New England Biz Law Update
After a trial attorneys’ advocacy group unsuccessfully lobbied for the inclusion of an express right to bring drug liability suits in state courts in the Food and Drug Administration bill now pending before Congress, litigators, drug companies and federal officials will be watching the Supreme Court next term to see if it can settle the issue of how much weight to give the FDA’s words.
The House recently passed an FDA measure, similar to that approved by that Senate in May, designed to boost the federal agency’s ability to monitor the safety of drugs by using user fees from drug companies to increase revenue. Industry user fees would fund more than half the FDA’s budget for reviewing drugs and granting approval.
The bill would create a clinical trial registry, a database of trial results and a nonprofit foundation to advance the mission of the agency to modernize medical, food and cosmetic product development and enhance product safety.
It would also establish an electronic network to root out potential drug problems identified by pharmacy and medical records, and create stricter conflict-of-interest rules for scientists who advise the agency – as well as tougher fines for those who violate the rules.
The American Association for Justice (AAJ), formerly the Association of Trial Lawyers of America, saw the new legislation as a chance to settle a longstanding issue in drug and medical device liability: whether approval by the FDA preempts state law, shielding drug manufacturers from state civil suits.
Although the group got anti-preemptive language into the bill expressly stating that FDA approval would not preempt claims in state court, the language was cut during markup in the House Subcommittee on Health before the bill reached the floor after opposition from congressional Republicans.
“Basically the House bill … leaves the same muddy status quo as it was before this bill was passed,” said Gerie Voss, regulatory counsel for the AAJ.
The jettisoned language would have read: “Nothing in this act or the amendments made by this act may be construed as having any legal effect on any cause of action for damages under the law of any state (including statutes, regulations, and common law).”
The Senate version of the bill did not contain the anti-preemption language.
According to Voss, it wasn’t always a battle for people claiming injury from allegedly defective drugs or medical devicesto seek redress in civil courts.
The FDA, she said, has made a position shift.
“After a long history of taking the position that the FDA will not preempt state law in any state action, just within the last two years the FDA had a turn-around,” she stated.
Agency view
Officially, the FDA declined to comment on the preemption issue, stressing through a spokesperson that the agency’s job is regulation.
“FDA is the expert federal public health agency charged with ensuring that drugs are safe and effective and that the labeling adequately informs users of the drugs’ risks and benefits,” said FDA spokeswoman Rita Chapelle in a statement. “FDA reviews the pertinent scientific evidence and, through the drug approval process, provides formal, authoritative conclusions on the conditions under which drugs can be used safely and effectively.”
But Voss said the intent of the FDA is clear from its own regulations and statements accompanying them.
For example, in a summary of revisions to regulations governing the content and format of labeling for prescription drugs, which went into effect on June 20, 2006, the agency stated: “FDA believes that under existing preemption principles, FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary state law.”
The summary also stated: “FDA has learned of several instances in which product liability lawsuits have directly threatened the agency’s ability to regulate manufacturer dissemination of risk information for prescription drugs in accordance with the act.” Specifically, the comments said, state actions promulgate improper interpretations FDA’s regulations, encourage the improper view that the FDA’s labeling requirements represent a minimum safety standard, and put pressure on drug manufacturers to include speculative risks on labels, threatening the quality of patient care.
The issue is indeed murky, and courts are split. For example, a U.S. District Court in Louisiana ruled in May that FDA approval did not shield a manufacturer of the controversial drug Vioxx from claims of inadequate warnings.
“The FDA’s current view on the question of immunity for prescription drug manufacturers is entirely unpersuasive,” the judge wrote. (In re Vioxx Products Liability Litigation, MDL No. 1657 (E.D. La.).)
However a state court in Harris County, Texas, dismissed the claim of another Vioxx user, saying that the FDA-approved warnings on the label created a presumption of adequacy. (Ledbetter v. Merck, No. 2005-59499).)
The drug company hailed that decision.
“Merck acted responsibly by providing the FDA with the required data and updating the label with FDA-approved language to reflect what was known at the time,” said Ted Mayer of Hughes, Hubbard & Reed, counsel for Merck said in a statement. “The label provided physicians with the relevant information available to help them determine whether to prescribe the medicine to a given patient.”
Supreme Court to weigh in
With no clarity from Congress on the issue of preemption, the Supreme Court is poised to address the issue. The Court has agreed to consider preemption in the medical device context in Riegel v. Medtronic, No. 06-179. In that case, the plaintiff sued a medical device manufacturer, claiming injury after a catheter balloon burst during an angioplasty procedure.
A petition for certiorari is also pending in a second case, which considers preemption in the drug context. (Wyeth v. Levine, No. 06-1249).
Voss said she is unsure which way the Court will go on this issue.
“It’s hard to have an opinion right now,” she said. “Once we see how the court interprets the Riegal case, I think we will have a better basis to speculate on Levine.”
