Pfizer Wins Dismissal of 23 Prempro Lawsuits

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For Pfizer (PFE), most of the news lately on the legal front has been bad. The pharmaceutical giant has faced setbacks in and out of courtrooms across the nation, and in September agreed to pay a record $2.3 billion to settle civil and criminal charges in a case about off-label drug promotion. But this week, Pfizer got a bit of good news regarding some of the hormone replacement therapy cases against it. A New York judge dismissed at least 23 lawsuits against Pfizer units Wyeth and Pharmacia & Upjohn, as well as Teva Pharmaceutical Industries Ltd. (TEVA), filed by women who claimed that the menopause drugs Prempro, Premarin and Provera had caused their breast cancers.

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The dismissals came less a month after Pfizer was ordered to pay more than $100 million in punitive damages in two similar cases in Pennsylvania. Pfizer inherited these problems when it purchased Wyeth for $68 billion this year and Pharmacia in 2002.

Prempro, a combination of estrogen and progestin (Premarin and Provera), is taken to treat menopause symptoms such as hot flashes, night sweats and mood swings. Such hormone therapies (often called hormone replacement therapy, or HRT) have been in use for decades. Though researchers had found evidence as early as the 1970s linking HRT to cancer, it wasn't until 2002, when a major government study linked the therapies to increased breast cancer and cardiovascular risks, that real headway occurred in making women and doctors aware of the possible dangers. Since then, sales of HRT drugs have plummeted, and lawsuits over them have swelled. There are more 10,000 such suits across the country, so while the dismissals are definitely a positive outcome for Pfizer, those 23 cases are just the tip of the iceberg.

A Long History of Conflicting Studies, Unheeded Warnings

In this case, New York State Supreme Court Justice Martin Shulman said in a decision filed Monday that while the plaintiffs' proffered evidence was extensive, the materials and the overall record "contain no evidence of fraud, misrepresentation or deception." The judge also concluded that the plaintiffs hadn't filed their complaints within the state's three-year statute of limitations, and denied their motions to discontinue without prejudice, which would have allowed them to file in other jurisdictions with longer statutes of limitations.

The judge also said the conflicting medical evidence "suggests an ongoing medical debate as to the risks versus benefits of taking HRT. Though this debate does not appear to be settled, the potential risk of contracting breast cancer from taking HRT medication was well known and at all times out there in the stream of public information." It's this very sentence that might be crucial to Pfizer's defense in the remaining cases, as it contends that the labeling on HRT drugs included the information for years.

Christopher Loder, a Pfizer spokesperson, called it "another legal victory for Pfizer subsidiaries." He said the company believes the court was right in its judgment in favor of Wyeth and Pharmacia & Upjohn. "After reviewing the evidence presented, the court also rejected the notion that Wyeth had 'engaged in any intentionally fraudulent or deceptive act' which might have excused a failure to timely file a claim against the company," he said. "As such, the ruling helps limit the exposure the company confronts in this matter. "

A recent article in The New York Times followed the history of these so-called hormone replacement therapies. Even the name is misleading, some doctors now say, as it suggests menopausal women need these hormones replaced. In 1980, a study estimated that the use of hormone therapy had caused more than 15,000 cases of endometrial cancer (cancer of the uterine lining) in the U.S. between 1971 and 1975 alone, representing what the researchers called "one of the largest epidemics of serious iatrogenic disease [a disease caused by physician-administered treatments] that has ever occurred in this country."

And yet, doctors kept prescribing the drugs, perhaps unaware of the risks, suggesting that the information wasn't as commonly known as the judge suggests it was before the 2002 study made waves. The court documents offer the study as the 2002 driver for the lawsuits. Studies suggesting that HRT drugs provided potential benefits to heart health and even possible protection from Alzheimer's confused the issue further, and encouraged doctors to prescribe them more in the 1990s.

Today, the FDA clearly says to use hormones at the lowest dose that helps, for the shortest time needed. It recommends other therapies to prevent bone thinning, and says not to take hormones to prevent strokes, Alzheimer's, protect against aging and wrinkles, or to increase the sex drive.

Pfizer Pushes Back Against "Inflammatory" Statements, "Phony News"


Meanwhile, Pfizer also asked a judge to order the removal of a video posted on YouTube by plaintiffs' lawyers who recently won more than $78 million in a Prempro case. Loder said the "video is packaged as a phony news story ('Prempro News Segment') in an attempt to spin its promotional and inaccurate content as authoritative information." He added, "Pennsylvania's judicial ethics rules were written expressly to protect juries from the very type of prejudicial information that plaintiffs are promoting through their self-serving video which fails to disclose their sponsorship."

In the motion, Pfizer's lawyers also requested that the court compel the plaintiffs' lawyers to "refrain from making any further inflammatory and prejudicial public statements." The video contains accusations that Wyeth minimized the risks of using Prempro, among other discussions with breast cancer patients and more. But the plaintiff's lawyers contend the video is not much different than a press release.
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