Medical Alley Association, DuVal & Associates & Skadden, Aps: How to Get Away With Fraud At Taxpayer Expense
March 2, 2016
If you, are like me, tired of Howard Root, I apologize this was sent to as a tip, and it’s timely so and links quite a lot together.
The medical device industry as this site has pointed out, is famous for misappropriating, in a purposeful, false or deceptive way, patient, health and taxpayer advocacy groups for the community, when in fact, they’re shells for the corrupt medical device & pharma industry to try and manipulate laws for their benefit at the expense of patients, consumers, and taxpayers. These are my personal favorites:
- Citizen Petition, a group of citizens working to cut taxes….for the wealthy venture capitalist who fund the startup medical device industry.
- The Medical Information Working Group defending First Amendment rights….for executives of the medical device and pharmaceutical companies to try and evade accountability while fraudulently off-label marketing.
So, when Citizen Petition and The Medical Information Working Group came together to defend people like NEA funded ExploraMed incubated startup Acclarent purchased by Johnson & Johnson’s Ethicon then, CEO William (Bill) Facteau (currently CEO of startup EarLens) and VP of Sales & Training Patrick (Pat) Fabian (currently COO of startup NxThera) and Vascular Solutions CEO Howard Root, it raised more than a red flag.
Who would want medical device executives to have the ability to place blame and without shame, remorse, guilt or accountability while manipulating facts all protected by the First Amendment? Surely, it wouldn’t be the employees who’ve experienced layoffs due to off-label promotion fraud, and surely it wouldn’t be consumers or patients harmed or killed by off-label promotion fraud, and I couldn’t imagine shareholders would approve this tactic, and why would taxpayers, who keep footing the bill for all the industry’s off-label promotion fraud, support Citizen Petition and The Medical Information Working Group? They wouldn’t.
Facteau and Fabian were, on April 9, 2015, arrested and indicted on 18 counts of fraud. And, as previously explained, I am a former medical device rep from June 2007 for NEA-funded, ExploraMed incubated, startup Acclarent that sold of Johnson & Johnson’s Ethicon for $785 million in January of 2010, where I was wrongfully terminated in January 2011. And, I know, the First Amendment does not protect fraud. The device in question the Relieva Stratus Microflow Spacer:
- What might be the first time in U.S. history, a company fraudulently obtained the 510 (k) approval (the device did not work as approved with saline) nor was it designed or intended for saline, it was designed for suspension steroid Kenalog-40
- Stratus Microflow Spacer, also, did not work with Kenalog-40, as the drug must be injected into viable tissue and not a device, reps did not know this; but, Johnson & Johnson was aware, stopped, the almost completed study in November 2011, and sold the device up until they decided, while served a federal subpoena, to pull the product from the U.S. market in May of 2013, and finally from the international market late last year.
- At the bottom of this site is a countdown to: USA v. Facteau et al Massachusetts District Court, Case No. 1:15-cr-10076, the criminal trial of William (Bill) Facteau. Facteau is represented by Wilson, Sonsini, Goodrich and Rosati and Skadden, Arps Slate, Meagher, & Flom, has a great interest in Facteau. The case is being prosecuted by Assistant U.S. Attorneys Sara Miron Bloom and Patrick Callahan of the District of Massachusetts with the assistance of Trial Attorney Ross Goldstein of the Civil Division’s Consumer Protection Branch in Washington, DC and Beth Weinman in the FDA’s Office of General Counsel. The case was investigated by the Federal Bureau of Investigation’s Boston Field Division; the FDA’s Office of Criminal Investigations; U.S. Department of Health and Human Services’ Office of the Inspector General; Department of Defense Office of Criminal Investigation; and the Department of Veterans Affairs’ Office of Inspector General.
The same Skadden, Arps Slate, Meagher, & Flom white collar crime criminal defense attorneys along with, DuVal & Associates who helps companies deal with FDA so the company can focus on innovating* and Medical Alley Association who helps serve the health technology community (ahem) are coming together Thursday, April 7, 2016 to present:
How to Get Away With Fraud At Taxpayer Expense Executive Liability For Alleged Marketing Misconduct With Today’s DOJ. I did not know Dante’s Eighth Circle (Fraud) offered any room large enough for all those egos.
*Those unfamiliar with the startup industry the word “innovation” is often used as manipulation, to evade the law. Startups notoriously and arrogantly think that the regular laws and rules do not apply.
Phew! I’m thrilled, Michael Loucks, who The New York Times referred to as “arguably the nation’s most influential prosecutor of healthcare fraud,” when he was former acting U.S. Attorney and first U.S. Assistant U.S. Attorney for the District of Massachusetts, landed on his feet alright at
the gates of Hell Skadden, Arps Slate, Meagher, & Flom.
For years, Mr. Loucks has argued that whistle-blowers are paid far much in health care fraud cases — bounties up to 30 percent, totaling $650 million in just the last two years, he said. These people would blow the whistle for less, he argued both inside the prosecutor’s office and more recently in a paper titled “the Great American Giveaway.” While that hostility toward what he considers the greed of some whistle-blowers is old news, Mr. Loucks’ views on unsealing their complaints are new.
It’s actually 15-25% of Medicare charges deducted from the total civil damages (the percentage is not taken from the total civil damages it’s a percentage of a percentage which is a manipulation of facts while blaming the whistleblower; and, this money is taxed in highest bracket something the media tends to gloss over buying into DOJ spin. An anonymous DOJ source, “no one, almost no one gets the full 25%.” This is an attempt from two known corrupt entities to vilify the whistleblower so that people don’t look at the actual crimes or ask DOJ where does all that money go they collect from whistleblowers? “We don’t know, none of us know [where or how the money collected from whistleblowers is spent within the US Government],” an anonymous source within DOJ.
Hmm, per The Sociopathic Business Model™ Selective Tolerance A, that’s inconsistent & contradictory language to action for someone in the AG’s office to want to bite the hand that fed him, literally. Without healthcare whistleblowers we could do away with entire divisions within the AG’s offices, DOD, FBI, FDA, CMS, HHS-OIG, saving taxpayers but also killing thousands of more taxpayers.
Clearly, Loucks didn’t understand the difference between pharmaceutical and medical device fraud, or that the Stratus Microflow Spacer case taught the DOJ:
- Venture capital funded startup medical device fraud is why all startups post-IPO or sale are now underperforming, which helped to prove the tech bubble popped in 2008, and linked to SEC crimes.
- Learned how NEA has a pathological history of funding startup medical device fraud creating a war on women, who are injured and forced to fight Congress to try and Bayer’s Essure off the market or why 26,000 women are awaiting trials in federal court, fighting with Johnson & Johnson all because of venture capital funding fraud.
- DOJ wouldn’t have known how startups are making “small subtle changes” to the 510(k), knowing the FDA wouldn’t catch it on and…
- DOJ, because of what they learned from the Stratus Microflow Spacer, venture capital funded startup fraud and the fraudulently obtained 510(k) wouldn’t have been able to prevent a startup crime where, for one of the first times in U.S. history, CMS prevented venture capital funded startup fraud when they exposed Theranos, running 250 tests when they were only FDA cleared for one.
Sure, whistleblowers should work for free just like Louck, who donates his entire salary…oh wait, that’s again inconsistent & contradictory…starting to notice a pattern in the Dante’s Eighth Circle other than fraud, hypocrisy & double standards from Root to Louck. And really, shouldn’t we the people, still be paying Louck for his crowning $2.3 billion settlement against Pfizer achievement capped at the end of a four-year secret investigation?
Oddly, DOJ press release for this landmark, historic case, omits the Pfizer CEO*’s name, the CEO who was set to get off on the original criminal charges; but, evidence supported he went back changed the date on an email. He should have charged with obstruction according to an anonymous source with the DOJ who also relayed frustration over the fact that Louck decided not to charge CEO criminally yet once he was passed over for an appointment in the AG’s office Louck left and then placed blame back on the DOJ saying they should have criminally prosecuted him (Pfizer CEO), when he was responsible for making the decision in the first place. Wow, talk about manipulation of facts while not recognizing the rights of others without shame, remorse, guilt or accountability.
*Pfizer CEO name is still difficult to attribute to this crime and why the Yates Memo is so important for the people and a weapon for the defense.
It’s a good think Louck is handling the Yates Memo discussion during the Dante playdate with the Devil because he can offer this lesser-known side of the Pfizer story for all his defense buddies. Frequent readers of this site know that the Pfizer case was handled by Covington LLP, you, know the place where for US Attorney General Eric Holder went back to work?
— Melayna Lokosky (@MelaynaLokosky) March 4, 2016
Ahh, yes, they’re all a match made in hell; and, why we as employees, consumers, patients, shareholder and taxpayers really need to look at the facts and not the spin that’s negotiated behind closed doors, which make no mistake, is never innocence if damages, fines or settlements, are negotiated, regardless of what unethical people representing unethical companies would like us to think. Thank you, to the person who sent the tip along about Medical Alley, as you anticipated, this was story was right up my alley.