Personal Injury Lawyer Blog

Supreme Court Limits Lawsuits on FDA-Approved Medical Devices - Thursday, February 21, 2008

In a major decision in favor of the pre-emptive power of the Federal government, the Supreme Court decided on February 20, 2008 that the Medical Device Amendments of 1976 (MDA) created a standard of safety oversight for medical devices that supersedes any requirements for "design, testing, inspection, distribution, labeling, marketing, and sale" of medical devices that might be interpreted as deriving from state law in the case of Riegel v. Medtronic. They decided that under the terms of the law, any medical device that has received FDA approval cannot be held to any higher standard of strict liability, breach of implied warranty, and negligence Furthermore, the Court decided that the FDA requirements provided for "reasonable assurance of safety and effectiveness."

Apparently, the Supreme Court is considering a different FDA and its process than the one I know. If one looks at devices like the Davol's Composix Mesh products, there was nothing like "reasonable assurance of safety and effectiveness provided by the FDA." In fact, the FDA never evaluated the company's quality control procedures or its manufacturing process until after issuing a Class 1 recall of the company's hernia patches, indicating that the product posed an imminent health threat. When it did carry out the inspection, it found that the quality control procedures were so ineffectual and the manufacturing so inconsistent that it expanded its recall to encompass all hernia patches produced by the company.

How can the FDA provide "reasonable assurance of safety and effectiveness" if it only carries out inspections of a company AFTER finding out a device is deadly? I agree with the Court that medical product manufacturers should be held to only one standard of quality and not have to deal with numerous conflicting regulations, but I think that this ruling only makes sense in a country where the FDA actually protects us, instead of simply giving medical device manufacturers a merge lane onto the highway of profits.

Note that this ruling only applies to suits involving medical devices. Next term, the court will consider a case involving whether FDA-approved drugs. Of course, we know the FDA's record in this area, since it responded so quickly to safety concerns about Trasylol, Vioxx, and others.

This ruling does not quite, however, ban defective product lawsuits against manufacturers of medical devices, it only makes the suits more difficult to argue and to win because they have to be argued under federal law only now, whereas many cases have been argued under state law in the past. Because of this restriction, it is even more important that you get a qualified and experienced personal injury lawyer to represent you. If you or someone you love has been injured by a defective medical device, contact PersonalInjury.com today to get in touch with a local personal injury lawyer who can represent your interests under the new restrictions.

Labels: defective medical device, FDA, preemption, Supreme Court

Families Sue over Navy Trainees Killed in Crash with Civilian Pilot - Wednesday, February 20, 2008

The families of three Navy crewmen killed in an airplane crash have filed a wrongful death suit against the civilian contractor who hired the pilot. The crash occurred on January 10, 2006, in the mountains of northern Georgia. The contractor is L-3 Communications Corporation, and its subsidiaries L-3 Communications Vertex and L-3 Communications Integrated Systems are also named as defendants.

A Navy investigation conducted after the accident revealed that both wings of the plane had struck ridgeline trees, severing part of the left wing to break off. Then the plane crashed into the side of a mountain. At this time, pilot error seems to be the most likely cause of the accident, as there was fair weather on the day of the crash. The attorney representing the families of the deceased, also a former navy pilot, says the case is straightforward, and blames pilot error, saying, "The pilot failed to maintain sufficient altitude and came into contact with the terrain.

This case highlights the use of civilian contractors in support roles--from cooks to pilots to security--that were traditionally performed by soldiers. This practice has led to much criticism of the military. The civilian contractors are expensive, making the current military conflicts the most expensive ever fought, despite the record-low number of troops involved, and there are questions about their effectiveness.

Airplanes are safer than ever, and with advances in technology and routine maintenance, there is no reason why a plane should ever go down in fair weather. If you have lost someone you love in an airplane crash, contact PersonalInjury.com today to get in touch with a local lawyer who can make those responsible pay for their negligence.

Labels: airplane accident, military, wrongful death

Sleep Driving: Ambien's Deadly Side Effect - Tuesday, February 19, 2008

In 2006 Representative Patrick Kennedy (D-RI), claimed he was under the influence of Ambien when his car crashed into a barricade on Capitol Hill, but his is only the most famous case of a person claiming to be driving while asleep under the influence of the sleeping drug. Although it seems like an insufficient claim, the truth is that it has proven to be a very successful defense. Also in 2006, an Andover, Massachusetts man was acquitted of vehicular homicide and driving under the influence when he claimed that the sleep drug caused him to get behind the wheel.

Sleep experts confirm that this is a rare side effect of Ambien. Because the drug is legal with a prescription, people driving under the influence of it are generally not charged. And driving, apparently, is not the only things people do when under the influence of the drug. Charges of rape against a man were dropped when the man claimed the woman, a patient in a psychiatric ward, had consented to intercourse. The woman had taken Ambien, and her memories of the events were unclear.

According to experts, sleepwalking, sleep driving, and other possible side effects of Ambien are relatively rare, but they are common enough to warrant their inclusion on labels, ordered by the FDA in December 2006. The FDA has also recommended that the drug manufacturers conduct clinical studies to determine their actual frequency.

But in the meantime, these drugs continue to lead to deaths. If you or someone you love has suffered as a result of Ambien-induced atypical behaviors, contact PersonalInjury.com today to get in touch with a local pharmaceutical injury lawyer who can take your case.

Labels: Ambien, auto accident

Trasylol Story a Sad Tragedy - Monday, February 18, 2008

As more facts come out about Bayer's antihemorrhagic drug Trasylol, it seems the story is more tragic and sordid that anyone might have guessed. When a Food and Drug Administration (FDA) panel voted to keep Trasylol on the market, it was acting in relative ignorance, an ignorance fostered and promoted by Bayer itself.

Although studies published in 2006 showed that the drug as much as doubled the risk of kidney failure in patients, the FDA was unconvinced, and on September 21,2006, 8 months after the largest of the studies was published in the New England Journal of Medicine by Dr. Dennis Mangano of the Ischemia Research and Education Foundation, voted to let the drug stay on the market with a caution about possible kidney failure.

By that time, however, Bayer's aggressive marketing of the drug had given it an equal share of the antihemorrhagic drug market for use during open-heart surgery. Over 200,000 people were being given the drug every year, often multiple doses. At $1000 a dose, Bayer was making $700 million a year from the drug. The two alternative drugs were nearly as effective at controlling bleeding, and were much cheaper at $50 per dose.

And now it seems that money was made with foreknowledge of Trasylol's possible side effects. In fact, in the early 1980's, a researcher at the University of Cologne went to Bayer with evidence that animals given the drug suffered kidney damage, but the company brushed him off. The company refused to accept that the drug was dangerous, and when Dr. Mangano's study was published, it hired Harvard professor Alexander Walker to conduct its own study, to be completed before the September meeting. However, when Dr. Walker's results came out the same as Dr. Mangano's, Bayer quashed the study and didn't report its results to the FDA.

A week after the committee voted to keep Trasylol on the market, Dr. Walker came to the FDA independently of Bayer and turned over his results, revealing that Bayer had tried to conceal them. However, the FDA did not at that time request a suspension of the drug. It was not until over another year later that this action occurred.

So let's review. Here's what the FDA did not consider sufficient to suspend the drug:

• Three studies showing that the drug increased the risk of death by 50-100%
• The possibility that more than 30 people were dying daily as a result of the drug
  
• Evidence that Bayer concealed results of damaging studies
• The existence of alternatives that in most cases were equally effective

All these things led to a label revision on the drug. So what was sufficient to ultimately prompt the removal of Trasylol from the market?

In 2007, a trial by the Ottawa Health Research Institute was halted because the group being given Trasylol showed an increased risk of death. This was considered the final result necessary to suspend the drug.

This is another situation in which our neighbor to the north has shown its strength in standing up to drug companies, similar to the Avandia ban late last year. In this country, the FDA seems content kowtow and toady to a drug industry eager to make profits despite the risks to patients. In this country, our only option is to try and make it unprofitable for pharmaceutical companies to market dangerous drugs, and the only way to do this is to make ruinous penalties for doing so. If you or someone you love has suffered dangerous side effects from taking Trasylol or another defective pharmaceutical, you have a responsibility to pursue your claim against the manufacturer. Contact PersonalInjury.com today to get in touch with a local defective pharmaceutical lawyer who can take your fight to the drug companies.

Labels: Canada, defective pharmaceutical, FDA, Trasylol