Healthy Skepticism Library item: 16151

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Publication type: news

Weidlich T, Cronin Fisk M.
Merck Won’t Face Punitive Damages in Fosamax Trial (Update2)
Bloomberg.com 2009 Jul 29
http://www.bloomberg.com/apps/news?pid=20601202&sid=a.sNhdoD7Hcg

Full text:

Merck & Co., facing more than 850 lawsuits over claims that its osteoporosis drug Fosamax may cause irreversible “jaw rot,” won’t face punitive damages in the first trial, a federal judge said.

U.S. District Judge John Keenan said at a hearing today in New York that he’ll release a decision as early as July 31 knocking out the possibility of punitive damages in the case. He’ll deny Merck’s request to rule in its favor on liability, which means the case will go to trial Aug. 11, he said.

“I am not granting summary judgment on anything else,” Keenan said.

Keenan has scheduled three so-called bellwether trials through January to show each side the other’s strategy and possibly point the way to settlements. The judge earlier denied the plaintiffs’ request to treat the litigation as a class, or group, lawsuit allowing them to ask for court-ordered medical monitoring of all Fosamax users.

The Fosamax patients claim Merck misrepresented the drug’s safety and failed to warn doctors and patients that it might hamper blood flow to the jaw, causing jawbone-tissue death and leading to partial removal in some patients. Jawbone tissue death is called osteonecrosis of the jaw, or ONJ. Merck, based in Whitehouse Station, New Jersey, has denied that Fosamax causes deterioration of the jawbone.

‘Just the Gravy’

“The punitive damages are just the gravy,” Timothy O’Brien, a lawyer for the plaintiffs, said after the hearing. “This woman has sufficient compensatory damages with her stage 3 ONJ,” he said, referring to Shirley Boles, the plaintiff in the first case. O’Brien is with Levin Papantonio Thomas Mitchell Echsner & Proctor PA in Pensacola, Florida.

“We are satisfied with the court’s ruling and agree that this case does not call for punitive damages because Merck acted appropriately in providing information to the medical, scientific and regulatory communities in a responsible and appropriate manner,” Paul Strain, a lawyer for Merck at Venable LLP in Washington, said in an e-mailed statement.

Fosamax, available in pill form or as an oral solution, is part of a group of medicines known as bisphosphonates. The only cases of “jaw necrosis” have been found in the drugs’ users and cancer patients receiving chemotherapy, according to Mahyar Etminan, a pharmacy expert for the patients. Users of intravenous bisphosphonates are more likely to contract ONJ than are users of the lower-dose oral version, Etminan said.

Boles, 71, of Walton Beach, Florida, says she used Fosamax from 1997 to 2006 and eventually developed ONJ.

Duty to Warn

She argues Merck had a duty to change the Fosamax label to warn doctors about a connection to the disease as early as the mid-1990s. She also said her condition worsened because the company’s failure to warn meant she kept taking the drug.

Merck and Boles disagree about when she was diagnosed with the condition. Keenan said today the evidence showed “she developed her injury by September 2003 at the latest” and he won’t allow evidence about Merck’s conduct after that date.

Merck has argued that any failure to warn doctors didn’t cause her injuries and that they wouldn’t have been less severe had it changed the label in October 2003. Her doctor continued to prescribe the drug after the warning was added in July 2005, according to Merck’s court papers.

The evidence will show that Fosamax didn’t cause Boles’s medical problems, Strain, the Merck lawyer, said in the statement.

‘Medical Problems’

“Unfortunately, Ms. Boles had medical problems that cause people to develop jaw problems, regardless of whether they were taking Fosamax,” including periodontal disease and a history of smoking, he said.

Merck, which is buying rival Schering-Plough Corp., had a reserve of about $24 million for the litigation, including lawyers’ fees, as of March 31, having spent $9 million on the cases in the first quarter, the company said in May. It hasn’t set aside any money to pay damages, it said.

Sales of Fosamax last year, when the drug first faced U.S. generic competition, fell by half to $1.55 billion from $3.05 billion in 2007. Sales fell 44 percent to $261.3 million in this year’s first quarter, Merck reported in April.

Keenan said today he won’t allow any evidence at the trial about how much money Merck made on Fosamax for fear it would sway the jury that any award would be “a drop in the bucket” for the drug company.

“So sales, profits — it’s not in the case,” he said.

856 Cases

As of March 31, Merck faced about 856 Fosamax cases, including suits with multiple patients, in state and federal court, the company said. About 700 of the lawsuits have been consolidated before Keenan in New York federal court for evidence-gathering. About 130 cases are before Judge Carol Higbee in state court in Atlantic City, New Jersey, Merck said.

Merck fell 15 cents to $29.87 in New York Stock Exchange composite trading.

The lawsuits are combined in In Re Fosamax Products Liability Litigation, MDL 1789, U.S. District Court, Southern District of New York (Manhattan).