It is old hat in the medical device and drug industry; do not ask for permission—simply deal with the fall out of asking for forgiveness.

The US Attorney’s Office announced indictments against a number of Stryker executives for lying to the Food & Drug Administration. Apparently, Stryker was given permission for “limited humanitarian” use of its bone growth products, OP-1 implant and OP-1 Putty, used in spinal and long bone surgeries.

The Stryker products were only supposed to be sold in limited quantities and were only approved for use in treatment of certain rare diseases. It may be hard to believe that Stryker reportedly invented a number of other uses for these products and promoted them to physicians.

Stryker is one of the companies, together with Breg and IFlow, who are being sued over doing this same thing with pain pumps. It has become clear in the pain pump litigation that manufacturers knew that the FDA would require clinical trials (and resulting cost overhead for the manufacturer) in order to promote the use of pain pumps directly into joint spaces. Although manufacturers knew that use of the pumps in the joint spaces was prohibited without prior clinical trials, they promoted that use to physicians anyway. In fact, some of the manufacturers went so far as to promote the use and also promote methods that would allow for higher charges if the pain pump was used the way manufacturers were promoting it.

Now, these same manufacturers are trying to argue in the pain pump litigation that no good scientific studies exist that supports the causal relationship between pain pump use in joint spaces and a devastating condition called chondromalacia. Effectively, manufacturers are trying to convince judges to dismiss lawsuits based on their violation of the FDA requirements and their failure to conduct the scientific studies which the FDA would have required had the manufacturers complied with the law.

So, when selling potentially dangerous drugs and medical devices, apparently the theory is do not ask for permission; reap the profits; and pay for forgiveness later.

There is certainly no shortage of tort reform crusaders who have, in their private lives, sought the assistance of trial lawyers to bring exactly the type of lawsuits that they decry in public: then-Gov. George W. Bush filing suit over a minor fender-bender involving one of his daughters in which no one was hurt; Sen. Rick Santorum and his wife recovering $350,000 in “pain and suffering” damages in a medical malpractice lawsuit;Sen. Trent Lott enlisting a well-known trial lawyer to sue his insurance company over Hurricane Katrina damages; Judge Robert Bork asking for punitive damages (!) after tripping on some steps at the Yale Club. But no group has more forcefully championed tort reform over the years than the U.S. Chamber of Commerce. One of their mottos is “Jobs, Not Lawsuits.” But, in recent months, filing lawsuits seems to have become one of its jobs.

When, in August of this year, the Chamber threatened to sue the Environmental Protection Agency over regulation of greenhouse gas emissions, I just added that to the list of tort reform hypocrisies. But the Chamber jumped straight from the ridiculous to the sublime with its lawsuit, filed this week in federal district court, against the Yes Men. The Yes Men have made quite a name for themselves pretending to be spokespersons for prominent organizations, making false announcements that generate publicity and, they hope, pressure the organizations to make real changes. On October 19, they held a fake press conference announcing that the Chamber of Commerce had reversed its position on climate change policy, and promised to immediately cease lobbying against the Kerry-Boxer pollution reduction bill. They even had cable news organizations fooled for about an hour. The only “damage” that the Chamber of Commerce suffered was having public attention focused on its views about climate change. Yet the Chamber responded by filing a multi-count federal lawsuit. Or maybe the lawsuit itself is another hoax??? If not, this may rank as the Greatest Moment in Tort Reform Hypocrisy … for now.

Insurance companies are always out there wringing their hands, crying poor, and accusing everyone else for high insurance rates and, oh yeah, those “frivolous lawsuits”. The truth is the insurance industry was designated as a special class of corporation over 50 years ago. This special class was caused by exempting them from the McCarran-Ferguson act that prohibits monopolies, among other things.

This special exemption has permitted insurance companies to legally collude over pricing, effectively giving them an invitation to participate in price fixing and limiting market availability.

I have wanted to write an entire article about this whole issue a number of times, but I frankly never had the time to do all the research necessary.

Joanne Doroshow has done the work and written an excellent article for the Huffington Post. Her article is titled:
Medical Malpractice Insurers: Time to End Their License to Gouge.

I highly recommend reading this article that sets forth some of the best reasons why crying about frivolous lawsuits, tort reform and insurance company breaks is so much, well, lies.

Thank you, Ms. Doroshow.

A Single vehicle automobile accident is not always what it appears to be on the surface. Typically, when an automobile crash happens involving a single car, even the police attribute it to driver error, environmental causes, or similar combination of contributing factors.

Not always as simple as it seems on the surface. In-depth investigation of single vehicle, including tractor trailer, accidents can often disclose more interesting information.

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Bangor, Maine’s most famous resident (no disrespect directed towards other Bangorians) is horror-writer extraordinaire Stephen King. It seems appropriate then that Bangor’s federal courthouse is the latest venue in which cigarette manufacturers’ horrific decades of long fraudulent practices will be put under the forensic microscope.

In 2005, Maine residents filed suit against cigarette manufacturing giant Philip Morris (i.e., Marlboro) and its parent company Altria Group, Inc., alleging that the cigarette makers advertised that their “light” cigarettes (i.e., Marlboro Light) deliver less nicotine and tar than regular brands, knowing that the message was, in fact, false.

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Learning to drive is one of life’s milestones. Parents can serve an important role by encouraging teen driver safety throughout the year.

Despite all of the recent and focused media attention devoted to making us all aware of the potential risks to younger people contracting the H1N1 virus, or Swine Flu, the Center for Disease Control also reminds us that this is not the greatest threat facing today’s teenagers.

Statistics are a good place to start, since they give us a picture of what’s happening. I have included a few sobering facts below from NHTSA, the National Highway Traffic and Safety Administration.

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This case is a tragedy about (4) young lives extinguished long before they should have been. This is also a story about a corporation that lost, destroyed and fabricated evidence in an effort to avoid liability for the death of these four young people.

BNSF Railroad’s story: the four youths tried to drive around the gate to beat the train.

ABC News reports that the Judge, Ellen Maas, felt it happened a little differently, but that the railroad engaged in improper conduct including:

The misconduct included the loss, destruction and fabrication of electronic and physical records, the failure for BNSF to follow its own policies for accident investigation and coordination with law enforcement, interference with the plaintiff’s access to witnesses and the accident site, according to Maas, who also said that BNSF employees provided misleading facts in depositions, sworn affidavits and trial testimony.

The jury returned a $24 million verdict; representing $6 million for each of the deceased.

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In a unanimous decision, the Massachusetts Supreme Court ruled on Monday that cigarette manufacturer, Philip Morris, may have to pay for screening/diagnostic scans for smokers.  The ruling paves the way for the possibility that Philip Morris could be required to pay for low-dose computed tomography (LDCT) scans, which can detect lung cancer much earlier than standard x-rays.  In a case brought in federal court by two long-time Massachusetts smokers, the lawsuit is seeking class certification of all Massachusetts smokers, 50 or older, who have smoked a pack or more of Marlboro cigarettes for at least 20 years.

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Do we need to do a study that driving after drinking is a really bad idea? Clearly, we know that drinking and driving do not mix.

Do we need to do a study that texting while driving is a bad idea? I would hope that it is not an enormous leap in logic that texting and driving, likewise, do not mix.

If we need studies, though, to reach those conclusions, I am all for it if that provides us with some laws that discourage those among us who cannot make the above mentioned leap of logic.

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In the early morning hours today, a Palm Beach County Sherriff’s Deputy was struck by a suspected drunk driver in Lake Worth. Yes, you heard correctly. I used “drunk driver” in the same sentence as “early morning”.

It is our hope that the Deputy in the patrol car was not badly injured. It is not enough that these brave public servants must dodge bullets in the course of their duties, but they now must also be vigilante for deadly drunk drivers; even right around breakfast.

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