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Fosamax Causes 'Bone Death,' Florida Class Suit Says
  By RONALD V. BAKER, Andrews Publications Staff Writer
A 60-year-old Florida woman has filed a national class-action suit alleging Merck & Co. Inc. failed to warn consumers that Fosamax, a drug used to increase bone density, actually causes bone death in the jaw.
Linda Secrest says she had used the Merck drug for about five years to combat osteoporosis when she was diagnosed with osteonecrosis, or bone death, in April 2005. Now, she says, she has a small area of exposed jawbone in her mouth.
Her lawsuit, filed in federal court in Fort Myers, Fla., seeks medical monitoring for Fosamax users.
Secrest also wants an order forcing Merck to comply with Food and Drug Administration requests that the company revise the drug's label to warn patients and doctors about the risks of jaw osteonecrosis.
According to the complaint, Merck put Fosamax on the market in 1995 without adequate testing and, despite FDA requests, has refused to add warnings about bone death to its packaging.
The suit says Fosamax produces $3 billion in sales for Merck and that the company refuses to change its label out of fear of lost profits.
Secrest alleges Merck has been well aware of the connection between Fosamax and jawbone death because a series of medical articles and studies throughout the 1990s and 2000s reported the problem.
She says the drug's chemical makeup "creates a compromised vascular supply in the affected area" that can turn a minor injury or disease into a non-healing wound and, later, widespread bone death.
The suit says that instead of "evaluating and verifying the safety" of Fosamax, Merck seeks even more widespread use of the drug. Through the variant Fosamax-D, Merck is seeking to extend its market exclusivity period for the product through 2018, the complaint says.
The class suit seeks punitive damages and includes claims against the New Jersey-based Merck for negligence, strict liability, breach of express and implied warranties, fraudulent misrepresentation, and fraudulent concealment.
The case was reassigned to U.S. District Judge Virginia Covington of the Middle District of Florida three days after it was filed when Judge John E. Steele, first charged to manage the dispute, recused himself because he owns Merck stock.
Secrest et al. v. Merck & Co. Inc., No. 2:06-cv-191, complaint filed (M.D. Fla.,
Fort Myers Div. Apr. 10, 2006).
Pharmaceutical Litigation Reporter
Volume 22, Issue 03
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