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Vol. 12, No. 4 · June 2008 · Editor: Martha L. Golar, Esq.
During the evening, attendees were asked to demonstrate their support for the October Courthouse Alert project by sponsoring the mammography vans. JALBCA’s Lawyer’s Division, working with the Women’s Bar Association of the State of New York, sponsors this annual project, disseminating literature and information at courthouses throughout the State and, through the American Italian Cancer Foundation and Women’s Outreach Network, subsidizing the cost of mammography screening vans. At the dinner, JALBCA received an extraordinary response. Listed below are the generous firms and individuals who agreed to serve as sponsors to help provide the free mammography screening for the 2008 JALBCA October Courthouse Alert.
Sponsors of Mammogram Vans Aaronson Rappaport Feinstein & Deutsch, LLP Duffy Duffy & Burdo Gair, Gair, Conason, Steigman & Mackauf Godosky & Gentile, P.C. Patricia Hynes and Roy Reardon Kramer Dillof Livingston and Moore Weitz & Luxenberg Sponsors of Mammograms Nancy Block, Esq. Hon. Anita Florio Sandra Forster, Esq. Desiree Fusco Carla Glassman & Susan Brown James Long, Esq. Hon. Sondra Miller Katherine Puzone, Esq. Deborah Raskin, Esq. Tina Scognamillo, Esq. Phyllis Solomon, Esq. Friends of Michael Stanton Eva Talel, Esq. PRESENTATIONS AT THE ANNUAL MEETING OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO) At this year’s annual ASCO meeting, held in Chicago, May 30 - June 3, 2008, several studies were presented. Listed below is a summary of some of those studies: UNITED STATES SUPREME COURT EXPANDS FEDERAL PRE-EMPTION IN MEDICAL DEVICE CASES The U.S. Supreme Court took up a series of cases that addresses the issue of whether federal agency approval of medical devices and drugs shields manufacturers of those products from liability under state laws. On February 20, 2008, in an 8-1 decision, the United States Supreme Court held that federal law preempts state common law tort claims against medical device manufacturers if certain medical devices received U.S. Food and Drug Administration (FDA) approval. This involved FDA approval under the Premarket Approval (PMA) process. Based on this ruling, plaintiffs can no longer sue medical device manufacturers for claims such as strict liability, breach of implied warranty, design defect, etc. under state law for devices that have passed the FDA’s PMA process. The FDA’s PMA process is its most rigorous medical devices review and is applied only to certain medical devices. The decision, Riegel v. Medtronic, No. 06-179, 2008 WL 440744 (US), significantly enhanced the regulatory compliance defense for Class III medical devices that receive PMA from the FDA. The case involved allegations that a Medtronic catheter (a balloon catheter used in angioplasty) was designed, labeled, and manufactured in violation of New York common law. The catheter was PMA-approved in 1994 by the FDA as a Class III device. Section 360k(a) of theMedical DeviceAmendments of 1976 (MDA) expressly pre-empts state requirements that “are different from or in addition to” FDA’s device safety or effectiveness requirements under the Federal Food, Drug and Cosmetic Act (FFDCA)(21 U.S.C. §360k(a)). Noting that FDA premarket review of a PMA application “is federal safety review”, the Court found that the PMA approval process “imposes ‘requirements” on Medtronic. (Op. at 9) Observing that “New York’s tort duties constitute ‘requirements’ under the MDA” that are expressly preempted by section 360k(a), the Court concluded “that common-law causes of action for negligence and strict liability do impose ‘requirement[s]’ and would be pre-empted by federal requirements specific to a medical device.” (Op. at 10) The Court also stated that section 360k(a) “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations. In this instance, the state duties would ‘parallel’, rather than add to, federal requirements”. (Op. at 17) The Court also made an observation with regard to possible pre-emption by requirements established under other federal laws, stating that “[a]bsent other indication, reference to a State’s ‘requirements’ includes its common-law duties”. (Op. at 11) Justice Ruth Bader Ginsburg was the lone dissenter in Riegel, arguing that Congress had no intent to curtail the public’s right to compensation when injured because “a legislative design to pre-empt state common-law tort actions” does not exist in MDA and because the FDA did not provide any federal compensation remedy. Riegel was the first of three significant pre-emption cases on the Supreme Court docket for the term. The second case, Warner-Lambert v. Kent, __ S.Ct.__ (No. 06-1498), raised the question of whether there is implied pre-emption of an exemption to the Michigan “FDA shield” statute that requires a court determination of fraud-on-the-FDA, i.e., the Michigan law allows liability suits against drug makers in cases where the company has misled the FDA during or after the approval process. In an amicus curiae brief, the Bush administration had argued, in favor of the drug makers, that the FDA and the drug makers have a relationship that is “inherently federal”. The judgment of the Circuit Court was affirmed by an equally divided court in a 4-4 vote, on March 3, 2008. Chief Justice John Roberts recused himself because he apparently owns stock in Pfizer Inc., the parent of the drug company, Warner- Lambert. The result of the tie vote is that the suit against the drug maker may proceed in Michigan courts. The third case, Wyeth v. Levine, __ S.Ct. __, 75 USLW 3500, 76 USLW 3018 (U.S.Vt. Jan 18, 2008) (No. 06-1249), will be heard in the October term. This is a drug, not device, liability case that could potentially extend pre-emption. Wyeth addresses whether FDA’s approval of prescription drugs under the New Drug Approval (NDA) process, particularly its labeling, preempts state law claims for failure to warn and other challenges to safety or efficacy when a prescription drug obtains FDA premarket approval for the drug and its label warning of potential side-effects associated with the drug. The case involves the FDA approval under the NDA process. The FDA weighed in on this issue and issued a preamble in the Federal Register stating that it believes state court claims regarding failure to warn should be pre-empted and barred for any prescription drug that passes FDA approval. BCERF SPRING REGIONAL CANCER AND ENVIRONMENT FORUM On Thursday, May 29, 2008, the Cornell University Program on Breast Cancer and Environmental Risk Factors (BCERF) held its Spring Regional Cancer and Environmental Forum. The all-day forum featured presentations on the following: Prevention of Weight Gain as a Strategy to Decrease Breast Cancer Risk; Phthalates, Obesity and Insulin Resistance: First Looks; The Estrogen Connection: Estrogenic Chemicals in Plastics, Personal Care Products and Electronics; and The Rochester Healthy Home: A Model for Integrated Toxics Education. For further information, contact Carmi Orenstein at (607) 255.1185 or csol@cornell.edu. Calendar / Contacts ELLEN’S RUN -- SAVE THE DATE Eleventh Annual Ellen’s Run Sunday, August 17, 2008 9:00 a.m. rain or shine East Hampton High School ADELPHI NY STATEWIDE BREAST CANCER Hotline & Support Program Adelphi University School of Social Work Garden City, NY 11530 www.adelphi.edu/nysbreastcancer/index.html CancerCare 275 Seventh Avenue NY NY 10001 www.cancercare.org 1-800-813-HOPE (4673) MEMORIAL SLOAN-KETTERING CANCER CENTER Post-Treatment Resource Program Educational Forums 215 E. 68th St., Ground Fl. New York, NY 10021 212-717-3527 www.mskcc.org/mskcc/html/19409.cfm Bendheim Medicine Center 1429 First Avenue (at 74th St.) SHARE (Self-Help for Women with Breast or Ovarian Cancer) 1501 Broadway, 704A New York, NY 11530 www.sharecancersupport.org 212-719-0364
JALBCA does not endorse the content or efficacy of any workshops or programs listed in the Calendar of Events; listings are for informational purposes only, so that our readership is aware of current offerings. |
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