Question: A woman developed primary pulmonary hypertension (PPH) 4 years after she had stopped using the prescription weight-loss drug, fenfluramine. The drug is known to cause valvular heart lesions as well as PPH. In a wrongful death lawsuit, her estate won a jury award of $1 billion in compensatory and exemplary damages. The defense appealed the size of the award, and argued that there are no studies demonstrating an association between fenfluramine and an increased risk of PPH that long after cessation of use. Which of the following is incorrect?
By Dr. S.Y. Tan
A. This is a products liability case.
B. The plaintiff can advance legal theories against the manufacturer based on warranty, negligence, or strict liability (that is, fault-free liability).
C. This can be a stand-alone case or part of a class action lawsuit.
D. The decision will definitely be overturned on appeal.
E. Such cases are frequently settled for a much smaller sum.
Answer: D. When a person is injured by a defective product, be it a car or a prescription drug, he or she can file a cause of action against the manufacturer or others who have placed that item into the stream of commerce. The law governing this general area of product-related injuries, broadly termed products liability, covers more than one specific tort, and the injured plaintiff can recover damages under a number of legal theories. Essentially, the claim is that the product was defective and unsafe, and the injury suffered by the plaintiff was a foreseeable consequence. In the medical field, patients treated with medications can sustain serious, even fatal, complications. Medical devices such as pacemakers and operating room equipment may malfunction and injure. And mass vaccinations do give rise, if rarely, to neurological sequelae and fatalities.
The above hypothetical is taken from an actual Texas case that was settled, presumably for much less than $1 billion, to avoid the unpredictability of an appellate outcome. Although this was a stand-alone case, such cases are frequently part of a class-action suit.
There are three legal theories in a products liability claim: negligence, breach of warranty, and strict products liability. The latter is the most favored, as there is no need to prove fault or warranty. The legal doctrine had its genesis in Greenman v. Yuba Power Products Inc. Mr. Greenman was injured when he used a power tool that was given to him as a gift. He sued the manufacturer, although there was no direct contract of warranty between him and the manufacturer as he did not make the purchase himself. The California Supreme Court went beyond the law of contracts to find the manufacturer liable, and in the process introduced the notion of strict liability, which goes beyond simple negligence, centering instead on whether a product is defective.
The strict liability approach has been adopted, in some cases with modifications, in virtually all jurisdictions. The theory holds that a professional supplier who sells a product that is both defective and unreasonably dangerous is strictly liable to foreseeable plaintiffs. "Defective" is usually defined as product quality that is less than what a reasonable consumer expects. "Unreasonably dangerous" is a conclusion that the risks that result from its condition outweigh the product’s advantages. Strict liability is not about negligence or fault, but about a social policy that shifts to the manufacturer the cost of compensating the injured consumer. To prevail, the plaintiff must show proximate cause, and assumption of risk is still a valid defense.
Manufacturers or suppliers of products that are unavoidably unsafe however, would be exempt from strict liability. In Hines v. St. Joseph’s Hospital, the plaintiff received blood transfusions and contracted hepatitis. The defendants were Blood Services Inc., the supplier of the blood, and St. Joseph’s Hospital, where the transfusions were ordered and given. In ruling for the defendants, the Court held that the product, blood in this case, was unavoidably unsafe and therefore not unreasonably dangerous. However, in Snyder v. Am Ass’n of Blood Banks, the Supreme Court of New Jersey found the trade organization liable for failing to recommend routine HIV testing of the nation’s blood supply in the early 1980s. The Court reasoned that the Association breached its duty of due care as it had projected itself as the guardian of blood safety and therefore ought to have recommended HIV testing even though the data were inconclusive at the time.
If a doctor fails to warn the patient of a medication risk, the patient may have a claim against the doctor but usually not the drug manufacturer. This is termed the "Learned-Intermediary" doctrine. The justification is that the manufacturer can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales representatives and in its package insert. The treating doctor, in turn, is expected to use professional judgment to adequately warn the patient, as it is not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship. Occasionally, a court would side-step the doctrine, for example, where a manufacturer knows that the drug will reach the consumer without the intervention of a physician such as over-the-counter preparations. Another situation is where extensive advertising of a drug to the public has taken place. Manufacturers may also be liable if they have failed to disclose all known risks, as alleged in the litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).