Posted on January 19, 2012
Topics: Product Liability
Johnson & Johnson’s subsidiary, Animas, is under scrutiny for failing to report complaints of complications involving the company’s insulin pumps. The FDA sent a warning letter to Animas management describing several instances where the company failed to comply with regulations and report events involving its devices. According to the letter, on two different occasions Animas waited months to notify regulators of instances where patients using the company’s devices were hospitalized.
The increasing quality issues at Johnson & Johnson have analysts confused. The problems in product quality and safety are difficult to reconcile with the company’s image. Decades ago, J&J set the standard for protecting public safety with a nationwide recall of Tylenol that an outsider had contaminated.
The FDA has given Animas until Jan. 20 to explain why it kept selling pumps that were known to fail and to submit a plan to rectify the company’s failure to report instances where the devices may have contributed to serious injury or even death.
The FDA posted the Dec. 27 warning letter to J&J and Animas online. It stated that inspectors had found that Animas failed to report one complaint regarding patient injury and stalled reports on two others. The patients were hospitalized with respiratory failure and coma, dangerously high blood sugar and a severe complication known as diabetic ketoacidosis, which is caused by a lack of insulin to break down blood sugar.
These problems arose in the wake of nearly 30 product recalls announced by J&J since September 2009, including a number of nonprescription drugs, such as Motrin and Tylenol, as well as prescription drugs for HIV and seizures, faulty hip implants and contact lenses, according to a recent article in the New York Times. There is a wide array of reasons for the recalls, including nauseating odors, contamination with glass and metal shards and inaccurate levels of active drug ingredients.
An Experienced Lawyer Can Help
If you or someone you love has been injured by a defective drug or medical device, contact the experienced personal injury lawyers of Davis, Saperstein and Salomon, P.C., today. We have been helping injured individuals since 1981, and have obtained more than $350 million in verdicts and settlements for our clients.
Call us today at (800) LAW-2000 or fill out our convenient online contact form for a free case evaluation. We do not charge attorney fees unless we are successful in your case.
