United States Attorney’s Office: Indict STORZ Executives For Criminal Negligence Causing American Deaths.
This week, a major civil case against the German medical device company, KARL STORZ, was settled in California.
Gager et al. v. Karl STORZ was filed in the Superior Court of California in the County of Los Angeles (Case No. BC617217). It alleged that the plaintiff was harmed by a negligently designed and marketed medical device, known as a power morcellator.
This case was scheduled to go to trial on October 16, 2017 — but the plaintiff and her lawyers decided to accept a big settlement offer from STORZ instead. This settlement was an unfortunately poor decision from a public health perspective and from the standpoint of ethics and justice. But, given that most malpractice attorneys are focused on the dollar payout and on minimizing risk to their coffers, I suppose it was predictable.
Specifically, because the internal documents provided to the plaintiffs likely demonstrated that the STORZ company had specific and detailed knowledge of the deadly cancer risk caused by STORZ’s power morcellator. Of course, these documents will now not be made public, as they would have if Gager et al had gone to trial — because along with the settlement comes a legally binding gag order.
Out of sight, out of mind!
But, not so fast. STORZ executives had knowledge of the deadly cancer risk posed by a product they continued to market for nearly 2 decades in the United States. And it is an established fact that hundreds, if not thousands of women, across the United States and abroad were harmed or killed because of this dangerously conceived and marketed product at the hands of gynecologists under-educated in the principles of surgery.
STORZ executives had specific knowledge of the deadly oncological risk of their product, but they failed to fulfill their legal duty under federal law to report the problem to FDA. It’s also a fact, confirmed by the FDA and GAO investigations that it wasn’t until November 2013 that my wife, Dr. Amy Josephine Reed, a physician-turn-patient, reported the deadly hazard of this medical device to FDA.
To be clear, when a corporation violates the legal duty it has under federal law, and this violation leads to avoidable deaths of unsuspecting Americans, a crime has been committed. Most criminal prosecutors worth their salt call it “negligent homicide”.
It’s doubtful that STORZ, being a well established medical device company, and its lawyers, were unaware of their legal duty to report device flaws and dangers to FDA under US federal law. But, why didn’t they? I think, like in many other examples of corporate misconduct, it was an absence of humility, utilitarian thinking, or both that led to their legally and ethically negligence conduct.
Of course, it is now a well established fact that this medical device spreads and upstaged cancers in women when used by gynecologists to perform “minimally invasive” hysterectomy and myomectomy operations. But STORZ knew about this problem long before Dr. Amy J. Reed and FDA alerted the public.
Since FDA contraindicated the use of this device in women in November 2014, hundreds of complaints have been filed against morcellator manufacturers across the nation — thus far, all have settled away from the public eye. So we don’t yet know exactly which corporate executive knew what and when. But we do know that they knew about the hazard.
J&J, the largest manufacturer of the power morcellator, withdrew its version from the market in summer 2014 — after the FDA hearing made it clear that this device poses a radically unacceptable mortality hazard on women. But not STORZ. Instead their executives chose to send a letter threatening to take legal action against Dr. Amy J. Reed and me for defaming their good name when we started our public critique of their unsafe and illegal corporate conduct. Now, that, is corporate hubris in the face of a public health disaster!
The Gager et al. settlement in California this week was very unfortunate and unsettling because the documents demonstrating STORZ’s illegal and negligent behavior will now be unavailable to the public, or to the US attorney’s offices.
STORZ and its lawyers know that their internal documents about the oncological risk of power morcellators are damning and will be judged as criminal — especially when exposed to the public eye. Why else would they make such a large settlement with the Gager family and others? The answer is simple. They know that they are in an indefensible position — so their lawyers are doing damage control to protect the corporate hierarchy. But, in fact, they are doing so by abusing the civil court system’s leeway in allowing settlements in negligence cases, and they are acting on the knowledge that most people will keep their mouths shut for money’s sake. But what is actually being white-washed here using our civil court process is a corporate crime against America’s public health — this, is why the US attorney simply must investigate STORZ.
What’s more, these same STORZ attorneys who are expeditiously settling the company’s power morcellator cases have simultaneously obtained some heavy duty protective orders from the Suffolk County Court in MA, to prevent me from even seeing their internal documents under a confidentiality agreement — alleging that I would violate such an agreement.
Despite their flimsy legal maneuvering, they fully understand that unlike other STORZ plaintiffs, and especially after the death of my wife in May 2017, my intent is not only to pursue civil liability charges against them on behalf of my family, but to also trigger a criminal investigation by the US attorneys office and to drive the company to follow J&J’s correct action in withdrawing this deadly device from the market.
STORZ executives deserve to be scrutinized for criminal wrong-doing — because their negligence in manufacturing and marketing the power morcellator has, without a question, caused many deaths and a lot of grief for American families across the nation.
The arithmetic in the case against STORZ for marketing its power morcellator in the United States is really very simple. The company executives, and especially the company’s matriarch, Dr. Sybill Storz, knew about a deadly hazard posed by their medical device for a long time — but they failed to report it to FDA, as was their legal duty under federal law. I know this to be the case based on my conversations with the famous minimally invasive gynecologist, and close STORZ associate and advisor, Dr. Camran Nezhat of CA, in 2013. Despite this knowledge by high level STORZ executives, their device was marketed extensively and used on hundreds of thousands of women across the world — and, even more astonishingly, it still is.
But, the public and our federal agencies now know that according to FDA and several prominent academic sources, morcellation exposes one out of 350 of these women to a totally avoidable mortality risk from cancer spread and upstaging — and many unsuspecting women in the US and abroad have died horrific and unnecessary deaths as a result. So the transparent attempt by STORZ and its lawyers to cover up their tracks will not fly.
It’s sad when corporate hubris and legal ineptitude by corporate lawyers causes a company, capable of doing great good, to fall. But when negligent corporate behavior leads to American deaths, a crime has been committed. The power morcellator cases against STROZ are not simply product liability cases — these, every one of them, is a case of criminal negligence by a corporation. The only question is if federal law enforcement agents in the United States are really about enforcing the law and keeping people safe or, they too, have only political.
With this writing, for the record, I am requesting that the US attorneys office look closely at STORZ and begin an investigation for criminal wrongdoing and negligent homicide by the STORZ company and its executives — it is the US DoJ’s high duty to hold any person or entity that threatens the safety and security of the American public to account. Even more so when that entity causes the avoidable deaths of likely hundreds of US citizens by sustaining a public health disaster.