Defective Products Archive

Menaflex: Influence Peddling at the FDA

October 22nd, 2010. By Hunter West

The revelation last week that the US Food and Drug Administration (FDA) would rescind a product previously given FDA approval, is yet another example of why the FDA needs to be overhauled from the ground up and the top down. 

That’s because, according to a report October 14^th in The New York Times, a medical device roundly criticized by the FDA’s own scientists and reviewers was approved by the agency largely due to political pressure (read lobbying) and the intervention of the former FDA Commissioner. 

Worse, it appears as though this situation was one “of several” at the agency in which outside forces were allowed to be brought to bear over the FDA’s own good scientific counsel. 

And this is the agency that ensures the drugs we take, and the medical devices we use are trustworthy? 

Oh…my…God… 

The issue is over Menaflex, an implantable knee patch manufactured by ReGen. According to an FDA report launched to investigate undue outside influence in its own agency, it was determined that the Menaflex product was given FDA approval in spite of the repeated, and unanimous declarations of FDA reviewers that Menaflex did not meet the criteria for approval. 

It should be noted that the FDA employs a fast-track route for approval if it is determined an Read the rest of this entry »

Tags: FDA, implantable knee patch, Menaflex, NJ, ReGen
Posted in Defective Products, Drugs/Medical | No Comments »

Chinese Drywall Tax Breaks? IRS Says Yes

October 12th, 2010. By LucyC

As the unfortunate saga of Chinese drywall continues to unfold, a new and welcome twist has emerged. On September 30, 2010, the Internal Revenue Services (IRS) made public its Revenue Procedure 2010-36—which implements tax breaks for people whose homes contain or contained the toxic stuff. In short, the IRS is allowing taxpayers to claim a casualty loss on the repairs of the drywall and any household appliances that were affected—against their taxes. 

Apparently, this tax break is the first large-scale effort by the federal government to provide financial relief to victims of Chinese drywall. The IRS says it will give tax breaks to homeowners who suffered property losses due to bad Chinese drywall installed in their homes between 2001 and 2009. People can file amended tax returns to claim the deduction. 

Deductions are allowed only on amounts that exceed $500. In order to receive the tax break, homeowners must also have started the process of repairing their homes, and the amounts paid for repairs must exceed 10 percent of the taxpayer’s adjusted gross income.  

This move could affect thousands, if not tens of thousands of homeowners. The Homeowners Consumer Center in Washington, DC says Chinese Drywall has allegedly been Read the rest of this entry »

Tags: chinese drywall
Posted in Defective Products | 3 Comments »

Maybe Chevy HHR should stand for How ’bout Having a Recall

October 6th, 2010. By AbiK

These are the kind of things that piss me off. A fellow LAS staffer just happens to have a Chevy HHR. The HHR apparently stands for “Heritage High Roof”. At least that’s what Wikipedia says (you can tell I didn’t research that one too deeply). But I’m thinking HHR ought to stand for “HOW ’bout HAVING a RECALL?”.

Yes, a recall. For a design defect. For the ignition switch. It seems the HHR ignition switch has a tendency to get a bit, well, stuck. And that’s precisely what happened when my colleague drove into her driveway last Saturday evening. The key in her HHR got stuck. In the ignition. With the car running. Repeat: running.

Now, I’m sure many of us have experienced that damn-the-key’s-stuck thing—or the opposite, when you go to start the ignition and the key won’t turn at all. Usually a quick tug on the steering wheel will unlock the mechanism that allows your key to function properly. But what if that doesn’t work? And the car is running? Repeat: running.

What do you do? Aside, that is, from flashing back to Jackson Browne’s Running on Empty and realizing your car’s heading there—only it won’t be running on, running behind, or into the sun. It’ll be dead. 

Here’s what our staffer did: She called AAA. Hell, she has a membership and they’re Read the rest of this entry »

Tags: Chevy HHR, chevy-hhr-ignition-problems-2009-steering-2, HHR, Ignition Switch, Recall
Posted in Automotive, Defective Products | 252 Comments »

Recall Notice: Dirty Words for Medical Devices

October 1st, 2010. By Hunter West

There are people walking around with faulty hip implants. If they can even walk at all. This month DePuy Orthopaedics, a division of the giant Johnson & Johnson family of companies, finally recalled troublesome hip implants after removing them from the market last year. DePuy undertook the latter response amidst a hail of criticism that the metal-on-metal implant featured a flawed design.

Okay, so recalls are nothing new. Cars and appliances are recalled all the time. But hip implants, and heart defibrillators are not cars and appliances. They are devices implanted in a patient’s body and not easily resolved. 

Who could forget the pacemaker lead from a few years ago that was recalled? The device, which made fans of surgeons who liked the ease and flexibility of the new, thinner leads that proved easier to thread to the heart, was initially hailed as a breakthrough. 

And then they started to break. Fracture, really. Hairline fractures. But just enough to affect the performance of the device. Patients who required life-giving shocks to keep their hearts going weren’t getting them; while others were injured or killed when a properly performing heart was suddenly hit with a rogue electric shock because the fractured lead impeded the flow of information from the heart to the pacemaker. Believing the heart to be failing (it wasn’t), the device went into action to re-engage a heart that in reality had not failed—often with tragic consequences. 

Which begs the question—why does this keep happening? 

Johnson & Johnson has been under siege of late, with a spate of recalls from the DePuy hip, to artificial knee joints, to medication such as Motrin. The company has had to shut down one of its manufacturing facilities due to a departure from GMP (good manufacturing practices), and there have been questions raised about the behemoth company’s oversight. The management and conduct of J&J has been the subject of congressional investigation. 

But a larger question remains, and it is one not tied to any one company—but any company Read the rest of this entry »

Tags: Defective Products, medical devices, Recall
Posted in Defective Products, Drugs/Medical | 2 Comments »

Segway Company Owner Dead, by Segway

September 27th, 2010. By AbiK

Ok, this one is rife with irony. The type I don’t like writing about. It seems that Jimi Heselden, the man who only recently bought the Segway scooter company—you know, those odd-looking stand-on motorized scooters that look a bit like a pogo stick on wheels—has died. And here’s the eerily ironic part: as a result of driving his Segway scooter over a cliff and into a river.

Now, the cliff was not the great White Cliffs of Dover (approx. 350 ft. high), but a smaller “cliff” that’s located near Jimi Heselden’s estate at West Yorkshire in Boston Spa—for those of you who are wondering where that is, it’s about a three-and-a-half hour ride north of London in the English countryside. And it’s reported at dailymail.co.uk that the drop was about thirty feet from a rocky path–the picture shown there looks more sloping and wooded in nature than a sheer drop. I bring up the nature of the nature (ie, the cliff) not to diminish the severity of the fall, but to draw attention to the fact that a Segway may not be the best vehicle for handling rougher terrain–and clearly there are risks involved in riding a Segway.

The Segway scooter is driven standing up; the driver leans to control the direction it’s going in. And a gyroscope mechanism keeps the scooter upright. The video above gives a sense of not only the contraption itself, but how it must feel to drive one (I haven’t; I also have no desire to).

So according to reports thus far, it hasn’t yet been determined whether Heselden’s death-by-Segway was actually due to a defective Segway, or due to driver error.

Either way, what is known, is that Jimi Heselden was quite a philanthropist who will be missed by many. According to the dailymail, Heselden had given £23 million (over $36 million) to a charity foundation—the Leeds Community Foundation—he set up in 2008. “The organisation helps disadvantaged youngsters, vulnerable elderly people and health improvement projects in the south and east of the city.”

Tags: Jimi Heselden, Segway, Segway death
Posted in Accidents, Defective Products, Emerging Issues | No Comments »