Although the U.S. Food & Drug Administration's drug approval system certainly has its flaws, it isn't "optional" or a mere recommendation -- the law requires pharmaceutical drug and medical device manufacturers to get the FDA's approval before marketing or selling a drug for a specific purpose. The law also requires manufacturers to get FDA approval again if they want to market and sell a product for a different purpose than one it has already been approved for.
While this may not be the system we want, it is the system we have to prevent patients in West Virginia and elsewhere from being harmed by dangerous drugs and defective medical devices. Unfortunately, as demonstrated by the story that's the subject of today's blog post suggests, drug makers and medical device manufacturers don't always play the rules.
In a wrongful death lawsuit filed in a Philadelphia federal court last week, the family of a woman who died after being injected with a bone cement product nearly a decade ago alleged that the manufacturers of that product -- a company called Synthes and a subsidiary called Norian -- marketed and even trained U.S. doctors to use the product for non FDA-approved purposes.
The bone cement in question had only been approved by the FDA for use with forearm fractures, not for vertebral compression fractures like the one the deceased woman underwent surgery for in 2003. Appallingly -- at the request of a Synthes consultant who was present in the operating room -- her doctors used the cement anyway. She went into cardiac arrest seconds after the injection and died on the operating table.
Two other patients also died under similar circumstances; their families filed a joint lawsuit earlier this year.
Both companies and four former executives have already pled guilty to criminal charges in connection with the illegal 2003 and 2004 clinical trials of this dangerous drug product. Included in that agreement was a requirement that Synthes (recently purchased by Johnson & Johnson) sell its Norian assets to Kensey Nash (now owned by Royal DSM).
Source: Philadelphia Inquirer, "Synthes sued for wrongful death, fraud in illegal bone cement trial," July 30, 2012