Author Archive

Mmmaybe not…BP up for Safety Award, Ceremony Quietly Postponed

May 7th, 2010. By Hunter West

If it wasn’t so tragic—with loss of life and the almost certain environmental threat—the explosion and sinking of the Deepwater Horizon would have taken on a completely unexpected spin with an irony so delicious you could taste it.

Instead, it’s just sad.

That’s because BP, the multinational oil company that had leased the Deepwater Horizon and is now scrambling to stem the flow of millions of gallons of crude oil beneath the surface of the Gulf of Mexico, was a favorite to win an environmental award last Monday that celebrated the safety and efficiency of the offshore drilling industry.

Needless to say, in the wake of the ongoing crisis, that ceremony was quietly postponed.

Somebody is thinking at the federal Minerals Management Service, the sponsor of the awards. Whomever handles their public relations over there deserves a raise in pay and a pat on the back, as going through with the ceremony in light of what has happened would be a gaffe of major proportions capable of reverberating around the world.

Can you imagine? Everybody from Jon Stewart to Jay Leno would be all over it. If people are already saddened and angered over the accident and the environmental impact, such an ill-advised decision to forge ahead with a self-serving glad-fest would leave the rest of us seeing red as we watch the Gulf of Mexico turn brown, as Mother Earth bleeds green.

Make no mistake, in any other scenario and at any other time the annual Industry SAFE Awards would be—and is—an important incentive for an industry that plays with fire as far as the Read the rest of this entry »

Tags: BP Oil Spill, Deepwater Horizon, Environmental Damage, Gulf of Mexico, Offshore Drilling, Oil Spill
Posted in Accidents, Emerging Issues, Environment | 4 Comments »

Guidant Forced to Toe the Moral Line

May 1st, 2010. By Hunter West

Tuesday a federal judge in Minneapolis rejected a plea deal arrangement that would have seen Guidant, the medical device manufacturer acquired by Boston Scientific about four years ago, plead guilty to a couple of misdemeanor charges and pay a fine. A big fine, mind you—$296 million, described as the largest fine ever thrown down in front of a medical device manufacturer. The relatively small fine paid by Toyota for leading the feds down the garden path is niggly in comparison. 

But that’s not the point. Given the risks associated with playing in the medical devices sandbox, one can assume that the players plan for this sort of thing. Their revenues are staggering as it is. And a plea of guilty to two misdemeanors, when the company knowingly vended life-saving devices that were faulty and led to the deaths of at least six individuals, just seems so wrong. 

A judge agreed, and rejected the deal. Donovan W. Frank noted in his ruling that the deal allowed the company to escape accountability. 

At least there were misdemeanor charges. How often have you heard companies of any stripe pay a huge fine for a proven misdeed but admit to NO wrongdoing? 

That’s like telling a child who knowingly was responsible for bad behavior, “okay Johnny, give Mummy five bucks and we’ll forget this ever happened…” 

No parent in his, or her right mind would ever offer that deal to a child. What are we teaching them? 

And yet, it appears de rigueur in big business. Do something bad, cop a plea where you don’t have to admit to anything, pay a fine for the privilege and move on. 

It is assumed that any new deal surrounding the Guidant situation involving those defective defibrillators will include a probationary structure as recommended by the judge, together with a fine. 

How big that fine will be, remains to be seen. Perhaps the same, perhaps smaller than the original. Either way it will be in the millions. 

As for where that money goes, I profess ignorance. Maybe it goes into a specific budget line, or to general revenues. A better place would be to help pay for the nation’s health care, just as fines levied to automotive manufacturers should go to fix up our roads and bridges—or finding a way to segregate massive trucks away from smaller cars, in an effort to mitigate the carnage on America’s roads when the ever-expanding rigs meet up with an increasingly-shrinking car. 

Or how about giving that money to the families of the victims? 

Sure, fines are important—even assuming big companies build that kind of thing into their business plans. The money could benefit someone, somewhere. 

But the payment of a huge fine should not prove a whitewash for moral irresponsibility. 

That’s the point the judge was making Tuesday.

Tags: guidant, medical devices
Posted in Defective Products, Drugs/Medical | No Comments »

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 »

Tags: Medical Device, Warranty
Posted in Defective Products, Drugs/Medical, Emerging Issues | 3 Comments »

Federal Regulators Must Share Some Blame for Toyota Recall Delays

April 15th, 2010. By Hunter West

Much has been made about the delays attributed to Toyota for acting on safety deficiencies with its vehicles—delays that didn’t appear to affect consumers in Europe and Canada but impacted those in the US. And while James Lentz, the president and chief operating officer of Toyota Motor Sales USA, stated in Congress in February that he did not know of reports of sticking pedals in Europe until the month prior (January, 2010), documents showed that engineers in the US were told about the sticking pedals as early as April, 2009. 

That said, US safety regulators—which have been famously holding Toyota’s feet to the fire throughout the recall process—couldn’t escape blame either. If Toyota is to blame for dragging its feet, so too did federal safety regulators. 

Case in point: according to the April 11th issue of The New York Times, officials from Toyota and the National Highway Traffic Safety Administration (NHTSA) met in Washington to discuss the accelerator pedals and floor mats issue—an issue linked to a fiery crash in California the previous month that killed four members of one family. At the meeting, the agency also pressed the automaker to announce just how it intended to fix the problem. 

Toyota made that announcement on November 25^th. However the meeting took place September 28^th. Two months went by before the announcement was made. 

There are those who feel the agency could have pressed Toyota to act sooner, or at the very least keep up the pressure. 

Recent federal fines levied against Toyota cite the breach in protocol that requires, by law, an automotive manufacturer to report a product safety deficit to federal regulators within a handful of business days. And yet while the Transportation Secretary was vowing to hold Toyota’s “feet to the fire” for delays in bringing the US into a loop that had already included Canada and Europe months earlier, the question remains why the NHTSA allowed Toyota so much lead time up to November 25^th. 

Since then there has been a steady diet of sensational media headlines and stories, congressional hearings and angry congressmen playing the role of protector to the American consumer. Toyota missed the deadline. Toyota allegedly withheld information. Toyota’s feet must be held to the fire for delays. Hardly a day has passed without some story on Toyota accompanied by a talking head from Washington crying foul. 

But for two months, Washington appeared to stand at the sidelines while Toyota sorted all this out. 

Says Kurt Bardella, a spokesman for Representative Darrell Issa, the ranking Republican on the House Committee on Oversight and Government Reform, “The bottom line is that both industry and regulators failed.” 

And in so doing, the regulators appear to be talking from both sides of their mouths.

Tags: Toyota, toyota recall
Posted in Defective Products | No Comments »

Pfizer’s Secret Friend

April 9th, 2010. By Hunter West

Mom and Dad told us not to be ‘too big for your britches.’ However in the Land of Big Pharma, that basic chestnut of moral integrity need not apply… 

Remember the debacle over Bextra? Pfizer was found to have actively marketed the drug for off-label use, for things not approved by the US Food and Drug Administration (FDA), and was called to the carpet over it, paying about $2 billion in penalties. 

However, it could have been a lot worse, according to a special investigation by CNN that found Pfizer escaped the expected death knell in such cases by being permanently excluded from Medicare and Medicaid. 

Most know the story of Bextra, the Cox-2 inhibitor that Pfizer brought to the painkiller market in 2001 with big plans. Cox-2 inhibitors were thought to be safer than generic drugs.

Also more expensive, coming in at 20 times the cost of ibuprofen. 

Nonetheless, the plan was to market Bextra for acute pain, such as that experienced by patients following surgery. 

Enter the FDA, which put a noose around Pfizer’s neck when it decreed that Bextra was not safe for patients at high risk for heart attack and stroke. Thus the approval was limited to pain treatment related to arthritis and menstrual cramps. 

Undaunted, the marketing and sales arms of Pfizer—allegedly without knowledge of top executives—set to work circumventing that regulatory authority by promoting its use off-label to anesthesiologists, orthopedic surgeons, “anyone that use[d] a scalpel for a living,” according to the words of one district manager. 

There were other lapses in marketing judgment that flew in the face of regulatory decorum. In the end, by the time Bextra was Read the rest of this entry »

Tags: Bextra, FDA, Pfizer, Pharmacia, Upjohn
Posted in Drugs/Medical | No Comments »