Rep. Rick Kriseman (D-53) is sponsoring a bill in the Florida House that would require proof of increased financial responsibility for bodily injury or death caused by owners or operators found guilty of, or who entered plea of guilty or nolo contendere to, regardless of adjudication of guilt, DUI offense or who had license or driving privilege revoked or suspended under specified provision. The bill provides an exemption if specified conditions are met; conforms provisions; revises provisions concerning motor vehicle security following motor vehicle license or registration suspension. The bill, if passed into law, will go a long way in ensuring that DUI victims’ rights are protected. Hopefully, it will also dissuade drivers from getting behind the wheel, if they’ve been drinking.
Rick has joined our firm and continues to fight for consumer justice, especially those victimized by drunk drivers.

In a recent Washington Post article, the Food and Drug Administration has known for years of contamination problems at a Sylvester, GA peanut butter plant as well as on California spinach farms, but failed to take action against the offending plant or farms. Consumer advocacy groups as well as some members of Congress have openly criticized the federal agency and called them incapable of safeguarding the nation’s food supply. Needless to say, this is alarming and a critical threat to the health and welfare of our nation’s citizens. According to published reports, the FDA has allowed manufacturing plants and farmers to police themselves as the number of processing plants has grown.

US marshals and investigators with the Food and Drug Administration seized all implantable medical devices from Shelhigh, Inc. after the Union, NJ plant was inspected last fall. Officials had warned the company in letters sent in 2000 and 2005 about the safety and effectiveness, including sterility of the implantable medical devices prior to seizing them. The plant was processing the devices for pediatric heart valves and conduits, or tube-like devices for blood flow, as well as surgical patches, arterial grafts and annuloplasty rings. Violations cited by the FDA included the processing of these products in a room that was poorly constructed and poorly maintained.

Pfizer is airing a new Celebrex commercial that is unique in a few ways. First, it isn’t the usual 20-30 second spot, it actually runs for 2 1/2 minutes! Secondly, it uses animated line drawings rather than actors. However, neither of these innovations drew the attention of the watch dog group Public Citizen which has called on the FDA to ban the ad from the airwaves. Public Citizen’s chief complaint about the ad is that it is misleading. According to the group, it implies Celebrex is no more dangerous than other painkillers. Celebrex belongs to the same class of drug as Vioxx which was withdrawn from the market in 2004 due to its link with cardiovascular problems. According to the letter Public Citizen sent to the FDA, Celebrex may have links to gastrointestinal and cardiovascualr problems. Here is an excerpt of the letter: “The overall purpose of the ad is to make it appear, contrary to scientific evidence, that the cardiovascular dangers of Celebrex are not greater than those of any of the other NSAID painkillers. Further, it asserts that certain gastrointestinal problems are, if anything, less frequent with Celebrex than with two popular over-the-counter (OTC) painkillers.”

The FDA has decided to increase the monitoring and investigation of processing plants that make peanut butter after its initial investigation has found that the peanut butter contamination poses a greater public health risk than originally believed. “Up until this point, peanut butter has not been considered a high-risk food,” said Dr. David Acheson, chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition. “We now know peanut butter can be a vehicle for salmonella.” The last time the ConAgra plant was inspected by the FDA was in 2005. ConAgra spokeswoman Stephanie Childs said Thursday the company traced the salmonella outbreak to three problems at its Sylvester plant last August.
The plant’s roof leaked during a rainstorm, and the sprinkler system went off twice because of a faulty sprinkler, which was repaired.

In today’s world where transparency has become operative, Public Citizen has released a study co-authored with the Journal of the American Medical Association wherein doctors are often receiving large payments in return for writing prescriptions for certain drugs. In addition, the general public has limited or no access to these transactions. “Full disclosure of these payments is an important way to help the public better understand the relationship between the drug industry and their doctors. We hope this will discourage many doctors from taking these payments and thus prevent an erosion of public trust,” said Wolfe. “It will also encourage the medical community to address the known impact of payments on prescription writing.” said Dr. Sydney Wolfe director of Public Citizen’s Health Research Group.
Politicians and financiers are subject to full disclosure (transparency) so why not the docs? Doctors play such an important role in public safety, citizens need to be able to trust their doctors when they write prescriptions.

Citing its March 2001 petition to the FDA, Public Citizen has criticized the FDA’s approval for use of the irritable bowel drug Zelnorm. According to Public Citizen, the drug should never have been approved in the first place. The watchdog group goes on to castigate the FDA for “both the adequacy of the FDA’s pre-approval review and post-marketing surveillance.”
It seems more and more drugs are being taken off the market for harmful side effects. With each withdrawal the criticism of the FDA grows more vociferous.

The FDA is concerned that anesthesia drugs may harm the developing brains of children. The concern stems from a recent study of animals using certain anesthesia drugs have killed brain cells. Now, the FDA has not made a corrolation between the findings in animals with children but the results bear watching for the safety of our children.