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 »

Today is D-day for Lead Paint Rule

April 22nd, 2010. By AbiK

Most of us don’t really think much about lead paint. Or lead anything for that matter. It only becomes an issue when there’s some report of lead appearing in a toy or someone’s about to buy (or renovate) an old house.

But lead was in the spotlight today, April 22nd, 2010. That’s because today was D-day for contractors who might find themselves working in homes, buildings, offices or schools that were built prior to 1978. Why 1978? Because that’s when the ban on lead paint went into effect—so anything built prior to ’78 may have used lead paint in its construction.

The EPA’s lead paint rule now requires contractors to take extra precautions—quite a few of them—when working in older homes and buildings to avoid unnecessary exposure to lead paint dust and particles. If you’re thinking, ok, so they’ll have to wear a dust mask, then you’re in for a bit of a surprise when you hear what this rule actually requires.

Contractors, as of today, have to be certified as “lead-safe” by the EPA—and at least one person on each job site must complete an eight-hour training course. They will have to wear special gear

 that includes air filters, goggles and hoods. The areas where they’re working will need to be protected with heavy plastic and sealed. And work sites have to be cleaned thoroughly with special vacuums. Warning signs need to be posted as well to alert others that they are in the midst of a lead-paint hazard area.

This new federal rule has, needless to say, sent some shockwaves through the construction industry— Read the rest of this entry »

Flip Side of Lawn Mower Lawsuit: Briggs & Stratton Earnings

April 22nd, 2010. By AbiK

A few of you had commented on the Lawn Mower Class Action settlement post about the impact that the settlement would have on the companies (defendants) involved, including engine maker Briggs & Stratton.

Today, Briggs & Stratton reported fiscal third quarter earnings, and—no surprise—the company said earnings were down due to the lawsuit. Five percent down, according to AP. Briggs & Stratton earned $24.1 million, down from $25.4 million a year ago. The company reported it would have earned 85 cents per share had it not been for the lawsuit; rather, it reported 48 cents per share, down from 51 cents per share a year earlier.

According to Briggs & Stratton, revenue rose 3 percent to $694.6 million from $673.8 million a year ago. The increase was attributed to engine shipments rising 6 percent over 3Q 2009—but the company stated the increase was offset by lower average prices.

Now, although this was a consumer fraud lawsuit and Briggs & Stratton admitted no wrongdoing, they did settle 65 class action horsepower-related lawsuits in February, agreeing to pay $31 million along with agreeing to change how they would label the horsepower of their engines for the next ten years. (And of course, the rest of the lawn mower settlement details you can read about over at the initial story we posted.)

Though 3Q earnings were down, the company stated that it would have earned 85 cents per share without the lawn mower lawsuit settlement. The reason for this was rising engine sales, particularly in the lawn and garden market.

According to AP, the adjusted earnings exceeded Wall Street expectations where analysts had expected 67 cents per share.

The postscript: Briggs & Stratton was up 35 cents (1.6 percent) to $22.21 in reports on afternoon trading.

Asbestos News Roundup: 4.22.10

April 22nd, 2010. By LucyC

A roundup of recent asbestos-related news and information that you should be aware of.

Asbestos Lawsuits

Huntington, WV:  A man from Point Pleasant has filed an asbestos lawsuit against his employer, alleging that during his work on the Motor Vessel Leila Shearer he was exposed to asbestos fibers.

The ship, owned by defendant Campbell Transportation Company, was temporarily taken out of service for asbestos abatement in 2008. However, prior to that, Martin Woodall claims he suffered from lung dysfunction, and that his lung dysfunction and other problems are due to his exposure to asbestos fibers on the ship.

Woodall claims in his suit that “he became sick, sore, lame and disordered; lost wages and his earning capacity; experienced pain and suffering; incurred substantial medical costs; and sustained disability because of his asbestos exposure.” Mr. Woodall is seeking compensatory damages, plus attorneys’ fees and other costs. (WV Record)

Madison County, IL: A couple from Massachusetts have filed an asbestos lawsuit against 45 defendant companies and the US Navy, alleging that the husband, Mr. Ronald A. Nichols, developed asbestos mesothelioma as a result of exposure to asbestos-containing products throughout his working life.

Mr. Nichols worked at the basic training electrician’s mate school for the U.S. Navy in 1957; worked as a machinist mate on the USS Hailey from 1957 until 1959; worked as an assistant parts manager at McKulkin Chevrolet from 1959 until 1960; worked as an operator, laborer, boiler and furnace worker at Gas Service Inc. from 1960 until 1987; performed home remodeling from 1965 until 1967; and worked as a shadetree mechanic from the 1950s until the 1960s, according to the complaint.

The complaint alleges that the defendant companies should have been aware of the detrimental Read the rest of this entry »

Don’t Get Lipodissolve to Get that Bikini Bod

April 21st, 2010. By AbiK

The countdown is on baby! There’s about 5 weeks till the official kick-off to summer season—Memorial Day weekend—is upon us and that means millions—yes, millions—of women are doing things like dieting, jogging, zumba, spinning, tanning (fake, out of a tube, hopefully), and heading to cosmetic surgeons and medispas in hopes of seeing an improved version of themselves in the mirror. Quickly.

Unfortunately, a number of women will look to some cosmetic treatments that maybe promise a bit more than they deliver. Case in point: Lipodissolve.

The FDA recently sent out warning letters to six medical spas in the US for making false or misleading statements about lipodissolve. The statements included things like claiming lipodissolve is safe and effective; claiming lipodissolve has an outstanding safety record; and stating that lipodissolve is superior to other fat-loss procedures, including liposuction.

Lipodissolve is a cosmetic procedure that’s touted as a less-invasive cousin to liposuction. It’s liposuction, minus the suction, so to speak. Lipodissolve patients receive a series of drug injections (typically, phosphatidylcholine and deoxycholate) that aim to dissolve and permanently remove small pockets of fat from the body.

I don’t really want to know what happens once the fat “dissolves” and, like, where does it go? or what form is it in? Questions I sense have queasy-feeling-inducing answers to them. Be that as it may, I guess the fat is supposed to go someplace better than one’s saddlebags, love handles, tummy bulges, arm flaps…

So what’s the FDA’s beef? For starters, the fact that the FDA never evaluated or approved the products for use in lipodissolve. That should be your first clue that maybe you ought to be a little gun-shy around the ol’ lipo needle.

Beyond that, here’s the list of FDA issues with lipodissolve: 

• The FDA is not aware of evidence supporting the effectiveness of the substances used in lipodissolve for fat elimination
• The safety of these substances, when used alone or in combination, is unknown
• The FDA is not aware of clinical studies to support medical uses of lipodissolve

In addition, FDA has reports of unexpected side effects in people who’ve undergone the lipodissolve procedure. These side effects include:

• permanent scarring
• skin deformation
• deep, painful knots under the skin in areas where the lipodissolve treatments were injected

In terms of the warning letters that were sent out, they went to…

Monarch Med Spa in King of Prussia, PA

Spa 35 in Boise, ID

Medical Cosmetic Enhancements in Chevy Chase, MD

Innovative Directions in Health in Edina, MN

PURE Med Spa in Boca Raton, FL

All About You Med Spa in Madison, IN

The FDA has requested written responses from the companies—and they should be due by next week.