On April 15, 2008, the FDA announced that the blood thinner heparin, which has been associated with several deaths and allergic reactions, may have been intentionally contaminated in order to reduce the cost of the drug. The contaminated heparin was manufactured by Baxter International and is commonly used before certain types of surgery and during hemodialysis as a blood clotting preventative.

 

In addition, the FDA reported last week that there has been a substantial increase in the number of people who have died while taking the blood thinner.  Its findings indicated that there have been 103 reports of heparin-associated deaths since January 1, 2007 and 91 of these were reported to the agency on or after January 1, 2008.  Baxter and the FDA recalled several dosage types of heparin in February after receiving reports of adverse reactions including breathing difficulty, vomiting, excess sweating and a rapid decline in blood pressure.  Baxter subsequently expanded the recall to include all remaining lots of its multi-dose, single dose and flush products.

Number of Deaths of Patients Receiving Heparin Reported to FDA, January 1, 2007 through March 31, 2008
Month the Medical Event(s) Occurred	Number of Reported Deaths*	Reported Deaths with One or More Allergic/Hypotensive Symptom(s)
Jan-07	3	1
Feb-07	1	1
Mar-07	4	2
Apr-07	2	2
May-07	1	0
Jun-07	3	1
Jul-07	4	2
Aug-07	1	1
Sep-07	1	1
Oct-07	6	2
Nov-07	9	8
Dec-07	20	12
Jan-08	24	16
Feb-08	20	11
Mar-08	0	0
Unknown date	4	2
Total	103	62
*The reports in this table concern heparin produced by any manufacturer.

 

• For comparison purposes, FDA reviewed the reports it received for all deaths of patients in whom heparin was listed as a potentially suspect drug in 2006.
• A total of 55 deaths were reported from January 1, 2006 to December 31, 2006 - an average of four or five per month.
• Across these 55 reports of death, there were a variety of underlying medical conditions.
• Three of the reports listed allergic reactions or hypotension (low blood pressure) as a medical event, similar events to the cases that prompted the heparin recall in 2008.

 

Cohen, Placitella & Roth is actively seeking referrals of cases that resulted in death or injury of individuals who were administered heparin.  If you would like additional information concerning this litigation, please contact Stewart Cohen at 215-567-3500 or scohen@cprlaw.com or complete the form below