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A Philadelphia judge has ruled in another hormone replacement therapy case that a breast cancer patient claiming her HRT prescriptions caused her cancer failed to prove that her doctors would not have prescribed the hormone therapy drugs if the drugs’ warnings were different.

Philadelphia Common Pleas Judge Nitza I. Quiñones Alejandro told the Pennsylvania Superior Court Dec. 26 in a Rule 1925(b) opinion that the appeal in Simon v. Wyeth should be rejected and that her decision to grant JNOV – wiping out a $1.5 million jury verdict – should be upheld.

“Plaintiffs failed to meet the requisite proximal cause burden of proof,” Quiñones Alejandro wrote. “That is, in order to prove proximate causation, plaintiffs were required to establish that plaintiff-wife’s treating physicians would not, under any circumstances, prescribe the dangerous drug HRT combination. That evidentiary threshold was not met.”

The decision echoed another opinion in December by Senior Judge Ricardo C. Jackson that the plaintiff in Nelson v. Wyeth did not show sufficient evidence that her physician would not have prescribed a hormone replacement drug if the drug warnings were better.

The Nelson and Simon cases are on appeal to the Superior Court. Those cases as well as five others were selected as bellwether cases for the 1,730 HRT cases pending in the First Judicial District’s Complex Litigation Center, according to Stanley Thompson, the director of the CLC.

A new trial has been granted in Daniel v. Wyeth, in which a jury initially awarded a $1.5 million verdict. Summary judgment was granted in Coleman v. Wyeth. Banks v. Wyeth, Mill v. Wyeth and Ferrigno v. Wyeth all were discontinued.

In the Simon case, Merle Simon and her husband, Steven A., of New Jersey, filed a negligent products liability action against Wyeth Pharmaceuticals and Pharmacia and Upjohn Inc. on July 1, 2004, Quiñones Alejandro said.

The Simons argued Merle Simon developed breast cancer because of her use of an estrogen and progestin HRT drug combination. On May 15, a jury rendered a verdict against Upjohn, manufacturer of the progestin drug Provera that Simon took between 1992 and 1996 in conjunction with an estrogen drug manufactured by Wyeth to combat menopause symptoms, Quiñones Alejandro said.

The jury, however, found in favor of Wyeth, manufacturer of the estrogen Premarin drug that Simon took between 1992 and 1996 and manufacturer of the combined estrogen and progestin drug Prempro that Simon took between 1996 and her diagnosis with breast cancer on May 21, 2002, Quiñones Alejandro said. The jury also rendered a verdict against Steven Simon’s loss of consortium claim.

Quiñones Alejandro agreed with Upjohn’s post-verdict arguments that JNOV should be granted because Simon did not prove that a different warning regarding Provera would have led Simon’s doctors away from prescribing the drugs to her and that Simon did not prove her case was an exception to the two-year statute of limitations. Quiñones Alejandro entered JNOV in favor of Upjohn on Sept. 7.

Medical studies showed a correlation between the long-term use of HRT and an increased risk of breast cancer even before the well-publicized discontinuance in July 2002 of the National Institutes of Health’s study on the impact of HRT on cardiovascular disease of post-menopausal women; the study was stopped because a high number of HRT patients were developing breast cancer, Quiñones Alejandro’s opinion said.

Quiñones Alejandro said Simon did not establish proximate causation under the learned intermediary doctrine.

Simon’s doctors, Kenneth Dollinger, who prescribed the Premarin and Provera to Simon, and Catherine Sladowski, one of two doctors who prescribed Prempro to Simon, testified during the trial they continue to prescribe the HRT combination but now counsel patients on the NIH study’s findings before doing so, according to Quiñones Alejandro’s opinion.

Simon argued that the two-year statute of limitations started when she learned of the NIH’s study sometime after July 9, 2002, rather than when she was diagnosed with breast cancer on May 21, 2002, Quiñones Alejandro said.

Simon argued she had no reason to believe that her HRT could have caused her breast cancer because her doctor didn’t tell her there was a causal link, the product labels were “similarly dismissive” and the link was not widely publicized by the media until the results of the NIH study, the judge said.

Quiñones Alejandro, however, said that Simon didn’t qualify for a discovery rule exception to the statute of limitations because there were medical studies introduced into evidence by Simon that were conducted prior to the NIH study that highlighted HRT’s potential causation of cancer and the packaging of Wyeth’s Prempro said that there was a possible increase of breast cancer risk by including progestin in estrogen hormone replacement therapy. Prempro’s packaging should have alerted Simon to the potential problems of using the Upjohn product with Wyeth’s Premarin, the judge said.

Quiñones Alejandro said her opinion also was consistent with the Sept. 24 decision by Judge Allan L. Tereshko in Coleman v. Wyeth that the plaintiff was time-barred from suing Wyeth and Upjohn because she was diagnosed with breast cancer in October 2000 and sued the pharmaceutical manufacturers on June 28, 2004.

Attorneys for Simon and Upjohn could not be reached for comment yesterday.

(Copies of the 29-page opinion in Simon v. Wyeth , PICS No. 08-0050, 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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