Trial-Lawyer Kowtow
By SCOTT GOTTLIEB
September 20, 2007; Page A12
Democrats staged an 11th-hour showdown this week over a bill that funds the Food and Drug Administration (FDA). Their aim: a huge handout to the trial bar.
The furtive give-away is buried in the Food and Drug Administration Revitalization Act (FDARA), a funding bill that needs to pass this week if the agency is to avoid a budget crunch that could force it to fire its drug reviewers. If drug safety is so critical, why would Democrats risk issuing pink slips at the FDA? The provision raises the question of whether the hyperbole and hearings over drug safety these past several years was about improving public health, or merely paying off the lawyers.
The key issue is whether state courts should second-guess FDA scientific decisions that are based on an exhaustive review of clinical data and the proposed drug labeling. This usually comes up when drug companies are alleged to have failed to warn consumers about emerging drug safety issues, which comprise the vast majority of product liability cases.
Companies and the FDA (under both Republican and Democratic administrations) have argued that when the FDA specifically addresses a safety issue -- often telling companies that they can't include certain warnings in drug labeling because it's not scientifically justified -- state courts are "pre-empted" from and have no business substituting their judgment for the agency's expert finding. Otherwise, drug labeling -- which is an important public health tool -- would get cluttered with dubious and confusing warnings aimed at only shielding firms from lawsuits.
One recent case where pre-emption was successfully asserted was Dowhal v. SmithKline Beecham in California. The company was sued for failing to warn consumers that nicotine-replacement products allegedly cause birth defects, even though there wasn't any credible scientific evidence establishing that link. The FDA not only forbade SmithKline Beecham from including the superfluous warning in the drug's label, it also said that the public health was best served by encouraging pregnant woman to use nicotine replacement instead of smoking.
A California court initially said that more warnings were always better. Fortunately, after the FDA asserted that its judgment should prevail, the California Supreme Court unanimously agreed.
Even though pre-emption is a well established practice with respect to many federally regulated products, Speaker Nancy Pelosi (D., Calif.) privately promised the American Association for Justice, a trial lawyer trade group, that Democrats would gut this doctrine when it came to drug regulation.
In a widely circulated email to its members, the American Association for Justice said "we have already begun implementing a strategy for seeking language in the House version of the bill that can improve the current landscape for plaintiffs." The result is the "rule of construction" in the FDA bill that says, notwithstanding massive new power being given to the FDA over drug labeling, that the bill should not be "construed to affect" the responsibility of drug companies to add additional risk information to drug labeling on their own, without regard to what the FDA tells them.
In other words, the FDA's very close regulation of drug labeling doesn't necessarily pre-empt state juries from second-guessing when companies, and the FDA, decide to issue new safety warnings.
Drug firms have come in for a steady drubbing from Democrats over the past several years for "going soft" on drug safety. The FDA's career scientists endured frivolous charges from Capitol Hill that they were "in the pocket" of "big drug companies." Each time Democrats dug into a prescription drug issue, they unleashed a mountain of piggyback litigation.
The new regulations being passed as part of FDARA will also force more drug labeling changes that create their own opportunities for lawyers to pile on to the agency's findings. Now thanks to the Democrats' maneuvering, the legislation will help trial lawyers more easily cash in off those suits.
The legislation has other shortcomings, such as a vast new framework for the government to actively regulate decisions doctors make with their patients in the name of promoting "safer" use of medicines. Nor does the bill fully address the need for changes in the way we collect information about how drugs are used and, more importantly, how safety findings are reported.
But in the end, after years of politicking on drug issues as a walk-up to the big "reform" package winding its way through Congress, Democrats who promised to bring a new way of doing business to Washington are showing that the only thing that matters is a high dose of steroids for the plaintiffs bar.
Dr. Gottlieb, a practicing physician, is a resident fellow at the American Enterprise Institute and a former deputy commissioner of the FDA.
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