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"Worldwide" Class Action Seeks Damages, Withdrawal of Serzone
Drug Recall Litigation Reporter
A federal class action lawsuit filed in Illinois seeks to establish a worldwide class of millions of people who have taken the anti-depressant Serzone since it went on the market in 1994. The drug has allegedly caused 23 cases of liver failure and 109 cases of liver damage. Sixteen of those users who developed liver failure either died or had to have a liver transplant, the plaintiffs claim. Galyean v. Bristol-Myers Squibb Co. Inc., No. 02C 2748, complaint filed (N.D. Ill., Apr. 16, 2002).
Serzone, the brand name for nefazodone hydrochloride , is manufactured by Bristol-Myers Squibb Company Inc., the sole defendant in the suit.
The named plaintiffs are Chrissy Ann Galyean of Lombard, Ill., who suffered mild seizures, stomach pains, headaches, dizziness, sleeplessness and nervousness after taking Serzone; James A. Johnson of Leslie, Mo., who may have liver damage as a result of taking the drug; and Edward L. Warren of Lompoc, Calif., who has suffered from extreme fatigue and deteriorating vision and also may have liver damage as a result of taking Serzone.
In addition to liver injuries and failure, the side effects of the drug can include dizziness; lightheadedness; drowsiness; blurred vision; dry mouth; prolonged, painful or inappropriate erections which may require surgery; or allergic reactions such as hives, difficulty breathing, closing of the throat, or swelling of the lips, tongue or face, the complaint alleges.
According to the lawsuit, the Food and Drug Administration granted Bristol-Myers approval to market Serzone as an anti-depressant on Dec. 22, 1994. In January 1999 the FDA required Bristol-Myers to change the safety label to include post-marketing adverse effect reports that showed that Serzone is associated with "rare reports of liver necrosis and liver failure, in some cases leading to liver transplantation and/or death." The FDA again required Bristol-Myers to change the label in January 2001 to remove the word "rare" from the 1999 statement.
Finally, on Dec. 4, 2001, the FDA required Bristol-Myers to include a "black box" warning on the safety label for Serzone because of the drug''s liver toxicity. A black box warning is the most serious form of notice the manufacturer can be required to give to physicians and patients. The warning is set off in a heavily outlined black square on the product''s package insertions so as to catch the attention of the health-care provider prescribing the drug and the patient taking it.
The lawsuit, filed in U.S. District Court for the Northern District of Illinois, seeks certification of a class of all persons throughout the world who were prescribed, p urchased, used and/or ingested Serzone. The proposed class includes four subclasses: all those who have taken the drug but have not yet manifested any injury (the medical monitoring subclass); all those who allege physical injuries or death as a result of taking Serzone (the injuries subclass); all those who seek a refund of the cost of the drug (the refund subclass); and all those who claim relief pursuant to the New York Consumer Protection Act (the consumer protection subclass).
The complaint alleges that the plaintiff class would be made up of hundreds of thousands of people in the United States and millions throughout the world who have taken Serzone, making them too numerous for individual actions to be practical.
The complaint cites 12 claims for relief: strict product liability (failure to warn), strict product liability (manufacturing and design defect), negligence, negligent manufacture, negligence per se, negligent misrepresentation, breach of implied warranty, breach of express warranty, unjust enrichment, wanton disregard, violations of the New York Consumer Protection Act and loss of consortium.
The negligent misrepresentation claim alleges that from the time Serzone was first manufactured, Bristol-Myers made false misrepresentations to the plaintiffs, their physicians and the general public that Serzone was safe, fit and effective for human consumption, without any reasonable grounds for believing that to be true.
The plaintiffs seek certification of the proposed class and subclasses and the appointment of Kenneth B. Moll of Kenneth B. Moll & Associates Ltd. in Chicago as the lead class counsel. They also seek an injunction to bar Bristol-Myers from continuing to manufacture and sell Serzone and a court order forcing the company to recall all supplies of Serzone remaining on the market.
The plaintiffs are also asking the court to establish and oversee a medical monitoring program to be funded by Bristol-Myers to periodically test class members to detect the development of any injuries caused by the drug.
Finally, the complaint seeks compensatory damages, punitive damages, prejudgment and post-judgment interest, damages for past and future mental and emotional distress, refunds of all purchase costs of the drug, dis-gorgement of profits, and court costs and attorneys' fees.
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