Trial lawyers’ win on suit provision threatens FDA bill

The Food and Drug Administration (FDA) and the pharmaceutical and medical device industries may pull their support of a bill because of language added to it under pressure from the trial lawyers’ lobby.

At a hearing of the House Energy and Commerce Committee’s Health Subcommittee this week, panel Republicans and representatives of the FDA and the drug and device makers objected to language, included in discussion drafts of the bill, that they said would expose companies to a greater number of lawsuits in state courts.

Following the protests at the hearing, Energy and Commerce Committee Chairman John Dingell (D-Mich.) postponed a planned subcommittee markup of the FDA bill for five days, until Tuesday. The full committee is set to mark up the bill Thursday.

“These are just drafts. What we end up with going into Thursday will evolve,” a committee spokeswoman said. “This is not a final bill.”

The American Association for Justice (AAJ), formerly known as the Association of Trial Lawyers of America, distributed an e-mail to members and supporters after the hearing declaring its lobbyists were responsible for the inclusion of the provisions.

“This week, our Public Affairs Department worked hard to get a provision in draft drug safety legislation which would prevent drug companies from using the FDA as a shield against accountability for the harm they cause — and we were successful,” the e-mail, obtained by The Hill, read. “Now the drug companies are pushing back — and we need your help.” A call to the AAJ for comment was not returned by press time.

The trial attorneys contend that federal preemption of most state-court lawsuits related to FDA-approved products shields drug and device companies inappropriately when they market unsafe or mislabeled products. AAJ also contends that the FDA and the industries it regulates are too closely tied together for the agency to be counted on to protect the public health adequately. Lawsuits filed in state courts also hold the promise of larger payouts than those in federal courts.

This dispute between Democrats and Republicans on the committee underscores the influence that trial lawyers and drug companies, respectively, have on the two parties. The trial bar is a traditional Democratic ally and a generous source of campaign cash. Likewise, pharmaceutical companies are strongly associated with Republicans and historically have directed most of their campaign contributions to GOP candidates.

At issue are a few short lines originally included in all nine of the “discussion drafts” of the sections of the bill distributed a few days before the hearing by subcommittee Chairman Frank Pallone Jr. (D-N.J.). Committee Democrats since have removed the language from all but two of the sections, but the change has not satisfied industry critics.

“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 language states.

The Senate-passed version of the FDA bill does not include analogous language.

Under the legal standard of federal preemption, most lawsuits on FDA-approved products cannot be brought in state courts. The language in question would codify expressly that no such preemption exists, which the industries and the FDA view as a reversal of current practice.

Democrats are not trying to roll back federal preemption, the committee spokeswoman said. “We are not attempting to change the status quo on preemption,” she said. Instead, the Democrats want to forestall the expansion of federal preemption into new areas of drug and device law.

The pharmaceutical and device makers contend that the change in the law could grant state courts the authority to override FDA decisions about the safety and efficacy of their products or about warnings on the products’ labels.

If state courts were permitted to rule in conflict with an FDA decision, “A device manufacturer would no longer know that getting approved by the FDA was sufficient,” said Stephen Ubl, the president of the Advanced Medical Technology Association (AdvaMed).

“Current discussion drafts being considered in the House include provisions that would allow state juries and judges essentially to overrule FDA’s expert judgment about prescription drug labels and warnings, which could ultimately confuse physicians and patients who rely on clear, concise and consistent labeling directions,” Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA), said in a written statement.

A spokeswoman for Energy and Commerce Committee ranking member Joe Barton (R-Texas) described the inclusion of the language as a sop to the trial bar.

“As nearly everybody suspected, the provision comes from lawyers who want to play doctor for fun and profit. It’s even worst than that, though, because its effect is to let trial lawyers instead of scientists determine which drug is safe and which is not.
Mr. Barton believes that a good drug safety law will put patients first and lawyers last, not the other way around,” Lisa Miller, Barton’s communications director, wrote in an e-mail.

The AAJ is engaging in a grassroots effort on the issue to bolsters its lobbying against PhRMA, AdvaMed and others. Citing the opposition to its position from these powerful industries, the AAJ provides on its website a form letter intended for lawmakers.