Source: http://newslawonline.blogspot.com/2015/12/
Timestamp: 2019-04-24 19:01:25+00:00

Document:
Here are our Honorable Mentions: (11) Shepherd v. Vintage Pharmaceuticals, LLC, ___ F. Supp.3d ___, 2015 WL 6956767 (N.D. Ga. Nov. 4, 2015). Plaintiffs don’t dare bringing personal injury class actions against prescription medical products much anymore. Shepherd is a timely reminder why that’s true. We blogged about denial of class certification here. (12) In re Accutane Litigation, 2015 WL 1504304 (N.J. Super. Law Div. April 2, 2015). The court’s ruling that the drug’s warnings were adequate as a matter of law pretty well shut down this long-running litigation, as discussed here and here. (13) PomWonderful, LLC v. FTC, 777 F.3d 478 (D.C. Cir. 2015). The First Amendment applies to the FTC, too, and truth is not to be judged by the FDA’s “substantial evidence” test. We celebrated another appellate free speech win here. (14) Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), and Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 5836973 (S.D. Ohio Oct. 2, 2015). These twin decisions would have ranked higher, except that Yates stole some of their thunder. Rheinfrank I was a relatively rare finding of preemption against plaintiff’s most dangerous warning claims under the Levine (2009-1), as well as some useful state-law (Ohio) rulings. Rheinfrank II added design defect preemption. We discussed Rheinfrank here, and Rheinfrank II here. (15) Johnson v. Smithkline Beecham Corp., 2015 WL 1004308 (E.D. Pa. March 9, 2015). How many of us – particularly in mass tort litigation – have thought that many of the plaintiffs’ cases are so patently weak as to be frivolous and sanctionable? In this case, the court granted sanctions, based on the statute of limitations and product identification. We never blogged on this case because of Reed Smith’s involvement in the litigation, but it merits an honorable mention. (16) In re Testosterone Replacement Therapy Products Liability Litigation, 2015 WL 6859286 (N.D. Ill. Nov. 9, 2015). TRT deflated the last-ditch generic plaintiffs’ argument that generic drugs that did double duty as FDA reference listed somehow lost the protection of preemption. We got a rise out of that, here. (17) Shuker v. Smith & Nephew, PLC, 2015 WL 1475368 (E.D. Pa. March 31, 2015), certif. for appeal denied, 2015 WL 4770987 (E.D. Pa. Aug. 13, 2015). Component parts, off-label use, failure to report – you name it, plaintiffs threw it at PMA preemption – without success, as we discussed here. (18) Mink v. Smith & Nephew, Inc., ___ F. Supp.3d ___, 2015 WL 7356285 (S.D. Fla. Nov. 19, 2015), the FDA has increasingly conditioned its approval of a product on the manufacturer conducting post-approval clinical trials. Does participation in such a trial avoid preemption. Fortunately, as a matter of first impression, Mink said “no” – a result we liked, here. (19) Latimer v. Medtronic, Inc., 2015 WL 5222644 (Ga. Super. Sept. 4, 2015). Believe it or not, the best reasoned trial court-level Infuse decision anywhere might just be state trial judge’s opinion from Bexis’ home town of Atlanta, Georgia. Read it and marvel, here. (20) In re Actiq Sales & Marketing Practices Litigation, 307 F.R.D. 150 (E.D. Pa. 2015). Nationwide third-party payer class action alleging state-law causes of action. While denial of certification is the rule, this opinion is jam-packed with the defense-side goodies that we detailed here.
Looking over our 2014 lists, we’re pleased that our number one bad decision, Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala. 2014) (2014 -1), was erased by the legislature before that opinion even had time to receive a reported citation. Unfortunately, courts arrogate to themselves authority to change law retroactively while refusing that power to legislatures, so there could still be some Weeks-governed stragglers.
All the other bad boys from 2014 still survive, although Lance (2014 -2) is menaced by Bartlett (2013 +1) preemption. Discretionary review in Hardin (2014 -5) and Scott (2014 -7) failed.
Our entire roster on the plus side of the 2014 ledger is intact, although as we mentioned last week Corber (2014 +4) was a victim of drive-by distinguishing by a subsequent panel. On the other hand, the preemption result in Booker (2014 +7) was effectively affirmed by Yates.
Looking ahead, the California Supreme Court in Bristol-Myers-Squibb will eventually rule on personal jurisdiction post-Bauman – almost certainly a top- or bottom-ten case depending on result, with an eventual appeal to the United States Supreme Court likely, again regardless of the result. United States Supreme Court certiorari petitions are currently pending in this year’s POMWonderful (good) and Reckis (bad). Guvenoz may join them, the Illinois Supreme Court having denied review, but the Supreme Court has turned down all post-Bartlett generic preemption (including Pennsylvania (2014 -4) and Iowa (2014 +3)) to date. Other cases almost sure to land on our top- or bottom-ten list for 2016 Cisson v. Bard, currently pending in the Fourth Circuit, on the issue of admissibility of FDA §510k clearance, and the Arizona Supreme Court’s review of Watts (2105 -6), concerning the learned intermediary rule.
Finally, on the administrative front, as we predicted, the FDA’s proposal to change the rules to eliminate generic drug preemption got nowhere in 2015. It’s now not even scheduled to be finalized administratively until July, 2015, at the earliest. Given the legal hurdles that await after a final rule, frankly, we don’t expect it ever to go into effect. We’re a lot less certain what will happen with the FDA’s proposal (discussed here) to amend the “intended use” regulations that it has used to prohibit truthful off-label promotion. Here’s hoping the Agency is forced to confront First Amendment issues so that, assuming this rule is finalized, the validity of the FDA’s ban can likewise be challenged directly via appeal from the Agency’s final rule.
So now we’re done with 2015. All in all, a pretty good year. We wish a Happy New Year to all our readers, especially to those on the right side of the “v.”.
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We are determined not to end 2015 on a bad note. Thus, we turn, as we do with surprising frequency (and as we did last week), to a federal court decision out of Mississippi for a heaping helping of solid legal reasoning. The case is Estes v. Lanx, Inc., 2015 U.S. Dist. LEXIS 171184 (N.D. Miss. Dec. 23, 2015), and the court got everything right. The case involves the usual panoply of product liability claims against a spinal fixation system. After a surgery on the plaintiff in 2011, two pedicle screws fractured. A revision surgery was performed in 2012. The plaintiff then sued, claiming that the pedicle screws were negligently designed or manufactured, that the defendant breached warranties as to the pedicle screws, and that the defendant had failed to obtain FDA clearance for the spinal fixation system.
Mississippi has a Products Liability Act (the MPLA) that supplants common law claims, such as negligence or negligent misrepresentation. We wish every state enacted a product liability act. In fact, we wish every state enacted the MPLA. The MPLA requires a design defect claim to suggest a feasible alternative design. The plaintiff offered no such alternative design, so that theory was dismissed. The manufacturing defect and failure to warn claims also foundered, though there were wrinkles to those claims, and the court’s ruling on those wrinkles made the decision even better.
The plaintiff’s amended complaint alleged that the “Pedicle Screws are not made in accordance with the defendants’ [sic] specifications or performance standards.” But the plaintiff never stated how the pedicle screws at issue deviated from manufacturing specifications. Nor did the plaintiff reference any manufacturing specifications at all. Rather, the plaintiff was reduced to arguing that the mere proof of malfunction created a genuine issue of material fact as to a manufacturing defect under the MPLA. Unfortunately for the plaintiff, Mississippi law says no such thing. There needs to be proof of an actual manufacturing defect. At this point, the plaintiff fell back on an accusation of spoliation, alleging that the defendant should have collected and maintained the broken pedicle screws after their removal. But remember what John Adams said about facts being stubborn things. It was undisputed that while the screws were not recovered after surgery, they had not been destroyed by the defendant or any of its representatives. Because there was no genuine issue of material fact as to bad faith on the part of the defendant, no spoliation instruction was warranted, and because there was no evidence of manufacturing defect, the manufacturing defect claim was dismissed.
On its own initiative (which we applaud), the Estes court raised the issue of whether the plaintiff’s claim that the spinal fixation system had not received proper FDA 510(k) clearance was foreclosed by Buckman. The court’s brief discussion of this point makes our flinty defense hearts warm and our minds optimistic. The court asked for further briefing as to whether federal law impliedly preempts the causes of action based on the propriety of submissions to the FDA. It is hard to see how the plaintiff wriggles out of that problem, particularly with a smart judge reading the briefs.
Finally, the breach of warranty claims also got consigned to the dustbin. There was no evidence of any express warranty being made to the plaintiff, or that the plaintiff relied on any such warranty (including whether the spinal fixation system had been properly cleared by the FDA). Lack of reliance also eliminated the claim for breach of an implied warranty of fitness for a particular purpose. Finally, the claim for breach of implied warranty of merchantability was dismissed because there was no proof that the plaintiff had attempted to contact the defendant when it was discovered that the pedicle screw was broken, or that the defendant had been afforded an opportunity to cure. Mississippi is a state that follows warranty law to the letter.
Thank you Mississippi, land of Faulkner, Viking ranges, great ballet, Manning football stars not named Peyton, and lovely product liability decisions.
We are no strangers to odd facts leading to odd results. The law develops in response to situations. When new or different situations arise, courts have to interpret the existing law and then apply it to the new circumstances. Usually the changes evolve over time – a twist here, a turn there. Legal precedent is hardly ever a straight line. There are even a few right angle turns and the occasional u-turn. Sure, there are a few straightaways as well – concepts so deeply rooted as to withstand almost any challenge. But more often than not, when there is a true dispute, it’s about those twists and turns. The places where authority is split or where the precise issue has yet to be dealt with. And when you have both unique facts and split authority – you get decisions like Raab v. Smith & Nephew, Inc., -- F.Supp.3d --, 2015 WL 9026631 (S.D.W.Va. Dec. 15, 2015).
Plaintiff underwent a hip resurfacing surgery in which defendant’s PMA, Class III medical device was implanted. Due to a fracture of the device, a revision surgery was needed during which some of the PMA device components were replaced with Class II, §510k cleared components. Plaintiff suffered complications after that surgery as well and eventually underwent a third surgery where all of the defendant’s devices were removed. Id. at *1.
Recognizing that she would be facing a preemption challenge to any allegations concerning the PMA device, plaintiff broke her complaint into three sections. Section I focused exclusively on the first surgery and purported to allege parallel violation claims premised on the FDCA’s Current Good Manufacturing Practices (CGMPs). Section II focused on the revision surgery and off-label use/promotion allegations. Id. at *2. Section III was directed only at the Class II device that was inserted during the second surgery and alleged strict products liability, breach of implied and express warranties, and failure to warn. Id. at *3.
The Raab decision is long and thorough. It devotes pages to discussing the FDCA, pre-market approval and 510k clearance. It also contains a detailed discussion of the core preemption decisions – albeit slightly skewed in our opinion. It is in the application of that precedent where things get a little wonky.
Explicitly conferring enforcement of this judgment-laden standard upon the Secretary alone establishes, we think, that Congress wanted to make the agency remedy that it provided exclusive, thereby achieving the expertise, uniformity, widespread consultation, and resulting administrative guidance that can accompany agency decisionmaking, and avoiding the comparative risk of inconsistent interpretations and misincentives that can arise out of an occasional inappropriate application of the statute in a private action.
Armstrong, 2015 WL 14194231, at *5. The Supreme Court has spoken -- vague statutory provisions coupled with an express administrative remedy, precludes private enforcement in the courts.
The discussion of these CGMP claims gets even more muddled when the court adds to the equation (a) a malfunction theory (because the device failed it must be defective); (b) negligence per se (pushing aside Buckman implied preemption), Raab, 2015 WL 9026631 at *13; and (c) a disregard for TwIqbal. As to TwIqbal, the court’s reasoning seems to mirror it’s feelings on the CGMPs – general and non-specific is fine to withstand a motion to dismiss and allow the plaintiff to get to discovery. But this ignores that the TwIqbal plausibility standard is a factual sufficiency standard and that the Supreme Court has said that Rule 8 “does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions.” Ashcroft v. Iqbal, 129 S. Ct. 1937, 1950 (2009).
The ultimate holding of Raab on preemption as to the PMA device is that a claim that the FDA-approved design was defective is preempted but plaintiff is given leeway on the claims that the defendant failed to comply with the CGMPs. Id. at *15. See id. at *20n.1 (“This Court determines that the plaintiffs’ first two claims for relief are not preempted only to the extent they allege noncompliance with federal regulations and the FDA approval process.”).
Section II of plaintiff’s complaint focused on plaintiff’s doctor’s decision to revise her surgery using some Class II medical device components – in other words, off-label use. Plaintiff’s first claim was that defendant failed to file a PMA supplement seeking approval for the way the device was utilized by her surgeon. Here the court got it right – the FDA does not regulate the practice of medicine. Id. “Accordingly, to the extent the plaintiffs seek to impose liability on the defendant based on [her doctor’s] off-label use of the BHR system, they seek to impose a requirement that is in addition to any provision of federal law and are expressly preempted from doing so.” Id.
What all of these these asserted violations have in common is an allegation that the defendant was negligent because it failed—in unspecified ways—to market its product in accordance with statutory provisions that merely empower the FDA to impose regulations of its choosing on devices it chooses to define as “restricted.” Critically though, Plaintiffs do not allege that any of the devices at issue were actually classified as restricted devices under § 360j(e), nor do they specify any regulation or restriction enacted by the FDA under any of the cited statutory provisions and made applicable to any device manufactured by the defendant.
Id. at *17 (plaintiff’s off-label promotion claim “fails to create an inference that any federal law was violated because it does not identify any substantive federal requirement made applicable to any device at issue). This is what we mean when we say odd facts make for odd law. Here it seems to have led to a split in authority within the decision. We won’t quibble with the second ruling.
That brings us finally to Section III – straight state law claims against the Class II devices used in the revision surgery. As to strict liability design defect, the court once again relied on the malfunction theory to allow plaintiff’s claim to proceed beyond the pleadings stage. Id. at *18. The court likewise and not surprisingly allowed the failure to warn claim to stand as well. Id. On her breach of warranty claims, the court ruled that an implied warranty of merchantability claim is co-extensive with the design defect claim and therefore allowed for the same reasons. Plaintiff’s claim for breach of implied warranty of fitness for a particular purpose was dismissed because plaintiff failed to allege a particular purpose that differed from the device’s ordinary purpose. Id. The court also dismissed the express warranty claim because plaintiff failed to allege any representations as to quality made to her or on which she relied. Id.
So, if you tally everything up – plaintiff can take some discovery on the alleged CGMP violations but she can’t use them to sustain a challenge to the FDA-approved design of the PMA device and her design defect and failure to warn claims regarding the 510k cleared device remain. While there’s quite a bit of reasoning and language in this decision we could live without, the overall holding isn’t horrendous. And that’s about as far as we’ll go on this one.

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