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Merck Starts New Trial on Fosamax Broken-Leg Claims

Merck & Co. is fighting a woman’s claim that its osteoporosis drug Fosamax weakened her femur, causing her leg to break when she fell in her driveway -- the first of thousands of such cases that could get a jury verdict.

A three-week trial started today before U.S. District Judge Joel Pisano in Trenton, New Jersey, involving medical experts on both sides of the dispute over the fracture suffered by Bernadette Glynn in April 2009. Merck claimed that Glynn, 58, tripped over a chainsaw in her garage and that the fracture is typical of women with osteoporosis.

It’s the second thighbone-fracture case against Whitehouse Station, New Jersey-based Merck to reach a jury. The earlier trial, in state court in Atlantic City, New Jersey, was called off after plaintiff Christina Su suffered a severe health problem last month that was unrelated to her use of Fosamax. Su died April 1, her lawyer Karen Menzies said today.

“It is a tragic loss,” Menzies said in an e-mail. “Ms. Su was committed to going forward with her trial -- she was on Fosamax over five and half years” and never had osteoperosis.

Merck, the second-biggest U.S. drugmaker, is accused in more than 3,300 lawsuits of ignoring signs that extended use of bisphosphonates such as Fosamax caused femurs to deteriorate in some patients. The company has said it faces another 1,230 cases alleging Fosamax caused similar fractures in jaws. Glynn’s case could be a bellwether, revealing litigation strategy and potential damages awards.

“Merck is saddened to hear of the passing away of Mrs. Su and our condolences are with her family,” Lainie Keller, a spokeswoman for the company, said in an e-mail today.

A jury was selected today in Glynn’s case and opening statements by the parties are scheduled to begin tomorrow.

Claims Rejected

In a statement before the new trial, Merck rejected Glynn’s claims that it didn’t properly study Fosamax before releasing it to the public.

“Unfortunately, the plaintiff had medical conditions and risk factors that cause people to have fractures,” Chilton Varner, a lawyer for Merck at King & Spalding LLP, said in the e-mailed statement. “The evidence will show that the plaintiff was at risk of sustaining a fragility fracture and that Fosamax significantly reduced, but could not eliminate that risk.”

About two months ago, Merck said it expected profit to decline this year because of generic competition to its top-selling Singulair and research setbacks that slowed efforts to get new drugs to market.

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. The drug is often prescribed for osteoporosis in women and for cancer sufferers worried about fractures from weakened bones.

Felt ‘Pinch’

Glynn said in her complaint that on April 17, 2009, she felt a “pinch” in her right leg when she bent over to pick something up in her driveway.

“She then attempted to take a step, but fell and sustained a fracture on her right femur,” according to the complaint. Her leg was ultimately repaired with a rod and screws, it said.

Glynn had taken the drug over a period of seven years, starting in 2002, and it was prescribed by four doctors and one nurse, Merck said in court papers. Glynn said in court papers she started taking the drug a year earlier, in 2001.

Glynn and her husband, Richard Glynn, residents of Cohoes, New York, sued Merck in September 2011, alleging Fosamax causes “serious and sometimes fatal injuries.” While the drug increases bone-mass density, the effect doesn’t always correspond to a reduction in fracture risk, they said in the complaint. The compound can cause bones to become “highly mineralized, homogeneous, brittle,” they said.

Glynn’s lawyer, Edward Braniff, didn’t return a call for comment on the trial.

Thighbone Breaks

Researchers said in 2010 that Fosamax and competing bone-loss drugs may be linked to increased risks of thighbone 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.

The case may hinge on whether the jury accepts Glynn’s injury was a so-called atypical femur fracture -- the type discovered to be a risk of Fosamax only after it was approved by regulators and sold to the public.

Merck has argued that Glynn’s doctors would have prescribed the drug even if they had been aware of the risk.

“Ms. Glynn’s Fosamax prescribers testified that today -- several years after the possible risk of femur fracture was added to the Fosamax label -- they still believe their decision to treat Ms. Glynn with Fosamax was appropriate,” Merck said in a motion in January to dismiss the claims. The request was partially denied by Pisano at a hearing on April 2.

The drugmaker claims there’s no evidence that a different warning on the label would have prevented her doctors’ decision to prescribe Fosamax to treat Glynn’s osteoporosis.

FDA Information

“There is not a scintilla of evidence that Merck knowingly withheld from FDA or misrepresented to FDA any information related to the risk of femur fracture,” Merck said in the filing.

In preparation for the trial, Pisano ruled on March 8 that Merck couldn’t block testimony or evidence about the short-term effectiveness of Fosamax. He granted the drugmaker’s bid to block evidence about e-mails containing opinions of non-Merck employees regarding the drug’s effectiveness, calling them “inadmissible hearsay.”

In the same ruling, Pisano said Glynn could only use so-called adverse event reports -- formal descriptions of similar injuries suffered by other people -- to show whether Merck had been properly notified of a possible connection between Fosamax and that injury.

Diagnoses ‘Skyrocket’

Fosamax and other osteoporosis drugs have become widely over-prescribed and diagnoses of the ailment have “skyrocketed” since the assessment method shifted from the use of clinical criteria such as prior bone fracture to testing bone-mass density instead, according to the complaint. The World Health Organization is probing the “arbitrary” diagnosis, Glynn’s lawyers said in the complaint.

Merck was able to inflate the effectiveness of Fosamax by calculating its reduction of so-called relative risk instead of “absolute risk.”

“Billions of dollars are being spent on a drug that has questionable utility for the ultimate goal of fracture reduction,” Glynn said in the complaint.

In the Su case, Christy Jones, a lawyer for Merck, told jurors that the woman had no evidence to support claims the drugmaker turned a blind eye to Fosamax’s safety problems.

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

The cases are Glynn v. Merck & Co., 3:11-cv-05304, U.S. District Court, District of New Jersey (Trenton); and Su v. Merck & Co., ATL-L-0789-11-MT, Superior Court of New Jersey (Atlantic City).

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