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A woman who sued Wyeth, claiming her breast cancer was caused by the company’s hormone-replacement drug, did not show sufficient evidence that her doctor wouldn’t have prescribed the drug if warnings were better, a Philadelphia judge explained as to why he overturned a $3 million jury award.

Philadelphia Common Pleas Senior Judge Ricardo C. Jackson outlined for the Superior Court yesterday why his grant of JNOV and his denial of a punitive damages phase in Nelson v. Wyeth should be upheld.

Attorneys for Wyeth say the opinion could have a significant effect on the 1,500 similar cases pending in Philadelphia.

After a tumultuous run through the court’s Complex Litigation Center, Jennie Nelson saw brief victory when a jury awarded her $3 million in compensatory damages in the retrial of her products liability case against the drug manufacturer.

Before the case went to the jury, Jackson had granted a Wyeth motion for compulsory nonsuit on the punitive damages claim. The jury came back with an award in February 2007 on the compensatory phase. On May 30, after oral arguments were heard on Wyeth’s motion for judgment notwithstanding the verdict, Jackson overturned the award.

An explanation for his ruling wasn’t clear until yesterday, when Jackson said in his opinion that Nelson failed to prove Wyeth’s negligence was the factual cause of her developing breast cancer.

A drug manufacturer only has a duty to inform the physician, not the patient, about any potential dangers, since the physician takes that into account along with other medical history when prescribing the drug, Jackson said.

Jackson relied heavily on the testimony of Nelson’s doctor, Kathryn Schubert-Moell, that she does not rely on information provided by drug companies when making prescription decisions, according to the opinion.

“If Dr. Schubert-Moell did not take into consideration [Wyeth's] Prempro warnings, a reasonable mind could not conclude that a different label would have resulted in Dr. Schubert-Moell altering her prescribing habits in such a way as to have prevented Jennie Nelson from developing breast cancer, by not prescribing Prempro,” Jackson said.

Michael Scott of Reed Smith, lead counsel for Wyeth in the case, said the most important aspect of Jackson’s opinion was that it clearly reflects that Wyeth did warn about the risk of breast cancer.

He said the judge found that improved warnings would not have made a difference and therefore negligence couldn’t attach to Wyeth. While that is not a principle of law in any doubt in Pennsylvania, Scott said it is the first time it has been applied to the hormone therapy cases.

Jackson also explained his ruling on the punitive damages issue. He said Prempro warnings actually suggested a higher causation of breast cancer during the time Nelson was taking the drug than was found to exist in the Women’s Health Initiative study done by the National Institutes of Health in 2002.

While Nelson might argue more stringent tests were needed, she couldn’t argue Wyeth was malicious in its actions, Jackson said.

“[Wyeth] was aware of a breast cancer risk, disclosed it in its Prempro label and further aided the medical community in better understanding the drug,” Jackson said. “As such, [Wyeth's] conduct could not rise to the requisite level necessary to justify an award of punitive damages which are intended to rectify a wrongdoer’s evil motive or oppressive behavior.”

There are about 1,500 hormone therapy-related cases currently in the Complex Litigation Center, and Scott said he thinks this opinion could affect many of them.

He said he doubts many of the doctors in those other cases would say they didn’t know about the risk or that they wouldn’t have prescribed the drug if the warnings were clearer.

Scott said hundreds of thousands of women still take the drug.

Nelson is one of eight cases selected from the 1,500 to be test tried in the Complex Litigation Center. Four were selected by Wyeth and four by the plaintiffs’ side.

Scott said three of the four selected by Wyeth were voluntarily dismissed by the plaintiffs and one of the plaintiffs’ side cases was also voluntarily dismissed.

Two cases, he said, were tried and Wyeth lost. One was Nelson, in which the verdict was ultimately overturned in Wyeth’s favor. The other was Daniel v. Wyeth, in which the jury awarded a $1.5 million verdict. Wyeth has been granted a new trial in that case, Scott said.

A third case, Coleman v. Wyeth, was dismissed in September 2007 when the judge found the plaintiff’s claim was barred by a two-year statute of limitations.

Wyeth received a defense verdict in the remaining case, Simon v. Wyeth, in April 2007.

Tobi Millrood of Schiffrin Barroway Topaz & Kessler in Radnor represented the plaintiffs in Nelson. While he was happy Jackson provided an explanation for the Nelsons, Millrood said the opinion was inconsistent with Jackson’s prior trial rulings.

Millrood said Jackson had agreed with the jury’s conclusions that there was proximate and medical causation between the drug and Nelson’s breast cancer.

The one thing consistent in all of the Pennsylvania hormone therapy cases was that juries have found the causation to exist, Millrood said.

Jackson’s opinion, he said, relied mainly on statements made by Wyeth. He said he was looking forward to arguing his case before the Pennsylvania Superior Court.

The Nelson suit had seen its fair share of litigation. The first jury in the case had concluded in mid-October 2006 that Wyeth, if found liable during the second phase in the bifurcated litigation, would have to pay the action’s wife-and-husband plaintiffs $1.5 million.

At one point, it seemed as if a mistrial in those proceedings might be declared post-verdict after the court learned that one juror had threatened another with a detached table leg during deliberations.

But ultimately, Senior Judge Norman C. Ackerman – the former head of the CLC – made the decision to have a second go-around after the new year when defendant Wyeth revealed that one juror had failed to disclose a felony theft conviction during voir dire.

The Nelson retrial was not bifurcated and the jury deliberated on negligence and compensatory damages only. They awarded Nelson $2.4 million, with the remaining $600,000 going to her husband.

The Superior Court has not yet issued a briefing schedule in Nelson.

(Copies of the 15-page opinion in Nelson v. Wyeth , PICS No. 07-1974, are available from The Legal Intelligencer . Please call the Pennsylvania Instant Case Service at 800-276-PICS to order or for information. Some cases are not available until 1 p.m.)

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