Alabama Court Decision May Open a New Door for Restitution

The Decisions

In 2011, the Supreme Court’s decision in Pliva Inc. v. Mensing held that in state courts, generic-drug manufacturers could not be held liable for failing to inform the Federal Drug Administration (FDA) when its label inadequately warns consumers of health risks. Pliva claimed that it was impossible for generic drug manufacturers to simultaneously adhere to state and federal law because federal law requires generic labels to be identical to labels approved for the name brand. As a result, Pliva stated that unilaterally strengthening the warning on the generic label to avoid state law liability would violate federal law requiring identical labels. This decision renders states unable to make generic drug makers responsible for the harm their products inflict on those that use them. This ruling impacts millions of individuals in the U.S., because generic drugs make up 75% of the prescription drug market.

In the recent Supreme Court of Alabama decision Wyeth v. Weeks, the Alabama court held that the plaintiffs can seek damages against the brand name manufacturers of the same generic drug that caused their harm, based on a theory of civil liability known as “innovator liability.”

The History

In an attempt to decrease the cost of prescription drugs, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984. This act enables generic drug manufacturers to produce drugs without the cost of development, research, and trials required of the brand name manufacturers before approval by the FDA. This act afforded the generic manufacturers to sell their product at a lower cost making prescription drugs more affordable to the general public. The law required that the drug be an exact duplicate of the brand name drugs and that their labels, including their warnings, replicate those of the brand name drug being copied. The restrictions placed on the generic drug manufacturers included the inability to alter their warning labels unless the brand name manufacturer changed its label.

The Cases

In Pliva, each plaintiff filed the equivalent of a failure to warn case against the generic drug manufacturers, Pliva, Inc. and Activus, Inc., in the Minnesota and Louisiana state courts. The plaintiffs won their cases at the state level under state law.

The manufacturers appealed to the Supreme Court. The manufacturers argued federal law does not allow the generic labels to be altered unless the brand name label does so first. The state law requires the generic labels to warn of side effects of the drugs that they knew or should have known could cause harm. The Court ruled in favor of the manufacturers on their “impossibility” defense. Simply put, they could not follow the state law without breaking the federal law. In its decision, the Court cited the Supremacy Clause, which declares that any state law that is in opposition to a federal law is rendered ineffective.

In Wyeth v. Weeks, the Alabama Supreme Court held that brand name drug manufacturers may be held liable for the generic manufacturer’s failure to warn. Wyeth argued that since they had no actual “dealings” with the Weeks, they were not responsible to them for the harm caused by the generic prescription that harmed them.

The court decision used the element of tort law that requires liability for injury if the defendant could reasonably foresee that their negligent behavior may harm a third party. Wyeth should have expected physicians would rely on its label when making decisions to prescribe the drug.

The decision in Weeks cited Conte v. Wyeth, Inc. In this decision, a California court ruled Wyeth, the brand name manufacturer of Reglan, could be held liable for injuries which were reasonably foreseeable due to intentional misrepresentation by the brand name manufacturer of the drug. Also cited in the Weeks decision was a Vermont case, Kellogg v. Wyeth, which also found Wyeth liable for harm to the plaintiff in that case even though the plaintiff had only used the generic form of the drug Reglan or metoclopramide.

The Future

The FDA confirms the “sameness” requirement of generic labels to their brand name counterparts. The agency also clarified that it prohibits changes to generic labels unless the brand name label is changed first. Though generic drug manufacturers have eluded liability under the impossibility defense of tort law, it may be that some state courts are opening the door for compensation of harm to consumers. The courts have possibly created a new avenue for those injured by drug manufacturers negligence to have their day in court by allowing third party liability cases against name brand manufacturers.

Experienced Dangerous Drug Representation

If you or a loved one has suffered an injury due to taking a dangerous prescription drug, the attorneys at Jacoby & Meyers can help you receive compensation for your damages. We have the resources of a national law firm, and we have the skills and experience needed to battle the high powered legal teams of large pharmaceutical companies. Our lawyers can review the facts of your case to determine whether you have a valid defective drug claim.

Please contact our defective drug lawyers today to schedule your free initial consultation.

Toni Zeller Kohlbeck, student intern Jacoby & Meyers.