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 […]
This news is putting a scare into the pharmaceutical cosmetics industry. The U.S. Food and Drug Administration (FDA) has written a warning letter to more than 350 medical practices about a bogus Botox that may have come from a foreign source distributed through Canada. The product may be contaminated, counterfeit, […]
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 […]
Texting takes concentration, whether you are behind the wheel of a car or walking down a busy street. And a new study of Seattle pedestrians finds many are putting their lives in danger by distracted walking. About 60,000 pedestrians are injured by cars every year and 4,000 are killed so […]
In a court decision that could open the floodgates for drug promotion, an appellate court has thrown out the conviction of a drug salesman who promoted a drug for off-label use citing his free speech rights. Alfred Caronia worked for Orphan Medical where he sold the narcolepsy drug Xyren. He […]
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 […]
Once again we are reminded how money talks and drug companies will do whatever it takes to sell their product, even if it is illegal, not to mention unethical. The state of Maine is the latest state expected to receive in excess of $1.2 million from GlaxoSmithKline LLC (GSK) over […]
By the end of the year, the U.S. Food and Drug Administration (FDA) had stated it would make sure that high-risk medical devices were approved through the most stringent premarket approval (PMA) review process to assure the safety of consumers. But it looks as though that will not happen. High-risk […]
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 […]
