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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.

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

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  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

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