May 10 is an important day in the history of the law.  On this date, way back in 1893, the Supreme Court ruled that the tomato is a vegetable, not a fruit.  The case was called Nix v. Hedden, 149 U.S. 304 (1893).  The issue concerned application of the Tariff Act of 1883, which imposed a tax on vegetables, but not fruits.  The appellant was one of New York City’s biggest produce sellers.  He imported lots of tomatoes, and was looking to dodge the tax.  He cited dictionaries defining tomatoes, in a technical/botanical sense, as the “’fruit’ as the seed of plants, or that part of plants which contains the seed, and especially the juicy, pulpy products of certain plants, covering and containing the seed.”  But, alas, the High Court ruled that “[t]hese definitions have no tendency to show that tomatoes are ‘fruit,’ as distinguished from ‘vegetables,’ in common speech, or within the meaning of the tariff act.”  Science be damned, people eat tomatoes in their salads, not desserts, so they are vegetables, not fruits.  Because common parlance prevailed, the taxpayer did not.

 

*                    *                    *                    *                    *

 

We’ll exploit this historical legal oddity and its exaltation of common understanding as a semi-ironic preface to a case where a pro se plaintiff went down in flames in a product liability case.  In Coleson v. Janssen Pharmaceutical, Inc., et al., , 2017 U.S. Dist. LEXIS 68072 (S.D.N.Y. May 3, 2017), the plaintiff filed a pro se complaint against the defendants in New York state court (the Bronx, to be specific) , which alleged that he developed gynecomastia as a result of taking Risperdal and generic risperidone. The defendants removed the suit to federal court.  Things were already heading in the right direction for the defense.  After discovery, during which the plaintiff apparently never found an expert on causation, the defendants moved for summary judgment.  The defendants won.  The plaintiff lost.  Common sense also won: the court rejected innovator liability for an alleged failure to warn by a generic competitor.  Finally, we are reminded of that most common of courts, The People’s Court, where Judge Wapner routinely blasted plaintiffs for not having the requisite paperwork to back up their claims. 

 

After the plaintiff in Coleson had been diagnosed with bipolar schizophrenia around 2009 or 2010, physicians prescribed Risperdal and risperidone. Risperdal is the brand name product and was manufactured/sold by the defendants.  Since at least 1996, Risperdal’s FDA-approved disclosures stated that Risperdal is associated with endocrine-related side-effects, including gynecomastia.   Risperidone is the generic version.  It had been available since 2008.  Medicaid paid for all of the plaintiff’s prescriptions. New York’s Medicaid program excludes coverage of brand-name drugs when there is an FDA-approved generic equivalent on the market unless one’s healthcare provider specifically requests an exemption for the patient.  So it looks as if the plaintiff was probably taking risperidone.  That is, he took risperidone until sometime in 2013-14, when he switched to an entirely different atypical antipsychotic, which was also associated with gynecomastia.  The plaintiff was diagnosed with gynecomastia in 2015. 

 

Despite his usage of generic risperidone and a different antipsychotic, the plaintiff sued only the Risperdal brand manufacturer.  As with most pro se complaints, the theories of the case were less than pellucid.  The defendants and the court construed the causes of action as failure to warn and design defect against the brand manufacturers.  The plaintiff alleged that the side-effect information in the generic risperidone was different from the FDA-approved Risperdal label.  The defendants’ summary judgment motion argued that the plaintiff’s claims failed for lack of any evidence that the plaintiff ingested name-brand Risperdal, as opposed to generic risperdone. The defendants argued that they could not be held liable for either failure to warn or design defect for an injury resulting from a product that they did not manufacture, distribute, or sell. The defendants also argued that the plaintiff could not show medical causation between Risperdal and his gynecomastia.

 

Yes, we are confronted yet again with the issue of innovator liability.  Under Erie, the federal court needed to determine the substantive law of the forum, New York.  The New York Court of Appeals has not yet addressed whether a manufacturer of a name-brand prescription drug can be held liable for injuries resulting from another company’s generic equivalent. But there is at least one federal case, Goldych v. Eli Lilly & Co., No. 04 Civ. 1477 (GLS)(GJD), 2006 WL 2038436 (N.D.N.Y. July 19, 2006), and one New York state case, Weese v. Pfizer, Inc., 2013 N.Y. Misc. LEXIS 4761, 2013 N.Y. Slip Op. 32563 (Sup. Ct., N.Y. Cty. Oct. 8, 2013), rejecting innovator liability.  Those two New York decisions are in accord with the majority of courts to consider the topic: fifty-five other state courts across twenty-one states, in addition to all six circuit courts of appeal, have ruled that innovator liability makes no sense.  See our general innovator liability posts here and here. The Conte decision in California, which applied such innovator liability, stands as an egregious, eccentric exception.   The Coleson court acknowledged that there are a couple of cases clumsily following Conte, but the Coleson court declined to join the heresy.

 

Supporting its decision, the Coleson court discussed a recent asbestos case that, at first blush (but only first blush) seemed to offer some hope for the plaintiff.   Last year, in In re N.Y. City Asbestos Litig., 27 N.Y.3d 765, 59 N.E.3d 458 (2016), the New York Court of Appeals held that manufacturers had a duty to warn of potential dangers resulting from their products’ use in conjunction with third party products. To support this interpretation, the asbestos court observed that the manufacturers had “knowledge and ability to warn of the dangers” when consumers used the product with a third party’s product. As we discussed at the time, here, that is quite a bit different from being required to warn about use of a competitor’s product, when the defendant’s own product was not being used at all.  The Coleson court reasoned that the asbestos ruling was unlikely to make “the cost of liability and litigation . . . unreasonable”  and, moreover, the manufacturers “derive[d] a benefit from the sale of the [other party’s] product.” This rationale weighed in the opposite direction in Coleson. The brand defendants “had no oversight in the manufacturing of the generic drugs. They earned no profit from the sale of the generic drugs. Given the length of time generic drugs can sell following a patent’s expiration, to find a new duty would unforeseeably expand the cost of liability on brand-name drug manufacturers.”  Coleson, 2017 U.S. Dist. LEXIS 68072 at *10.  

 

Goodbye failure to warn claim.  The plaintiff’s failure to warn claim was dismissed because he alleged a warning defect as to only risperdone, over which the defendants had no duty of care.

 

The Coleson plaintiff’s design defect claim also failed.  He could not show by a preponderance of the evidence that he ever ingested name-brand Risperdal. The plaintiff’s declaration and deposition stated that he was prescribed, amongst other drugs, “Risperdal (risperidone)” and that a hospital in 2009 or 2010 dispensed “Risperdal and/or risperidone.” The plaintiff also claimed that hospital records proving he actually received Risperdal in the hospital were likely destroyed by a fire in January 2015. [We know some especially nettlesome plaintiff lawyers who would turn this misfortune into a spoliation claim, but the pro se plaintiff lacked either the expertise or chutzpah to pursue that vexatious path.] It was true that the plaintiff’s medical records at times recorded his prescription as only for Risperdal.  But generic risperidone is regularly written as “Risperdal (risperidone),” a nomenclature even the plaintiff repeatedly adopted in his papers.  That a drug is prescribed under its brand-name does not mean that a patient receives that name-brand drug, and it is hardly justifiable to infer that it does. In the absence of real evidence, the Coleson court was unimpressed by the plaintiff’s “mere speculation or conjecture” as to Risperdal usage.  Coleson, 2017 U.S. LEXIS 68072 at *11.

 

But let’s for the moment speculate that a “fair-minded jury” could speculate that the plaintiff was prescribed brand name Risperdal somewhere in the relevant time-frame. And yet it was undisputed that by 2009, when the plaintiff was first prescribed the medicine, risperidone was a widely available generic to Risperdal. It was also undisputed that all of the plaintiff’s prescriptions were paid by Medicaid.  Aside from exceptional circumstances the plaintiff never showed, the plaintiff’s prescriptions under Medicaid needed to be filled with generic drug equivalents. Thus, from the evidence presented, no jury could draw the “justifiable inference” that the plaintiff received name-brand Risperdal for his prescriptions. There might well have been an inference of injury from ingestion of risperdone, but the Coleson plaintiff had not sued the generic manufacturer.  Id. at *12.

 

Even assuming that the plaintiff had ingested Risperdal, his design defect claim against the defendants would still fail because he could not establish that Risperdal caused his gynecomastia. The Coleson court embraced the requirement in products liability cases that, to establish causation, plaintiffs must offer admissible expert testimony regarding both general and specific causation. The requirement is particularly pertinent where a causal link is beyond the knowledge or expertise of a lay jury.  In the Coleson case, there was no such expert in sight. Id. at *13.   

 

The plaintiff suggested he did not need an expert on causation when he had something even better:  the Risperdal label.  That label contains a warning regarding gynecomastia.  The plaintiff also pointed to a  July 2015 medical report, which concluded that the plaintiff’s gynecomastia “is related to phychiatric [sic] medical ingestion.”  The court did not buy either of these arguments.  First, Risperdal’s warning label cannot establish general causation: “Product warning labels can have over-inclusive information on them, often out of ‘an abundance of causation or the avoidance of lawsuits.’  Coleson, 2017 U.S. Dist. LEXIS 68072 at *14 (quoting In re Mirena IUD Prods. Liab. Litig., , 202 F. Supp. 3d  304, 323 (S.D.N.Y. 2016)).  Unless a warning label specifically says that an alleged injury can be caused by a drug, courts have held that a drug’s product warning label alone cannot “raise a genuine issue of material fact with respect to general causation.”  Id. Risperdal’s label states merely that it “elevates prolactin levels” and that “gynecomastia . . . ha[s] been reported in patients receiving prolactin elevating compounds.” This information is not the same as an admission of “a genuine phenomenon” creating a “material fact with respect to general causation.”

 

Nor did the Coleson plaintiff’s July 2015 medical report establish proximate cause. The plaintiff claimed to have taken Risperdal around only 2009-10. Throughout 2010 to 2014, the plaintiff took risperidone. In early 2014, the plaintiff switched to a different antipsychotic, which is also associated with cases of gynecomastia. The plaintiff was diagnosed with gynecomastia only in early 2015, and the medical report to which the plaintiff points indicates the plaintiff had taken both risperidone and the other antipsychotic. This report does not state which, if any, of these drugs was responsible for the plaintiff’s injury. Without competent medical expert testimony on the issue of causation, a jury would be left only to “theorize” as to how the plaintiff came to suffer from gynecomastia. Id. Accordingly, the defendants’ motion for summary judgment was granted.

 

So what we have here is a good result from a smart court.  That decision was made a bit easier because a pro se plaintiff sued the wrong party, hired no expert who would render some frail opinion on ‘substantial causative factor,’’ and failed to assemble decent evidence of usage.  What’s that saying about someone who acts as his own lawyer?

 

 

We’ve all had cases where plaintiffs try to use their prescribers and treaters as their experts on everything from failure to warn and causation to design defect and company conduct. Even on the medical aspects of the case, a treater needs to offer more than just an unsupported general conclusion in order to withstand scrutiny under Daubert. But, when a surgeon or an orthopedist, for example, starts to offer opinions on product defects; when he or she has sufficiently wandered away from the parameters of their general expertise; the bar needs to be set even higher. Or, at least the proffered opinion needs to be even more carefully scrutinized. And certainly something more than — gee, I’ve never seen this before – is required.

But – gee, I’ve never seen this before – is all plaintiffs had to offer in Whybark v. Synthes, Inc., 2017 U.S. Dist. LEXIS 67988 (W.D. Ken. May 4, 2017). And that’s why defendants were awarded summary judgment. The case involves a bone screw (a product dear to Bexis and me). Plaintiff had one implanted in his foot to correct an osteoarthritis issue. Id. at *1. Two months after surgery, x-rays revealed that the plaintiff’s bones had not yet fully healed. X-rays taken four months after surgery show the bone still not completely healed and also that the bone screw had fractured. Id.

Kentucky products liability actions are governed by the Kentucky Product Liability Act which allows three potential claims: defective design, defective manufacture, and failure to warn. Id. at *4-5. Plaintiffs abandoned both their design defect and their failure to warn claims. On design defect, the only evidence in the case was that plaintiff’s surgeon testified the product was safe and effective. Id. at *5. Nor did plaintiffs challenge that the package insert contained an adequate warning about the risk of screw fracture. Id. at *6.

Plaintiffs instead decided to place their sole focus on manufacturing defect. The court begins its analysis of the claim by determining that indeed plaintiffs needed expert testimony to support it. Knowledge of the design and manufacture of bone screws is “far outside the realm of common experience” of lay jurors. Id. at *7.   But the only expert proffered by plaintiffs was the implanting surgeon. The surgeon’s only testimony regarding defect was that “he suspected the breakage of the [defendant’s] screw was due to a manufacturing defect because he had never seen a bone screw break after surgery.” Id. at *2. While it’s reassuring to know that the doctor has had such a good track record, that tells us absolutely nothing about whether this particular screw contained a manufacturing defect.

But even before getting to the substance or basis for his opinion, the surgeon’s testimony failed Daubert because he was unqualified on manufacturing issues. The first point was obvious, he had no training, education or experience in manufacturing, metallurgy, or biomedical engineering. Id. at *12. Beyond that though, plaintiff could offer no reason for why the doctor’s clinical experience and personal knowledge of bone screws qualified him to offer an expert opinion on manufacturing defect. Id. The treater/prescriber’s testimony is generally admissible as to care, treatment, prognosis – things he observed, concluded, or formed an opinion on in the course and scope of treatment. Id. This is another reason to challenge a treater/prescriber’s testimony on causation, if not supported by an independent expert report that withstands Daubert. While causation is in the realm of the doctor’s expertise, if it’s not something he opined on during care and treatment, he shouldn’t be allowed to opine on it at trial.

Even though clearly not qualified, the court went on to assess the reliability of plaintiff’s surgeon’s opinion. Here, the doctor failed to state his opinion, such as it was, to a reasonable degree of medical certainty. Id. at *13. That is because he couldn’t. He had done no research. Reviewed no company or manufacturing documents. He could cite no principles to support his conclusion. Id. at *14-15. But, he was well aware that “it is generally accepted in the medical community that bone screws can fracture secondary to fatigue when subject to loads caused by non-union [non-healing].” Id. at *14. So, even though he’d never seen it before, he knew it could happen. As if that wasn’t enough to take the wind from his sails, he also testified that he would “absolutely” defer to a metallurgist on the issue of defect. Id. at *15. As luck would have it, defendants had a metallurgist and he opined that the screw met industry standards and contained no manufacturing defects. Id. at *2.

Finally, plaintiffs attempted to argue res ipsa loquitur – they didn’t need an expert because the circumstantial evidence justified an inference that the screw would not have fractured absent some defect. Id. at *17. But that theory only works if plaintiffs can eliminate “all other reasonable explanations for the accident;” in this case the fracture. But they can’t because plaintiff’s own surgeon and sole expert witness conceded that the non-healing of the bone may have caused the screw to fracture. Id.

This case appears to have been a loser for plaintiffs from the outset. Relying on the treater as a defect expert just sealed its fate. The defense relies on prescribers as learned intermediaries and we don’t go after them unless really forced to. If they step this far outside their expertise, we’re sort of forced to.

As our post-Levine preemption cheat sheet demonstrates, Mensing/Bartlett preemption is breathing down the necks of all prescription drug design defect claims.  Recent cases finding preemption of design defect claims due to the need for FDA pre-approval of “major” or “moderate” design changes (basically, anything that could be causal in a product liability lawsuit) include:  Yates v. Ortho-McNeil Pharmaceuticals, Inc., 808 F.3d 281, 298 (6th Cir. 2015); Young v. Bristol-Myers Squibb Co., 2017 WL 706320, at *5 (N.D. Miss. Feb. 22, 2017); Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449, at *12 (S.D.N.Y. Dec. 23, 2016); Brazil v. Janssen Research & Development LLC, 196 F. Supp.3d 1351, 1364 (N.D. Ga. 2016); Fleming v. Janssen Pharmaceuticals, Inc., 186 F. Supp.3d 826, 832-34 (W.D. Tenn. 2016); Batoh v. McNeil-PPC, Inc., 167 F. Supp.3d 296, 320-22 (D. Conn. 2016) (OTC drug); Barcal v. EMD Serono, Inc., 2016 WL 1086028, at *4 (N.D. Ala. March 21, 2016); Rheinfrank v. Abbott Laboratories, Inc., 137 F. Supp.3d 1035, 1040-41 (S.D. Ohio 2015); Trahan v. Sandoz, Inc., No. 3:13-CV-350-J-34MCR, 2015 WL 2365502, at *6 (M.D. Fla. March 26, 2015).

We don’t expect the other side just to sit idly by and watch their design defect claims get washed away by a preemptive deluge, and they haven’t. To counter preemptive FDA-pre approval design requirements, they’ve conjured up the idea of a “pre-approval” design defect.

What the heck is that, you ask?  Well, since preemption depends on the regulatory requirement to get FDA approval for any design change that could affect product safety, these cockamamie claims try to change the time-line – targeting the design as it stood before the drug was submitted to the FDA in the first place.  Since way back when, the prospective NDA holder could have chosen to submit some different molecule to the FDA, plaintiffs claim that the failure to do that was a “design defect.”  That is, they contend the drug was defectively designed before it could ever legally be produced commercially.

Got it?

Thankfully, this “pre-approval” defect concept hasn’t done all that well, even as a matter of preemption. In Yates the Sixth Circuit, the first appellate court to pass on such a claim, accurately rejected it as another variant of a preempted claim that the defendant should never have sold its product.

In contending that defendants’ pre-approval duty would have resulted in a [product] with a different formulation, [plaintiff] essentially argues that defendants should never have sold the FDA-approved formulation of [their drug] in the first place.  We reject this never-start selling rationale for the same reasons the Supreme Court in Bartlett rejected the stop-selling rationale of the First Circuit.

808 F.3d at 800; accord Utts, 2016 WL 7429449, at *11; Brazil, 196 F. Supp.3d at 1364 (subjecting pre-approval design defect claims for preemption for similar reasons.

However, a few recent cases from Fifth Circuit turf have let pre-approval design defect claims escape preemption.  See In re Xarelto (Rivaroxaban) Products Liability Litigation, 2017 WL 1395312, at *3 (E.D. La. Apr. 13, 2017) (“Louisiana law imposes a duty on all manufacturers to consider feasible, alternative designs. . . .  Federal law does not prevent a drug manufacturer from complying with this state-imposed duty before seeking FDA approval.”) (following Guidry v. Janssen Pharmaceuticals, Inc., 206 F. Supp.3d 1187, 1206-97 (E.D. La. 2016)); see also Young v. Bristol-Myers Squibb Co., 2017 WL 706320, at *8 (N.D. Miss. Feb. 22, 2017) (“there is no conflict between [plaintiff’s] pre-approval theory and the defendants’ federal law duties”) (also following Guidry).

We, of course, think Yates nailed it on preemption – any common-law claim, the result of which would be a jury finding that an FDA-approved product design should never have been sold, is a stop-selling claim barred by Mensing/Bartlett.  The FDA determines what products may be marketed, not individual juries misled by reptile-minded plaintiffs’ lawyers.

But this post isn’t about that – it is not another defense of preemption.  Another thing Yates had to say about pre-approval design defect claims was:

[Plaintiff’s] argument regarding defendants’ pre-approval duty is too attenuated.  To imagine such a pre-approval duty exists, we would have to speculate that had defendants designed [the drug] differently, the FDA would have approved the alternate design.  Next, we would have to assume that [plaintiff] would have selected this [hypothetical product].  Further yet, we would have to suppose that this alternate design would not have caused [plaintiff’s injuries].  This is several steps too far.  Even if New York law requires defendants to produce and market a different design, the ultimate availability to [plaintiff] is contingent upon whether the FDA would approve the alternate design in the first place.

808 F.3d at 299.  Thus, the Sixth Circuit was “unable to conceive of any coherent pre-approval duty that defendants would have owed to [plaintiff] when it was developing” the product.  Id. at 300.  See also Young, 2017 WL 706320, at *8 (“the parties have not argued whether Mississippi law recognizes a pre-approval claim, and the Court does not reach the issue”).

The reason that Yates (and, apparently, Young) was “unable to conceive of” a state law pre-approval duty is because such duties do not exist.  Design defects under Restatement (Second) of Torts §402A (1965), do not suffer from the “attenuation”/”speculation” problem identified in Yates because §402A is limited to products that are defective at sale.  “The rule stated in this Section applies only where the product is, at the time it leaves the seller’s hands, in a condition . . . which will be unreasonably dangerous” to the ultimate consumer.  Restatement (Second) of Torts § 402A, comment g (1965).

In the Third Restatement, this time in the black letter, rather than the comments, all “categories of product defect” are likewise determined “at the time of sale or distribution.”  Restatement (Third) of Torts, Products Liability §2 (1998).  The comments reinforce this view.  “[F]or the liability system to be fair and efficient, the balancing of risks and benefits in judging product design and marketing must be done in light of the knowledge of risks and risk-avoidance techniques reasonably attainable at the time of distribution.”  Id., comment a.  “[T]he plaintiff must prove that such a reasonable alternative was, or reasonably could have been, available at time of sale or distribution.” Id. comment c.  Similarly the black letter of Restatement Third §6(b), specifically applicable to prescription medical products, expressly measured defectiveness – including design defect, to the extent allowed at all − “at the time of sale or other distribution.”

Statutory product liability schemes are generally similar to the common law stated in the Restatements with respect to when defectiveness is measured.  Since both Xarelto and Guidry (on which it almost exclusively relied) are from Louisiana, we looked up the equivalent provision of the Louisiana Product Liability Act, which for design defects provides:

A product is unreasonably dangerous in design if, at the time the product left its manufacturer’s control:  (1) There existed an alternative design for the product that was capable of preventing the claimant’s damage. . . .

La. Stat. Ann. §9:2800.56 (emphasis added).  Thus, under Louisiana law, an available alternative design must exist “at the time the product left its manufacturer’s control.”  E.g., Reynolds v. Bordelon, 172 So. 3d 607, 614 (La. 2015) (“the plaintiff was first required to show an alternative design for the [product] existed at the time it left [defendant’s] control”); Roman v. Western Manufacturing, Inc., 691 F.3d 686, 700–01 (5th Cir. 2012) (“the statute required [plaintiff] to prove (i) that an alternative design existed at the time [defendant] manufactured the [product]”)  (applying Louisiana law).

Thus, quite apart from preemption, there is no common-law claim for a product that became defective at some time – years, perhaps decades, before the product itself was sold – when the design was first submitted to a government regulator like the FDA.  This essentially universal common-law requirement exists, as the Restatement Third discussed, to ensure that defendants are judged by the state of the art existing at the time of manufacture, not some other time way later, or presumably way earlier (although we suspect that the Restatements’ drafters were, like the court in Yates, “unable to conceive of” something as bizarre as a purported duty to redesign a product years before it had ever been sold to anyone).

In order to avoid this result, Guidry was forced to ignore the express terms of the Louisiana statute – “at the time the product left its manufacturer’s control.”  Contrary to what the Louisiana legislature had mandated, Guidry replaced “product” with “design” – specifically “chemical composition”:

Defective design claims are supposedly preempted because the drug manufacturer loses control to alter the chemical composition of the drug once the FDA approves it.  Application of the defendants’ preemption theory necessarily entails that the drug “leaves the manufacturer’s control” when the FDA approves it, not when it is sold to consumers.  Consequently, the “unreasonably dangerous” analysis in the defective design context necessarily occurs pre-FDA approval (the only period in which the drug manufacturer has control over the drug’s design).

206 F. Supp.3d at 1208.  As a regulatory matter, that proposition is simply false.  A manufacturer still has “control” of product design.  It can file what’s called a “supplement” to its NDA at any time to change a design.  However, the FDA gets to evaluate the supplement first, before it can go into effect – and that triggers preemption.

But for present purposes, note how Guidry put the rabbit in the hat.  It truncated its quotation of the statute – starting just after the legislature’s operative term “the product.”  The LPLA even defines “product”:

(3) “Product” means a corporeal movable that is manufactured for placement into trade or commerce, including a product that forms a component part of or that is subsequently incorporated into another product or an immovable.

La. Stat. Ann. §9:2800.53(3).  A “product” is thus “corporeal” – it is not merely its “design,” nor is it just its “chemical composition.”  Guidry never acknowledges this statutory definition.  “Corporeal” nowhere appears in that extremely long opinion.

Thus Guidry conveniently omitted what the legislature in fact enacted.  Only by substituting “design”/“chemical composition” for “product” as defined by the LPLA could Guidry advance to its next remarkable proposition:  that in the case of all FDA-approved products, Louisiana’s (or presumably some other state’s) “’unreasonably dangerous’ analysis in the defective design context necessarily occurs pre-FDA approval.”  206 F. Supp.3d at 1208 (emphasis added).

“Necessarily”?  Come on, now.

What does Guidry cite for this remarkable proposition that juries must determine the defectiveness of an FDA-approved design at a point before it was ever approved by the FDA – that is, many years before it was ever used by any plaintiff?

Nothing at all.  Zilch.  Not a single statute.  Not a single case.  Guidry made it up.

As we have stated many times before, for a federal court to invent new state law, expanding liability where the state’s courts and lawmakers have not gone, is a serious violation of federalism under Erie v. Tompkins.  “As always, in conducting [an Erie] inquiry our task is ‘to predict state law, not to create or modify it’ − that is, we are ‘to apply existing Louisiana law, not to adopt innovative theories for the state.’”  Holden v. Connex-Metalna Management Consulting GmbH, 302 F.3d 358, 365 (5th Cir. 2002) (quoting United Parcel Service, Inc. v. Weben Industries, Inc., 794 F.2d 1005, 1008 (5th Cir. 1986)).  As the en banc Fifth Circuit explained thirty years ago:

As a federal court, it is not for us to adopt innovative theories of state law, but simply to apply that law as it currently exists. . . .  We are emphatically not permitted to do merely what we think best; we must do that which we think the [state’s] Supreme Court would deem best.  Finally, under Erie we cannot skirt the clear import of state decisional law solely because the result is harsh.

Jackson v. Johns-Manville Sales Corp., 781 F.2d 394, 397 (5th Cir. 1986) (en banc) (citations and quotation marks omitted), overruled in part on other grounds, Salve Regina College v. Russell, 499 U.S. 225 (1991) (rejecting appellate deference to in-state district court Erie predictions).

As Jackson “emphatically” held, “under Erie we cannot skirt the clear import of state decisional law solely because the result is harsh.”  That’s exactly where Guidry erred.  Before mangling Louisiana’s statutory defect-at-sale requirement, Guidry complained about a harsh result:

The Court first notes that, if it finds the plaintiff’s defective design claim is preempted, even under a pre-FDA approval theory, the result is that a Louisiana plaintiff can never bring a defective design claim against a drug manufacturer. . . .   And no federal remedy exists either. . . .  As a result, if the defendants’ preemption argument prevails, Louisiana plaintiffs will have no remedy against a drug manufacturer for a defect in a drug’s design.

206 F. Supp. at 1206-07 (Levine quotation omitted) (emphasis original).  Thus, the Erie error in Guidry is no accident.  The decision deliberately flouted the law to avoid a result it didn’t like.  For the hundredth time we’ll say, strange things happen in tort preemption cases.  In Guidry, that strangeness was the invention out of whole cloth of a novel “pre-approval” design defect that is flatly inconsistent with Louisiana’s defect-at-sale requrement for design defects.

Not only that, but the contortions that this novel idea of “pre-approval” design defects require of the well-established defect-at-sale requirement (both statutory and common-law) will have unintended consequences.  The LPLA, similarly to the common-law as stated in the Second and Third Restatements, imposes the exact same “at the time the product left its manufacturer’s control” limit on warning defects.  La. Stat. Ann. §9:280.57(A).  Warnings are FDA approved, too, so if defect analysis “necessarily occurs,” Guidry, 206 F. Supp.3d at 1208, prior to FDA approval, consider whether a plaintiff should be able to “claim[] that the defendants intentionally concealed or downplayed the seriousness and likelihood of these adverse side effects” during post-approval promotional activities.  Id. at 1199.  Guidry found nothing amiss with the warning claims, id., but unless we are dealing with a “heads plaintiffs win; tails defendants lose” situation, the defect at sale requirement – whether statutory or common-law – has to run from the same date for both warning and design claims.  And on warning claims, that absurdly early date favors defendants.

In sum – forgetting about preemption − the notion of a “pre-approval” design defect is a non-starter under state law, and rightly so. The legal requirement that a product be defective at the time of distribution is a bedrock product liability principle in all states, and as just discussed, that requirement is utterly incompatible with plaintiffs’ new defect theory that pushes the defect analysis earlier by years if not decades.  This novel theory is being asserted solely to avoid the FDA-pre-approval trigger for preemption first recognized in Wyeth v. Levine, 555 U.S. 555 (2009).  But federal courts under Erie are not supposed to make up new state law just because Levine’s preemption analysis happens to require broad preemption in design defect cases.

Executions by lethal injection are in the news. Arkansas recently executed four inmates in just eight days. One of the drugs that it uses for its three-drug lethal injection protocol was set to move beyond its expiration date. And, apparently, Arkansas wanted to use them before that happened.  It seems that states are finding it more and more difficult to get the drugs that they need for lethal-injection executions.

In fact, Texas so badly needs to get access to one of those drugs that it is now suing the FDA to get it. The drug—thiopental sodium—is used to render inmates unconscious before the lethal drugs are administered. But Texas can’t get thiopental sodium anymore because the FDA, as of five years ago, bans its importation. It did so after a group of inmates successfully sued the FDA in federal court to stop it from allowing thiopental sodium into the country. The inmates claimed that thiopental sodium (i) was “misbranded” and (ii) an unapproved new drug. Interestingly, the FDA conceded both points. It argued that it could still allow thiopental sodium into the country, however, by exercising its enforcement discretion. The federal court disagreed. See Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012), aff’d in part, rev’d in part sub nom., Cook v. FDA, 733 F.2d 1 (D.C. Cir. 2013). The court held that the language of the Food, Drug and Cosmetic Act, in particular its repeated use of the word “shall,” gave the FDA no such discretion. We wrote about that decision here.

Since then, the FDA has banned the importation of thiopental sodium. And that’s where Texas comes in. Texas needs thiopental sodium for its lethal injection program. In 2015, Texas attempted to import thiopental sodium to be used in its lethal injection protocol, and the FDA detained it. On April 20, 2017, after a lengthy administrative process, the FDA reached (what Texas calls) a final decision, holding firm to its determination that it must follow the Beaty decision and ban the importation of thiopental sodium.

And so, just over a week ago, the Texas Department of Criminal Justice filed an amended complaint in federal court in Texas challenging the FDA’s determination. Texas, however, does not claim that the FDA does in fact have the enforcement discretion necessary to allow thiopental sodium into the country. Instead, it tries to shift the focus of the dispute, claiming that thiopental sodium is not misbranded and that its distribution does not require FDA approval.

In particular, Texas claims that thiopental sodium does not meet the FDCA’s definition of a “new drug” and therefore does not require FDA approval. Under the FDCA, a drug is a “new drug” requiring approval if it is not generally recognized by experts “as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.” 21 U.S.C § 321(p). Texas claims that the labeling of the thiopental sodium it imported makes no statements about its use at all and, therefore, it does not qualify as a new drug that requires approval. Texas also claims that its proposed use of thiopental sodium falls under a “law enforcement” exception (21 C.F.R. § 201.125) to the statutory requirement that a drug come with instructions for use and, therefore, the thiopental sodium was not “misbranded” for failure to come with such instructions.

Well, these are certainly interesting claims, ones that we are quite sure that the FDA will fight. In fact, the FDA’s administrative decision states that it doesn’t buy this arguments. The FDA believes that the statements made on the thiopental sodium packaging, as limited as they are, suggest its use for lethal injections and therefore constitute labeling requiring its approval as a new drug. It also believes that the “law enforcement” exception does not apply when the drug is to be administered to humans.

From our point of view, we know that a regulatory agency like the FDA is not going to accept a claim that limits it authority or jurisdiction without a fight—particularly when, as here, it addresses whether the FDA must approve a “new drug,” one of the most important roles that the FDA plays. Accordingly, this litigation will address important issues related to labeling and “new drugs,” and we will follow it.

This guest post by Andrew C. Bernasconi, of Counsel at Reed Smith, is about a hopeful development in a False Claims Act case we’ve already blogged about once.  The previous post queried, what happens when a FCA relator, blinded by the dollar signs in his/her eyes, resorts to questionable means to gin up “facts” that substitute for the personal knowledge that the statute assumes the relator has, but in this case did not?

This time, the chickens came home to roost.  Read and enjoy.

As always, our guest bloggers are 100% responsible for their insights – entitled to all the credit (and any blame – maybe for the asides about the greatest Super Bowl ever played).

*********

“I’m sure you all share my view when I say, ‘Go, Patriots.’”

These words from Boston-based U.S. Judge Dennis Saylor IV of the District of Massachusetts, when closing out a motion to dismiss hearing just a few weeks prior to Super Bowl 51, undoubtedly intended to reference the mighty New England Patriots and their impending appearance in what would become a historic win over the outmatched Atlanta Falcons.

Judge Saylor’s recent decision dismissing a qui tam False Claims Act (FCA) case, based on what he determined were deceit and ethical violations by plaintiff’s counsel, calls to mind the words of a different kind of patriot, Chief Justice John Marshall:

“Let the end be legitimate, let it be within the scope of the constitution, and all means which are appropriate, which are plainly adapted to that end, which are not prohibited, but consist with the letter and spirit of the constitution, are constitutional.”

McCulloch v. Maryland 17 U.S. 316, 421 (1819) (interpreting the Necessary and Proper Clause).  While the context of Judge Saylor’s recent decision differs dramatically from the issues considered by Justice Marshall in 1819, the focus of both on just ends and means provides a common theme.

We first blogged back in November about the case of U.S. ex rel Leysock v. Forest Laboratories LLC, where we explained that the defendant filed a motion to dismiss the qui tam relator’s False Claims Act allegations that were premised on false claims tied to alleged off-label marketing of a drug indicated to treat Alzheimer’s Disease.  Although the court denied a prior motion to dismiss relator’s complaint, finding that it contained sufficient particularity to satisfy Rule 9(b)’s heightened pleading standard, the defendant took the unusual step of filing a subsequent motion to dismiss while discovery was ongoing.  In the subsequent motion to dismiss, the defendant relied on discovery showing that relator’s counsel had hired a physician as an “investigator” to persuade other unwitting physicians, under the guise of conducting a “research study,” to provide confidential patient medical records for what (unknown to these other physicians) turned out to be for litigation purposes.  Relator’s counsel, of course, vigorously opposed the motion and contended that they had not engaged in any wrongdoing.

On April 28, 2017, Judge Saylor issued his opinion (copy here), in which he granted the defendant’s motion and dismissed the relator’s complaint. Leysock, No. 12-11354-FDS, slip op, (D. Mass. Apr. 28, 2017).  In a well-reasoned decision, Judge Saylor found there was “no dispute” that relator’s counsel had engaged in a scheme that involved “an elaborate series of falsehoods, misrepresentation, and deceptive conduct,” including:  (1) designing an investigation to obtain confidential information from physicians under the guise of a medical research study and (2) employing a physician as their agent to tell other physicians that records supplied by physicians to facilitate the “study” would remain confidential.  Slip op. at 14.

According to the court, this conduct violated ethical rules prohibiting knowing false statements of material fact made to third persons (Mass. R. Prof. Conduct 4.1(a)), and engaging in conduct involving dishonesty, fraud, deceit, or misrepresentation (Mass. R. Prof. Conduct 8.4(c)).  Slip op. at 15.  While acknowledging limited exceptions to these rules, where counsel may employ deception in investigations (e.g., using “discrimination testers” or investigators to uncover evidence of racial discrimination), the court concluded that the extreme conduct authorized by relator’s counsel – obtaining the confidential health information of innocent and unsuspecting patients under false pretenses from innocent physicians, and then breaching the disclosing-physicians’ trust by publishing confidential patient information in a lawsuit – easily distinguished this case from those where counsel’s deception was permissible.  Id. at 15-21.  [Editor’s note:  As a fan of the Patriots, Judge Saylor was well-positioned to evaluate whether sleazy schemes involved permissible deception or something worse.  Take that how you want, good reader.]

The court also rejected the argument by relator’s counsel that the ends justified the means.  Slip. op. at 21-23.  Relator’s counsel essentially argued that if relators are not permitted to use the type of deception at issue here, then it would be “difficult, if not impossible” for qui tam relators to satisfy the Rule 9(b) particularity requirement applicable to FCA cases.  Id. at 22.

This is where the concerns we mentioned in our earlier blog post, about opportunistic plaintiffs’ attorneys who manufacture cases lacking legitimate factual bases in hopes of obtaining financial windfalls, come to mind.  As Judge Saylor recognized, the FCA is designed to encourage claims by relators with actual, personal knowledge of fraudulent conduct, slip. op. at 22-23 – not by those who must resort to such deceptive tactics, like now-adjudicated unethical intrusions into the sanctity of the physician-patient relationship, as their only basis to prepare a complaint with sufficient information to survive a Rule 9(b) motion to dismiss.  A proper whistleblower has knowledge.  Different labels apply to those who mislead people for their own gain.

Employing the court’s inherent powers, Judge Saylor removed from relator’s complaint all information derived from the unethical investigation, and evaluated whether the remaining allegations could satisfy Rule 9(b).  They could not.  In other words, relator’s complaint had survived the defendant’s initial motion to dismiss only because of the information obtained from the unethical investigation.  Slip. op. at 23-27.  As a sanction, the court dismissed the relator’s complaint with prejudice to the relator (and without prejudice as to the United States, the real party in interest in qui tam cases).  Id. at 27.  But for a benevolent fan of patriots and Patriots (is there any other kind?), who determined that individual sanctions against relator’s attorneys were “not appropriate in this proceeding,” slip. op. at 24, there could have been more severe monetary or other sanctions for the use of deceptive or fraudulent means to advance that case.

As Judge Saylor held, the ends did not justify the unethical means employed by relator’s counsel.  Thus, for the defendant, justice finally (albeit belatedly) prevailed in this case.  If only relator’s counsel had been fans of patriots like Chief Justice Marshall, and employed only “means which are appropriate” to reach legitimate ends, this entire situation could have been avoided.

Next week, we are traveling to Budapest, with a side trip to Vienna. We are visiting the Drug and Device Law Rock Climber, who is spending this semester abroad studying computer science (in Budapest) and climbing rocks (in Majorca, etc.).  Aside from the beloved visage of our only child, we are most excited about seeing the Lipizzaner stallions perform at the Spanish Riding School in Vienna.  When we were eleven years old, we read “My Dancing White Horses” by Colonel Alois Podhajsky, director of the School.  This wonderful autobiography recounts Podhajsky’s extraordinary efforts to save the Lipizzaners during World War II.  It was (and is) a compelling read, and it led us to “My Horses, My Teachers,” Podhajsky’s homage to his stunning equine mentors.  Since that time, the Lipizzaners have occupied a permanent spot atop our bucket list, and we are beyond thrilled to hold tickets to one of their performances.  Beyond that, we had to start from scratch to plan this trip.  We Googled and researched, and our takeaway was how much we didn’t know about Budapest’s history and culture.

Perhaps the plaintiff’s would-be experts in today’s case should have engaged in similar assessments of their knowledge bases. Regular readers of this blog are familiar with our ongoing rant against “experts” who aren’t, and with the cases that nonetheless ride on the “experts’’ unqualified shoulders.  In this case, the Court agreed with us.

In Hale v. Bayer Corporation, 2017 WL 1425944 (S.D. Ill. Apr. 20, 2017), the plaintiff alleged that the defendant’s product, an over-the-counter (“OTC”) non-steroidal anti-inflammatory drug (“NSAID”) caused him to develop a permanent kidney injury known as “Minimal Change Disease” (“MCD”). He asserted the usual product liability claims sounding in strict liability and negligence, and identified three experts.  The defendant moved to exclude all three – the plaintiff’s primary care physician, the plaintiff’s treating nephrologist, and a pharmacist — under Daubert, arguing that none had rendered an opinion that was “properly founded in or based upon sufficiently reliable medical, scientific, or other specialized knowledge.” Hale, 2017 WL 1425944 at *1 (citation omitted).

Plaintiff’s Primary Care Physician

The plaintiff’s primary care physician testified that he referred all kidney patients to a nephrologist and that he had never studied whether NSAIDs may cause particular kidney injuries. Naturally, the defendants moved to exclude him because he was unqualified to offer causation opinions and because he relied on the plaintiff’s treating nephrologist’s opinions and diagnosis as the basis of his opinions.  In their response, the plaintiffs stated that they would not offer the expert to testify about causation,  but only to discuss his care and treatment of the plaintiff.  The Court agreed that the doctor would be permitted to testify about his treatment of the plaintiff but would not be permitted to offer causation opinions.

Plaintiff’s Treating Nephrologist

Next, the plaintiff offered his treating nephrologist, who diagnosed the plaintiff with NSAID-induced MCD.  The defendants argued that the nephrologist’s opinions were “insufficiently supported by medical science” and that he was “not able to definitively establish by any medical or laboratory test that the plaintiff’s consumption [of the NSAID] was the cause of his MCD.” Id. at *3.  They also argued that the nephrologist’s purported “differential diagnosis” was based on insufficient scientific data.  The plaintiffs argued that the doctor had 30 years of experience as a nephrologist, that he managed the plaintiff’s case, and that he relied on scientific literature in reaching his causation conclusion.

The court cited case law confirming that, while a properly-performed differential diagnosis can constitute a reliable methodology, such diagnosis must go “beyond the mere existence of a temporal relationship” between the plaintiff’s ingestion of the defendant’s product and the onset of his symptoms. Id. at *4.  Analyzing the doctor’s methodology, the court observed that the doctor had ruled out certain diseases that can cause MCD.  He also ruled our food poisoning and some infections.  But most MCD is idiopathic.  (Idiopathic means nobody knows what causes it.)  To rule out idiopathic MCD in the plaintiff’s case, the doctor testified that he relied on the temporal relationship and on scientific literature that had acknowledged “for the last 25 years that NSAIDs can cause renal injury or renal malfunctions.” But the data the doctor cited involved prescription-strength NSAIDs, and he testified that he did not know of studies involving lower-strength OTC NSAIDs and had never read an article linking the defendant’s specific NSAID to renal injury.  The court concluded that the doctor could not “provide any scientific and/or medical data with regard to the relationship of over-the-counter NSAIDs and kidney disease,” let alone any specific data related to the defendant’s product.  As such, the doctor’s opinions were “unreliable based on the lack of supporting medical science as required by” Fed. R. Evid. 702.  Moreover, though the doctor had general knowledge about the diagnosis and treatment of kidney disease, he lacked “expert knowledge with the specific subset of over-the-counter NSAIDs” and MCD.  And so, like the PCP, the nephrologist was permitted to testify about his care of the plaintiff but was precluded from offering causation testimony.

The Pharmacist

Finally, the plaintiff offered a pharmacist to testify, as an element of Illinois’s “consumer expectation test,” that the plaintiff’s particular kidney injury was foreseeable to the defendant and that the danger of this injury went beyond that which would be contemplated by the “ordinary patient with ordinary knowledge common to the community.” The pharmacist was qualified to offer this opinion, they argued, “based on many years of educating and working with healthcare providers and providing healthcare services to patients.” Id. at *6.  He said that he “regularly interacted with [patients] and understood their level of awareness regarding OTC . . . NSAIDs and kidney injury.” Id. at *7.

The court pointed out that the pharmacist was not a physician, had never participated in clinical trials involving any NSAID, and was not aware of any cases of MCD associated with OTC use of the defendant’s product. Though he had reviewed 203 case reports, none involved MCD, and, in any event, the court had previously rejected expert opinions based on case reports.  As the court emphasized, “Because of their limitations, case reports have been repeatedly rejected as a scientific basis for a conclusion regarding causation. Such case reports are not reliable scientific evidence of causation, because they simply describe reported phenomena without comparison to the rate at which the phenomena occur in the general population or in a defined control group. . . [T]hey do not isolate and exclude potentially alternative causes . . . and do not investigate or explain the mechanism of causation.”  Id. at *8 (citation omitted).

Finally, the court held that the pharmacist “clearly [did] not have the necessary background to offer an opinion of whether the risk and danger of [the product] outweighed its benefits.”  His entire opinion was “based on the fact that there are alternative [products] that may achieve the same relief benefit.  That is like saying that an individual could safely ride the train to work and thus have avoided a car accident, [but] . . . there is no indication of a complete risk/benefit analysis being conducted by [the pharmacist] or that [he] relied on any studies” conducting such an analysis.  Id. at *7.  (We have posted on this issue before.  You can see some of the posts here.)  The court concluded that the pharmacist had “provided no support – other than his general experience – of the opinions” he had offered. As such, the court held that the pharmacist’s opinions were “unreliable based on the lack of supporting data as required by Federal Rule of Evidence 702.” Id. at *8.

And then there were none. And with no experts, the plaintiffs could not meet their burden of proof of causation.  Moreover, while the court acknowledged that Illinois had not decided whether the consumer expectation test required expert testimony, the plaintiff had not demonstrated that the defendant’s product was unsafe, because “every expert deposed stated that they believed [the product] to be safe when used as directed.” Id. at *11.  Check and mate – summary judgment granted for defendants.

Sometimes, when we write this stuff, we have trouble keeping a straight face because the plaintiffs’ arguments so lack merit as to verge on silliness. It continues to puzzle us that these experts – and these cases – even see the light of day.  But we are grateful for the sensible judges who extinguish them.

We’ll be back in a week or so, with pictures of beautiful white stallions (and one beautiful daughter) in hand. E-mail us – we’ll send you copies.

 

Today, the Tenth Circuit affirmed in part, reversed in part, and remanded the post-Levine branded drug preemption decision in Cerveny v. Aventis, Inc., No. 16-4050 (10th Cir. May 2, 2017).  You can read our discussion of the district court opinion in Cerveny here.

While any decision with a description of “affirmed in part, reversed in part, and remanded” is necessarily something of a mixed bag, we’re pleased to report that the defense side won the two most important preemption issues presented in Cerveny (preemptive effect of FDA citizen’s petition denials and of FDA “no evidence” determinations, the court dodged the third (the judge/jury issue from Fosamax), and did its reversing and remanding on issues that could still eventually be preempted, but that it thought the district court had paid insufficient attention.

Cerveny was a birth defect case, and the plaintiff’s major claim was that she took the drug before becoming pregnant.  Slip op. at 2, 13 (all “parties agree that [plaintiff mother] took [the drug] before she became pregnant, but not afterward”).  Plaintiff made a secondary claim – about warnings of risks that the plaintiff did not actually encounter – that if a warning the FDA had actually proposed, concerning the possibility of birth defects during pregnancy, had been included, she wouldn’t ever have taken the drug, even though she never actually took it during pregnancy.  Id. at 3-4.  As we recently discussed in our Smoke Screens & Side Shows post, the law overwhelmingly rejects warning claims based on risks that the plaintiff never actually encountered.

The first theory was the important one, and the Tenth Circuit affirmed preemption:

The ruling was correct on [plaintiffs’] first theory, for the undisputed evidence shows that the FDA would not have approved a warning about taking [the drug] before pregnancy.

Slip op. at 4. As for the second, stay tuned, we’ll discuss it in the order the opinion addressed the claims.

The “clear evidence” required by Wyeth v. Levine, 555 U.S. 555 (2009), existed as to plaintiffs’ before-pregnancy theory because that issue was directly presented to the FDA prior to the injuries claimed in Cerveny by a citizen’s petition that the FDA rejected for lack of evidence.  Thus Cerveny presented the same “changes being effected” exception to FDA pre-approval of warning changes situation as had Levine.  However, “even when this exception applies, the FDA will ultimately approve the label change only if it is based on reasonable evidence of an association.”  Cerveny, slip op. at 7-8 (regulatory citation omitted).

Plaintiffs first tried to argue that there could never be preemption in branded drug warning cases, claiming that Levine’s “discussion of the “clear evidence” standard [w]as dicta.”  Id. at 11.  That Hail Mary pass went nowhere:

[O]ur court has relied on Levine in holding that a state tort claim is preempted if a pharmaceutical company presents clear evidence that the FDA would have rejected an effort to strengthen the label’s warnings.  Thus, we must apply the “clear evidence” test.

Id. at 11-12 (citing Dobbs v. Wyeth Pharmaceuticals, 606 F.3d 1269 (10th Cir. 2010)).

Next, as this blog has discussed, while Cerveny was pending, the Third Circuit decided In re Fosamax Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), including its precedent-shattering holding that the “what the FDA might have done” question posed by Levine “clear evidence” preemption wasn’t a question of law after all.  Id. at 286-89.  Plaintiffs in Cerveny had not argued that proposition, but once Fosamax was decided, they belatedly tried to raise it.  The Tenth Circuit was not inclined to go there.

[Plaintiffs] insist that we should adopt the Third Circuit’s approach and deny summary judgment if “no reasonable juror could conclude that it is anything less than highly probable that the FDA would have rejected” the proposed label.  We are reticent to take this approach, for the parties’ appeal briefs do not address this issue.

Cerveny, slip op. at 11-12.  Ultimately, though, Fosamax didn’t matter because even assuming that its standard applied, preemption barred plaintiffs’ before-pregnancy warning claim.

The court first looked at the direct regulatory history of the drug, and FDA consideration of teratologically-related warnings.  Not enough, the court held:

[The drug’s] regulatory history is similar to Phenergan’s [the drug in Levine].  Like Phenergan, [this drug] had appeared on the market for decades before [plaintiff mother] took [it].  And [defendant] has intermittently corresponded with the FDA about [the drug’s] labels. . . .  Likewise, the FDA’s approval of [the drug’s] labels suggests only that the FDA knew about potential issues involving pre-pregnancy use . . . not that the FDA would have rejected a stronger warning if one had been proposed.

Cerveny, slip op. at 17.  So, if that was all the regulatory history, the defendant would have lost. – but it wasn’t.

Enter the citizen’s petition.

A plaintiff’s lawyer brought a citizen’s petition seeking to force the FDA to add a pre-pregnancy birth defect warning to the drug after the use at issue in Cerveny.  Id. at 14 & n.8, 18-19.  That petition was denied in 2009 (the use in Cerveny occurred in 1992).  Id. at 19.  Critically, the FDA denied that petition for lack of scientific basis – using the same regulatory standard of proof applicable if the manufacturer had sought the same change.

The FDA concluded that . . . “the scientific literature [did] not justify ordering changes to the labeling that warn of such risks beyond those presently included in labeling”. . . .  [Petitioner] sought reconsideration, which he twice supplemented with more information.  The FDA declined to reconsider, explaining that the original denial had “appropriately applied the standards in the [FDCA].

Cerveny, slip op. at 19.

The petition denial satisfied Levine’s “clear evidence” standard.  Plaintiffs’ “failure-to-warn claims are based on the same theories and scientific evidence presented in [the] citizen petition.”  Id.

Cerveny rejected plaintiffs’ argument that citizen’s petitions shouldn’t count.  First, label changes are serious business.  “[T]he FDA views overwarnings as problematic because they can render the warnings useless and discourage use of beneficial medications.” Id. at 20.  Second, “the FDA standard for revising a warning label does not discriminate between proposals submitted by manufacturers and proposals submitted by citizens.” Id. at 21 (regulatory citation omitted).  Arguments that the FDA nonetheless differentiated between manufacturers and independent petitioners didn’t hold water:

[Plaintiffs] suggest that the FDA disobeys its own regulations to apply different standards depending on the source of the proposed change. But we do not presume that the FDA deviates from regulatory requirements.

*          *          *          *

[plaintiffs] hypothesize that the FDA would be more receptive to a manufacturer’s request to strengthen a warning than to a citizen’s effort to compel a stronger warning.  But a factual dispute cannot be based on speculation that the FDA would jettison its legal requirements and rubber-stamp [defendant’s] hypothetical proposal notwithstanding the risk of overwarning.

Under the same standard for manufacturer-initiated changes, the FDA rejected a citizen petition containing arguments virtually identical to [plaintiffs’].  We will not assume that the FDA would have scuttled its own regulatory standard if [defendant] had requested the new warning.  Thus, we reject [plaintiff’s] challenge to [defendant’s] reliance on [the] citizen petition.

Id. at 21, 23 (citations and alternative explanations for FDA conduct omitted).  Third, even under a Fosamax standard, the FDA’s rejection of the citizen’s petition was a “smoking gun” that “foreclose[d] any reasonable juror from finding that the FDA would have approved” the label change advocated by plaintiffs.  Id. at 23 n.11.

Thus a no-evidence rejection of a comparable warning change was preemptive.  There was no “bright-line rule” that such a rejection was insufficient to constitute “clear evidence” satisfying Levine.  Thus, Cerveny rejected contrary cases, including one that we have criticized – slip op. at 25-27 (rejecting Reckis v. Johnson & Johnson, 28 N.E.3d 445 (Mass. 2015), Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F. Supp.2d 1125, 1133 (D. Minn. 2011), and Forst v. Smithkline Beecham Corp., 639 F. Supp.2d 948, 954 (E.D. Wis. 2009)) − and distinguished others.  Slip op. at 24-25, 27 (distinguishing Mason v. SmithKline Beecham Corp., 596 F.3d 387, 396 (7th Cir. 2010), Koho v. Forest Laboratories, Inc., 17 F. Supp.3d 1109, 1117 (W.D. Wash. 2014), Dorsett v. Sandoz, Inc., 699 F. Supp.2d 1142, 1158-59 (C.D. Cal. 2010), and Hunt v. McNeil Consumer Healthcare, 6 F. Supp.3d 694, 700-01 (E.D. La. 2014)).  Critically, Cerveny distinguished Mason because there, the petition “had been rejected before the plaintiff’s injury.”  Cerveny, slip op. at 24 (emphasis original).  The “bright line” were interested in – that an FDA insufficient-evidence rejection after a plaintiff’s injury is necessarily preemptive, since even less evidence would have existed at any earlier time – remains intact in Cerveny.

Finally, some clarity for the “clear evidence” standard.

However, the court reversed dismissal of the plaintiffs’ weaker claim, that if they had received a stronger warning about a birth-defect risk existing only during pregnancy, they wouldn’t have taken the drug at all (even before pregnancy) and thus the injury wouldn’t have occurred.  As to that risk, they could point to a label change proposed (but not required) by the FDA.  Slip op. at 28-29.  That proposal “d[id] not suggest that the FDA would have approved a warning about taking [the drug] prior to pregnancy,” id. at 29, and thus did not affect preemption of plaintiff’s pre-pregnancy claims.  Id.

Plaintiffs’ pre-pregnancy claim is exactly the sort of attenuated allegation that we addressed at length in our Smoke Screens & Side Shows post – that the plaintiff mother “would not have taken [the drug], even pre-pregnancy, if [defendant] had used the FDA’s proposed wording” about post-pregnancy risks.  Id. at 32.  The problem on appeal in Cerveny was that dismissal had been sought from, and granted by, the trial court solely on preemption grounds, whereas (as our post demonstrates) the best defense was that remote causation claims did not exist under state law.  Id. at 34.

The Tenth Circuit cut plaintiffs a break. Even though the district court had pointed out that it “would be a nonsensical result if a plaintiff could avoid a preemption defense by arguing that a drug label could have been strengthened in any form, regardless of its relevance to the plaintiff’s case,” id. at 34 (quoting Cerveny v. Aventis, Inc., 155 F. Supp.3d 1203, 1220 (D. Utah 2016)), the appellate court decided that wasn’t enough to affirm dismissal on non-preemption grounds.

In sum, the district court did not consider whether it could rest on Utah law when deciding a summary judgment motion that had relied solely on federal preemption.  Because the district court did not consider this question and it has not been fully briefed on appeal, we leave this question for the district court to address on remand.

Cerveny, slip op. at 36.  So much for affirming on any ground.  Strange things happen in tort preemption cases.  At least the blog’s already done some of the defendant’s research (although we didn’t find any Utah cases, unfortunately).

The last bit was the disposition of plaintiffs’ fraud, misrepresentation, and implied warranty claims. The district court had dismissed them as just preempted warning claims under different names.  Id. at 37.  Again the court cut the plaintiffs a break, holding that any preemption dismissal needed to address those claims separately:

[W]e reverse and remand the award of summary judgment on the claims of fraud, negligent misrepresentation, and breach of an implied warranty.  We do not foreclose the possibility that these claims might be preempted.  But on remand, the district court should explain the effect of preemption on th[os]e claims.

Id. at 38.  Finally, the Tenth Circuit held that plaintiffs were not entitled to additional discovery before preemption was decided.  Id. at 38-41.  At least, on remand, the defendant won’t be forced to incur additional discovery costs before teeing up preemption again.

Although not every claim was held preempted on appeal, in our books Cerveny is a significant defense win.  It finds “clear evidence” as a matter of law to preempt the plaintiffs’ main claim.  It holds that citizen’s petition denials are as preemptive as any other form of FDA decisionmaking.  It affirms the importance of overwarning, and thus that an inadequate-information FDA label change preempts all prior claims where there can be no claim of additional information being discovered in the interim.

We wonder whether plaintiffs will appeal.  There is now a direct conflict between Cerveny (a court of appeals) and Reckis (a state high court) on FDA citizen’s petition denials being “clear evidence” under Levine.  We’ve thought from day one that Levine was appallingly reasoned and should be reconsidered, and maybe this is the vehicle.  We also think that Justice Gorsuch, a textualist, won’t put much stock in the Reckis (and plaintiffs’ in Cerveny) rationale that the identical FDA standard doesn’t mean the same thing depending on who is submitting a proposed label change.

Do plaintiffs roll the dice?

‘Pointing to the empty chair’ is a well-known defense trial tactic.  It allows the defendant to go on offense.  Maybe the plaintiff deserves some compensation, so the narrative goes, but the plaintiffs sued the wrong party.  If the jury believes that narrative, it might exonerate the defendant completely.  Or it might at least assign some percentage of fault elsewhere and reduce the damage award.

 

Playing the blame game can be a way of redirecting jury anger.  It can also be tricky.  Is pointing to the empty chair inconsistent with major defense themes?  If you’re saying that an injury is not real, or not so bad, or was caused by something completely different, can you also say that non-party X should be on the hook?  The great Texas trial lawyer Racehorse Haynes died last week.  He won some trials that nobody thought were winnable.  He famously told a story about how he would defend a dog-bite case:

 

Say you sue me because you say my dog bit you. Well, now this is my defense:

My dog doesn’t bite.

And second, in the alternative, my dog was tied up that night.

And third, I don’t believe you really got bit.

And fourth, I don’t have a dog.

 

Of course, a little too much of that alternative pleading and the jury might start to doubt the lawyer’s credibility.  Here, we are talking about a slightly different defense:  some other dog bit you.  That other dog might be a health care practitioner.  But, as is often the case, doctors sometimes get special, favorable treatment from the judicial system.  In some jurisdictions, a defendant cannot point to a non-party doctor at all, or can do so only by making out a prima facie case of medical malpractice, complete with an expert opinion.  (At this point we are not even getting into the fact that many of our clients do not ever want to point the finger at a doctor, whether that doctor is a co-defendant or is a non-occupant of the empty chair.  Granted, the latter is much easier conceptually if not practically.) 

 

The toughest version of the empty chair defense is trying to pin blame on an actor that enjoys some degree of immunity.  That is what happened in the eccentric case of In re New England Compounding Pharmacy, Inc., Prods. Liab. Litigation, 2017 WL 1458192 (D. Mass. April 24, 2017).  The plaintiffs alleged that contaminated compounded drugs hurt a lot of people.  The main defendant  went bankrupt, so the plaintiffs went about suing all manner of unusual defendants on unusual theories.  A couple of relatively minor defendants asserted the comparative fault of the FDA, the Massachusetts Board of Pharmacy (“MBOP”), and some Tennessee governmental entities.  The Plaintiffs’ Steering Committee (“PSC”) moved for judgment on the pleadings against those defendants.  They won a little and lost a little.  The bit they lost is fascinating and prompts us to speculate on all sorts of outlandish possibilities. 

 

But first to the part the PSC won.  The Tennessee public duty doctrine shields public employees from suits for injuries caused by the breach of a duty owed to the public at large.  A duty owed to everyone turns out to be a duty owed to no one.  The public duty doctrine renders the public actors immune from duty and immune from fault.  Therefore, there can be no comparative fault laid at the door of such public actors.  Of course there is an exception to the rule of non-liability.  It seems there are always exceptions to non-liability rules.  That exception is triggered when the public employee owes a “special duty” to the plaintiff.  Such a special duty arises when, (1) the public employee undertakes to protect the plaintiff, and the plaintiff relies upon such undertaking, (2) a statute specifically creates a cause of action against an official or municipality for injuries resulting to a particular class of individuals, of which the plaintiff is a member, from failure to enforce certain laws, or (3) the public employee acted intentionally, maliciously, or recklessly.  The defendants in this case did not even allege that the Tennessee entities fit into these categories, so those Tennessee entities cannot be the focus of a comparative fault defense.

 

Goodbye Tennessee entities.  Any hopes of dragging them into the case via comparative fault “rode away on a Tennessee stud.”

 

By contrast, the defendants did allege that the FDA and the MBOP acted recklessly.  The defendants alleged that the FDA and MBOP were aware long ago that the compounder had sterility and potency issues, but failed to take any “meaningful, substantive action.”  The FDA had issued a warning letter to the compounder but, according to the defendants, never followed up appropriately.  Viewing the defendants’ allegations in the light most favorable to them, the court concluded that the comparative fault defense lived to fight on in the case.  Perhaps it will be tested again. 

 

Meanwhile, one cannot help but wonder how an FDA comparative fault defense might play out in future cases.  Many drug or device defendants face the issue of how much to highlight the fact of federal regulation in defending against liability.  It seems a worthwhile point to make, if only to let the jury know that companies cannot unleash products on the populace without some sort of review, clearance, and/or approval from the FDA.  We know of one court that has held that a 510(k) clearance is so meaningless as to merit preclusion from trial, but that opinion seems to be an outlier.  More often, the decision for the defendant is whether the fact of FDA regulation is worth the inevitable onslaught from plaintiffs and their experts about how the FDA is allegedly a paper tiger.   But now that we have read the New England Compounding case, we wonder whether that plaintiff onslaught potentially sets up a comparative fault defense — that the FDA acted recklessly in not initiating stricter enforcement action.  That would be a weird and risky position for a defendant to take.  But if the plaintiffs are doing everything they can to make the case, why not take advantage of it?  Still, there are wrinkles everywhere in such a scenario.  The Food, Drug and Cosmetics Act affords the FDA with discretion.  See 21 U.S.C. §336 (“Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution . . . whenever he believes that the public interest will be adequately served by a suitable written notice or warning”). Such discretion might protect the FDA from suit under the Federal Tort Claims Act.  It might even preempt this kind of argument. We don’t know, because we haven’t seen it before.  Even aside from that legal impediment, given FDA discretion, the concept of a common-law duty owed to any person to enforce the law in a particular way would seem to be a challenging argument.  As to the Massachusetts regulators, the comparative fault theory is intriguing as an empty chair defense, but what if someone tries to fill that empty chair with an actual state entity defendant?  Could parties in one state sue the regulatory bodies of another state for negligence concerning damages caused by a regulated product sold in interstate commerce?  The 11th amendment would seem to be an insuperable barrier, at least in federal court such as this MDL.    

 

Sometimes, weird little one-off rulings in unusual cases do not end up being so one-off.   

 

 

 

 

Last week, the United States Supreme Court also heard argument in the “other” litigation tourist personal jurisdiction case pending before it – BNSF Railway Co. v. Tyrell, No. 16-405 (U.S. argued April 25, 2017) (“BNSF”) (link to transcript).  While BNSF mostly concerned statutory issues under the Federal Employees Liability Act (“FELA”), it does involve a personal jurisdiction question related to litigation tourism.  The Court considered it sufficiently related to BMS that it scheduled oral argument back-to-back with BMS (see here for last week’s post on the BMS oral argument).  Because we’re interested in personal jurisdiction as a constitutional check on the litigation tourism phenomenon, we’ve also taken a look at what went down during the BNSF argument.

Once again the United States government appeared as amicus supporting the defense.  Tr. at 1, 12-18.  It appears to us that the plaintiff in BNSF had an even tougher time before the Court than the plaintiffs in BMS – and that’s saying something.  Another perhaps notable aspect of the oral argument was that the Justices, particularly as to the defense and defense-supporting United States arguments, were a lot less engaged than in BMS.  These counsel actually argued for entire pages of transcript without being interrupted by questions.  Indeed, the defendant’s rebuttal argument in BNSF drew no questions at all, and thus the defense used only a fraction of its reserved time.  Id. at 43-44.  The entire BNSF transcript was 44 pages – 20 pages (almost 1/3) shorter than BMS.

Justice Sotomayor, the sole dissenter from the personal jurisdiction rationale in Daimler AG v. Bauman, 134 S.Ct. 746 (2014), seemed most animated when discussing an issue that was not even before the Court in BNSF – nonconsensual “consent” to general jurisdiction by virtue of mere registration to do business in a state.  Tr. at 4-6.  We’ve written on this Bauman dodge before, and were somewhat perplexed to see it arise in a United States Supreme Court argument – until we heard from Chief Justice Roberts:  “[T]he issue . . . was not addressed below and is not before us.”  Id. at 6.  Whew!   We thought we’d missed something significant.

The heart of the plaintiff’s argument was that FELA, in provisions that spoke only to venue (it’s a peculiar statute in that it allows plaintiffs to choose to bring federal claims in state court), somehow also authorized an expanded form of personal jurisdiction that permitted litigation tourism.  We gathered from the argument that the plaintiff was a North Dakota resident claiming workplace injuries in Washington State, id. at 40 – so of course, he sued the defendant in Montana, which was neither the defendant’s principal place of business nor its state of incorporation.

Since BNSF was a statutory case, the Court was interested in whether Congress could authorize litigation tourism by statute.  The defense response was that Congress could authorize nationwide service of process allowing expanded federal court jurisdiction, should it choose to create a federal cause of action, but that Due Process would render problematic any attempt to expand state-court personal jurisdiction to accommodate litigation tourists.  Tr. at 8.  The fundamental problem with the plaintiff’s statutory argument was put most succinctly by the Assistant Solicitor General arguing for the government:

[T]here’s a strong Federal interest in not having words that don’t say anything about service of process being interpreted to in fact say something about service of process[.  W]e have a first sentence that refers to venue only in Federal courts, and then a second sentence referring to State courts.  But all it does is to clarify that there’s concurrent jurisdiction in the State courts.  And we just don’t see how you can get to conferral of personal jurisdiction in the State courts.

Tr. at 13.

Nobody, not even Justice Sotomayor, the justice most sympathetic to litigation tourism, seemed comfortable with that argument. The statutory argument was criticized by:

Chief Justice Roberts:  Tr. at 23-24, 29-30.

Justice Ginsburg:  Id. at 19-20, 31, 40.

Justice Alito:  Id. at 25-26.

Justice Sotomayor never appeared inclined to support plaintiff’s statutory argument in BNSF.  Rather, she suggested that “we could just say it [FELA §56] doesn’t apply to State courts,” id. at 37 – which was precisely where the plaintiff had sued.

So, aside from the seemingly doomed argument that FELA should be interpreted to say what it didn’t say – and apparently what no federal statute has ever provided – about personal jurisdiction/service of process, what did the argument have to say about Bauman and Due Process?

The government argued that “[i]f the Court’s decisions in Goodyear and Daimler mean anything,” it “just can’t be correct” that “a company like BNSF is subject to general personal jurisdiction in 28 or more States.”  Tr. at 14.  Justice Breyer did not “really see the difference” between Bauman and BNSF.  Id. at 38-39.  Justice Kagan tried to limit the plaintiff’s non-statutory personal jurisdiction argument to railroads being “so unique that they should be subject to general jurisdiction everywhere.”  Id. at 32.  After some hemming and hawing plaintiff agreed, id. at 34, but plaintiff seemed even more interested in a fact-specific, Montana-only exercise of Bauman personal jurisdiction.  Id. at 33, 36 (arguing that the defendant was “at home” because it had Montana “lobbyists”).  Unlike the plaintiffs in BMS, the plaintiff in BNSF was never so bold as to call for overruling Bauman.

Finally, when pushed by Justice Gorsuch, plaintiff abandoned altogether the argument that Bauman be limited to “foreign corporations.”  Id. at 41-42.

We’ve been burned making Supreme Court predictions before, but we frankly can’t see a path to affirmance for the plaintiff in BNSF.  It could well be a unanimous reversal of the Montana Supreme Court, albeit with at least one concurrence offering a different rationale (similar to Bauman).

As our loyal readers know, the Reed Smith side of the blog has been very interested in 3D printing, and particularly in its product liability implications. We recently shared with you the most comprehensive law review article to date on this subject (here) – authored by Bexis and Reed Smith associate (and sometimes guest blogger) Matt Jacobson – and we have posted about 3D printing here, here, here and here.

If you’ve found yourself equally fascinated by this new technology – and its potential impact on life sciences product liability – we’re pleased to announce that Bexis and Matt will be presenting a free 60-minute webinar on “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers” on May 8 at 12 p.m. ET.

This webinar is presumptively approved for 1.0 general CLE credit in California, Illinois, New Jersey, Pennsylvania, Texas and West Virginia. For lawyers licensed in New York, this course is eligible for 1.0 credit under New York’s Approved Jurisdiction Policy.

The program is free and open to anyone interested in tuning in, but you do have to sign up, which you can do here.