The district court’s order dismissing claims in Ebrahimi v. Mentor Worldwide LLC, No. CV 16-7316, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017), is a good antidote to the Ninth Circuit’s wrongly decided opinion in Stengel v. Medtronic. Stengel is where the Ninth Circuit held that the plaintiff avoided express preemption by alleging
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Parallel Claims in PMA Medical Device Complaint Warrant Federal Question Removal
We were wondering when the courts would catch on to this Catch 22. In order to survive preemption, plaintiffs suing the manufacturers of pre-market approved (“PMA”) medical devices have to allege “parallel claims” in which all “common-law” claims must be genuinely equivalent to violations of FDA regulations. But under Grable & Sons Metal Products, Inc. …
Spoiler Alert: Florida Appellate Court Upholds PMA Preemption and Rejects Parallel Claim
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.Continue Reading Spoiler Alert: Florida Appellate Court Upholds PMA Preemption and Rejects Parallel Claim
New York Appellate Division Rejects Parallel Violation Claims Based on Off-Label Promotion
This post comes from the Cozen O’Connor side of the blog.
Last week, the New York Appellate Division upheld a preemption decision in a medical device case involving alleged off-label promotion. Pitkow v. Lautin, 2016 WL 2746469 (N.Y. App. Div. May 12, 2016). While the Appellate Division’s opinion was only three-paragraphs long, it affirmed the trial court’s ruling in every respect, making the trial court’s lengthier opinion that much more important. We obtained a copy, and here it is.
The plaintiff’s claims were based on complications that arose after her use of an injectable product, Sculptra, for cosmetic purposes, which was an off-label use. Plaintiff sued the doctors who injected her and the manufacturers of Sculptra. Among other things, she alleged that the manufacturers had improperly promoted off-label use of Sculptra.
After discovery, the manufacturers moved for summary judgment, arguing that all of plaintiff’s claims were preempted. The trial court agreed and, quite effectively, walked through the manner in which both Riegel and Buckman preempted plaintiff’s claims as well as the deficiencies of plaintiff’s attempts at parallel violation claims.
First up was Riegel preemption, since Sculptra was approved under the FDA’s PMA process:
Sculptra is a Class III medical device that was undeniably approved through the PMA process. What is more, all of the plaintiff’s claims against the [manufacturers] regard the safety and effectiveness of the device or require a finding that Sculptra’s design, labeling, and/or manufacturing process should have differed from that approved by the FDA via the PMA process . . . . Thus, the claims are preempted by the federal law.
Slip. Op. at 8-9.Continue Reading New York Appellate Division Rejects Parallel Violation Claims Based on Off-Label Promotion
Think Mink, part 2: Florida Federal Court Slams Door on Parallel Claims
Last November we blogged about “specialized” preemption issues in several cases, including Mink v. Smith & Nephew, Inc., 2015 WL 7356285 (S.D. Fla. Nov. 19, 1015). The plaintiff in Mink claimed physical injuries from a metal-on-metal hip replacement. What made the Mink case unusual was that the plaintiff had been a clinical trial participant. Thus, in addition to the usual product liability personal injury claims, the plaintiff also challenged the early termination from the clinical trial, calling it a breach of contract. The hip replacement system had made it through the FDA’s rigorous Pre-Market Approval (PMA) process, and the court dismissed the plaintiff’s claims because, as summarized in our deathless prose, “participation in post-approval clinical trials doesn’t provide any extra basis for a plaintiff avoiding Riegel preemption.”
The plaintiff was afforded an opportunity to amend the complaint, and did so by adding much specificity as to how the medical device allegedly deviated from manufacturing and regulatory requirements. The claims at issue were: (1) negligence, (2) strict liability, (3) breach of contract, and (4) misrepresentation. But the result was no different: the court still dismissed the claims. Check that; the result was different. This time the dismissal was with prejudice. That decision is Mink v. Smith & Nephew, Inc., 2016 U.S. Dist. LEXIS 32519 (S.D. Fla. March 11, 2016), and some of the court’s prose, as well as its reasoning, is pretty deathless, too.Continue Reading Think Mink, part 2: Florida Federal Court Slams Door on Parallel Claims
Parallel Claims – What Happens Post Surviving Preemption
Movie makers have been sharing their vision of post-apocalyptic worlds for decades now. They keep making them because we keep watching them. Arid landscapes, plague, squalor. The struggle between hope and hopelessness; between abandon and a belief that there will be a better tomorrow. The topic begs for epic movie treatment and there are quite a few good ones. Last year saw what many would consider one of the best in the genre – Mad Max: Fury Road. It won 6 Oscars for almost everything that assaults your eyes and ears in a film — costume design, makeup, sound editing, sound mixing, production design and film editing. But it is in no means the only post-apocalyptic film worthy of a couple of hours in the dark. Among some of the more recent entries in this film category The Road stands out not only as a fairly good novel adaptation but also for provoking the audience to think “what would you do?” There is also Children of Men dealing not only with the devastation of world war but with the extinction of humans from infertility. And if you haven’t seen Terry Gilliam’s Twelve Monkeys, well just shame on you. And, if this is all just a bit too heavy for your tastes, you can still enjoy the genre through the beautifully animated, heart-string pulling, Pixar’s WALL-E about a small waste-collecting robot left alone on Earth who ends up saving humankind. (We know we haven’t even scratched the surface, and haven’t mentioned Hunger Games, but you get the idea).
Continue Reading Parallel Claims – What Happens Post Surviving Preemption
Ghostbusters – Phantom “Parallel Claim” Exorcized by Generic Drug Preemption
With claims related to warnings, design, and recall all preempted, plaintiffs seeking to sue makers of generic drugs don’t have many options. After all, as we’ve discussed before, if state common law can’t require changing a defendant’s warnings, changing the design, or making the defendant stopping selling the product altogether, there’s not much left for a plaintiff to allege.
So, who ya gonna call?
One straw that generic drug plaintiffs have grasped at is the footnote in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), “not address[ing]” the issue of “parallel claims” – facially dictum about something not raised in Bartlett:
We do not address state design-defect claims that parallel the federal misbranding statute. The misbranding statute requires a manufacturer to pull even an FDA-approved drug from the market when it is “dangerous to health” even if “used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.” 21 U.S.C. § 352(j). The parties and the Government appear to agree that a drug is misbranded under federal law only when liability is based on new and scientifically significant information that was not before the FDA.
Because the jury was not asked to find whether new evidence concerning [the drug] that had not been made available to the FDA rendered [it] so dangerous as to be misbranded under the federal misbranding statute, the misbranding provision is not applicable here.
Id. at 2477 n.4 (other citations omitted).Continue Reading Ghostbusters – Phantom “Parallel Claim” Exorcized by Generic Drug Preemption
The District of New Jersey Holds That You Can’t “Discover” Your Way to a Parallel Violation Claim
This post is from the non-Reed Smith side of the blog.
Smith & Nephew, Inc. continues to push the plaintiffs out of court in a hip implant case pending in federal court in New Jersey. Earlier this year, Smith & Nephew won its motion to dismiss plaintiffs’ first complaint because it contained almost no facts and plaintiffs’ counsel opposed the motion with nothing more than a tardy letter attaching medical records, correspondence and no legal authority. See Becker v. Smith & Nephew, Inc., 2015 U.S. Dist. LEXIS 6853 (D.N.J. Jan. 20, 2015). We blogged about it here.
The court gave plaintiffs another chance, however, and plaintiffs took it. Things didn’t get any better. To quote Bugs Bunny’s sign from the classic Gashouse Gorillas episode: “Was this trip really necessary?” It wasn’t.Continue Reading The District of New Jersey Holds That You Can’t “Discover” Your Way to a Parallel Violation Claim
Far from Dumbo: M.D. Fla. Gets “Parallel Claim” Case Right
This is the time of year when our thoughts start migrating southward. We can see all those birds’ nests in our suddenly denuded poplar trees. The driveway is a skating rink of damp leaves. The baseboards in our home now gurgle from the operation of an ancient oil heating system.
Over the last two weeks our posts leaned against a pair of intemperate blasts from a Vermont federal court. The results were dreary and/or indecipherable. Thus, it is with some relief that we bask in the warm glow of a nice, straightforward decision from the happiest place on Earth, the federal court in Orlando. In Stanifer v. Corin USA Ltd, Inc., 2014 U.S. Dist. LEXIS 158587 (M.D. Fla. Nov. 10, 2014), a hip resurfacing system was implanted into the body of the plaintiff during a right hip arthroplasty procedure. Subsequent failure of the system allegedly caused the plaintiff to suffer a revision left total hip arthroplasty and surgical removal of the system. The plaintiff filed a lawsuit in state court seeking to recover “damages and losses” from the defendants based on state law strict liability claims for breach of warranty, manufacturing defect, and design defect. After removal of the action to federal court, the defendants moved to dismiss the claims based on federal preemption.
The hip system was a class III device, and therefore subject to the PMA process and the attendant federal preemption. After the Supreme Court’s decision in Reigel, a plaintiff injured due to use of a Class III PMA device can escape preemption only by asserting a “parallel” state law claim. As readers of this blog likely know, we think of the parallel claim exception as something crazy and made-up, like a fairy tale or a Johnny Depp movie. Luckily, the Stanifer case is governed by the law of the Eleventh Circuit, a place that knows how to deal with such things. The Stanifer court embraced Eleventh Circuit precedent to the effect that plaintiffs cannot effectively state a “parallel claim” absent allegations that the defendant violated a “particular federal specification.” Ah – we are far from the windy incoherence of Vermont (or Chicago – the Bausch case still stands as the babbling zenith of parallel claim doofus-prudence).Continue Reading Far from Dumbo: M.D. Fla. Gets “Parallel Claim” Case Right
How to Flunk the Bass v. Stryker “Parallel Violation” Claim Checklist
The Fifth Circuit’s decision in Bass v. Stryker allowing a parallel violation claim to survive a motion to dismiss based on allegations of violations of CGMPs earned an honorable mention in our worst decisions for 2012. The reason it wasn’t ranked higher is largely because the complaint in that case was fairly detailed and as we posted here provided a pretty good checklist of what a plaintiff has to have pleaded, under TwIqbal, to state an unpreempted manufacturing defect “parallel violation” claim:
- The identity of the particular product that the plaintiff claims caused injury;
- The nature of the claimed “parallel” violation (“the FDA had previously warned [defendant] of bioburden in excess of FDA regulations in its final rinse of the [device]”);
- That the violation could be causal in that it pertained to the plaintiff’s device (“after [plaintiff’s] surgery, [defendant] ultimately voluntarily recalled [the device], including the [device] specifically used in [plaintiff’s] implant”);
- The nature of the plaintiff’s injury;
- That the violation could be causal in that it bore a relation to the plaintiff’s claimed injury (“the lack of bony ingrowth is a known effect of an excess of bioburden and manufacturing residuals on [the device]”); and
- That the alleged violation be of a sufficiently specific FDA regulation (which could include a CGMP as applied to the device by particular specifications in the approved PMA).
Bass v. Stryker, 669 F.3d 501, 510, 511-12 (5th Cir. 2010).Continue Reading How to Flunk the Bass v. Stryker “Parallel Violation” Claim Checklist