A considerable amount of buzz has surrounded the use of 3-D printing technology lately. Forbes magazine recently reported on Wall Street investors’ increasing interests in 3-D printing companies and the anticipated growth of the industry. Medical science has also reported stories of lives being saved or improved by the use of 3-D printed medical devices. In one case, the life of a 3-month old boy with a rare bronchial condition was saved by the use of a 3-D printed stent. Other medical devices that have been manufactured using 3-D printers include prosthetics, skull implants, and hearing aids.
We have previously discussed the role of the U.S. Food and Drug Administration (FDA) and its oversight of medical device and pharmaceutical products. With so many stories in the news about food and drug dangers, consumers need to understand the function of the FDA and how it works to protect them.
Health care products giant Johnson & Johnson has made headlines recently due to a series of concerns and investigations into its marketing practices for drugs and medical devices. Johnson & Johnson disclosed to its shareholders in its most recent quarterly earnings report that a federal investigation is currently underway regarding its marketing practices of the antibiotic Doribax and the sinus device Relieva Stratus MicroFlow Spacer.
by: Edward B. Mulligan V , Attorney
On Friday August 10, 2012, the United States Court of Appeals for the Sixth Circuit overturned a district court’s decision to dismiss the claims filed by Rachel Krumpelbeck in a product liability suit against Breg, Inc., a manufacturer of pain pumps and other medical devices.
Like hundreds of others in the pain pump litigation, Ms. Krumpelbeck’s claims arose out of her use of Breg pain pump following arthroscopic surgery. Ms. Krumpelbeck’s surgery occurred in March 2005, when she was just seventeen. Pain pumps were designed–as an alternative to conventional narcotics–to manage post-operative pain by continuously injecting local anesthetic directly into a patient’s shoulder joint.
by: David B. Allen, Attorney
The following is an excerpt from an article written for Indiana Trial Lawyers Association Verdict publication. The full article can be found in the June 2012 edition of Verdict.
Litigation is pending around the country against manufacturers of transvaginal mesh implants that were used to repair the condition of pelvic organ prolapse (POP). Many women suffered great harm by these untested and unsafe products. For the period 2008 to 2010, the most frequent complications reported to the FDA from the use of surgical mesh devices for POP repair included vaginal mesh erosion, pain, infection, urinary problems, bleeding and organ perforation.
Rarely does a month go by without a pharmaceutical or medical device company making headline news for illegal marketing or failing to disclose dangerous side effects of its products. Many times the conduct is so egregious you are left wondering how a drug or device even made it to the market in the first place. Surely the Food and Drug Administration (FDA), the worldwide regulatory “gold” standard, would not have approved a product that was bad for us? Conventional wisdom tells us that the FDA is the gatekeeper for our safety. The FDA monitors and tests all products so its rubber stamp of approval must be absolute proof that consumers are safe? Unfortunately, this is an example where perception varies greatly from reality.
People generally assume that because someone is a lawyer, they must know about every area of law. While lawyers might have a basic understanding of multiple areas of law, asking a tax lawyer about class actions and mass torts, is the equivalent of asking a pediatrician about brain surgery. While the paths of class actions and mass torts may cross paths, they are separate and distinct legal proceedings. People often, understandably, confuse the two.