The Food and Drug Administration has identified an information gap in its system of clinical trials and is working to fill it. The gap relates to women. There aren’t enough of them enrolled. “Underrepresentation of women (or minority or ethnic groups) results in a lack of information for these patients […]
On July 11, 2014, Judge Joseph R. Goodwin of the United States District Court for the Southern District of West Virginia, ruled that a lawsuit filed against Boston Scientific in connection with its Obtryx transvaginal mesh device was time barred under Massachusetts’ three year statute of limitations because the plaintiff […]
The Alabama Supreme Court in Wyeth v. Weeks has reaffirmed its ruling in a case questioning whether a brand-name drug maker can be held liable for injuries from a generic version. Plaintiffs Danny and Vicki Weeks sued drug manufacturers for injuries that Danny Weeks allegedly suffered as a result of […]
Covidien is not one of the large names associated with pelvic mesh lawsuits. There are 65,000 product liability lawsuits consolidated in a federal court in West Virginia filed by women alleging life-altering complications from transvaginal mesh. But look at the fine print, the Dublin-based company is associated with one of […]
The Food and Drug Administration (FDA) is warning consumers that some popular over-the-counter acne medications may cause serious allergic reactions and tissue damage that can limit breathing and cause swelling of the face. The exact ingredients causing the trouble may not be known. Consumers should stop using these products if […]
Oregon, Washington State and Vermont say the slogans for 5-Hour Energy drink are hype that is misleading. Last week the Attorneys General of all three states filed lawsuits against the drink’s maker, Living Essentials LLC and Innovation Ventures LLC of Farmington Hills, Michigan. They are seeking civil penalties against the […]
The public needs to understand that an additive used by industry to fatten cattle up before slaughter has been banned by China, Russia and the European Union. What do they know that the U.S. doesn’t? The drug is called Zilmax and it’s made by Merck & Co. Last year Merck […]
A newly published study involving 24,000 male Medicare patients given testosterone treatment has fuelled the ongoing debate about the risk-versus-benefit of testosterone therapy in men. In this newest study, the hormone reportedly did not increase the risk of heart attack and actually seemed to lower the risk by about 30 […]
Morcellator is a surgical instrument sold under the name of Gynecare Morcellex, Morcellex Sigma and Gynecare X-Tract, and which are used for division and removal of large masses of tissues during laparoscopic surgery. Morcellators are also used in minimally invasive surgery to perform hysterectomies and in the removal of uterine […]
The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued guidances are non-binding and only “represent the Food and Drug Administration’s current thinking […]
