Tampa Bay Personal Injury Lawyer

Injury Board Lawyers Organizing and Seeking Ways to Help Haiti

Joe Saunders — Wed, 13 Jan 2010 16:37:26 GMT

In the midst of the devastation and tragic suffering in Haiti, the Injury Board community is discussing ways in which we can lend a hand and hopefully make a difference in the relief efforts. Several IB members have suggested websites that are involved in Haiti relief efforts. They include http://www.healinghandsforhaiti.org and http://www.mfkhaiti.org These are just two of the charitable organizations that IB members have suggested. I'd welcome more suggestions from the IB community as well as the readers of this blog. The important thing is that we act and do it rather quickly. Haiti is only some 300 miles from the Tampa Bay area and many in our area have been directly affected by the earthquake.

Originally posted at InjuryBoard by Joe Saunders

Federal Fines for Off-Label Marketing May Be Paying Dividends

Joe Saunders — Tue, 22 Dec 2009 09:05:45 GMT

Perhaps the large pharmaceutical companies are finally starting to pay attention. After a few years of being penalized by large monetary fines, it may be that the big pharma executives are starting to take notice and change their practices. At least that's the indication from an article in the Wall St. Journal today. In an interview with the Journal, Astra Zeneca CEO David Brennan acknowledged that the stiff fines have altered company marketing practices. Of course, his statement comes in the wake of his company being fined $520 million to settle an investigation into Astra Zeneca's marketing of schizophrenia drug Seroquel.

While doctors are free to prescribe drugs for uses they deem appropriate, the FDA has required that drug companies market their drugs for FDA approved uses only. So-called off-label marketing practices by pharmaceutical companies has led to investigations, lawsuits, and monetary penalties.

Perhaps, federal intervention is starting to show signs that it's working to keep consumers safe.

Originally posted at InjuryBoard by Joe Saunders

Potential Link Between St. John's Wort and Cataracts Investigated

Joe Saunders — Fri, 11 Dec 2009 09:20:34 GMT

St. John's Wort has been widely touted as an herbal remedy for depression. Since it's a natural herb, most consumers believe it's completely safe just as those who use Kava kava for its relaxing qualities think it's also safe. However, new evidence is showing a potential link between the use of St. John's Wort and eye problems including the early onset of cataracts and macular degeneration. Injury Board colleague, Jane Akre has posted an informative article on the possible relationship between St. John's Wort and serious eye diseases.

There have been reports of more than 250,000 St. John's Wort users contracting cataracts. While the correlation between St. John's Wort and cataracts is not definitive, researchers at the University of Alabama found that participants in a study who reported cataracts were 59% more likely to also report use of the St. John's Wort.

Homeopathic medicines and herbal remedies are touted as safe because of their so-called natural qualities. However, this is not always the case. Further investigation concerning the potential link between serious eye disease and the use of St. John's Wort is necessary.

Originally posted at InjuryBoard by Joe Saunders

Toyota's Massive Recall Leaves Some Questions Unanswered

C. Todd Alley — Tue, 08 Dec 2009 10:57:07 GMT

As thousands of sources are reporting, Toyota has issued a massive recall of over 4 million vehicles after numerous reports of stuck accelerators cause some vehicles to accelerate out of control. As this CBS video shows, the accelerator pedals in certain Toyota models can get physically stuck to the floorboard.

To remedy the vehicles, Toyota dealers will install a re-designed accelerator pedal, meant to be higher off the floor board. In addition, Toyota dealers will replace existing Toyota-made floor mats with a newly designed one. Toyota is currently scrambling to manufacturer a re-designed pedal which would eliminate this risk. Dealers are expected to be ready to repair the recalled vehicles late this year or early next, depending on the model of the vehicle. Until then, owners of these affected vehicles are urged to remove their driver’s side floor mat.

Toyota is also including a brake-override modification to the vehicle’s computer system in some models, but bizarrely not all. All Toyotas in recent years utilize “drive by wire” throttle control. This means that rather than the traditional mechanical link between the accelerator pedal and throttle control on the engine, the accelerator pedal sends an electronic signal to the car’s computer, which then interprets and relays the signal to the throttle control.

The brake-override modification will override any throttle input when the driver presses the brake pedal. Even if the accelerator pedal is all the way down, hitting the brake would tell the computer to ignore the accelerator pedal’s signals and not apply any throttle. This simple solution is only being offered in a handful of the affected vehicles – which seems puzzling. Toyota is also not distinguishing between automatic and manual vehicles in determining which vehicles get the modification. There has been no official word on why this is the case.

The recall comes after numerous complaints to the National Highway Traffic and Safety Administration (NHTSA) about run away acceleration in Toyota vehicles. According to Time Magazine, the NHTSA has opened up an investigation into the issue six separate occasions. Each time the NHTSA concluded that it was unable to find a specific vehicle defect which caused the acceleration error.

But the accidents weren’t going away. An off-duty state trooper and his family were traveling in a Lexus when their vehicle’s accelerator got stuck. In a panic, the trooper called 911 and was on the phone with them in the moments leading up to the fatal crash which claimed the lives of all those onboard. Investigation into the crash linked the floor mats as the cause of the accelerator becoming stuck, a problem a previous driver of the exact same vehicle had experienced.

The accelerator becoming stuck is a huge design flaw, and to make matters worse even Toyota-made floor mats can cause it. If you own a Toyota affected by this recall, the best thing to do right now is to remove your driver’s side floor mat. Only then can you be sure that this won’t happen to you.

Originally posted at InjuryBoard by C. Todd Alley

Toyota Recalls 4.26 Million Vehicles for Accelerator Defect

Joe Saunders — Mon, 30 Nov 2009 09:45:45 GMT

Toyota has recalled more than 4 million vehicles due to a defect with the car's accelerator. The defects involve accelerators that are jammed open by floor mats. The dangerous defects have led to auto deaths including the death of a California Highway Patrol officer and three family members. Since 2002, the sudden acceleration defects have claimed the lives of at least 19 motorists who've experienced such Toyota accelerator defects.

Toyota has received strong criticism for their inaction and failure to warn motorists of the problem. "They knew something was wrong way before that San Diego accident happened," said Rebecca Lindland, an auto industry analyst for consulting firm IHS Global Insight. "That was just the catalyst to get them to finally do something."

Originally posted at InjuryBoard by Joe Saunders

Deadline for Chinese Drywall Class Action Lawsuit

Joe Saunders — Mon, 16 Nov 2009 10:08:37 GMT

Now that one of the major manufacturers of the contaminated Chinese drywall has agreed to accept service of a class action lawsuit, the time to act is now. If your home has been contaminated by Chinese drywall and you're contemplating a lawsuit, you must contact a lawyer so that your home can be inspected. The inspection will determine if the Chinese drywall in your home comes from Knauf. If the inspection proves positive for Knauf Chinese drywall, your claim has to be submitted to the class by December 2, 2009. There will be no extensions for this deadline so the time to act is now!

Originally posted at InjuryBoard by Joe Saunders

FDA’s Oversight of Post-Marketing Studies Inadequate

C. Todd Alley — Tue, 10 Nov 2009 11:05:08 GMT

The Government Accountability Office (GAO) has released a new report about the FDA’s lack of post-marketing oversight in a number of the drugs which it conditionally approved.

The FDA normally makes a decision to approve a drug based on clinical trials. If the clinical trials yielded favorable results, the FDA would then likely approve the drug and sales of the drug can be introduced to the U.S. market. The downside to this traditional route, though, is that the clinical trials can take years to complete, and cost the pharmaceutical company millions of dollars. With this in mind, in 1992 the FDA instituted an optional route to approval: surrogate end-points. Surrogate end-points are the end-results yielded by a drug in a laboratory setting which tend to show positive health benefits. For example, HIV-related drugs are often approved based on its virus-lowering power, a major factor in increased survival for HIV-infected patients. A cholesterol drug could be approved to prevent heart disease, an end-point, by showing that the drug lowers cholesterol – since there is a connection between high cholesterol and heart disease. Utilizing this approval route means that manufacturers can get their drugs to the market faster and patients in need have faster access to the drug.

Unfortunately with surrogate end-point approval there are often many factors unknown, namely long-term effects of the drug’s usage. Long term clinical studies provide this information, but drugs using surrogate end-point trials are often approved so quickly that long-term effects are not known until the drug is on the market - which means that adverse effects may not be known until after the drug’s approval. As such, the FDA approves these drugs conditionally. This means that the FDA will require the manufacturer to conduct ongoing research beyond the drug’s approval, or else the drug’s approval will be revoked.

Despite all of these conditionally approved drugs requiring the conduction of post-marketing studies, the GAO found only 52% of these drugs actually have adequately completed them. 18% haven’t even started, 7% were still ongoing, and 2% were delayed. The remaining 21% were either not yet reviewed or found no longer necessary.

The GAO also noted the FDA’s inability to provide accurate record keeping of post-marketing research. Additionally, the GAO found that no drug approved under the surrogate-endpoint system has ever been unapproved, despite a large number of delinquent manufacturers.

This is not the first time the FDA has come under fire from the GAO. In 2006, the GAO chastised the FDA for its lack of a clear oversight process, and inability to quickly evaluate post-marketing data. Clearly, the FDA has a responsibility to demand post-marketing studies be completed and submitted to prove a drug’s long-term safety and efficacy

Originally posted at InjuryBoard by C. Todd Alley

Chinese Drywall Defendant Agrees to Accept Service of Class Action Lawsuit

Joe Saunders — Wed, 04 Nov 2009 11:51:46 GMT

Chinese drywall defendant Knauf Plasterboard Tianjin Co. Ltd. has agreed to accept service of process concerning a Chinese drywall class action lawsuit in which Knauf is being sued for manufacturing and importing the contaminated Chinese drywall into the United States.

This is a major victory for the thousands of homeowners who've had their homes contaminated with the drywall. The agreement means that all the drywall lawsuits can be consolidated into a class action and the homeowners won't have to pay the $15,000 fee for each lawsuit filed in the court.

However, Chinese drywall homeowners must submit proof that their home has been contaminated with the drywall and secure a lawyer to represent them by December 2, 2009.

Originally posted at InjuryBoard by Joe Saunders

The FDA Must Improve Communication to Patients

C. Todd Alley — Thu, 29 Oct 2009 15:36:27 GMT

The American Recovery and Reinvestment Act allocated $1.1 billion dollars to coordinate research and guide investments in comparative research funded by the Act. Some critics suggest that a whole lot of money could have been saved just by looking to the FDA.

Dr. Lisa Schwartz and Dr. Steven Woloshin have co-authored a New England Journal of Medicine article titled Lost in Transmission – FDA Drug Information That Never Reaches Clinicians, in which they talk about the fallacies of the current system, and possible ways to correct it. Primarily, on the journey from clinical trials to FDA approval to the production of a drug label, potentially vital information is lost. For example, the FDA approved the drug Rozerem in 2005 to treat chronic insomnia, but in one phase 3 clinical trial, the drug failed to provide any benefit at all for this condition. In fact, a memo created by the FDA’s own medical review team debated whether to even approve the drug since the insignificant benefits provided by the drug may be outweighed by its potential side effects, but Rozerem was eventually approved. Obviously, knowing this background information would certainly appear to have an effect on a doctor’s enthusiasm to prescribe the drug, and a patient’s willingness to take the drug. Unfortunately, though, this type of important information is not placed on the FDA’s approved drug label, so none of it is clearly communicated to the public.

To its credit, the FDA has issued new guidelines about drug labeling, such as including phase 3 trial results and other effectiveness data, but this information is not mandated as it should be. In the case of Rozerem, the effectiveness data is still absent even after the label was updated. Bottom line - more needs to be done.

The FDA is currently undergoing a pilot test of a “drug fact boxes” which would include a succinct table of effectiveness data such as reviews and labels. This would give doctors more pertinent information about drugs and also allow patients to make a more educated decision before they take a new medication. The FDA is still debating internally how to use these “drug fact boxes.”

There are other potential alternatives, but the authors concisely (and correctly) conclude, “Whatever approach the agency adopts, it needs a better way ofcommunicating drug information to clinicians. We don’t needto wait for new comparative-effectiveness results in order toimprove practice. We need to better disseminate what is alreadyknown.”

Originally posted at InjuryBoard by C. Todd Alley

Injectable Pain Drug Recall Expanded

Joe Saunders — Fri, 23 Oct 2009 11:40:58 GMT

The manufacturer of an injectable pain medicine is expanding its recall due to possible contamination. The recalled drug Ketorolac Tromethamine Injection USP 30 mg/ml, is used to treat moderate to severe pain. The contamination may cause blockage in blood vessels which can lead to pulmonary emboli or thrombosis. The drug had been distributed nationwide to wholesalers and hospitals, surgical centers, and pharmacies have been notified of the product recall.

Originally posted at InjuryBoard by Joe Saunders