About
The FDA's new Preemption Rule
New twists in ongoing COX-2 litigation
Device litigation and recalls
The stakes have never been higher…
The past year has had many watershed moments in drug and device litigation. The FDA-amidst ongoing turmoil-has boldly preempted state labeling laws through its rulemaking ability. COX-2 litigation continues to be waged; and there has been an unprecedented focus on device-related litigation.
The publication for
ACI's Drug and Medical Device Litigation provides presentations that include:
The ramifications of the FDA's new preemption rule on the drug and device industries
Plaintiffs' latest theories – including procedural tactics, new twists on traditional causes of action, private civil liability claims, and the latest consumer protection actions
How to coordinate the defense in MDL claims
The foremost strategies for drug and device recalls
Best methods for controlling the corporate message and PR tactics
Cross-examination approaches to communicate critical information to your jury effectively
Contents & Contributors
FEDERAL PREEMPTION AND PRODUCT LABELING
Daniel E. Troy, Sidley Austin Brown & Wood LLP
EMPLOYING THE FDA REGULATORY PROCESS TO MINIMIZE PRODUCT LIABILITY RISKS
Sandra J.P. Dennis, Morgan, Lewis & Bockius LLP
FDA-RELATED ISSUES IN DRUG AND MEDICAL DEVICE LITIGATION
Daniel J. Stephenson, Dykema Gossett PLLC
Bryan J. Anderson, Dykema Gossett PLLC
DRUG AND MEDICAL DEVICE LITIGATION: PREPARING FOR PLAINTIFF'S LATEST THEORIES: EMERGING CHALLENGES AND TARGETS OF MASS TORTS LITIGATION
Peter L. Resnik, McDermott, Will & Emory
PREPARING FOR PLAINTIFFS' LATEST THEORIES: CONSUMER FRAUD CLAIMS AND CHALLENGES TO CLINICAL TRIALS
Vivian M. Quinn, Nixon Peabody LLP
J. Christopher Allen, Jr., Nixon Peabody LLP
RECENT TRENDS IN MEDICAL MONITORING CLAIMS IN MEDICAL DEVICE AND PHARMACEUTICAL CLASS ACTION LITIGATION
Francis A. Citera, Greenberg Traurig LLP
Edward M. Shin, Greenberg Traurig LLP
THIRD PARTY PAYER SUITS: OBSERVATIONS FROM THE TOBACCO CASES
Murray R. Garnick, Arnold & Porter LLP
DEFENSE OF THIRD PARTY PAYOR PHARMACEUTICAL CASES
Anthony Vale, Pepper Hamilton LLP
STRUCTURING DEFENSE COUNSEL FOR PHARMACEUTICAL AND MEDICAL DEVICE MULTIDISTRICT LITIGATION
J. Carter Thompson, Jr., Butler, Snow, O'Mara, Stevens & Cannada, PLLC
William M. Gage, Butler, Snow, O'Mara, Stevens & Cannada, PLLC
Lisa Martin, Butler, Snow, O'Mara, Stevens & Cannada, PLLC
COORDINATING THE DEFENSE OF MDL CLAIMS: IMPORTANT CASE MANAGEMENT CONSIDERATION
Stephen A. Wood, Kelley, Drye & Warren, LLP
THE GUIDANT INDEPENDENT PANEL REPORT: IMPLICATIONS FOR THE MEDICAL DEVICE INDUSTRY
Steven M. Kohn, Reed Smith, LLP
Rosemary F. Luzon, Reed Smith, LLP
POST-MARKETING EVENT REPORTS AND CLINICAL TRIAL DATA: POTENTIAL USES AND ABUSES IN LITIGATION
Stephanie A. Scharf, Jenner & Block LLP
ISSUES RELATED TO FOREIGNERS BRINGING PERSONAL INJURY, MASS TORT CLAIMS IN THE UNITED STATES
Richard L. Berkman, Dechert LLP
EFFECTIVELY MANAGING A MEDICAL DEVICE RECALL
Robert Durgin, Biomet, Inc.
HOW DO YOU DEFEND A PRODUCT THAT HAS BEEN RECALLED
Connie Matteo, Porzio, Bromberg & Newman PC
RECALL SYSTEM
Thomas J. Stukane, Schering Plough Corporation
CRISIS MANAGEMENT – CONTROLLING THE CORPORATE MESSAGE AND LIMITING NEGATIVE EXPOSURE
Tanya J. Dobash, Taro Pharmaceuticals U.S.A., Inc.
BERMUDA FORMS AND COVERAGE FOR DRUG AND MEDICAL DEVICE LIABILITY
Richard P. Lewis, Anderson, Kill & Olick, P.C.
INSURANCE COVERAGE CONUNDRUM – WORKING TOWARD A BETTER RELATIONSHIP
Richard P. Lewis, Anderson, Kill & Olick, P.C.
Cindy Khin, Insurance Operations Medmarc Insurance Group
Lee Farrow, ACE Medical Risk
THE ADMISSIBILITY OF EXPERT WITNESS TESTIMONY: DEBUNKING JUNK SCIENCE
Randall L. Christian, Clark Thomas & Winters
Harvey L. Kaplan, Shook, Hardy & Bacon, L.L.P
.
DIRECT TO CONSUMER ADVERTISING AND MEDICAL DEVICES
Mark T. Piazza, Depuy Orthopaedics, Inc.
DIRECT-TO-CONSUMER ADVERTISING AND THE LEARNED INTERMEDIARY DOCTRINE
Daniel A. Kracov, Arnold & Porter, LLP