Prempro litigation and preemption

Prempro is a hormone replacement therapy marketed by Wyeth Pharmaceuticals. It is a combination therapy of the estrogen and progesterone replacement drugs that has been linked to increased rates of breast cancer. Wyeth claims that victims of Prempro use are preempted from bringing lawsuits against the company because the Food and Drug Administration (FDA) had to approve the drug. However, Aylstock says that preemption may not be the proper term. He explained:

I think that preemption is probably a confusing word. I think the word that more accurately describes what the drug companies are trying to achieve is immunization. They would like to be completely immunized from any liability regarding their drugs, regardless of whether they lied to the FDA, regardless of whether they made misrepresentations to doctors and what they knew and when they knew it.

As most people know by now, the FDA is an under-funded and under-staffed organization that usually gets all of its information directly from the drug companies. If the FDA approves a drug, drug manufacturers want to be immunized from any liability no matter what the facts are and no matter whom they hurt in the process. The Supreme Court of the United States has recently taken up a case involving Wyeth and another drug that Wyeth makes and will determine if the FDA approval of that drug preempts any state court causes of action.

While Wyeth may claim preemption as a defense, that defense isn't always recognized, according to Aylstock, who said, "Thus far, only a handful of these have been tried. However, now that internal documents [such as the Women's Health Initiative study] have become public, we've been able to show juries the evidence – which has resulted in multi-million dollar verdicts. In fact, the last trial resulted in an award of over $100 million."

Using experts to prove cases

Along with the internal documents that have surfaced to help attorneys prove clients' cases, Aylstock also uses a variety of experts. He explained, "We use epidemiologists who can speak to the studies and the strength of the studies and demonstrate the causal link between the hormone replacement therapy and cancer, to oncologists who can speak about the cancer itself."

"We also use pathologists who can speak about the tissue and diagnosis of a hormone-receptive breast cancer and determine what happened in that individual when the hormone replacement was discontinued. They can tell us whether the rate of cancer growth slowed. If it did, that's a pretty good indication that it was the drugs that were causing the growth of the cancer itself. We also use economists and family doctors who can speak to the effect that the cancer has had not only on the individual, but on the family as well."

If you or a loved one has been injured due to the use of Prempro, contact an attorney to discuss your situation. The consultation is free, without obligation and strictly confidential. To contact a qualified attorney whose practice focuses in this area of the law, please click here.

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