(July 18, 2011)
On May 23, a West Virginia judge allowed for claims of breach of the implied warranty of merchantability and design defect to proceed against makers of a drug used in hormone replacement treatment which led to a woman developing breast cancer.
Rosemary Keffer was prescribed HRT drugs for menopause roughly 30 years ago. She took Premarin and Prempro (manufactured by Wyeth Inc.) and Provera (manufactured by Pharmacia & Upjohn Co.).
Keffer underwent a mastectomy in 1999 after being diagnosed with breast cancer. She later sued Wyeth and Upjohn in 2004 on claims of negligence, strict liability and breach of implied warranties.
Judge John T. Copenhaver Jr. relied on case law from other states, as the West Virginia Supreme Court of Appeals had not yet addressed inadequate labeling issues in regards to products liability.
Judge Copenhaver Jr. found that “under West Virginia’s strict products liability doctrine, a plaintiff may pursue a failure to warn theory of recovery. Because courts have recognized that claims for strict liability and breach of the implied warranty of merchantability are essentially coextensive in products liability actions, the court anticipates that the West Virginia Supreme Court would permit a plaintiff to pursue an implied warranty of merchantability claim based on a failure to warn theory.”
When mentioning the failure to warn theory, the judge is referring to Keffer’s argument that the drug labeling did not warn Keffer or her doctors of the risk of developing breast cancer.
Keffer also argued that during the time she took these HRT drugs, studies demonstrated a significant risk of breast cancer associated with estrogen treatment when combined with progestin. However, Upjohn’s 1994 labeling on Provera did not mention this at all. Wyeth’s 1994 Premarin labeling mentioned a possible increased risk of developing breast cancer, however they went as far as to say that “the majority of studies have not shown an association with the usual doses used for estrogen replacement therapy.”
Keffer wanted to show the jury that there were safer alternatives available, so she introduced oral micronized progesterone (OMP), which is a non-synthetic progestin drug. Since OMP is not known to increase risk of developing breast cancer, Keffer argued that it is a safer alternative. She also showed that studies on OMP have been available since the 80s and the defendants claimed that they were aware of these studies.
The judge responded to Keffer’s argument by saying that “inasmuch as Keffer has… offered expert evidence showing that OMP generally creates a lesser risk of breast cancer than synthetic progestin when used in an HRT regimen, a genuine issue of fact exists as to whether OMP would have avoided Keffer’s breast cancer.”
Therefore that leaves the question of whether OMP is a reasonable alternative to the synthetic progestin like the ones that Keffer took – and subsequently developed breast cancer from – should be left for the jury to decide.
If you or a loved one has developed breast cancer as a result of taking hormone replacement treatment drugs such as Prempro or Provera, you may be eligible to file a dangerous drug claim. contact one of our attorneys at 1-800-246-4878.