Merck's Fosamax and osteonecrosis - ding ding end of Round 2

Merck Wins Second Fosamax Trial on Jaw Death Claims (Update2)

By Thom Weidlich

May 5 (Bloomberg) -- Merck & Co. won the second case to go to trial over claims its osteoporosis drug Fosamax causes so- called jaw death.

Louise Maley of Muncie, Indiana, said she developed osteonecrosis of the jaw, or ONJ, by taking Fosamax, in a complaint filed in May 2006. A federal jury in Manhattan ruled today that Maley didn’t have ONJ.

“Unfortunately, the plaintiff had multiple medical conditions that cause people to develop the jaw and dental problems she claims she has, regardless of whether they were taking Fosamax,” Christy D. Jones, a lawyer for the drugmaker, said in a statement after the verdict.

The trial, overseen by U.S. District Judge John Keenan, began April 19. In September, Keenan declared a mistrial in the first Fosamax case to go to a jury over claims that the drug might hamper blood flow to the jaw, causing jawbone-tissue death. That jury couldn’t reach a unanimous verdict. The case is to be retried in June.

“The jury found that this particular patient didn’t have ONJ,” Timothy M. O’Brien, a lawyer for Maley, said in a phone interview. “The jury never had to get to the bigger picture issues like failure to warn.”

Merck, based in Whitehouse Station, New Jersey, as of Dec. 31 faced about 978 Fosamax cases, including suits with multiple patients, the company said in a March 30 regulatory filing. About 771 lawsuits have been consolidated before Keenan for evidence gathering.

Throat Irritation

Maley took Fosamax from at least January 1998 to March 2006 to prevent osteoporosis, according to court papers. She stopped taking it due to a throat irritation, according to Merck.

The drugmaker argued in court papers that Maley didn’t offer any evidence Fosamax causes ONJ or that it caused her jaw condition. She was never diagnosed with ONJ, it said.

Instead, she was diagnosed in 2005 with a different condition, neuralgia-inducing cavitational osteonecrosis, or Nico, the company said. That condition doesn’t necessarily imply dead bone, Merck said. It’s characterized by diminished blood flow in the jaw’s bone marrow, causing spaces of marrow to dry out and become hollow, it said.

Maley said in court papers that at least three experts put in reports or pretrial testimony stating that Fosamax causes ONJ. She also said she has ONJ, not Nico, and it was caused by Fosamax.

‘Acted Appropriately’

“Merck presented evidence that it acted appropriately in researching and developing Fosamax and in monitoring the medicine after it was placed on the market,” the company said in its statement today.

Merck had Fosamax sales of $1.1 billion in 2009, compared with $1.55 billion in 2008, the first year the drug faced U.S. generic competition. Sales in 2007 were $3.05 billion.

“We asked for $100,000,” said O’Brien, Maley’s lawyer. “Merck spent over $2 million trying the case. The shareholders really need to wonder when is this going to end. Why has Merck spent more than $100 million defending a little over 1,000 cases?”

O’Brien is with Levin Papantonio Thomas Mitchell Echsner & Proctor PA in Pensacola, Florida. Jones, the lawyer for Merck, is with Butler, Snow, O’Mara, Stevens & Cannada PLLC in Jackson, Mississippi.

Bellwether Trials

Keenan, the judge who’s overseeing the federal Fosamax litigation, scheduled three so-called bellwether trials that may point the way to out-of-court settlements and show each side the other’s strategy. The plaintiff in the first trial, Shirley Boles of Fort Walton Beach, Florida, had sought $1 million in damages.

In November, Keenan ruled that Bessie Flemings, a Mississippi resident, couldn’t establish that the drug caused her ONJ and dismissed the case, which was set to be tried last January.

In February, Keenan picked a new bellwether case to replace Flemings’s, which is scheduled to be tried in September.

As of Dec. 31, Merck set aside $38 million for defending the litigation, according to the regulatory filing. It hasn’t earmarked any money for damages.

Merck fell 22 cents to $35.59 in New York Stock Exchange composite trading.

The case is Maley v. Merck & Co., 06-cv-4110, and the lawsuits are combined in In Re Fosamax Products Liability Litigation, MDL 1789, U.S. District Court, Southern District of New York (Manhattan).

To contact the reporter on this story: Thom Weidlich in New York federal court at tweidlich@bloomberg.net.

Last Updated: May 5, 2010 17:56 EDT

via bloomberg.com

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