U.S. Supreme Court Reviews Generic Drug Warning Label Requirements

January 11, 2012 (Press-News.org) A variety of defective products or substandard care can cause serious setbacks to people who seek out medical treatment. Defective drugs and medical devices, faulty hip replacement technology, medical malpractice and other negligence present real risks to individuals who are injured or ill and trust that they will receive proper care to remedy a medical condition.

One important development in 2011 regarding safety warnings for prescription drugs came out of the US Supreme Court. In PLIVA, Inc. v. Mensing, a narrow majority held that federal labeling regulations applicable to generic drugs are in conflict with tort claims under state laws. For that reason, certain types of state-court actions are preempted by federal law, a conclusion that has implications for drug lawsuit plaintiffs nationwide.

People who are harmed due to defective pharmaceuticals, undisclosed side effects or prescription errors can suffer tremendous harm. Ongoing medical expenses, lost income and other losses can accompany any serious drug-related illness or injury, and the damages can be even worse in the event of a tragic wrongful death.

Federal Drug Labeling Laws and the State Law Duties to Warn of Drug Hazards

The Mensing case consolidated two closely related actions involving use of the drug metoclopramide and a drug company's obligation to warn generic-drug consumers of hazards. Metoclopramide, which is used to treat problems with the digestive tract such as diabetic gastroparesis and gastroesophageal reflux disorder, has been marketed under the brand name Reglan since 1980.

The plaintiffs had each been prescribed Reglan a decade ago, and both received the generic form of metoclopramide from their pharmacists. After several years of using the drug to treat their digestive tract problems, each of the women developed a condition called tardive dyskinesia, a severe neurological disorder that is characterized by involuntary repetitive movements such as tongue protrusion, rapid eye blinking and movement of the extremities.

Because of evidence that long-term use of metoclopramide increases the risk of neurological problems, Reglan warning labels have recently been modified to warn patients about the risks of therapy lasting longer than 12 weeks. After being diagnosed with tardive dyskenesia, the women filed state common law claims against generic drug manufacturers in Louisiana and Minnesota, alleging that they did not adequately warn of the danger of developing the neurological condition.

The drug companies argued that the state-law claims should be dismissed because federal law required them to mimic the safety labeling of a drug's brand-name counterpart. While the plaintiffs had prevailed in federal appellate courts on this issue, the Supreme Court held that it was impossible for the drug companies to simultaneously meet the requirements of federal drug labeling laws and state common-law tort duties.

When Does Federal Regulation Trump State Law Remedies for Injury Victims?

The Court's reasoning involved a complex legal concept known as federal preemption of state laws. Preemption comes up frequently in cases involving allegedly defective products such as automobiles, medical devices and pharmaceuticals that are heavily regulated by agencies of the federal government. Under the Supremacy Clause of the U.S. Constitution, state law provisions must give way to federal laws when they are found to be in direct conflict.

While a recent Supreme Court case from 2009 had held that preemption did not apply to claims against manufacturers of brand-name pharmaceuticals, the court carved out an exception for generic drugs manufacturers. The Court's analysis focused on the different level of participation that brand-name manufacturers have with the processes that the Food and Drug Administration (FDA) uses to approve drugs. One clear difference it noted is that a company like Wyeth that manufactures brand-name drugs is specifically authorized by the FDA to unilaterally strengthen its warnings, while producers of generic medicines must receive approval before taking any such actions.

The Supreme Court's opinion represents a significant change in the rights of plaintiffs to sue generic drug companies under state laws that create a duty to warn of dangerous drugs. Some personal injury attorneys and consumer safety advocates worry about the implications for the long-established presumption against preemption in federal caselaw.

After a patient suffers harm due to a defective drug, knowledge of his or her legal remedies can quickly become a vital concern. While cases such as Menning may make legal recovery more challenging for some plaintiffs, an experienced product liability lawyer can explain the importance of identifying all potentially liable and negligent parties to provide accountability for products that cause harm due to undisclosed risks.

Article provided by Clark, Hunt, Ahern & Embry
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