Tuesday, February 3, 2009

Heparin Lawyer | Baxter Recall | Side Effects Attorney

Our heparin lawsuit lawyers and attorneys have discovered that a recall of tainted heparin made by heparin manufacturer Baxter has caused severe tainted heparin side effects and other injuries that our heparin attorneys may be able to recover compensation for through a heparin lawsuit. Our heparin side effects attorneys have considerable experience litigating heparin side effects cases and are the right attorneys to take on heparin manufacturer Baxter.

On Monday, February 11, 2008, on the heels of reports of 4 deaths and 350 adverse reactions caused by apparent allergic reactions to Heparin, Baxter International, one of the leading medical device and drug manufacturers in the world, announced that it would no longer sell multi-dose vials of Heparin. As of April 9, 2008, 62 deaths have been reported from what we now know to be heparin that was contaminated in China.

The Heparin recall crisis began late last year when four children undergoing dialysis in Missouri exhibited severe allergic reactions just minutes after receiving Heparin. Reports of adverse reactions to Heparin continued to mount, leading to last month’s recall by Baxter International of certain batches of Heparin. As the reports continued to spread to include more and more Heparin lots not recalled, Baxter realized the recalled batches were not the problem and decided to recall Heparin.

Products affected are: Baxter’s Heparin Sodium Injection multiple-dose vials (1000 units/mL concentration, 10 mL and 30 mL vials; 5000 units/mL concentration, 10 mL vials; and 10,000 units/mL, 4 mL vials). These are used when patients need large intravenous doses given quickly, sometimes called “bolus doses” in order to thin their blood over a very short period of time. Patients affected are: patients with kidney failure on hemodialysis; patients undergoing certain types of cardiovascular surgery; patients undergoing other specialized treatments called photopheresis and plasmapheresis and some patients who have blood clots in arteries or veins.

FDA learned of the occurrence of adverse events on January 9 from CDC investigators who were evaluating small clusters of these events in dialysis centers. On January 16, 2008, FDA initiated an inspection of Baxter’s manufacturing plant in Cherry Hill, New Jersey. At the time of the inspection, Baxter notified the Agency that nine lots of its heparin sodium were being recalled due to an increase in the rate of adverse events with these lots. The recall was initiated on January 17, 2008.