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 […]
In 2011 Endo Health Solutions bought American Medical Systems for $2.9 billion. That may have been a mistake because since then, the number of product liability lawsuits naming AMS over its transvaginal mesh has grown to 22,000 cases. Now the company is looking ahead to the impact on its bottom […]
In the production of pharmaceutical drugs there are large scale drug manufacturers which produce brand name and generic drugs, and there are compound pharmacies which are specialty pharmacies made to fill out unique orders for clients using already existing medications. Drug manufacturers fall under FDA standards and regulations, while compounding […]
General Motors has received reports of 13 deaths caused by an ignition-switch failure. GM’s Chief Executive says she is sorry. Mary Barra, who took over the Detroit-based company in January, told Reuters the company will initiate a recall which will “take time to play out” and that GM will cooperate […]
Generic drugmakers are increasingly becoming more frightened of the threat of products liability lawsuits because of a proposed rule that would require them to change their labels if the company receives new safety information about the drug. These label changes would overturn a three decade old regime of prohibiting generic […]
In 2009, the U.S. Supreme Court in Wyeth v. Levine held that brand-name drug manufacturers are responsible for their warning labels and may be liable for not adding additional warnings when new risks are discovered. However, in 2011, the Supreme Court held that failure-to-warn claims brought against generic drug makers […]
The boy was just 10-years-old and he wanted a male rat to join his female pet rat. Petco was the nearest pet store and grandma bought the rat companion. But when Aiden Pankey got the rat home, it bit him. Aidan died June 12, 2013 from a bacterial infection, allegedly from the […]
