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Novartis Properly Warned About Bone-Drug Risks, Lawyer Says

Novartis AG, Europe’s second-biggest drugmaker by sales, properly warned a Rhode Island man that Zometa, its bone-strengthening drug for cancer patients, could cause jaw damage, a company lawyer argued at the end of a trial.

Karlene Hogan sued Novartis in 2006 claiming her late husband, Timothy Hogan, developed so-called jaw death as a result of getting Zometa injections, according to the complaint. Hogan’s case is the fourth to go to trial over Zometa and Aredia, another Novartis bone-strengthening drug.

“The labels included the risks that were known and knowable at that time,” Bruce Berger, a lawyer for Novartis, told jurors in federal court in Brooklyn, New York, today in his closing argument.

Novartis, based in Basel, Switzerland, faces about 700 suits over the two medicines. The Hogan case is the fourth to go to trial. In November, a federal jury in Winston-Salem, North Carolina, ruled that Novartis should pay more than $12.8 million to a North Carolina woman’s family over claims Zometa and Aredia damaged her jaw. The award was reduced under state law to $1.26 million, including interest.

Other Cases

In October, a New Jersey jury rejected a woman’s claims that Aredia and Zometa caused her jaw deterioration. In October 2009, a Montana jury ordered Novartis to pay $3.2 million in damages to a cancer patient who made the same claims over the medicines.

If the jury rules against the company in the Hogan case, damages will be determined later. There is no possibility of punitive damages in the case.

Zometa and Aredia are bisphosphonate drugs that doctors prescribe to alleviate pain in bone-cancer patients. The drugs also help to strengthen bones to avoid fractures. The patients who sued contend the drugs can cause users’ jawbones to deteriorate to the point of causing osteonecrosis of the jaw, or ONJ.

Timothy Hogan, who lived in Coventry, Rhode Island, died in December 2005. He began taking Zometa in March 2003 after being diagnosed with multiple myeloma, according to the plaintiff’s court papers. In December 2004, a dental surgeon noticed dead bone, which by May 2005 he suspected was “potentially associated” with Hogan’s Zometa treatment, according to court papers.

Added Warnings

“Mr. Hogan’s jaw problems were caused by his cancer,” Berger, of Hollingsworth LLP in Washington, told the jurors. “Unfortunately, multiple myeloma took his life.”

Novartis added warnings about ONJ in September 2003 after it got reports about problems, Berger said.

Zometa, apparently beneficial for some patients, also carries risk of ONJ, particularly for patients who have dental work done, Daniel Osborn, a lawyer for Karleen Hogan, told jurors in his closing argument.

“Novartis knew about that risk,” Osborn, of Manhattan, said. “It never warned Tim’s doctors about that risk. Because Tim’s doctors were never warned, he was never warned.”

Osborn said the company ignored warnings about Zometa it had before Hogan started taking it.

The trial, presided over by U.S. District Judge Brian M. Cogan, began May 16.

Suits Consolidated

Some of the hundreds of Novartis lawsuits have been consolidated before a federal judge in Tennessee. Others, like Hogan’s, have been sent back to their home courts for trial. Still other cases have been heard in state courts around the country.

Novartis has asked U.S. District Judge James A. Beaty Jr. in North Carolina to overturn the jury’s verdict in that case. The plaintiffs have appealed the New Jersey case and, after losing an appeal to the Montana Supreme Court, Novartis has asked the U.S. Supreme Court to review that verdict.

The case is Hogan v. Novartis Pharmaceuticals Corp., 06-cv-260, U.S. District Court, Eastern District of New York (Brooklyn).

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