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from MEALEY'S Emerging Drugs & Devices November 3, 2003 $16.2 Million Medmal / Failure To Warn Verdict Upheld In Assay Case SEATTLE -- A Washington appellate panel on Oct. 27 affirmed a $16.2 million verdict against Abbott Laboratories and a hospital for a laboratory test that produced false negatives and caused a plaintiff to undergo unnecessary cancer surgeries and chemotherapy (Jennifer Rufer, et al. v. Abbott Laboratories, et al., No. 48909-7-I, Wash. App., Div. I; 2003 Wash. App. LEXIS 2496). In an unpublished opinion, the Division I Court of Appeals panel rejected appeals and cross-appeals by the plaintiffs and one defendant but remanded the trial court's decision to unseal confidential information under a pretrial protective order and refusal to seal Abbott's confidential evidence. (Opinion. Document #28-031103-109Z.) Jennifer Rufer was seen in January 1998 for abdominal pain and vaginal bleeding. Her blood was tested for human chorionic gonadotropin (hCG) with the AxSYM BhCG assay, made by Abbott Laboratories. hCG is an indicator of pregnancy and gestational throphoblastic disease, a serious form of cancer. That and subsequent repeat tests came back positive for hCG, and through 1999, Rufer received chemotherapy and underwent a hysterectomy and partial removal of a lung. Pathology from both surgeries found no cancer, but hCG levels continued to be present. Alternate tests subsequently showed that Rufer never had cancer. Rufer and her husband sued Abbott for product liability and the University of Washington Medical Center (UWMC) for medical malpractice in the King County Superior Court. In 2001, a jury awarded the Rufers $16.2 million in damages for failure to warn and malpractice and apportioned the judgment equally between Abbott and UWMC. It found for Abbott on a design defect claim. The trial court denied Abbott's post-judgment motions for judgment as a matter of law based on the learned intermediary doctrine or a new trial for improper jury instruction on duty to warn under learned intermediary. Abbott appealed, arguing that there was insufficient evidence that it failed to warn about false positive results. The Rufers and UWMC cross-appealed. Copyright 2003, LexisNexis, Division of Reed Elsevier Inc., All Rights Reserved This story and the complete archive of Mealey's Litigation Reports including related court documents are available online by subscription or on a pay-per-view basis. Go to Mealeys Online
______________________________________________________________ from MEALEY'S LITIGATION REPORT: Fen-Phen/Redux October 22, 2003 Wyeth Sets Aside $2 Billion More For Diet Drug Litigation WASHINGTON, D.C. -- Wyeth announced Oct. 22 that it has set aside an additional $2 billion for litigation involving the diet drugs Pondimin and Redux, bringing the charges taken for the litigation to $16.6 billion. Kenneth J. Martin, Wyeth chief financial officer, told stock analysts in a conference call that the $2 billion was the minimum needed to cover settlement claims, heart valve and PPH opt outs and legal fees. Of the total amount set aside for diet drugs, $3.6 billion remained as of Sept. 30, according to a Form 8-K filed Oct. 22 with the U.S. Securities and Exchange Commission. Wyeth said that may not be enough to resolve tens of thousands of matrix claims within the settlement and notices from thousands more former diet drug users of their intent to opt out of the settlement and proceed to trial. "[I]t is not
possible to predict the ultimate liability of the Company in connection
with its diet drug legal proceedings," the 8-K says, including
its effect on cash flow, dividends, capital expenditures and debt repayment. Wyeth also reported that the trust has adopted a program to prioritize the handling of claims, with highest priority given to those that "are least likely to be illegitimate." Wyeth warned that even if the trust's Integrity Program, aimed at rooting out unsubstantiated claims, makes substantial progress, significant numbers of claims might satisfy eligibility criteria. "If so, matrix claims found eligible for payment after audit may exceed the $3.75 billion cap of the settlement fund," it said. If the settlement fund is exhausted, Wyeth said claimants may opt out under the settlement's Sixth Amendment, unless the company elects to pay the benefits. As of Sept. 24, Wyeth said the trust has received 108,000 claims forms. The $2 billion charge contributed to a $426 million third-quarter loss. Copyright 2003, LexisNexis, Division of Reed Elsevier Inc., All Rights Reserved This story and
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______________________________________________________________ from MEALEY'S LITIGATION REPORT: Diabetes Drugs October 9, 2003 Limitations Not Relevant For Doctor's Summary Judgment Motion In Rezulin Case NEW YORK -- The Rezulin MDL judge has ruled that the statute of limitations, under which MDL Magistrate Judge Theodore H. Katz had recommended denial of summary judgment for a physician, is immaterial because the magistrate had concluded that the plaintiffs had "no reasonable possibility" of recovering against the physicians (In Re: Rezulin Products Liability Litigation, MDL No. 1348, S.D. N.Y.). "Judge Katz's report and recommendation, as to which no plaintiff has objected, concluded that the claims against the physician defendants are legally insufficient and were fraudulently joined," U.S. Judge Lewis A. Kaplan of the Southern District of New York said Sept. 29. "The limitations issue therefore is immaterial." (Report. Document #19-031009-101Z. Order. Document #19-031009-102R.) Magistrate Judge Katz found nondiverse defendant physicians Barry Carroll, M.D., and James Crouch, M.D., to be fraudulently joined in a Sept. 3 report and recommendation. The magistrate found that the complaints in the 10 cases under consideration failed to state a claim against the physicians. Magistrate Judge Katz went on to consider motions by the two physicians for summary judgment. He said Crouch last saw the patient in question July 23, 1998, which under Arkansas' continuing treatment doctrine, would have caused the statute to expire either two years from that date or one year from March 23, 2000, when the withdrawal of Rezulin from the U.S. market put the plaintiff on constructive notice of the potential tort. The lawsuit was filed March 19, 2002. Carroll's case was different, the magistrate said, because the plaintiff-patient continued to see him until Oct. 27, 2000. Under the continuing treatment doctrine, the plaintiff's March 21, 2002, complaint was timely, the magistrate said. Carroll had objected to the report and recommendation. Copyright 2003, LexisNexis, Division of Reed Elsevier Inc., All Rights Reserved This
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______________________________________________________________ from MEALEY'S LITIGATION REPORT: Ephedra & PPA November 5, 2003 Dietary Supplement Maker Nutraquest Files For Chapter 11 Bankruptcy TRENTON, N.J. -- Citing increasing litigation costs and an $18 million judgment against it, dietary supplement manufacturer Nutraquest Inc., formerly known as Cytodyne, filed for Chapter 11 bankruptcy Oct. 16 (In Re: Nutraquest, Inc., No. 03-44147, D. N.J. Bkcy.). (Nutraquest's verified application for order. Document #43-031105-101B.) Nutraquest filed its Chapter 11 application in the U.S. Bankruptcy Court for the District of New Jersey. In an Oct. 17 court document, Nutraquest says it was forced to file because of the increasing volume of lawsuits being filed against for its ephedra product Xenadrine RFA-1, which received negative press after the March death of Baltimore Orioles pitcher Steven Bechler, who was allegedly taking the product. Also, a judge overseeing a false advertising class action in the San Diego Superior Court on Oct. 3 issued a final judgment ordering the company to pay more than $18 million in damages, costs and attorneys' fees, Nutraquest says. The judge issued a tentative ruling on the case on May 30, concluding a six-week trial (Jason A. Park, et al. v. Cytodyne Technologies, Inc., et al., No. GIC 768364, Calif. Super., San Diego Co.). "If the Park plaintiffs and their attorneys were to be permitted to execute upon the judgment and seize the assets of the Debtor, the Debtor's ability to classify and treat each of its creditors equitably and its ability to carry on its business would likely be severely impaired," Nutraquest says. All litigation against Nutraquest has been suspended because of the Chapter 11 filing. The California plaintiffs sued Cytodyne, alleging that its advertisements for Xenadrine RFA-1, which contains ephedra, were false and deceptive. Copyright 2003, LexisNexis, Division of Reed Elsevier Inc., All Rights Reserved This story and
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_____________________________________________________________ from MEALEY'S LITIGATION REPORT: Baycol® October 22, 2003 Baycol
Judge Rules MDL Will Try 1st Case Beginning June 7 (Pretrial Order No. 96. Document #52-031022-107R.) Judge Michel J. Davis of the District of Minnesota issued Pretrial Order No. 96 Oct. 17. He said the parties have met and conferred with each other and with the MDL special masters in creating the list. The six cases are Anderson v. Bayer (No. 02-1103), Goulet v. Bayer (No. 03-3636), Lee v. Bayer (No. 02-1053), Pierce v. Bayer (No. 03-1003), Schmidt v. Bayer (No. 03-897) and Soliman v. Bayer (No. 03-3635). The judge also established deadlines for plaintiff and physician depositions and for discovery. All generic and case specific expert reports and depositions are to be complete by March 5. The hearing on oppositions to expert motions is scheduled for April 1. Summary judgment motions will be heard April 29. The final pretrial conference will take place June 3. Copyright 2003, LexisNexis, Division of Reed Elsevier Inc., All Rights Reserved This story and
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_____________________________________________________________ from MEALEY'S LITIGATION REPORT: Latex October 29, 2003 State Court Attorney Subject To Latex MDL Assessment, Judge Rules PHILADELPHIA -- Although a plaintiff lawyer's latex cases were litigated in state court, he is still subject to the MDL withholding of 3 to 5 percent of settlement proceeds to access the Plaintiffs' Document Depository and MDL Cost Account, a federal judge ruled last month (In Re: Latex Gloves Products Liability Litigation, MDL No. 1148, E.D. Pa.). (Opinion. Document #33-031029-102R.) U.S. Judge Edmund V. Ludwig of the Eastern District of Pennsylvania, who is presiding over the latex multidistrict litigation, issued a ruling on Ronald R. Benjamin's motion on Sept. 5. On June 24, the MDL special master ruled that Benjamin must comply with Case Management Order (CMO) 48, which requires "confidentiality and assessments on plaintiffs' recoveries." Benjamin was arguing that under Rappaport v. Showa Denko, K.K (In Re Showa Denko K.K L-Tryptophan Products Liability Litigation II, 953 F.2d 162 [4th Cir. 1992]), a "federal court lacks jurisdiction over state court cases and a transferee court does not obtain jurisdiction via the transfer of the administration of multi-district litigation." Judge Ludwig said that Showa Denko is not controlling in his district and that the transferee court's order was "much more sweeping" than the latex MDL's CMO 48. "Under CMO 48, it is unnecessary to theorize that every claimant benefits from the discovery completed by the plaintiffs' steering committee, regardless [of] whether the case is in federal or state court, and whether suit has been instituted," Judge Ludwig said. "CMO 48 was crafted and carefully considered to facilitate access to discovery materials produced by the PSC, and in return to compensate the PSC for its work. The process has functioned as envisioned and without problems since the administrative order was entered some four years ago," Judge Ludwig said. Copyright 2003, LexisNexis, Division of Reed Elsevier Inc., All Rights Reserved This story and the complete archive of Mealey's Litigation Reports including related court documents are available online by subscription or on a pay-per-view basis. Go to Mealeys Online.
_____________________________________________________________ from MEALEY'S LITIGATION REPORT: Thimerosal & Vaccines October 23, 2003 Federal Judge Overturns Reliance On Stevens In Tetanus Vaccine Case WASHINGTON, D.C. -- A federal judge has remanded to the Office of Special Masters the case of a woman denied relief based on a claim the tetanus toxoid vaccine set in motion an acute demyelinating illness, overturning in the process a 2-year-old evidentiary procedure the special masters had been using to analyze causation (Margaret Althen v. Secretary, No. 00-170V, Fed. Clms.). (Opinion. Document #56-031023-104Z.) Judge Susan G. Braden of the Court of U.S. Claims said Sept. 30 the elements of the "five-prong" analysis set out by Chief Special Master Gary J. Golkiewicz in Stevens v. Secretary (No. 99-594V, Fed. Clms., Office of Spec. Masters; 2001 U.S. Claims LEXIS 67), which had not been reviewed, was contrary to law because it shifted evidentiary burdens of the Vaccine Act. The first prong of Stevens lowers the petitioner's burden of proof by demanding only medical plausibility for the theory of causation, while the second prong, confirmation of that plausibility in the literature, increases the plaintiff's burden beyond that contemplated by Daubert v. Merrill Dow Pharm., Inc. (509 U.S. 579, 590 [1993]), Judge Braden said. Because Margaret Althen's theory of injury was not supported in the literature, the chief special master did not go beyond Prong 2 of his Stevens analysis, the judge said. "Petitioner proffered reliable medical records, a reputable medical opinion, a logical sequence of cause and effect, and a medical theory causally connecting the vaccination to the onset and development of her demyelinating illness," Judge Braden said. "In other words, petitioner established that but for the vaccine, it is more likely than not (greater than 50) that she would not have incurred optic neuritis and subsequent symptoms of demyelinating illness. Moreover, petitioner has established that it is more likely than not (greater than 50) that the vaccine was a substantial factor in causing her demyelinating illness. "Therefore, the Chief Special Master erred as a matter of law because the petitioner met the statutory burden to establish causation in fact . . . albeit that causation was not established to a medical certainty," the judge said. "Petitioner, therefore, is entitled to relief under the Vaccine Act." Copyright 2003, LexisNexis, Division of Reed Elsevier Inc., All Rights Reserved This story and the complete archive of Mealey's Litigation Reports including related court documents are available online by subscription or on a pay-per-view basis. Go to Mealeys Online.
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