• 13
  • October
    2011

In our previous post, we began looking at a recent New Jersey case which dismissed the lawsuit of two women who claimed drugs used during hormone replacement therapy caused them to develop breast cancer.

The decision puts an end to three and a half years of litigation on the issue, but there are reportedly still 150 similar lawsuits pending over hormone replacement therapy across the county. While the dismissal of the two New Jersey women's lawsuit doesn't set any precedent for cases outside New Jersey, it does call into question how far they can go.

In the trial judge's 2008 opinion, she noted that the companies rewrote their drug labels soon after the FDA revised them. Upjohn, one of the companies involved in the suit, reportedly placed the revised warnings on the labels of its drug in 2007 after the women were no longer taking the drug. The trial judge concluded that that company's action was consistent with FDA regulations.

Sources said the appellate court panel relied heavily on the trial judge's dismissal of the suit, which stated there was no evidence that the pharmaceutical companies misled doctors or patients concerning the risks of taking the drugs. The allegations include claims of manipulating the FDA regulatory process and failing to conduct safety studies of the drugs. But according to the judge who wrote the appellate opinion, the trial court's ruling was "legally unassailable."

The appellate opinion has been criticized for relying on the trial court's conclusions and failing to conduct its own analysis. It has reportedly already been appealed to the New Jersey Supreme Court for further challenge.

Source: nj.com, "N.J. manufacturers cannot be sued for claim that their drugs caused breast cancer, panel says," MaryAnn Spoto, September 29, 2011.