Drugs and Genetic Harms

Traditional medical liability doctrines seek to establish that the plaintiffs were in fact "injured," usually meaning that they sustained some physical harm as a result of the medical intervention. But in addition to "adverse reactions," drugs also have the ability to create genetic harm, a modification of the germ cells that damage one's progeny or leave one's progeny more susceptible to disease. Medical liability law's traditional response to increased risk of disease is best illustrated by the manner in which courts reacted to the increased intergenerational risks of various forms of cancer associated with DES.

The California Supreme Court ruled that the daughters of women who had taken DES to prevent miscarriages could not hold the manufacturers liable under product liability doctrine because DES injured them in utero (Brown v. Superior Court, 1988). The plaintiff-daughters' increased risk of cancer and other reproductive abnormalities meant that more medical monitoring and procedures to prevent malignancies as well as some actual cancers were not the legal responsibility of the manufacturers of DES. In formulating a rule for prescription drugs that set them apart from general product liability doctrines, the court noted that the manufacturer had a duty to properly prepare the drug and warn of its "dangerous propensities that were either known or reasonably scientifically knowable at the time of manufacture" (Brown v. Superior Court, 1988). This latter duty has been characterized as one arising out of negligence, whereas the plaintiff's proposed product liability theory has been called a theory of "strict liability" or "liability without fault."

In their action based in strict liability, the plaintiff sought a ruling that the drug was defectively designed because it created the risk of intergen-erational harm. If DES were labeled a "defective product," the plaintiffs could have established a legal link between the product and the increased risk of cancer. In rejecting the applicability of strict liability, the California court reduced the pharmaceutical company's legal duty to warn of the dangerous propensity of DES at the time of its manufacture (a negligence standard). Because the harm complained of was not apparent until the 1970s, it was impossible for the plaintiffs to prove that the manufacturer knew of the drug's risks in the 1950s, when the plaintiffs' mothers ingested DES. The California litigation, however, was only one of several cases involving DES filed after a 1971 article described how a rare form of vaginal cancer in a 15-year-old was linked to her mother's ingestion of DES during pregnancy.

A group of women who were a part of a double-blind test of the effectiveness of DES filed a lawsuit in federal district court against a hospital and one of the manufacturers (Mink v. University of Chicago, 1978). The federal court, applying the liability doctrine of Illinois, ruled that the women could potentially recover against the doctors, employees of the hospital, who prescribed DES on the theory that the physician committed a battery—a form of strict liability—when the patients took DES without any knowledge of what it was. But the court also ruled that the DES mothers could not hold the manufacturer liable for an allegedly defective product. The plaintiffs' lack of success on the product liability claim was a function of the lack of "injury" to themselves as opposed to the risks of cancer to their offspring. Plaintiffs' claims that the defendants had a duty to warn them of the inherent risks—at least after 1971—also failed in the court's view, because of the lack of injury to the plaintiffs themselves.

The Illinois and California cases together provide a snapshot of how the traditional medical liability analysis handles the risks of intergenerational harm from drugs. The DES daughters cannot recover from the drug manufacturer on a "strict liability" theory, but the DES mothers might recover under a "battery" action for unconsented touching against the doctors administering the drug without the patients' knowledge or consent. Otherwise, the plaintiffs are relegated to various theories of negligence, most of which are not provable under the facts of the DES cases. The startling—at least to our modern ears—facts about DES are that a study in the 1950s mentioned in the Illinois federal case actually demonstrated that DES caused rather than prevented miscarriages. Even more surprising is that the FDA regulatory structure did not require that DES be proven safe or effective for preventing miscarriages when it was first prescribed for this purpose in 1947 (Weitzner and Hirsh, 1981). Given the present climate of a "gene rush," the clearest indication that DES is from a different era is the fact that the drug was never patented!

This analysis assumes implicitly that prescription drugs are different from most products because a physician will weigh the risks and benefits of prescribing the drug to a particular patient. This traditional analysis further supports the exemption of drugs from the strict liability doctrine by asserting that, today, the FDA is required to assess both the safety and efficacy of drugs before they are allowed in the market place (Henderson and Twerski, 2001). The drug manufacturer's responsibility for risks and injury is primarily determined by using standards of negligence. Negligence is also the standard by which the physician's relationship with a patient is usually analyzed. So the use of a negligence standard for most of the DES-related problems, except for the experimentation, is premised on the theory that the physician-patient relationship is the appropriate framework for weighing the various risks and benefits of drug intervention. The hindsight perspective of the intergenerational harm of DES could not undermine the primacy of physician risk-benefit analysis in prescribing drugs—which is what a negligence standards boils down to.

Recall that liability for malpractice requires proof that the defendant-physician violated not the jury's standards, but the standards of fellow practitioners when prescribing DES. The allocation of the liability risks in the DES cases between manufacturer and physician is only illustrative rather than prescriptive of the form of allocation that will occur for the products of pharmacogenomics. The main thrust of the DES cases is to illustrate that the standard of care for physicians undergoes a major shift when physicians are operating on the frontiers of medical practice or engaged in clinical research. This allows for the manufacturer's responsibility to be derivative of the physician's duty to deal "fairly" with patients with regard to the risks.

Pregnancy Guide

Pregnancy Guide

A Beginner's Guide to Healthy Pregnancy. If you suspect, or know, that you are pregnant, we ho pe you have already visited your doctor. Presuming that you have confirmed your suspicions and that this is your first child, or that you wish to take better care of yourself d uring pregnancy than you did during your other pregnancies; you have come to the right place.

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