Quality Control Issues Raised as J&J Issues Second Recall this Week

johnson-and-johnson_quality_controlIn one week, health care giant, Johnson & Johnson, recalled two of its key products over quality issues. This, after working to reverse some bad press over scores of recalls, also due to quality issues, over the past couple of years.

Last week J&J implemented a large recall of 200,000 bottles of liquid Motrin for babies after particles of plastic were discovered in the infant medication, according to The New York Times. This week, J&J unit, Janssen, advised physicians and patients that it was recalling one lot of its injectable antipsychotic medication, Risperdal Consta due to potential mold contamination. Both recalled products were manufactured by third-party companies, the Times noted.

This is just one of a number of recalls issued by the health care giant in recent years. Since 2009, J&J has announced about 40 recalls. This year alone, J&J recalled millions of oral contraceptives over defective tablets, defective Adept hip implants, OneTouch VerioIQ blood glucose meters that shut when they should have issued an alert when patient blood sugar levels rose dangerously high, South Korea manufactured Children’s Tylenol that contained too much acetaminophen, and K-Y Jelly personal lubricant that may not have received mandated regulatory approval, Newsday reported. Recalls have been initiated over inappropriate active ingredient levels, glass or metal shards in liquid medicines, and foul odors. A previous Wall Street Journal report indicated that J&J’s string of recalls have cost the company about $900 million.

The Times pointed out that the recent recalls have many wondering if J&J really is working to improve the way in which its products are produced, noting that the company is working under a consent decree with the U.S. Food and Drug Administration (FDA) under which it has agreed to overhaul production at three of its manufacturing plants. One plant, located in Fort Washington, Pennsylvania, has been shuttered since 2010.

Although the drug and device maker states that this week’s recalls pose minimal safety issues, some recalls have led to mounting lawsuits over serious injuries. For example, J&J is also the parent company of DePuy Orthopaedics, which recalled 93,000 ASR metal-on-metal hip implant devices over premature failure issues. The defective device has led to patients undergoing revision surgery, a serious procedure in which the device is removed and replaced with a different device. The device maker is facing more than 11,000 lawsuits over the ASR.

There are other issues. Risperdal has been tied to growing legal action over alleged side effects. The Arkansas’ attorney general filed a brief backed by his peers in 35 states seeking to have the Arkansas Supreme Court uphold a $1.2 billion fine that had been levied against Janssen Pharmaceuticals Inc., over the way in which it marketed the drug.

J&J and Janssen are also facing 420 lawsuits over allegations of personal injuries related to Risperdal, the company indicated in a January 2013 regulatory filing. About 130 of the cases involve allegations that Risperdal caused young males to develop breasts, Bloomberg.com previously indicated. At that time, Risperdal was not approved for pediatric patients.

This entry was posted in Acetaminophen / Tylenol, Defective Medical Devices, Defective Products, Depuy, Pharmaceuticals, Product Recalls, Recalled Drugs, Recalled Medical Devices. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.