Federal appeals court upholds Wyeth's favorable verdict in Prempro case

Michelle Massey, East Texas Bureau Feb. 14, 2008, 5:21am

LITTLE ROCK, Ark., -- The Eighth Circuit Court of Appeals released an opinion at the end of January, upholding a verdict in favor of Wyeth Pharmaceuticals, which was sued by an Arkansas woman claiming the company's hormone drugs caused breast cancer. The case is part of a larger multi-district litigation on hormone replacement therapy drugs.

Little Rock resident Helene Rush sued the hormone manufacturer in 2005, accusing the company of negligence in its Prempro and Premarin hormone therapy.

Rush, at the age of 55, began taking Wyeth's hormone replacement therapy drug Premarin to relieve menopausal symptoms. Three years later, Rush's doctor discovered an abnormality in Rush's breast. The doctor discussed the association between breast cancer and hormone replacement therapy. The doctor told Rush that she "may want to stop hormones."

However, Rush continued hormone replacement therapy for a year, until another breast abnormality was found. It was then that she stopped the treatment but only for eight months before resuming hormone replacement therapy.

Seven years later, Rush switched doctors. Her new doctor switched her to Wyeth's Prempro and advised of a "slight risk of cancer." After 10 years of taking the hormone replacement drugs, Rush, now 65, was diagnosed with breast cancer. Rush filed her lawsuit against Wyeth's drugs nearly six years after being first diagnosed with breast cancer.

During last year's trial, Wyeth's lawyers argued Rush had other health factors, such as weight gain and smoking, that would likely have caused her to develop breast cancer without taking any hormone replacement drugs. The lawyers argued that the drugs contained warnings regarding the risks and link to breast cancer. At the trial, Rush admitted that she never read the drug's warnings. Rush's doctors also testified that they knew the risks prior to prescribing the drugs to their patients.

After the end of the lengthy federal trial, the jury concluded that Rush failed to prove Wyeth was negligent or inadequately warned patients of the drugs' risks. The jury also found that the plaintiff did not prove the drugs were defectively designed or that any of Wyeth's actions caused Rush's breast cancer.

Rush appealed the decision to the Eighth Circuit Court of Appeals. She argued the district court gave incorrect jury instructions, allowed undisclosed and improper expert testimony, incorrectly disallowed Rush's expert opinions and failed to provide the jury instructions on fraud.

Within her appeal, Rush argued the jury instruction that stated "every person using care has a right to assume, until the contrary is or reasonably should be apparent, that every other person will use ordinary care," was incorrectly applied to Wyeth in assuming that others (Rush) would use ordinary care.

The appeals court declared that this instruction was not an abuse of the district court's power and that, "the instruction only explained Wyeth was not negligent in assuming Rush would read the warnings. The jury could still have found Wyeth negligent and Wyeth's warnings were inadequate."

Further arguments failed as the appeals court agreed with the lower court's decisions and upheld the previous verdict in favor of Wyeth.

Wyeth is defending itself in thousands of lawsuits against its hormone replacement drugs and is refusing to settle a single case. Wyeth denies all negligent claims and continuously argues that since it first marketed the drugs, they carried warning labels regarding the heightened risk of breast cancer. Further, the drugs remain FDA-approved for treatment of menopause and postmenopausal osteoporosis.

In related lawsuits, Wyeth has had inconsistent results with its defense.

With the first case going to trial, an Arkansas jury found that Wyeth did adequately warn physicians and patients of the drugs' associated risks.

After another trial, one woman was awarded $3 million but the judge overturned the award.

A third case against Wyeth resulted in a favorable verdict for the plaintiff for $1.5 million but, on appeal, the court overturned the award.

Prior to trial in a Houston case, a judge stated Wyeth was not liable for failure to warn because the FDA regulated the drug's labels.

In a Philadelphia case, the jury awarded $1.5 million against Pfizer's hormone replacement drug Provera but ruled Wyeth properly warned of the risks.

A Minnesota state court judge found that the drug-induced breast cancer was not backed by scientific evidence and granted Wyeth's motion for summary judgment.

In Nevada last year, a jury awarded three woman $134 million in damages. However, on a recent appeal, a Nevada judge ruled that the verdict would stand and did not grant another trial.

Currently, Wyeth is defending itself in an ongoing Little Rock trial. The jury is expected to decide, among other things, if doctors knew of the "magnitude of risk of ingesting HRT and developing breast cancer" and whether the drugs were unreasonably dangerous and defective in condition. The trial is expected to carry over until March. U.S. District Judge William R. Wilson Jr. is presiding. (Scroggin v. Wyeth, Case No. 4:04cv01169)

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