Minnesota Attorney General Supports Widow in Zoloft Suicide Case
Tue, 22 Mar 2005
A press release from the law firm, Baum Hedlund announces that Minnesota’s State Attorney General filed a legal brief refuting Pfizer’s claim that “it should be immune from liability for failing to warn about dangerous side effects associated with its drug because Zoloft was approved for use by the FDA.”
Under the unofficial leadership of Daniel Troy when he was chief counsel of the FDA, the agency engaged in intervening on behalf of drug manufacturers–including Pfizer–in civil suits involving harm from drugs whose hazardous effects were concealed from physicians prescribing the drugs and from consumers ingesting them.
Barry Turner an attorney in the UK (below the press release) provides insight about the essence of separation of powers and the danger posed to a democracy when federal agencies intervene in state jurisdictions.
Contact: Vera Hassner Sharav
212-595-8974
~~~~~~~~
The amicus brief of Mike Hatch, The Attorney General for the State of Minnesota is an important issue. The drug companies have time and time again used the argument that FDA approval vindicates their every move. Hatch has correctly pointed out that the issue is not whether the FDA approved the drug but on what information that approval was obtained.
To suggest that FDA approval alone is sufficient to negate any action is like suggesting that an ‘approved’ application for welfare is in itself vindication for that approval having been gained by deceit and that any person who is prosecuted for obtaining welfare by deceit only has to state in their defense that their receipt of welfare was ‘approved’
It is of course the right of the state legislatures and the Attorney General of the states to question the FDA’s actions and to place their own duty’s to citizens of the state as a primary responsibility. The state legislatures are not bound by the decisions of the FDA in absolute and it is not only the rights of the state legislatures and judiciary to question this but also their responsibility.
Interventions by Federal agencies against the wishes of the citizens of the state and their elected representatives is not a democracy or the rule of law. The intervention of the FDA to support commercial interests against those of the citizens of both the individual states and the Union itself cannot be justified by reference to its own system of ‘approval’
If the drug companies can continue to use this spurious defense, that an agency of the Federal Government has the authority to overrule the states rights to govern and the state judiciary’s obligations to protect its citizens, then no legal action at this level can ever succeed. It was never the remit of the FDA to undermine legitimate legal action based on an unsupported argument that FDA approval means there cannot have been mistakes
Where drug companies have lied about efficacy and side effects the FDA has no authority to legitimise this defense. Authority gained by concealing side effects, questions about efficacy and dangerous adverse effects is void. This is a contract uberimmae fides. The drug companies must in utmost good faith declare these defects in their products, the FDA must in utmost good faith protect citizens of the United States from injury and the taxpayers of the United States from fraud. Lying or concealment in any contract uberimmae fides destroys the contract. Lying in FDA drug approval destroys the approval.
Barry Turner, lecturer in legal studies, Department of Biological Sciences, University of Lincoln UK; Criminal Litigator; and Mental Health Law Consultant.
March 21, 2005
FOR IMMEDIATE RELEASE
Baum Hedlund, A Professional Corporation
12100 Wilshire Blvd., Ste. 950
Los Angeles, CA 90025
Contact: Robin McCall, Media Relations
(800) 827-0087 or (310) 207-3233
Web: www.baumhedlundlaw.com
Minnesota Attorney General Supports Widow in Zoloft Suicide Case Minneapolis, Minnesota, March 21, 2005 – – The Attorney General for the State of Minnesota filed a legal brief today with the Federal District Court in Minneapolis arguing that the Food and Drug Administration’s regulations regarding prescription drugs do not preempt stronger state laws.
Pfizer, the maker of Zoloft, filed a motion in Witczak v. Pfizer arguing that it should be immune from liability for failing to warn about dangerous side effects associated with its drug because Zoloft was approved for use by the FDA. Kimberly Kay Witczak, the widow of Timothy “Woody” Witczak, who committed suicide in 2003 while taking Zoloft, contends Pfizer knew this deadly side effect is associated with Zoloft but failed to warn doctors and patients.
However, the Minnesota Attorney General, Mike Hatch, argued in his amicus brief 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.”
A Court hearing on the preemption issue is scheduled to take place on April 8, 2005.
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.
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 Ms. 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.
Ms. Witczak is represented by Baum Hedlund, a national pharmaceutical products liability law firm. The firm represents many clients in SSRI-related suicide cases.
On March 22, 2004, the FDA asked Pfizer and the makers of a number of other antidepressant drugs to include in their warning labels that patients (both adults and children) should be closely monitored for the emergence of suicidality. See: http://www.fda.gov/cder/drug/antidepressants/AntidepressanstPHA.htm
————-
Robin McCall
Media Relations
Baum Hedlund