Defective Products Archive

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 »

Whatever Happened to that Zicam Securities Lawsuit?

June 16th, 2010. By AbiK

Wrong time of year to be thinking about Zicam, but hey, legal decisions happen when they happen. And so it was for Zicam earlier this week when the US Supreme Court gave the go-ahead to consider the challenge Zicam-maker Matrixx Initiatives Inc. is bringing against the lawsuit that claimed Matrixx had failed to inform investors of its little loss-of-smell issue.

The Zicam securities lawsuit, as reported in the Wall Street Journal, has been going on now since 2005—it was first thrown out and then just last year (when it became a hot news topic again) it was reinstated by an appeals court.

But this isn’t about noses that can no longer smell—well, sort of. It’s about the fact that even though Matrixx apparently knew of some “adverse event” reports (i.e., 12 reports between 1999 and 2003 of folks who claimed to have lost their sense of smell after Zicam use), the company still marketed the over-the-counter sniffle reliever in a positive light—no hint of any potential problems regarding ability to smell. And, the plaintiffs have gone as far as to claim that the marketing statements made by Matrixx were false and misleading and—here’s what’s at the crux of this—inflated the stock price of the company.

So, as you can see, for these plaintiffs, it’s not about personal injury; it’s about securities.

Needless to say, Matrixx is countering the above allegations saying that the adverse event reports were not statistically significant enough, and that no true causal relationship had been established, so what’s the beef? (beef being my word, not thatof Matrixx, of course). The petition Matrixx submitted to the Supreme Court also states Matrixx’s position that reinstating this lawsuit “would have immense consequences for the pharmaceutical industry, potentially making companies liable for securities violations if they didn’t disclose even small numbers of adverse-incident reports.”

So that’s the latest, and now that the Court has agreed to consider Matrixx’s challenge, WSJreports that oral arguments will most likely begin in the fall. Hmm, just in time for cold season…

Tags: Matrixx, Smell, Zicam
Posted in Defective Products, lawsuits | 1 Comment »

CertainTeed Organic Shingle Settlement has Green Light

June 16th, 2010. By AbiK

Know what gets a lot of traffic at LawyersAndSettlements.com? Anything CertainTeed. CertainTeed lawsuits. CertainTeed settlements. CertainTeed-related comments about the weather. You name it, folks love clicking a CertainTeed link. So, in honor of all of you who’ve clicked away, here’s a CertainTeed story that might pay off for you: the CertainTeed Organic Shingle Settlement was approved at a court hearing last week.

[Little disclosure: as with the Lawn Mower settlement, LawyersAndSettlements.com has absolutely nothing to do with this—we’re not affiliated or connected in any way to the Settlement, not in bed with the law firms involved, not getting any cut of this…we’re just reporting it…]

So this Settlement is the result of a defective product lawsuit claiming that CertainTeed Organic Shingles that were manufactured between July 1, 1987 and December 31, 2005 were defective and failed to perform as promised when installed on homes and/or buildings in the US and Canada.

Now, don’t get all giddy too quickly. I’m telling you upfront, this Settlement—if you’re a part of it—will require a bit of homework on your part. So here we go…

The settlement applies to these folks only (aka, the “Class Members” —and yes, you need to be a member of this little club to receive any settlement monies) AND you also need to meet certain eligibility requirements once you pass the “test” to be considered a Class Member. So first, let’s look at who qualifies as a Class Member…

You are a CLASS MEMBER of the CertainTeed Organic Shingle Class Action Settlement if you:

1. Owned a home or other building in the US or Canada as of December 15, 2009 on which CertainTeed Organic Shingles were or had been installed;

OR

2. Owned such a home or building prior to December 15, 2009 but sold or Read the rest of this entry »

Tags: Certainteed, CertainTeed Organic Shingles
Posted in Class Action, Defective Products, Emerging Issues, Settlement | 18 Comments »

Lawyer Needs a Date – Help!

May 28th, 2010. By AbiK

We hear a lot (A LOT) of tales of woe here at LawyersAndSettlements.com about love. Not unrequited love. Not long- lost love. But love that just never materialized. From sites like Match.com or eHarmony.com, and “placement firms” (my words) like Great Expectations.

Now, to be upfront here, I’m not a fan of such sites and services. I’m a believer in the “when it’s there, you’ll know it” kind of love-finding. Why? Well, here’s 3 examples from people I know who’ve found their love (or not) from such services—names are withheld, for obvious reasons.

Love Contestant #1: Meets lawyer on dating site (yes, a LAWYER). They fall in love in a matter of weeks. She gets pregnant. He skips town. It’s a few years later now and all told, he’s contributed $400 to his child’s support. For those of you wondering, that works out to $50 a year. Yup, there’s some dating material for you.

Love Contestant #2: Has joined just about every dating site known to man. Wonders why no one’s floating her boat when all she has to go on prior to meeting for coffee is a filled in questionnaire and a couple of email exchanges. No photo or headshot. Also wonders why no one she gets hooked up with seems to match her criteria for getting hooked up.

Love Contestant #3: Did meet her true love. In her mid-60’s. They’re married now. She teaches tapping classes. Oh—not that kind of tapping. As in Emotional Freedom Technique tapping therapy. Uh-huh. She’s on another wavelength from the rest of us, if you get my drift.

So enter another lawyer—John Friedland. He was lookin’ for love. Apparently at the wrong Read the rest of this entry »

Tags: Amy Laurent, Dating Service, John Friedland
Posted in Consumer Fraud, Defective Products | No Comments »

With where Cars are Heading, my Money’s Going in Funeral Homes

May 21st, 2010. By Hunter West

I love to drive—but I just may have to give it up and be done with it. Because I don’t like where the cars of the future are going. 

For that matter, I don’t like where they are now. 

A recent article in The New York Times focused on the cars of the future and what our dashboards are going to look like. Specifically, a demonstration by Cisco Systems showed how an LED dashboard display can be manipulated and customized much like the screen on your smart phone, iPad or laptop. 

In other words, if you don’t like the fuel gauge over HERE, you can drag and drop it over THERE. 

Same with the icons for the car’s web browser, the weather channel, the stocks channel, the news feed, the video screen, the keyboard and the GPS. 

Here’s the problem…  

It’s one thing to have the dashboard evolve from a collection of mechanical dials to integrated electronic bars, and graphs. This gee-whiz stuff has been happening since the 1980’s. 

The problem—and I’ll say it again—is all the interconnectivity that automotive manufacturers have, or are bringing into the car. 

Were cars to have the capacity to drive themselves, then I’d be all for it. Just like the cockpit of an airliner, where you can throw the multi-million-dollar jet on autopilot and play with your laptop while the plane overshoots the airport by an hour… 

Oh, wait a minute. That’s not so good, either. 

The point is, even if cars were to have the kind of sophistication that commercial jets have, Read the rest of this entry »

Tags: Automobile, Automotive, Cars, Cisco, LED Dashboard, Smart Car
Posted in Accidents, Automotive, Defective Products | No Comments »