We have a point of view. Our readers understand that we represent folks on the right side of the v., and our posts tend to read cases and legal trends with a pro-defense bent, although you can rest assured that we put a lot of thought into it. From time to time, however, we see
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…
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.
Today’s guest post is by Aggie Lee of Tucker Ellis, about a PMA preemption win that she briefed in California. The medical device is a hemostatic matrix, which is unusual, and this type of device isn’t usually targeted in product liability litigation. As is always the case, our guest posters are 100% responsible for their submissions, so Aggie deserves all the credit (and any blame) for what follows.
Judge Gonzalo P. Curiel in the Southern District of California has been in the national spotlight since then-candidate Donald Trump questioned his impartiality in the then-pending Trump University lawsuits. While now-President Trump might not number among his admirers, we like Judge Curiel’s recent contribution to Premarket Approval (PMA) preemption, where he recently dismissed with prejudice all of plaintiffs’ claims in Weaver v. Ethicon, Inc., No. 16CV257-GPC(BGS), 2017 WL 680725 (S.D. Cal. Feb. 21, 2017).
But it took a long time and many motions to get there, specifically four complaints, one personal jurisdiction-based motion to dismiss, and three preemption-based motions to dismiss. Defendant Ethicon, Inc., finally prevailed when the Court dismissed Plaintiffs’ Third Amended Complaint with prejudice.
Over the years, comedian Adam Carolla has played the “Germany or Florida” game on his various radio and tv programs and podcasts. The game is based on the observation that many of the most bizarre stories of human ineptitude come from Germany or Florida. Callers describe News of the Weird headlines, and Carolla and guests try to guess whether the events happened in Germany or Florida. You can listen to this segment from the old Loveline radio show.
Here are some examples of “Germany or Florida” clues:
- Man ate his dog.
- Carjacker forced to flee after realizing he could not drive a stick-shift.
- Trio shoots at imaginary foe, thereby attracting police to their homegrown meth lab.
- Naked swimmer hospitalized after angler hooks his penis.
- Man dies after blowing up condom machine.
- Sister assaults twin over sexy toy.
- Government creates blatant ex post facto law depriving tobacco companies of basic tort defenses.
Okay, you probably know about that last one. The answers to the others are below. By the way, Carolla is not alone in identifying The Sunshine State as also being The Sublimely Strange State. 30 Rock had a running gag about Florida craziness. See examples here. Also, Seth Meyers on the Late Show runs a “Fake or Florida” bit that can, at best, be charitably labeled as being derivative of Carolla’s gag. On last Sunday’s Last Week Tonight, John Oliver reported a story about a Florida man who planned to bomb Target stores up and down the east coast, with the idea of buying up Target stock on the cheap afterwards. After pointing out how the story involved home-made explosives, a big box store, and a terrible get-rich-quick scheme, Oliver noted that if the story also had a snake on meth, we would have full-on Florida Bingo.
Even before we earned our law license, we were aware that there is something … different … about Florida’s legal system. In our law school library, you could pull the 12 So. 2d volume off the shelf and it would automatically open up to the Lason v. State case, in which the Florida Supreme Court upheld the conviction of a 76 year old man for “abominable and detestable crimes against nature.” Some law school libraries have needed to insert photocopies of the Lason case after the original pages were worn out completely. Good times.
Last week there was a mini-eruption of Florida case law, and we will cover some of those opinions this week. It is not quite Shark Week for our blog, but it is close. Today’s case, Wolicki-Gables v. Doctors Same Day Surgery, Ltd., 2017 WL 603316 (Fla. DCA 2d Feb. 15, 2017), is unusual. The case is ostensibly about spoliation, but it is really about preemption and the dreaded parallel claim exception. Luckily, the case comes out the right way. But getting there was like doing a couple of laps on Mr. Toad’s Wild Ride. (You didn’t think you were getting out of this blogpost without at least one Disney World reference, did you?)
Mrs. Wolicki-Gables claimed a physical injury from a failed pain pump system. She and her husband initially sued the manufacturer of the pain pump, alleging causes of action for strict liability and negligence. The case was filed in state court, but was then removed to federal court. The pain pump system had received pre-market approval from the FDA. Because of that fact, and because of the Supreme Court’s decision in Riegel, the federal court held that the Wolicki-Gables’ product liability claims against the manufacturer were preempted by federal law. The Eleventh Circuit affirmed the summary judgment in favor of the manufacturer.
We’re serious – we’re not planning to give a flip answer like “an extortion racket.” No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?” (Hint – that’s discussed in Frigaliment Importing Co., Ltd. v. BNS International Sales Corp., 190 F. Supp. 116 (S.D.N.Y. 1960)). The…
Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”? Id. at 493. In the same vein:
“[S]ubstantial equivalence determinations provide little protection to the public. These determinations simply compare a post − 1976 device to a pre − 1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.”
Id. (quoting from pro-plaintiff law review article).
Most of our readers know that this characterization, assuming it was true for the 1980s-era (implanted 1987) device that the Court considered in Lohr, was no longer true, even at the time Lohr was decided, and certainly hasn’t been the case since the FDAAA was passed a year after Lohr was decided. Still, this anachronistic view of §510k has flourished for twenty years, affecting first preemption and now (thanks mostly to Mesh MDL rulings) admissibility of evidence.
That’s why we were interested in what the FDA had to say about today’s §510k clearance process in its recent memorandum entitled “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products,” which is available here. One of our guest bloggers, Liz Minerd, recently discussed the First Amendment aspects of that document, here.
It seems that we have posted hundreds of times about attempts to impose liability on the manufacturer of a PMA device that a doctor chose to use off-label. Recently, a bunch of those have involved Infuse. Cales v. Baptist Healthcare Sys., Inc., No. 2015-CA-001103-MR, 2017 Ky. App. LEXIS 10 (Ky. Ct. App. Jan.…
Some bloggers on this site have openly admitted to being swayed by the length of an opinion in choosing whether to blog about it. Shorter decision, shorter post. Less words, less work. In all honesty, a 56-page summary judgment opinion does tend to elicit a slight groan or at least an audible sigh. But sometimes, if you can manage to push through, you find that 16,000 words can be summed up very succinctly – preemption, preemption, preemption.
That’s not to say that the 15,999 other words in Babayev v. Medtronic, Inc., 2017 WL 90403 (E.D.N.Y. Jan. 5, 2017) are not important or interesting but there is a lot of case specific detail and a fairly lengthy recitation of preemption law, including the division among the circuits and within the Second Circuit as to the scope of implied preemption in the context of parallel violation claims. Id. at *14-20. We’ve covered this history in significant detail and anyone with even a passing familiarity with our blog knows well our feeling that the Eighth Circuit’s interpretation of the interplay between Riegel and Buckman gets it right – that there is only “a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape express or implied preemption.” In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010). Babayev goes on to lay out the split in the circuits on the issue of whether Current Good Manufacturing Practices (CGMPs) are specific FDA regulations on which a parallel violation claim can be based. Babayev, at *22-23. Again, we align with the Eighth Circuit’s conclusion that CGMPs, which apply to all devices, not just PMA-devices, are too general to give rise to a parallel violation claim. Rather, a parallel claim that survives preemption must be based on an alleged violation of a PMA, device-specific requirement. Id. at *22. While Babayev doesn’t go quite as far as the Eighth Circuit, it went far enough to reach the right result here – the federal violations alleged by plaintiff aren’t specific enough to warrant surviving preemption.
Babayev involved an implanted neurostimulator. Following surgery, a technician employed by the manufacturer assisted in testing the device and making sure it was functioning. As plaintiff prepared to leave the hospital he connected the device as instructed and received a shock that caused him to spasm and jump. Plaintiff did not fall. Id. at *6. The device was disconnected and plaintiff was sent home. He returned to the hospital in pain and the leads were removed. Over one week later it was discovered that plaintiff had a fractured hip which he alleged he suffered during the shock incident. Id. at *6-7.
This post is from the non-Reed Smith side of the blog.
We use products with warranties every day. There are warranties on frying pans, on light bulbs, on computers. We once saw a warranty on a pair of nail clippers that cost $1.49 that allowed the owner to send them in for repair or replacement as long as you included $3.00 for return shipping. What a bustling warranty department that company must have had. Generally speaking, we don’t pay much attention to warranties unless they are on big ticket items. If something goes wrong with your car, you’re scrambling to see whether it’s covered by a warranty. If a light bulb that’s supposed to last five years burns out in three, you most likely just toss it out and screw in a new one. You probably forgot how long it’s been since you last changed it anyway (speaking for this blogger at least).
Medical devices such as implantable spinal neurostimulators (guess what today’s case is about) don’t come with warranties of the kind alluded to above. You’re not going to see a provision on the labeling that says should this device break or malfunction within 3 years of implant, just send it back for a new one. There are many reasons for this, the most obvious of which is the device is inside someone’s body. Returning the device it isn’t always an option, because revision surgeries aren’t always the best option. Moreover, most product warranties talk about normal wear and tear or under normal conditions. There is no such thing as “normal” or “typical” when you are talking about inside the human body. There are simply too many unknowns for medical device manufacturers to guarantee their products.
But that doesn’t stop plaintiffs from including express warranty claims in their complaints. Typically the allegations in express warranty claims in drug and device cases are general statements that the manufacturer’s labeling and advertising represented that the product would be safe, effective, fit, proper, etc. When pressed for the actual representations that constitute the express warranty or for proof of reliance on such statements – well, that’s when plaintiffs’ express warranty claims often fall away. That’s because they don’t exist. And, that’s usually the focus of our discussion on express warranty. Occasionally, however, plaintiffs come armed with a little more specificity.