Drug caused osteonecrosis of jaw, plaintiff claimed
|Design Defect, Products Liability - Failure to Warn, Products Liability - Breach of Warranty, Products Liability - Pharmaceutical|
|Barbara Davids and Helene Deutsch v. Novartis Pharmaceuticals Corporation, No. 06 431|
|U.S. District Court, Eastern District, NY|
|Arthur D. Spatt
- John J. Beins; Beins, Goldberg & Hennessey, LLP; Chevy Chase, MD, for Barbara Davids
- John J. Vecchione; Valad & Vecchione, PLLC; Fairfax, VA, for Barbara Davids
- Richard Kraut D.D.S.; Oral Surgery; Bronx, NY called by: John Vecchione, John Beins
- Robert Marx D.D.S.; Maxillofacial Surgery; Miami, FL called by: John Vecchione, John Beins
- Wayne Ray Ph.D.; Epidemiology; Nashville, TN called by: John Vecchione, John Beins
- Suzanne Parisian Ph.D.; FDA New Drug Review/Approval Procedures; Phoenix, AZ called by: John Vecchione, John Beins
- Salvatore Ruggiero D.M.D., M.D.; Oral Surgery; West Islip, NY called by: John Vecchione, John Beins
- Bruce J. Berger; Hollingsworth LLP; Washington, DC, for Novartis Pharmaceuticals Corp.
- Jacqueline Bushwack; Rivkin Radler LLP; Uniondale, NY, for Novartis Pharmaceuticals Corp.
- Robert E. Johnston; Hollingsworth LLP; Washington, DC, for Novartis Pharmaceuticals Corp.
- Kenneth Fleisher M.D.; Maxillofacial Surgery; New York, NY called by: Bruce Berger, Jacqueline Bushwack, Robert Johnston
- Graham Russell M.D.; Skeletal Biology; Oxford, MA called by: Bruce Berger, Jacqueline Bushwack, Robert Johnston
- Janet Arrowsmith; FDA New Drug Review/Approval Procedures; Ruidoso, NM called by: Bruce Berger, Jacqueline Bushwack, Robert Johnston
In October 2003, plaintiff Barbara Davids, 56, a bank's teller, commenced use of a bisphosphonate: Zometa, which is manufactured by East Hanover, N.J.-based Novartis Pharmaceuticals Corp. Davids was suffering cancer of a breast, and the drug's administration was intended to suppress metastatic damage of her bones.
In January 2005, a doctor determined that Davids was suffering osteonecrosis of her jaw. The doctor opined that the condition was a by-product of Davids' use of Zometa. Davids' osteonecrosis ultimately necessitated the removal of portions of her jaw.
Plaintiff's decedent Helene Deutsch also suffered cancer of a breast. Her treatment included the administration of Zometa and another drug that Novartis Pharmaceuticals manufactured, Aredia. Deutsch also developed osteonecrosis of her jaw, and she also claimed that her osteonecrosis was a result of her use of Novartis Pharmaceuticals' drugs.
Davids and Deutsch sued Novartis Pharmaceuticals. They alleged that Aredia and Zometa were inherently dangerous drugs that caused osteonecrosis, that Novartis Pharmaceuticals was aware of the drugs' dangerous effects, that the company failed to provide warnings that adequately disclosed that danger, and that that failure constituted a breach of Zometa's implied warranty of merchantability.
Deutsch died after the suit had been filed. Her estate and Novartis Pharmaceuticals ultimately negotiated a pretrial settlement. Terms were not disclosed. The matter proceeded to a trial that addressed Davids' claims.
Plaintiffs' counsel claimed that Novartis Pharmaceuticals knew that Zometa caused osteonecrosis, and they contended that that knowledge dated to the initial testing of the product. They presented documents that had been written by employees of Novartis Pharmaceuticals. The documents' topics included Zometa's link to osteonecrosis, evaluations of studies that confirmed the link and potential preemptive responses to those studies. Some documents dated to May 2003. Plaintiffs' counsel also noted that Zometa's harmful effects were deeply explored in a May 2004 article that was published by the Journal of Oral and Maxillofacial Surgery. The article's author, Salvatore Ruggiero, agreed that Zometa caused Davids' osteonecrosis.
Plaintiffs' counsel further claimed that Zometa's label and instructions did not satisfy governmentally mandated guidelines that addressed the disclosure of potential hazards. They contended that the drug's original label and instructions did not mention osteonecrosis, and they claimed that revisions did not clearly warn that osteonecrosis could stem from the drug's use.
Defense counsel contended that evidence has not established that Zometa caused osteonecrosis, and they claimed that Davids' osteonecrosis was a result of her cancer. They also claimed that Zometa's label and packaging included warnings that adequately disclosed the drug's potential effects.
In November 2004, Davids developed osteonecrosis of her jaw. The condition was diagnosed in January 2005.
Davids' jaw became infected and swollen, and her mouth emitted a foul odor. Her jaw's weakened condition caused the loss of several teeth. She claimed that her disfigurement caused anxiety, discomfort, embarrassment and fear, and she contended that she could not easily chew.
In 2006, Davids underwent the first of several procedures that involved the removal of necrotic portions of her jaw. The procedures continued until 2008, and they included the implantation of dentures that replaced teeth that had been lost.
Davids claimed that her disfigurement caused anxiety, discomfort, embarrassment and fear. She also claimed that she suffers permanent residual numbness of one side of her face.
Davids sought recovery of damages for past and future pain and suffering. She also sought punitive damages.
Defense counsel contended that Novartis Pharmaceuticals did not exhibit the reckless conduct that would have warranted an award of punitive damages.
The jury found that Novartis Pharmaceuticals did not adequately disclose the hazards that could stem from Zometa's use, that the company's failure constituted a breach of Zometa's implied warranty of merchantability, and that Davids' osteonecrosis was caused by her use of Zometa. It determined that Davids' damages totaled $10.45 million.
$10,000,000 Personal Injury: Punitive Exemplary Damages
$350,000 Personal Injury: Past Pain And Suffering
$100,000 Personal Injury: Future Pain And Suffering
Defense counsel has moved for a mistrial.
This report is based on court documents and information that was provided by plaintiffs' counsel. Defense counsel did not respond to the reporter's phone calls.