them had the pill sequence reversed. Foreseeably, this debacle resulted in a number of unplanned pregnancies – and live births. Legal action soon followed.

▶ Product liability: A simple negligence lawsuit would typically cover a situation in which a wrongdoer has breached the requisite standard of care, as appears to be the case here. However, when a product such as a prescription drug leads to “harm,” an injured party, using the law of product liability, can sue the manufacturer that had placed it into the stream of commerce. This allows the plaintiff to rely on legal theories other than negligence, including breach of warranty and strict liability.

Under the latter legal theory, there is no need to prove fault or contractual breach, and the significant part of the complaint is whether the product is both defective and unreasonably dangerous. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects, and “unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Although the medication itself in this case is not defective or unreasonably dangerous, the assembly and labeling fiasco would suffice to keep the lawsuit within the product liability category. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

▶ Class action: A class action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.

However, four prerequisites must be present before a lawsuit can be certified a class action: numerosity, commonality, typicality, and adequacy.

Although there is the possibility of going forward with a class action suit, a federal judge in Georgia refused to certify class action status in the 2011 recall case. The judge stated that only 53 of the half-million recalled blister packs had the pills arranged in reverse order, and each woman’s case should be individually adjudicated given the controlling laws in her state, the need to prove use of the product, and whether she became pregnant and carried the pregnancy to term.

▶ Wrongful life: Strictly speaking, tort issues in this case can be divided into two categories: wrongful pregnancy (sometimes confusingly referred to as wrongful birth) alleged by the mother, and wrongful life by the child. Unfortunately, these claims are frequently lumped together under the rubric of wrongful life.

The women affected by this mix-up are reportedly seeking damages for lost income, medical costs, and, in some cases, the cost of raising their children, including the cost of college. However, the common law has traditionally barred a wrongful life action, although state laws have evolved over the years. So, court decisions and statutes in each state should be carefully consulted for any individual case.

The prime reason for disallowing a wrongful life action is that life, even if imperfect, is always preferable to non-life. Besides, it will be impossible to assess the quantum of damages, because this necessarily requires placing a monetary worth on human existence.

The seminal case is the 1967 New Jersey decision of Gleitman v. Cosgrove (227 A.2d 689 [N.J. 1967]), but the state’s position has since changed. In Berman v. Allan (404 A.2d 8 [N.J. 1979]), the court allowed damages for maternal emotional distress, though not for medical and other expenses of raising the child.

Overall, the law of wrongful life appears to be increasingly willing to award damages to the mother for the physical, emotional, and financial costs of pregnancy and delivery, but not the cost associated with the normal rearing of a healthy child.

The legal situation is quite different for a lawsuit filed by the child, who in essence is arguing that he/she should not have been born at all. Courts continue to refuse a claim brought by a healthy infant for wrongful life, adopting the reasoning in Berman that the infant has not suffered any damage cognizable at law by being brought into existence. Even an infant with birth disabilities will not prevail in the majority of jurisdictions, with California being a notable exception.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: Oral contraceptives are prescription drugs sold with highly specific manufacturer instructions on how and when to take them, because the sequence of pill ingestion is critical to their anovulatory efficacy.

Suppose a manufacturing mishap resulted in improper labeling and sequencing of the pills, and some women, relying on the product, became pregnant. In a lawsuit against the manufacturer, which of the following choices is best?

A. This is a case of product liability.

B. Affected plaintiffs should consider filing a class-action lawsuit.

C. Mothers can sue for wrongful pregnancy.

D. Children can sue for wrongful life.

E. All are possible legal causes of action.

Answer: E. This hypothetical is adapted from a recent report that the use of mispackaged oral contraceptives had resulted in more than 100 women becoming pregnant. The prescription drugs, available in blister packs, were erroneously sequenced such that the daily use of active or inactive drug was asynchronous with the woman’s ovulatory cycle, thus foiling the drug’s pregnancy prevention efficacy.

Typically, each packet of oral contraceptives comes with 28 days’ worth of color-coded pills, with the first 21 containing the active principle to inhibit ovulation, followed by 7 inert pills. Each monthly pack begins with the same strict pill sequence.

In 2011, the manufacturer of several brands of oral contraceptives recalled half a million such packs when it was discovered that some of them had the pill sequence reversed. Foreseeably, this debacle resulted in a number of unplanned pregnancies – and live births. Legal action soon followed.

▶ Product liability: A simple negligence lawsuit would typically cover a situation in which a wrongdoer has breached the requisite standard of care, as appears to be the case here. However, when a product such as a prescription drug leads to “harm,” an injured party, using the law of product liability, can sue the manufacturer that had placed it into the stream of commerce. This allows the plaintiff to rely on legal theories other than negligence, including breach of warranty and strict liability.

Under the latter legal theory, there is no need to prove fault or contractual breach, and the significant part of the complaint is whether the product is both defective and unreasonably dangerous. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects, and “unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Although the medication itself in this case is not defective or unreasonably dangerous, the assembly and labeling fiasco would suffice to keep the lawsuit within the product liability category. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

▶ Class action: A class action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.

However, four prerequisites must be present before a lawsuit can be certified a class action: numerosity, commonality, typicality, and adequacy.

Although there is the possibility of going forward with a class action suit, a federal judge in Georgia refused to certify class action status in the 2011 recall case. The judge stated that only 53 of the half-million recalled blister packs had the pills arranged in reverse order, and each woman’s case should be individually adjudicated given the controlling laws in her state, the need to prove use of the product, and whether she became pregnant and carried the pregnancy to term.

▶ Wrongful life: Strictly speaking, tort issues in this case can be divided into two categories: wrongful pregnancy (sometimes confusingly referred to as wrongful birth) alleged by the mother, and wrongful life by the child. Unfortunately, these claims are frequently lumped together under the rubric of wrongful life.

The women affected by this mix-up are reportedly seeking damages for lost income, medical costs, and, in some cases, the cost of raising their children, including the cost of college. However, the common law has traditionally barred a wrongful life action, although state laws have evolved over the years. So, court decisions and statutes in each state should be carefully consulted for any individual case.

The prime reason for disallowing a wrongful life action is that life, even if imperfect, is always preferable to non-life. Besides, it will be impossible to assess the quantum of damages, because this necessarily requires placing a monetary worth on human existence.

The seminal case is the 1967 New Jersey decision of Gleitman v. Cosgrove (227 A.2d 689 [N.J. 1967]), but the state’s position has since changed. In Berman v. Allan (404 A.2d 8 [N.J. 1979]), the court allowed damages for maternal emotional distress, though not for medical and other expenses of raising the child.

Overall, the law of wrongful life appears to be increasingly willing to award damages to the mother for the physical, emotional, and financial costs of pregnancy and delivery, but not the cost associated with the normal rearing of a healthy child.

The legal situation is quite different for a lawsuit filed by the child, who in essence is arguing that he/she should not have been born at all. Courts continue to refuse a claim brought by a healthy infant for wrongful life, adopting the reasoning in Berman that the infant has not suffered any damage cognizable at law by being brought into existence. Even an infant with birth disabilities will not prevail in the majority of jurisdictions, with California being a notable exception.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: Oral contraceptives are prescription drugs sold with highly specific manufacturer instructions on how and when to take them, because the sequence of pill ingestion is critical to their anovulatory efficacy.

Suppose a manufacturing mishap resulted in improper labeling and sequencing of the pills, and some women, relying on the product, became pregnant. In a lawsuit against the manufacturer, which of the following choices is best?

A. This is a case of product liability.

B. Affected plaintiffs should consider filing a class-action lawsuit.

C. Mothers can sue for wrongful pregnancy.

D. Children can sue for wrongful life.

E. All are possible legal causes of action.

Answer: E. This hypothetical is adapted from a recent report that the use of mispackaged oral contraceptives had resulted in more than 100 women becoming pregnant. The prescription drugs, available in blister packs, were erroneously sequenced such that the daily use of active or inactive drug was asynchronous with the woman’s ovulatory cycle, thus foiling the drug’s pregnancy prevention efficacy.

Typically, each packet of oral contraceptives comes with 28 days’ worth of color-coded pills, with the first 21 containing the active principle to inhibit ovulation, followed by 7 inert pills. Each monthly pack begins with the same strict pill sequence.

In 2011, the manufacturer of several brands of oral contraceptives recalled half a million such packs when it was discovered that some of them had the pill sequence reversed. Foreseeably, this debacle resulted in a number of unplanned pregnancies – and live births. Legal action soon followed.

▶ Product liability: A simple negligence lawsuit would typically cover a situation in which a wrongdoer has breached the requisite standard of care, as appears to be the case here. However, when a product such as a prescription drug leads to “harm,” an injured party, using the law of product liability, can sue the manufacturer that had placed it into the stream of commerce. This allows the plaintiff to rely on legal theories other than negligence, including breach of warranty and strict liability.

Under the latter legal theory, there is no need to prove fault or contractual breach, and the significant part of the complaint is whether the product is both defective and unreasonably dangerous. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects, and “unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Although the medication itself in this case is not defective or unreasonably dangerous, the assembly and labeling fiasco would suffice to keep the lawsuit within the product liability category. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

▶ Class action: A class action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.

However, four prerequisites must be present before a lawsuit can be certified a class action: numerosity, commonality, typicality, and adequacy.

Although there is the possibility of going forward with a class action suit, a federal judge in Georgia refused to certify class action status in the 2011 recall case. The judge stated that only 53 of the half-million recalled blister packs had the pills arranged in reverse order, and each woman’s case should be individually adjudicated given the controlling laws in her state, the need to prove use of the product, and whether she became pregnant and carried the pregnancy to term.

▶ Wrongful life: Strictly speaking, tort issues in this case can be divided into two categories: wrongful pregnancy (sometimes confusingly referred to as wrongful birth) alleged by the mother, and wrongful life by the child. Unfortunately, these claims are frequently lumped together under the rubric of wrongful life.

The women affected by this mix-up are reportedly seeking damages for lost income, medical costs, and, in some cases, the cost of raising their children, including the cost of college. However, the common law has traditionally barred a wrongful life action, although state laws have evolved over the years. So, court decisions and statutes in each state should be carefully consulted for any individual case.

The prime reason for disallowing a wrongful life action is that life, even if imperfect, is always preferable to non-life. Besides, it will be impossible to assess the quantum of damages, because this necessarily requires placing a monetary worth on human existence.

The seminal case is the 1967 New Jersey decision of Gleitman v. Cosgrove (227 A.2d 689 [N.J. 1967]), but the state’s position has since changed. In Berman v. Allan (404 A.2d 8 [N.J. 1979]), the court allowed damages for maternal emotional distress, though not for medical and other expenses of raising the child.

Overall, the law of wrongful life appears to be increasingly willing to award damages to the mother for the physical, emotional, and financial costs of pregnancy and delivery, but not the cost associated with the normal rearing of a healthy child.

The legal situation is quite different for a lawsuit filed by the child, who in essence is arguing that he/she should not have been born at all. Courts continue to refuse a claim brought by a healthy infant for wrongful life, adopting the reasoning in Berman that the infant has not suffered any damage cognizable at law by being brought into existence. Even an infant with birth disabilities will not prevail in the majority of jurisdictions, with California being a notable exception.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.