Plaintiffs’ Attorneys Keep Trying Novel Theories But Innovator Liability Is Still An Elusive Target

Background

Over the past few years, three courts have overturned the fundamentals of tort law, holding that a manufacturer of a brand-name prescription drug can be subject to liability even when a plaintiff alleges that he or she was harmed by a generic drug made by the brand manufacturer's competitor. Most courts, including four federal courts of appeal and dozens of federal district and state trial courts, have rejected this expansion of tort law. This tension intensified after two U.S. Supreme Court rulings on the viability of state failure-to-warn claims against manufacturers of prescription drugs created different liability rules for generic manufacturers than for makers of brand-name drugs.

In the first case, the U.S. Supreme Court held that federal drug law does not preempt state failure-to-warn claims with respect to brand-name drugs;1 in the second case, it ruled that federal law does preempt failure-to-warn claims stemming from the use of generic products.2 As a result, the U.S. Supreme Court allowed users of brand-name drugs to potentially have an avenue for recovery not available to users of generic drugs.

The brand-name ruling came from the 2009 case Wyeth, Inc. v. Levine. The Court considered whether a plaintiff who had been administered brand-name Phenergan, an antihistamine used to treat nausea, could claim that its manufacturer, Wyeth, inadequately warned of the risk of developing gangrene when the drug is injected into a patient's vein rather than administered through an IV drip.3 At the time of the suit, the drug had long been available in generic form.4 In allowing the claim against Wyeth to go forward, the majority of the Court reasoned it was not impossible for Wyeth to comply with both federal labeling law and any state law warning requirements that would be derived if the litigation deemed its warnings inadequate.5 The majority opinion explained that Wyeth could have used the "changes being effected" (CBE) process to add the safety information required by the jury's determination and then seek FDA approval for that change.6 In order to demonstrate that FDA labeling law preempts a state failure-to-warn claim against a brandname manufacturer, the manufacturer must show "clear evidence that the FDA would not have approved a change to [the drug's] label."7 While Wyeth showed that the FDA had approved Phenergan's label and worked with the company to update the label several times, the Court said it did not show that the FDA would have prohibited the change required if the warning was deemed inadequate under a state's tort law.8 As a result, plaintiffs who take brandname drugs can generally move forward with state failure-to-warn claims against the drug's manufacturer.

Two years later, in PLIVA, Inc. v. Mensing, the Supreme Court faced the preemption issue, but this time with respect to generic drugs. In Mensing, two individuals who developed tardive dyskinesia claimed that the drug's manufacturer failed to adequately warn of this risk.9 Here, plaintiffs' doctors wrote the prescription for the brand-name version of the drug, Reglan.10 Pursuant to state substitution laws, the pharmacists filled the prescriptions with generic metoclopramide, manufactured by PLIVA.11 As in Levine, the Court applied the forward-looking "impossibility preemption" test. Here, though, the majority found that it would be impossible for PLIVA to adhere to both its federal labeling requirements to use the "same" warning approved for the brand-name drug and to change those warnings to cure any defect a jury in a state failure-to-warn suit determines to exist.12 Unlike...