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A Philadelphia judge has ruled the plaintiffs in a hormone replacement therapy case were time-barred by the statute of limitations from suing the HRT pharmaceutical manufacturers Wyeth Pharmaceuticals Inc. and Pharmacia & Upjohn Co.

The judge originally ruled the case was time-barred in September 2007. The new opinion was triggered by the plaintiffs’ appeal to the Superior Court.

Philadelphia Common Pleas Judge Allan L. Tereshko asked the Superior Court to affirm his order from last fall granting summary judgment in Coleman v. Wyeth.

Plaintiff Elizabeth Coleman, a 67-year-old Arkansas resident, claimed in her June 28, 2004, lawsuit she was diagnosed with breast cancer in her right breast on Oct. 20, 2000, after using the HRT drugs Wyeth’s Premarin and Prempro and Pharmacia & Upjohn’s Provera since 1991, Tereshko said.

The plaintiffs filed their suit upon the basis of the discontinuation of the Women’s Health Initiative Study, which was cut short on July 29, 2002, because of the higher risk of breast cancer for study subjects taking hormone replacement drugs, Tereshko said.

He said Coleman should have filed her claim within two years of being diagnosed with breast cancer.

The Coleman case was the “first [Philadelphia bellwether] case decided on a full record with respect to statute of limitations,” said Michael T. Scott with Reed Smith, a Wyeth defense attorney in the case.

“I think it pretty well establishes that plaintiffs who did not file within two years of the time they were diagnosed have a statute of limitations problem,” Scott said.

Other test cases in the First Judicial District’s HRT, 1,700-strong program have gone against plaintiffs. The $1.5 million jury verdict in Simon v. Wyeth was wiped out when Judge Nitza I. Quiñones Alejandro granted JNOV for similar reasons as Tereshko’s rulings in the Coleman case; that case is on appeal. Senior Judge Ricardo C. Jackson also ruled against the plaintiffs in Nelson v. Wyeth; that case is also on appeal. A new trial has been granted in Daniel v. Wyeth, in which a jury initially awarded a $1.5 million verdict; that case is also on appeal. Other bellwether cases have been discontinued.

Tereshko said in a footnote his original Sept. 24 findings addressed most of the issues raised in the plaintiffs’ 1925(b) statement of matters, but in a supplemental March 7 opinion the judge addressed the issue of whether Coleman’s statute of limitations was tolled under the doctrine of fraudulent concealment, “which plaintiffs raised for the first time in their motion for reconsideration and again in their 1925(b) statement.”

The plaintiffs argued that Coleman’s physicians relied on information provided by Wyeth and Pharmacia & Upjohn to deduce if HRT caused breast cancer and that the manufacturers’ marketing misrepresented the drugs’ risks, according to Tereshko.

But Tereshko said the plaintiffs’ fraudulent concealment argument was unfounded in light of plaintiffs’ failure to provide evidence that an act of concealment by the defendants was relied upon by Coleman or her physicians in her health care decisions. In fact, Coleman’s physicians were aware of a correlation between breast cancer and the use of HRT and informed patients of that associated risk, the judge said.

“Had plaintiffs truly believed that defendants concealed relevant information and ‘lulled plaintiff … into believing that Prempro could not possibly have caused or promoted her breast cancer’ this court has no recourse but to believe they would have argued that point in response to the motion and at oral argument rather than waiting to raise it for the first time in a motion for reconsideration,” Tereshko said.

Coleman’s statute of limitations began to run when she was diagnosed with breast cancer, and Coleman has not presented any evidence that the defendants’ actions prevented her from learning the cause of her cancer, Tereshko said.

Coleman also checked the package inserts in her medication and failed to perform any investigation into the causes of her cancer when diagnosed and directed to stop the use of her HRT prescriptions, the judge said.

“This court concludes that an objectively reasonable person, informed by her doctors, prescription fact sheet inserts and national and local media that the HRT medicine she was taking for nine years could cause breast cancer who is later diagnosed with breast cancer, is under a duty to investigate the correlation between HRT and breast cancer at the time she is told she has breast cancer,” Tereshko said.

Ken Rothweiler of Eisenberg Rothweiler and one of the attorneys representing the plaintiffs, said that Tereshko misapplied the state’s discovery rule by ruling that Coleman was on notice of her claim after being diagnosed with cancer because the company defendants would not have given her a sufficient answer about the possible harm from the use of their HRT drugs to put her on notice at the time of her diagnosis.

Coleman brought her lawsuit “within two years when there was generally accepted information concerning the risk of hormone replacement therapy,” Rothweiler said.

The judge also did not properly consider Wyeth’s fraudulent concealment of the “true cancer-causing risk” of HRT drugs, Rothweiler said.

“We believe the trial court ruling was wrong and the appellate court will see it otherwise,” Rothweiler said.

Smith said the record in the Coleman case established there was information, including medical studies and mainstream reportage, in the public domain to put patients using HRT and then diagnosed with breast cancer on notice of a possible valid claim.

“The idea that publicity involved in the WHI study in 2002 should restart a statute of limitations I think is unprecedented in Pennsylvania law, and there really is no basis to believe that one study should restart the statute of limitations,” Scott said.

(Copies of the 26-page opinion in Coleman v. Wyeth Pharmaceuticals , PICS No. 07-1485, 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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