Stryker Corporation, the artifical hip manufacturer, has received a subpoena regarding the agency’s probe into Stryker’s sale of medical device prodcuts to foreign countries. Stryker was one of five medical device companies to settle with the federal government and avoid prosecution over kickbacks to doctors in exchange for using their hip implants. Stryker has been in the news recently after it recalled its Trident PSL and Trident Hemispherical Acetabular Cups used in hip replacement surgery. Stryker has known about problems with the hip devices since at least January 2005 when it began receiving complaints from patients who had received the hip replacement devices. The problem with the hip replacement components are two-fold involving manufacturing processes as well as issues regarding defective design.

Boston Scientific as well as some medical device competitors are under federal investigation for possible off-label and unapproved marketing of their bile duct stents. The US Justice Department is investigating whether the company marketed the stents for off label use, a violation of FDA rules. The FDA met with Boston Scientific last March to discuss their concerns over possible off-label use of the stents in blood vessels rather than in bile ducts. The stents have been approved to prop open the bil ducts in patients whose ducts have become obstructed due to pancreatic cancer.

1.5 million Americans are injured or killed by prescription drug errors each year. Prescription errors in hospitals are so common that patients are subject to drug errors each day they are hospitalized. These are the conclusions drawn by the notable Institute of Health. These errors not only cause further injury and sometimes death, they cost billions of dollar to correct. The Institute noted that many of these mistakes could be avoided if doctors used electronic prescribing methods and hospitals utilized a standardized bar code system. According to the Institute, 25% of the errors are preventable.

Biogen’s multiple sclerosis drug Tysabri has been linked to liver injury. The link was strong enough that the FDA posted a warning on its website. Biogen sent warning letter to doctors advising them of the potential liver damage. Signs of liver injury can manifest themselves as early as 6 days from initially taking the drug. Tysabri has also been used to treat Chron’s disease.

The U.S. Food and Drug Administration refused to approve a request by Eli Lilly and Co. to approve a long action injectable version of the schizophrenia drug Zyprexa. The FDA was concerned that injecting the drug could case dangerous excessive sedation. Zyprexa and a related drug Seroquel which is made by Astra Zeneca are both the subject of many injury lawsuits on behalf of consumers who developed diabetes. The manufacturers of Zyprexa and Seroquel downplayed the risk of diabetes to increase sales of these very profitable drugs. Many Zyprexa and Seroquel users are at greater risk of diabetes due to their mental challenges and Eli Lilly and Astra Zeneca knew of this predisposition.

Baxter International has announced that it is taking all of its heparin supply off the market just as the FDA is reporting that the number of deaths associated with the bad heparin has risen from 4 to 21. The FDA has inspected the proper Chinese plant this time but still has not been able to determine the exact cause of the heparin problem. However, a redacted report from the FDA indicated the plant’s failure to properly follow the steps for identifying impurities and deficiencies related to manufacturing equipment.

There’s a great deal of media attention as well as Congressional scrutiny concerning the safety of drugs, medical devices, and food stuffs, all of which are supposed to be monitored by the FDA. In an interview with the Wall St. Journal, Dr. Andrew von Eschenbach, FDA chief, admitted that the federal agency is understaffed and woefully underfunded. An outside agency has said that the FDA needs 150% added to its budget in order to begin to do its job effectively. At the same time, China has weighed in on the heparin debacle by stating that it’s really not their responsibility to ensure the safety of the drugs they export. Rather, the responsibility lies with the countries that import their drugs. This is ludicrous but that’s the state of affairs with China. To make matters worse, the Supreme Court has given ultimate authority to the FDA over Class III medical devices, such as Medtronic’s Sprint Fidelis cardiac defibrillator. This adds up to a nightmarish situation for consumer product and drug safety in this country.
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After facing a Congressional hearing and increased public scrutiny, drug manufacturer Pfizer has decided to stop using Robert Jarvik as its pitchman for the cholesterol lowering drug Lipitor. While Jarvik is best known for developing the artificial heart, he’s never practiced medicine and is not a trained cardiologist. The Lipitor ads mention that Jarvik is a doctor without mentioning that he’s never practiced medicine, a problem for Rep. John Dingell (D-MI) who sent letters to Pfizer and the FDA complaining that Jarvik’s not so subtle message could mislead patients about Jarvik’s actual qualifications. This is a positive move for consumer safety and it demonstrates that big pharmaceutical companies can succumb to public pressure to do the right thing. Often, these drug companies are more concerned about their profits than public or consumer safety. That’s my concern with the recent Supreme Court ruling authored by conservative justice Antonin Scalia. The ruling bars civil liability claims involving Class III medical devices that have been approved by the FDA. According to the ruling, such claims, under the premarket approval process (PMA), are preempted by federal law. Essentially, this means that consumer protection has been forfeited by the ruling. Even the FDA used to believe that that ability to bring civil liability claims in state courts kept the medical device manufacturers honest and more accountable to the public. The Supreme Court, with its pre-emption ruling, puts consumer safety behind big business and corporate profits.

A team of researchers from the University of Sydney, Australia published a study in the January 28, 2008 edition of the World Journal of Gastroenterology which supports earlier literature linking Kava to liver failure. The United State Food and Drug Administration (FDA) had issued a health warning for the risk of liver failure in 2002 but many health food, herbal remedy, and natural food stores have continued to sell the product in the U.S.A.
The new study entitled “Influence of kavain on hepatic ultrastructure” was an animal study in which rat livers that had been exposed to kava were examined with an electron microscope.
This study provides additional scientific evidence that will likely be used in personal injury and death lawsuits pending in the U.S. against the manufacturers and distributors of Kava products. This study also provides further evidence that could lead the FDA to issue additional warnings for Kava. It is not clear that the FDA has authority to order a drug recall for Kava because it is considered a food supplement under U.S. law. The FDA tried to do a drug recall for ephedra a few years ago and was reversed by the courts because ephedra was also classified as a food supplement
There have been a number of liver transplants and deaths associated with the use of Kava around the world.

Auto accidents remain the leading cause of death for Americans under the age of 34. Each year, 40,000 people lose their lives in auto crashes. The resulting psychological, economic, and physical toll places tremendous strain on families and individuals alike. If the accident is not stressful enough, the aftermath can be a nightmare dealing with issues such as medical treatment, car repairs, mounting hospital bills, lost time from work, and lost wages. Yet, the decisions you make during this stressful period can have lasting impact upon you and your family. Florida Accident Lawyers
If you’re involved in an accident what should you do?
Call the Police immediately
Fill out an accident report thoroughly
Obtain names and phone numbers of witnesses
Seek medical treatment even if you feel ok at the scene (your adrenaline may mask a serious injury)
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