Propofol , distributed by Astra Zenica, is used for general anesthesia during surgery, sedation, and reduction of intracranial pressure in head injury patients. Propofol administration has been associated with the development of propofol-infusion syndrome in pediatric and adult patients. The syndrome consists of myocardial failure, metabolic acidosis, rhabdomyolysis, and hyperkalemia developing on day 4 or 5 of high-dose propofol therapy.
Drug Products
Big Pharmaceutical Companies
When the FDA approved new rules making pharmaceutical companies provide clearer labeling and detailed warnings about their drug products, they also slipped in a second rule change that is both ridiculous in its scope and profoundly anti-consumer. This new rule change argues that because the FDA approves drugs before they can be marketed to the general public, only federal courts should hear cases where someone claims they were injured by those drugs. It’s called “federal preemption” and if upheld, will require injured victims of dangerous drugs to sue a drug company in federal court not state court. Joan Claybrook, President of Public Citizen, summed it up perfectly, “This is a sneak attack on consumer rights. Bush is once again abusing his executive powers, this time in his attempt to protect the big pharmaceutical companies from the consequences of their actions. Thousands of people in this country have died or been seriously injured by drugs approved by the FDA, and this administration is saying it doesn’t think people should have any recourse.”
Doctors Urge Ending Use of Heart Surgery Drug Trasylol
A drug used worldwide to reduce bleeding during heart surgery can increase the risk of kidney failure, heart attacks and strokes, and should be abandoned, doctors are reporting today. They say other medicines are safer and cheaper, and should be used instead. The drug, aprotinin, is sold under the brand name Trasylol and manufactured by Bayer. The report was published in The New England Journal of Medicine.
Joseph H. Saunders, Attorney at Law
Joseph H. Saunders: born in Montgomery, Alabama, January 31, 1953. Admitted to the California State Bar in 1981 and the Florida State Bar in 1982. Also admitted to practice in the United States District Court, Middle District of Florida and the United States Court of Appeals, Eleventh Circuit.
Saunders & Walker, P.A.
Saunders & Walker represents seriously injured or abused persons and the families of persons whose lives have been adversely affected by the negligence of others. We seek justice and compensation from corporations, organizations, and individuals who intentionally or negligently cause harm, injury, or death to our clients.
If you or a loved one have been injured, please contact us at (727) 579-4500 or 1-800-748-7115.
The law firm was founded in 1987 and is located in Pinellas Park, Florida were it was founded. Pinellas Park is on the west coast of Florida midway between St. Petersburg and Clearwater. A second office was opened in Bradenton, Florida in 1994.
The law firm represents individuals both in Federal and State Courts. In one Federal court case which involved civil rights and police brutality, the City of St. Petersburg paid a client of our firm the largest settlement ever by the City for any type of injury or death case. The Federal cases also involve maritime claims and products liability cases based upon diversity jurisdiction.
The State court cases include medical malpractice, automobile accident, premises liability, products liability and general negligence cases.
Mr. Saunders is a Board Certified Civil Trial Lawyer by the Florida Bar Board of Legal Specialization and Education. He is an Eagle Member of the Academy of Florida Trial Lawyers, a member of Association of Trial Lawyers of American and a member of Maritime Law Association of the United States.
New England Journal of Medicine Accuses Drug Companies of Hiding Key Data
According to a study published this week in the New England Journal of Medicine, several major pharmaceuticals are withholding important details about clinical drug trials, despite urging from federal regulators and medical journal editors. The New England Journal of Medicine specifically cites Merck & Co., Pfizer, and Glaxo Smith Kline PLC as obscuring basic information in reporting on trials of drugs to treat serious or life-threatening diseases. Some of the drugs involved are already on the market.
For years, some drug companies kept secret the results of studies that reflected badly on their porducts and published only positive results. Critics say this helped mask safety problems. As the pharmaceutical companies continue to garner huge profits, it’s time for the federal government to provide proper oversight of these huge profit machines.
FDA Orders NeutroSpec Withdrawn from Market After 2 Deaths
The FDA has ordered the withdrawal of the diagnostic imaging agent Neutro Spec after two reported deaths were associated with the product. Reports submitted to the FDA suggest NeutroSpec caused allergic reactions within minutes following administration. Those reactions led to the death of two patients and to cardiopulmonary failure, central nervous system problems and infusion reactions in other patients.
FDA officials emphasized all of the reactions occurred immediately after NeutroSpec was administered and there is no evidence that patients who already safely received the drug face any long-term risk.
NeutroSpec, approved for marketing in July 2004, is a diagnostic imaging agent that’s administered intravenously to help diagnose appendicitis in patients 5 years and older.
New England Journal of Medicine Says Merck Left Out Data About Heart Attacks
The New England Journal of Medicine posted an “expression of concern” that three heart attacks among patients who used Vioxx were left out of the date in a crucial Vioxx study called Vigor, making Vioxx appear safer than it actually was. In a statement released December 8, 2005 the New England Journal of Medicine said it became of the problem when plaintiffs’ attorneys subpoenaed a Journal Editor regarding the Vigor publication. Gregory D. Curfman, executive editor of the Journal was deposed on November 21, 2005. According to the New England Journal of Medicine Statement, the Journal learned that “relevant data on cardiovascular outcomes had been deleted from the Vigor manuscript prior to its submission to the Journal and that the authors had withheld data on other relevant cardiovascular outcomes. For the full stament from the New England Journal of Medicine go to:
http://online.wsj.com/public/resources/documents/
nejm_vigorconcern12082005.pdf
Expert Doctor Testifies that Vioxx Can Cause Heart Attacks
On December 1, an expert doctor testified that Vioxx can cause heart attacks and trigger an event in less than a month. The doctor, Wayne Ray, has studied the risks and benefits of drugs, including Vioxx, reached his conclusion after analyzing numerous studies, including the one that pushed Merck to remove Vioxx from the market last year. “The totality of the evidence clearly indicates that Vioxx causes heart attacks,” said Ray, head of the Pharmaco-Epidemiology department at Vanderbilt University School of Medicine.
Birth Control Patch Warning Signs
Now that the FDA has “re-labeled” Ortho Evra the popular birth control patch, it’s important to recognize the symptoms of impending health issues caused by the patch. Women who use this patch are at a significantly increased risk for blood clots, strokes, and death than those women who use other forms of oral contraceptives. The manufacturer of Ortho Evra, Ortho-McNeil now admits that women using the patch can be exposed up to 60% more estrogen than those using oral contraceptives. Critics of both the patch and the FDA’s approval and monitoring practices, however, see the warning as simply another example of economics being placed above public safety. There has been a constant chorus of warnings about the extremely serious side-effects associated with the patch from a number of experts as well as the consumer watchdog group, Public Citizen (www.worstpills.org) and the Associated Press.
Who watches the watchdogs?