FDA's Preemption Gift to Big Pharma

Evelyn Pringle November 18, 2006

An item sure to end up on the chopping block with the Democrats back in power, is the Bush administration's multi-billion dollar gift to Big Pharma, that bars people who have been injured by drugs approved by the FDA from suing the drug's maker in state courts.

Under the FDA’s federal preemption position, victims injured by dangerous drugs would go uncompensated, the regulatory powers of the states would end, and the drug companies would only be answerable to the FDA.

The claim of preemption was inserted into the preamble of new drug labeling guidelines in January 2006. At the time, Ken Suggs, president of the Association of Trial Lawyers of America, told the Washington Post: "The fact that the drug industry can get the FDA to rewrite the rules so that CEOs can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet of how much control these big corporations have over our political process,"

But then the FDA claimed it had preemptive authority long before the new rule was announced. The agency has repeatedly supported drug companies in failure-to-warn lawsuits since former Pfizer attorney, Daniel Troy, took over the helm of the FDA's legal division.

Bush's appointment of a Pfizer attorney as lead council at the FDA has been criticized far and wide. An investigation by Representative, Maurice Hinchey (D-NY), found that Mr Troy had received more than $350,000 in legal fees from Pfizer in the year before he took the FDA position, according to a July 13, 2004 Press Release from Rep Hinchey's office.

As soon as he settled into his public employment, Mr Troy registered his on-going allegiance to Pfizer by filing an amicus brief in the Motus v Pfizer lawsuit, a case involving a widow whose husband committed suicide after taking the SSRI antidepressant, Zoloft.

In fact, the Bush administration's FDA and Justice Department joined together in arguing that Pfizer should be immune from lawsuits in state courts by plaintiffs alleging that the company failed to properly inform the public about the increased risk of suicidality with Zoloft.

The court in the Motus case denied the motion noting that other courts had found FDA requirements to be minimum standards, and that FDA approval of a new drug did not shield the drug maker from liability, and that Pfizer had not cited a single case to the contrary.

Since the FDA brief was filed in the first case, Pfizer has used it, albeit with little success, to support its summary judgment motions in other Zoloft-induced suicide cases against private citizens.

With a large part of his work on behalf of Big Pharma completed, Mr Troy did not stay at the FDA for long, before he returned to private practice, but the FDA "ultimately drafted the formal Preemption Preamble before he left," according to the October 23, 2006 report, "FDA Plays Both Sides," by Melissa Davis, for The Street.com.

"Troy now offers his services," Ms Davis reports, "to companies facing state lawsuits that could be derailed by the new rule."

Houston attorney, Andy Vickery, has been battling the giant SSRI makers on behalf of injured victims for more years than he likes to count. He has represented clients in civil and criminal cases involving SSRI-induced violence and suicides.

Along with a majority of the nation's attorneys, Mr Vickery views the FDA preemption position as an assault on the rights of everyday citizens. "For 38 years," he says, "through both Democratic and Republican administrations, the FDA took the stance that private tort litigation was a good thing."

"By and large," he notes, "it avoided becoming embroiled in civil litigation but when it did intervene, usually with amicus briefs, its position typically protected consumers."

Attorneys note the FDA's total reversal in position from 1996, when the agency's argument was favorable for private citizens against federal preemption in the medical device case of, Medtronic v Lohr, in the US Supreme Court.

In 1998, the FDA's statements were that its labeling regulations established minimum standards, and in 2000, when the FDA published the proposed new labeling rule, the FDA said that it did not preempt state law. 65 Fed Reg 81082, 81193 (December 22, 2000) specifically stated: "FDA has determined that this proposed rule does not contain policies that have federalism implications or that preempt State law."

But the next year, after Bush took office, the FDA began what can only be viewed as the "kick-off" for its preemption campaign by filing briefs arguing in favor of drug companies.

Mr Vickery says the state tort system has worked well as a scheme of checks and balances for many years. Civil litigants and their lawyers, he reports, have on many occasions uncovered information about the hidden dangers of drugs that had escaped the attention of the FDA.

This is precisely what happened, he notes, with the issue of Paxil and suicidality. On June 6, 2001, in a Wyoming case he was handling against GlaxoSmithKline, a federal jury found that “Paxil can cause some people to commit homicide and/or suicide.”

In the wake of that verdict, Mr Vickery says, Glaxo should have issued a warning immediately and the FDA should have begun its reclassification and analysis immediately, but they did not.

"Instead," he states, "the FDA rode to the defense of industry via its first pro-preemption brief in the Motus case."

He currently represents Jackie Giles and Annabelle Dobbs, who he refers to as, “Effexor-widows,” against Effexor maker, Wyeth, in federal wrongful death actions.

Specifically, the lawsuits allege that Jackie Giles’ husband Jeff died from a self-inflicted gunshot wound on October 30, 2002, only two days after his general practitioner prescribed Effexor; and Terry Dobbs died on December 30, 2002, only 6 days after his doctor switched him from another SSRI to Effexor.

According to Mr Vickery, numerous federal courts have rejected preemption claims in the drug-induced suicide cases. "At the present time," he says, "the only Article III judge to consider claims of preemption by Wyeth in Effexor-suicide cases has denied Wyeth’s motion," in the case Jackson v Pfizer, et al.

He handled that case, in which the Jackson’s 11-year-old son was under the influence of both Zoloft and Effexor, when he killed himself, and the court refused to give deference to the FDA’s precatory preamble and advisory amicus briefs. The case has since been settled.

Mr Vickery also handled the Kallas v Pfizer lawsuit, another case in which the FDA filed a brief in support of the drug maker's preemption position, but the action was settled before any decision was reached on Pfizer’s preemption motion.

In that case, Shyra Kallas was only 15 when she went to her doctor seeking treatment for warts and came home with a prescription for Zoloft on October 8, 2002.

A mere two days later, on October 10, 2002, the FDA formally asked Glaxo to reanalyze the pediatric data on Paxil, to help the FDA understand the “greater number of adverse events” it had observed in the data the company had submitted to the FDA.

Nonetheless, the FDA took the position in its amicus brief that it would have considered an added warning to Shyra’s physician about Zoloft “false and misleading” when her initial prescription was written two days before the agency formally asked Glaxo for an explanation about the increased number of adverse events.

Attorneys agree that this "false and misleading" argument is the most silly of all because, 21 CFR § 201.57(e) requires a manufacturer to provide warnings in a drug's label "as soon as there is reasonable evidence of an association of a serious hazard with a drug."

In fact, during a Vioxx trial in March 2006, a New Jersey judge told the jury, "I just want to advise you that the law under FDA regulations does allow a company to change their warnings, to warn consumers and physicians about dangers they find out about after the label is approved."

"They're allowed to make changes," the judge said, "through a special procedure, without prior FDA approval."

Mr Vickery says the hidden studies uncovered in the Wyoming litigation in 2001, as well as the jury verdict that said Paxil could cause some people to commit homicide and or suicide, at least started the ball rolling down the hill, as far as alerting the public about the suicide risks associated with SSRIs.

Since then, he points out, the Attorney General of New York sued Glaxo for fraudulently concealing the studies that showed the increased risks of Paxil-induced suicidality and the ineffectiveness of Paxil with children, and obtained a settlement that requires the company to post its clinical trial data on the internet.

The same year, there was also the revelation that the FDA itself had suppressed a study that showed SSRI-related suicidality in children by one of its own scientist, Dr Andrew Mosholder.

Attorneys point out that many more studies, some dating back to before many of the SSRIs were even approved for use, have been unearthed through private litigation that show the SSRI makers knew about the serious side effects associated with the drugs, but concealed the reports and only allowed the positive studies to become public.

The preemption rule could not have come at a worse time for consumers. Under the current Big Pharma backed administration, the FDA is not adequately policing the marketing activities of drug makers. A recent investigation by the House Committee on Government Reform, found a sharp decline in enforcement actions taken against the pharmaceutical industry since December 2001.

From 1999 to 2001, the investigators reported that the FDA had sent out 250 "Notice of Violation" or "Warning" letters to drug companies; but for the period between 2002 through 2004, the FDA only sent out 70 letters, or a reduction of more than two-thirds.

According to Robert Brava-Partain, an associate attorney with the Baum Hedlund law firm, "there has been a steady decline in the FDA’s consumer-based orientation resulting in an FDA that is a conduit for large drug and device manufacturers to gain access to the US market where they reap billions of dollars in profit."

Mr Brava-Partain says the FDA has traditionally been known to favor the health and safety of consumers over the interests of drug makers, but says "this focus has recently shifted towards the protection of the companies whose drugs the agency is supposed to be regulating."

Mr Brava-Partain is a member of Baum Hedlund's pharmaceutical products liability department which handles SSRI-related suicide and suicide attempt cases. Along with other members of the firm, he has successfully defended against preemption arguments in cases, including Witczak v Pfizer, Cartwright v Pfizer, and Zikis v Pfizer.

Baum Hedlund is currently also handling SSRI-related birth defect lawsuits involving cases where infants of mothers who took SSRIs during pregnancy were born with serious heart birth defects or a life-threatening long disorder.

The antidepressants involved in litigation include the SSRIs Paxil, Zoloft, Prozac, Lexapro, and Celexa. Effexor, a slightly different antidepressant, is also known to be associated with many of the same adverse effects associated with the SSRIs.

The majority of judges in cases where FDA briefs were submitted, have been critical of the FDA's position. In a Minnesota Zoloft-induced suicide case, the court rejected Pfizer' attempt to use the FDA to support its arguments, stating that it "declines to treat statements from a single FDA legal brief as declarations afforded the preemptive force of law," and called the arguments "perverse" and a "public policy argument gone awry."

The fact is, only Congress has the authority to enact preemption legislation and it has not chosen to do so. And furthermore, with the Democrats in power, it is not likely to do so anytime soon.

In response to the FDA's initial preemption announcement, Senator Edward Kennedy (D-MA), issued a statement making his opinion clear by stating, "It's a typical abuse by the Bush Administration -- take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry."

Senator Kennedy will take over as chairman of the powerful Senate Committee on Health, Education, Labor, and Pensions when the Democrats regain control of the Senate in 2007, and legal analysts say to look for the FDA's preemption gift to Big Pharma to be high on the list of priorities for change.