Failure to Warn and Federal Preemption

The United States Supreme Court has taken on the question of federal preemption in the products liablility arena in a big way. By next summer significant limitations may be created to the right of an individual to sue product manufacturers, especially drug and medical manufacturers, for failing to properly warn about the risks in using their product.

The predominant issue in Wyeth concerns whether the FDA regulations for drug labeling and warning pre-empt a state tort failure to warn suit. Federal preemption has become an increasingly controversial issue due to the Bush Administration's efforts to place limits on tort litigation by reinterpreting the laws and regulations of federal agencies to preempt. Before this decade, the FDA has maintained that regulatory laws passed by Congress do not bar such lawsuits. However, earlier this year, the Supreme Court ruled that a law passed over thirty years ago expressly pre-empts product liability claims by people who are injured from FDA approved medical devices. Last month, the Supreme Court heard a case involving whether or not federally approved cigarette advertising preempted product liability claims in state court. On Monday, November 3 , 2008, the Supreme Court heard Wyeth and will eventually be deciding whether preemption also encompasses federal labeling and warning standards for drugs.

In Wyeth, Diana Levine went to a clinic where she was given a drug in response to her nausea. Although administering the drug using an IV drip is almost risk-free, the physician's assistant instead used a method called an IV push. Unfortunately for Ms. Levine, the assistant missed the vein and hit an artery, a serious error that the drug label (approved by the FDA) warned could cause "gangrene requiring amputation." As a result, Ms. Levine did in fact contract gangrene and had to have her lower arm removed. Ms. Levine argued that she was never informed of the risks involved in using the IV push method, and after settling with the clinic, sued Wyeth for products liability, arguing that Wyeth's labeling was an inadequate warning for a method with such serious potential consequences. In trial, the jury awarded 6.7 million dollars to Ms. Levine for her damages against Wyeth. Wyeth appealed, but the Vermont Supreme Court affirmed the ruling. However, the Supreme Court granted Wyeth's petition for certiorari. On Wyeth's side of the courtroom stands, a broad collection of business groups, the pharmaceutical industry and the FDA. Conversely, Ms. Levine is supported by consumer protection groups, trial lawyers, state attorney generals, and doctors.
Unlike the medical device case, a decision that was based on statutory interpretation, FDA labeling and warning standards do not expressively require preemption. Instead, Wyeth is asking the court to go beyond the confines of the legislative text and find "implied preemption," arguing that the company could not possibly comply with both the federal standard and a more stringent one established by a state court jury. Additionally, they contend that while the FDA has the expertise to balance the risks against the benefits of a product and offer a consistent, bright-line standard that applies nationwide, juries from the fifty different states cannot possibly offer the expertise, consistency, or authority to determine what kind of labeling and warnings are needed. Likewise, Wyeth argues that allowing juries to make such determinations would put drug companies to the impossible task of correctly speculating what juries from state to state might require of them. Such uncertainty may even dissuade the industry from putting beneficial drugs on the market for fear of being sued despite FDA approval.

Ms. Levine argues, on the other hand, that tort lawsuits achieve the benefit of compensating innocent victims for injuries caused by inadequate warnings and the FDA ought not to be the final word on what is adequate. The FDA standards ought to be a floor or minimum requirement not a ceiling and when viewed in this way, she argues, companies could easily fulfill both federal and state requirements and provide a safer environment for their consumers overall.

If in fact there are facts not considered or properly analyzed by the FDA or risks unknown to it, it may approve a warning that under more careful analysis by a judge and jury is simply unreasonably lacking. This may be especially true where new information is discovered or new conclusions can be made from new analysis of existing information.

Additionally, without a second level of protection for consumers, companies are given no incentives to improve their products beyond the minimum standards that the government agency requires, increasing the risk to the health and safety of consumers.

If the Supreme Court rules in Wyeth's favor, its decision could potentially eliminate the entire field of drug failure to warn case and place the exclusive right of establishing standards for warnings with the FDA, and other product manufacturers subject to federal government regulation will likely follow suit (literally).
Presently, numerous lawsuits have been put on hold awaiting the Supreme Court's decision, and dozens of injured plaintiffs with claims against drug makers could see their cases end here. For example, some drug companies are telling plaintiffs' lawyers that they won't settle for as much now as they would have before the Supreme Court picked up the Wyeth case; in fact, one drug maker in particular allegedly told a plaintiff's lawyer that it wants the "Wyeth discount." Yet other manufacturers are refusing to even entertain settlement until Wyeth is decided.

At the hearing all but one justice entered the fray in vigorously questioning both Wyeth's and Ms. Levine's attorney. The justices seemed particularly concerned as to how the FDA could have ever concluded that gangrene is a reasonable risk to the chosen means to combat nausea. They were concerned that information learned after a warning is approved or even old information analyzed in a new way and not ever considered by the FDA could lead to the reasonable requirement that a warning be made more stringent.

In contrast, concern was raised with the potential deterrent affect on manufacturers in the development and sale of drugs people need out of fear of unpredictable state lawsuits; manufacturers ought to be able to rely upon the FDA's expertise and approval.

In the end, I believe the court will rule that some level of implied preemption in drug failure to warn cases is appropriate. The question is, will they find that preemption stops at the line where new information or the new analysis of existing information reasonably leads to the conclusion that a stronger warning is appropriate.