LawyersUSA

Hormone-replacement therapy litigation appears to be stalled while judges across the country await the U.S. Supreme Court's ruling next term in a key pharmaceutical product liability case.

Zoe Littlepage, a partner at Littlepage Booth in Houston and lead plaintiffs' counsel in the federal HRT multi-district litigation (MDL), said trials in Texas, Florida and Alabama have been postponed while judges await the Court's decision in Wyeth v. Levine (No. 06-1249).

The court will decide whether FDA approval of a prescription drug's label preempts a state law claim over how the drug was administered to patients.

A ruling in favor of preemption would have a huge impact on litigation against drug manufacturers.

James Morris, a plaintiffs' attorney with Brent Coon & Associates in Austin, Texas, represents about 370 women who claim their use of hormone replacement drugs caused breast cancer, strokes, ovarian cancer and heart disease.

The suits name Wyeth Pharmaceuticals, which sold Premarin and Prempro, and Upjohn, a division of Pfizer, which sold Provera.

So far, only two of Morris's HRT cases have gone to trial.
"Some of the plaintiffs I represent are passing away, and some are incurring further medical bills," he said. "They certainly need living expenses, and I'm unable to collect anything for them."

In March 2008, Morris won a jury verdict in the first MDL case against Wyeth and Upjohn on behalf of Donna Scroggin, a breast cancer survivor. In July, a U.S. District Court judge in Arkansas overturned a $27 million punitive damages award in the case; a $2.7 million compensatory damages award remains intact.

In May 2007, Morris obtained the first HRT verdict, for $1.5 million, against Pfizer in state court in Philadelphia. He represented Merle Simon, who developed breast cancer after taking a combination of Premarin and Provera to relieve menopause symptoms.

But Morris's next HRT trial isn't scheduled until April 2009 in Texas.

Morris said he believes the trials have been put on hold because of what he called an "over-estimation" by judges of the impact of Levine, and assumptions that the Supreme Court will rule in favor of Wyeth.

"Judges are granting stays like it's a foregone conclusion," Morris said. "I've never seen anything like it. There's this panic attack over Levine."

Alexandra Lahav, an associate professor at the University of Connecticut School of Law, said that from an efficiency perspective, it makes some sense to wait for the Supreme Court's decision, as it could be the basis for a defense appeal if it comes out in favor of preemption.

"A trial is a costly endeavor and court resources are scarce," she noted.

On the other hand, she said in an e-mail, "[I]f cases are trial-ready, then delaying them while waiting on a Supreme Court decision, the timing of which is uncertain, seems unfair."

Recent ruling favors defense

HRT litigation has also faced difficulties in specific venues based on judges' interpretations of state law.

In July, a state judge in New Jersey dismissed the first two of 168 hormone-replace drug suits against Wyeth and Upjohn.

The judge ruled that the plaintiffs "failed to provide the specific type of evidence necessary to overcome the presumption of adequacy afforded [to] FDA-approved labeling" by New Jersey law, and that the warnings were "adequate as a matter of law."

Esther Berzofsky, liaison counsel for the HRT litigation in New Jersey, said the ruling would impact other failure-to-warn claims in New Jersey, but that she plans to appeal.

Also in July, Wyeth agreed to settle claims by two Las Vegas women that its hormone-replacement drugs caused their breast cancer.

Another trial involving similar charges against Upjohn recently settled two weeks into trial, according to Littlepage, who represented the plaintiffs – Vesta Wodehouse, 71, and Annie Woods, 61.

As of July 31, Wyeth was facing 8,200 claims in federal and state courts. Littlepage said she expects the final number to total about 10,000.

So far, Wyeth has lost five of seven cases that have gone to trial since 2006, although the company has fared better post-trial.

The current wave of litigation arose after a study in July 2002, known as the Women's Health Initiative, found that using Prempro for five years increased the risk of breast cancer by 26 percent, heart attacks by 29 percent, strokes by 41 percent and blood clots by 113 percent.

Questions or comments can be director to the writer at: nora.tooher@lawyersusaonline.com