Supreme Court to hear J&J pre-emption case
WASHINGTON Within the next couple of months, the Supreme Court could render a decision that could prove to be monumental for the pharmaceutical industry. The court will soon hear its third case on pre-emption. The pharmaceutical companies are hoping that the court states that the Food and Drug Administration has pre-emption status over state laws.
The new case involved Johnson & Johnson and its birth control patch Ortho Evra, according to The New York Times. Lawsuits have stated that the drug actually released more estrogen than standard birth control pills and as such put women at more of a risk for blood clots and strokes. Johnson & Johnson has admitted to providing faulty information in regard to the estrogen level and has said that it has taken care of it with the FDA, who amended the drug’s label. The lawsuits are seeking damages from the manufacturer for allowing the drug to be used even though they knew it was harmful. The company fights back stating that the FDA, who approved the drug is the only entity that can challenge and regulate the drug, therefore ruling out the need for a trial. The Bush administration has sided with the pharmaceutical companies.
The other two cases seeking pre-emption involve the manufacturers Wyeth and Pfizer. Wyeth’s case involved the anti-nauseas drug Phenergan and Pfizer’s case involves the drug Rezulan, which the company acquired when it bought Warner-Lambert.
Since the FDA released the new findings in 2005 showing that the patch was more powerful than original thought to be, prescription sales of the contraceptive have taken a nose-dive by 80 percent.
The Supreme Court is expected to hear the case regarding Wyeth in the fall, which could lead to a huge decision regarding the Johnson & Johnson case.
Study shows no increased heart risk for newborns with mothers on Paxil
TORONTO According to a new study published in the American Journal of Psychiatry, infants whose mothers took the GlaxoSmithKline antidepressant drug Paxil during early pregnancy do not have an increased risk of heart defects.
The study was performed by the Motherisk program at the Hospital for Sick Children and University of Toronto. Almost 1,200 infants were studied and the results showed that infants who had been exposed to the medication had the same risk for the defects as infants not exposed, 0.7 percent.
GSK had originally published a report stating that risk of cardiovascular defects was 2 percent. Adrienne Einarson, the lead author of the new report called GSK’s initial report, “preliminary information.” GSK later adjusted its figure to 1.5 percent.
In general, the incidence of heart defects in the general population is about 1 percent.
Personal injury lawsuit filed against makers of contaminated drug Heparin
CAMDEN, N.J. A personal lawsuit against Baxter Healthcare has been filed following a near fatal reaction to the contaminated prescription drug Heparin, according to published reports.
Accounts of deaths and hundreds of severe allergic reactions stemmed from an active ingredient in the drug, which was identified as a chemically altered form of chondroitin sulfate. According to published reports, the chemical serves as a dietary supplement made from animal cartilage that is used to treat joint pain.
The contamination was rooted in China, where the drug is manufactured. The Federal Drug Administration filed a report on March 19 alerting the public of the dangers of taking the Heparin, and the medications were almost immediately recalled as a result.
“Prescription drug manufacturers have a duty to produce products that are safe and free of dangerous ingredients,” stated Wendy Fleishman of the New York City office of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein. “Only through a lawsuit or otherwise making a claim against Baxter can patients obtain compensation for their injuries. The American public needs the drug companies, like Baxter, to take responsibility for the safety of their products—especially those like Heparin, which are manufactured in part in China.”
The suit claims that Baxter did not adequately inspect the product before selling it, making them negligent, and as a result contributing to many unnecessary deaths.