Based on new documents uncovered within the bowels of the Food and Drug Administration (FDA), researchers at Harvard University have joined voices with many FDA watchers to conclude the way most medical devices make it to market does nothing to assure patient safety. Specifically, the researchers were looking at how […]
Category: Articles
Shareholders have sued the maker of a surgical robot claiming the company has “grossly underreported” injuries and deaths attributed to the da Vinci. The 67-page shareholder derivative complaint was filed by the city of Birmingham and Alabama’s Relief and Retirement System naming Intuitive Surgical of Sunnyvale, California, the maker of […]
The U.S. Attorney General’s office says it is reviewing an open letter submitted by a consumer group encouraging a criminal probe into the destruction by Johnson & Johnson (J&J) of pelvic mesh litigation documents. That announcement comes after Corporate Action Network (CAN) asked Eric Holder Jr. to explore how and […]
Yesterday afternoon, Congress’s Subcommittee on Health held a hearing to examine the FDA’s proposal to change the rules of generic drug labeling. Under the current law, enacted in 1984, warning labels for particular drug formulations are created by the brand-name manufacturers, and generic manufacturers are legally prevented from altering them. […]
Johnson and Johnson (J&J) and its subsidiary Janssen Pharmaceuticals have been dealing with multiple lawsuits stemming from its drug Risperdal. Shortly after dodging a $1.2 billion judgment in Arkansas, J&J has returned its focus to the multidistrict litigation (MDL) currently pending in Pennsylvania. The company is now trying to shield […]
The Wall Street Journal reports on conflict of interest disclosures that have evolved as a result of transvaginal mesh (TVM) lawsuits filed against healthcare giant, Ethicon, a division of Johnson & Johnson. Amid the hundreds of thousands of pages of documents provided in the 17,000 cases filed in federal court […]
Doctors and physicians are given a great deal of discretion when it comes to prescribing drugs for uses other than those indicated by the FDA. This is known as “off-label” use. The FDA, realizing the danger of off-label promotion in its 2009 guidance, has set forth rules to restrict the […]
While it is not official, Bloomberg is reporting that Coloplast A/S, one of the smaller manufacturers of transvaginal meshes, is said to be willing to settle a number of lawsuits for $16 million. Three different individuals tipped the news outlet, but none were reportedly authorized to speak. The Danish company […]
A federal report issued by the Centers for Disease Control and Prevention (CDC) indicates that extensive prescribing of antibiotics is at least partially responsible for the development of C. diff (Clostridium difficile), an antibiotic-resistant bacterial infection also known as a superbug. C. diff infections affect about 250,000 patients every year […]
It is a supplement used to treat children with a genetic disorder but instead has hospitalized at least one child. The Food and Drug Administration (FDA) reports lots of L-citrulline, sold by Medisca, had none of the active drug. The Plattsburgh, N.Y.-based compounding company was forced to recall eight lots […]
