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Mounting a Criminal Defense or an Insanity Plea? Facteau, & Fabian, First Amendment & Motion to Dismiss Indictment

Mounting a Criminal Defense or an Insanity Plea? Facteau, & Fabian, First Amendment & Motion to Dismiss Indictment


UPDATED September 28, 2015 Last week the anonymous med device site Medtech[y] hosted among topics arguments supporting & opposing Bill Facteau & Pat Fabian’s First Amendment rights regarding federally alleged fraud. Guess someone isn’t fond of the First Amendment as the site has been down the better part of the last two days.

When exposing the truth others would rather remain hidden people will often resort to unethical & illegal behavior to control image/profits.

When exposing the truth others would rather remain hidden people will often resort to unethical & illegal behavior to control image/profits.

September 22, 2015

Apologies to regular readers of this site as this and the last few posts have been very targeted and not meant as exclusionary but understandably hard to follow.  Please check back Friday for regular content.  Thank you for your understanding-Melayna

A grand jury determines if the federal prosecution has enough evidence to indict the target of their investigation for a criminal trial.  A grand jury does not determine guilt or innocence, only if there’s enough factual evidence to go to trial where the prosecuting & defense attorneys are forced to prove or disprove their case.

Roughly 99% of the time a grand jury indicts the target of the federal investigation.

95-98% of targets of the investigation are federally charged and punished for their crimes.

Those are grim statistics if you’re a federally indicted target of a grand jury investigation.

Criminals like to manipulate facts while not recognizing the rights of others without shame, remorse, guilt or accountability while shifting blame.  That’s what got them in their own mess and they’ll double-down and try that same approach to avoid accountability (ex: federal prison). 

Most federally indicted white criminal defense cases involve tactics that manipulate the facts to make their clients look innocent but usually only highlight their client’s guilt by shifting blame to avoid accountability as a means to avoid Club Fed or places like #7 the Federal Correctional Institute of Dublin, CA according to America’s 10 Cushiest Prisons.  Luckily the defense’s strategy of using one crime to dismiss another seldom works well for their client and could result in mistakingly exposing additional crimes of their client (whoops!) .  A risk every defense attorney and their client take when they opt to play games with taxpayer money to avoid accountability.

Let’s throw some stuff and at the wall and see what sticks!

Defense attorney stall tactics cost taxpayers million if not billions; but, what it doesn’t do is change the facts in the case.  Try as they might it usually just delays the inevitable.  We’ll look at two such tactics that reflect a bit of desperation mixed with arrogance swirling in over six million evidentiary documents that spin a very different tale from that of the defense goals; and, these arguments appear not to deny guilt but rather appear to only mask it:

The First Amendment Defense*

  • Manufactuer responses to unsolicited requests
  • Scientific Exhange
  • Interactions with formulary committees, payors & similar entities

Motion to Dismiss the Indictment Defense

  • defense argues they’re entitled to grand jury testimony
  • defense argues goverment instructed improperly

As a former Johnson & Johnson Ethicon Acclarent sales rep from June 2007-January 2011 under the direction of both former CEO William (Bill) Facteau and VP of Sales & Marketing Patrick (Pat) Fabian their 18 count federal indictment is of great interest in part because I’ve elected to follow this case closely as a means of helping other companies not make the same unethical & illegal mistakes by demonstrating a company can in fact run both ethically and profitably.  Former reps/employees should follow this indictment because if they thought the manipulation of facts was over, it’s just beginning and it still affects every one of you.

Manipulation started with the company history, continued with the Stratus Microflow Spacer when Josh Makower, John Chang & William (Bill) Facteau among others knowingly & willfully mislead the FDA not once but  twice.  First, as some of you know or may have found out, by trying to get the device approved for use with Kenalog 40; and, a second time with Saline with the intention of selling it off-label* from the beginning knowing Stratus did not work with Saline or Kenalog 40. Kenalog 40 must be injected directly into living human tissue where it’s suspended to be viable and did not work (does not work) as a topical.

That’s right each and every Stratus placed in a patient’s head was 100% useless per the IFU regardless of the original 510K (Kenalog 40) and also the amended (or second) 510K (saline).  Which again is later confirmed when Johnson & Johnson decided to stop the study despite its near or total completion. (First Amendment Fail)

I remember calling John Chang, whom I once very much respected, to discuss if a Stratus was safe in a patient having a MRI and him half laughing and half in disgust stating that it was very clearly stated in IFU.  Hey John! You know what was missing from the IFU? That Stratus was 100% useless 100% of the time-FU!

*Illegal acts are not protected by the First Amendment. Setting out to defraud the U.S. Government twice & 100% of payors (not just on off-label coaching as an implant) but because not a single implant worked per the IFU is not a protected act.

  • Manufactuer responses to unsolicited requests
  • Scientific Exhange
  • Interactions with formulary committees, payors & similar entities

Allergan, in Nevyas-Wallace v. Allergan argued that the advice & educational information disseminated and offered were free speech protected by the First Amendment, the judge however disagreed stating “we’re not talking about your speech we’re talking about your conduct.”

Armin v. FDA another flawed champion of the First Amendment steps forward awaiting data to support claims says FDA is preventing their free speech.

Data? What’s that? Oh so are Facteau & Fabian next going to try and say they’re waiting for the Stratus study results (that were pulled in November 2011) to support their free speech?

The First Amendment protects truthful speech, but as the Supreme Court pointed out in Illinois v. Telemarketing Associates, it “does not shield fraud.”

In United States v. Harkonen, a federal appeals court in California upheld the conviction of a drug company executive for issuing a news release promoting the off-label benefits of a drug based on a study. The defendant’s statement was misleading because it misrepresented the results of the study, so there was no First Amendment protection that would preclude prosecution.

In United States v. Caputo, a federal appeals court in Chicago rejected a First Amendment claim of a defendant sentenced to 10 years in prison for marketing a medical device to hospitals. The F.D.A. had not approved the device for any use, only a companion product that worked differently, so it was not an off-label promotion but an unlawful sale, which receives no constitutional protection.

The absence of facts is a manipulation:  Facteau, Fabian, founders, and executives/managers in the company unethically, illegally and knowingly manipulated reps who unknowingly manipulated our surgeons who in turn unknowingly manipulated their patients who were ultimately implanted with a medical device needlessly, offering zero value to surgical or patient outcomes; and, in some cases doing harm, now at the loss of every single reps professional integrity and costing taxpayers and insurance companies millions in false claims all to line the pockets of Josh, John, Bill, Pat and anyone else who made millions on the sale of the company.

Still feel like white-knighting for people who thought nothing of exploiting your hard earned, developed and trusted relationships with your surgeons (in a community where most of you still work) potentially ruining your credibility all for their continued benefit?

Johnson & Johnson Ethicon Acclarent manipulation still has a hold on all of us with William (Bill) Facteau & Patrick (Pat) Fabian’s latest attempt to again manipulate facts while not recognizing the rights of every person who took time away from family & work to testified before the grand jury because again without shame, remorse, guilt or accountability they shifting blame by trying to get the grand jury testimony dismissed.

Bill & Pat are no longer blaming the reps for their failure to execute on projections they over-inflated for their financial benefit (hello SEC); but now blaming the government for not giving into their demands of all grand jury testimony (which is not a requirement of the prosecution) and finding fault in the way the jury was instructed*.

Fabian was vice president of sales (oops & marketing fixed that for ya) at the California private-equity start-up Acclarent in 2010, when Johnson & Johnson’s Ethicon division bought it for roughly $785 million. Fabian denies the government’s contention that the $4 million he made from the deal via stock options and compensation was based on inflated revenue projections stemming from off-label sales of the Stratus. (Whoops! That sounds like a lot like Mr. Fabian just admitted to an SEC violation while trying to get hide behind the First Amendment)

Even if their defense attorneys were successful it doesn’t negate the facts and more importantly it does not dismiss the charges.  What it does is force each person who testified in the grand jury to potentially re-testify with a reconvened (second) grand jury.  This is manipulating the facts for their personal gain (anyone seeing a pattern here) while the rest of us, former employees are on the hook with taxpayers footing the bill while they try to wiggle free of accountability, again.

Too many people told the same story to too many important people and 6 million documents support that claim. A very small company of less than 250 generated 6 million documents, so it appears that more than one of us is angry and ready for a few to finally be held accountable.   Are these really the actions of innocent men or desperate men doing anything they can to avoid accountability? Well, I guess there’s always that insanity plea, right?

Also, since they (Facteau & Fabian) are not allowed to reach out to ex-Acclarent reps as part of their tampering clause, they are having friends reach out to certain players and others willing to put in a good word. (REDACTED Former Acclarent Rep turned Manager) told me he reached out to (REDACTED Defendant’s) assistant at (REDACTED Defendant’s current company). He was then put in contact with REDACTED’s defendant’s new attorney to share how (REDACTED) was a good guy and also to refute some of the testimony that was listed in the unsealed charges, particular to the behavior at the Sales Meeting in 2009.

Where have we heard that “good guy” talk before?

“Bill Facteau is a guy who has worked hard all his life. He’s extremely ethical. I’ve been representing executives like him for over 20 years, and I’ve prosecuted people. And Bill is one of the good guys. That’s what we think the evidence is going to show once it’s blatantly understood,” said Cunningham, who is a partner at is a partner in Wilson Sonsini Goodrich & Rosati in Palo Alto, CA.

Jason Bono Sales Manager at startup Invuity. Inc. is contacting former Acclarent reps and asking them speak on positvely on behalf of the federally indicted

Jason Bono former Acclarent Manager and currently Area Sales Manager at startup* Invuity Inc is unethically contacting former Acclarent reps and asking them to contact Wilson Sonsnini Goodrich & Rosati to speak positvely on behalf of the federally indicted executives. *Invuity IPO’s July 2015

To the Facteau & Fabian fan club running around trying to get former reps to testify for the affirmative (yes, we all know you exist), you will be outted (not by me, initially) and, more importantly, none of us can predict what the angry mob of former reps & employees will do to you if they’re forced to re-testify for a second grand jury.  Would you really potentially perjure yourself for the likes of these two?

I also stand firmly behind Case Study: Patrick (Pat) Fabian, Johnson & Johnson Ethicon Acclarent to NxThera The Sociopathic Business Model™ and after reading this if it doesn’t make you question ethics I don’t know what will.  Respectfully my only hope is that not everyone was familiar with all the facts and were once again manipulated into making what now can only be perceived as a poor choice.

** Thank you to the person who paid for and emailed all the Facteau & Fabian court documents. It’s a lot to get through, so I’ll keep updating.





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