Tuesday, August 16, 2016

INFUSED With Anger at Medtronic

The anger will shoot right up your spine once you find out who they misled and defrauded to the tune of hundreds of millions of dollars:

"Whistleblower case contends surgical device maker misled FDA — and patients paid the price" by Sheila Kaplan, August 15, 2016

Jerome Lew is a Hollywood screenwriter, and what happened to him could have come straight out of a horror film.

Lew rhymes with.... never mind.

In 2009, Lew went to UCLA Medical Center for surgery to relieve numbness and pain in his hands. The operation appeared to be a success. But he later began having trouble speaking. His left eye drooped. He developed severe nerve pain and weakness in his neck, arms, and hands.

In July, Lew, 52, settled with the University of California for $4.2 million; the manufacturer of the device, Medtronic, also settled for a confidential amount. Both parties denied any wrongdoing. 

I'm glad the horror film had a happy ending.

Yet the legal challenge is not over for Medtronic. The company, one of the world’s largest medical device manufacturers, now faces a whistleblower lawsuit that claims it sought Food and Drug Administration approval for its devices under false pretenses — and that the devices have been regularly used for a purpose that was never intended by regulators.

Medical devices are lightly regulated by the FDA, and once they have been cleared by the agency, physicians may use them however they see fit. But patient advocates and others say the story of the Medtronic implant is a cautionary tale when it comes to medical device safety.

The case, they say, is only the latest in which a manufacturer is alleged to have promoted its devices for unapproved or “off-label” uses, despite regulations prohibiting them from doing so.

Medtronic makes a host of devices for use in spinal surgeries. For fiscal 2016, the company reported $2.9 billion in spinal device sales, including the INFUSE system, and its products are used in about 100,000 spinal surgeries each year.

But the company has been beset by personal injury lawsuits. Corporate filings to the Securities and Exchange Commission in June show that at least 6,000 people have sued the company — or plan to — for INFUSE-related personal injuries, among them bone and nerve injury, urinary problems, male sterility, and infection.

The whistleblower lawsuit against Medtronic is what is known as a qui tam, or False Claims Act case, in which a person or persons with inside knowledge of a fraud against the government files suit on the government’s behalf, seeking restitution and penalties.

In an unusual move, the whistleblower in the case is named only as the Dan Abrams Co. LLC, and may represent more than one present or former Medtronic employee.

Attorneys for the whistleblower or whistleblowers contend Medicare, Medicaid, and other federal agencies reimbursed health care providers using the Medtronic device with hundreds of millions of dollars for “false claims” — that is, payments for devices that were illegally marketed, misbranded, and not proven safe.

That's TAXPAYERS that got ripped off, and yeah, Obummercare is a disaster. The pre$$ won't tell you that, but it's the truth. 

“The case illustrates the unfortunate imbalance of influence that companies like Medtronic exercise over everything from patient safety to doctors and hospital systems and the government health care system … and then as well as regulatory bodies that are supposed to hold them in check,” said John Parker, an attorney with Cutter Law, who is one of the attorneys for the whistleblower. “Medtronic is the 800-pound gorilla.”

Experts say damages could be significant if the court sides with the whistleblowers.

“It’s a very expensive product and the False Claims Act provides for triple damages plus penalties,” said Ross Brooks, who co-chairs the whistleblower practice at the law firm Sanford Heisler LLP and who has been involved in other litigation against Medtronic.

“As a practical matter, this type of case could result in astronomical penalties,” he said.

Medtronic has not yet responded to the whistleblower suit. Court records in the case were unsealed in April, and the company has until October to respond.

Patient advocates say the case highlights the shortfalls of the regulatory system. Medical devices, unlike prescription drugs, are not subject to clinical trials, as is the case with prescription drugs.

And they have done a great job regulating those!

If the case moves forward and a court rules against Medtronic, the whistleblower would get a sizable chunk of whatever money is awarded — generally 25 percent to 30 percent. The US Treasury would reap the rest....

OMG, it's like the bank frauds! Government allowed the conduct so it can get a kickback!

And their mouthpiece media makes it sound like the whistleblower is only in it for the money.


Related: Medtronic's Heart Ma$$age

They have since inverted!