Courts will ultimately decide the impact of the Food and Drug Administration’s assertion that drug labels often pre-empt state laws that govern liability, but the agency’s move may change the tactics of plaintiff lawyers and drug-industry defense attorneys.
This comes amid high-profile litigation involving the drug industry. Merck & Co. faces more than 9,200 lawsuits over its painkiller Vioxx, which it withdrew from the market in 2004.
The agency yesterday declared the pre-emption policy in the preamble of a regulation that lays out a new format for drug labeling. The FDA’s move drew quick complaints from plaintiff attorneys and state officials, who argued that the agency was overstepping its bounds. But drug makers said that they supported the FDA’s decision and that the agency should determine how safety information is communicated.
In the rule, the FDA said that under the law, its approval of labeling “pre-empts conflicting or contrary state law,” including statutes that deal with requirements to warn consumers about potential side effects. The rule gave specific cases in which such pre-emption would apply, but added that it was true in “at least” those situations. It also said pre-emption would apply to cases against health-care providers that deal with claims that they failed to tell patients about a risk “beyond what is included in the label.”
The move is likely to spark a fight in Congress. Republicans won’t be eager to move against the FDA, so it isn’t clear if a bill would make much headway, because they are in the majority. Sen. Edward M. Kennedy (D., Mass.) called the pre-emption language an “abuse.”
On the other side, the Pharmaceutical Research and Manufacturers of America, a trade group for the drug industry, said it backs the FDA’s endorsement of pre-emption. Merck, as well as Pfizer Inc., which has used pre-emption briefs filed by the FDA in litigation related to its antidepressant Zoloft, support the FDA.
But the real impact of the FDA’s policy will play out case by case, as drug makers seek to use it in their defenses against plaintiffs asserting that a company failed to warn them about a potential side effect. “It’s going to be up to judges to decide whether they find FDA’s argument that pre-emption applies persuasive…in the particular circumstances,” said Daniel Troy, a former FDA chief counsel who helped build the pre-emption argument and now represents industry clients in private practice.
Increasing use of pre-emption as a defense may change how cases play out. Plaintiff attorneys may seek out states and particular judges that they perceive as more likely to reject federal agencies’ authority over state law. New York and New Jersey judges “have been very consistent on the theme—they’re independent states and not bound by” a federal rule unless Congress has explicitly stated that it intends to pre-empt state law, said Christopher Seeger, a leading attorney in the litigation against Merck.
Several thousand Vioxx cases have been consolidated in a New Jersey state court. New Jersey and Michigan law prohibit punitive damages for FDA-approved products unless plaintiffs prove the drug maker knowingly lied to the agency. Because the FDA policy asserts that it is simply codifying a stance that is implicit in the law, it isn’t clear what impact the rule will have on previously filed cases such as those over Vioxx.
The FDA’s policy still leaves gray areas, with the result that lawyers may increasingly focus on the details of drug makers’ interactions with the agency—particularly what they disclosed and the arguments company representatives had with FDA officials over label language. It isn’t clear what the impact of pre-emption would be in cases where it took months or years for a drug risk to get into the label, which can happen when drug makers fight with the agency over how to word such warnings.
Plaintiff attorneys may find new bases for suits that avoid arguments over a drug’s label, though lawyers caution that some of these, such as manufacturing or design defects, are rarely applied to drug makers. “Anyone who says the courthouse doors are shut, that’s not true,” said Victor Schwartz, a partner at Shook, Hardy & Bacon.