Category — FDA Approval

Jan. 26, 2012 – On Wednesday, January 25, the Fourth Circuit affirmed a West Virginia federal court’s decision dismissing a claim involving a Class III, FDA-approved Medtronic SynchroMed pump on grounds it was preempted by the express preemption provision of the 1976 Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetics Act.  The case is  Walker v. Medtronic, Inc., No. 10-2219 (4th Cir. Jan. 25, 2012). [Read more →]

[This post comes to us from Diane Romza-Kutz , Robert E. Browne, Jr., John F. Costello, Jr. and Matthew M. Morrissey of Troutman Sanders' Life Sciences Practice Team.  We thought it might be of interest to our readers.]

Sept. 12, 2011 -  The recent furor in the medical device industry over a new recommendation that the U.S. Food & Drug administration abandon its approval process for medical devices has prompted a new round of public meetings and comment. This provides a critical opportunity for the medical device industry to comment on these potential new hurdles to market entry. [Read more →]

Aug. 3, 2011 -   Intelliject, Inc., a Richmond-based specialty pharmaceutical firm that develops drug/device combination products, announced earlier this week that it has received tentative FDA approval for its lead product, the “e-cue.”  The e-cue is a credit card-sized epinephrine auto-injector device used to treat severe allergic reactions, such as those experienced by persons with bee allergies.  Those of us born or with children born in the ‘80’s certainly know how useful this portable device would have been to Martin Short’s character, Eugene Proctor, in the 1991 movie “Pure Luck.” [Read more →]

[This post comes to us from Diane Romza-Kutz and Seth Erickson of Troutman Sanders' Life Sciences Practice Team.  We thought it might be of interest to our readers.]

July 16, 2011 -  On June 14, 2011, the U.S. Food and Drug Administration (the “FDA”) issued new regulations for sunscreens currently sold over-the-counter (“OTC”) (i.e., without a prescription). The new regulations, which become effective June 18, 2012, establish labeling and testing requirements for OTC sunscreen products containing specific ingredients, or combinations of ingredients, and marketed without an approved application under section 505 of the Federal Food, Drug, and Cosmetic Act (the “Act”). [Read more →]

June 24, 2011 -    I love a good British comedy, and few are better than Monty Python And The Holy Grail.  One of my favorite scenes is “Bring Out Your Dead,” in which John Cleese’s character attempts to put a nearly deceased, elderly man on the “death cart”, while the elderly man cries out “I’m not dead yet….I’m getting better.”  Unfortunately for the old man, as he breaks into cries of “I feel happy…I feel happy,” the scene ends with the mortician, played by Eric Idle, clubbing him over the head to expedite his passing.

Why is this morbid scene on my mind this morning?  Naturally it is because of yesterday’s U.S. Supreme Court decision in Pliva v. Mensing, 131 S. Ct. 2567 (2011), which proves that preemption of prescription drug failure to warn claims based on “impossibility” is indeed not dead yet, even in the wake of the Supreme Court’s 2009 decision in Wyeth v. Levine, 555 U.S. 555, 129 S. Ct. 1187 (2009). [Read more →]