4/29/2015 Pressure from various officials finally got the FDA to step in regarding beta-methylphenethylamine (BMPEA), a substance used in weight loss, energy boosting and pre-workout supplements. The FDA issued stop distribution letters to companies producing BMPEA-containing supplements. This is a move I can support, unlike many other FDA positions on non-Big Pharma products. Image: Wikipedia,
Colorful Pills by Vera Kratochvil Continual increases have states asking big pharma about astronomical drug prices. Many states are even proposing legislation that will force big pharma to share its development costs and profits as justification for ever-increasing prices. Tony DeLuca, a democratic representative in Pennsylvania, introduced legislation this week saying, “We need to have some
Olympus Corp., manufacturer of the TJF-Q180V duodenoscope, might have known about a risk involving their product at least two years ago. At least that’s when it issued letters to European hospitals warning that, without proper cleaning, it’s a possibility that Olympus duodenoscopes carry deadly disease. Unfortunately, in the U.S. that possibility may have become a
The Tenth Circuit issued an opinion on Tuesday, finding that state law claims asserted against Medtronic, manufacturer of the InFuse bone growth stimulator were preempted by FDA approval of the medical device under the Medical Device Act (“MDA”). Plaintiff in the case alleged that Medtronic representatives promoted an off-label, posterior surgical approach for the device,
The Mirena IUD may increase the chances of developing pseudotumor cerebri creating a potential new cause of action. Certain plaintiffs in a 2014 suit regarding the Mirena IUD even asked to have their pseudotumor cerebri claims separated into a unique class. The request was denied based on there not being enough pseudotumor cerebri claims to
In a landmark investigation released this week, the Center for Public Integrity (CPI) uncovered the alarmingly small and insular circle of experts who are used by food manufacturers to determine if a new ingredient is “Generally Regarded As Safe,” or GRAS. The investigation discovered that at least one of 10 particular consultants participated in over
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.
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