Drug's label didn't disclose all risks, plaintiff alleged
|Failure to Warn, Products Liability - Design Defect, Products Liability - Pharmaceutical|
|Rhoda E. Scheinberg v. Merck & Co., Inc., No. 1:08-cv-4119|
|U.S. District Court, Southern District, NY|
|John F. Keenan
- Timothy M. O'Brien; Levin, Papantonio,Thomas, Mitchell, Rafferty & Proctor, P.A.; Pensacola, FL, for Rhoda E. Scheinberg
- Alastair Goss D.D.S.; Oral Surgery; Adelaide, Australia called by: Timothy O'Brien
- Barbara Dunn; Internal Medicine; Bronx, NY called by: Timothy O'Brien
- Richard Kraut D.M.D.; Oral Surgery; Bronx, NY called by: Timothy O'Brien
- Suzanne Parisian M.D.; FDA New Drug Review/Approval Procedures; Phoenix, AZ called by: Timothy O'Brien
- Chilton Davis Varner; King & Spalding; Atlanta, GA, for Merck & Co. Inc.
In September 2000, plaintiff Rhoda Scheinberg, a retiree in her 60s, began prescribed use of Fosamax, which is an orally ingested drug that inhibits the resorption of bone. The drug was intended to reduce Scheinberg's likelihood of sustaining a fracture of a bone. Scheinberg's doctor had detected deficiency of the mass of Scheinberg's bones, though she did not definitively diagnose the often-associated clinical condition: osteoporosis.
In October 2006, Scheinberg learned that she was suffering osteonecrosis of her jaw. She claimed that the condition was a result of her use of Fosamax.
Scheinberg sued Fosamax's manufacturer, Whitehouse Station, N.J.-based Merck & Co. Inc. She alleged that the drug was defectively designed. She further alleged that Merck failed to provide warnings that disclosed the dangers that could have stemmed from the drug's use.
Plaintiff's counsel claimed that Fosamax's label inaccurately stated that the product could prevent fractures of non-osteoporotic bones. He contended that studies had demonstrated that the drug could not provide such a benefit, and he claimed that the drug's benefits did not extend to patients who did not suffer osteoporosis.
Plaintiff's counsel also claimed that Merck had known that Fosamax could cause osteonecrosis of the user's jaw, but that that risk was not disclosed by the product's label. They contended that the U.S. Food and Drug Administration had mandated use of a standardized label that disclosed the risks that could have stemmed from the use of orally ingested drugs that addressed osteoporosis, but that Merck used a customized label that did not adequately disclose Fosamax's associated risks. Scheinberg's treating doctor claimed that accurate warnings may have altered her belief that the drug could have benefited Scheinberg. Plaintiff's counsel argued that the drug's associated risks outweighed any benefits that it may have provided.
Defense counsel contended that the U.S. Food and Drug Administration had determined that Fosamax's potential benefits outweighed its risks. She also contended that the agency had approved the label's warnings that addressed osteonecrosis, and she claimed that the label adequately disclosed the drug's associated risks. She contended that those risks should have been readily understood by Scheinberg's doctor.
Defense counsel also contended that Fosamax was not defective. She claimed that the drug provided excellent benefits. The defense's expert surgeon noted that Scheinberg's osteonecrosis developed after Scheinberg had undergone an extraction of a tooth. The expert contended that the extraction caused an infection that led to osteonecrosis.
In October 2006, Scheinberg underwent the extraction of a tooth. The underlying bone did not properly heal, and a doctor determined that the bone had developed osteonecrosis. Scheinberg claimed that the condition was a result of her use of Fosamax.
Scheinberg underwent two procedures that involved the debridement of necrotic bone. Her recovery spanned six months. She has fully healed.
Scheinberg sought recovery of damages for her past pain and suffering.
Defense counsel maintained that Scheinberg's osteonecrosis was not a result of Scheinberg's use of Fosamax.
The jury found that Fosamax was not defectively designed. However, it also found that Merck failed to provide warnings that disclosed the dangers that could have stemmed from the drug's use. It determined that Scheinberg's damages totaled $285,000, all for past pain and suffering.
This report is based on information that was provided by plaintiff's and defense counsel.