(CN) – A federal judge in Manhattan refused to dismiss a lawsuit alleging Merck & Co.’s osteoporosis drug Fosamax causes a condition known as dead jaw.
Indiana resident Louise Maley said Merck has long known that Fosamax had the potential to lead to osteonecrosis of the jaw, but failed to adequately warn doctors and the public of the side effects.
U.S. District Judge John F. Keenan kept Maley’s failure-to-warn claim, but dismissed strict liability and warranty claims.
It’s the third bellwether Fosamax case scheduled for trial after hundreds of multi-district lawsuits have been consolidated before Judge Keenan.
Merck was facing more than 900 Fosamax-related lawsuits as of last year, the company said.
“Plaintiffs claim does not fail as a matter of law from a lack of evidence of exposed necrotic bone,” Keenan wrote. “Specific causation remains a material issue of fact for the jury.”
The American Association of Oral and Maxillofacial Surgeons (AAOMS) wrote in a position paper that the presence of “exposed, necrotic bone in the maxillofacial region” was a characteristic of bisphosphonate-related ostenonecrosis of the jaw, or BRONJ.
Fosamax is a bisphosphonate, a class of drugs designed to prevent the loss of bone mass.
Maley began taking the osteoporosis drug in 1998, and by 2004 she was experiencing “severe aching pain in the upper-right side of her jaw,” according to the ruling. Maley described having “bad attacks” of “stabbing” pain in her jaw, extending through her forehead, which would last for hours at a time.
She stopped taking the medication in 2006.
The parties dispute what caused the pain.
Maley was diagnosed with neuralgia-inducing cavitational osteonecrosis, or NICO, by one of the many doctors she had visited. That occurs when small areas of bone in the jaw develop cavitations and die, and it hasn’t been linked to bisphosphonates, the judge said.
But the plaintiff and her expert witness insisted that Maley does not have NICO.
Merck argued that Maley’s witness’ testimony was “conclusory,” and said he failed to address other factors that could have caused her injuries. It also noted the lack of evidence that Maley had exposed necrotic bone in her jaw, a pre-requisite for a BRONJ diagnosis, according to the AAOMS report.
Her physician witness conceded that there was no finding of exposed dead bone, but said “fatty bone marrow” and “prominent resting lines” were found, which he believes is evidence that Maley’s jawbone was degenerating.
Judge Keenan determined that the witness, Dr. Rand Redfern, sufficiently addressed alternative causes.
“Dr. Redfern reached his conclusion by reviewing the records of plaintiff’s treating physicians, who went through an extensive process of attempting to rule out various causes of plaintiff’s persisting jaw condition,” Keenan wrote. “From their records … and a pathology report with findings consistent with dead or dying bone, Dr. Redfern was able to rule out the other potential causes for her injury, including trigeminal neuralgia, metastasis of breast cancer, bone tumors or cysts, fractures, and periodontal problems, and deduce that plaintiff suffered from BRONJ caused by her Fosamax use.”
The case will go to trial on April 19 at 10 a.m.