1 / 9

Marc P. Weingarten The Locks Law Firm 601 Walnut Street, Suite 700 E Philadelphia, PA 19106

The Anatomy of a Pharmaceutical Lawsuit The 30 th Annual Emergencies in Medicine Conference March 7 th , 2012 Park City, Utah. Marc P. Weingarten The Locks Law Firm 601 Walnut Street, Suite 700 E Philadelphia, PA 19106 Phone: 215-893-3404 Email: mweingarten@lockslaw.com. Disclosure.

blue
Download Presentation

Marc P. Weingarten The Locks Law Firm 601 Walnut Street, Suite 700 E Philadelphia, PA 19106

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. The Anatomy of a Pharmaceutical LawsuitThe 30th Annual Emergencies in Medicine ConferenceMarch 7th, 2012Park City, Utah Marc P. Weingarten The Locks Law Firm 601 Walnut Street, Suite 700 E Philadelphia, PA 19106 Phone: 215-893-3404 Email: mweingarten@lockslaw.com

  2. Disclosure • The presenter has no relationship of a business or commercial nature with any pharmaceutical companies. In the course of the presenter’s practice of law, many pharmaceutical manufacturers are sued by the presenter and/or his law firm.

  3. Factual Background • Aprotinin – antifibrolytic used to reduce bleeding after cardiac bypass surgery (CABG) • Approved by FDA in 1993 for CABG surgery with high bleed risk • Alternative antifibrolytics: • Aminocaproic acid • Tranexamic acid (TEA)

  4. My Client • Retired School Principal • CABG Surgery 10/14/03 • ½ dose aprotinin • h/x renal insufficiency • Treated with medication • Post-surgery • On hemodialysis 3 times/week for life • Medical Expenses $3,400,000 and growing each month • No wage loss

  5. Timeline • January 2006 • Articles in NEJM and Transfusion question aprotinin safety. FDA commences review • September 21, 2006 • FDA holds public meeting to discuss safety and risk-benefit profile • September 29, 2006 • Manufacturer informs FDA of additional safety study suggesting possible kidney damage, increased chance of death, CHF and stroke • FDA recommends limiting use to situations where clinical benefit of reduced blood loss outweighs potential risks

  6. Timeline • September 14, 2007 • Second FDA Advisory Committee hearing-panel votes to wait for results of Canadian study (BART) comparing aprotinin, aminocaproic acid and TEA • October 19, 2007 • Aprotinin arm of BART halted due to excess mortality • November 1, 2007 • Manufacturer voluntarily suspended worldwide marketing

  7. Expert Witnesses for the Plaintiff – Generic • Cardio-thoracic anesthesiologist • Pharmacologist • Nephrologist • Cardiac Surgeon • Epidemiologist • Former FDA employee

  8. Expert Witnesses for the Plaintiff – Case Specific • Cardio-thoracic surgeon • Nephrologist

More Related