Closing arguments in Rosenberg v. Merck were heard today in Atlantic City, New Jersey. Defense attorney Christy Jones, of Butler Snow, went first.
According to Ms. Jones, Merck did not know at the time of the alleged failure to warn that Fosamax posed a risk of osteonecrosis of the jaw, and still does not know whether a causal relationship exists. Merck was not even certain that Ms. Rosenberg suffered from osteonecrosis, as opposed to osteomyelitis.
Ms. Jones told the jury that Merck started studying Fosamax in 1988, and conducted 150+ studies on animals, and 125+ clinical studies in humans. 17,000 people had taken Fosamax in these studies, and there was not a single report of bone necrosis.
Some studies had even shown a favorable effect on the jaw, said Ms. Jones, so Merck actually did periodontal studies because they thought they might discover a beneficial effect. But there was no early evidence that Fosamax caused bone cells to die.
The first report of osteonecrosis was in September, 2003, which involved a cancer patient taking alendronate intravenously. It wasn't until 2006, said Ms. Jones, that Merck received information about osteonocrosis of the jaw.
Ms. Jones challenged the jury to compare the recommended 2005 label with the label eventually approved and predicted they would conclude that removing the word "orally" did not water down the warning. Moreover, in October 2005, Merck responded to Dr. Somers' request for information and directly advised her of the risk of ONJ while on biphosphonate therapy, and Dr. Somers continued to prescribe it.
Finally, said Ms. Jones, no causal relationship has been established between oral bisphosphonates like Fosamax and osteonecrosis of the jaw. Maybe, said Ms. Jones, some day in the future we'll be able to understand whether there is a relationship between Fosamax and ONJ, but not now, because ONJ has many causes.
For the plaintiff, Paul Sizemore of the Sizemore Law Firm told the jury, "We're here because Fosamax killed a piece of Ms. Rosenberg's jaw, and Merck new it could happen, and didn't warn about it... Merck new that this drug could cause jaw bone death, and it did, in my client."
According to Mr. Sizemore, Merck did not warn in 1999, when Ms. Rosenberg began her treatment, nor did they warn when Ms. Rosenberg's prescribing physician, Dr. Debra Somers, continued prescribing Fosamax in March 2005. At that point, Ms. Rosenberg was no longer osteporitic, and was only mildly osteopenic, and should have stopped taking the drug. Dr. Somers testified that she would have warned her patient if she had known of the risk.
Merck finally "warned" Dr. Somers in October 2005, said Mr. Sizemore, because Dr. Somers found out about the risks on her own and asked a sales rep. But the rep had been instructed by Merck not to discuss the risk of osteonecrosis. Instead, Merck sent Dr. Somers a written response, but this alleged warning in October 2005 claimed that there had been no reports of ONJ associated with Fosamax use, even though Merck had internally acknowledged 80 adverse reports in June 2005.
In fact, said Mr. Sizemore, Merck had a report of bare exposed jaw bone as an adverse event as early as 1999, and there were subsequently other adverse event reports involving the jaw.
Health Canada had recommended that Merck issue an ONJ warning for oral biphosphonates in December 2004. The US FDA had also indicated a risk in 2004, and Merck's own scientists noticed the ONJ reports in 2004 and in 2005 said that the risk of ONJ "must be there." Moreover, said Mr. Sizemore, Merck told its own consultants in June 2005 that there was a "definite link" with osteonecrosis, and that underreporting was a certainty. Therefore, Mr. Sizemore concluded, Merck knew there was a problem with Fosamax, and nonetheles first refused to warn, and then downplayed their warning.
As for damages, Mr. Sizemore reminded the jury that Ms. Rosenberg had undergone five surgeries involving filing, scraping, and drilling away the dead bone. Bone death, he said, involved the same kind of chronic severe bone pain experienced by cancer patients. Even after the fifth surgery, said Mr. Sizemore, Ms. Rosenberg continued to suffer bone loss.
Jurors will begin deliberating Thursday morning at 9am.