(Note that this post comes from the Cozen O’Connor side of the blog.)
Good morning. Do you have your coffee? If so, start sipping it. You will need it. Because this morning we’re going to discuss leads for implantable cardiac defibrillators (“ICD”), Riata Leads to be precise. Now, while this may not be the most
Several years ago, in a post entitled “Negligence Per Se Trivia,” we included the following:
In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the FDCA) are prohibited. St. Luke Hospital, Inc. v. Straub, 354 S.W.3d 529, 534 & n.14 (Ky.
This post is from the non-Reed Smith side of the blog.
In our post earlier this week “No Causation, No ‘Parallel Claim’” we examined the enormous causation hurdle plaintiffs face in trying to prove a Stengel or Hughes type failure to warn claim in those jurisdictions where such a claim has been found
Put a New Yorker and a Californian in a room together and the debate will begin almost immediately. Hollywood v. Broadway. Atlantic v. Pacific. Dodgers v. Yankees or Giants v. Forty-Niners. Shake Shack v. In-N-Out (or is Five Guys overtaking both?). And more generally speaking that east coast/west coast divide extends beyond those two urban
This post originates from the non-Reed Smith side of the blog.
A federal judge in Texas recently ruled that Texas law does not allow a claim for negligence per se based solely on alleged violations of the FDCA or FDA regulations. Monk v. Wyeth Pharmaceuticals, Inc., 2017 U.S. Dist. LEXIS 72477, *21-23 (W.D. Tex
We’ve addressed sunscreen class actions here from time to time. The FDA regulates sunscreen as an OTC drug, and so these class actions can generate decisions of interest in areas of preemption and primary jurisdiction. For instance, we told you about, Gisvold v. Merck & Co., 62 F. Supp. 3d 1198 (S.D. Cal. 2014),
Back in October we posted about the Eastern District of Pennsylvania decision McLaughlin v. Bayer Corp, 2016 U.S. Dist. LEXIS 37516 (EDPA Mar. 22, 2016) saying that while we liked the ultimate result – tossing out most of plaintiffs’ claims – some pieces of the decision weren’t as strong as we would have liked. Well, McLaughlin’s back and it’s still not a slam dunk, but plaintiffs’ don’t have too much left of their cases either.
As a reminder, this is actually a decision in 5 cases each alleging injury from plaintiffs’ use of a Class III, PMA contraceptive device, Essure. McLaughlin v. Bayer Corp., 2017 WL 697047, at *1 (E.D.Pa. Feb. 21, 2017). Several of plaintiffs’ original causes of action were dismissed with prejudice, but they were given an opportunity to amend to try to salvage their claims for negligent training, negligent risk management, breach of express warranty, fraudulent misrepresentation, and negligent manufacture. Negligent misrepresentation and failure to warn premised on failure to report survived the first motion to dismiss.
The decision methodically goes through each cause of action.
Negligent Training: In its first decision, the court opined it was possible to state a parallel claim for negligent training, but since plaintiffs failed to specify how defendant’s training deviated from federal training requirements or how those deviations caused plaintiffs injuries, the claim had to be dismissed as insufficiently pled. Id. at *3. In the amended complaint, plaintiffs alleged 6 such failures by defendant. As to 3, the court couldn’t find any federal directive that required defendant to do what plaintiffs alleged it failed to do. So, as to those 3 allegations, the claim was dismissed as expressly preempted. Id. at *4-5. As to the remaining 3 alleged violations, defendant challenged them on causation grounds but was unsuccessful. The court found the complaint sufficiently alleged that because defendant failed to properly train the doctors, the doctors in turn did not properly place the device causing it to migrate and cause plaintiffs’ injuries. Id. at *5. The complaint, however, lacked any specific allegations about the actual doctors who performed plaintiffs’ surgeries. The court didn’t find that fatal at the pleadings stage – that was for discovery. Id. at *6. But if you look at what the 3 bases for the failure train claim are, they appear to all be things plaintiffs could have asked their doctors about before filing these lawsuits. Did the doctor successfully complete 5 preceptorings? Did the doctor read and understand the training manual? Did the doctor successfully complete the simulator training? If the answers to those 3 questions are yes in each case – this claim is over.Continue Reading PMA Preemption Revisited in Pennsylvania
One doesn’t see many new PMA preemption issues raised, but we found a case that does just that – Vincent v. Medtronic, Inc., 2016 WL 7374271 (N.D. Ill. Dec. 20, 2016). We are used to seeing plaintiffs try to use off-label use to circumvent PMA preemption. Just check out any of our Infuse posts to see how badly that has worked out for plaintiffs. They largely unsuccessfully have argued that if a product is used off-label, it is used for a purpose for which its PMA approval does not apply and therefore, the PMA requirements likewise don’t apply which plaintiffs contend means preemption should not apply. The courts have disagreed.
In Vincent, plaintiffs tried a similar end run around preemption. Plaintiff underwent surgical implantation of a pacemaker on February 12, 2004. The pacemaker lead used in the surgery was a Class III, PMA medical device. Shortly before plaintiff’s surgery, Medtronic had submitted the lead for supplemental pre-market approval. The approval was granted on March 10, 2004. Id. at *1. Ten years later, plaintiff had to undergo explant surgery due to a fractured lead and then filed a products liability suit. Id. at *2. In addition to standard claims based on failure to warn and design defect, plaintiff alleged that the lead had not received FDA approval at the time of the initial procedure, which was not disclosed to plaintiff or his surgeon. Id.Continue Reading A Twist on PMA Preemption
This post is from the non-Reed Smith side of the blog.
When we last talked about Shuker v. Smith & Nephew PLC, No. 13-6158 (E.D. Pa.), it was with high praise for the court’s decision tossing out almost all claims as preempted and any non-preempted claims for being inadequately pleaded. Our post on that decision is here. The court gave plaintiff a second chance to re-plead the non-preempted claims, which he did. Defendant again moved to dismiss and this time it was granted with prejudice. Shuker, 2016 WL 5461900 (E.D. Pa. Sep. 29, 2016).
Plaintiff underwent hip replacement surgery. For that surgery, plaintiff’s surgeon opted to use defendant’s R3 hip replacement system, but also used a component, the metal liner, from defendant’s BHR hip resurfacing system. Admittedly, an off-label use. Plaintiff suffered complications that required multiple revision surgeries. Id. at *3.
In its original decision, the court’s leave to amend went only to parallel claims based on allegations of off-label promotion. Id. at *1. Those claims were for “tortious misconduct based on off-label promotion” and fraud. Id. at *4. Plaintiff cites to a single press release to support his allegation that defendant “actively marketed” the metal liner as an option for the R3 system “in a way that led” doctors to believe the liner was a component of the R3 system and safe to use with the R3 system. Id.Continue Reading Hip Implant Off-Label Promotion Follow-Up
This post is from the non-Reed Smith side of the blog.
If you’re even remotely interested in the topic of preemption in Pre-Market Approved (PMA) medical devices that were used in an off-label manner, simply search this blog for our Infuse cases. There are dozens and almost all are complete victories for the defense. What occasionally survives are fraud or misrepresentation claims, although they have a tough time meeting the heightened pleading standard of Rule 9(b), or failure to warn claims where a court recognizes failure to submit adverse events to the FDA as parallel to a state law duty to warn physicians. As you’ll easily see from our prior writings, we don’t understand that parallelism at all.
The most recent Infuse victory strikes a blow at each and every attempt by plaintiffs to circumvent, dodge, sidestep, and elude preemption and pleadings standards. And with each by-pass blocked, plaintiffs’ claims had nowhere to go.
As a quick refresher, Infuse is a medical device used to stimulate bone growth in spinal fusion surgeries. It is a multi-component device that received FDA PMA approval for use in single-level, anterior, lumbar surgeries. Aaron v. Medtronic, Inc., — F. Supp.3d –, 2016 WL 5242957, *1-2 (S.D. Ohio Sep. 22, 2016). Aaron is actually a consolidation of the claims of several hundred plaintiffs who alleged they were injured by their surgeon’s use of the Infuse device in an off-label manner. Specifically, they allege the device was either implanted without all of its component parts, implanted posteriorly, implanted at multiple levels, or implanted in their cervical or thoracic spines. Id. at *2. Plaintiffs’ causes of action are fraud/misrepresentation, strict liability failure to warn, strict liability design defect, negligence, and breach of express and implied warranties. Id. Defendants moved to dismiss all claims on several grounds, including most predominantly preemption.
Before getting to the substantive analysis, the court had to consider what pleadings standard to apply. Wait. Isn’t it TwIqbal? What’s the issue? The answer is the Seventh Circuit decision in Bausch v. Stryker. The Aaron plaintiffs alleged that they did not need to plead the specific federal law or regulations that defendant allegedly violated because medical device products liability cases should have a “more permissive” review standard. Id. at *3. Plaintiffs got that idea from Bausch which held that particularity in pleading the specific FDA regulations violated was not necessary due to much of the “critical information” being kept confidential. Id. at *3-4. Many courts disagree with Bausch, including the Sixth Circuit which held in a non-medical device case that a “natural imbalance of information” does not warrant lowering Rule 8’s pleading standards. Id. at *4. The discovery process cannot be used to find sufficient factual support for plaintiffs’ pleadings after the fact. So, Aaron applies TwIqbal, not some watered down version (although the court does state that some of plaintiffs’ claims might not have withstood application of that lesser standard).Continue Reading Another Slam Dunk Infuse Win – Preemption and More