According the Food and Drug Administration (FDA), Johnson & Johnson’s unit the Animas Corporation failed to follow regulations that mandate a firm that manufactures medical devices to report within 30 days of receiving or becoming aware of information that suggests the device may have caused or contributed to death or serious injury. FDA inspectors found that J&J’s Animas unit failed to report one incident of serious patient injury and delayed reporting two others.  Those patients were hospitalized with dangerously high blood sugar, respiratory failure and coma, and a life-threatening complication called diabetic ketoacidosis. The Animas unit stated that the incidents were not reported because each involved the patients improperly using the pumps.

Johnson & Johnson is also faulted with manufacturing insulin pumps after learning of malfunctions. Bloomberg news reported that the FDA blames Johnson & Johnson’s Animas unit for not explaining “why your firm continued to manufacture insulin pumps” after they “had known failures”. A spokeswoman for the Animas unit Caroline Pavis said the pump malfunctions involved the devices key pad which controls how much insulin is pumped into the bloodstream. The Animas unit did redesign the key pad to make it more durable but have yet to answer the FDA’s question of why the insulin pumps with faulty key pads continued to be manufactured with known deterioration problems.

Johnson & Johnson could be facing seizure, injunctions and fines if it does not promptly respond to the FDA’s warning and correct the violations.  These most recent issues are one of many similar problems to plague Johnson & Johnson. Since September 2009 they have recalled nearly 30 products including but not limited to non-prescription drugs, prescription drugs, contact lenses and defective hip implants.

If you have been injured by a defective medical device, you should immediately seek advice from a lawyer that is experienced in handling medical device cases.  For a free consultation with such an attorney, complete the form to the left or call 212-566-1000. Based in New York City, Sullivan & Brill, LLP represents clients throughout the United States, as well as in Manhattan, Brooklyn, Queens, Bronx, Staten Island, Nassau County, Suffolk County, Westchester County as wells as other upstate New York counties.