The Anatomy of a Pharmaceutical Lawsuit

The 30th Annual Emergencies in Medicine Conference

March 7th, 2012Park City, Utah

Marc P. WeingartenThe Locks Law Firm601 Walnut Street, Suite 700 EPhiladelphia, PA 19106Phone: 215-893-3404Email: mweingarten@lockslaw.com

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.

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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)

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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

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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 5

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

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Expert Witnesses for the Plaintiff – Generic

Cardio-thoracic anesthesiologist Pharmacologist Nephrologist Cardiac Surgeon Epidemiologist Former FDA employee

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Expert Witnesses for the Plaintiff – Case Specific

Cardio-thoracic surgeon Nephrologist

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