Friday, April 10, 2015

Bellwether Bone Loss Drug Case Settles

Bellwether Bone Loss Drug Case Settles

by Mary Pat Gallagher

 "One of only two cases to go to trial in New Jersey in litigation involving the bone loss drug Zometa has been settled on unknown terms just before a state appeals court was scheduled to issue a ruling.
The three-judge Appellate Division panel that had been expected to decide on April 9 whether to affirm or reverse the no-cause verdict won by Novartis against plaintiff Beverly Meng instead announced that day that “the issues in the dispute have been amicably resolved.”

Attorneys on both sides declined to discuss the settlement terms in Meng v. Novartis, or the fate of the 119 Zometa/Aredia cases that remained in New Jersey as of April 1.
The suits were designated as a mass tort in January 2008 and centralized in Middlesex County Superior Court.
Prior to that, in April 2006, the Judicial Panel on Multidistrict Litigation had consolidated federal actions around the country in the U.S. District Court for the Middle District of Tennessee.

The plaintiffs claim that the bisphosphonate drugs Aredia and Zometa, made by Novartis Pharmaceuticals Corp., of East Hanover, which are used to treat osteoporosis, caused osteonecrosis of the jaw, or “bone death,” according to court documents. They allege pain and disfigurement as a result, from loss of teeth and the jaw bone itself, which in some cases has to be surgically removed and a metal plate or rod inserted.

Similar allegations have been made about another bisphosphonate, Fosamax, which is manufactured by Merck. New Jersey’s Fosamax litigation—comprising 3,158 cases as of April 6—is also centralized in Middlesex County, before the same judge handling the Zometa/Aredia litigation, Jessica Mayer.
In the recently settled Zometa case, Meng sued in 2007, alleging that, except for about six months in mid-2006, she had monthly intravenous infusions of Zometa from July 2002 until November 2006, according to court documents.
It was prescribed to control bone metastases from breast cancer that had spread to her spine, court documents said. She stopped the Zometa in November 2006 around the time her dentist noticed exposed bone in her mouth. Osteonecrosis was diagnosed in February 2007.

Before Meng’s case went to trial in the spring of 2013 on a claim of failure to provide an adequate warning, Mayer dismissed other counts—for strict liability, design defect, breach of express warranty and consumer fraud—on a motion for summary judgment.
Mayer applied the law of Mississippi, where Meng lived while taking Zometa.
In allowing the failure-to-warn claim to proceed, Mayer discussed the warnings provided by Novartis regarding the bone death risk.
The first mention was a September 2003 package insert stating that there had been reports of osteonecrosis but the condition had “other well-documented multiple risk factors” and it was not possible to determine if it was connected to Zometa, court documents said.

A February 2004 revision of the warning added that most of the osteonecroses reported were in cancer patients who had other risk factors such as chemotherapy, corticosteroids, anemia and infection. It described those cases as “attendant to a dental procedure” and concluded “it is prudent to avoid dental surgery.”
An August 2004 update mentioned that the majority of instances were associated with tooth extraction and many people had signs of local infection, according to court documents.

The warning recommended having a dental examination before taking the drug and avoiding invasive dental procedures while on it.
That warning was the one in effect when Meng had the dental procedure that allegedly triggered osteonecrosis, according to Mayer’s summary judgment opinion.
Mayer found Meng’s evidence sufficient to raise an issue of fact as to adequacy.
Meng’s labeling expert, Dr. Suzanne Parisian, criticized the warning as “‘misleading’” because of the associations it drew to other risk factors, according to Mayer.

In addition, Meng’s doctor, Louis Puneky, testified that if he had better understood the risks, he would have prescribed the Zometa differently, according to Mayer. He said he would not have kept Meng on Zometa for four years and probably after two years would have “‘backed down on the dosage to maybe every three months.’”"

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