Author Archive

Football isn’t Tennis: Brain Injury Lawsuits Brew on Eve of Super Bowl

February 4th, 2011. By Hunter West

 

Uh, Maybe Not. (Design: good.kv)

This Sunday’s Super Bowl is not only the biggest night in professional football, but also arguably the biggest spectacle in professional sport. Witness the gate, the viewing audience and the lucrative broadcast and advertising contracts.

When you’re watching the big game this Sunday, look for the guys in the three-piece suits standing on the sidelines. No, they’re not journalists. And they won’t have headsets like the coaches do. But they will have binoculars, and notepads.

Those guys will be the lawyers—working for the teams, the league, and the players association. They’ll be watching every play, every tackle, taking notes.

They will disappear just before the Gatorade starts flying. Unless, of course somebody gets beaned in the head by the Gatorade bucket and incurs a concussion. That will bring the lawyers back for more note taking. 

Of course, I’m taking license with reality, here. There will be no suits impeding the pending war between the Steelers and the Packers. But make no mistake: the legal Beagles are catching up with pro football…

As recently reported in publications such as the New Yorker and Slate, the National Football League (NFL) is potentially facing two class-action lawsuits brought by players alleging the NFL knew, or suppressed knowledge of the long-term neurological risks of playing football. The latter stance alleging fraud would be the most aggressive. A lesser position would be one of negligence—to wit, the league was not aware, but should have known of the dangers posed by concussions and how play according to current rules increased the risk.

As this story gains traction, a huge debate will emerge between football purists who agree that ‘football is not tennis’ and anyone who thinks otherwise is not living in reality—and advocates representing players and the medical community who feel the NFL could, and should have been doing a lot more than it has been.

The pro football purists will think the lawsuits frivolous. It’s football, for crying out loud. Of course Read the rest of this entry »

Tags: Brain Injury, Concussion, Football, NFL, Super Bowl
Posted in Personal Injury | No Comments »

Christmas Comes Early for Medical Device Manufacturers, FDA Plays Santa Claus

January 31st, 2011. By Hunter West

It was recently that the US Food and Drug Administration (FDA), the government agency charged with responsibility over drugs and medical devices in this country, is seeking to further streamline the review, and approval of medical devices.

Can you hear the cries of joy in the medical device manufacturing heartland?

Well, not entirely. The FDA is also thinking of creating a new category of devices that would require more data than is currently required for approval. That would make it tougher for medical device manufacturers to get new products to market.

Oh, but according to a report by Reuters appearing January 19^th in The New York Times, the FDA is going to defer that idea for a period of time. Which is a good thing, I guess, because the device industry was worried that such a change would slow the progress of devices to market. Devices that can now take advantage of an increasingly streamlined process.

That process—which the FDA is looking to expand, while deferring any effort that might make it tougher for device manufacturers—holds that if a manufacturer seeks approval for a new product that is substantially similar to an existing product already on the market, it can take advantage of a streamlined approval process requiring less scrutiny and testing.

Naturally, that’s a win for the device manufacturers. One spokesperson for a major manufacturer called the news of an expansion of streamlined approvals, and the deferral of tougher policy a more ‘balanced’ approach that shows the FDA is engaged, listening and concerned.

Yes—but to whom is the FDA really listening? And about whom are they really concerned?

It sounds to me like the FDA’s greatest role is to assist device manufacturers (and drug companies).

Is the FDA not a government agency, whose mandate is to first and foremost represent and protect Read the rest of this entry »

Tags: FDA, medical devices
Posted in Drugs/Medical | No Comments »

Deadly Medicine, Even More Deadly Oversight…by the FDA

January 26th, 2011. By Hunter West

Anyone with any misgivings about the state of the Drug Union in this country and the role the US Food and Drug Administration (FDA) plays—or doesn’t—would not want to pick up a copy of the January issue of Vanity Fair in their doctor’s office.

Especially if their doctor is about to prescribe yet another drug…

In ‘Deadly Medicine,’ writers Donald Barlett and James Steele reveal troubling aspects of the prescription drug culture in America.

In sum, it is estimated that prescription drugs kill more than 200,000 Americans each year. That figure is based on information from the Institute for Safe Medication Practices that identified 19,551 people who died as a direct result from a prescription medication.

That, in itself is a huge number. However, according to Vanity Fair that figure is low, given the widely held belief that only about 10 percent of such deaths are ever reported. Thus, a ‘conservative’ estimate would be 200,000 deaths a year from drugs that the FDA considers, according to its mandate, as safe and effective and whose benefits outweigh the risks.

When compared against other maladies and behaviors that are known to have life-ending outcomes, that’s three times the number of people who die from diabetes, and four times the number who succumb to kidney disease. Prescription drugs claim more lives than heroin and cocaine. Fewer people die each year in car accidents in America, than those whose lives are cut short from a drug written to their care by a physician.

It gets better…

Clinical trials are moving offshore, where regulatory authority is lax and drug companies have greater control over the outcomes than they otherwise might on US soil.

By the numbers, the Department of Health and Human Services reported 271 clinical trials Read the rest of this entry »

Tags: Big Pharma, Clinical Trials, FDA
Posted in Drugs/Medical | No Comments »

Does your Town Need a Disclaimer as a Defense?

January 16th, 2011. By Hunter West

Imagine, driving down a highway enroute to a major city and encountering the ‘Welcome’ sign that often heralds a municipality’s singular asset, or slogan. “Welcome to Anytown: the Friendly City,” or for that matter ‘You Are Entering the Sunshine State…” 

Well how about this… 

“Welcome to Anytown. Our Smog Can Kill You. Wear a Mask. Stay Indoors, Shut the Windows and Have a Nice Day.” 

Or, 

“Welcome to Anyville. You’ve Been Warned…” 

A study appeared last week in the Journal of the American College of Cardiology that warns against the possibility of adverse effects for healthy people living in, or within close proximity to air pollution. 

Specifically, the impact air pollution may have on heart arrhythmias that could lead to sudden death. 

The possibility that dirty air could prove a problem for people with heart conditions has been debated for some time. But this is something new, because now we are talking about healthy people, with relatively healthy hearts. 

The small study found that air pollution could interfere with the heart’s inherent capacity to reset its electrical properties in an orderly manner, according to the researchers involved. That can lead to arrhythmias—which can cause sudden death in certain individuals. 

Mind you, the study was small—just 25 participants. However, this is the first time that concern Read the rest of this entry »

Tags: Air Pollution, Heart Arrhythmias
Posted in Drugs/Medical, Environment | No Comments »

The Risk of Sleepy Surgeons

January 11th, 2011. By Hunter West

There was a study recently that demonstrated sleepy drivers were just as careless, just as accident-prone and just as dangerous as people who were driving drunk. Sleep deprivation, the researchers found, was just as much an impairment as being high on alcohol. 

So what about doctors? What about surgeons? 

An editorial that came out December 30^th in the New England Journal of Medicine (NEJM) makes that same point for medical professionals. To wit, sleepy doctors are potentially as impaired as drunken doctors. 

It’s something, as patients, we never think about. But think about it—how many times have you been caught yawning on the job? How many times have you nodded off at the computer? How many times have you had to pull over while driving endless miles along a highway, in order to catch a bit of rest because you feel yourself nodding off? 

Should we not assume that surgeons are capable of the same sleepiness? 

The concern is certainly warranted, according to the authors of the NEJM editorial. And one can certainly understand the issue. As an example, a surgeon who has not slept all night following emergency bowel surgery throughout the wee hours is seen scrubbing up for an elective colostomy at nine the following morning. 

Pretty scary thought, huh? 

The editorial authors say that sleepy surgeons should not be allowed to operate without a patient’s Read the rest of this entry »

Tags: medical malpractice, NEJM, Sleep, Surgeon
Posted in Drugs/Medical, Emerging Issues | No Comments »