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Medtronic Under Fire with Questions of Financial Conflict

July 7th, 2011. By Hunter West

A blockbuster investigation by some print media outlets has spurred a US Senate Finance committee to start beating the bushes once again around the medical devices industry.

There are many questions:

How safe are the products that wind up in your body?

What do the manufacturers know about potential safety issues, but aren’t telling?

Why is it okay for a doctor or surgeon to be paid by a medical device manufacturer? And can you really trust what a doctor [who is paid by the device maker] says about that device?

Do you feel like a guinea pig?

It was revealed yesterday through a series of articles published by the Milwaukee Journal Sentinel and MedPage Today that there is some controversy surrounding Medtronic Infuse, a popular bioagent known as bone morphogenetic protein-2, designed to foster bone growth required for spinal fusions.

Infuse was approved by the US Food and Drug Administration (FDA) in 2002 and doctors love it. It’s easy to work with. And you don’t have to harvest a patient’s own bone from elsewhere, in order to accomplish the surgery. You have to love something that allows a surgery to proceed faster, and more easily.

But here’s the rub—and the reason for the Senate Committee investigation. It seems that a cadre of surgeons around the country were paid by the device manufacturer, Medtronic. Those same surgeons with financial ties to Medtronic were involved both in the clinical trials for Infuse, Read the rest of this entry »

Tags: Infuse, Medtronic
Posted in Defective Products, Drugs/Medical | 2 Comments »

Distracted Driver Alert: Keep your Hands off My Ford Touch

June 13th, 2011. By Hunter West

The distracted driver is becoming just as serious a problem as drunk driving used to be before society woke up, looked in the rear view mirror and saw themselves as the pariahs they had become. People still drive drunk—or tired, which is almost as bad—but the penalties for a DUI have increased and there is no longer any tolerance for it.

Distracted driving is the new battleground. The other day near where I live an 18-year-old plowed head-on into a transport truck with his small car. He didn’t stand a chance; the tragedy is that he had been texting while driving. His phone records indicate he had sent a text to a friend just seconds before his promising life came to a tragic end, in an instant.

So why, are manufacturers putting more distracting technology in their vehicles? Because the other guy is, and they want to out-tech to compete? Are drivers asking for this stuff?

Has everybody gone nuts?

Consumer Reports magazine is a bastion of common sense. No ties to lobbyists or manufacturers, funded privately through subscriptions with no bias, with independent testing facilities and protocols second to none. When Consumer Reports likes, or dislikes something, there is significant weight to that recommendation or rejection.

So it is telling that Consumer Reports no longer recommends the Ford Edge Sport.

Why? Because the 2011 model has too much damned technology on board, available to the driver in the cockpit. Specifically, the issue is the MyFord Touch system.

Witness a recent summation of the system by a reviewer in The New York Times:

“Ford has added an 8-inch LCD touch screen in the center of the dash that now coordinates not only entertainment functions, like the radio, satellite radio and MP3 playback, but also phone calls, the navigation system and the climate control, as well as settings for, among many others, the traction and cruise controls.”

In other words, way too much stuff to fiddle with. Consumer Reports has come down hard on it, and cited the system as one of the reasons why the vehicle had low test scores.

There is no question that the technology is amazing. It’s just out of place. And the addition of a touch screen to the dashboard of the 2011 Ford Edge had engineers at Ford balking, arguing that it could be considered a source of driver distraction.

But Ford went ahead with it anyway, assuming presumably that such technology would make boffo TV ads. And it does. The system sounds mighty impressive.

But it’s misplaced in a car, accessible to the driver.

Here’s reviewer John R. Quain again, writing May 27^th in The New York Times:

“While [the screen] has some benefits, like a crystal-clear view from the rear-facing camera, it lacks tactile feedback. So when you reach down to tap on a music selection you must take your eyes off the road or you’ll touch the incorrect tiny button…”

He also noted that the screen is about four or five inches too low, forcing the driver to look down and to the right when accessing the screen.

Which means, the driver is taking his eyes off the road—just for an instant.

That’s how long the 18 year-old took his eyes off the road to hit ‘send’ on his smartphone, a microsecond before his car slammed head-on into the transport truck.

Ford may have a techno-marvel on its hands. However, I have to disagree that the cockpit is the proper place for it. And if a family member of mine were ever to be hurt or maimed by a distracted 2011 Ford Edge driver due to the complexity and availability of the MyFord Touch system, I would make damn sure that the manufacturer that built the silly system into the car in the first place, was one of the primary defendants of my car accident lawsuit.

Tags: Car Technology, Dashboard Computer, Distracted Driver, LED Dashboard, My Ford Touch, MyFord Touch
Posted in Accidents, Automotive | No Comments »

Takes Lives but can’t Take a Joke? Hey Asbestos, You got Punked!

May 20th, 2011. By Hunter West

I feel for the town of Asbestos, in Quebec. I really do.

Perhaps you haven’t heard of Asbestos, Quebec—a town of 6,000 located in the Canadian province that is home to the Jeffrey asbestos mine. It used to be the world’s largest asbestos mine until recently. And yes, it’s still active. In fact, the mine remains the town’s largest employer. 

You may know that already, if you watched the recent segment of Jon Stewart’s ‘The Daily Show’ that lampooned the mine, and the town. (And if you didn’t, there’s an amateur clip of the segment above.)

There is little doubt that ‘The Daily Show’ was out to make fun of Asbestos, Quebec. How could they not? Asbestos the fiber, in the last several years, has become known as a scourge—the cause of asbestosis, mesothelioma and asbestos cancer. The latency is something like 30 years or more between exposure and certain death.

Asbestos the fiber has been banned in many parts of the world, and is tightly controlled elsewhere. An entire industry has sprung up to facilitate the safe removal of asbestos. The latter could be prohibitively expensive. Perfectly good buildings have been torn down, rather then re-purposed because the costs of asbestos removal were just too great.

For heaven’s sake, there have been examples of family members of asbestos fiber workers meeting their maker just being in close proximity with asbestos (the fiber, not the town). Some wives have died simply washing their husband’s asbestos-laden work clothes.

There is no question that asbestos is bad stuff.

But it is still used. There is still a market for it—such as India, for example. And when the Read the rest of this entry »

Tags: Asbestos, Asbestos Mesothelioma, asbestos_mesothelioma
Posted in Asbestos Mesothelioma | No Comments »

FDA & Post-Market Testing of Hip Devices: Too Little, Too Late

May 16th, 2011. By Hunter West

The requirement by the FDA for post-market testing on metal-on-metal hips is a sign that the federal regulator may be finally coming to its senses over the longstanding invitation to manufacturers to escape the road of rigorous testing for some medical devices. 

It’s about bloody time. 

The FDA is both a regulatory body and a political body, with the majority of its power reserved for manufacturers of new drugs and new medical devices. To that end the FDA can play hardball and make a manufacturer jump through hoops until the agency is satisfied that a device or drug delivers more benefit than it does risk. 

Once a device is on the market however, the FDA has pretty weak powers. A letter, such as the one sent to about 20 manufacturers of metal-on-metal hips on Friday, is about the extent of the FDA’s post-market authority. 

Basically, the FDA has ordered all artificial hip manufacturers to conduct post-market testing of their devices, in light of the failure rate of various artificial hips. 

However, had this testing been conducted in the first place, hundreds if not thousands of patients with problematic hips would have been spared the pain and frustration that comes with having an allegedly defective hip placed inside your body—at great expense—only to have it fail within five years of an expected 15 to 20-year lifespan. 

A failed artificial hip needs, in most cases, to be replaced—along with more pain, more downtime, and more money. 

At least it can be replaced… 

Witness the situation over heart leads a few years ago. One brand of defibrillator lead, a wire Read the rest of this entry »

Tags: Defective hip replacement, FDA, hip implant, hip surgery, metal-on-metal hip
Posted in Drugs/Medical | No Comments »

Pissed off Canadian Tells Sony ‘Game On’ with PlayStation Class Action

May 5th, 2011. By Hunter West

Natasha Maksimovic is mad as hell and she deserves to be. 

Natasha is the 21-year-old resident of Mississauga, a city in the Greater Toronto corridor in Canada, serving as the lead plaintiff of a proposed class action lawsuit against Sony over the potential theft of personal information. 

There are some 77 million people worldwide who may agree with her. 

At issue is personal information belonging to gamers and users of Sony PlayStation and Oriocity systems. Such information includes, but may not be limited to names, street addresses, birthdates, passwords, security answers, logins, billing information, and so on. 

Sony has reportedly apologized for the breach and offered a 30, or 60-day free membership for users on its PlayStation network. 

Maksimovic says that’s not good enough. “If you can’t trust a huge multi-national corporation like Sony to protect your private information, who can you trust?” she asks. 

Exactly. 

It appears that Sony has done two things wrong. First, the electronics juggernaut appears to have dropped the ball in protecting its system sufficiently from hackers who constantly cruise the Internet looking for portals to plunder. Second, they appear to have taken the potential theft of 77 million sets of personal information worldwide—about a million in Canada—somewhat lightly. 

The lawsuit alleges that Sony was aware of the breach, but failed to advise clients in a Read the rest of this entry »

Tags: hackers, internet security, Natasha Maksimovic, Oriocity, Play Station, Privacy, Sony, Sony Class Action, Sony PlayStation
Posted in Class Action, Internet/E-commerce | 2 Comments »