On August 26, 2010, DePuy Orthopaedics Inc. and its parent company Johnson & Johnson announced a safety recall of its ASR XL and ASR Hip Resurfacing systems, citing evidence that the failure rate for these two hip implants was a disastrous 12-13 percent within the first 5 years. The DePuy hip implant recall deeply affects the lives of some 93,000 patients globally, including 37,000 in the United States, in which the faulty devices were implanted.
But these DePuy hip implant recipients aren’t the only ones affected by Johnson & Johnson recalls. According to Bloomberg / Business Week, the 125-year-old, $60-billion company issued more than 50 product recalls in 15 months, and there is evidence to show that these recalls are not a temporary fluke caused by one of Johnson & Johnson’s manufacturing units, but a more fundamental company-wide crisis of quality.
In addition to DePuy hip implants, some of the other products Johnson & Johnson has recalled in recent months include Tylenol and St. Joseph Aspirin, which people complained emitted a stench and made them sick; Rolaids, because they contained wood and metal fragments; Benadryl and Zyrtec, after their formulas were botched; Motrin, Benadryl, and Simply Sleep for a number of other quality-control issues, and many more.
Johnson & Johnson representatives told Bloomberg that most of the recalled drugs came from its McNeil Healthcare facilities, which U.S. regulators have cited for poor sanitary conditions and lax controls. The Food and Drug Administration shut down one of the McNeil plants in Fort Washington, Pennsylvania, while two others in Lancaster, Penn. and Puerto Rico were so shoddy that they will stay under the federal agency’s oversight for five years.
Johnson & Johnson CEO William Weldon told Bloomberg that all the talk of a “systemic” problem and “broader malaise” in his company are merely an example of “Monday morning quarterbacking.” He said that “everything has been overshadowed by one company [McNeil] … This is not an issue around Johnson & Johnson.”
But Bloomberg shows how this is a systemic problem at Johnson & Johnson, and one in which quality and safety have taken a backseat to profits. The magazine notes that the company has many other products such as “contact lenses, syringes filled with prescription medications, hernia devices, and other products made by subsidiaries around the world” all in the last 15 months. Go back 10 years, and you find a history of the company denying its products were defective, downplaying safety risks in its marketing, directly promoting the off-label use of drugs and devices, buying up defective products to avoid the negative publicity of a recall, and frustrating FDA regulators who told the company to improve quality control issues at the same manufacturing facilities that are turning out tainted products today.
“This is a real American tragedy,” Erik Gordon, a professor and biomedical industry expert at the University of Michigan’s Ross School of Business told Bloomberg. “They really have blown one of the great brands.”