Edwards Lifesciences Rebranding & Voluntary Retrieval of Medical Devices Are Often Signs of Fraud
February 5, 2016
Edwards Lifesciences Rebranding & Voluntary Retrieval of Medical Devices
Are Often Signs of Fraud
Frequent readers of this site have become suspicious when a major medical device company “decides” to pull a product from the market or to “rebrand” a product before deciding to pull it from the market altogether, both things Edwards Lifesciences did regarding the Myxo cardiac medical device, later renamed, dETlogix. The Sociopathic Business Model™ maintains that companies will often change names of subsidiaries or devices as a means to distance from unethical and or illegal behavior. Oh, I’ll give it to the creative marketing people at Edwards Lifesciences, this is a new one:
The maker of the device, Edwards Lifesciences, stopped selling the device to the United States market in 2008 because of safety concerns related to the new indication which was not tested in any animal models only human patients, which it termed a “voluntary retrieval” rather than a recall in Edward’s 2009 SEC 10-K filings. (It is still marketed in Europe.) Qmed
Let’s be honest, because we really can’t count on the companies for that, can we? No company decides or does a voluntary retrieval without serious pressure from the FDA behind closed doors. We recently saw something similar with Johnson & Johnson’s, Ethicon’s Acclarent:
2010 Johnson & Johnson decided to make the Relieva Stratus Microflow Spacer a catalog only product (meaning reps no longer commissioned but the company still profited) amid concerns of the product’s off-label usage, (despite Johnson & Johnson lowering startup Acclarent’s original price of $820 million to $785 million for concerns of the Stratus Microflow Spacer’s off-label use).
2011 Johnson & Johnson decided to stop the study on the Relieva Stratus Microflow Spacer, amid concerns the product did not work, which was later confirmed that solution injected into the device, Kenalog 40, only worked only when directly injected into the patient’s tissue, not a medical device. Yep, they stopped the study that would conclusively prove the product didn’t work. (yikes!)
2013 again Johnson & Johnson decided to voluntarily pull the product from the United States Market
2015 decided yet again to pull the device from the European market. So kind of companies like Johnson & Johnson and Edwards Lifesciences to look out for their patients and not profits…oops, except we know that Johnson & Johnson, in 2012 was served a federal subpoena, on the Relieva Stratus Microflow Spacer, meaning that Johnson & Johnson knowingly and willingly sold a medical device that fraudulently obtained an FDA 510(k) from 2010-2013 in the U.S. market and from 2010-2015 in the European market.
Stemming from the same 2012 subpoena, in 2015 nabbed Johnson & Johnson’s Ethicon’s Acclarent’s then CEO and VP of Sales and Training who were arrested, federally indicted on 18 counts of fraud and currently awaiting trial. Hope Edwards Lifesciences’
PRSpin marketing team is alright if we decided to dig a little deeper into their company and don’t just take their word that a voluntary retrieval was done out of the kindness of their hearts. Click the link below to Qmed for more on Edwards Lifesciences voluntary retrieval.
Updated July 2016
Johnson & Johnson’s Acclarent pays $18 million in False Claims case involving Stratus & the former Chief Executive Officer William (Bill) Facteau and Vice President of Sales of Acclarent, Inc., a medical device company, Patrick (Pat) Fabian were convicted by a federal jury in connection with distributing adulterated and misbranded medical devices.
Killing My Career often demonstrates that startup medical device (later sold to conglomerates) and startup tech follow similar patterns to distance from unethical and or illegal behavior.