Fosamax Fracture Trial Begins

Merck Knew of Fosamax Bone Risk in ’90, Lawyer Tells Jury
By Erik Larson – Apr 9, 2013 1:18 PM CT

Merck & Co. (MRK) was aware its Fosamax osteoporosis treatment might cause brittle bones and increase fracture risks years before the drug was made available to the public, a lawyer told a jury at the start of a lawsuit trial.

Starting in 1990, five years before Fosamax won approval by U.S. regulators, consultants began warning Merck that the drug could lead to spontaneous fractures in some users by preventing bones’ natural daily repair of so-called micro-fractures, Paul Pennock, the lawyer for plaintiff Bernadette Glynn, said today in federal court in Trenton, New Jersey.

“This company should have warned of the problems that they saw coming,” Pennock said in his opening statements to the jury, while holding a life-size replica of a thigh bone. “The company should have warned of the problems they learned actually were happening — that’s an obligation of the company.”

Merck, based in Whitehouse Station, New Jersey, faces about 3,300 femur-fracture suits. Glynn, 58, may the first such claimant to get a jury verdict, after an earlier lawsuit ended in mistrial last month. The case may be a bellwether revealing litigation strategy and potential damages awards.

The trial before the jury of three men and five women chosen yesterday is scheduled to last three weeks and will hear from medical experts on both sides of the dispute.

‘Theoretical’ Warnings
The second-biggest U.S. drugmaker denies the claims. Its lawyer, Chilton Varner, said the consultants’ early warnings were “theoretical” and that early studies showed people who took Fosamax instead of a placebo had fewer fractures.

Glynn, an elementary school worker from Cohoes, New York, who regularly takes long bike rides and yoga classes, claims Fosamax weakened her femur over a seven-year period, causing the leg bone to snap in April 2009, when she bent over in her garage to pick up a frog-shaped lawn ornament while gardening.

Glynn’s leg was repaired with surgery and the use of rods, according to her complaint. She and her husband, who sued in September 2011, appeared in court today with their children. She has never had osteoporosis and was prescribed the drug due to low bone-mass density, her lawyer said.

Merck claims Glynn’s fracture was the result of her bone condition, and that tests showed Fosamax had helped. Merck also claims Glynn broke her leg after tripping over a chain saw in her garage and falling down — a description Merck says she gave to emergency workers on the day of the accident.

‘Spontaneous Fractures’
“You might think from what you’ve heard this morning that Fosamax causes these spontaneous fractures,” Varner said in her opening statements. “Such fractures occur in people who have never taken Fosamax as well as people who have — such fractures have occurred long before Fosamax.”

Merck also denies claims that doctors and patients weren’t properly warned when the company learned of reports that Fosamax could cause so-called atypical femur fractures in some people — a warning that went on the drug’s label in 2009.

Merck also says that regardless of what was on the label and when, Glynn’s fracture wasn’t atypical, because the break was spiral in nature instead of straight across, the bone broke into more than two pieces, and the wound healed quickly. Varner also said that Fosamax doesn’t accumulate in the part of the bone that fractured in Glynn’s case.

Strongest Bones
Pennock said femurs, as the strongest bones in the body, usually only break in high-force incidents, such as car accidents, and not from falling down. Because Fosamax is designed to repair daily bone damage by stopping the natural clearing of old bone, the process results in micro-fractures building up instead of being naturally replaced, he said.

“The evidence is going to show you that it wasn’t a surprise — it wasn’t coming out of the blue,” he said of Merck’s discovery of Fosamax’s possible fracture risks. “They looked for it and studied it — when all the information starting coming in, they did nothing about it.”

The company faces another 1,230 cases alleging Fosamax caused similar fractures in jaws.

The case is Glynn v. Merck Sharp & Dohme Corp., 3:11- cv-05304, U.S. District Court, District of New Jersey (Trenton)

To contact the reporter on this story: Erik Larson in federal court in Trenton, New Jersey, at elarson4@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net