High court allows state claims against drugmakers over inadequate warning labels

Physicians differ in how the decision could impact patient care.

By Amy Lynn Sorrel — Posted March 16, 2009

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Some physicians say a recent U.S. Supreme Court ruling preserves a key safeguard in holding pharmaceutical manufacturers accountable for drug safety -- the courts.

But other doctors worry the decision could stifle drug access if juries are allowed to second-guess scientific determinations on the risks and benefits of certain medications.

On March 4, the high court ruled 6-3 that federal law does not preempt state claims against drugmakers over allegedly inadequate warning labels, despite approval of those labels by the Food and Drug Administration.

"Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness," Justice John Paul Stevens wrote for the majority. "The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information ... as new risks emerge."

Justices found little merit in arguments by drugmaker Wyeth that FDA regulations barred such failure-to-warn claims because pharmaceutical companies could not comply with conflicting state and federal standards. The court said FDA rules permit drugmakers to change or strengthen drug warnings before receiving approval, adding that "manufacturers -- not the FDA -- bear primary responsibility for their drug labeling at all times."

The decision upholds a 2006 Vermont Supreme Court ruling awarding Diana Levine nearly $7 million after she lost an arm following complications from an IV injection of Wyeth's anti-nausea drug Phenergan. A jury found the label provided insufficient cautions on the medication's dangers, a claim Wyeth denied.

Split views

The case attracted widespread attention from physicians, consumer advocates, trial lawyers and drug industry groups on different sides of the debate.

Some doctors said the threat of liability has helped ensure drug manufacturers monitor their drugs and report new or revised safety information to doctors and the FDA.

"Many times the manufacturer is the only one with that information," said Francisco Silva, California Medical Assn. vice president and general counsel. "Most importantly, the ruling does not shift the burden to physicians," who could be left liable if patients had no recourse against drug manufacturers.

The CMA filed a friend-of-the-court brief in the case. The Texas Medical Assn. and North Carolina Medical Society jointly filed a brief with similar concerns.

Levine's attorney, David C. Frederick, said Congress never intended to deny patients a remedy if a drugmaker was negligent. The court reaffirmed that "it's the drug company's responsibility to provide [safety] information to doctors so they can treat their patients in the safest and best way possible," he said.

But other doctors fear juries are not equipped with the expertise that trained medical professionals and regulators possess to decide safe and effective medication use.

"If that [duty] is switched over to a court or jury, it creates significant variability and uncertainty" that could interfere with physicians' medical judgment, said Brian F. Keaton, MD, past president of the American College of Emergency Physicians, which filed a brief in the case.

The decision also could result in commonly used drugs, such as Phenergan, becoming so tightly regulated "that it takes it out of [doctors'] hands," Dr. Keaton said.

Wyeth attorney Bert W. Rein said in a statement that FDA experts "are in the best position" to weigh medication benefits and risks, and convey them in warning labels.

In a dissenting opinion, Justice Samuel A. Alito Jr. echoed similar concerns, saying "juries tend to focus on the risk of a particular product's design or warning label that arguably contributed to a particular plaintiff's injury, not on the overall benefits of that design or label."

The decision is unlikely to lead to more lawsuits against drug companies because plaintiffs still have to prove negligence, said Tracy Van Steenburgh, an attorney specializing in pharmaceutical and medical device litigation. Though it could prompt drug firms to request additional warnings to avoid potential liability "to the point warnings become so diluted that [doctors and patients] don't know what's serious," said Van Steenburgh, a partner with the Minneapolis-based law firm Halleland Lewis Nilan & Johnson.

However, the ruling likely preempts claims in which the FDA explicitly rejects a manufacturer's suggested warning or change, she said.

The high court's ruling runs counter to a February 2008 decision in which the court favored preemption of lawsuits involving certain FDA-approved medical devices. Democratic lawmakers in March reintroduced legislation to reverse the ruling in Riegel v. Medtronic.

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Case at a glance

Does federal law preempt state failure-to-warn claims against drugmakers if labels are FDA-approved?

The U.S. Supreme Court said no.

Impact: Some physicians and consumer advocates say the courts have helped encourage transparency by manufacturers about drug risks and benefits. The ruling also relieves doctors of potential liability if patients were denied recourse against drugmakers. Other physicians and drug industry representatives fear treatment options could be limited if lay juries can question the FDA's expertise. Pharmaceutical companies also could pursue additional warnings to avoid potential liability.

Wyeth v. Levine, U.S. Supreme Court

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