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T HE A NATOMY OF A P HARMACEUTICAL L AWSUIT T HE 30 TH A NNUAL E MERGENCIES IN M EDICINE C ONFERENCE M ARCH 7 TH, 2012 P ARK C ITY, U TAH Marc P. Weingarten.

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Presentation on theme: "T HE A NATOMY OF A P HARMACEUTICAL L AWSUIT T HE 30 TH A NNUAL E MERGENCIES IN M EDICINE C ONFERENCE M ARCH 7 TH, 2012 P ARK C ITY, U TAH Marc P. Weingarten."— Presentation transcript:

1 T HE A NATOMY OF A P HARMACEUTICAL L AWSUIT T HE 30 TH A NNUAL E MERGENCIES IN M EDICINE C ONFERENCE M ARCH 7 TH, 2012 P ARK C ITY, U TAH Marc P. Weingarten The Locks Law Firm 601 Walnut Street, Suite 700 E Philadelphia, PA Phone:

2 D ISCLOSURE 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. 2

3 F ACTUAL B ACKGROUND 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) 3

4 M Y C LIENT 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 4

5 T IMELINE 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

6 T IMELINE 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 6

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

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

9 9


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