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…

WTF?!? Just Got my Expedia Settlement Check

June 22nd, 2010. By AbiK

Given where I work, you realize I tend to lean on the side of reasonable litigation where consumer wrongs are concerned. Key word: reasonable. But I, like you, am susceptible to feelings of profound absurdity when I receive a settlement check in the mail for fifty-six cents. As I just did, from the Expedia settlement. I also received a plea to “Act now!” from Go Daddy Girl Danica Patrick that also borders on the absurd (did Danica major in Computer Science in college? did I miss that?)—but that’s perhaps for another post sometime.

So.

56¢.

2 quarters, a nickel and a penny.

And I love the added insult on the check (above) where the amount is spelled out: “Zero Dollars…” Oh sure—I realize it’s protocol. But it taunts me. It’s as if it’s Expedia’s snidely sly way of delivering a “Take that, you claimant!”

Take it I will.

Mere pittance though it is, I do realize the settlement was only applicable to hotel reservations. Not flights. And I’ve booked way more flights via Expedia than hotel stays. Those of you who know me know that I kind of have an “in” on the hotel front, so why go through some middle man?

Still, 56¢ is not worth the gas to go to the ATM to deposit the check.

It is also not worth my time to do so.

And, it was not worth the postage and processing it probably took to send it to me.

So why am I going to go to the bank and schlep up to the ATM to deposit it?

Because, much like the classic MasterCard ads—the ones that end with a statement about something being “priceless”, this is in its own way, priceless. It’s not about the money. It’s about calling someone on the carpet for a wrongdoing—in this case, bilking travellers by bundling fees.

So off I go. Just do me a favor—if I ever get to the point where I’m defending a lawsuit brought about by attorney Alfred Rava—who’s apparently big on the concept of suing on “principle” (and who surprisingly hasn’t been in the news as of late)—please feel free to call me on the carpet.

BP Oil Spill Fix #15 – Channeling Martha Stewart?

June 21st, 2010. By AbiK

I’m ashamed to admit that after spending seemingly countless hours with a garden hose nozzle in-hand, I have not correlated it to a possible fix for the BP Oil Spill. (Clearly, I am no match for that self-made perpetual font of “good things”, Martha Stewart.) But, then again, that’s what folks like Elle and Steve are for. Elle, or Steve, or both of them, emailed this one to us. So as we now await—at day #63 of this mess—the upcoming ruling on whether the 6-month moratorium on deepwater drilling will be lifted, here’s their idea:

Fix the BP Oil Spill Idea #15

“Create a massive “garden hose” from tarp-like material. it should be 100 feet in diameter at the base to absorb the pressure  and funnel into a smaller size at the top. have divers (or something) secure the hose to the ocean bed around the pipe (pipe at the center of the hose). then funnel the oil into boats on the surface that are pumping the contents of the hose from
the center of the contained spill.”

100 feet in diameter—now that’s a lot of hose! But inspiration does, indeed, sometimes come from some of the simplest and most commonplace things…

Got an idea you’d like to share? Let us know. Or email our editor at .

Thanks Elle and Steve!

BP Experience Should Have us Catching a Fracking Clue

June 21st, 2010. By AbiK

We’ve posted before about fracking—the hotly debated method of extracting natural gas from the ground, aka “hydraulic fracturing”. It’s a topic that shows up almost daily in newspapers of towns situated in the area of the Marcellus Shale—places in Pennsylvania, West Virginia and New York—where new sources of natural gas have been discovered. And it’s being debated because some folks aren’t completely convinced that there is no risk of contamination of underground drinking water sources.

So tuck that thought away for a moment and let’s just recap what’s dominated the news for close to two months now. That would be the BP Oil Spill.And that’s led to some reminiscing about the Exxon Valdez spill. And gee, everyone thought all that was safe, right? Who could’ve predicted any of this? Oh—of course, in hindsight you’ve got folks who say there were “issues” with the Deepwater Horizon and something was “bound to happen”—but clearly, those that voiced such concerns even three or six months ago were poo-pooed.

Fine, we’re a nation built on optimism. Capitalism itself could never thrive with a glass-is-half-empty world view. But, be that as it may, it’s always prudent to plan for the “what ifs”—what if, perchance, the proverbial glass Read the rest of this entry »

BP Oil Spill Fix #14 – Dutch Masters

June 18th, 2010. By AbiK

You would think in a country that not only put a man on the moon but also spawned such tongue-tripping loquaciousness as supercalifragilisticexpialidocious that we’d be able to come up with a fix—a long-term, solid solution—to the BP Oil Spill. It’s apparently been more of a challenge than the bigwig oil engineers could contend with—and, rather than bringing together the collective brain power of the oil industry to find a fix, it seems the Big Oil fraternity is steering clear of this baby in a way not dissimilar to the way everyone flees the frat brother who’s left holding the tap at an underage drinking party.

Case in point, a quote from Chevron’s CEO, John Watson, as reported in The New York Times this week, “I believe the independent investigation will show that this tragedy was preventable.” True though it may be, clearly you can kiss camaraderie—and help—goodbye. 

So, one of our readers recommends looking elsewhere for a viable solution. Namely, Holland. Here’s what he says…

Fix the BP Oil Spill Idea #14

“It is my understanding that Holland (within days) offered assistance with the spill and was debuffed. First, Holland has some of the best engineers in the world. Second, we need all the help we can get. This kind of arrogant pride is stupid and, “the stongest democatic nation” did not get to that point by acting stupid.”

I can’t speak in depth to the Dutch engineering prowess—they can certainly engineer a good beer and between bicycles and windmills they knew how to be “green” before anyone on this side of the pond knew what the word “compost” meant. But if there’s one nation that knows water management and containment and all things shipping, it’s The Netherlands. And as I think about that Dutch legend of the little boy using his finger to plug the hole in the dike—btw, that picture is from Madurodam and if you’re ever in Holland, it’s a miniature must-see marvel of the entire country—it strikes me that maybe, just maybe, we should be taking the Dutch up on any offers of assistance.

Got an idea you’d like to share? Let us know. Or email our editor at .

Thanks to our reader (who didn’t leave his name)!