Personal Injury and Social Security Disability Blog

Boston Scientific Heart Defibrillator Recall Under Investigation

The Department of Justice and the Securities and Exchange Commission are investigating medical device maker Boston Scientific Corp.'s recent recall of implantable heart defibrillators, according to an internal company memorandum reviewed by The Wall Street Journal.

Last year, Boston Scientific agreed to settle a Justice Department investigation into problems with Guidant Corp. defibrillators by paying $296 million and pleaded guilty to two misdemeanor charges for failing to include information in reports to the FDA. Also last year, the company agreed to pay $22 million to resolve allegations its Guidant unit paid kickbacks to doctors to get them to use pacemakers, ICDs and other products. Here are excerpts from the Wall Street Journal article:

Prosecutors have sent Boston Scientific a subpoena, and the Securities and Exchange Commission has begun an informal inquiry, said the memorandum, which General Counsel Timothy Pratt sent to certain employees Friday.

The two agencies "are requesting information in connection with the recent" recall, the memorandum said. "We are cooperating with these investigations."

The company declined to comment on the memo.

Boston Scientific halted sales and began retrieving all unsold defibrillators on March 15, after discovering it had not asked regulators to approve two manufacturing changes. The Natick, Mass., company described the situation as a documentation problem, saying no patients had been injured.

The company is now waiting for the Food and Drug Administration to clear the manufacturing changes. The FDA is also investigating the recall, as well as Boston Scientific's previous failures to follow reporting requirements.

According to the memorandum, SEC and Justice investigators are seeking company documents regarding the company's discovery that it hadn't gotten FDA approval, as well as communications with regulators, physicians and stock analysts about the withdrawal. Investigators are also seeking any reports of injuries, the memorandum said.

Implantable cardioverter defibrillators, or ICDs, are implanted in patients' chests to deliver electronic shocks to hearts that are beating abnormally so they return to a normal rhythm.

How 'Black Boxes' Help in Car Crash Reconstructions

Should "black boxes" be mandatory in all vehicles? That's one of the questions addressed in an article in USA Today. The article is lengthy, but interesting. Here are the opening paragraphs:

When it comes to "black boxes" in cars, there's one thing everyone from regulators to automakers agrees upon: These onboard crash-data recorders have their limitations.

Even so, in alleged unintended-acceleration incidents, there may be no better way to try to figure out whether the car or the driver is to blame.

Prompted by Toyota's recalls and questions about whether they fully remedy possible runaways, the National Highway Traffic Safety Administration is considering whether to require so-called black boxes — officially "event data recorders" or EDRs — in every vehicle sold in the USA. It estimates that two-thirds of new cars now come with them; about 40% of the cars on the road have them.

When it comes to "black boxes" in cars, there's one thing everyone from regulators to automakers agrees upon: These onboard crash-data recorders have their limitations.

Even so, in alleged unintended-acceleration incidents, there may be no better way to try to figure out whether the car or the driver is to blame.

Prompted by Toyota's recalls and questions about whether they fully remedy possible runaways, the National Highway Traffic Safety Administration is considering whether to require so-called black boxes — officially "event data recorders" or EDRs — in every vehicle sold in the USA. It estimates that two-thirds of new cars now come with them; about 40% of the cars on the road have them.

Evenflo Recalls Top-of-Stair Plus Wood Gates Due to Fall Hazard

The U.S. Consumer Product Safety Commission has announced a product recall of the Evenflo Top-of-Stair™ Plus Wood Gates. About 150,000 units are affected, all manufactured by the Evenflo Company of Ohio, and sold at Toys "R" Us, Burlington Baby Depot, Kmart, and other stores. The hazard relates to the slats on the gate, which can break or detach, posing a fall hazard to children.

The recall involves Evenflo models 10502 and 10512 Top-of-Stair Plus Wood Gates made from October 2007 through July 2009. The model number can be found on the bottom rail.

The CPSC recommends that consumers stop using the recalled gate and contact Evenflo to obtain a free newer model 10503 or 10513 Top-of-Stair™ Plus Wood replacement gate. For additional information, call Evenflo toll-free at (800) 233-5921 between 8 a.m. and 5 p.m. ET Monday through Friday or visit the firm’s Web site at safety.evenflo.com.

Cancer Hazards of Tanning Beds May Lead to Federal Ban for Teenager

The cancer hazard of tanning beds is a particular concern to me. I have had several employees over the years who visit tanning salons far too frequently, against my fatherly advice. I was just as bad when I was young, although since we didn't have tanning beds, I just played outdoors to get tan. But we didn't know as much about skin cancer back then. Now, there's no good excuse to subject your body to harmful sunlamps. Yes, a nice tan is attractive, but it doesn't add enough to your appeal to make it worth the risks of cancer mutilating your body when you're older.

Texas bans tanning salon use by kids under age 16.5, and requires parental permission for use by kids under age 18. Here are excerpts from a recent article by the Associated Press discussing the possibility of a federal ban on tanning bed use by teenagers:

Federal health experts say more restrictions are needed to protect teenagers from the cancer risks of tanning beds, including a potential ban for people under 18.

A panel of advisers to the Food and Drug Administration recommended Thursday that the agency put tighter controls on artificial tanning, ranging from requiring parental consent forms to banning the practice in younger teens.

The FDA has regulated sunlamps for more than 20 years, but a recent report by the World Health Organization tied the devices to skin cancer, prompting a call for tougher rules.

The WHO analysis showed that the deadliest form of skin cancer increases 75 percent in people who use tanning beds in their teens and 20s.

More than 30 states already have tanning salon regulations in place — including a handful that require parental consent — but new FDA requirements would apply nationally.

The panel also recommended the FDA add bolder warning labels to tanning beds and change how they are regulated.

Dr. William James, president of the American Academy of Dermatology Association, said his group has seen a startling increase in skin cancer among women in their teens and twenties.

"What was formerly considered a disease of older men is ballooning in young women, the very target audience and number one customer of the tanning industry," James said.

Nearly 69,000 U.S. cases of melanoma, the most dangerous form of skin cancer, were diagnosed last year. Also linked to ultraviolet exposure are basal and squamous cell cancer carcinomas, which affect more than 1 million Americans a year. They're usually easily removed but the American Cancer Society counts 2,000 annual deaths.

Fair-skinned people who don't tan easily are at highest risk for skin cancer. Melanoma is particularly linked to sunburns at a young age, though it is usually diagnosed in the 40s and 50s.

The Safest Car?

Each year automakers improve the safety of their models with advanced safety features and improved design and construction to help increase survivability, decrease injuries, and decrease repair expenses. From the introduction of safety glass in 1927, the padded dash and seat belts in the 1960s and 1970s, to the inclusion of "crumple zones" and electronic collision avoidance systems now available, injuries and fatalities due to car accidents are more preventable than ever.

The safest cars currently in production, tabulated by Forbes magazine are Five-star Crash Test rated according to the National Highway Traffic Safety Administration (NHTSA) and "triple good" rated by the Insurance Institute for Highway Safety (IIHS). For 2009, the top 5 include :

Audi Q7
Mitsubishi Outlander
Volvo XC90
Saturn Vue
Mercedes-Benz M Class

The Small Car Dilemma
Most notable is the fact that the top 5 contenders are all SUVs, a segment which until recently received much negative press about safety problems, including rollover vulnerability. While it is comforting to drive a large vehicle with superior marks for surviving a crash, a troublesome traffic accident statistic persists in which compact cars account for the highest fatality rate in collisions while car manufacturers continue building smaller and lighter vehicles for the sake of fuel economy.

Beyond the Safest Cars
In order to remain in business, car companies need to make sure vehicles coming off production lines reflect qualities consumers feel are important. In addition to cost and fuel efficiency, safety remains a high priority. We will soon reach a point where crumple zones, passenger restraints and airbags will achieve their maximum effectiveness. Installed in the newest cars and more so in the future are safety features like electronic stability control which compensate for lapses in driver attention, judgment, skill and reflexes.

The Utopian Future
Pushing the concepts of parking assist and lane change assist to the boundaries of science fiction, researchers are testing autonomous automobiles equipped with lane detection systems which can someday shuttle passengers on highways. Onboard systems of sensors and servos will control the vehicle's speed and direction. Although this technology removes the enjoyment many of us experience from driving, removing the human driver from the process of getting from Point A to Point B will substantially alter these car accident statistics; 45,000 deaths and $230 billion lost per year on our highways.

This article is reprinted by permission from CarInsuranceList.com.

Friday Fun

This is the strangest way I have ever seen a cat drink!

Featured Link - Top 50 Newspaper Blogs

I worked my way through college and law school at a newspaper, and it saddens me to see the current loss of readership. I hope papers can find a business model that allows them to survive. That will almost certainly include some form of online information, so I was interested to see this list of the 50 Most Popular Newspaper Blogs. It's from last year, but the rankings probably haven't changed all that much. Please do what you can to support your local newspapers.

Clay Jenkins Recommended for Dallas County Judge by Dallas Morning News

Attorney Clay Jenkins has again been recommended in an editorial by the Dallas Morning News for the position of Dallas County Judge. In the primary election Mr. Jenkins was also endorsed by the Dallas Morning News and he came within 85 votes of winning outright, without a runoff election. Now in the runoff, he has the newspaper's recommendation again.

Early voting begins April 5, and the runoff election is April 13.

Here is the editorial from the Dallas Morning News:

For more than three years, the Dallas County Commissioners Court has lacked a true leader. County Judge Jim Foster has been sitting at the helm, but he's never really managed to steer the ship.

Early voting: April 5-9

Primary runoff Day: April 13

And as scandals, controversies and general discord boiled over into public view, the leadership void on the court became more apparent.

Fortunately, Democratic primary voters recognized that the status quo was insufficient when they left Foster in distant third on March 2. Clay Jenkins came within a hair's breadth of winning that contest outright and avoiding a runoff. Voters should return to the polls April 13 to ensure that Jenkins advances to the general election, where he would face a Republican opponent.

Jenkins, a 45-year-old lawyer and co-owner of a health services company, is a relative newcomer to county politics, but he is well prepared and would bring the leadership skills that have been lacking.

He is assertive but willing to work with others. And it's difficult to imagine that the shouting matches and temper tantrums that have become hallmarks of the Commissioners Court would persist under Jenkins' watch.

Jenkins has correctly identified fostering economic development in southern Dallas County and improving air quality as important challenges that the next county judge must tackle. His experience in the health care field also provides him with a strong knowledge base that should prove useful in addressing public health issues and overseeing Parkland.

While Jenkins has offered thoughtful ideas for improving efficiency and transparency within county government, his opponent has been less than specific in outlining his plans. Larry Duncan, the Dallas County Schools Board president and a former Dallas City Council member, has made sweeping promises to root out corruption and do things "the right way." But left unsaid is how, precisely, he will accomplish these broad goals.

Duncan, 64, also does not seem as well equipped to defuse tensions and build consensus among county leadership.

Jenkins has the backing of many local high-profile Democrats. But more important, he's the better choice for Democratic voters who have grown tired of the ever-present drama in county government.

For more than three years, the Dallas County Commissioners Court has lacked a true leader. County Judge Jim Foster has been sitting at the helm, but he's never really managed to steer the ship.

And as scandals, controversies and general discord boiled over into public view, the leadership void on the court became more apparent.

Fortunately, Democratic primary voters recognized that the status quo was insufficient when they left Foster in distant third on March 2. Clay Jenkins came within a hair's breadth of winning that contest outright and avoiding a runoff. Voters should return to the polls April 13 to ensure that Jenkins advances to the general election, where he would face a Republican opponent.

Jenkins, a 45-year-old lawyer and co-owner of a health services company, is a relative newcomer to county politics, but he is well prepared and would bring the leadership skills that have been lacking.

He is assertive but willing to work with others. And it's difficult to imagine that the shouting matches and temper tantrums that have become hallmarks of the Commissioners Court would persist under Jenkins' watch.

Jenkins has correctly identified fostering economic development in southern Dallas County and improving air quality as important challenges that the next county judge must tackle. His experience in the health care field also provides him with a strong knowledge base that should prove useful in addressing public health issues and overseeing Parkland.

While Jenkins has offered thoughtful ideas for improving efficiency and transparency within county government, his opponent has been less than specific in outlining his plans. Larry Duncan, the Dallas County Schools Board president and a former Dallas City Council member, has made sweeping promises to root out corruption and do things "the right way." But left unsaid is how, precisely, he will accomplish these broad goals.

Duncan, 64, also does not seem as well equipped to defuse tensions and build consensus among county leadership.

Jenkins has the backing of many local high-profile Democrats. But more important, he's the better choice for Democratic voters who have grown tired of the ever-present drama in county government.

Avandia Diabetes Drug Supporters Had Financial Ties to Glaxo

A disturbing report by the Mayo Clinic alleges that about 90% of the scientists who published articles supporting GlaxoSmithKline's diabetes drug Avandia had financial ties to the company, as reported by Bloomberg News. Here are excerpts from the article:

The Mayo researchers examined more than 200 articles that appeared after an analysis in the New England Journal of Medicine linked Avandia to a 43 percent increased risk of heart attacks, and a subsequent clinical trial found no greater danger of heart disease. Almost 90 percent of scientists who wrote positive articles, reviews or commentaries about Avandia had financial ties to London-based Glaxo, the study published in the British Medical Journal found.

Almost three of every four authors who expressed negative views of the drug had no financial ties to manufacturers of diabetes medicines, while just 6 percent of those with positive opinions of the drug received no funding or fees from industry. The relationships between scientists and pharmaceutical companies may help explain why the interpretations of the published articles varied so widely, the researchers said.

“We aimed to determine whether financial conflicts of interest with pharmaceutical manufacturers could be fuelling this fire,” wrote the researchers, led by Amy Wang, a resident in internal medicine at the Mayo Clinic in Rochester, Minnesota. “From our findings, it appears that the answer is yes.”

“It’s vital that people have trust in the way we do research and the way it’s made public,” said Jo Revill, Glaxo spokeswoman, in a telephone interview today. “Part of that is sharing data. What we have done is develop policies that will have disclosure and encourage disclosure.”

Glaxo will disclose all the research payments it makes to investigators and their institutions in the U.S. starting this year, Revill said.

The Tort Reform Crowd Thinks This Was A Frivolous Lawsuit

This was the headline of a recent post on the excellent Boston Personal Injury Blog, written by Massachusetts attorney Alan H. Crede. With Alan's permission, I am reprinting his post here:

Reading the tort reform blog Pointoflaw.com, I came across a link captioned: "'Ford failed to warn seating unsafe for obese persons' suit fails." Sounds pretty frivolous, right?

I followed the link to Abnormal Use, a corporate defense blog, which has the virtue of being intellectually honest, unlike Pointoflaw. There I got the whole story.

It wasn't just some overweight person who was suing Ford for failure to warn a chair might collapse under her weight.

The plaintiff in the case was a 300 pound woman driving a Ford Explorer that was rear-ended by another SUV at the (relatively low) speed of 30 mph. The impact of the accident caused her seat to collapse backwards. The accident also left her a paraplegic.

Ford hadn't tested or designed the seats for anyone above 220 pounds. Now here's a little graph that I just found through a simple google search that shows about 5-10 percent of men are in the 220 pound range. Yet Ford didn't bother testing above 220 pounds.

And this poor woman wound up a paraplegic in a 30 mph accident. Sound frivolous now?

Yet, according to the blog post, the trial court entered a directed verdict against her on her failure-to-warn claim and didn't even let that claim get to the jury.

I assumed that this woman's failure-to-warn claim was not her only claim and that she also brought breach of warranty claims against Ford. I was hoping that she managed to prevail on one of those other claims. I went to the (unreported) decision on Westlaw. It appears the other claim did make it to jury and that the jury found against her.

I have a great respect for juries and jury verdicts so I'll leave alone the fact that the jury found against her on a strict liability standard that should've been unfavorable to Ford.

But the online reporting about this case illustrates how the media stir up worries about frivolous lawsuits.

This wasn't an overweight person who sued Ford because the seat collapsed under her weight and she fell on her butt. This was a woman who was rendered a paraplegic, in part, because Ford didn't test its seats above a weight range within which some ten percent of the adult male population falls. And she wasn't suing Ford for failing to include a warning label on the chair saying, "If you're too heavy, this seat may cause injuries." Her failure-to-warn claim was just one of the legal theories she pursued (her claim for breach of the warranty of merchantability was much stronger).

From a societal perspective, cases like these should really boil down to: Who should bear the cost? As a paraplegic, this woman will require millions of dollars in medical care for the rest of her life. Who should bear the cost of that? We, the taxpayers, or Ford, a company that profits from a car seat that it never bothered to test at 30 mph with a dummy weighing more than 220 pounds? If Ford has to bear the cost do you think that maybe next time they might design a better seat?