When our clients discover that their metal-on-metal (MoM) hip has failed and never went through U.S. Food and Drug Administration (FDA) approval for safety and efficacy, they ask – how did that happen? Most Americans do not understand that medical devices are largely unregulated, even for those devices that are […]
Author: Cal Warriner
An MDL (multidistrict litigation) was established for the prosecution of individual personal injury lawsuits against Biomet in the fall of 2012. The Judicial Panel on Multidistrict Litigation (JPML) heard attorney arguments on September 20, 2012, at a hearing in New York City. The plaintiffs requested consolidation of the pending lawsuits […]
A Florida grandmother has filed a complaint against the maker of the antidepressant Zoloft over a birth injury suffered by her grandchild. The lawsuit was filed November 28, 2012 in federal court in the Northern District of Florida, which is in Pensacola. According to the complaint against drug maker Pfizer […]
This study published in the December issue of Arthritis Care & Research is the first to look at the risk factors that could lead to a revision after a primary total hip replacement (THR). In the U.S. population, identified by Medicare claims from 29 states, patients who were younger, taller […]
Next spring, the U.S. Supreme Court will soon look at the very profitable policy called “pay for delay.” Profitability in this case extends primarily to both the brand-name manufacturers and generic drug makers at the expense of the consumer. Estimates are “pay for delay,” costs consumers an extra $3.5.8 billion […]
January first marks a new chapter for medical device manufacturers, who will be required to pay an excise tax of 2.3 percent on total revenues. Medical devices range from small stents and CT scans to pacemakers, defibrillators, metal hips and synthetic surgical mesh. The $125-billion-a-year industry complains it will be […]
A British Columbia court has agreed to allow a class-action lawsuit to proceed and to be headed by the case of an infant born with a hole in her heart after her mother took the antidepressant Paxil (paroxetine). The mother, Faith Gibson, is suing GlaxoSmithKline Inc. (GSK), the maker of […]
Almost no one believes it’s easy to quit smoking, so when the drug Chantix hit the U.S. market in May 2006, some smokers breathed a sigh of relief they had finally found a way out from the grip of cigarettes. Chantix works by blocking the pleasant effects of nicotine on […]
Johnson & Johnson (J&J) is fighting a patient lawsuit and seeking to have it dismissed on the grounds that the company did warn patients of the potential for metal erosion and the need for revision surgery. This California case was filed by plaintiff Loren Kransky in December 2010, just after […]
The U.S. Food and Drug Administration announced this week it has formed a collaboration with medical device manufacturers in order to speed up the development and approval of devices. The nonprofit group is called the Medical Device Innovation Consortium (MDIC) and is made up of industry, academics as well as […]
