The Biomaterials Access Assurance Act of 1998 (or “BAAA”) comes up in our case searches only about once every year or two, but this 23-year-old law packs a punch as strong as its acronym is catchy. (See for example our posts here and here). Today’s post features another example of the power of this
This post is from the non-Reed Smith side of the blog.
We’ve posted on two other occasions about the Shuker v. Smith & Nephew case as the Eastern District of Pennsylvania systematically dismantled the case on the grounds of preemption and pleading deficiencies. You can find those posts here and here. Unfortunately, the recent…
This post is from the non-Reed Smith side of the blog.
Today’s case is no “mixed bag,” no cautionary tale. We don’t have to look for a silver lining or a rose among the thorns. Rather, Shuker v. Smith & Nephew, PLC, 2015 U.S. Dist. LEXIS 43141 (E.D. Pa. Mar. 31, 2015) is one of those cases that just keeps giving and giving and giving. We’ve got component parts, preemption, off-label use, failure to report, pleading deficiencies, and plenty of other small but delightful nuggets. So we’ll get straight to it.
In April 2009, plaintiff underwent a total hip replacement. Id. at *12. Plaintiff eventually had to have multiple revision surgeries to correct and alleviate complications from the original hip replacement. The lawsuit ensued alleging claims for (1) negligence/negligence per
se, (2) negligence based on violations of FDA regulations and FDCA provisions, (3) strict products liability, (4) breach of express warranty, (5) breach of implied warranties of merchantability, (6) fraud, and (7) loss of consortium. Id. at *39-40.Continue Reading A Jam Packed Hip Implant Case From the Eastern District of Pennsylvania
Last week we wrote about body part transplants. In legal terms, we asked whether body parts could be the basis of a product liability action. No, they cannot. In cinematic terms, we asked whether grafting a killer’s body part onto an otherwise good person can lead to mayhem. Yes, it can. At least that scenario…
Yesterday we blogged about Bertini v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS (E.D.N.Y. July 15, 2013) – a hip implant case that was dismissed because the court found the complaint woefully deficient. Keeping with the same subject matter, today we have another hip implant case, from a neighboring court, with another insufficient complaint, plus a positive preemption ruling. Sort of a variation on a theme.
In Simon v. Smith & Nephew, Inc., 2013 U.S. Dist. LEXIS 170413 (S.D.N.Y. Dec. 3, 2013), plaintiff also alleged that she was injured by implantation of the R3 Acetabular System. It’s important to the preemption discussion to know a little bit more about the device. The R3 System includes a liner component made of cross-linked polyethylene (non-metal). Id. at *6. The R3 System, with its non-metal liner, received §510(k) approval (“substantial equivalence”) from the FDA. Id. Defendant also manufacturers the Birmingham Hip Resurfacing (“BHR”) System — a separate PMA-approved device. The BHR System was designed to be used with a metal liner. As part of the BHR System, the metal liner also received PMA approval. Id. at *7. Plaintiff’s surgeon opted to implant the R3 System with the metal liner from the BHR System. Id. at *2.
Plaintiff alleged three causes of action: negligence, strict liability design defect, and breach of implied warranty. The court dismissed all three for roughly the same reasons. If the crux of plaintiff’s allegations are that her injury was caused by the R3 System as a whole – her complaint fails to state a claim. If she is alleging injury from the metal liner component alone – her claims are preempted.Continue Reading Hip Implant Litigation Part II – TwIqbal Plus Preemption
Every now and then, an administrative law decision – usually involving the FDA – contains something that’s useful to our product liability defense practices. In that light we offer Cytori Therapeutics, Inc. v. FDA, ___ F.3d ___, 2013 WL 1164775 (D.C. Cir. March 22, 2013). The device in Cytori was a §510k “substantial equivalent” device (for extracting stem cells from
fat), except that the FDA held that it wasn’t. And that was the whole point of the decision, as the aggrieved manufacturer appealed the FDA’s not substantially equivalent (“NSE”) letter in the courts.
For a discussion of the administrative law impact of Cytori, we refer you to the FDA Law Blog. We’re only interested in the case because an NSE letter is essentially the FDA’s administrative decision that, in order to be marketed, a medical device is required to go through the PMA process rather than through §510k clearance. As we all know, the PMA process is preemptive (Riegel), whereas the §510k clearance process is not (Lohr).
Plaintiffs in product liability cases often argue that this or that piece of a PMA-approved device system was already/should be treated as a §510k device, and thus preemption should not be recognized. That’s where Cytori can come in handy. Why? Because the DC Circuit holds that deference is to be afforded to FDA decisions determining whether medical devices require either PMA or §510k clearance.Continue Reading Interesting FDA Administrative Law Holding
The Biomaterials Access Assurance Act of 1998?
Why the heck are we writing about that now?
Well, first, it’s our blog; if we entertain no one else, at least we can entertain ourselves.
And, second, one of us recently received a call from a sophisticated in-house lawyer at a sophisticated drug or device…