-Bloomberg

08/10/2009 - Merck & Co., the drugmaker facing 900 lawsuits over claims that its osteoporosis drug Fosamax causes the death of jawbone tissue, goes to trial tomorrow in a case that may affect all the others.

The trial in New York of the first case of the group, filed by Shirley Boles, 71, will be one of three so-called bellwether cases that may point the way to out-of-court settlements.

“In mass litigation, all eyes are on the first trial, not only because it shows the strategy of each side, but also because it’s the first information about how jurors respond to the evidence,” said Howard Erichson, a law professor at Fordham University in New York and an expert on civil procedure.

Merck faced about 900 Fosamax cases as of June 30, including suits with multiple patients, the company said in an Aug. 3 regulatory filing. Whitehouse Station, New Jersey-based Merck, which is buying rival Schering-Plough Corp., had a reserve of about $42 million for the litigation, including lawyers’ fees, it said. It hasn’t set aside any money to pay damages, it said.

There are as many as 1,200 plaintiffs in state and federal cases, Merck says. Timothy O’Brien, a lawyer representing about 400 plaintiffs, said the number is closer to 2,000.

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.

On July 29, U.S. District Judge John Keenan said he won’t allow any evidence at the Boles trial about how much money Merck made on Fosamax since jurors might think any award would be “a drop in the bucket” for the company.

No Punitive Damages

He ruled out the possibility of punitive damages in the case and rejected Merck’s request to find in its favor without a trial.

Keenan last year denied the patients’ request to treat the litigation as a class-action, or group, lawsuit allowing them to ask for court-ordered medical monitoring of all Fosamax users.

The Fosamax plaintiffs 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.

The patients claim Merck didn’t sufficiently warn about the drug’s risks when it changed the label in 2005. “They were the only drug company not to use the language that the FDA requested,” O’Brien said, referring to the U.S. Food and Drug Administration.

Merck’s Position

Merck disputes the claims, saying there’s no reliable evidence the medicine causes the bone condition.

“Merck acted appropriately in providing information to the medical, scientific and regulatory communities,” Paul Strain, a lawyer for the company at Venable LLP in Washington, said in a July 29 e-mailed statement.

Fosamax, available in pill or liquid form, 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 intravenously injected bisphosphonates, which Merck doesn’t make, are more likely to contract the condition than users of the lower-dose oral version, Etminan said.

Boles, of Walton Beach, Florida, says she used Fosamax from 1997 to 2006 and eventually developed osteonecrosis. She argued in court papers that Merck had a duty to change the Fosamax label to warn doctors about a connection to the disease as early as the mid-1990s.

What Merck Knew

“Merck had notice through adverse reports starting in 1996,” her lawyer O’Brien, of Levin Papantonio Thomas Mitchell Echsner & Proctor PA in Pensacola, Florida, said in an interview. The company had “thousands of reports” of jawbone loss since, he said.

Merck and Boles disagree on when she developed her condition. Keenan, the judge, said July 29 that evidence showed “she developed her injury by September 2003 at the latest” and that he won’t allow evidence about Merck’s conduct after that. The jury must decide whether Merck had a duty to warn about Fosamax before then, he said in an Aug. 5 ruling.

Merck argues that one of Boles’s experts said the drugmaker didn’t have a duty to warn doctors until October 2003, when the first reports appeared in the medical literature connecting bisphosphonates and the jaw condition. That was after she developed the disease, the company says.

No Link

The company also argues 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.

“We’re going to demonstrate that there’s no causal link between Fosamax and the plaintiff’s injury,” Strain said in a phone interview. “There isn’t any scientifically reliable evidence of causation.”

Boles had medical conditions, including periodontal disease and a history of smoking, that cause jaw problems, Strain said.

O’Brien said patients with dental problems are most vulnerable to developing ONJ by using Fosamax. “Those are the people at risk,” he said.

One issue raised in the litigation is whether Fosamax can cause the jawbone disease if taken for less than three years. Keenan last week postponed a decision on expert testimony he’ll allow on that issue in future trials. It won’t arise in Boles’s trial since she took the drug for a longer time.

Change of Mind

Robert Marx, chief of oral surgery at the University of Miami School of Medicine and one of the patients’ experts, originally said the medicine can’t cause the condition if taken less than three years. He has since changed his mind, he said in pretrial testimony.

Merck, citing Marx’s first position, is asking Keenan to dismiss cases involving less than three years of taking the drug. The company estimates as many as 25 percent of the Fosamax plaintiffs are in that category. O’Brien said it could be as many as 40 percent.

Two experts besides Marx are prepared to testify that Fosamax can cause ONJ before three years’ use, O’Brien said. “We’re real safe on the three-year issue,” he said.

Federal-court trials are scheduled for December and January. A trial is scheduled in Alabama state court later this year.

About 700 of the lawsuits have been consolidated before Keenan in New York federal court for evidence-gathering. About 140 cases are before Judge Carol Higbee in state court in Atlantic City, New Jersey, Merck said.

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

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