Last term, in a case that the Blog completely ignored, the Supreme Court held that a provision of the Medicare Act, 42 U.S.C. §1395hh(a)(2), required the Centers for Medicare & Medicaid Services (“CMS”) to subject all Medicare-related determinations “that establish[] or change[] a substantive legal standard” to formal notice-and-comment rulemaking. Such determinations explicitly include (as
Today’s case doesn’t involve prescription drugs or medical devices. But it is a circuit court opinion that we thought warranted bringing to the attention of our readers who deal with False Claims Act (“FCA”) claims. We’ve discussed FCA claims as an “awkward vehicle” in pharmaceutical cases here and we hold true to that belief. But,
Many things look good at first, and then not so much after you look closer. “As seen on TV” is never as good as “as seen in person.” On TV, the Sham WoW is like a shammy, a towel, a sponge. It cleans the house, the car, the boat, the RV. Why even think of
This post is about a hidden gem. That brings to mind a hiking trail that’s one of the two best in Pennsylvania (along with Ricketts Glen), but isn’t found in any of the “Fifty Hikes in [fill in the blank]” books that one finds in outdoorsy stores. The hike is part of the Appalachian
What follows is a guest post from Joe Metro and Andy Bernasconi of Reed Smith. Andy has some experience with the guest post gig (here and here), and Joe has finally heeded the call to share his fraud and abuse expertise with our readers. That particular expertise is not in abusing the legal
Private plaintiffs love to scream “fraud on the FDA”! Agency fraud is their magic potion for dissolving any FDA action that they don’t like. Just assert that the FDA was bamboozled and invite some jury somewhere to ignore what the FDA actually did. Unfortunately for the other side, Buckman Co. v. Plaintiffs Legal Committee,
We’ll be hitting all the Presidents’ Day sales today, but something tells me we’ll be disappointed because we won’t be able to buy, beg, borrow, or steal a new one. So we keep trying.
With plaintiffs desperate to find some way to continue pursuing aggravated, aggregated product liability litigation in their favorite venues after Daimler
We have always thought that the False Claims Act resides in some sort of alternate universe when it comes to pharmaceutical products. The central concept behind the FCA is easy: The FCA penalizes anyone who presents, or causes to be presented, to the federal government “a false or fraudulent claim for payment or approval.” 31
With Bexis having originally conceived the preemption argument that became Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), we are always on the lookout for ways in which plaintiffs attempt to circumvent Buckman’s result and thus to pursue private litigation over fraud on the FDA.
Plaintiffs love to claim fraud on
Our day job has been keeping us busy, so busy with depositions, motions, delayed flights, and assorted drama that we have not posted in more than a month. After such a long layoff, we had hoped to return with a vengeance, a “the North remembers” sort of vengeance. Instead, we get fair market value, Current