Merck Hid Fosamax’s Bone-Weakening Risks, Lawyer Contends

Merck & Co. officials hid the risks that its Fosamax osteoporosis drug could weaken bones and lead to femur fractures, a lawyer told a New Jersey jury in the first case raising such claims to come to trial.

Merck researchers ignored signs that extended use of drugs known as bisphosphonates, such as Fosamax, caused femurs to deteriorate in patients such as Christina Su, said Karen Menzies, one of Su’s lawyers, today in opening statements of the trial of the woman’s claims over the drug. Merck officials have said in securities filings that they face more than 3,300 lawsuits alleging Fosamax caused such fractures.

To ramp up Fosamax sales, Merck officials “disregarded safety risks” and pushed the drug for women who weren’t suffering from osteoporosis, Menzies said.

The trial in state court in Atlantic City comes more than a month after Whitehouse Station, New Jersey-based Merck said it expected profit to decline this year because of generic competition to its top-selling drug Singulair and research setbacks that slowed efforts to get new medicines to market.

Merck officials contend Fosamax didn’t cause the 67-year-old Su’s femur fracture and the company properly warned doctors and patients about the drug’s risks.

Christy Jones, a lawyer for Merck, told jurors today that Menzies had no evidence to support claims Merck turned a blind eye to Fosamax’s safety problems. The U.S. Food and Drug Administration repeatedly approved the medicine as safe and effective for women worried about bone-density loss, Jones said.

‘Fragility Fractures’

Merck’s lawyer also said Su’s medical records showed her bones were strengthened by her Fosamax use and that she fell into the category of women who were at risk for “fragility fractures.”

Medical evidence that will be presented in the four-week trial will show Su “suffered the same kind of fracture” suffered by women who didn’t take Fosamax, Jones said in her opening statement.

Fosamax, approved for sale in the U.S. in 1995, generated sales of as much $3 billion a year until patent protection lapsed in 2008 and it faced competition from generic rivals. The drug is often prescribed for osteoporosis in women and for cancer sufferers worried about fractures from weakened bones.

Merck has faced claims over Fosamax since 2009, when cases brought by women who blamed the drug for their jawbone deterioration began going to trial.

Court Victories

The company has won five of the seven cases weighed by juries on the jaw claims. In February, a federal-court jury in New York ordered the drugmaker to pay $285,000 to a woman who blamed the drug for her jawbone injuries.

Merck said in filings with the U.S. Securities and Exchange Commission that it faces 2,075 cases in state court in New Jersey alleging that Fosamax causes femur fractures. It faces another 850 cases consolidated before a federal judge in New York and 420 gathered in state court in Orange County, California, according to the filings.

Researchers said in 2010 that Fosamax and competing bone-loss drugs may be linked to increased risks of thigh-bone fractures. As many as 94 percent of 310 patients who had an uncommon type of fracture to the thigh bone were also taking a bisphosphonate-based drug, according a September 2010 report in the Journal of Bone and Mineral Research. Most had taken the medicine for more than five years, according to the report.

Metal Rod

Su, who lives outside New Brunswick, New Jersey, is a retired computer-systems analyst who took Fosamax for more than five years starting in June 2003, according to court filings. She suffered a broken right femur in 2009 and doctors later that year inserted a metal rod in her left femur to deal with stress fractures, according to the filings.

To protect Fosamax sales, Merck officials for 15 years ignored studies and side-effect reports indicating that long-term Fosamax use put women taking it to prevent osteoporosis at risk for “atypical femur fractures,” Menzies told jurors today.

In 2006, a Merck official based in Singapore sent an e-mail to company executives warning of reports that Fosamax users in that country were suffering from “brittle bones,” Menzies said. Merck only took serious notice of the drug’s red flags in 2008 after it came off patent, she said.

The reports indicated that Fosamax, which was supposed to protect women from femur fractures, “was causing them instead,” Menzies said.

The case is Su v. Merck & Co., ATL-L-0789-11-MT, Superior Court of New Jersey (Atlantic City).

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