The Food and Drug Administration is investigating Johnson & Johnson unit Animas Corp., the unit that makes insulin pumps for diabetics. The company is accused of selling pumps known to fail and neglecting to promptly report cases where the company’s products might have caused or contributed to death or serious injury. The unit has been warned that the company could face fines and other sanctions for selling faulty insulin pumps and delaying the disclosure of serious injuries to patients using OneTouch Ping and 2020 pumps sold by the company.
Inspectors found that Animas never reported to authorities on one complaint about a serious patient injury and delayed their reporting on two other incidents. The patients affected were hospitalized with dangerously high blood sugar, respiratory failure, coma, and a life-threatening complication called diabetic ketoacidosis, caused by lack of insulin to break down blood sugar.
Erik Gordon, a professor and analyst at the University of Michigan’s Ross School of Business, said, “Any company can have one of these things pop up and smack them, and you can have a bad coincidence when two of them come and smack you three weeks apart. But it’s not bad luck when you have this many. The amazing thing is that Bill Weldon (Johnson & Johnson CEO) still has a job.”
The quality problems at the health giant have regulators and analysts bewildered. This is at least the seventh Johnson & Johnson business to come under scrutiny in recent years. The company set the standard for protecting public safety decades ago with a nationwide recall of Tylenol bottles that an unknown assailant had poisoned. The corporate credo that is prominently displayed at the company’s headquarters stresses the company’s responsibility to the doctors, patients, and parents who use Johnson & Johnson products.
Johnson & Johnson has announced nearly 30 product recalls since September 2009. The recalled products have included millions of bottles of Tylenol, Motrin and other nonprescription medicines, prescription drugs for seizures and HIV, faulty hip implants, and contact lenses. The recalls have occurred for various reasons, including contamination with metal shards, glass particles, nauseating odors, and inaccurate levels of active drug ingredients.