Facing $73 Million Award, Pfizer Settles Case Where Hormone Caused Breast Cancer

Posted December 14, 2011 in Medical Malpractice by

The Pfizer drug company agreed to settle a lawsuit over hormone replacement therapy rather than risk a huge payout to plaintiffs who claimed the drugs gave them breast cancer.

  • Women eligible for $72.6 million in damages from use of hormone therapy treatment
  • Suit settled prior to ruling on drug company’s liability
  • Hormone therapy still prescribed in certain cases despite risks

Drugs Tied to Breast Cancer

A Philadelphia jury ruled last week that three women who suffered from breast cancer were eligible for at least $72.6 million—if the court found that the former Wyeth Drug company was actually liable for their diagnoses, in a “reverse bifurcated” court process whereby damages are decided before the liability. Instead, Pfizer, which purchased Wyeth in 2009, settled with the plaintiffs on Friday for an undisclosed amount.

All three plaintiffs, current and former Pennsylvania residents Susan Elfont, Bernadette Kalenkoski and Judy Mulderig, were diagnosed with breast cancer after taking hormone replacement therapy, or HRT, for periods ranging between two to 11 years.

HRT was a once-standard practice where women took estrogen and progestin to ease symptoms of menopause. However, a U.S. government study released in 2002 found a number of serious potential health consequences from taking HRT, including invasive breast cancer.

At question in the lawsuit was whether Wyeth had correctly labeled the HRT drugs to disclose what they knew of the potential side-effects at the time. The company took further criticism for allegedly paying ghost-writers to publish medical reports under doctors’ names to promote the now-controversial therapies.

Trial Decides Damages First, Liability Last

In an unusual “reverse bifurcated” trial process, the jury first determines the damages owed, then later rules if defendants are in fact liable for the damages. The case settled on Friday as the liability stage was set to start.

Attorney Michael Fishbein

“The idea is to get the jury to decide the question of causation, injury and damages without being influenced by the liability testimony,” says Michael Fishbein, an attorney with Philadelphia personal injury firm Levin, Fishbein, Sedran & Berman. “The general thinking is if the jury hears so-called bad conduct evidence, that evidence will then influence them or sway them for reasons unrelated to merits to inflate the damage award above what they would.”

However, even though reverse birfucation is expected to tamp down awards, the $72.6 million in damages in this case were the highest yet in an HRT suit. “Obviously in this case it didn’t have anticipated effect of lowering the award,” Fishbein says.

The Philadelphia Court of Common Pleas announced this week that starting next year, pharmaceutical cases will no longer be tried using reverse bifurcation. What’s more, future cases will be tried individually, no longer under mass tort rules.

Many Lawsuits Still To Come

We haven’t heard the last of HRT suits against Pfizer. Bloomberg News reported that “Pfizer’s Wyeth and Upjohn units have now lost 10 of the 18 Prempro cases decided by juries since trials began in 2006,” and Pfizer has set aside $772 million to help cover ongoing settlements. According to the Legal Intelligencer, some 932 HRT suits in Philadelphia were still outstanding as of September.

The large damages awarded in this case may make Pfizer more inclined to settle other cases, Fishbein surmises. “I would think that to have such a large compensatory award without evidence of wrongdoing, if a jury reacted like that, I would suspect that it Wyeth or Pfizer would be more likely to want to avoid going to trail,” the attorney says. However, he cautions, “It’s impossible to say. They’re the only people who really know that.”

Hormone Replacement: Worth the Risk?

In 2002, around 6 million women were taking hormone replacement medications. Since the study linking it to cancer, the number has dropped off dramatically.

The National Institute of Health now warns women of the potential consequences of taking HRT:

  • It can increase your risk of breast cancer, heart disease and stroke.
  • Certain types of HRT have a higher risk, and each woman’s own risks can vary depending upon her health history and lifestyle.
  • You and your health care provider need to discuss the risks and benefits for you.
  • If you do decide to take HRT, it should be the lowest dose that helps and for the shortest time needed.
  • Taking hormones should be re-evaluated every six months.

Some women still may be prescribed the drugs, despite the potential consequences. The Mayo clinic suggests HRT may still be beneficial to women who:

  • Experience moderate to severe hot flashes or other menopausal symptoms
  • Have lost bone mass and either aren’t able to tolerate other treatments or aren’t benefitting from other treatments
  • Stopped having periods before age 40 (premature menopause) or lost normal function of your ovaries before age 40 (premature ovarian failure)

After last week’s settlement, Pfizer released a statement defending HRT drugs: “Hormone therapy medicines are an important treatment option for many women with debilitating symptoms of menopause. The FDA has regularly and thoroughly reviewed the benefits and risks of these medicines, and states that ‘hormone therapy is the most effective FDA approved medicine for relief of hot flashes, night sweats or vaginal dryness.'”

Aaron Kase is a news reporter for Lawyers.com.

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