Blog of the Society for Menstrual Cycle Research

Update in Prempro Case

November 4th, 2009 by Elizabeth Kissling
Image from Online Journal

Image from Online Journal

Even though the verdict regarding punitive damages awarded to Connie Barton in her suit against Prempro was sealed (as we wrote last week), the figure has leaked out. A Philadelphia jury awarded her $75 million in punitive damages, in addition to $3.7 million in compensation for her trouble.  Although Pfizer/Wyeth will surely appeal, it’s a substantial victory to see punitive damages in an amount that is more than 20 times the compensatory damages. The jury found Wyeth’s conduct in marketing and selling the drug was “willful and wanton,” and put their money where their mouth is.

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Pyrrhic Victory for Prempro Users

October 27th, 2009 by Elizabeth Kissling

Connie Barton, an Illinois woman who developed breast cancer after taking Prempro for menopausal symptoms, was awarded punitive damages by a jury in Philadelphia yesterday. The jury has already awarded her $3.7 million in compensatory damages, back in September, but we will not learn the amount of punitive damages until another Philadelphia jury reaches their verdict in similar case against the Pfizer, the drug’s manufacturer. (Technically, the case was filed against Wyeth, but the two companies just completed a merger deal last week, and Wyeth is now a subsidiary of Pfizer.)

Wyeth’s attorneys successfully argued that public revelation of the amount of damages might influence the jurors in Kendall v. Wyeth. However, the jury’s finding that Wyeth ignored evidence that the drug could cause cancer is now public information. Would I sound bitter if I said I hope that news influences potential jurors?

According to the news story about Barton’s case at philly.com, Pfizer has now lost five of eight trials over its hormone-replacement drugs since cases began reaching juries in 2006. 1500 more trials against Wyeth are pending at the Philadelphia Court of Common Pleas. But a longer story in Philadelphia Magazine reports 23 out of 31 cases set for trial have been resolved favorably for Wyeth; the company has settled five, and several are on appeal.

Christine Speer also writes,

The future of Prempro . . . seems pretty stable, no matter what the juries decide. Doctors in some 85 countries continue to prescribe it for hot flashes.

[. . . .]

The Philadelphia judge who basically invented mass tort pharmaceutical litigation — Sandra Mazer Moss — has made it her court’s mission to get through this docket and hear all 1,500 Philly-based trials. There might even be cases tried in groups. “The plaintiffs are due their day in court,” Moss says. “And so are the defendants. That is justice. Even one-tenth of a courtroom in your lifetime is better than nothing because you’re dead.”

If you were on the jury, you’d likely hear that Moss — who came to this court’s bench in January — arrived too late for the 205 women who died still waiting for their cases to come to trial. If you were on the jury, you’d hear that WHI’s lead researcher thinks 200,000 women who got breast cancer in the past decade have long-term hormone therapy to thank for it. If you were on the jury, you’d hear that Wyeth did everything a responsible drug company can possibly do in getting out a drug whose benefits still outweigh its risks.

Of course, if you’re not on the jury, you might never hear any of that. You might just be a patient.

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What is the future of YAZ?

September 26th, 2009 by Elizabeth Kissling

The popular birth control pill, Yaz is in the news again. Readers may remember that last autumn, Bayer (the maker of Yaz) was sanctioned by the FDA for their television commercials, “because they encourage use of Yaz in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with Yaz.” The FDA actually required Bayer not only to end the advertising campaign immediately but to make amends by publicizing corrective information — an unusually bold move from the FDA. That led to the ad shown at right.

Bayer was cited by the FDA again earlier this year, for failure to follow proper quality control in the plant that manufactures the synthetic hormones used in Yaz.

Bayer is now defending itself against 74 lawsuits filed by users who developed health problems, such as blood clots or heart attacks. Bayer is taking the FDA citations seriously and plans to “defend itself vigorously against the suits.” Dr. David A. Grimes, a clinical professor of obstetrics and gynecology at the University of North Carolina medical school and paid consultant to Bayer says the risk of injury from Yaz is tiny. “My dictum is that a multiple of a rare event is still a rare event,” says Grimes. And the New York Times seems far more concerned with how the FDA citations and the lawsuits will affect Yaz’ image and sales than they are with women’s health.

Didn’t these people learn anything from the saga of the Dalkon Shield?

October 2, 2009

Edited to Add: The New York Times report neglected to mention that Swissmedic is investigating the death of a young woman from the effects of pulmonary embolism that may be linked to her use of Yaz.

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Readers should note that statements published in re: Cycling are those of individual authors and do not necessarily reflect the positions of the Society as a whole.