Posts Tagged ‘ Medical Device ’

Zimmer and Surgeon Split Ways–FDA in the Middle?

June 22nd, 2010. By janem

Zimmer Holdings, the manufacturer of medical devices, has cut loose its long-time consultant, Dr. Richard A. Berger, after his reports that Zimmer’s mechanical knee replacement is prone to failure. He could’ve been a whistleblower. Instead he complained to Zimmer and his next year’s contract has not been renewed.

I wonder what would have happened if he first complained to the federal government and the FDA—which is typically the first action to take if a whistleblower plans to file a qui tam lawsuit ( claims against pharmaceutical companies are becoming almost commonplace). Second, you find a good attorney.

Getting back to the good doctor. It’s not like he needed the money: according to the New York Times, Zimmer portrayed Dr. Berger as a master surgeon and paid him more than $8 million over a decade. On his website, Dr. Berger freely admits that he “receives royalties and payments from the manufacturers of these devices”.

But in 2005, Dr. Berger implanted Zimmer’s NexGen CR-Flex device in about 125 patients and within about a year, x-rays showed that the device was loose and had not fused completely. Patients were in pain, apparently because of the loose joint. Dr. Berger did his due diligence and reported the problems to the maker.

Here’s the crunch: the FDA never required Zimmer to study the device in patients before selling it. Zimmer dismissed the doctor, saying it was his technique to blame and not a manufacturing defect. Dr. Berger told the Times that other surgeons were soon reporting similar problems.

In the Times article, experts cited that the falling out between Dr. Berger and Zimmer highlights the lack of independent, unbiased information about orthopedic implants, since there is no system of tracking the performance of artificial hips and knees in the US.

Whisteblowers have file qui tam lawsuits against several medical device companies, alleging improper marketing when the products were sold off-label, which resulted in Medicare paying excessive reimbursements. If successful, these suits can reimburse the government big time. But what would happen if a whistleblower came forward in the case of the Zimmer knee replacement, when the FDA didn’t require any controls, nor clinical trials? It would seem that someone should blow the whistle on the FDA…

Tags: Dr. Berger, knee replacement, Medical Device, Zimmer
Posted in Defective Products, Drugs/Medical | 5 Comments »

Is Your Medical Device Under Warranty?

April 26th, 2010. By Hunter West

If you buy a car and it breaks down within the warranty period, the manufacturer fixes it. If your laptop goes wonky within the first year (usually under warranty), you ship it back and they’ll send you another one, or they undertake to fix it. 

That’s what warranties are for—to protect the consumer against substandard workmanship, faulty parts, or basically a lemon. Wear-and-tear is one thing. You can’t warrant against that. But when something fails well ahead of the best-before date, somebody is made to step up to the plate and extend some responsibility. 

Why does that not happen in the medical device industry? 

Back in January, William R. Morris had to have his artificial hip replaced after just three years. The replacement surgery cost about $50,000. Lucky for Morris, much of the bill was covered through his employer’s health insurance plan. But he figures, due to co-payments and other out-of-pocket expenses, he’s out about $10,000 for his initial replacement and two additional surgeries. 

That’s right—he’s had three replacements. The first operation in 2006 replaced the original hip his creator gave him. That one lasted less than a year—so the replacement was replaced. For a year, he told The New York Times, he felt good, but then THAT hip replacement went wonky. 

This year, he had another one. 

His first artificial hip lasted one year. His second, only three. 

They’re supposed to last 15. 

The April 3^rd edition of The New York Times reported that the manufacturer of the failed hip has Read the rest of this entry »

Tags: Medical Device, Warranty
Posted in Defective Products, Drugs/Medical, Emerging Issues | 3 Comments »