J&J Recalls Another Medical Device, Just the Latest Among Many
If Johnson & Johnson is a family company, I’m not sure if it’s a family I want to belong to.
The latest black eye for the once stellar and highly respected American company is the recall of 157,000 surgical staples used to treat hemorrhoids. The Wall Street Journal reports malfunctions can lead to serious adverse health consequences bringing J&J a Class I recall, considered the most serious by the U.S. Food and Drug Administration (FDA).
The official recall notice says a malfunction can cause incomplete firing and staple formation that can lead to sepsis and death as well and rectal wall damage, severe pain and infection. The staples are manufactured by the company’s Ethicon Endo-Surgery division.
While Johnson & Johnson once was associated with safe consumer products, this is just the latest in a line of shoddy practices either in the design and/or manufacture of consumer goods.
Last year it was announced J & J might have to shell out $1 billion to cover for the damages done by the DePuy Orthopaedics division and the metal-on-metal hip replacements. Thousands of product liability lawsuits, including those filed by the Searcy Denney law firm, accuse J&J of producing a defective product, negligence, and failure to warn about the recalled DePuy ASR metal total hip replacement (THR).
In 2010, the company’s DePuy division was ordered by the FDA to stop selling its Corail Hip replacement.
The J & J subsidiary Ethicon in June announced it would stop selling four of its vaginal meshes due to thousands of lawsuits filed by women who have had life-altering complications. Many of these women cannot find relief from the pain even after multiple surgeries, and those are the lucky ones in a way. Many just suffer and live on pain meds. J& J will update the product label for the Gynecare Gynemesh PS to further restrict its use for abdominal sacrocolpopexy procedure for which there is no FDA warning.
Maybe the company was just having a bad year.
In 2010 the company recalled more than 40 over-the-counter medications for contamination. The FDA inspectors along with the Department of Justice found conditions so bad at three manufacturing plants that the government took over the plants so they could comply with manufacturing guidelines.
J &J may be on the hook for $2 billion for the illegally promoting Risperdal off-label to be used in nursing homes on the elderly suffering from dementia even though the drug was linked to an increased death rate.
Things got so bad for Johnson & Johnson that earlier this year even its shareholders had had enough. They filed a corruption lawsuit charging that for years the corporate directors failed to stop wrongdoing in the company’ many subsidiaries that acted as their own little conglomerates.
The investors sued 10 board members from 2010 and several executives including current CEO Alex Gorsky and former CEO William Weldon. And they want up to $10 million in legal fees from J&J. For its part, the company has promised to do better and to following new quality and regulation goals.
In the meantime, this is the type of company the FDA still relies on for honesty and integrity when it brings a new medical device to market.
When sales trumps science and aggressive salesmen take over the CEO position rather than scientists, as used to be the case, we end up with products that are less than quality.