FDA Warns J&J Unit for Failing to Report Products’ Problems

January 23, 2012

For the last few years, Johnson & Johnson (J&J) has encountered numerous problems with its subsidiarys’ products: Repeated recalls of name-brand pharmaceuticals due to “musty odors” emanating from packaging materials, malfunctioning heart devices, leaking insulin cartridges, and of course, the DePuy hip replacement recall. The latter has been especially embarrassing for the medical conglomerate due to the high number ASR XL Acetabular Systems and ASR Hip Resurfacing Systems involved and the hip replacement lawsuits DePuy Orthopaedics, the J&J subsidiary, faces. Now, the U.S. Food and Drug Administration (FDA) is admonishing a different J&J subsidiary, Animas Corp., over its failure to report problems with its insulin infusion pumps.

‘Seizure, injunction, and/or civil money penalties’ If Animas Fails to Comply

Animas, headquartered in West Chester, Pennsylvania, creates and sells equipment designed to treat diabetes. One of Animas’ product lines, insulin infusion pumps, delivers insulin injections to diabetics. Between July 18 and August 10, 2011, the FDA conducted a site evaluation of Animas’ manufacturing facilities, and it determined Animas’ practices breached FDA regulations. On December 27, 2011, the FDA sent Animas a “Warning Letter,” published on its Web site, listing the regulations it believed Animas violated.

Specifically, Animas failed to alter its manufacturing practices that created “nonconforming and other quality problems” in its IR1200 and IR1250 insulin pumps. It also did not correct flaws in its One Touch Ping and 2020 insulin pumps. Finally, the FDA claims Animas failed to report incidents of people suffering injuries by these products via the FDA’s adverse events reporting system. The FDA argues Animas neither developed nor implemented any reporting procedures.

The FDA found Animas’ response “inadequate.” Its new “Medical Device Reporting” procedure did not follow regulatory guidelines required for filing adverse event reports with the FDA, and its “decision tree flowchart” was illegible. The FDA demanded Animas resolve these problems or face “regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.”

RLG Advocates for ASR Recipients

With any luck, Animas’ alleged failure to comply with FDA regulations didn’t result in harm to any of its customers, and it will be a minor event in the story of J&J’s products’ problems. For those who received an ASR device, however, the damage can be permanent and the road to restitution difficult to walk. If you believe your all-metal hip replacement injured you, it’s important to know that the amount of compensation from a hip replacement lawsuit might be greater than what DePuy is offering through its recall reimbursement program. A lawsuit against the manufacturer might allow you to recover lost wages, full medical expenses, transportation costs, damages for pain and suffering, and possibly punitive damages. For a free legal consultation with the Rottenstein Law Group, click on this link or call 1-877-619-5087, and one of our hip replacement lawyers will reach out to you as soon as possible.

For more information, download this free DePuy ASR brochure.