Pennsylvania jury awards $34.3M against hormone therapy drug makers

BOSTON, MA — In one of two hefty verdicts within a month, a Pennsylvania jury handed down a $34 million award against Pfizer, finding that the drug maker willfully failed to warn patients of cancer risks associated with the hormone replacement drugs Premarin, Provera and Prempro.

The jury awarded $6.3 million in compensatory damages and $28 million in punitives to Donna Kendall, a Decatur, Ill., woman who developed invasive breast cancer leading to a double mastectomy after taking the hormone replacement drugs from 1991 to 2002.

“Both she and her doctor believed at the time that the drugs were good for the heart, good for osteoporosis prevention and good for use in the long term,” said Tobias Millrood of the Conshohocken, Pa., law firm Pogust Millrood, lead trial counsel for Kendall.

Instead, the plaintiff claimed, Pfizer failed to conduct studies on the long-term effects of the drugs, and downplayed reports of cancer links in an effort to continue marketing them.

“The company [told doctors] that the benefits outweighed any risks and that these drugs should be taken long term,” Millrood said.

The same day the Kendall verdict came down a jury award in a similar case was unsealed, revealing a $75 million punitive damages award in favor of an Illinois woman who developed cancer after taking the drug Prempro.

These are the first verdicts among a number of cases pending over the drugs, which are still on the market.

Kendall took Premarin (an estrogen replacement) and Provera (a progesterone supplement), manufactured by drug company Upjohn, for six years before taking Prempro – a combination of the two drugs manufactured by Wyeth – for five years.

Upjohn merged with Pfizer in 2000, and earlier this year Wyeth merged with Pfizer.

Pfizer says it is considering all options, including an appeal.

“We are disappointed with the verdicts in these cases,” Pfizer’s statement read. “The company believes that neither the awards of punitive damages nor the liability verdicts were supported by the evidence or the law.”

Failure to study long-term risks

Millrood said that Kendall and her physician had no idea that taking the hormone replacement therapy medications over the course of years put her at risk until she was diagnosed with invasive breast cancer in 2002.

After the diagnosis, which found that the cancer had spread to five lymph nodes, Kendall underwent a mastectomy of the left breast, followed by painful and debilitating radiation therapy that severely damaged her skin and internal organs.

“The radiation caused such burns [to her skin] that not only did the skin break open and her chest bleed, but ultimately when a future heart surgery was needed, the preferred artery [for surgery] was useless because it was burned to crisp,” Millrood said. “It was shriveled from radiation burns.”

The burns also prevented successful reconstructive surgery after the mastectomy, according to Millrood.

“Not only did they take her breasts, they took her femininity and her dignity,” he said.

In addition, Kendall’s doctors have told her that the cancer could return.

“She is not out of the woods,” said Millrood.

He noted that the plaintiff’s experts predicted a 50 percent recurrence rate, and that the defense expert put the potential of recurrence even higher, at 75 percent.

But the key evidence, he said, was contained in documents showing that the drugs were approved by the FDA provisionally, on the condition that the Wyeth and Upjohn conduct studies of the drugs’ long term effects. Yet the defendants failed to do so.

Millrood also presented evidence that Wyeth and Upjohn officials discouraged the use of oncology experts at continuing medical education programs associated with the drugs for fear that other studies linking them with cancer would surface. In one instance, a Wyeth executive expressly prohibited an oncology expert from speaking at a CME event.

“We had handwritten comments from an executive at Wyeth [in response to another] executive who recommended an oncologist as a potential speaker. And the handwritten feedback was: ‘NO! NO! NO! NO! And NO!’ all in caps and with a string of exclamation points.”

Millrood said that not only did the defense decline to make a settlement offer, but the plaintiff’s demand – $6.5 million – was also only a fraction different than the ultimate compensatory award.

“We felt the demand was really reasonable given the damages that Donna had,” Millrood said. “It was very reaffirming that jury saw the case the same way.”

He was disappointed in the company’s vow to appeal in lieu of compensating the remaining plaintiffs whose claims are pending.

“With one win and another and then another, you would think they would get the message and give these women reasonable compensation,” said Millrood.

Plaintiff’s attorneys: Tobias Millrood and T. Matthew Leckman of Pogust
Millrood in Conshohocken, Pa.; Brian D. Ketterer and Robert K. Jenner of Janet, Jenner & Suggs in Baltimore.

Defense attorneys: Barbara R. Binis, Amy M. Vanni and Adam M. Masin of Reed Smith in Philadelphia.

The case: Kendall v. Wyeth Pharmaceuticals, Inc.; Nov. 23, 2009; Court of Common Pleas of Philadelphia County, Pa.; Judge Sandra Mazer Moss.

by Kimberly Atkins
Dolan Media Newswires

© Dolan Media Newswires 2009.