N.J. verdict could affect many bone-drug suits

ATLANTIC CITY - What Merck & Co. knew about risks associated with its popular osteoporosis drug Fosamax and when are the crux of a product-liability trial under way to determine whether the pharmaceutical giant is liable for a Montgomery County woman's painful jawbone loss.

Alison Rosenberg, 67, of Wyncote, never had osteonecrosis, in which bones decay and die, contend lawyers for Merck, based in Hunterdon County, N.J.

Company representatives say that her oral health problems and use of steroids to treat various conditions led to the degeneration and that it was unrelated to Fosamax use.

Neither Rosenberg, who used the drug between 1999 and 2006, nor her physician, Debra Somers of Philadelphia, was aware of concerns that the Food and Drug Administration expressed to Merck in 2004 about the possible connection between osteonecrosis of the jaw and oral bisphosphonates such as Fosamax, according to the lawsuit.

Rosenberg's lawyers assert that Merck continued to market and distribute Fosamax without changing its warning label. The lawsuit says the drug caused the eventual death of a portion of Rosenberg's jawbone after a tooth extraction in March 2005. She underwent outpatient surgery five times at the Hospital of the University of Pennsylvania to file, scrape, and drill away the bone and is in chronic pain, her lawyers said.

The trial, before Judge Carol B. Higbee in Atlantic County Superior Court, is the fourth involving such claims and could help guide settlements in nearly 1,200 similar lawsuits involving Fosamax. The case wrapped up Thursday; jury deliberations are to resume Monday.

After FDA approval in 1995, Merck sold the drug alendronate sodium under the name Fosamax, saying it would increase bone density in postmenopausal women. The drug also has been prescribed to men.

According to Rosenberg's lawyers, studies published as early as 2000 showed that oral bisphosphonates could increase the risk of osteonecrosis of the jaw - known as ONJ or "jaw death" - in addition to joint pain, constipation, and diarrhea.

In her closing argument Wednesday, Merck's lawyer, Christy D. Jones, said the company had done everything it could to inform health-care providers about all possible side effects in a timely manner.

Lawyers for Rosenberg said her physician, Somers, had written to Merck for information about the drug's role in ONJ in summer 2005. That October, Merck informed Somers that it had updated its packaging in July to indicate ONJ had been "observed" among users of bisphosphonates.

"Merck, indeed, provided an adequate warning to Dr. Somers," Jones said in her summation.

Had she known earlier, Somers testified, she never would have prescribed the drug.

About 20 million people have used Fosamax since it was introduced, according to Merck literature. Annual sales were as high as $810 million before the drug became available as a generic in 2008, according to the company's regulatory filing.

Attorney Paul Sizemore of Los Angeles, who is representing Rosenberg, contended that Fosamax had been such a revenue generator, and so close to ending its brand-name exclusivity, that Merck dragged its feet in publicizing all side effects.

During the trial, which began Jan. 24, Sizemore presented e-mails and reports by Merck scientists and physicians that he said showed in-house concern about Fosamax during the height of its sales. Despite the FDA warning and inquiries from concerned physicians and patients, he said, Merck was slow in changing its labeling.

That was information "every person in this room deserved to know as soon as it became available," Sizemore told the jury.

Jones, of the firm Butler, Snow, O'Mara, Stevens & Cannada in Ridgeland, Miss., countered that Rosenberg's osteonecrosis diagnosis had been incorrect and that Fosamax had played no role in her condition. Jones said that studies had shown Fosamax to be safe and effective, and that there was no evidence specifically linking it to osteonecrosis.

Rosenberg v. Merck is the first Fosamax trial to be held in state court and the first jury trial. Three previous trials were held in U.S. District Court in Manhattan, where about 1,200 lawsuits from across the United States have been consolidated.

The trials resulted in two verdicts in favor of Merck and a verdict in which the plaintiff was awarded $8 million. A judge reduced that award to $1.5 million.

The trials, in addition to two others set for federal court, will be used as so-called bellwether cases to determine how juries respond to evidence, testimony, and oral arguments. Bellwether trials are often test cases in complicated product-liability litigation and can influence out-of-court settlements. U.S. District Judge John F. Keenan of the Southern District of New York recently requested that two additional cases go to trial as bellwethers.

About 300 cases in New Jersey have been centralized for "mass tort" treatment before Higbee. It is unclear whether they will be tried individually, a court spokesman said.

Merck and the makers of generic Fosamax also face a growing number of lawsuits involving the use of the drug by patients who suffered femur fractures after low- or no-impact falls. The latest was filed Jan. 4 in U.S. District Court in New Jersey for a Massachusetts woman.