Monthly Archives: January 2008

Medical Device Companies Want Direct to Consumer Access

With the wildly popular marketing campaigns of drugs touting benefits for erectile dysfunction, high cholesterol, sleep disorders, and anxiety attacks, the marketing departments of medical device makers are plunging into the direct-to-consumer market. They want to be able to place ads in print media, tv, and internet touting the benefits of their medical device such as stents, defibrillators, and surgically implanted hips and knees. However, some medical professionals including doctors are warning that the trend is a dangerous one for consumers. Just as the tv ads for drugs tend to emphasize the benefits of the drug while downplaying its risks, doctors are leary of allowing Madison Avenue replace good science. The new aggressive ad campaigns come at a time when medical device makers are facing more scrutiny from Congress and the FDA for their manufacturing processes as well as their marketing practices. If the device makers are allowed to market their products like the drug companies, the real loser is the consumer who may not be aware of the risks involved.

Pfizer’s Chantix Has Some Nasty Side Effects for Those Trying to Kick the Habit

So one of your New Year’s resolutions is to finally kick the habit and give up smoking. You see tv ads running that tell you that this pill makes giving up smoking easier. What the ad doesn’t tell you is there are some pretty nasty side effects to Chantix such as depressed mood, agitation, suicidal thinking and suicidal behavior. The side effects are serious enough that Pfizer, the drug’s manufacturer has strengthened the warning on the drug’s label. The warning asks doctors to monitor their patients for signs of those side effects. So much for a magic pill that makes it easier to stop smoking.

Drug Companies Hide Their Research in Order to Obtain Government Approval

In what is becoming an alarming trend, the makers of certain anti-depressant drugs withheld 1/3 of their studies’ results in order to obtain government approval for their drugs. Pharmaceutical companies that manufactured the popular anti-depressants Prozac and Paxil never published 1/3 of their drug trial studies in order to get the government to approve the drug, misleading doctors and consumers about the drugs’ effectiveness and safety. The new findings, published in the New England Journal of Medicine, found that about 60 percent of people taking the drugs report significant relief from depression, compared with roughly 40 percent of those on placebo pills. But when the less positive, unpublished trials are included, the advantage shrinks, calling into question the real value of the drugs themselves. It’s alarming to note that 94 percent of the positive studies found their way into print, just 14 percent of those with disappointing or uncertain results did. This leaves doctors and their patients at a significant disadvantage when trying to determine treatment options.

7 Deaths and 14 Liver Transplants Linked to Kava Kava Use

The World Health Organization has issued a 91 page report detailing the dangers of Kava kava use. In the report, Kava kava is associated with 7 deaths and 14 liver transplants. Eight cases were determined to have a close association between the use of kava and liver dysfunction because the patients recovered on withdrawal of kava and no other plausible cause for the liver problems would be identified. Fifty-three cases were classified as having a possible relationship, but they could not be fully assessed due to insufficient data or other potential causes of liver damage. Five cases had a positive rechallenge, meaning the patient improved on withdrawal of kava, but worsened with reintroduction. Most of the other case reports could not be evaluated due to lack of information.
It’s interesting to note that the kava dangers have been found in the supplement manufactured and sold in health food stores. It has not been found to be a problem when it is consumed by the natives who mix it with water. Our law firm has received a database report from the Center for Food Safety and Applied Nutrition, the US FDA branch overseeing food and dietary supplements which containing 84 adverse events associated with Kava from early 2002 through June 2007. Three reports are associated with “Happy Camper,” manufactured by Natural Balance, Inc., a subsidiary of Nutraceutical International Inc. Nevertheless, kava is still available for use in the United States as a dietary supplement for anxiety.

Wildfires and Fog Have a History of I-4 Auto Crashes

Last week’s 70 car crash pileup caused by dense fog and a controlled burn wildfire wasn’t the first time a tragedy occurred in the Lakeland section of I-4. According to a story reported in the Lakeland Ledger, there have been 11 such fatalities since 1974. The low lying area is prone to dense fog. When the fog is coupled with a fire, the I-4 road becomes a terrible hazard. With this history, it seems officials should have been proactive in closing I-4. There have been no significant changes in I-4 safety measures since 1974. Other states such as Tennessee have encountered similar problems with fog and smoke and have taken steps such as installing signs and fog/smoke monitoring systems. Florida has not taken such steps.

I-4 Reopens After Chain Reaction Car Crash

Interstate 4 has now reopened but officials are monitoring weather and the wildfire. If circumstances suggest hazardous conditions, the highway just east of the east entrance/exit of the Polk Parkway to U.S. 27 in Haines City will be closed again. It’s unfortunate such vigilance hadn’t been present prior to Wednesday’s tragic 70 car crash. A portion of the highway had to be resurfaced due to the extreme heat generated from the multiple vehicle fires.
Florida Interstate Auto Accident Lawyer Information Page
No lawsuits have been filed yet. However, we expect a large number of legal claims to be filed in the near future. Obviously, the carelessness of the state employees who could’ve prevented this disaster will prompt many victims and their families to hold the state accountable. These claims will also likely be against other drivers who failed to slow down or exit the highway considering the limited visibility due to heavy fog and smoke. Those who bring the first claims may have an advantage due to limited auto insurance coverage as well as caps on damages against the State of Florida.

Complex Lawsuits For Lawyers From Florida Interstate 4 Accident

The lawsuits that will be filed over the 70 car chain reaction crash near Lakeland, Florida will involve complex issues of legal liability. Certainly, there is evidence the workers for the Florida Fish and Wildlife Conservation Commission were negligent in allowing the controlled burn of brush get out of control causing the excessive smoke in the area. The State of Florida is likely legally liable for the smoke that was a contributing cause of the crash on I 4. The State of Florida’s legal liability is limited by caps on damages that only apply to the state under the doctrine of sovereign immunity. It is also possible the the State of Florida may be liable for failing to close the interstate once the burn got out of control and the smoke mixed with the early morning fog to cause the loss of visibility on the highway.
Attorneys will also be able to show that some of the drivers of the trucks and cars involved were partially at fault for failing to slow down sufficiently or stop when they saw the smoke. Each of the various segments of the 70 car chain collision may involve partial legal liability of different cars and trucks. Furthermore, those individuals who bring claims first may have an advantage by being able to demand all the insurance coverage from at fault vehicles and collecting it. It will be interesting to see how the Florida courts handle these issues. Most of the crashes occured in Polk County, Florida which includes Lakeland, Bartow, Lake Alfred, Polk City, and Haines City. Depending on the specific parties involved there could be legal jurisdiction for lawsuits in counties other than Polk County for some of the cases.
It is likely there will be some significant legal decisions involving governmental liability that will progress through the Florida courts for many years as a result of this horrific chain reaction crash.

Orlando Sentinel Details Chronology and Causes of I-4 Car Crash Pileup

The Orlando Sentinel has provided an early timeline of the 70 car chain reaction crash this morning on I-4 in Lakeland. While the investigation is in its infancy, dense fog and smoke from a wildfire or controlled burn were substantial contributing causes to the car crashes. Five people are now reported dead with many injured as a result of the early morning car crash. Those injured were taken to local hospitals such as Lakeland Regional Hospital.
Polk County Deputy Sheriff Jack “Carlton” Turner was the first on the scene of the car crash and wasn’t able to get out of his patrol car before being hit multiple times. Turner, obviously distraught, described to his colleagues the crash scene: “”I could still hear metal grinding as cars went into each other. I did all that I could but I watched a man burn to death today.”
Tragedies such as this car crash in Lakeland are never easy to understand or come to grips with especially if you have lost a loved one yourself in the crash. They are even more difficult when preventive measures may have spared people this pain and suffering. It appears at this point that I-4 should have been shut down well before this crash.

Lakeland Florida Smoke and Fog Cause 50 Car Crash

MSNBC is reporting that at least 3 people have died and 38 were injured in a 50 car pile up near Lakeland, Florida today. The crash on Interstate 4 was caused by a controlled burn by Florida state workers that got out of control and combined with early morning fog. The interstate has been closed for most of the day. The highway was littered with cars and tractor trailers on fire. The State of Florida is protected to some degree by sovereign immunity caps on damages. Therefore, it is likely that many of the injured victims or families of those killed will not receive fair compensation from the State of Florida eventhough it appears that the state workers’ carelessness with the controled burn caused the pile up. Maybe this terrible crash will make the public realize the injustice of sovereign immunity caps on damages in lawsuits against the state of Florida.

Congress Begins Inquiry of Pfizer’s Use of Dr. Jarvik as Lipitor Pitch Man

It’s difficult to go one day without seeing an ad featuring Dr. Jarvik as Pfizer’s pitchman for the cholesterol drug Lipitor. The strange this is that Dr. Jarvik, the inventor of the artificial heart, is not licensed to practice medicine. It’s curious enough that Congress has sent a letter to Lipitor’s manufacturer, Pfizer, asking about Jarvik’s qualifications to be recommending the cholesterol drug. In his press release, Rep. John Dingell (D-MI) wrote, “In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine.” The Jarvik inquiry is part of the House Committee on Energy and Commerce inquiry into drug companies’ practices of using celebrity endorsements of pharmaceutical products. Dr. Jarvik drew the attention of the Congressional committee because he is so often seen on television and he appears to be giving medical advice. Last year, NBC’s Robert Bazell reported that Jarvik graduated from a medical school in Italy because his academic credentials didn’t qualify him for a US medical school. Furthermore, Jarvik never completed an internship or practiced medicine.