July 22, 2005
FOR IMMEDIATE RELEASE
12100 Wilshire Blvd., Ste. 950
Los Angeles, CA 90025
Federal Judge Rejects Pfizer’s Efforts to Dismiss Zoloft-Suicide Lawsuit
Minneapolis, Minnesota - - On July 20, 2005 United States Chief District Court Judge, James M. Rosenbaum rejected Pfizer’s effort to dismiss Kimberly Witczak’s Zoloft-suicide lawsuit. Mrs. Witczak asserts that Zoloft induced her husband, Timothy (“Woody”) Witczak, to commit suicide after suffering severe adverse reactions to the drug. Mrs. Witczak claims that Pfizer fraudulently marketed Zoloft as safe and effective and failed to provide warnings about Zoloft’s propensity to induce suicidality, despite Pfizer’s knowledge of the risk, as evidenced by internal memoranda and studies obtained through discovery.
In an effort to prevent this evidence from reaching a jury, Pfizer sought to dismiss the case, arguing that Mrs. Witczak’s state law claims are "preempted" by federal law. Pfizer argued that, since the FDA approved Zoloft and did not, until recently, require a warning about suicide risk, any lawsuit blaming Pfizer for failing to warn about the risk is legally impermissible. Judge Rosenbaum, however, refused to accept Pfizer’s argument, stating that “FDA regulations allow drug manufacturers to strengthen warning labels ‘in the interest of drug safety’ at any time without FDA pre-approval precisely so that the warnings can be ‘placed into effect at the earliest possible time’ and ‘to enable prompt adoption of such changes.’” Judge Rosenbaum stated that the “crucial flaw” in Pfizer’s argument is that “Congress certainly did not intend to bar drug companies from protecting the public when enacting the [Food Drug and Cosmetics Act]; its goal was to protect the public ... Any contrary interpretation of Congress's intent is perverse.”
To support its position, Pfizer touted a legal brief (“amicus” or “friend of the court” brief) filed by former FDA Chief Counsel, Daniel Troy. The amicus brief argued that, even though Pfizer never sought to strengthen Zoloft’s warning label, any warning, no matter how worded, that suggested a link between Zoloft and suicidality would have been false and misleading, would have “misbranded” the drug, and the FDA would have rejected any effort by Pfizer to use such a warning. Judge Rosenbaum soundly rejected this argument, stating:
Defendant [Pfizer] proffers the FDA's amicus brief in Motus v. Pfizer in support of its position. ... There, the FDA -- which has since modified its own position -- avers that it would have deemed any warning of a causal link between Zoloft and suicidality to be false and misleading. ... These assertions do not preempt state law. (Order, p. 7.)
The Court ... declines to treat statements from a single FDA legal brief as declarations afforded the preemptive force of law. (Order, p. 8.)
[T]he Court has 'reason to suspect that the [Motus brief's] interpretation does not reflect the agency's fair and considered judgment on the matter in question.' (Order, p. 8.)
FDA has no authority to declare, ipse dixit, that a label is false and misleading. (Order, p. 8.)
Judge Rosenbaum called one of Pfizer's arguments a “public policy argument gone awry” (that “any warning of a possible link between Zoloft and suicidality would have frustrated Congress's goal of ensuring the scientific validity of drug label information”).
The judge also stated:
State consumer-protection law compliments, rather than frustrates, the FDA's protective regime. This is especially apparent when one considers that prescription drugs were once marketed primarily to trained health care providers -- sophisticated and discerning intermediaries. Today, on the other hand, pill-rolling apothecaries and the mortar and pestle have disappeared. They have been replaced by drug manufacturers who urge the use of their drugs in mass-market print and television advertisements targeted directly at the public. Defendant, for example, advertises the drug involved in this case by personifying it as a happy, bouncing-oval cartoon character.
This new drug-marketing environment calls out for enhanced consumer protection. But [Pfizer] urges the Court to find Congress intended to obviate the very state laws that provide remedies to consumers harmed by dangerous and deceptive marketing.” (Order, p. 12.)
Mrs. Witczak’s position was supported by Minnesota Attorney General, Mike Hatch, who stated in an amicus brief filed with the Court that Minnesota has a strong interest in protecting its citizens from hazards associated with prescription drugs. Mr. Hatch cited the State's almost $1 billion per year purchase of prescription drugs for its Medicare program. He stated that it was important to protect the State's right to bring suit against drug manufacturers under the State's Consumer Protection statutes against manufacturers who may have “lied about the drug's efficacy and side effects.”
Pfizer's federal preemption arguments have recently been rejected by three other federal court judges (in Texas, Louisiana, and Illinois) and one state court judge (in California). In the California case, the FDA’s Amicus Brief was stricken from the record as “hearsay and irrelevant.”
In the Illinois case, the Court stated that “Pfizer improperly relies upon an Amicus brief filed by the United States Government in another case that contains nothing more than legal argument by counsel.” The Illinois Court described Pfizer’s argument as based on “speculation and imagination” and complained that Pfizer was attempting to “artificially construct conflicts where none actually exist.”
The Texas court pointed out that the law “allows, even encourages, manufacturers to be proactive when learning of new safety information related to their drug. ... Manufacturers, not the FDA, are tasked with the responsibility of taking proactive steps once a manufacturer learns of 'reasonable evidence of an association of a serious hazard with a drug.’” The Illinois court similarly found that a manufacturer may provide “additional warnings along with those required by the FDA.”
Mrs. Witczak is represented by Baum Hedlund, a national pharmaceutical products liability law firm. Baum Hedlund attorney Robert Brava-Partain, who argued for Mrs. Witczak and against Pfizer stated, “The Court correctly recognized that drug manufacturers, like Pfizer, cannot hide behind the rules and regulations of the FDA when they engage in conduct that harms the public. We look forward to having a jury consider the full extent of Pfizer’s fraudulent conduct in this case.”
Timothy (Woody) Witczak was a 37-year-old dynamic and upbeat, happily married man who was prescribed Zoloft because he was having difficulty sleeping due to job-related stress. He was on Zoloft for about five weeks with an increased dose before he committed suicide (by hanging himself from the rafters in his garage). He had no history of mental illness or suicidality nor does there appear to be any history in his family.
His symptoms after Zoloft and before his death included profuse sweating, worsened insomnia, horrible nightmares, headaches, agitation and an odd feeling in his head (he told his wife that he felt like his head was "detached from [his] body.") This phenomenon has been acknowledged by Pfizer in internal company documents to be a side effect of Zoloft. (This, and a number of other internal company documents, were recently released from confidentiality by Court Order.)
Kim Witczak has traveled to Washington D.C. on numerous occasions to lobby Congress to increase FDA scrutiny and raise awareness of the risks of Zoloft and other drugs in its class. She testified at the FDA advisory committee meeting in September of last year which resulted in the FDA's request for black box warnings concerning the increased risk of suicidality in children and adolescents.
The Witczak's story was covered in an I-Team feature on WCCO TV in Minneapolis (http://www.wcco.com/iteam/local_story_142142535.html) and Mrs. Witczak has been quoted in a number of news stories. (See e.g., Star Tribune article “The battle for Woody.”) She has a website devoted to her husband's memory and raising awareness about the risks of Zoloft and similar drugs: www.woodymatters.com. She can be reached at 612-877-0570.
Witczak Court Ruling
Texas Federal Court Ruling
llinois Federal Court Ruling
California State Court Ruling
Louisiana Court Ruling (Note: Although the Louisiana Federal Court denied Pfizer’s preemption motion, it has not yet issued a memorandum of opinion.)
Minnesota Attorney General Amicus Brief: http://www.baumhedlundlaw.com/media/zoloft/Woody/MSJ-OPP-AMICUS-BRF(State-of-MN).pdf
July 1, 2005, FDA Public Health Advisory regarding the increased risk of suicidality in adults taking antidepressants: http://www.fda.gov/cder/drug/advisory/SSRI200507.htm
Boston Globe - FDA Counsel's Rise Embodies US Shift
US News & Wolrd Report - Mr. Outside Moves Inside
"The Fox in the Chicken Coop" FDA's Recent Intervention in Pharmaceutical Litigation, ATLA Education, 2003, by Karen Barth Menzies
Recent Congressional testimony of FDA scientist, Dr. David Graham, graphically illustrates the point that FDA approval of a drug as "safe" does not mean it is free of defects or that, once the drug is marketed, defects will not become apparent. He testified that "in order to demonstrate a safety problem with 95% certainty [the FDA's standard], extremely large studies are often needed. And guess what. Those large studies can't be done." Dr. Graham used the following analogy to prove his point:
Imagine for a moment that you have a pistol with a barrel having 100 chambers. Now, randomly place 95 bullets into those chambers. The gun represents a drug and the bullets represent a serious safety problem. Using CDER standard, only when you have 95 bullets or more in the gun will you agree that the gun is loaded and a safety problem exists. Let's remove 5 bullets at random. We now have 90 bullets distributed across 100 chambers. Because there is only a 90% chance that a bullet will fire when I pull the trigger, CDER would conclude that the gun is not loaded and that the drug is safe.
According to Dr. Graham's testimony, "the FDA and its Center for Drug Evaluation and Research ("CDER") are broken" and the FDA "as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless"
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