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We don’t often write about statutes of limitations because the cases tend to be fact bound and not all that illuminating on larger points of law and/or practice.  However, a case in California struck a chord with us recently because it highlights a point that we think every litigator should understand:  Tolling agreements should not and typically do not revive already-stale claims, and they should be drafted to leave no ambiguity about that specific point.  As the lawyers demonstrated in Rustico v. Intuitive Surgical, Inc., No. 18-cv-02213, 2019 WL 6912702 (N.D. Cal. Dec. 19, 2019), care in drafting can mean the difference between winning and losing.

Here is what you need to know.  The plaintiff underwent a surgical procedure on January 12, 2012, and experienced a complication that one surgeon purportedly attributed to “problems” and a “malfunction” with surgical equipment.  Id. at *1-*2.  Notwithstanding the complication, the plaintiff was discharged days later in good condition, and although she was seemingly no worse for the wear, she contacted an attorney in September 2013 after seeing a television advertisement.  Id. at *2.  The timing is obviously important—the plaintiff’s outreach to counsel was just a few months short of two years after her procedure.

As it turns out, attorneys for the device manufacturer had sent plaintiffs’ counsel a tolling agreement for cases involving the device, under which the tolling period would be triggered by notice from the plaintiffs’ lawyers.  Because the devil is in the drafting, we will lay out relevant terms verbatim:

[The agreement will] toll the applicable statute of limitations for a three month period starting on the date [Defendant] is provided with a claimant’s name.  If necessary, this period may be extended upon agreement of the parties. . . .

. . . .

The tolling of the applicable statute of limitations is not intended to and shall not for any purposes be deemed to limit or adversely affect any defense, other than a statute-of-limitations defense, that [Defendant] has, may have, or would have had in the absence of this agreement.  Nor does this agreement waive or release any statute of limitations defense that could have been asserted before the date of the tolling period.  Upon completion of the tolling period, [Defendant] will have all the defenses available to it as it had on the first day of the tolling period.

Id. at *2 (emphasis added).  The highlighted text at the end will become important because the plaintiffs’ attorney executed the tolling agreement on August 9, 2013, but did not send the plaintiff’s name (and thus commence the tolling) until February 3, 2014—more than two years after the plaintiff’s procedure.  Id. at *2.

You are no doubt starting to see how this played out.  The parties extended the tolling agreement again and again, until the plaintiff finally filed a complaint in the Northern District of California on April 13, 2018.  Was the claim time barred?  The answer was clearly yes, since by the time the plaintiff became a party to the tolling agreement, her claim was already untimely.

The district court’s order granting summary judgment for the defense came down to (1) choice of law, (2) the express terms of the tolling agreement, and (3) application of California’s discovery rule and doctrine of fraudulent concealment.

First, the district court determined that California’s two-year statute applied, rather than Connecticut’s three-year statute.  Although the plaintiff had her procedure in Connecticut, she resided in Florida and the Defendant was headquartered in California.  Id. at *1.  The district court therefore applied California’s “governmental interest” framework for choice of law, and it determined that because California was the forum and because the only defendant was a California resident, California was the only state interested in applying its statute of limitations.  Id. at *4-*7.  The discussion is long, but that’s the gist of it, and it left the plaintiff trying to evade California’s two-year statute.

Second, Plaintiff attempted to evade the statute by invoking the tolling agreement and arguing that the defendant was equitably estopped from asserting a statute-of-limitations defense.  This is where the tolling agreement spoke for itself.  The agreement did not prevent the defendant from asserting the statute because the claim was already untimely when the tolling period commenced.  Id. at *7-*8.  Recall that counsel signed the tolling agreement in August 2013, but did not give notice to commence the tolling until months later—in February 2014, which is more than two years later than the plaintiff’s alleged complication in January 2012.  The plaintiffs simply could not explain away the agreement’s express terms, under which the plaintiff became a party to the agreement on February 3, 2014, and the defendant expressly did “not waive or release any statute of limitations defense that could have been asserted before the date of the tolling period.”  Id. at *8-*9.  If there is one takeaway from this post, this is it.  The agreement’s clear language (and counsel’s faulty calendaring) made the difference.

Third, the plaintiff argued that California’s discovery rule and doctrine of fraudulent joinder delayed the accrual of her claims.  Id. at *12-*15.  But California’s discovery rule requires only inquiry notice for claims to accrue, and “so long as a suspicion exists, it is clear that the plaintiff must go find the facts; she cannot wait for the facts to find her.”  Id. at *12 (quoting Jolly v. Eli Lilly & Co., 44 Cal. 3d 1103, 1111 (1988)).  Plaintiff’s surgeon had told her and her husband that she experienced a complication and that there had been “problems” and a “malfunction” with the surgical equipment.  That was enough to find as a matter of undisputed fact that the plaintiffs knew or should have known, or at least had the suspicion, that they had a claim.  Id. at *13.  Finally, fraudulent concealment does not apply “if a plaintiff is on notice of a potential claim,” as the plaintiffs were here.  Id. at *14.

This is a good case to put away for reference.  The particular facts may not recur, and we express no opinion here on whether tolling agreements are a good idea.  Sometimes they are, and sometimes they are not.  If, however, you draft and execute one, be careful and be clear.

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We had to shake our heads at the recent 360 story entitled, “Allergan Breast Implant Risk MDL Heading to New Jersey” – the link is here for those of you with a subscription.

The idea of a “risk” MDL seems bizarre.  The story involves a particular type of cancer, and states that “four proposed class actions” are being coordinated.  If it’s one thing that our federal and state class action cheat sheets teach, it is that class actions are inappropriate for cases involving personal injury.  Hence, it appears that the description of a “risk” MDL is shorthand for class actions alleging a “risk” of that type of cancer in persons who have never (and probably will never) be diagnosed.

But according to the story, at least some of these would-be class representatives have actually “fallen victim” to the cancer.  That’s another blatant class action no-no – actually injured persons cannot represent classes of purportedly “at risk” persons with no present injury.  E.g., Amchem Products, Inc. v. Windsor, 521 U.S. 591, 624 (1997) (“exposure-only plaintiffs especially share little in common, either with each other or with the presently injured class members”) (citation and quotation marks omitted).  Further, if (as the 360 article states) the plaintiffs are demanding that the defendant “cover the costs of removing and replacing” the products, there are no state-law claims for medical monitoring either, because (putting aside the many other individualized issues) medical monitoring is just that:  an action solely for costs of “monitoring,” not prophylactic treatment.  This kind of claim was tried, and roundly rejected, in the cases involving Shiley heart valves we list in our compensatory injury cheat sheet.

But it gets worse.

This isn’t your mother’s breast implant litigation.

Breast implants are now Class III pre-market approved (“PMA”) medical devices.

That means express preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Even one of the worst post-Riegel preemption decisions recognized that 21 U.S.C. “Section 360k provides immunity for manufacturers of new Class III medical devices to the extent that they comply with federal law.”  Bausch v. Stryker Corp., 630 F.3d 546, 553 (7th Cir. 2010).  That’s a statement of the “parallel claim” exception to PMA preemption that courts have read into Riegel.

Back to the 360 article.  “The suits allege that [defendant] used a loophole in the U.S. Food and Drug Administration’s reporting requirements” and “it wasn’t until the agency tightened the requirements in 2017 that more adverse event reports came to light.”  Translation:  the complained-of reporting complied with the FDA’s requirements at the time, and when the FDA changed its requirements, the defendant changed its reporting to remain in compliance.  The complaints claim that, while “[m]anufacturers are supposed to report possible safety concerns about their products to the FDA through its public, searchable database” called “MAUDE,” the defendant instead “report[ed] them in so-called alternative summary reports, which are not required to be reported to MAUDE.”  Translation:  the defendant used an available, if “overlooked,” FDA reporting procedure to satisfy its legal obligation to report adverse events.  Or, as the FDA itself puts it on its website:

In 2017, the FDA began to sunset the ASR [alternative summary report] Program and requiring manufacturers with ASR exemptions to submit, in addition to the spreadsheet, a companion report that includes the total number of events being summarized.

We were also able to find the FDA’s – now withdrawn – guidance on alternative summary reports on its website, here.

Thus, it is readily apparent that the complaints don’t state any actual FDCA violation – only that the defendant, until 2017, had a choice as to how to report adverse events to the FDA, and chose the most streamlined route (allowing “submi[ssion] in a line-item format,” according to the then-applicable FDA guidance) available for meeting its FDA reporting obligations.  When the FDA “rolled out more rigorous reporting requirements in 2017,” the defendant also complied, which resulted in more public reports.

Thus, the plaintiffs in this “risk MDL” are claiming that, even though the FDCA did not obligate the defendant to use MAUDE reporting prior to 2017, some state common-law duty to use MAUDE existed and gave rise to tort liability.  What part of “different from or in addition to” (the preemptive language of §360k(a)) don’t these plaintiffs understand?  The claims described by 360 facially assert state-law reporting duties both “different from” FDA requirements (which at the time allowed “alternative summary reports”) and “in addition to” those same requirements.  What the 360 article reports isn’t even a “failure to report” claim – because at minimum that kind of claim asserts an actual violation of an FDCA reporting duty.  Again, this much is established even in cases we love to hate.  A failure-to-report claim:

alleges that, under federal law, [a defendant] had a “continuing duty to monitor the product after pre-market approval and to discover and report to the FDA any complaints about the product’s performance and any adverse health consequences of which it became aware and that are or may be attributable to the product.”  It further alleges that [defendant] failed to perform its duty under federal law to warn the FDA.

Stengel v. Medtronic Inc., 704 F.3d 1224, 1232 (9th Cir. 2013) (applying Arizona law) (emphasis added), overruled on state law grounds, Conklin v. Medtronic, Inc., 431 P.3d 571, 578-79 (Ariz. 2018).  Here, assuming the 360 article is accurate, no actual federal reporting violation is alleged.  At all times, the defendant’s reporting complied with what FDA regulations then allowed.  Sure, these plaintiffs don’t like what FDA regulations permitted – but that’s precisely why Congress imposes preemption in this type of case.

So our reaction to the “risk MDL” described in the 360 article is that:  (1) it can’t be a class action; (2) state law doesn’t provide the relief being requested; but in any event (3) the only common issue should be that the whole thing is preempted under Riegel.

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How many of us entered law school dreaming of following the paths of Brandeis, Marshall, etc. in the field of constitutional law? How many of us now can go weeks, or even months, without reading a Supreme Court case? Paying off student loans led many of us to work for law firms where there was far less available to do in constitutional law than in, say, commercial disputes, securities, or product liability law. But we’re not mooning over the path not taken. Somewhere in that perineum between law school graduation and partnership, we learned that while constitutional law gets the headlines, it can also be in some ways, a less satisfying practice area. We don’t merely mean that it doesn’t pay as much, at least not reliably. The problem with constitutional law is that it turns too much on the predilections of a few judges, and turns too little on rules and realities. Statutory interpretation or antitrust analysis or a Daubert dispute demand rigor. Perhaps there is rigor in unwinding the doctrinal wanderings of First or Fourth Amendment law (and their “penumbras”), too, but politics and prejudice seem to take positions at the head of the line in those flashy areas. (There is currently an abortion case before the Supreme Court that asks whether a precedent set way, way back in 2016 should be overturned. Question: what has changed? Answer: politics and the makeup of the nine solons who get to tell us what the constitution means.).

Every once in a while, constitutional law intersects with other legal battlegrounds in interesting ways. Our blog, for example, has had multiple occasions to discuss the tension between the First Amendment and regulatory/judicial restraints on drug and device marketing. Now comes a brilliant, nervy law review article that examines this issue and makes some exciting proposals. The article is by Florida law professor Lars Noah, it appears in the Fall 2019 edition (volume 92) of the Temple Law Review, and is entitled, “Does the U.S. Constitution Constrain State Products Liability Doctrine?” The article is insightful and blessedly brief, so you should check it out yourself. We won’t step on too many of the article’s points, but here is a preview that we hope will inspire you to take a look at the article before you draft your next summary judgment brief.

Professor Noah begins by focusing on the dreadful decision by the New Jersey Supreme Court in the Perez case holding that the learned intermediary doctrine, which limits the duty to warn when selling prescription drugs and devices, did not apply whenever manufacturers had engaged in direct-to-consumer (DTC) advertising. The article boldly suggests that the rule announced in Perez might run afoul of the Constitution. After all, in cases such as Virginia State Board of Pharmacy and Thompson v. Western States Medical Center, the Supreme Court has applied the first amendment to limit government efforts to bar truthful and nondeceptive pharmaceutical advertising.

(The article reminds us that Perez involved a contraceptive. The New Jersey court apparently believed that the product “did not qualify as a therapeutically important product,” and seemed willing to carve out another exception to the learned intermediary doctrine for “lifestyle” drug and devices, whether or not directly advertised to consumers.)

Professor Noah points out that the DTC exception in Perez “plainly singles out for unfavorable treatment defendants that engage in commercial speech simply because some of the judges in that state have no use for the practice.” That sounds like content-related discrimination (both speaker- and topic-based) against certain speech.

The article does not confine itself to the Perez issue. It explores whether constitutional protection should extend to the marketing of certain products that implicate certain rights. Contraceptives – such as the product at issue in Perez – would be among those products, something we’ve noted here on the Blog. An analogy is drawn to the First Amendment’s requirement of tolerating some defamatory falsehoods in order to avoid chilling valuable speech. Why shouldn’t other fundamental rights (think of some of the most controversial SCOTUS opinions, such as Griswold, Roe, and Heller) require tolerating the “sale of certain arguably defective products lest suppliers become spooked about distributing even nondefective versions that individuals have a right to use“?

That is not an absolute principal; there aren’t that many absolutes in constitutional law. Professor Noah proposes that “Constitutional regard for ensuring the availability of certain products would not entirely insulate sellers, just as authors and publishers remain subject to defamation lawsuits, but it would necessitate imposing a higher pleading standard on plaintiffs. In order to really safeguard constitutionally valuable products, even allegations of negligence would not suffice, instead, courts should have to recognize a regulatory compliance defense.”

The article concludes that “[t]he time may have come to extend the U.S. Supreme Court’s drive to constitutionalize the domain of speech torts into the field of products liability.” That notion is intriguing not only because of its potential scope and consequences, but also because it is grounded in precedent and logic. At a minimum, we should ponder possible constitutional dimensions before we put the finishing touches on our dispositive motions.

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We all know that absent extraordinary circumstances, failure to warn claims against generic drug manufacturers are preempted under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).  But as far as we are aware, no other court has been asked to decide whether that same preemption applies to cross-claims for contribution or indemnity.  Until now.

In Haney-Williams v. GlaxoSmithKline LLC, 2019 WL 7284737 (D. Nev. Dec. 27, 2019), plaintiff filed a failure to warn claim against the manufacturer of a generic drug prescribed to treat her epilepsy.  She also brought claims against the pharmacy that filled the prescription alleging they gave her the wrong strength of the medication.  Plaintiff originally also sued the manufacturer of the brand name product, but dropped those allegations early on.  Id. at *1.

The pharmacy filed a cross-claim against the generic manufacturer for comparative negligence, equitable indemnity, and declaratory relief, along with some contract-based claims. Id.  The contract-based claims were dismissed because the contract had expired prior to plaintiff’s injury.  Id. at *5.  The generic manufacturer moved to dismiss both the direct action by the plaintiff and the contribution claims by the pharmacy as preempted.

The failure to warn claim was easily dismissed under Mensing after the court took judicial notice of the ANDA which identified the drug as a generic product, a fact that was omitted from the complaint.  Id. at *3.  The court then turned to the pharmacy’s cross-claims.  Under Nevada law, a comparative negligence claim provides that “each defendant is severally liable to the plaintiff only for that portion of the judgment which represents the percentage of negligence attributable to that defendant.”  Id. at *4.  Similarly, equitable indemnity “allows a defendant to seek recovery from other potential tortfeasors whose negligence primarily caused the injured party’s harm.”  Id.  Under both scenarios, recovery is only permitted from another tortfeasor.  Therefore, for the pharmacy to recover under either theory, there would have to be some way the generic manufacturer could be find liable.  Id.  But, because plaintiff’s sole cause of action against the generic manufacturer is preempted, the generic manufacturer cannot be found a tortfeasor and there can be no derivative claim.  As the pharmacy’s request for declaratory relief was derivative to its other claims, it too was dismissed.

The rationale is simple, straightforward and should apply in all preemption cases resulting in a complete dismissal of plaintiff’s claims, not just generic preemption.  A little surprising that it has taken this long to get this one in the books.  Granted it’s a twist we don’t see that often.  But if you do find yourself in this vexing situation, it’s good to know the law is on our side.

 

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In their unending quest to make a plaintiff out of everyone, some creative members from the other side of the “v.” have concocted a claim that we call “fourth-party payor” liability.  Regular blog readers are certainly familiar with “third-party payor” actions brought – entirely for economic losses – by insurers, pension funds, and other organizations that are under obligations to pay for their insureds’/members’ health care costs.  They typically claim that, for one reason or another, our prescription medical product clients charged them too much for this or that product.

Fourth-party payor litigation goes a step beyond that.  In Enriquez v Johnson & Johnson, 2019 WL 5586557 (N.J. Super. Law Div. Oct. 10, 2019), the plaintiff never even claimed to have used the product, paid for the product, acquired the product, or had any interaction with the product (or its alleged manufacturers) in any way.  He was simply “a [state] resident who alleges that he purchased health insurance.”  Id. at *1.  Following the principle that “to err is human, but to really screw up the law, bring a class action,” this plaintiff sued the defendant manufacturer for allegedly driving up the cost of health insurance generally:

Plaintiff asserts that as a result of the conduct of Defendants, New Jersey health insurers paid higher costs for both [the defendant’s products and their alleged adverse reactions], resulting in increased costs to health insurers.  Plaintiff alleges that health insurers passed these higher costs on to their insureds, causing class members to pay higher costs for health insurance.

Id.  Like we just said – make everybody a plaintiff.

Fortunately, this theory of liability was a bridge too far.  A claim such as this, “brought by persons claiming to have paid higher insurance costs as a consequence of misconduct by manufacturers, distributors and marketers,” had never been brought before.  “There are no reported decisions directly on point.”  Id. at *2.  The Enriquez decision did its best to make sure this kind of suit is never brought again.

The liability theories were:  (1) violation of New Jersey’s Consumer Fraud Act (“CFA”); (2) public nuisance; (3)unjust enrichment; (4) negligent marketing; and (5) “negligent interference with prospective economic advantage.”  Id. at *4.  All of these theories made a mockery of anything resembling traditional causation:

Plaintiff . . . he would first obtain a sample of prescriptions . . . written by physicians.  Plaintiff asserts that it is unnecessary to explore each patient’s medical record for his evaluation.  From this statistical data, Plaintiff then would have an expert evaluate which prescriptions were appropriate and which should not have been written.  Presumably, Plaintiff then would determine a percentage of prescriptions . . . that should not have been written and extrapolate from that data to calculate the total unnecessary . . . prescriptions.  Plaintiff then intends to have an expert evaluate how the costs of the prescriptions they determine should not have been written impacted the amount charged to class members for health insurance.

Enriquez, 2019 WL 5586557, at *4 (emphasis added).

Consumer protection claims of fourth-party liability failed for reasons of remoteness and causation.  Following one of the firearms marketing cases that Bexis was involved in years ago, Enriquez held, “alleged harm in the form of increased costs for medical expenses which were merely derivative of injuries to others was too remote to support [a CFA] claim.”  Id. at *7.  As for causation:

A complete lack of any relationship between the defendant’s unlawful conduct and the plaintiff’s loss compels a finding of a lack of causation under the CFA.  In cases in which the alleged misrepresentation was made to a prior purchaser and not to a plaintiff asserting the CFA claim, courts have held there was a fatal lack of proof of a causal connection between the misrepresentation and the alleged loss.

Id. at *8 (citations omitted).  Such precedent controlled this case, where only indirect economic effects were alleged:

Defendants had no contact with Plaintiff, and did not make any misrepresentations or omissions to Plaintiff.  Rather, the allegations are that Defendants’ misrepresentations and omissions were made to doctors for the purpose of increasing the volume of prescriptions written, and to health insurers for the purpose of obtaining approval of their pharmaceuticals on the formulary list. . . .  Plaintiff’s causal theory, that if Defendants had not marketed [their products] aggressively to doctors and health insurers the rate paid by Plaintiffs and other proposed class members for health insurance would have been lower, is speculative and attenuated.

Id. (citations and footnote omitted).  “Speculative and attenuated” – that is the takeaway from Enriquez.  “There is no allegation Plaintiff was aware of Defendants’ misrepresentations before he purchased health insurance, or that even if Plaintiff was aware he did not have the option to switch to a provider unaffected by Defendants’ misrepresentations.” Id. at *9.

Public nuisance also failed under New Jersey precedent from the firearms marketing cases.  Preclusion of fourth-party payor liability was a fortiori from that litigation .  “Public nuisance claims are typically restricted to those connected with real property or the infringement of public rights. . . .  [N]o New Jersey court has ever allowed a public nuisance claim to proceed against manufacturers for lawful products that are lawfully placed in the stream of commerce.”  Enriquez, 2019 WL 5586557, at *10 (quoting and following Camden County Board of Chosen Freeholders v. Beretta, U.S.A. Corp., 273 F.3d 536, 539-40 (3d Cir. 2001)).  Enriquez also followed (at *11) In re Lead Paint Litigation, in which the New Jersey Supreme Court noted, as to public nuisance:  “Whether these plaintiffs . . . are authorized to sue for damages, instead of seeking abatement, is debatable.”  924 A.2d 484, 502 n.10 (N.J. 2007).  Thus:

Typically, a suit involving a public nuisance is sustainable only by a suit brought by a governmental entity or an individual who sustains some special damage over and above that suffered by the general public.  Here, the allegations of the Complaint do not demonstrate or allege the type of special injury which would allow an individual as opposed to a public entity to bring an action seeking monetary damages resulting from an alleged public nuisance.

Enriquez, 2019 WL 5586557, at *11 (citation omitted).

Unjust enrichment simply had nothing to do with fourth-party liability – since the plaintiff never paid anything to the defendant manufacturers.  Once again,

Unjust enrichment is not an independent theory of liability. . . .  Plaintiff can point to no direct benefit received by any Defendant from Plaintiff.  Rather, any benefit Plaintiff conferred was directed to his health insurer.  The facts presented are far too remote to permit a cause of action based upon unjust enrichment to proceed.

Id. at *12 (citations omitted).

The fourth-party aspects of negligent marketing also foundered on the rocks of remoteness.  A product marketer’s duty of care has never extended to persons with no need for the product, and to whom no marketing was directed.

Plaintiff’s Complaint alleges that Defendants had a duty to exercise reasonable care in manufacturing and distributing [their] medications in the State of New Jersey.  The critical issue presented here however is how far that duty extends.  There is no doubt that this duty extends to individuals likely to purchase [those products].  Conceivably, that duty could extend to a non-patient purchasing the [products] who is not a consumer.  Consumers of health insurance however are simply far too remote from the conduct of Defendants to find a duty to exist as a matter of law.  The nature of the risk to consumers of health insurance is too far removed, and any risk too attenuated, to find as a matter of fairness that a duty should extend to such outer limits.

Enriquez, 2019 WL 5586557, at *13 (emphasis added).

Finally, “tortious interference with prospective economic advantage” is a claim we’ve never seen raised before in product liability litigation.  Opportunity costs – to the extent that’s even “a thing” in product liability – have been addressed by pre-judgment interest.  In New Jersey, that cause of action was not viable.  “No reported decision has recognized a cause of action for negligent interference with prospective economic advantage.”  Id. at *13.  The closest thing in New Jersey law was for “tortious interference with a prospective business relation.”  Id.  That was obviously not an issue in Enriquez.  “While Plaintiff alleges that the conduct of Defendants impacted the price which they paid for health insurance, health insurance was not the business of Plaintiff.”  Id.

Having rejected each of the plaintiff’s causes of action, Enriquez then bounced the rubble by holding that plaintiff also failed to allege proximate cause.  “It is not enough to show a fraud on the marketplace.”  Id. at *16.  But general, overarching allegations of fraud untethered to any particular plaintiff were all that fourth-party payor liability offered – or could offer:

Plaintiff cannot establish an ascertainable loss through statistical data as proposed.  This is essentially a fraud on the market theory which has been rejected as a basis to establish an ascertainable loss in a claim based upon the CFA. . . .  Plaintiff’s proposal to prove the increased costs of [these products and their alleged adverse effects] through statistical data, and then further establishing its impact on the cost of health insurance with statistical data, essentially constitutes a fraud on the market theory to prove damages which has been rejected in this state.

Enriquez, 2019 WL 5586557, at *16 (citation omitted).

Finally, Enriquez inspired us to name this bogus cause of action with its observation that “[t]his case is most similar to, although one step further removed from, third party payor actions which have been routinely dismissed by courts as failing to establish sufficient causation.”  Id. at *19.  What’s “one step” beyond “third party payor” actions?  Fourth-party payor liability.  Tort liability such as this is simply not a way to fix the rising cost of healthcare:

There are a myriad of reasons . . . which have an impact on insurance costs.  Some costs may be borne by insurers resulting in lower profits, some may be paid by employers and some may be passed on to the purchasers of health insurance.  These costs may also be subject to higher co-pays, deductibles or limitations of coverage, Plaintiffs argument that statistical data can be used to determine what increases were the direct cause of Defendants’ actions, and what increases are attributable to other factors, is inadequate to establish the facts required.

Id. at *20.  Thus, “this particular proposed class are simply not the appropriate vehicle to vindicate the rights of those who have been impacted by the alleged conduct of Defendants.  The alleged harm to Plaintiff is far too attenuated and remote.”  Id.

Fourth-party payor liability is to the law what the fourth dimension is to daily life.  It doesn’t exist, and even if it did, it would too remote to for the law (or daily life) to address.

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This post is solely by the non-Reed Smith side of the Blog.

There are lots of great pairings.  Bud Abbott and Lou Costello.  Paul Simon and Art Garfunkel.  Michael Jordan and Scottie Pippen.  Michael Scott and Dwight Schrute.  Rum and coke.  Chocolate and peanut butter.  Chocolate and pretzels.  Chocolate and strawberries.  Chocolate and wine.  We think you get the point.  But for every great duo, there is a great don’t.  Oil and water.  Texting and driving.  Water and electricity.  Toothpaste and orange juice.  These are things to stay away from. Now Andrusis v. Microvention, Inc., 2019 Pa. Super. Unpub. LEXIS 4759 (Pa. Super. Dec. 26, 2019), tells plaintiffs not to mix malfunction theory strict liability with medical malpractice negligence.

Plaintiffs’ decedent underwent surgery to repair an aneurysm.  Decedent’s surgeon used a microcatheter with defendant’s product.  But the product was larger than what was recommended for use with that particular microcatheter.  The relevant Instructions for Use contain strict time frames for repositioning once the product is introduced and recommends removal if they cannot be positioned properly within the time period.  Because the doctor was using a two devices that were not intended to be used together, he selected his own targeted time period for repositioning.  Ultimately, the surgeon could not complete the surgery successfully.  Complications occurred and decedent died a day later.  Id. at *2-4.

While plaintiffs filed suit against the surgeon, hospital, and the product manufacturer, the only claim actually pursued against the manufacturer at trial was a cross-claim filed by the hospital.  Id. at *5.  At the conclusion of plaintiffs’ case-in-chief, defendants informed the court they had reached a settlement and would not be providing evidence against the manufacturer, which left the plaintiff with no case as to that defendant.  The manufacturer moved for a compulsory nonsuit since plaintiffs presented no evidence of a product defect.  It was denied but renewed at the close of defendants’ case at which time it was granted.   After a jury verdict in favor of the surgeon and hospital, plaintiffs appealed.  Id. at *23-24.

Plaintiffs argued that the jury should have been given the strict liability claim because there was sufficient evidence to support a malfunction theory strict liability claim.  The malfunction theory allows a plaintiff to prove a product defect with both evidence of a malfunction and “evidence eliminating abnormal use or reasonable, secondary causes for the malfunction.”  Id. at *26.  It is a case built on circumstantial evidence and that is why it requires both evidence to show that a malfunction occurred and evidence of no other reasonable causes.  Only then will a court allow a jury to infer that a defect caused the injury.  Id.

The appellate court presumed that plaintiffs had provided sufficient evidence that a malfunction occurred.  Note that the trial court did not so conclude because the claimed product failure was a “rare, but foreseeable risk” and a known possibility could not be evidence of a malfunction.  Id. at *28 n.10.

The appellate court focused on the second element of a malfunction theory – other causes.  The court held that for plaintiff to pursue a malfunction theory, plaintiff “must present a case free of abnormal use and secondary causes.”  Id. at *30 (citation and quotation marks omitted).

[I]f the plaintiff’s theory included facts that the plaintiff was using the product in violation of its directions . . . no reasonable jury could infer that an unspecified defect caused a malfunction when either (1) the more likely explanation is the abnormal use or (2) the facts presented by the plaintiff suggest a cause for the malfunction unrelated to the alleged, unspecified defect.

Id. at *30-31.

In this case, plaintiffs’ entire theory of the case was that the product did not malfunction, but rather it was the surgeon’s negligence, including his failure to follow the product’s directions, that caused decedent’s death.  Plaintiffs wanted to rely on the medical malpractice defendants’ defense.  Of course the surgeon argued there was no misuse.  Plaintiffs argued that if the jury accepted that defense argument, it would have eliminated the alternative cause and therefore they should be allowed to proceed on a malfunction theory.  But, Pennsylvania law requires plaintiff’s case be “free of abnormal use and secondary causes” to “establish a prima facie malfunction theory case sufficient to proceed to the jury.”  Id. at *31-32.  Not true here.

Plaintiffs also argued that pursuing a medical malpractice theory did not preclude them from pursuing the alternative malfunction theory.  In principle, they are correct.  In application to the facts, not as much.  The case plaintiffs rely on is Rogers v. Johnson & Johnson, 565 A.2d 751 (Pa. 1989), in which at trial plaintiff presented evidence that eliminated medical malpractice as the cause of his injury and he proceeded with a malfunction theory case against the manufacturer of a plaster splint.  Defendant manufacturer’s expert evidence supported that it was malpractice that caused the injury.  The question was whether the malfunction theory should not have been submitted to the jury based on the defense evidence. The Pennsylvania Supreme Court said no:  “[W]e believe that so long as the plaintiffs presented a case-in-chief free of secondary causes which justified the inference of a defect in the product, the jury was free to accept their scenario.”  Rogers, 565 A.2d at 755.

But Rogers was the exact opposite of plaintiffs in Andrusis, who attempted to “back-door” a malfunction theory claim through defendants’ evidence that failed to materialize because of the settlement.  Because a malfunction-based claim is a form of circumstantial evidence of a defect, it is defeated where plaintiff’s own case, as here, contains evidence of a reasonable secondary cause of the malfunction – such as a surgeon’s abnormal use of the product.  Plaintiffs attempted to turn their medical malpractice case into a products liability case by relying on a co-defendant doctor to make out the case against the manufacturer.  Fortunately, the court saw the ploy for what it was and held plaintiffs to their case-in-chief.  So, if you see medical malpractice and malfunction theory together, remember it’s not Bogie and Bacall.  Think more Schwarzenegger and DeVito.

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There is an exhibition at the National Museum of the American Indian in Washington DC showing a warrior with eyes on the back of his head and a blank, eyeless face on the front. That odd image reflects the profound truth that we have seen what has already happened but are blind to the future. (We are reminded a bit of Dr. Bunsen Honeydew, the muppet character who has no eyes. But Dr. Honeydew does have glasses. Talk about odd.)

At the start of 2020 we can only guess as to the coming triumphs and indignities. The calendar has turned but we find ourselves still looking backwards at some of the drug and device law developments in 2019. Bexis shared the 2019 top 10 and bottom 10 lists. (Keep alert for the upcoming CLE program.). Even aside from the positive and negative game-changers of 2019, there were other cases with interesting holdings. We did not get to them all. Some are worth retrieving, holding up to the light, and scrutinizing.

For example, Hofer v. Wright Medical Technology, Inc., 2019 WL 3936130 (S.D. Cal. Aug. 20, 2019), takes us back. The date of the decision takes us back to a birthday dinner for the Drug and Device Law Son in Budapest. The location of the decision takes us back to our first years as a practicing attorney, when we worked on transactional matters in San Diego and proved on a daily basis our ineptitude in drafting trust indentures and other triple-tier finance documents. Most important, the substance of the Hofer decision takes us back to the days when courts took seriously the requirement under Fed. R. Civ. P. 9(b) that plaintiffs must plead fraud claims with particularity.

The plaintiff in Hofer claimed injuries from an artificial hip system that broke into pieces. His complaint included causes of action for failure to warn, negligence, and negligent misrepresentation. The defendant moved to dismiss the negligent misrepresentation claim because it flunked the heightened pleading requirement of Rule 9(b). The defendant prevailed, and the court’s reasoning might be a gift to defendants accused of negligent misrepresentation.

The plaintiff first argued that Rule 9(b)does not apply to negligent misrepresentation. Surprisingly, the Ninth Circuit has not addressed this legal issue. It is hard to believe that, as big as the Ninth Circuit is, the issue has not already been resolved. But it has been resolved at the district court level in the Southern District of California several times, and those sun-blessed judges have consistently applied Rule 9(b) to claims of negligent misrepresentation. Maybe the Ninth Circuit will review the question. Unlike some (most?) other commentators, we do not assume that the Ninth Circuit would mangle the law in a pro-plaintiff fashion. Maybe it is because we clerked on the Ninth Circuit in our salad days, but we foresee a solid affirmance. The Ninth Circuit has a lot of smart judges (and, with the recent addition of our old AUSA colleague Dan Collins, maybe the one of the very smartest). Then again, we are like that Native American warrior, gazing into the future with more hope than vision.

The Hofer plaintiff argued that even if Rule 9(b) governed the case, his complaint satisfied it. No, it didn’t. The complaint referred to various marketing materials that hawked the hip implant’s record of success. But the only representation that the plaintiff alleged had been relied upon by the implanting doctor was that the hip implant system “was properly cleared by the FDA and that it had a good clinical history.” It runs out that there would be problems with these representations. It does not matter. The plaintiff “failed to allege who made any of these representations, when and where any of the representations has been made, and how they were made.” Moreover, the not allege whether or how the alleged misrepresentations has affected the doctor’ s “decision regarding his selection of the device.”

Accordingly, the court dismissed the negligent misrepresentation claim for failure to meet the heightened pleading requirement of Rule 9(b). In the midst of exchanging hearty New Year’s wishes, let’s not forget some of the cases that made 2019 as good as it was. Hofer in its own quiet way, was one of them.

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Welcome to our annual Elysium tour, in which we electronically acknowledge the sweet nectar of victory flowing from the top ten drug/device product liability decisions of the year.  It’s time to salute those fortunate decisions that brought the judicial Midas touch to our clients’ cases.  We echo what we said last year:  “we’re looking for nothing but pleasant news . . . [a]nd make no mistake about it, there’s plenty to celebrate this year.”

Occasionally, a court will do something decidedly anti-Dionysian, with an eleventh-hour awful decision (the infamous Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), was decided two days before Christmas), but barring that, we’re expecting pleasant dithyrambs from 2019’s paragons of judicial reasoning.

Before the Great Panathenaia begins, we remind readers that our scope of coverage is limited.  Our top (and bottom) ten lists are limited to cases involving prescription medical product liability litigation (relatively broadly defined).  Cases are decided each year that significantly impact what we do, even though not involving prescription medical products.  So, we’ll tip our collective pilei to In re Amendments to the Florida Evidence Code, 278 So.3d 551 (Fla. 2019) (discussed here), not really a “case” at all, but a monumental step forward for Florida law – adopting a Daubert-based standard for admissibility of expert witnesses.  Kudos also to two talc wins, State ex rel. Johnson & Johnson v. Burlison, 567 S.W.3d 168 (Mo. 2019) (discussed here), granting mandamus to disapprove venue abuse in St. Louis; and Johnson & Johnson Talcum Powder Cases (Echeverria), 249 Cal. Rptr. 3d 642 (Cal. App. 2019) (discussed here), j.n.o.v.ing several parts (including punitive damages) of an absurd $400+ million verdict and granting a new trial as to the rest due to inadequate causation evidence.  Also noteworthy is Fitzpatrick v. Wendy’s Old Fashioned Hamburgers, ___ N.E.3d ___, 2019 WL 5792847 (Mass. App. Nov. 7, 2019) (discussed here), the first express appellate condemnation of plaintiff-side “reptile” tactics.  Finally, we recognize American Beverage Ass’n v. City & County of San Francisco, 916 F.3d 749 (9th Cir. 2019) (en banc) (discussed here), for holding that the First Amendment precludes governmental mandate of a controversial “safety” statement in product advertising.

Enough with the introductions.  Now, let’s proceed with the panegyrics.

  1. Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019).  Even though Albrecht has enough aspects we don’t like to be named simultaneously as our sixth worst case, the Court’s disposition of the core preemption issues promises to be so beneficial to all defendants that Albrecht is also our number one best case for 2019.  Already, it wiped out our worst case of 2017, as well as two decisions that otherwise might have made this year’s bottom ten.  The impact of Albrecht’s holding that preemption is always a question of law for the court – including resolution of any subsidiary factual disputes – should have numerous beneficial effects.  The Third Circuit’s ill-fated “clear and convincing evidence” standard likewise vanished with the “question of fact” misnomer, and with no facts for juries to decide, the summary judgment “most favorable to nonmovant” standard for viewing facts also drops out (it hasn’t applied in analogous patent litigation).  Albrecht thus removed pro-plaintiff thumbs from the evidentiary scale in preemption cases.  In 95% of preemption cases (at least), we think defendants have the better side of the regulatory record, thus we should win most straight-up preemption arguments.  Courts can no longer cop out, or kick the can down the road, with the excuse of “disputed” facts.  Since expert testimony on questions of law is improper, obfuscation of preemption issues by paid “FDA experts” should lessen.  Also, with preemption as a discrete legal issue, separate from trial, arguments for interlocutory review of adverse preemption decisions improve (although judicial factual determinations, where present, may well get appellate “clearly erroneous” deference).  These points improve defense chances in all preemption cases, implied or express, since a level playing field should also greatly assist defeating FDCA intensive “parallel violation” claims in PMA preemption cases.  Other useful points include the Court’s first discussion of “overwarning” as a policy concern.  Albrecht omitting any “presumption” about preemption in its extensive Levine (2009-1) discussion, instead using only the older “assumption” language.  The last vestiges of the so-called “presumption against preemption” are now in doubt.  Albrecht also doubled down on the FDA changes-being-effected (“CBE”) regulation defining Levine’s safe harbor against impossibility preemption, which creates preemption arguments for everything that CBE doesn’t cover.  Even the reformulated FDA “fully informed” gloss on Levine “clear evidence” opens the door to the FDA itself answering that question (see the above 95% reference).  Likewise, the decision’s discussion of “force of law” also cuts both ways, and should restrict plaintiffs’ ability to rely on warning letters and other FDA actions lacking the required legal status.  Since preemption is the strongest defense our side has, all these favorable holdings and implications make Albrecht our number one decision for 2019.  We analyzed Albrecht on multiple occasions, most notably here and here, and will undoubtedly do so again.
  2. Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir. 2019).  Gibbons is a two-fer.  Its preemption ruling is extremely helpful – affirming in all respects the district court’s extensive and expansive preemption rulings based, not on Levine (2009-1) clear evidence, but on the “newly acquired information” limitation in the FDA’s CBE regulation.  Those rulings showed the strength of “newly acquired evidence” as a separate preemption basis, enough to be our top district court decision in 2017.  Gibbons also confirmed that Mensing (2011+1)/Bartlett (2013+1) preemption is indeed of universal applicability, and not limited (as plaintiffs argued) to generic drug cases.  Thus, whenever FDA pre-approval is required for a given alteration in the design or warning of a drug (or device), the Mensing independence principle mandates preemption.  Gibbons also confirms the value of TwIqbal in preemption cases, upholding preemption where plaintiffs failed to plead any “newly acquired information” that could get them into Levine’s CBE preemption safe harbor.  Gibbons demonstrates the power of preemption – an entire MDL went down to defeat.  That’s one.  The second part of Gibbons strongly confirmed that defendants can properly remove cases to federal court before service of process on a “forum defendant” that would otherwise prevent removal.  That’s what the statute said, so that’s what defendants can do.  Litigation tourist plaintiffs have exploited the archaic “forum defendant rule” to create mass torts in their favored locales, even though their target defendant is otherwise diverse and would be exposed to pro-plaintiff “home cooking” in such places.  For handing defendants wins in both preemption and removal, Gibbons comes in second only to a Supreme Court decision.  We goggled over Gibbons here.
  3. Weber v. Allergan, Inc., 940 F.3d 1106 (9th Cir. 2019).  Preemption, again.  Hey, it’s our strongest defense.  In this pre-market approval case, the plaintiff sought to prove the FDCA violation necessary to support a “parallel violation” claim on what amounted to res ipsa loquitur – asserting that a device malfunction allows the inference, not just of a product defect, but of a regulatory violation (but don’t ask the plaintiff what it was).  Weber became the first appellate court to hold that plaintiffs can’t do that.  Res ipsa loquitur may allow inference of a product defect, but not a violation of any particular regulation.  Instead, to avoid preemption, a plaintiff must show that the defendant device deviated from the device’s pre-market approval requirements or some other applicable FDA standard.  The FDA approves devices knowing they can malfunction.  Since full compliance can’t eliminate malfunctions, no inference of regulatory violation from a mere malfunction is possible.  A secondary, and helpful, ruling in Weber was that a factual description of clinical trial results did not create any express warranty that every device would always perform within that description.  Such a mandatory guarantee was “different from” applicable FDA requirements, and thus also preempted.  We welcomed Weber here.
  4. In re 3M Bair Hugger Litigation, 924 N.W.2d 16 (Minn. App. 2019).  The appellate decision that put an end to the Bair Hugger litigation rates as our best state-court decision of 2019.  The opinion described what we called the “Dostoyevskian” origins of the litigation, stirred up by the jilted inventor of the device, who left the company under a legal cloud, invented a competing device, and then tried to use this product liability litigation as a tool either to obtain a competitive edge or to force the defendant to buy his company.  Suffice it to say, that it did not end well for plaintiffs – particularly since the FDA disagreed with the inventor’s supposed “scientific” study of comparative device safety.  Of course, the thrice-jilted inventor also served as plaintiffs’ expert in the litigation.  Minnesota doesn’t follow Daubert, but in Bair Hugger that hardly mattered.  The novel scientific theory touted by plaintiffs and their expert wasn’t generally accepted, so all the Bair Hugger claims failed on causation grounds.  The best legal ruling in Bair Hugger was that the Frye test (Minnesota’s version, anyway) applied to both methods and to ultimate opinions.  In other words, even when an expert is devious enough to manipulate accepted methods to reach a crazy result, the craziness of the result is sufficient to require exclusion.  We gave Bair Hugger a big hug here.
  5. Robinson v. Davol, Inc., 913 F.3d 690 (7th Cir. 2019).  Robinson was our best Rule 702 decision of the year.  Plaintiff had a medical device – later recalled – implanted.  Plaintiff also died from after implantation of the device.  Plaintiff’s problem was that the two didn’t relate to each other.  The recall did not involve any risk pertinent to the the decedent’s death.  Plaintiffs’ three experts tried, but failed.  The first simply wasn’t competent to make such a diagnosis.  He was a “biomedical engineer” but didn’t know the medical issues surrounding the death.  The second, the coroner who performed the autopsy, and later hired as a plaintiff-side expert, was properly excluded on the procedural ground of not being timely disclosed as a retained expert, since those opinions went beyond the autopsy.  The third expert made up a novel causation theory, but had no pre-existing science to support his ipse dixit.  He claimed to have seen it happen in his other patients, but refused to identify the patients or produce relevant medical records.  Nor did the decedent’s medical records or autopsy contain any support.  The Seventh Circuit found that opinion the paradigm of unreliability.  No “differential diagnosis” worthy of the name was conducted, because the expert lacked any basis for ruling in the device as a possible cause.  We recommended Robinson here.
  6. Sherman v. Pfizer, Inc., 440 P.3d 1016 (Wash. App. 2019).  Mostly because of preemption, we don’t run across many product liability decisions involving generic drugs anymore.  Sherman points out other reasons, besides preemption, why this is so.  All of the usual inadequate warning claims would have been preempted (or might have been in the trial court; we can’t tell) so plaintiff appealed duty-to-update allegations and a claim that warnings should have been given “in ways other than the package insert.”  Didn’t work.  Turns out the prescriber didn’t rely on package inserts for drug risks at all.  Preemption or no, non-reliance on an allegedly inadequate warning kills causation.  Preemption probably would have taken out the “other ways” claim, but a quirk of the Washington product liability statute got there first.  Warning claims by statute are limited to material “provided with the product.”  The statute says what it says, so non-label-based claims don’t fly in Washington state.  We saluted Sherman here, and, the Washington Supreme Court has since denied review.  2019 WL 6682200 (Wash. Dec. 5, 2019).
  7. In re Genentech, Inc., Herceptin (Trastuzumab) Marketing & Sales Practices Litigation, 367 F. Supp.3d 1274 (N.D. Okla. 2019).  As was the case last year with Gustavsen (2018+2), garbage, no-injury class actions claiming dosage-related economic losses tend to produce favorable rulings.  The product, a biologic, cannot be easily produced (if at all) in exactly identical units, so the FDA approved it for marketing within plus-or-minus weight tolerances around a specified midpoint.  Plaintiffs claimed (in a class action, of course) that anything less than the specified midpoint shorted them out of valuable product.  That’s the opposite of the aforementioned Gustavsen case, where too-large doses allegedly wasted valuable product.  But the result was the same – preemption.  First, FDA regulations specifically permitted “reasonable variation in dose, creating a direct, and preemptive, conflict.  Second, plaintiffs could not challenge the FDA classification of the product.  Third, a “draft guidance,” particularly one after-the-fact, did not create any enforceable FDA requirements that could be violated.  Third, plaintiffs misinterpreted an FDA compliance guide to invent an exact dosage number that did not, in fact, exist.  Finally, to comply with plaintiffs’ demands for exact dose would require a change in manufacturing processes requiring prior FDA approval, meaning preemption under the Mensing (2011+1) independence principle.  We note that Genentech is currently on appeal, and given the numerous FDA-related arguments, our side of that appeal should be helped by Albrecht’s ruling that judges simply decide, straight up, which side is correct on preemption issues.  We grooved on Genentech here.  The district court’s decision is currently on appeal.
  8. Greager v. McNeil-PPC, Inc., ___ F. Supp.3d ___, 2019 WL 5549524 (N.D. Ill. Oct. 28, 2019).  Historically, generic preemption has been very extensive, whereas the role of preemption in over-the-counter (“OTC”) drugs has been rather more limited.  Thus, a lot of liability potentially depends on which side of that line generic OTC drugs fall.  This question of first impression was answered in Greager, and its application of generic preemption is good news for any potential defendant manufacturer of generic OTC products.  The drive-a-truck-through exception to OTC express preemption in the FDCA doesn’t affect application of generic preemption, because Mensing (2011+1)/Bartlett (2013+1) preemption is based on implied impossibility preemption.  Implied and express preemption operate independently, meaning that the express saving clause (which is limited to “this section” in any event) doesn’t restrict the wide scope of implied generic preemption.  The duty of sameness applies to OTC as well as prescription generics.  For this potential impact on litigation over an entire class of drugs, Greager makes our list.  We gloried in Greager, here.
  9. In re Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), 387 F. Supp.3d 323 (S.D.N.Y. 2019).  Simply the name of the injury plaintiffs were claiming in this latest tort-based assault on contraceptive choice indicates severe Daubert problems ahead – “idiopathic intracranial hypertension.”  “Idiopathic” means an unknown cause.  And that’s what happened.  In 2018, the Daubert hammer came down on these claims, in a decision that was the first of our honorable mentions that year.  But in an MDL, plaintiffs never give up no matter how weak their position.  So despite all their experts being excluded, they claimed that they could prove that the drug caused “idiopathic” injury without any experts at all.  Mirena held that argument was just as dumb as it sounded to us.  Reviewing the law of all 50 states, Mirena found that, without exception, this kind of technical causation issue absolutely required expert support.  Further, general causation was a requirement for all tort claims.  As for the rather disorderly mess of non-expert “evidence” that plaintiffs claimed could prove causation, that “end run” was simply “unsustainable.”  Last and least, plaintiffs’ Seventh Amendment challenge to an MDL-wide ruling was rejected.  MDL Daubert decisions are a two-way street, a plaintiff loss has the same litigation-wide scope that plaintiffs claim when they win.  We not only made much of Mirena, here, but Mirena inspired us to create our own 50-state survey of expert-required causation decisions here.
  10. Forrest Laboratories v. Feheley, 2019 WL 5485548, __ So.3d __ (Ala. Oct. 25, 2019).  What is our only state high court decision in the top ten doing way down here?  Because, frankly, the result should have been obvious.  As we discussed at the time, in 2015 the Alabama legislature statutorily abolished the misguided innovator liability theory that a divided Alabama Supreme Court had created the year before in Weeks (2014-1).  This statute even timed its effective date to match with the very day that Weeks was decided.  So, of course, plaintiffs claimed that this statute either hadn’t, or couldn’t abrogate Weeks.  In Feheley that Alabama Supreme Court held that, yes, the legislature had actually abolished innovator liability.  Not surprisingly, this result was mandated by “the plain meaning of the words as written by the legislature.”  Plaintiffs’ last-ditch constitutional argument also failed.  Thus, the same court that decided Weeks accepted that its ruling had been overturned by the legislature as a co-equal branch of government.  That’s great, but the legislative intent was so obvious that plaintiff should have been laughed out of court rather than being able to appeal all the way to the state’s highest court.  We focused on Feheley here.

So these are our top ten picks as the best drug/medical device decisions of 2019.  While our list seems preemption heavy (4 of 10), that’s actually no different than 2018 or 2017.  Our picks reflect the simple fact that, where preemption exists, there is no stronger defense.

But we’re not done.  2019 was another good defense year (aside from opioids, which we can’t discuss for client reasons), so we found more than ten deserving decisions.  Thus, here are our runners up, the next ten good 2019 decisions that didn’t quite crack our top ten.

Honorable Mentions:  (11) Cerveny v. Aventis, Inc., 783 F. Appx. 804 (10th Cir. 2019), ended litigation that produced top-ten decisions in 2017 and 2016, holding that a claim about pregnancy warnings didn’t make any sense where the plaintiff only took the drug before being pregnant − with the added bonus of rejecting the post-Albrecht argument that preemption can’t be based on citizen petitions filed by non-manufacturers (here).  (12) In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, 358 F. Supp.3d 418 (E.D. Pa. 2019), demonstrates how personal jurisdiction can win cases, even where the plaintiffs aren’t litigation tourists (here).  (13) In Nowell v. Medtronic Inc., 372 F. Supp.3d 1166 (D.N.M. 2019), the same judge who had, several years earlier, questioned the learned intermediary rule under New Mexico law resoundingly reaffirmed the rule’s application (here and here).  (14) Delfino v. Medtronic, Inc., 2019 WL 2415049 (Minn. App. June 10, 2019), would probably cracked the top ten had it been published, due to its first-in-the-nation post-Albrecht appellate ruling that FDA experts aren’t needed to decide “legal” preemption issues.  The defendant won because plaintiff’s purported “violations” misconstrued FDA regulations (here).  (15) Ideus v. Teva Pharmaceuticals USA, Inc., 361 F. Supp.3d 938 (D. Neb. 2019), rejected contraceptives and direct-to-consumer advertising as exceptions to Nebraska’s learned intermediary rule, and held the defendant’s warnings adequate as a matter of law (here).  (16) Powers v. Merck & Co., 773 F. Appx. 304 (6th Cir. 2019), exemplifies how the Vaccine Act has killed off vaccine-related litigation, ruling that an intentionally added substance cannot be a “contaminant” (here).  (17) Marroquin v. Pfizer, Inc., 367 F. Supp.3d 1152 (E.D. Cal. 2019), landed a one-two punch – first, the manufacturer’s warning was adequate as a matter of law, and second, since it was impossible for mere distributors to alter drug labels, preemption barred those claims (here).  (18) Davis v. McKesson Corp., 2019 WL 3532179 (D. Ariz. Aug. 2, 2019), demonstrates that, for Rule 702 reasons, the other side’s second assault on gadolinium contrast agents will be much less successful than the first (2010-5) (here).  (19) In McNeil-Williams v. DePuy Orthopaedics, 384 F. Supp.3d 570 (E.D.N.C. 2019), another court rejected the Stengel (2013-2) proposition that ordinary inadequate warning claims are somehow “parallel” to novel failure-to-report claims.  No such claim exists in North Carolina (here).  (20) Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., 2019 WL 4806271 (Conn. Super. Sept. 11, 2019).  The best state trial court decision of the year.  While ostensibly affirming this particular plaintiff’s verdict, it thoughtfully held that the claims most plaintiffs pursue in this mass tort are preempted, for the same “newly acquired information” rationale discussed, above, in Gibbons (here).

Our 2019 collection of cases concludes with a couple of near misses:  Hindermyer v. B. Braun Medical, Inc., ___ F. Supp.3d ___, 2019 WL 5881073 (D.N.J. Oct. 30, 2019) (here), and Kelsey v Alcon Laboratories, Inc., 2019 WL 1884225 (Utah Dist. April 22, 2019) (here).

Reviewing our prior lists of best and worst decisions, as already mentioned, the Supreme Court in Albrecht vacated the worst case of 2017, In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017).  Recently the Third Circuit remanded the preemption issue to the trial court, so we’ll be watching what happens.  More generally, we’re pleased to report that of our thirteen previous worst cases of the year (2017 had two), almost half are no longer good law, by reason of outright reversal (2017-1; 2016-1; 2012-1), legislative abrogation (2014-1; 2007-1), or being limited to their facts by subsequent rulings (2010-1).  By contrast, all twelve of our annual best cases are still good law.

From this year’s lists, A.Y. (2019-3) is the subject of a pending reargument petition in the Pennsylvania Superior Court.  From last year’s lists, on the dark side, Hammons (2018-3), has an appeal pending before Pennsylvania Supreme Court.  All of those other rotten tomatoes appear to be final, at least on direct appeal.  All of 2018’s top ten also seem to be concluded, with denial of certiorari in Dolin (2018+5).  There is more activity, however, among the honorable mentions, as discussed above, Mirena (2018-11) will undoubtedly be appealed.  An appeal to the Kentucky Supreme Court has been granted in the Russell (2018+17) IDE preemption case.  Further appeal was denied in Caltagirone (2018+16), another preemption case, and an appeal was withdrawn in Byrd (2018+19).  The others appear final.

As we thought last year at this time, the cy pres Supreme Court appeal in Frank v. Gaos turned into a rather good standing decision.  See Frank v. Gaos, 139 S. Ct. 1041 (2019).  The cy pres issues remain unresolved.

A quick and dirty review of the last few years of our earlier top/bottom ten lists found nothing suggesting further appeals or other consideration of the resolutions reached in those cases.

Looking forward, we know that an appeal from the adverse post-Safe Medical Devices Act §510(k) preemption decision in In re Bard IVC Filters Products Liability Litigation, 2017 WL 5625547 (D. Ariz. Nov. 22, 2017), is pending in the Ninth Circuit.  A win would have a huge upside – recognizing express 510(k) preemption on the basis of the 1990 rewriting of the Medical Device Amendments – whereas a loss would leave our side basically where it is now.  Closer to home, the Pennsylvania Supreme Court has a significant non-prescription medical product expert evidence decision pending (Walsh) on theories that could create some version of industry-wide liability.  Pennsylvania Superior Court has a pending appeal (Emmet) on comment k and medical devices, as well as a pending non-prescription medical product en banc appeal (Murray) on corporate registration to do business as “consent” to personal jurisdiction.  Bexis has filed amicus briefs in all of those appeals.

Finally, on the administrative front, we still haven’t seen any real FDA movement on its long-delayed promise to address the First Amendment obsolescence of its 1950s-vintage “intended use” regulations.  Nothing concerning off-label use issues appears in the FDA Commissioner’s recent comprehensive remarks on the direction of the Agency.  It appears, however, that the FDA itself has decided to go into the business of truthful promotion of off-label use.  The FDA also released, last September, a “Medical Device Safety Action Plan,” available here.  An interesting aspect of this plan is the National Evaluation System for health Technology (“NEST”), which is intended “to be an active surveillance and evaluation system.”  Id. at 6.  That should be one more nail in the coffin of claims predicated on failure to report, since if something’s serious, the FDA will probably learn about it (and thus be statutorily required to act, 21 U.S.C. §355(o)(4)(A)) independently of any reporting of adverse events.

Legislatively, there is a lot of talk about “high drug prices,” but whether that will actually result in legislation is questionable.  We think that any legislation should address the high and increasing “tort tax” that all the litigation we write about is imposing on prescription medical products.  All those crazy verdicts that we see – from Philadelphia, St. Louis, California, and elsewhere – would (if they stand up on appeal) only be satisfied by higher prices for all of the targeted defendants’ products, and the same goes for MDL settlements and litigation costs.

 

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As we’ve gleefully chronicled, recently the tide has been running distinctly in our favor on defendants being permitted to remove cases to federal court before plaintiffs – every one of them a non-resident litigation tourist – can serve a so-called “forum defendant” – that is, a completely diverse defendant that is also a resident of the jurisdiction where the action is originally filed.  A resident (that is, not a litigation tourist) plaintiff suing a forum defendant would not be diverse, and thus the case would not be removable at all.

This “forum defendant rule” limits removal of diverse cases to federal court when any (also diverse) defendant residing in the state is sued, no matter how many out-of-state defendants there are, and no matter how relatively unimportant the forum defendant is to the overall lawsuit.  Think of it this way:  the rule would trap six diverse, non-resident multinational corporations in state court whenever a diverse litigation tourist plaintiff also sues a single in-state mom-and-pop drugstore.

Removal before service lets those six target defendants remove the action to federal court – away from the friendly jurisdiction the litigation tourist selected − as long as they do so before the litigation tourist serves mom-and-pop with initial process (usually, but not necessarily, the complaint).  Removal before service has no effect on any plaintiff from suing anybody in the courts of that plaintiff’s home state.  Only litigation tourists would benefit from elimination of removal before service.

Two courts of appeals, the second and third, with jurisdiction over mass tort fleshpots in New York, Pennsylvania and New Jersey (as well the increasingly important personal jurisdictional haven, Delaware), have upheld the language of the statute, 28 U.S.C. §1441(b)(2), against plaintiffs’ claims that Congress couldn’t have meant what it rather clearly said.  See Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 705-07 (2d Cir. 2019); Encompass Insurance Co. v. Stone Mansion Restaurant, Inc., 902 F.3d 147, 152 (3d Cir. 2018).  As discussed in our most recent general post about this subject, these appellate rulings also appear to be moving district courts nationwide, particularly in California, in our direction.

So what have the plaintiffs done?  What they always do – forum shop.  Having first lost in the courts, and then having a rules proposal bounced by the Advisory Committee on the Civil Rules just before Halloween, they have now turned to Congress.  The Courts (and other things) Subcommittee of the House Judiciary Committee recently took time out from more important business to hold a brief hearing on removal before service (also called “snap” or “wrinkle” removal).  Two practicing attorneys – Ellen Relkin of Weitz & Luxenberg, and Kaspar Stoffelmayr of Bartlit Beck – testified, for plaintiffs and defendants, respectively.

Fair enough, but then two law professors also testified, both of whom offered schemes for precluding removal before service.  Thus, the final witness tally was an unbalanced one for our side of the “v.” and three for the other.  Law professors almost always favor more litigation, since that increases demand for lawyers, and thus the demand for professors to teach would-be lawyers.

Here’s a link to a video of the entire hearing.  Note, that for some unknown reason the video plays for over half an hour (30:22, to be precise) before anything at all happens.  Skip to that point to save yourself time.

We learn from the subcommittee chairman’s opening statement (30:39-34:58) that the aforementioned “forum defendant rule” has been around since 1789.  Also that removal before service is a “problem” because it “circumvents” that rule.  Shockingly, modern technology allows “well resourced” defendants to remove cases as little as “ten minutes” after filing.  Removal before service is “machination,” “bizarre,” “gamesmanship.” “manipulation,” “ironic absurdity,” “inherently unfair,” and so on and so forth.  Suffice it to say that the chairman does not like this removal tactic that our blog helped popularize, starting with this post back in 2007 (see also, here, here, here, and here).  Removal before service “eviscerates” the forum defendant rule.

The ranking member (who is retiring) expressed concerns in her opening statement (35:08-37:43) over “negative impact on fairness in litigation by giving one party a clear advantage over the other.”  She recognized that what is going on here is forum shopping, and that forum defendants are being joined “only included to keep a case in a state court that may be seen favorable to the plaintiffs.”  Removal before service “has served to return some balance” in determining where litigation is venued.  Suffice it to say that the ranking member is more favorable to removal before service than the subcommittee chair.

The chairman of the full Judiciary Committee also stopped by to speak (37:50-40:54).  He declared that removal before service is “the latest effort to game the system to favor the wealthy and the powerful” – and so on.  You get the drift.  We agree with him on a number of issues (Bexis recently met him at a White Plains memorial service for a friend), but not this one.  He did made the point that Congress created the forum defendant rule because the “bias” that led the framers to create diversity jurisdiction, “no longer exists” when a forum defendant is sued in that defendant’s home court.

Each witness had five minutes to testify and then answered questions.

Witness Relkin (45:26-50:40) had the usual complaints that defendants were using modern technology to prevent plaintiffs from keeping cases in whatever court they originally chose.  Removal before service was the most “dramatic” procedural “alteration of the landscape of civil litigation” that she has seen in 35 years of practice.  So our side must be doing something right, and she can’t stand it.  It’s a “perfect storm” combining increasing electronic dockets in state court and appellate courts following the plain language of the removal statute.  She dates the “problem” with removal before service to after 2011, when Congress last amended the statute.  (However, by 2010, the Blog already had ten posts on removal before service, which we detailed here, and we knew of 31 favorable cases from 14 states).  She seemed more upset about “hide and seek” with physical acceptance of service, than with removal before service itself.  She also blamed defendants for removing non-diverse cases – a limited point on which we agree (nondiverse cases can’t be removed), but one not germane to removal before service.  Her last point, that suing in the defendant’s home state was the “only state court option for out-of-state plaintiffs,” only underscores (albeit without her saying so) that removal before service only benefits litigation tourists.

Witness Stoffelmayr (50:49-55:57) (whose firm name, we noticed, was misspelled) addressed the forum defendant rule “in practice.”  Litigation tourists are seeking “some special benefit” from their choice of forum.  Removal before service is only effective where “there is proper federal diversity jurisdiction.”  Plaintiffs usually ignore the forum defendant, whose usefulness ends with successful assertion of state-court jurisdiction.  Thus, non-resident defendants are trapped in hostile state courts, notwithstanding full diversity.  The service requirement is “an important limit” on the forum defendant rule.  Amending the statute to eliminate removal before service could have “unintended consequences” that create “gamesmanship of a different kind.”  Empirical data shows that removal before service is “infrequent” (50 times a year) and thus not worth unknown possible consequences.  In any event “a plaintiff who wants to sue in their local home court” is never disadvantaged by removal before service; we are only here because of litigation tourism.  Such plaintiffs really don’t have anything to complain about.

The first of the two law professors, Arthur Hellman (56:04-1:01:16) testified that Congress intended a defendant sued in its “home state” should not be able to remove.  He was mostly interested in a technical fix to “restore symmetry.”  His recommended change would create a fixed “snap back” period during which a forum defendant could be served, even following removal, that would restore state-court jurisdiction under a modified forum defendant rule and require remand  This minimal change would, he testified, reduce the likelihood of unintended consequences and not open any new “loopholes.”

The second law professor, James Pfander (1:01:24-1:05:50) advanced four points.  First, one lesson from removal before service is that forum-shopping matters, so the best we can do is establish rules within which both sides can jockey for position.  Second, removal techniques are good candidates for legislation, since they do not involve any substantive policy.  Courts allow removal before service because of the text of the current statute.  “If Congress chooses to preserve the forum defendant rule,” removal before service should be eliminated.  Third, such removal should be prohibited rather than subject to an after-the-fact snap back.  “Ounce of prevention….”  Fourth, a solution to removal before service might be part of a larger legislative overhaul of removal procedures generally – possibly by delegating everything to a judicial rules committee.  We don’t know if Prof. Pfander was aware that the plaintiffs’ side had already unsuccessfully peddled a rules-based proposal to the existing Civil Rules Committee.

We found the following responses to questions (1:06:04-1:24:02, 1:24:45-1:30:03) interesting, or occasionally, incredible:

Hellman − The forum defendant rule rests on the assumption that as long as there is one resident defendant, no defendant needs protection from local bias.

Stoffelmayr – The forum defendant rule, when not “too quick, does have plenty of justification,” but becomes questionable when non-resident defendants are also involved.  Large non-resident defendants derive “cold comfort” from a small resident co-defendant.

Relkin – removal before service has become “an epidemic” recently.

Relkin – BMS is making fraudulent joinders “go away.”

Stoffelmayr – There are always five or ten “state court hotspots” that litigation tourists like.  Plaintiffs have “asymmetric” ability to file in federal court, whenever they want, but can prevent defendants from having that same forum.

Relkin – Defendants can rely on fraudulent joinder to solve forum shopping.  Even resident defendants use removal before service.  Defendants like unanimous juries.  [Note:  defendants like preemption, Daubert, and TwIqbal even more.]

Stoffelmayr – Fraudulent joinder is of little use because the standard is “incredibly high.”

Stoffelmayr – Both removal and service of process have been speeded up by technology.

Hellman – Once in effect, snap back, would have a preventative, or at least deterrent, effect on rapid removal.

Relkin – unless removal before service is banned, “state court jurisdiction will go away.”  Only federal courts will be able to decide what should be state-law issues, unless they certify questions.

Relkin – “Plaintiffs are not going to have the opportunity to have their cases heard where the very defendant who committed the alleged tort . . . performed it.”  [Note: this is the incredible one, since litigation tourists almost always are fleeing the state where they were the were allegedly injured.]

Relkin – is OK with snap back as a fix.

Relkin – An example of fraudulent joinder was Missouri allowing joinder of 99 plaintiffs, with only one resident plaintiff, which has been changed by that state’s supreme court.

Stoffelmayr – Missouri situation wasn’t an issue of federal fraudulent joinder at all, but a different state-law question involving personal jurisdiction, not removal.  Real problem is state mass torts with 5,000 plaintiffs, 4500 of which are non-residents, with local distributors not serious defendants but surviving a fraudulent joinder analysis.

Relkin – That example was fixed by BMS.  No problem anymore except for removal before service.

What do we think?  We think that everybody pretty much missed the point – except for fleeting references to “preserving” the forum defendant rule, and witness Stoffelmayr’s point that only litigation tourists currently benefit from that rule.

The problem as we see it is not removal before service.  That’s only a symptom.  The real problem is the explosion of litigation tourism – particularly in the mass torts that witness Relkin specializes in (she is W&L’s drug/device practice co-chair).  Litigation tourism is enabled by the forum defendant rule, which as the chairman noted has been more or less unchanged since 1789.  Think about that.  Had they lived back then, it is doubtful that either the subcommittee chair, or the ranking member, could even have voted in their home states.  More to the point, 1789 was long before widespread litigation tourism ever existed.  In 1789, litigation tourism would have meant weeks on horseback, travelling over unpaved roads, just to get to the courthouse.  Moreover, modern-style litigation tourism wouldn’t have worked once the plaintiff got there, because of the territorial limitations on personal jurisdiction exemplified by Pennoyer v. Neff, 95 U.S. 714 (1877) – but existing long before Pennoyer itself:

The authority of every tribunal is necessarily restricted by the territorial limits of the State in which it is established.  Any attempt to exercise authority beyond those limits would be deemed in every other forum, as has been said by this court, in illegitimate assumption of power, and be resisted as mere abuse.

Id. at 720, citing D’Arcy v. Ketchum, 52 U.S. 165, 172 (1850) (New York judgment could not be enforced against non-resident under a 1790 statute).  A plaintiff in 1789 could not trap a non-resident in state court by also joining a forum defendant because s/he could not obtain personal jurisdiction over the non-resident (unless lucky enough to make actual personal service by ambush).  Back when the forum defendant rule was created, a corporation was amenable to suit only in its State of incorporation.  Bank of Augusta v. Earle, 38 U.S. (13 Pet.) 519, 589 (1839).  That’s why states eventually enacted statutes requiring foreign corporations to register to do business.

The forum defendant rule itself, therefore, now operates in ways totally unintended when it was originally enacted.  It serves only to require that state courts adjudicate cases involving non-resident litigation tourist plaintiffs, injured elsewhere, as to which the states being imposed upon have no significant legal interest.

We believe that modern litigation tourism has rendered the entire concept of the forum defendant rule obsolete and archaic.  The mere presence of one “forum defendant” – in whom the plaintiff often (if not invariably) has only a nominal interest – does not prevent other, non-resident, defendants from suffering from the “home cooking” of a state court specifically selected for that purpose by the plaintiff.  That is particularly true when hundreds, or thousands, of other plaintiffs likewise lie in wait in the same place.  Removal before service is simply a tool that modern technology has handed defendants to combat the phenomenon of litigation tourism, something that the Congressional contemporaries of the Founding Fathers never contemplated, and would not have countenanced if they had.

So Congress should address the disease, not the symptom.  Removal before service is an imperfect way of combating injustices that flourish under the forum defendant rule as currently applied.  That rule should not be “preserved” or “maintained” in anything resembling its current scope.  We would happily trade a ban on removal before service for the abolition of the forum defendant rule – or the rule’s limitation to actions brought by a plaintiff who, for some reason (usually jurisdictional), is not able to sue a defendant in the plaintiff’s home state.  The forum defendant rule operates contrary to its reason for being, and thus has no place, whenever other, non-resident defendants are joined.  Until Congress is willing to put litigation tourism itself on the table, though, we believe that removal before service serves a valuable ameliorative function and should be maintained.

Photo of Eric Alexander

If you have read more than a few posts on this Blog, then there is a good chance that you realize we have strong views on preemption. You might have also picked up that we think the way an issue is analyzed, not just the ruling after the analysis, matters. We have talked about the recurring issues with purported parallel claims for PMA devices under Reigel more times than we can insert handy links—one link will have to suffice—and many of those posts have raised how implied preemption under Buckman is a real obstacle to navigating the rocky waters of parallel claims. Sometimes it seems that courts forget that a parallel claim not preempted under either express or implied preemption principles has to start with a state law claim that actually exists under the state law. State law is supposed to be the starting point and it should not expand to meet the exigencies of preemption, any more it should expand to overcome poor pleading under Fed. R. Civ. P. 12(b)(6) or TwIqbal.

OK, you say. What does this have to do with manufacturing defect claims and why is there a conundrum, you ask, patience fading like a child asked to wait to open gift-wrapped socks. Bad decisions on pleading parallel claims for PMA devices have made it easier to get to discovery—at least—on manufacturing defect claims, but actual manufacturing defect claims are very hard to prove. Among other things, there are typically records demonstrating that the lot of devices including the one plaintiffs is suing over actually met the prescribed specifications for its release and distribution. Because manufacturing defect claims are fundamentally about the particular product alleged to have produced injury not being as it was designed to be, the lot record evidence and the absence of evidence to the contrary can be dispositive on summary judgment. Our experience is that lots of manufacturing defect claims in medical device cases quietly drop out along the way. If the only claim that escapes preemption or other hurdles at the pleading stage in a PMA device case is a manufacturing defect claim, then a case may linger and soak up judicial resources for a while until an inevitable end.

Knoth v. Apollo Endosurgery US, Inc., No. 5:18-CV-49 DCB-MTP, 2019 WL 5865563 (S.D. Miss. Nov. 8, 2019), may end up being one of those cases. The plaintiff sued over a PMA gastric surgery device, asserted only expressly preempted claims, got a chance to amend, and then had her second complaint teed up on a motion to dismiss. Mississippi has a product liability act that abrogates common law claims, so (skipping ahead and omitted some details) plaintiff only had a few purported state law claims that, if pleaded properly, might avoid preemption of one kind or another. Down in the Fifth Circuit, a case called Bass (filleted and re-fried) had done what we alluded to earlier. It made it pretty easy to plead a non-preempted manufacturing defect claim for a PMA device. “The Fifth Circuit has determined that a plaintiff who pleads a violation of Current Good Manufacturing Practices—a significantly more general requirement—may succeed.” 2019 WL 5865563, *19. This path was permitted in part because of sympathy to the idea that the plaintiff would need access to the manufacturer’s documents to figure out in what way her particular device had been defectively manufactured. Id. at ** 20 & 27.

Even though her design defect and warnings claims were preempted and her express warranty claim was not—all fairly straightforward and expected rulings—the meat of the decision focused on whether plaintiff met the Bass standard by pleading “that Apollo’s failure to abide by the CGMPs resulted in the defect that injured Knoth.” Id. at *22. Plaintiff offered “several allegations of failure to comply with the [FDCA] – each specifically addressing the issue of spontaneous hyperinflation and the resulting contamination of human blood and tissue,” noted that FDA had sent warning issues on hyperinflation, and apparently offered facts that her injury “is consistent with hyperinflation set forth in the FDA warning.” Id. at **21-24. That was enough to determine that “Plaintiff’s claims for relief are sufficiently plausible.” Id. at *25. The conclusion that a MPLA claim for manufacturing defect was not preempted soon followed. Id. at **27-29.

Here is where we return to our gripe about the order of analysis when it comes to parallel claims. Precious little attention is paid to state law here, except when it comes to abrogation. The MPLA section on manufacturing defect, cited but not quoted in Knoth, requires proof that the particular product at the time it left the manufacturer’s control “was defective because it deviated in a material way from the manufacturer’s specifications or from otherwise identical units manufactured to the same manufacturing specifications.” Plaintiff pled that one or more components in her device “were defective because they deviated in a material way from the manufacturer’s . . . specifications.” While this is non-specific boilerplate and we understand that the court was going to give plaintiff a pass on having supporting facts before discovery, the earlier discussion of Plaintiff’s allegations suggests she was really asserting a design defect claim. In other words, it looks like she claims her device caused her injury because it was designed in a way that posed a risk of the injury she claims, not that her device deviated from otherwise good specifications.

In this case, Knoth identified a specific medical device, the Orbera gastric balloon system, that was manufactured and produced by the defendant. Knoth sets forth specific allegations that the Orbera gastric balloon was unreasonably dangerous and that the defendant was negligent, citing several violations of the CGMPs. For example, allegations that the defendant “failed to accurately establish the in vivo life expectancy of the Orbera gastric balloon system,” “failed to validate the anticipated wear on both healthy tissue and the Orbera gastric balloon prior to their release into commercial distribution,” and “failed to appropriately respond to adverse incident reports that strongly indicated the Orbera gastric balloon was Malfunctioning (sic) [as defined in 21 C.F.R. §803.3], or otherwise not responding to their Design Objective Intent,” taken as true, suggest a defect in the Orbera balloon as manufactured. Amend. Compl. ¶ 81(a), (b), & (h).

Id. at *25 (record citation omitted). Other than throwing in “as manufactured” at the end, these are design defect allegations, allegations in support of a preempted claim. None of these allegations, even with the court’s gloss on them, begins to suggest that plaintiff’s particular device deviated from its specifications, which Mississippi law requires to impose liability for manufacturing defect regardless of anything about federal law. Loading up a complaint with references to purported CGMP regulations should not change the result.

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