PENNSYLVANIA RECORD

Three plaintiffs in a consolidated mass tort trial who had alleged their respective breast cancer diagnoses were directly related to their ingestion of hormone therapy medications have won the first part of their quest to hold a pharmaceutical giant responsible for their conditions.

A Philadelphia Common Pleas Court jury Tuesday awarded the three women a collective $72.6 million in compensatory damages in their case against the drug manufacturer Pfizer, according to the law firm representing the plaintiffs.

The individual lawsuits were originally filed in July 2004 against Wyeth Pharmaceuticals and Pharmacia Upjohn, both of which have since been acquired by Pfizer.

Attorneys with Conshohocken, Pa.-based Pogust, Braslow & Millrood filed the civil actions, which were eventually consolidated, on behalf of Susan Elfont, who previously resided in Huntingdon Valley, Pa., but now calls the West Coast home, as well as Shenandoah, Pa. resident Bernadette Kalenkoski and Judy Mulderig of Carlisle, Pa.

The women had alleged that they each had developed breast cancer after taking hormone therapy drugs such as Prempro, which was designed to treat their menopause symptoms.

After a trial in front of Common Pleas Court Judge Gary S. Glazer, the jury awarded $20 million to Elfont, $27.85 million to Kalenkoski and $24.75 million to Mulderig, according to the plaintiffs’ attorneys.

The liability phase in the bifurcated trial is expected to commence later this week.

The company’s spokesman, Chris Loder, didn’t return a message seeking comment Wednesday from the Pennsylvania Record, but he was quoted in a statement distributed to local media as saying that the drug manufacturer will most likely continue its legal fight.

“We are obviously disappointed with the verdict in this case,” Loder said in the statement. “Once the verdict is finalized, the company will weigh its legal options to determine how it will continue with the case.

“Hormone therapy medicines are an important treatment option for many women with debilitating symptoms of menopause,” the statement continued. “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.’”

The women who received the compensatory damages award seemed to relish the award.

“The plaintiffs were pleased with the phase one outcome, and they look forward to presenting phase two evidence beginning Friday,” attorney Tobias Millrood, one of the plaintiff’s lawyers, said in a statement.

Elfont, 66, a former Northeast Philadelphia resident, had taken hormone therapy drugs for two-plus years before she was diagnosed with breast cancer in 1997.

Kalenkoski, 68, who was diagnosed with the disease in 2002, had taken the menopause medication Prempro for more than four years, and Mulderig, also 68, ingested Premarin and Provera for 11 years before she received her breast cancer diagnosis.

According to a Bloomberg News report, Pfizer’s Wyeth and Upjohn units have lost 10 out of the 18 hormone therapy cases against them in civil court trials since 2006.

This spring, Pfizer announced that it had settled a third of the pending Prempro cases, of which the pharmaceutical giant had set aside $772 for the claims, Bloomberg reported.

The statement by the plaintiffs’ attorney’s said this case was “one of thousands of Prempro cases that has kept the Pfizer legal team busy. In an SEC filing in May, the company said it had set aside $300 million to cover pending litigation.”

The highest Prempro award prior to the Philadelphia case was a $58 million award in a Nevada case involving three women that was appealed by Pfizer to the U.S. Supreme Court. The high court opted not to hear the case, leaving the verdict intact.

In its statement, Pfizer said of all trial-set hormone therapy cases that have been resolved for either party, 44 have come out in the company’s favor “through a combination of rulings by judges, jury verdicts and dismissals by plaintiffs themselves to avoid going to trial. Nine juries have found for Wyeth, including six of the last eight; and there are eight final judgments for Wyeth.

“While eight plaintiff’s verdicts are in effect, five are not final, as they are being or will be challenged by the company as legally deficient. Additionally, more than 3,000 other cases have been dismissed or withdrawn before even being set for trial.”

It wasn’t until a decade ago that the risks associated with the hormone therapy drugs were made public in a study sponsored by the National Institutes of Health.

A Women’s Health Initiative report released early last decade found that women taking hormone replacement therapy drugs experienced an increased risk in developing breast cancer.

Prempro and Premarin, the two most commonly prescribed forms of hormone replacement therapy, saw their steepest decline in 2002 and 2003, after the study’s findings were published, from 61 million prescriptions written in 2001 to 21 million in 2004, according to the National Institutes of Health.

The New England Journal of Medicine reported in a 2007 published study that age-adjusted breast cancer incidence rates in American women fell 6.7 percent in 2003, the same time period for which hormone replacement therapy prescriptions drastically fell.

Hormone replacement therapy cases are among the last that will apparently be tried in Philadelphia’s civil trial division using what his known as reverse bifurcation, this after Common Pleas Court Administrative Judge John W. Herron issued a notice to the mass tort bar Tuesday that mass tort cases beginning next year will be tried individually and without reverse bifurcation, which is where damages are assessed during an initial trial phase, and liability is addressed in a follow-up phase.

According to the Legal Intelligencer, there were a total of 932 hormone replacement therapy cases still pending in Philadelphia’s Complex Litigation Center, which handles the court’s mass torts program.