The preemption question	January 2009

The U.S. Supreme Court is being asked to decide whether federal regulations governing product liability litigation can preempt state law. In Wyeth v. Levine, a patient who developed gangrene and had her arm amputated due to an improper administration of the Wyeth sedative and nausea drug Phenergan won a ruling from a Vermont jury that found that Wyeth should have changed the drug’s labeling.

Levine argues the label did not warn against the risks of I.V. push method of administration. This labeling, Wyeth argues, was approved by FDA and mandated by federal law, exempting the company from any such liability. Nov. 3, the Supreme Court heard opening arguments in Wyeth v. Levine.

The court will consider whether Wyeth could have changed the labeling in the manner Levine claimed without violating federal law and whether allowing states to decide what instructions or warnings should appear on drug labeling is consistent with FDA’s approval decision. The Supreme Court will give ruling by the end of the term, or anytime before next summer.

The legal implications of preemption are important because a pharmaceutical company cannot be sued if a patient experiences an adverse event that is discussed within the FDA label. The Supreme Court is likely to rule in favor of Wyeth and in favor of preemption according to Peter Pitts, senior VP, director, global health affairs, MS&L Global Healthcare, New York (mslworldwide.com). He believes, however, that the new Congress may debate new legislation to explicitly prohibit FDA to have this authority, which would likely be led by Representative Henry Waxman.

“The label is both a floor and a ceiling,” Mr. Pitts says. “The company is not allowed to add or subtract to what is on the FDA label. To say Wyeth could have added to the label or that any company has within its authority the ability to add to the label without FDA’s specific instruction is wrong and ignorant.”

FDA approves products because the benefits outweigh the risks for most people, when used properly. The few that are injured bring lawsuits where a jury has to decide whether a product is safe based on that one person’s injury, not the majority who use it, according to Sheldon Bradshaw, former chief counsel of the FDA and current partner in the food & drug practice at Hunton & Williams LLP (hunton.com).

“That’s why FDA rather than lay juries and judges make decisions related to that difficult balancing of risks and benefits that decide whether a drug is safe or not and how it should be labeled,” Mr. Bradshaw says. “Even if you have new evidence, if that new evidence is merely an adverse event report and you have no idea if there’s a causal relationship between the event and the drug, that wouldn’t be sufficient to unilaterally change the warning.”

The package insert indicated that if Phenergan was administered using an I.V. push method it could cause infection and gangrene. Levine is claiming that the label warning wasn’t strong enough and that the package insert should have instructed physicians not to use Phenergan via the I.V. push administration.

“When you do that, you’re tying the hands of doctors,” says Jill Wheaton, leader, pharmaceutical and medical device litigation team, Dykema (dykema.com). “When there is an agency with as much authority and expertise as the FDA, we shouldn’t allow them to be second guessed.”

The court may find that Wyeth was negligent – that preemption does not apply – for failing to amend the label to include the language Levine believes should have been there. Mr Bradshaw believes that this would put companies in an awkward position. “The court would be saying companies are liable for failing to include warnings the FDA has said don’t meet the legal standard for adding new warnings,” Mr Bradshw says. “It’s going to put companies, potentially, in a real Catch-22 about what they should do and how they should operate,” Mr. Bradshaw says.

Should Wyeth prevail, Mr. Bradshaw believes that it will be a narrow ruling. “In cases where FDA becomes aware of new safety information, they have an obligation to amend the labeling, and if they don’t, they could be held liable in tort law,” Mr. Bradshaw says.

A narrow ruling will only protect companies if there is no new safety information, or if the new information did not meet the standards of a label change.

A similar case, Riegel v. Medtronic, involved medial devices. In that case, the Supreme Court held that consumers injured by medical devices can no longer sue device manufacturers for failing to warn them about known but undisclosed risks.

“[The Supreme Court] is going to be very nervous about preempting any lawsuits against drug companies, because unlike a device, you’re pretty sure that a certain amount of the fault could lie with the drug company,” says Gary Liberson, Ph.D., partner, life sciences, PA Consulting Group (paconsulting.com). “You think of a device as only as good as the person handling it. A drug should be less concerned with who is handling it versus what the drug’s capabilities are.”