A 1958 law offers food companies who want to market new ingredients in their products a way to bypass extensive and costly FDA safety testing. The law provides the option for companies to demonstrate that the ingredient in question has been deemed “Generally Regarded As Safe” (GRAS) by a consensus panel of scientists and experts.
Health & Medicine
Pfizer wins first Zoloft birth defect case, Pesante v. Pfizer, Inc. On Friday, April 17, the verdict came in that mega-corporation Pfizer’s Zoloft anti-depressant was not the cause of plaintiff’s heart abnormalities. This is the first of over 1,000 such cases currently in the judicial system. The fact that Pfizer won will have widespread repercussions
U.S. District Judge Landya McCafferty ordered that VA must pay $21.5M to stroke victim in record-breaking medical malpractice case. It is the largest individual personal-injury judgment in New Hampshire history. The judge ruled that the VA failed to properly diagnose and treat a stroke victim. New Hampshire’s former highest personal-injury award was $21.06M in a
Drug giant Novartis settles Zometa “bone death” case, Meng v. Novartis, one of two cases in New Jersey concerning the bone loss drug to make it to trial. The settlement was reached at the last minute before the case was to go before a state appeals court. The three-judge panel that was to hear the
No one can reasonably deny that law often resembles a game of chess, in which the filing of a claim is the opening salvo. However, there is a disturbing new trend that would have Bobby Fischer throwing up his hands in disgust, namely, premature removals of cases from state to federal courts. Some background is
The U.S. Food and Drug Administration (FDA) opened an investigation of Bayer pharmaceuticals in response to a citizen’s petition filed March 26th on behalf of over 2100 women regarding the Essure permanent birth control device. Bayer, who acquired the product’s maker, Conceptus in 2013, is being accused of hiding falsified medical records and reports of
The orders from the March JPML panel hearing have been posted, and the JPML issued an order denying a motion by a plaintiff to centralize her case in the Mirena IUD device litigation MDL proceeding in the SDNY. In its order, the JPML indicated that centralization into the pending MDL was denied because the potential
Federal preemption of claims against generic drug manufacturers has prevented (or severely limited) the ability of users of generic drugs from bringing products liability claims premised upon the failure to warn. Certain state courts have indicated that some state tort law claims may not necessarily be barred by federal preemption, but these “baby steps” potentially
FDA Re-opens Comment Period on Proposed Regulation Allowing Generic Drug Manufacturers to Initiate Label Changes
The FDA held a public meeting on March 27, 2015 to hear new comments on a proposed regulation that would permit generic drug manufacturers to initiate labeling changes as new information about their products became available. In addition to the meeting, FDA also invited comment submission via electronic means as well as by snail mail.
Patients treating hepatitis C with Harvoni (ledipasvir/sofosbuvir) or Sovaldi (sofosbuvir) in conjunction with another direct acting antiviral such as the investigational drug daclatasvir or Olysio (simeprevir) and also treating arrhythmia with amiodarone are at serious risk of developing symptomatic bradycardia. This dangerous combination has already resulted in one patient death due to cardiac arrest and