Not too many weeks ago, our Houston medical device injury attorneys ran an article on the recall of a bone putty from Johnson & Johnson’s Synthes unit that had a tendency to ignite during surgery, presenting great risk to the patients involved. We just read a horrific expose by Fortune Features of Time Warner Cable News from September 18th covering illegal human experimentation and off-label marketing of a deadly bone cement product by Synthes.
Apparently Synthes, founded as a company in 1958 to pursue the as-yet unexplored field of implant surgery as a therapy for bone disease and injury, sought to do an end run around FDA rules governing medical device products. Just after 2000, the company, under its executive leadership, sought to market a bone cement approved for use in the arm and the skull as a solution for filling compression fractures in the spine.
Under the scheme spearheaded by company executives, the bone cement Norian, branded as Norian XR, would be mixed with another substance to treat Vertebral Compression Factures (VCFs). But our Houston medical device injury attorneys point out that the U.S. FDA explicitly told Synthes that the product could not be marketed to treat VCFs, that the labels must contain specific warnings, and that it should not be mixed with another substance before being injected into the spine. In effect, the FDA specifically told the company that it could not sell the product for spinal repair uses, in which the company saw a huge new market.
Off-label marketing (marketing a product for a use for which it does not have FDA approval and for which its label does not indicate approval) is a common practice in the medical device industry as in the pharmaceutical industry. Indeed, off-label marketing of medical devices is such a common practice that very few people take it seriously or regard it as a real problem.
The FDA had indicated to Synthes that if it wanted to market Norian to treat VCFs, the company would need to seek an Investigation device Exemption (IDE). Under the IDE, Synthes would have to recruit large numbers of patients to consent to testing of the product in a controlled study and at considerable cost. Our Houston medical device injury attorneys understand that the company’s executive leadership apparently nixed that idea. And then decided to quietly recruit small numbers of surgeons to test the product on their patients.
Synthes’ leadership apparently thought that this unethical practice would build a track record of product success that they could use to tout their product and rake in the profits. But unfortunate things happened during these small, unapproved trials. Patients died in mere minutes on he operating table as bone cement leaked into their vascular-pulmonary system and quickly generated large amounts of clotting that blocked arteries and caused blood pressure to plummet.
Our Houston medical device injury attorneys note that many of the patients were elderly people with bone deterioration. Because of their advanced ages, family members did not initially question their sudden deaths on the operating table. Many of these family members only recently learned that an unapproved, defective medical device and corporate greed might be to blame for their family members’ deaths.
Four Synthes executives indicted in the matter pleaded guilty under a misdemeanor provision that usually only results in probation or a small fine. But prosecutors, feeling that the company’s disregard for the public safety was egregious in this matter, actually took the unprecedented step of sentencing these executives to prison.
And the recent Synthes recall about which we wrote several weeks ago involved a bone putty apparently designed to prevent the problem of leakage and bleeding. Designed perhaps to prevent the very bleeding and clotting problem that led to deaths of several patients on whom Norian had been used, this Synthes product instead erupted in flame on the operating table under certain conditions. You can read more about this recent bone putty recall in the article lined to this page.
There’s no question that bone fractures and bone deterioration can be very painful. However, our Houston medical device injury attorneys caution that the treatment of injecting the bone with various cements and putties, at least those made by Synthes, seems risky at best.
The Synthes saga reveals how little some medical device manufacturers really care about public health and well being. Patients and family members of patients who have suffered mysterious pain, injury, or death after surgery should seek the cause of that suffering.
Contact our Houston medical device injury attorneys if you would like a free and confidential legal consultation to discuss your injury case. We’ve been successfully investigating, trying, and obtaining full financial recoveries for injured patients and their families for mare than a decade.
Our goal is to hold defective medical device manufacturers accountable for their callous disregard of public safety and ensure that you get the just financial compensation you deserve after a needless injury or family members’ death. Call or email us today for your free case evaluation consultation.