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FDA Plays Both Sides

It's supposed to protect patients, but industry is using a recent rule change to its advantage.

Drug and device makers have started testing a simple but potentially powerful argument when their customers wind up hurt.

In a nutshell, they say this: It's not our fault. The Food and Drug Administration approved our products and deemed them safe for public use. A blessing from the FDA, which boasts a slew of medical experts, trumps your lawsuit any day.

In a twisted deal, critics claim, the FDA has stacked the deck against the very people it is supposed to protect. Early this year, the agency announced long-awaited labeling changes meant to better explain drugs and their side effects. But before issuing its new guidelines, the agency quietly added a preamble that could give its own stamp of approval more power than state laws allowing consumers to sue drug makers for failing to warn them of possible risks. Judges must now decide whether the rule applies to those cases or not.

Daniel Troy, former chief counsel of the FDA, explained the so-called Preemption Preamble in a recent issue of

Legal Times


"The FDA's bottom-line concern is that 'state-law attempts to impose additional warnings can lead to labeling that does not accurately portray a product's risks, thereby potentially discouraging safe and effective use of approved drugs,'" Troy wrote in the magazine's Oct. 9 issue. "A few courts have refused to defer to the Preemption Preamble and have rejected preemption on a variety of grounds. But few, if any, of those decisions carefully analyze the nature and extent of the FDA's decision-making or the degree of deference due to the FDA's views."

The FDA claimed such pre-emptive authority even before passing its new rule. The agency repeatedly threw its support behind drug makers facing failure-to-warn lawsuits when Troy led its legal department. It ultimately drafted the formal Preemption Preamble before he left.

Troy now offers his services to companies facing state lawsuits that could be derailed by the new rule.

The FDA has been regularly accused of favoring the companies it is supposed to regulate over the consumers it is supposed to protect. The agency, already under fire for approving risky drugs like Vioxx, suffered another black eye last week. In a startling development, former FDA Commissioner Lester Crawford revealed that he owned stock in companies that his agency was charged with policing when he was in charge.

Crawford has since pleaded guilty to misdemeanor charges of conflicts of interest and failing to properly declare his stock holdings. He could face jail time and financial penalties as a result,



Both Troy and Crawford served at the FDA during a time when, some feel, the agency grew overly close to the industry it oversees.

The FDA failed to answer a phone message seeking comment for this story. Meanwhile, consumer groups -- and even medical experts -- have started to cry foul.

"Thousands of people in this country have died or been seriously injured by drugs approved by the FDA," executives at Public Citizen complained. "Ultimately, we are confident that the courts will not defer to the FDA's opinion on pre-emption, which is not based on any authority given to the FDA by Congress. In the meantime, however, the drug companies will be emboldened by this preemption statement and use it to complicate injury cases and deter victims from seeking justice in the courts."

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They have already tried.

This summer, the

Philadelphia Inquirer



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managed to get a lawsuit dismissed using the new FDA rule as a weapon. A federal judge threw out the case in which the victim had slashed herself to death -- writing "thanks" in her own blood -- while taking an antidepressant that has since been linked to suicide, the newspaper reported. The case is among the first to test the new FDA rule and is expected to go all the way to the U.S. Supreme Court, the newspaper added.

GlaxoSmithKline has denied that its antidepressant, Paxil, caused the victim's suicide.


Johnson & Johnson

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is reportedly using a similar strategy in an effort to fend off lawsuits filed by customers who suffered after using the company's Charite artificial discs. Pete Flowers, a Chicago-area attorney who represents hundreds of disc recipients, says that J&J has filed motions seeking summary judgment declaring that FDA approval of the devices shields the company from state tort claims.

As a matter of policy, J&J does not comment on pending litigation.

"Even if it is proven that Johnson & Johnson fraudulently concealed facts from the FDA, this law still does not allow patients to sue," Flowers says. "It's brutal when you understand the full extent of what this law means if it is upheld -- which it has already been. ... We are very optimistic that we will be successful in beating this preemption" in court.

Flowers feels that his clients have suffered considerably. They underwent disc replacement surgery in an effort to relieve their back pain, he says, but many of them wound up disabled -- and even suicidal -- instead.

Some experts claim that all lumbar discs feature a major design flaw. Others believe that the Charite -- as the first device of its kind -- has encountered early problems and that future discs, free of those same faults, will inevitably work better.

Regardless, patients continue to pay a price.

"This is similar to the problems we saw in the early days of knee implants," says Thay Lee, director of the orthopedics biomechanics laboratory operated by the VA Long Beach Healthcare System and the University of California at Irvine. "But there's a difference: If you make a mistake in the spine, the patient can have a catastrophic outcome. So I think that the stakes are much higher here."

Even so, some fear, patients who suffer could have no recourse.

The FDA has come under fire as a result. This summer, shortly before the new FDA rule took effect, two doctors questioned the agency's priorities in a pointed article published by the

New England Journal of Medicine


"The changes the FDA will begin implementing next month include a regulatory time bomb that could severely limit the accountability of companies that fail to adequately evaluate or report the risks associated with their products," the doctors wrote. "Yes, the agency is trying -- but how effectively, and on whose behalf?"