Healthy Skepticism Library item: 1099
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: media release
Widow Fights Zoloft-Maker's Attempt to Throw Out Court Claim that Zoloft Caused Husband's Suicide: Minnesota Attorney General Argues For Her Right to Pursue Claim
Baum Hedlund 2005 Apr 8
Full text:
Widow Fights Zoloft-Maker’s Attempt to Throw Out Court Claim that Zoloft Caused Husband’s Suicide: Minnesota Attorney General Argues For Her Right to Pursue Claim
Public Hearing April 8, 2005
Minneapolis
Minneapolis, Minnesota, April 7, 2005 – Pfizer, the maker of Zoloft, has argued in court papers that the lawsuit of a widow, Kimberly Witczak, whose husband committed suicide while taking Zoloft, should not proceed because her claims are “preempted” by federal law. Mrs. Witczak claims that her husband’s suicide was caused by an adverse reaction to Zoloft. Pfizer argues that, since the FDA approved Zoloft and didn’t, until recently, require a warning about suicide risk, any lawsuit blaming Pfizer for failing to warn about the risk is legally impermissible. The hearing on Pfizer’s motion will take place on April 8, 2005 at 9:30 a.m., in Courtroom 15E, United States District Court, 300 South 4th Street, Minneapolis, MN 55415. Pfizer’s position was challenged by the Minnesota Attorney General, Mike Hatch, who stated in an amicus brief filed with the Court on March 21, 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.
In addition, Hatch 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 position was also recently rejected by two separate federal court judges, one in Texas and the other in Louisiana. The Texas Court found Pfizer’s argument, that “there is no support for a suicide warning,” flawed because “there is support for such a warning.” The Court stated:
“Given the hearings by both Congress and the FDA regarding suicidality, the FDA’s [Psychopharmacologic Drugs Advisory Committee’s] recent decision to recommend black box warnings regarding suicidality in children and adolescents, and the numerous experts who have concluded that there is a link between SSRIs, like Zoloft, and suicidality, it would be inconceivable to this Court to argue that an additional warning regarding suicidality would be false and misleading” as Pfizer argued.
In response to Pfizer’s argument that it (Pfizer) is required to follow what the FDA instructs it to do and the FDA never required it to add a suicide warning to its label, the 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 Court stated that Pfizer has been aware of the suicide risk “for many years.”
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 and Mrs. Witczak has been quoted in a number of news stories. 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.
Mrs. Witczak is represented by Baum Hedlund, a national pharmaceutical products liability law firm. The firm represents many clients in SSRI-related suicide cases.
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Link to the Minnesota Attorney General Amicus Brief:
http://www.baumhedlundlaw.com/media/zoloft/Woody/MSJ-OPP-AMICUS-BRF.pdf
Additional Information
March 22, 2004 FDA Public Health Advisory announced that the FDA has asked antidepressant manufacturers, including Pfizer, to place, in the Warnings section of their drugs label, a warning that “both children and adults should be monitored closely at the beginning of drug therapy, or when a patients dosage is increased or decreased, for signs of worsening depression, or emergent suicidality that is severe, abrupt in onset, or was not part of the presenting symptoms.”
In this advisory, the FDA also stated that “health care providers should be aware that worsening of symptoms … might be a result of drug therapy.” The symptoms listed are: “anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (extreme restlessness), hypomania, and mania.”
May 26, 2004 Pfizer issued a Warning in Canada concerning the “increased risk of suicidal ideation and behavior over that of placebo” for those under 18 taking Zoloft; and that for both adults and children, patients should be monitored for suicidality, “emotional changes” and “agitation-type“events such as: “akathisia, agitation, disinhibition, emotional liability, hostility, aggression, depersonalization.”
October 15, 2004 FDA issued a Public Health Advisory announcing that it had directed antidepressant drug manufacturers to revise the labeling of their respective antidepressants to include a black box warning that alerts health care providers to an increased risk of suicidality caused by antidepressants in children and adolescents under 18.
The FDA also announced that it had requested that a Patient Medication Guide (MedGuide) be provided to patients with each prescription that will advise patients of the risk. Significantly, the FDA stated: “A causal role for antidepressants in inducing suicidality has been established in pediatric patients.”
January 2005 The new warnings include the statement: “Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.”
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”
Recently, the FDA’s deputy director for the Office of New Drugs, Dr. Sandra Kweder, testified under oath at a hearing before the Senate Committee on Health, Education, Labor and Pensions regarding improving drug safety in the wake of the Vioxx debacle.1 Specifically, the Senators were seeking information regarding what legislative changes may be necessary to strengthen the FDA’s ability to protect the public. When asked about the FDA’s authority to require a drug company, such as Pfizer, to change its label, Dr. Kweder testified that the FDA does not “have the authority to tell a company ‘this is how your label has to look. This is the language that needs to go in your label, here’s where it goes, end of story.’ We have to negotiate with the company the specific language of how things should be worded, placement, those kinds of things . . . .”
Senator Patty Murray (Washington) specifically asked Dr. Kweder if the FDA needed “authority in [her] opinion to change labeling.” Dr. Kweder testified that “stronger ability to require changes in labeling would be very helpful.” Finally, Senator Murray asked Dr. Kweder whether the FDA had the authority to change a drug’s label. Dr. Kweder testified that the FDA does “not have the authority to require a specific label change.”
When questioned by the British Medical Journal (“BMJ”) as to the reason the FDA deleted causation language and made other changes in the warnings that FDA had initially proposed in its October 15th letter, FDA spokeswoman Christine Parker told the BMJ: “Although we obviously have influence over product labeling, especially at the time that new drugs or claims are being approved, labeling ultimately is the prerogative of the sponsors [industry].”
The Director for the Centers for Disease Control (CDER) at FDA, Dr. Janet Woodcock, testified two days later that she does not think the FDA requires additional labeling or testing authority, however, she stated: “We are now … planning to put information out directly to the public on emerging safety issues” and “that’s likely to eliminate the need for new warning labels or testing authority.”
April 5, 2005 The British House of Commons issued a report regarding “The Influence of the Pharmaceutical Industry.” The report, 126 pages in length, is available online at
http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf
The same problems documented in this report exist in the United States.
Robin McCall
Media Relations
Baum Hedlund
RMcCall@BaumHedlundLaw.com
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