When you suffer from a chronic headache over a period of a couple of days or experience lingering pain after an injury, your first thought may be to pop open that bottle of Tylenol to alleviate the pain as quickly as possible.
The Food and Drug Administration's decision last week to revoke the approval of a popular drug used to treat breast cancer has caused a great stir amongst patients, cancer specialists and advocacy groups in the U.S.
In our last post, we discussed a potentially dangerous drug manufactured by Medtronic called INFUSE. A June review of the original safety studies of INFUSE, a biologic bone growth product, suggested that those Medtronic-funded studies, which formed the basis for approval of the drug, may have significantly underestimated INFUSE's potential risks, including an increased risk of cancer for some patients.
In 1992, Medtronic Inc., the world's largest medical device manufacturer, received FDA approval for a device called INFUSE, which is used to promote bone growth after spinal fusion surgery. The genetically engineered bone graft product has since become one of Medtronic's top-selling products, with sales of $700 million a year.
Last week, our Fairfield pharmaceutical products law blog discussed the $3 billion settlement that was announced on Nov. 3 between the U.K.'s largest drugmaker, GlaxoSmithKline, and the U.S. government. The settlement was reached after more than a decade of investigations into whether or not the drugmaker illegally marketed its drugs including Avandia, which was one of the company's most profitable drugs.
In 2007, a 20-year-old college student died after suffering from a diabetes-related illness. Prior to his death, the student had been taking an antipsychotic drug called Zyprexa. The parents of the young man later filed a lawsuit against drugmaker Eli Lilly and Co., claiming that the company failed to properly warn consumers about the dangerous side effects of the drug and the risk of developing diabetes from using the drug.
It was not uncommon for pharmaceutical companies to misrepresent their drugs in marketing campaigns during the 1990s and early 2000s. As a result, the U.S. government has been going after drugmakers for several years to hold the companies liable for not being honest with patients and consumers about the benefits and side effects of prescription drugs.
As we have discussed in previous posts on our Fairfield pharmaceutical products law blog, companies do not always follow best practices or exercise caution when designing and manufacturing new medical devices to be used by consumers. As a result, a flaw in the design of a medical device could result in the product not working properly, potentially causing its user to suffer serious harm or death.