You’ll find any number of places on this blog where we argue emphatically that FDA warning letters are far from final and therefore should not be able to be used in products liability actions.  See here for our latest post on the issue (which also collects our other posts). These posts cite case law, FDA internal manuals, FDA’s own position in formal briefing, and learned treatises.  All of which say that an FDA warning letter has no binding legal effect.  Warning letters are informal and tentative and rarely lead to formal agency action.

But, a recent decision involving a letter issued by the Centers for Medicare and Medicaid Services (“CMS”) has us wondering if there is a chance warning letters could be viewed as final agency action after all.  The case is Ipsen Biopharmaceuticals, Inc. v. Azar, — F.3d —, 2019 WL 6482392 (D.C. Cir. Dec. 3, 2019).   At the heart of the case is the self-reporting scheme in the Medicaid drug-rebate program.  Without going into the details that aren’t important to us, the bottom line is CMS disagreed with defendant’s self-reporting and issued a series of letters advising defendant to change its data.  The letters stated that they were not “a final agency action or even an initial determination on a reimbursement claim.”  Id.at *1.  Defendant filed suit and CMS moved for summary judgement on the ground that the letters were not final agency action and therefore not appropriate for judicial review.  Id. at *2.  The D.C. Circuit disagreed.

An agency action is final if (1) “the action marks the consummation of the agency’s decision-making process” and (2) “it is an action by which rights or obligations have been determined, or from which legal consequences will flow.”  Id. (citing 5. U.S.C. § 704).  And, the provision open to debate is “from which legal consequences will flow” – which the Supreme Court has called a “pragmatic” inquiry.  Id.  That means the court has to look at the consequences of the agency’s action in the context of the specific regulations at issue.

Here, the defendant argued that the Medicaid statute provides penalties for “knowingly provid[ing] false information.”  Id. at *3.  Therefore, the CMS letters increased the probability that defendant could be found to have knowingly provided false information.  The court agreed that because the letters carried an “increased risk of prosecution and penalties,” it was a “legal consequence” and thus met the definition of a final agency action.

CMS also argued that the risk that defendant may incur penalties in some future action was too attenuated and uncertain to render it a legal consequence.  Apparently, the court found that since the letter could some evidence against defendant — that was enough.  The court also found that because defendant had a self-reporting obligation, each time defendant submitted the same data to CMS after receiving the letters, defendant was exposed to civil penalties.  For this the letter itself was the trigger.  Id. at *4.

The court also was persuaded by the fact that there is no further action defendant can take at the administrative level.  In this way, the letters constitute the agency’s final decision which includes informing defendant that it must change its rebate calculations.  Id. Finally, the court noted that agencies often communicate decisions and interpretations via letter without formalizing or finalizing their action.  Id. at *5.  Here the court found that because the letter “expressly applied CMS’s interpretation of governing law to the specific facts of [defendant’s] case . . . [it] closely resembles an individual adjudication, which is a well-recognized form of final agency action.”  Id.

Put that all together and you have a decision by the D.C. Circuit that informal agency letters asserting specific regulatory violations sufficiently increase the risk of enforcement action so as to be final and appealable.  Unfortunately, that sounds like an FDA warning letter.

Think about an FDA warning letter that concludes that a specific sales aid is false and misleading because it omits risk information or includes unsubstantiated claims.  We’ve all seen them.  The letter will state that the specific sales aid misbrands the product under the FDCA and makes its distribution violative of FDA regulations.  The letter will usually contain at least some examples of what the FDA finds misleading or false.  It will conclude with a request that the manufacturer cease using the sales aid (or cease misbranding the product) and take corrective action.  The letter requires a response by the manufacturer in a given timeframe.

It seems to tick a lot of the same boxes the court found convincing in Ipsen.  Warning letters do more than merely interpret a regulation, they apply those interpretations to the specific facts and reach conclusions regarding whether those facts violate the FDCA.  FDCA violations carry the risk of both civil and criminal penalties.  If a manufacturer continues to use sales materials that violate the FDCA as found in the warning letter, manufacturer is open to additional penalties.  FDA uses warning letters as a routine method of conveying violations to manufacturers.

We surely aren’t persuaded that the court reached the correct conclusion in Ipsen and if confronted with Ipsen in a pharmaceutical warning letter context, we’d be relying on all those sources we mentioned at the outset of this post and diving deeper to find differences between the FDA scheme and the CMS scheme.  For now, it’s enough to know it’s out there and some more work may need to be done.

The opinion, Schrecengost v. Coloplast Corp., 2019 WL 6465398 (W.D. Pa. Dec. 2, 2019), recently “predicted” that Pennsylvania would allow strict liability design and warning defect claims in cases involving prescription medical products.  Id. at *11-13.  In so doing Schrecengost was not only wrong, but loud wrong.  First, without even a serious discussion, Schrecengost violated the fundamental principles of federalism inherent in the Erie doctrine.  Second, Schrecengost ignored over 75 years of unbroken Pennsylvania appellate precedent, offering extremely flimsy excuses for what is simply an activist, pro-plaintiff result.  Thus, we object.

The Wrong Court

First, we object jurisprudentially.  For the same reasons expressed in our prior Wrong Court post, Schrecengost failed entirely in its obligation under Erie Railroad Co. v. Tompkins, 304 U.S. 64 (1938), to respect existing state precedent in applying state law in an action based on federal diversity jurisdiction.  Briefly, since we covered this topic with Third Circuit-specific analysis extensively both in Wrong Court and earlier here, “[a] federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.”  Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3,4 (1975). “[A] federal court is not free to apply a different rule however desirable it may believe it to be, and even though it may think that the state Supreme Court may establish a different rule in some future litigation.”  Hicks v. Feiock, 485 U.S. 624, 630 n.3 (1988).  For a complete discussion of on-point United States Supreme Court cases, see our recent (and non-Third Circuit specific) post, Why Erie Is an Inherently Conservative Doctrine.

This means, as the Third Circuit has stated many times, that federal courts sitting in diversity cannot “act as . . . judicial pioneer[s]” by deciding “whether and to what extent they will expand state common law.”  City of Philadelphia v. Lead Industries Ass’n, 994 F.2d 112, 123 (3d Cir. 1993).  “[F]ederal courts may not engage in judicial activism.  Federalism concerns require that we permit state courts to decide whether and to what extent they will expand state common law. . . .  Our role is to apply the current law of the jurisdiction, and leave it undisturbed.”  Leo v. Kerr-McGee Chemical Corp., 37 F.3d 96, 101 (3d Cir. 1994).  See also Sheridan v. NGK Metals Corp., 609 F.3d 239, 254 (3d Cir. 2010); Travelers Indemnity Co. v. Dammann & Co., 594 F.3d 238, 253 (3d Cir. 2010); Lexington National Insurance Corp. v. Ranger Insurance Co., 326 F.3d 416, 420 (3d Cir. 2003); Werwinski v. Ford Motor Co., 286 F.3d 661, 680 (3d Cir. 2002); City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415, 421 (3d Cir. 2002); Camden County Board of Chosen Freeholders v. Beretta, U.S.A. Corp., 273 F.3d 536, 541-42 (3d Cir. 2001); Northview Motors, Inc. v. Chrysler Motors Corp., 227 F.3d 78, 92 n.7 (3d Cir. 2000); Adams v. Madison Realty & Development, 853 F.2d 163, 168 (3d Cir. 1988); Falcone v. Columbia Pictures Industries, 805 F.2d 115, 118 (3d Cir. 1986); Bruffett v. Warner Communications, 692 F.2d 910, 918 (3d Cir. 1982).  We note that this issue is currently pending – and indeed is front and center − in the Oberdorf v. Amazon litigation, and we hope (and expect) that it will once again be reaffirmed, this time by an en banc court.

The Schrecengost decision departed from 75 years of consistent Pennsylvania practice, as well as the Erie predictions of over two score of other federal district court judges applying Pennsylvania law (see below) without any basis under Erie for doing so.  Indeed, Schrecengost’s entire Erie discussion is:

The Pennsylvania Supreme Court has not ruled definitively on the issue.  In the absence of a decision from the Pennsylvania Supreme Court, this Court must predict how the Pennsylvania Supreme Court would rule on this issue.  See Berrier v. Simplicity Mfg., Inc., 563 F.3d 38, 45-46 (3d Cir. 2009).  A federal district court in this position should consider “relevant state precedents, analogous decisions, considered dicta, scholarly works, and any other reliable data tending convincingly to show how the highest court in the state would decide the issue at hand.”  Id. at 46 (quoting McKenna v. Ortho Pharm. Corp., 622 F.2d 657, 663 (3d Cir. 1980)).

2019 WL 6465398, at *11.  Thus, Schrecengost fails to acknowledge, anywhere, that federal courts are not, in fact, free to make up Pennsylvania law any way they want, without regard to existing precedent.  Indeed, the Berrier decision, the only Third Circuit case directly cited in Schrecengost, is probably the Third Circuit’s most spectacularly wrong product liability prediction of all time – “predicting” that Pennsylvania would abandon Restatement (Second) of Torts §402A (1965), in favor of the Third Restatement.  Cf. Tincher v. Omega Flex, Inc., 104 A.3d 328, 394-99 (Pa. 2014) (rejecting Berrier “prediction).

Thus, even if Schrecengost were right about the direction of Pennsylvania law – and the rest of this post is devoted to proving that it is flat wrong – a federal district court sitting in diversity jurisdiction is the wrong forum for making that claim.  Changing Pennsylvania law is the province of Pennsylvania state appellate courts, not federal judges acting as what Justice Cardozo memorably called “knights errant,” using litigation for result oriented purposes:

A judge, even when he is free, is still not wholly free.  He is not to innovate at pleasure.  He is not a knight-errant roaming at will in pursuit of his own ideal of beauty or of goodness.  He is to draw his inspiration from consecrated principles.  He is not to yield to spasmodic sentiment, to vague and unregulated benevolence.

Benjamin N. Cardozo, Nature of the Judicial Process, at 141 (1921)

Schrecengost is also 100% wrong under current Pennsylvania law.

The Wrong-er Reasoning

What is that law?

Three-Quarters of a Century of Pennsylvania Prescription Medical Product Liability Precedent

Since the beginning of product liability litigation in Pennsylvania, the Pennsylvania Supreme Court has always, whenever the issue was raised (which has happened relatively often), rejected any form of strict liability in product liability cases involving prescription medical products.  The first case goes back to 1942, and the most recent on-point decision was the aforementioned Tincher case itself.

Pennsylvania precedent rejecting strict liability in prescription medical product liability litigation begins with Henderson v. National Drug Co., 23 A.2d 743 (Pa. 1942), well before the concept of §402A strict liability in tort first reared its ugly head in California.  The plaintiff in Henderson failed to prove negligence but claimed that “‘even if the Drug Company was not negligent . . . its product was not safe and therefore on the proof of breach of warranty alone the plaintiff would be entitled to a verdict.’”  Id. at 748-49 (quoting from plaintiff’s brief).  The Pennsylvania Supreme Court unanimously said no:  “This action is not founded on a breach of warranty.  An action against a druggist to recover for personal injuries should be ex delicto and not ex contractu.”  Id. at 749 (citation and quotation marks omitted).

Thus, with respect to prescription medical products, the “warranty” predicate for the “consumer expectation” prong of the “composite” strict liability design defect test announced in Tincher, 104 A.3d at 401-02, has not existed in Pennsylvania since 1942.  As held in Henderson, manufacturers of such products are held “to a high degree of responsibility under both the criminal and the civil law,” 23 A.2d at 748, but that responsibility remains a negligence duty, since eliminating the traditional negligence framework would “ill-serve” the public:

This consideration, however, does not justify the courts in lowering the standards of proof in tort cases of this kind.  If we did so the public interest would be ill served.  If those who make and compound drugs and medicines in packages or bottles, under the strict conditions prescribed by the [forerunner of the Food, Drug & Cosmetics Act], can be mulcted in damages every time some person uses such drugs or medicines with harmful results, the making and selling of such products would be a most peculiarly hazardous enterprise.

Id. (citations omitted) (emphasis added).

Henderson rejected what modern law would consider a warranty of “merchantability.”  Some 20 years later, a plaintiff tried again to impose warranty style strict liability – asserting a “warranty of fitness for use” − against a prescription drug manufacturer in DiBelardino v. Lemmon Pharmacal Co., 208 A.2d 283, 283 (Pa. 1965).  The Pennsylvania Supreme Court reaffirmed what it held in Henderson, again rejected the proposition that a “drug company would be liable, even if not negligent,” for all injuries caused by its product.  Id. at 285.

[I]n Henderson, disposing of a contention that the drug company would be liable, even if not negligent, if the drug was not safe on theory of a breach of warranty, this Court held that, unless the action is based upon an express warranty, an action against a drug company must be ex delicto and not ex contractu, the action being based upon a breach of duty imposed by law.  Under Henderson, . . . [plaintiff], relying on a breach of implied warranty, would be restricted to an action in trespass rather than an action in assumpsit.

Id. at 585, 208 A.2d at 285-86 (footnote and other citations omitted).

In 1966, Pennsylvania adopted Restatement (Second) of Torts §402A (1965).  See Webb v. Zern, 220 A.2d 853 (Pa. 1966).  The first Pennsylvania Supreme Court prescription medical product liability case after Webb was Incollingo v. Ewing, 282 A.2d 206 (Pa. 1971) (abrogated in part on irrelevant grounds).  Incollingo reaffirmed Henderson’s policy-based rejection of strict liability.  Id. at 219 (“public interest would be ill served” by “lowering the standards of proof in cases of this kind”).  The court found this conclusion was only reinforced by the policies articulated in Restatement (Second) of Torts §402A, comment k (1965), holding that negligence was the only viable cause of action in cases involving prescription-only products:

The Restatement reaches the same conclusion as to a product which is incapable of being made safe for its intended use, such as new or experimental drugs, as to which, because of lack of time and opportunity for sufficient medical experience there can be no assurance of safety, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk.

“The seller of such products”, concludes this comment (Comment k), “again with the qualification that they are properly prepared and marketed and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product attended with a known but apparently reasonable risk.

282 A.2d at 219-20 (quoting Restatement §402A, comment k) (emphasis added).  Just as comment k itself embraced “drugs, vaccines, and the like” as unavoidably unsafe – expressly not limiting itself to prescription drugs – so did the Pennsylvania Supreme Court in Incollingo.  Indeed, the prescription medical product used as an example in Restatement §402A, comment k was not a prescription drug at all, but rather a vaccine.  See Comment k (“An outstanding example is the vaccine for the Pasteur treatment of rabies”).

Incollingo thus reiterated – and expanded in light of Restatement §402A − Henderson’s holding that negligence was the only viable cause of action in cases involving prescription-only products:

Since the strict liability rule of §402A is not applicable, the standard of care required is that set forth in §388 of the Restatement dealing with the liability of a supplier of a chattel known to be dangerous for its intended use.

Id. at 220 n.8.

Pennsylvania’s highest court again rejected prescription medical product strict liability in Baldino v. Castagna, 478 A.2d 807 (Pa. 1984).  Baldino followed Incollingo’s holding about the absence of strict liability:.

In Incollingo we held that, assuming proper preparation and warning, a manufacturer of drugs is not strictly liable. . . .  Rather, such a manufacturer is liable only if he fails to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous.

Id. at 810 (citations omitted) (emphasis added).

The Pennsylvania Supreme Court returned to the issue of strict liability in prescription medical product liability litigation in Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383 (Pa. 1991), rejecting a claim of “strict liability independent of the issue of inadequate warning” brought against a pharmacist who had sold a prescription drug.  Id. at 1384.  The Court held that comment k’s “explicit exception” to strict liability, id. at 1385, “necessarily” applied to “the type of product covered by comment k,” id. at 1386, and barred any purportedly “independent,” non-warning-based form of strict liability:

[Plaintiffs] also argue . . . that [a pharmacist] may be subject to strict liability as a supplier of a defective product. . . .  It is unclear in what sense [plaintiffs] contend that the drug was defective beyond that it allegedly carried a risk, of which no warning was given. . . .  It is not alleged that [the drug] was useless for the purpose it was prescribed for, or that it invariably caused the adverse consequences complained of.  It would thus seem that [the product] is necessarily the type of product covered by comment k of Section 402A, “an apparently useful and desirable product, attended with a known but apparently reasonable risk.”

Id. (footnote omitted) (emphasis added).  The plaintiff’s “independent” non-warning claims failed in Coyle because:

[T]he fact remains that [the product] is [one] whose distribution is limited precisely because its benefits and risks are to be assessed only by licensed physicians.

Id. at 1387.  Thus, Coyle not only reaffirmed Incollingo’s application of Restatement §402A, comment k, but without dissent it expanded that rationale to include pharmacists, because it would be “incongruous” to hold pharmacists to a stricter standard of liability than is applicable to these products’ manufacturers.  Id. at 1386.

An allegedly defective prescription medical device (a jaw implant), as opposed to a drug, was before the Pennsylvania Supreme Court in Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521 (Pa. 1995).  The result was the same – a rejection of strict liability.  The court “holds that even if [defendants] could be shown to have ‘marketed’ the prosthesis, strict liability does not apply.”  Id. at 523.  The no-fault, cost-shifting “policy” of strict liability was inappropriate and did not justify converting claims usually sounding in negligence to strict liability.  “To assign liability for no reason other than the ability to pay damages is inconsistent with our jurisprudence.”  Id. at 526 (citing Coyle).  “[R]esearch and innovation in medical equipment and treatment would be inhibited.”  Id. at 527.  Cafazzo also presaged Tincher by voicing significant second thoughts about strict liability theory under Pennsylvania law.

[B]efore a change in the law is made, a court, if it is to act responsibly must be able to see with reasonable clarity the results of its decision and to say with reasonable certainty that the change will serve the best interests of society. . . .  It is . . . not clear enough that strict liability has afforded the hoped for panacea in the conventional products area that it should be extended so cavalierly in cases such as the present one.

Id. at 527 (citation and quotation marks omitted).

The next year, the Pennsylvania Supreme Court decided Hahn v. Richter, 673 A.2d 888 (Pa. 1996), which directly examined whether strict liability should be generally inapplicable to prescription medical products.  Unlike Schrecengost, the Court of Common Pleas in Hahn had followed binding precedent, id. at 889, so the question presented in Hahn was precisely whether Incollingo and its progeny should be overturned.  The court’s response was resounding reaffirmance of the broad application of comment k’s negligence rule to prescription medical product liability litigation:

Incollingo and Baldino, as well as [§402A] comments j and k, make it clear that where the adequacy of warnings associated with prescription drugs is at issue, the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer’s negligence, is the only recognized basis of liability. . . .  Hence, the trial court properly instructed that [the defendant] could be found liable if [plaintiff’s] injuries were caused by a negligent failure to provide adequate product warnings.  The court did not err in declining to give an instruction on strict liability.

Id. at 891 (citation omitted) (emphasis added).

What came to be known as the “Hahn rule” was next addressed by the Pennsylvania Supreme Court in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014).  Lance reiterated both “this Court’s adoption of comment k in the strict-liability setting,” id. at 446, and its concomitant “refusal to extend strict liability to prescription drug manufacturers, consistent with the treatment for ‘unavoidably unsafe products’ reflected in comment k to §402A.”  Id. at 438 (citing Hahn).  “Pennsylvania, ha[s] taken a blanket approach applying comment k to preclude strict-liability design-defect claims for all prescription drugs.”  Id. at 442 n.11.  Due to “the potency of liability in the absence of fault . . . [t]here is greater flexibility . . . with regard to traditional, fault-based liability – i.e. negligence.”  Id. at 452-53 (emphasis original).

[I]n the [Incollingo] line of cases . . ., which have constrained the application of strict liability theory vis-à-vis pharmaceutical companies . . . neither [defendant] nor its amicus references any decision of this Court retrenching from [its] position as it pertains to fault-based liability.  While for policy reasons this Court has declined to extend strict liability into the prescription drug arena. . . .

Id. at 453 (block quote from Incollingo omitted) (emphasis added).  No member of the Lance court indicated – such as by filing a separate opinion – any inclination to change the Hahn rule.

Finally, Tincher, while not involving any prescription medical product, specifically mentioned and preserved the Hahn rule.  The Hahn rule was not at issue in Tincher, as Tincher involved only building products that anyone could buy at the local Home Depot – not prescription medical products.  However, Tincher recognized Hahn’s holding that prescription medical product “manufacturer[s were] immune from strict liability defective design claim[s]” as an explicit exception to §402A’s “presumption . . . that strict liability may be available with respect to any product,” and further that liability “was premised upon sale of prescription drugs without adequate warning.”  104 A.3d at 382 (describing Hahn).  Thus, contrary to Schrecengost, the Tincher court both understood that strict liability is not available for prescription medical products and viewed this exception as harmonious with strict liability generally.  More on that below, after we finish with current Pennsylvania law.  As in Lance, no justice on the Tincher court expressed any criticism of the Hahn rule.

The Pennsylvania Superior Court has also consistently rejected strict liability in prescription medical product liability litigation.  The Superior Court first followed Incollingo and the negligence standard of Restatement §402A, comment k in Leibowitz v. Ortho Pharmaceutical Corp., 307 A.2d 449, 457 (Pa. Super. 1973), however Leibowitz was non-precedential, as the court split 3-3 – although the other opinion nowhere discussed, and thus did not disagree with, Incollingo’s holdings.

Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374 (Pa. Super. 1987), foreshadowed Coyle (involving the same drug) in rejecting strict liability against pharmacies selling prescription medical products.  “[T]he very nature” of such products “precludes the imposition of a warranty of fitness for ‘ordinary purposes.’”  Id. at 377.  Likewise, a pharmacy is not subject to strict liability “as a retailer of a defective product.”  Id. at 378.  “It is well settled that a manufacturer of a prescription drug is liable ‘if he fails to exercise reasonable care to inform [prescribing physicians] of the facts which make it likely to be dangerous.’”  Id. (quoting Baldino).  “[W]e can perceive no benefit to be derived from the imposition of strict liability upon the pharmacist who properly dispenses a prescription drug.”  Id. at 379.

Next, in Hahn v. Richter, 628 A.2d 860 (Pa. Super. 1993) – affirmed on this ground by the Pennsylvania Supreme Court – another Superior Court panel explained that that prescription medical products are both inherently dangerous and greatly beneficial to society.  Id. at 871. To hold their manufacturers strictly liable for “unforeseeable reactions to their products . . . would stifle the incentive to produce new products.”  Id.

As in Cafazzo, strict liability claims – including design defect claims − involving a medical device (an implanted spinal stimulator) were rejected in in Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006).  The Creazzo plaintiffs suffered dismissal under Hahn of both warning and design defect claims against that prescription medical device and asked the Superior Court to decide “[w]hether the court erred in ruling that strict liability is not a basis for liability.”  Id. at 27 (quoting the plaintiff’s fourth issue).  The Creazzo court unanimously found no difference between prescription drugs and prescription medical devices for purposes of the application of Restatement §402A and strict liability.

[Plaintiffs] contend that the trial court misconstrued Hahn, and that comment k does not apply to medical devices because the comment text does not mention them.  They cite no authority, however, for so restrictive an interpretation either of comment k or of Hahn, nor do they provide significant analysis of the language they seek to apply.  We find no reason why the same rational applicable to prescription drugs may not be applied to medical devices.

Id. at 31 (citation omitted).  Accordingly, the Creazzo plaintiffs’ “fourth question [wa]s without merit.”  Id.  Creazzo addressed precisely the same question that Schrecengost did − availability of strict liability design and warning claims against medical devices – and rejected such liability.

Most recently, in Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d 909 (Pa. Super. 2011), the Superior Court again acknowledged the Hahn rule, following Hahn and Baldino.  Daniel noted that “strict liability will not be imposed upon the drug manufacturer, and instead the claim will be analyzed and adjudicated in accordance with the negligence standard.”  Id. at 924 n.13.  However, Daniel did not involve design related claims.

This massive, long-standing, and unbroken Pennsylvania appellate precedent had – before Schrecengost − proven unanimously persuasive with federal courts applying Pennsylvania law.  In Mazur v. Merck & Co., 964 F.2d 1348 (3d Cir. 1992), the Third Circuit affirmed application of what was then the Incollingo rule to a vaccine, holding:

With respect to “unavoidably unsafe products,” the district court said, the “strict liability principles of section 402A do not apply.”  Instead, the district court held that section 388 of the Restatement (Second) of Torts applies, regardless whether the plaintiff’s failure to warn claim is founded in negligence or strict liability.  Under that section, “the supplier has a duty to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous.”

Thus, the district court concluded:

Since [plaintiffs] assert that [defendant] is both strictly liable and liable for negligence in failing to warn . . ., a liability analysis under either theory will depend on whether [defendant] complied with the “duty to exercise reasonable care to inform” the [plaintiffs] of health risks associated with [the product’s] use.

Id.  We agree.

964 F.2d at 1353-54 (3d Cir. 1992) (quoting and following Mazur v. Merck & Co., 742 F. Supp. 239, 252 (E.D. Pa. 1990)).  The Third Circuit thus has never arbitrarily limited the Hahn rule to prescription drugs.

This past August, Mills v. Ethicon, Inc., ___ F. Supp.3d ___, 2019 WL 4053880 (D.N.J. Aug. 27, 2019), comprehensively reviewed Pennsylvania law, including twenty prior federal district court decisions applying that law, and concluded:

Federal courts, faced with the same issue of Pennsylvania law, have unanimously held that Comment k applies to medical devices, barring strict liability design defect and failure-to-warn claims.  Likewise, every federal district court to confront this issue has predicted that the Pennsylvania Supreme Court would extend Comment k’s application to strict liability design defect and failure to warn claims related to medical devices.  While I am not bound by those cases, I agree with them, and am persuaded by the analysis of the Pennsylvania Superior Court in Creazzo.

Id. at *9-10 (D.N.J. Aug. 27, 2019).  Mills cited Rosenberg v. C.R. Bard, Inc., 387 F. Supp.3d 572, 576-78 (E.D. Pa. 2019); Smith v. Howmedica Osteonics Corp., 251 F. Supp.3d 844, 848 (E.D. Pa. 2017); Carson v. Atrium Medical Corp., 191 F. Supp.3d 473, 477 (W.D. Pa. 2016); McLaughlin v. Bayer Corp., 172 F. Supp.3d 804, 833 (E.D. Pa. 2016); Runner v. C.R. Bard, Inc., 108 F. Supp.3d 261, 266 (E.D. Pa. 2015); Kee v. Zimmer, Inc., 871 F. Supp.2d 405, 410 (E.D. Pa. 2012); McPhee v. DePuy Orthopedics, Inc., 989 F. Supp.2d 451, 459-61 (W.D. Pa. 2012); Soufflas v. Zimmer, Inc., 474 F. Supp. 2d 737, 750 (E.D. Pa. 2007); Parkinson v. Guidant Corp., 315 F. Supp.2d 741, 747 (W.D. Pa. 2004) (dismissing strict liability design and failure to warn claims); Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 442 (E.D. Pa. 2004); Atkinson v. Ethicon, Inc., 2019 WL 3037304, at *5, (W.D. Pa. July 11, 2019); Buck v. Endo Pharmaceuticals, Inc., 2019 WL 1900475, at *8, (E.D. Pa. April 29, 2019); Wallace v. Boston Scientific Corp., 2018 WL 6981220, at *6-7 (Mag. M.D. Pa. Nov. 29, 2018), adopted, 2019 WL 137605 (M.D. Pa. Jan. 8, 2019); Krammes v. Zimmer, Inc., 2015 WL 4509021, at *5, (M.D. Pa. July 24, 2015); Cogswell v. Wright Medical Technology, Inc., 2015 WL 4393385, at *49 (W.D. Pa. July 16, 2015); Shelley v. Ethicon, Inc., 2013 WL 3463505, at *2 (E.D. Pa. July 9, 2013); Kline v. Zimmer Holdings, Inc., 2013 WL 3279797, at *6 (W.D. Pa. May 31, 2013); Tatum v. Takeda Pharmaceuticals North America, Inc., 2012 WL 5182895, at *2 (E.D. Pa. Oct. 18, 2012); Doughtery v. C.R. Bard, 2012 WL 2940727, at *6 (E.D. Pa. July 18, 2012); Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420, at *2 (W.D. Pa. Nov. 10, 2011).

Even the Mills court’s research, while comprehensive, was not complete.  An additional 28 federal district court decisions have followed the Hahn rule and rejected strict liability design and/or warning claims involving prescription medical products.  These are:  Wagner v. Kimberly-Clark Corp., 225 F. Supp.3d 311, 315 (E.D. Pa. 2016); Carson v. Atrium Medical Corp., 191 F. Supp.3d 473, 477 (W.D. Pa. 2016); Wilson v. Synthes United States Products, LLC, 116 F. Supp.3d 463, 465-467 (E.D. Pa. 2015); Cutruzzula v. Bayer Healthcare Pharmaceuticals, 2015 WL 8488670, at *3 (Mag. W.D. Pa. Nov. 17, 2015), adopted, 2015 WL 8492767 (W.D. Pa. Dec. 10, 2015); In re Zimmer NexGen Knee Implant Products Liability Litigation, 2015 WL 3669933, at *34 (N.D. Ill. June 12, 2015) (applying Pennsylvania law); Rowland v. Novartis Pharmaceuticals Corp., 34 F. Supp.3d 556, 568-69 (E.D. Pa. 2014); Terrell v. Davol, Inc., 2014 WL 3746532, at *3-5 (E.D. Pa. July 30, 2014); Stout v. Advanced Bionics, LLC, 2013 WL 12133966, at *8 (W.D. Pa. Sept. 19, 2013); Bergstresser v. Bristol-Myers Squibb Co., 2013 WL 1760525, at *2-3 (M.D. Pa. April 24, 2013); Gross v. Stryker Corp., 858 F. Supp.2d 466, 478-82 (W.D. Pa. 2012); Killen v. Stryker Spine, 2012 WL 4498865, at *3-4 (E.D. Pa. Sept. 28, 2012); Salvio v. Amgen, Inc., 810 F. Supp.2d 745, 754-55 (W.D. Pa. 2011); Esposito v. I-Flow Corp., 2011 WL 5041374, at *4 (E.D. Pa. Oct. 24, 2011); James v. Stryker Corp., 2011 WL 292240, at *3 (M.D. Pa. Jan. 27, 2011); Leonard v. Taro Pharmaceuticals, 2010 WL 4961647, at *3-5 (W.D. Pa. Dec. 2, 2010); Geesey v. Stryker Corp., 2010 WL 3069630, at *3-5 (E.D. Pa. Aug. 4, 2010); Aaron v. Wyeth, 2010 WL 653984, at *6-7 (W.D. Pa. Feb. 19, 2010); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009) (applying Pennsylvania law); Kline v. Pfizer, Inc., 2008 WL 4787577, at *2-3 (E.D. Pa. Oct. 31, 2008), reconsideration denied, 2009 WL 32477 (E.D. Pa. Jan. 9, 2009); Blain v. Smithkline Beecham Corp., 240 F.R.D. 179, 194 (E.D. Pa. 2007); Bearden v. Wyeth, 482 F. Supp.2d 614, 618 n.5 (E.D. Pa. 2006); Colacicco v. Apotex, Inc., 432 F. Supp.2d 514, 548 (E.D. Pa. 2006), aff’d, 521 F.3d 253 (3d Cir. 2008), vacated on other grounds, 556 U.S. 1101 (2009) (preemption); Henderson v. Merck & Co., 2005 WL 2600220, at *4 (E.D. Pa. Oct. 11, 2005), reconsideration denied, 2005 WL 2864752 (E.D. Pa. Oct. 31, 2005); Heindel v. Pfizer, Inc., 381 F. Supp.2d 364, 382 & n.8 (D.N.J. 2004) (applying Pennsylvania law); Murray v. Synthes U.S.A., Inc., 1999 WL 672937, at *6-8 (E.D. Pa. Aug. 23, 1999); Burton v. Danek Medical, Inc., 1999 WL 118020, at *7 (E.D. Pa. March 1, 1999); Taylor v. Danek Medical, Inc., 1998 WL 962062, at *7-9 (E.D. Pa. Dec. 29, 1998); Ferrara v. Berlex Laboratories, Inc., 732 F. Supp. 552, 555 (E.D. Pa. 1990) (applying Pennsylvania law), aff’d without opinion, 914 F.2d 242 (3d Cir. 1990).

Thus, aside from Schrecengost there has essentially been no dispute that strict liability design and warning claims in cases involving prescription medical products are barred by the Hahn rule.  The only real dispute has concerned the relatively uncommon category of manufacturing defects, which are beyond the express terms of comment k.  Compare Rosenberg, 387 F. Supp.3d at 579-80 (barring strict liability manufacturing defect claims under Hahn rule), with Wallace, 2018 WL 6981220, at *7-8 (exempting strict liability manufacturing defect claims from Hahn rule).  Thus, “even under the most permissive interpretation, [strict liability] claims exist only with respect to manufacturing defects in medical devices and not with respect to other theories of strict liability.”  Atkinson, 2019 WL 3037304, at *5.

Finally, further underscoring the insubstantiality of claimed distinctions between prescription drugs and prescription medical devices is that the category “medical device” only dates from the 1976 passage of the Medical Device Amendments.  21 U.S.C. §§360c et seq.  Three of the Hahn rule’s antecedents, Incollingo, DiBelardino, and Henderson, did not, and could not, have drawn that distinction, since prior to 1976 all medical devices were approved via new drug applications.

In federal court, for over twenty years, plaintiffs have shopped various arguments seeking to avoid the Hahn rule to judge after judge.  In well over forty cases, they failed – a rather admirable record.  Finally, in Schrecengost, the other side finally got a judicial bite.  We’ll next address what the plaintiff’s arguments were in Schrecengost, and why they should have failed.

Schrecengost’s Massive, Bogus Claim of Implied Overruling of Existing Pennsylvania Law

While it would be easy to condemn Schrecengost for ignoring the Pennsylvania Supreme Court’s rejection of strict liability in the Cafazzo, as well as its failure to cite and follow stare decisis as to the Third Circuit’s express application of the Hahn rule to a vaccine (thus precluding limitation to drugs) in Mazur, and leave it at that, we won’t.  Even at the risk of making an already long post longer, we will closely examine Schrecengost.

Most of the rationale in Schrecengost was based on a huge extrapolation from “the discussion of strict liability in Tincher.”  2019 WL 6465398, at *11.  There is also a much less developed citation to Beard v. Johnson & Johnson, Inc., 41 A.3d 823 (Pa. 2012).  2019 WL 6465398, at *12.  We’ll address both arguments, as we understand them.

First, Tincher.  As we’ve already discussed, the Supreme Court’s opinion specifically recognized the Hahn rule as an exception to a general §402A “presumption” that strict liability applies to any given product.  104 A.3d at 382.  The Tincher “presumption” thus expressly excepted prescription medical products, leaving Tincher as the antithesis of the sort of implied overruling postulated in Schrecengost.  Pennsylvania courts reject implied overruling arguments in situations like this.  “It defies logic to suggest that [an appellate court] would have overruled precedent sub silentio when it had expressly reaffirmed that precedent.”  Commonwealth v. Kleinicke, 895 A.2d 562, 571 n.9 (Pa. Super. 2006).

In this instance, none of the usual indicators of imminent doctrinal change are present.  In both Lance and in Tincher itself, the Hahn rule was not essential to the Pennsylvania Supreme Court’s decisions.  Far from criticizing that rule, as discussed above, in both instances the court went out of its way to indicate that the rule was recognized and preserved.  Further, these references to Hahn produced no separate opinions by any justice indicating disagreement with the court’s doing so.

Yes, Tincher did “note[] that its decision ‘may have an impact upon other foundational issues’ of strict liability law.”  Schrecengost, 2019 WL 6465398, at *12 (quoting Tincher, 104 A.3d at 409).  That might have meant something – except that Tincher also expressly acknowledged the exception to strict liability represented by the Hahn rule.  104 A.3d at 382.  A claim of implied overruling cannot trump express preservation.  By purporting to locate in Tincher an implied disapproval of decades of Pennsylvania prescription medical product liability litigation precedent in one fell swoop, Schrecengost missed the “principal point” of that decision, which “is that judicial modesty counsels that we be content to permit the common law to develop incrementally.”  104 A.3d at 406.

Unsurprisingly, other courts facing this argument have unanimously held that Tincher in no way impaired the Hahn rule.  the recent Rosenberg decision held:

  • Tincher, by reaffirming Pennsylvania’s adherence to §402A, ratified comment k of that section as an exception “where strict liability is unavailable.” 387 F. Supp.3d at 576.
  • “[C]omment k’s plain language appears to include prescription medical devices,” thus confirming the basis of Creazzo. Id. at 577-78.
  • “[T]he plain language of comment k precludes strict liability claims for design defects because it specifically carves out ‘unavoidably unsafe’ products from the reach of Section 402A.” Id. at 578 (citation omitted).

Rosenberg is one of many such decisions by federal courts applying Pennsylvania law.  “Federal courts, faced with the same issue . . . [have] held that Comment k applies to medical devices, barring strict liability design defect and failure-to-warn claims.”  Mills, 2019 WL 4053880, at *9.  Just since Tincher, these decisions also include:  Wallace, 2018 WL 6981220, at *6 (“[w]ith respect to strict tort liability claims that rest upon design defect or failure-to-warn theories . . . Pennsylvania Courts have spoken in a way which would preclude these claims”); Bell, 2018 WL 928237, at *3 (denying that Hahn rule was “antiquated”; “Hahn is still good law and is controlling”); Smith, 251 F. Supp.3d at 850 (following “the line of Comment k cases that have limited design defect and failure-to-warn claims against prescription drug manufacturers to negligence”); Carson, 191 F. Supp.3d at 477 (given Lance, Hahn, and Creazzo, “Plaintiff’s argument that exceptions be made is unpersuasive, and the Court will apply Comment k, without exceptions, to medical devices”); McLaughlin, 172 F. Supp.3d at 833 (“Comment k’s prohibition of strict liability-design defect and strict liability-failure to warn claims for prescription drugs should also apply to medical devices.”); Runner, 108 F. Supp.3d at 266 (following “settled doctrine . . . that comment k bars the imposition of strict liability against medical device manufacturers”); Krammes, 2015 WL 4509021, at *4 (“there is a consensus among courts that comment k applies to prescription medical devices for failure to warn and design defect claims”); Zimmer Nexgen, 2015 WL 3669933, at *35 (“the court is unwilling to read Tincher’s tea leaves so expansively absent more explicit language from Pennsylvania’s highest court cabining Hahn to prescription drugs only”).  Tincher in no way impairs 75 years of Pennsylvania law in prescription medical product cases.

Indeed, Schrecengost, is permeated with “heads I win, tails you lose” reasoning.  Certainly, if the Pennsylvania Supreme Court in Tincher had instead adopted the Third Restatement – as defendants sought – plaintiffs would have made the same implied overruling argument about the Hahn rule, since Pennsylvania would have abandoned Restatement §402A, and with it, comment k.  But defendants would not have minded much, because the Third Restatement (except for manufacturing defects) was negligence-based.  Tincher, 104 A.3d at 372 (referencing “Third Restatement’s negligence-derived standard”).  Yet plaintiffs, and Schrecengost, seek the same implied overruling result even though only Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978), and not §402A itself, was jettisoned in Tincher.  Given the still-uncertain status of much Azzarello-based craziness, such as the admissibility of state of the art evidence, the need for the expressly “policy” based Hahn rule remains.

Second, Creazzo.

It is deeply ironic that Schrecengost criticized, and ultimately ignored, Creazzo, for its purportedly making “no analysis of the relevant policy issues.”  2019 WL 6465398, at *12.  The policies preserved by the Hahn rule have been repeatedly recognized by Pennsylvania appellate courts, from the inception of the rule.  Lance, 85 A.3d at 453 (“for policy reasons this Court has declined to extend strict liability into the prescription drug arena”); Coyle, 584 A.2d at 1387 (the product “is [one] whose distribution is limited precisely because its benefits and risks are to be assessed only by licensed physicians”); Cafazzo, 668 A.2d at 527 (“research and innovation in medical equipment and treatment would be inhibited”); Incollingo, 282 A.2d at 219 (“public interest would be ill served” by “lowering the standards of proof in cases of this kind”); Henderson, 23 A.2d at 748 (“the public interest would be ill served.  If those who make and compound drugs and medicines . . . can be mulcted in damages every time some person uses such drugs or medicines with harmful results, the making and selling of such products would be a most peculiarly hazardous enterprise.”); Hahn, 628 A.2d at 871 (liability for “unforeseeable reactions to their products . . . would stifle the incentive to produce new products”); Makripodis, 523 A.2d at 379 (“we can perceive no benefit to be derived from the imposition of strict liability upon the pharmacist who properly dispenses a prescription drug”).  Since the policies of the Hahn rule have been restated time and time again, it was not necessary for every decision following the rule to examine them anew.

Schrecengost also discounted Creazzo because the appellant plaintiffs were “pro se.”  2019 WL 6465398, at *12.  Nonetheless, the Superior Court panel unanimously concluded that its initial unpublished opinion, Creazzo v. Medtronic, 907 A.2d 1142 (Pa. Super. 2006) (table, dated May 22, 2006), was important enough to revise and make precedential, at 903 A.2d 24 (dated June 27, 2006).  Given that the Creazzo court affirmatively acted to publish − and thus to accord its rulings precedential effect – Schrecengost’s way after-the-fact second-guessing is hardly appropriate.  Indeed, also contrary to the impression given in Schrecengost, 2019 WL 6465398, at *12, Creazzo has been repeatedly cited by other courts.  Westlaw counts 73 citing references, including Mills, Wallace, Rosenberg, Buck, Wagner, Carson, McLaughlin, Wilson, Krammes, Cogswell, Runner, Zimmer Nexgen, Terrell, Zimmer NexgenRowland, Stout, Shelley, Kline, McPhee, Killen, Daughtry, Kee, Gross, Horsmon, Esposito, James, Geesey, Delaney, and Soufflas from the prior discussion of federal district court precedent.  In addition, Breen v. Synthes-Stratec, Inc., cited Creazzo among many cases nationwide in “conclud[ing] that the application of comment (k) is not limited to prescription drugs only.” 947 A.2d 383, 388 n.5 (Conn. App. 2008).

Third, Beard, which Schrecengost cited as supposedly “cast[ing] the Creazzo decision into doubt.”  2019 WL 6465398, at *12.  The assertion that Beard somehow impliedly overruled the Hahn rule is equally, if not more implausible, given that Beard explicitly “advocated restraint in the acceptance of subsidiary [strict liability] issues” not directly before the Court.  41 A.3d at 836.  Beard reviewed only Azzarello-era “preliminary” risk/utility review (something abolished by Tincher, 104 A.3d at 400) in a case involving a non-implanted medical device (surgical stapler).  Beard clarified that such review encompassed all uses of a multi-use product, requiring reversal of a plaintiff’s verdict.  Id. at 838.

The defendant in Beard had not objected to strict liability, thereby waiving any Hahn issue.  See 41 A.3d at 839 (stating that the “strict-liability design defect” issue was “waived”) (Baer, Todd & McCaffery, JJ., concurring).  See also Schmidt v. Boardman Co., 11 A.3d 924, 942 (Pa. 2011) (“because Appellant did not challenge the [doctrine at issue] before the trial court and the Superior Court, we agree . . . that the question is waived”).  With the issue here not before the Beard Court, that decision cited neither Hahn nor Restatement §402A, comment k, and never considered grounds for precluding strict liability altogether in prescription medical product liability litigation.  Prior courts had repeatedly rejected Beard-based arguments against the Hahn rule in medical device cases.  See Rosenberg, 387 F. Supp.3d at 578 n.2 (“there is no discussion of comment k in Beard”); Wagner, 225 F. Supp. at 315 (Beard “did not specifically address Comment k to §402A”).

For these reasons, Tincher and Beard never overruled, or even questioned, the repeated preclusion of strict liability design and warning defect claims recognized by appellate courts applying Pennsylvania law in Lance, Hahn, Cafazzo, Coyle, Baldino, Incollingo, DiBelardino, Henderson, Creazzo, Makripodis., and Mazur.  Treating all this precedent as overruled sub silentio is “improvident” unless existing law is “irreconcilable” with an intervening, controlling decision.  Durante v. Pennsylvania State Police, 809 A.2d 369, 372 (Pa. 2002) (emphasis original).  “Simply put, [a prior decision] could not have overruled law . . . when it did not address such issue.”  Commonwealth v. Ligons, 971 A.2d 1125, 1141 (Pa. 2009).

*          *          *         *

Rarely, if ever, will a decision be as fundamentally wrong on so many levels as Schrecengost.  A federal court armed only with diversity jurisdiction is not supposed to make dramatic predictions of expanded state-law tort liability.  Second, Schrecengost’s rationale for doing so is belied by 75 years of uninterrupted Pennsylvania precedent, reinforced by almost a dozen appellate decisions and over forty contrary court decisions by the court’s colleagues on the federal district court bench.  Schrecengost’s reliance on Tincher and Beard are belied by the express language of those decisions as well as by the strict standards imposed by Pennsylvania law limiting claims that precedent has been impliedly overruled.

For a few years, it seemed like we were blogging about the Weeks case every few months.  Beyond providing an opportunity for temporal quippery, Weeks caught our attention because it was one of the holdout cases against the tide of cases rejecting Conte, the crappy California case that invented innovator liability.  After the Alabama Supreme Court recognized that nefarious doctrine (and some federal courts had started to limit its holding), the Alabama legislature stepped in and enacted the following:

In any civil action for personal injury, death, or property damage caused by a product, regardless of the type of claims alleged or the theory of liability asserted, the plaintiff must prove, among other elements, that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based, and not a similar or equivalent product. Designers, manufacturers, sellers, or lessors of products not identified as having been used, ingested, or encountered by an allegedly injured party may not be held liable for any alleged injury. A person, firm, corporation, association, partnership, or other legal or business entity whose design is copied or otherwise used by a manufacturer without the designer’s express authorization is not subject to liability for personal injury, death, or property damage caused by the manufacturer’s product, even if use of the design is foreseeable.

The connection between that act and the Weeks decision was pretty darn clear.  Since then, Alabama cases have been pretty quiet when it comes to attempts to impose liability on a drug company that did not make the drug consumed by the plaintiff seeking to recover.

There is always another fact pattern to test what might seem like settled law—even what the settlement comes from a determined legislature—and that brings us to Forrest Labs. v. Feheley, No. 1180387, 2019 WL 5485548, __ So.3d __ (Ala. 2019).  The facts of this case are so tragic that they make us think of the aphorism that “bad facts make bad law.”  They also make us think that desperate plaintiffs will find someone to sue and something to sue about, which is not quite so pithy.  An individual was prescribed an antidepressant by his doctor and filled it the same day with a generic version made by company X.  The next day, maybe before he started the drug, he fatally shot his estranged wife and then killed himself.  Her estate sued his estate, as well as a drug manufacturer other than company X, along with fictitiously named defendants.  As to the drug company whose antidepressant was not taken by the shooter, her estate alleged a wide range of essentially product liability allegations related to the purported ability for the antidepressant, referenced by its branded name, to produce violent behavior.  Skipping and summarizing some procedural steps, the defendant manufacturer teed up the application of the Alabama statute based on the stipulation that the shooter had not taken a drug made by the defendant.  Summary judgment for the manufacturer was denied, but the trial court certified the following question for permissive appeal:

The controlling question is whether Alabama Code 1975, § 6-5-530, abrogated the Weeks decision and whether under current Alabama law a pharmaceutical manufacturer can have liability for a product it did not manufacture.

Plaintiff also contended that the statute was unconstitutional if it did abrogate the claims she asserted, but that was not presented on appeal.

On the issue presented, the decision was fairly straightforward, pretty much starting and ending with “the plain meaning of the words as written by the legislature.”  The only real addition was the clear timing of the legislation.  “[T]he enactment of § 6-5-530, coming on the heels of this Court’s decision in Weeks, clearly demonstrates the legislature’s intent in enacting that statute.” Moreover,

[I]t appears that, in enacting § 6-5-530, the legislature also incorporated provisions that rejected some of the reasoning this Court relied upon in reaching its decision in Weeks. Based on the foregoing, it is clear that, in enacting § 6-5-530, the legislature intended to abrogate this Court’s decision in Weeks. Further, under the plain language of § 6-5-530, a pharmaceutical manufacturer cannot be held liable for injury caused by a product it did not manufacture.

So, the very court that decided Weeks accepted that the legislature overruled it on purpose. That is how the rule of law and separation of powers are supposed to work. Those principles will also allow a further challenge that the Alabama statute was unconstitutional, although it is abundantly clear that legislatures can limit or even abolish certain court-made theories of liability.

 

We appreciate the emails in support of the position we took in our October 14 post on Apportionment Misadventures that we have received from ALI members.  We have just reviewed “Council Draft No. 6,” (we can’t link to it as per ALI guidelines) and are pleased to report that the section we criticized has been removed from the draft being submitted to the ALI Council in January.  We hope this means that a more even-handed draft will be forthcoming in the future, with provisions that more closely adhere to what the law actually has been.  For now, though, it doesn’t look like we need to be ready to go to the mat at next year’s annual meeting.

The Holiday season is also the cinema season. We’re giddy about movies right now. Today sees the release of the trailer for No Time to Die, the 25th Bond film (counting only the “official” EON productions – sorry about that, Casino Royale (1967) and Never Say Never Again (1983)). No Time to Die (hereinafter NTTD) will be Daniel Craig’s last performance as 007. While we won’t quite say that nobody does Bond better (Sean Connery was the first we saw in the role, and will always be first in our heart), Craig has been a brooding, menacing agent on Her Majesty’s Secret Service. To tide us over until NTTD premieres in April, we have Craig’s current fun, showy performance as a drawling detective in Knives Out, which is Rian Johnson’s take on Agatha Christie-esque murder mysteries. Rian Johnson is probably most famous for directing The Last Jedi, which was … fine. We’re hoping that the ninth episode in the Skywalker saga, The Rise of Skywalker, due out in a couple of weeks, will be more than fine. (One further tie-together: Daniel Craig had a brief moment in The Force Awakens as a stormtrooper reluctantly complying with Rey’s mind commands.)

Star Wars popped into our heads (it doesn’t take much) while reading a recent court opinion regarding child custody issues. That case also made us think about Sir Kenneth Clark’s great Civilisation series from 1969.

Let us explain.

The case is Matheson v. Schmitt, 2019 WL 6245773 (Mich. Ct. App. November 21, 2019). A divorced couple was squabbling over several child custody issues, but the only one of real interest to us is whether the child would be vaccinated. The mother, who had primary custody, said no, while the father said yes. The mother had religious objections to vaccination. Michigan law permits parents with religious objections to opt out of vaccinations, but here it was only the mother who harbored such objections. The father did not share those religious objections, and argued that his child should be vaccinated. Because of this dispute, the issue was tossed to the court, which needed to consider the best interests of the child. Satisfying the religious objections of one parent did not further those best interests (more on that later), so the mother grabbed hold of a fig-leaf of bogus medical objections. She contended that vaccination of the child was not in the child’s best interests “because vaccinations were medically contraindicated.” In support of this theory, the mother relied on testimony from the child’s pediatrician who stated that “a child’s potential predisposition to an adverse reaction from a vaccine can be gleaned from reviewing the child’s family medical history.” The plaintiff asserted that the child’s family’s medical history includes ailments “such as lupus, rheumatoid arthritis, psoriasis, and other autoimmune disorders, and therefore, the child would be predisposed to developing rheumatoid arthritis from her vaccinations.” But when the trial court asked the pediatrician whether a medical test exists that would predict a child’s predisposition to injuries arising from vaccines, the doctor responded that such a test does not exist.

The plaintiff presented evidence that vaccines can have adverse effects. That should arrive as news to precisely nobody. The Centers for Disease Control and Prevention (CDC) also acknowledges that vaccines carry a “remote chance” of causing serious injury or death. Additionally, the product insert for the MMR vaccine indicates that the vaccine may have an adverse reaction of causing thrombocytopenia, and a variety of other serious ailments, such as encephalitis and encephalopathy. In short, it was undisputed that vaccines can potentially cause very serious adverse effects. It was also undisputed that there was a family history of autoimmune disorders. Then the mother’s expert took things to crazy-plaintiff-town by testifying about undue influence exerted by pharmaceutical companies over the CDC.

The Matheson appellate court preferred the land of lucidity. In affirming the trial court’s order in favor of vaccination, the appellate court held that “the dispositive issues are not whether vaccines can potentially cause adverse effects, or whether the vaccine manufacturing industry and pharmaceutical companies are unduly influencing governmental regulatory agencies. Instead, what is at issue is whether the administration of vaccinations is in the child’s best interests, taking into account her physical health. Even accepting as valid and accurate plaintiff’s contention that the child bears some predisposition to incurring an autoimmune disorder because of her family history, this attenuated risk, in and of itself, simply does not outweigh the significant benefits that would inure to the child by protecting her from the threat of serious and life-endangering diseases in the population. Put another way, the threat of harm to the child by exposing her to vaccines that could potentially trigger an autoimmune disorder is speculative, and the record does not otherwise demonstrate that the child would be put at risk of harm by receiving vaccinations.”

Both the treating pediatrician and the father’s expert medical witness testified that they recommend that children receive the vaccinations suggested by the CDC and the state of Michigan. Conversely, the mother’s expert witness had not personally evaluated the child and, while familiar with the child’s “medical records and her family history, testified generally about potential adverse reactions to vaccines and notably did not provide any substantive evidence, aside from possibilities and speculation that the child would be harmed by the administration of vaccines.” That thin presentation against vaccines could not overcome evidence that whooping cough is at “epidemic proportions” in Michigan and that it can lead to pneumonia, and even death for a child. The plaintiff did not present persuasive evidence establishing that “[the child] will be harmed by any particular vaccination and/or that any particular vaccination is otherwise contrary to [the child’s] best interests.” On the grounds of science, the mother’s cases against vaccination was a loser.

What really drove the case was the mother’s strong religious objections to the use of vaccines because “some vaccines are cultured in aborted fetal cells” and also contain animal blood. The trial court duly considered plaintiff’s objections to vaccines when considering “[t]he capacity and disposition of the parties … to continue the education and raising of the child in his or her religion or creed, if any.” The trial court ultimately did not find that the plaintiff’s testimony on the subject of her religious objections rendered this factor “more or less favorable to either party.” Accordingly, the appellate court held that “the trial court did not err by determining that it was within the child’s best interests to be vaccinated.”

The appellate court in Matheson also held that the trial court did not abuse its discretion in rejecting the mother’s proffer of expert testimony by a doctor “in the areas of adversomics, which addresses the adverse effects of vaccine injuries.” The expert had an “extensive educational and professional background in pediatric medicine, and her interest and work with vaccine-related topics,” but there was no showing that the expert had “been educated in , or worked professionally in, the specific and specialized area of adversomics for which plaintiff sought to qualify her as an expert.” Moreover, the court was “unable to discern exactly what comprises the specialty of adversomics,” and what “specialized knowledge” the expert could offer the trier of face in these proceedings.

Indeed.

****

If you haven’t seen the Civilisation series (the “s” is the British spelling), do yourself a favor and watch it. It is as relevant today as it was 50 years ago. The first episode is called “The Skin of Our Teeth.” It is about the Dark Ages (the six centuries following the fall of the Roman Empire) when Europe survived and ultimately emerged from violent paganism only because some monks huddled off the Irish coast and preserved art and scholasticism. By the end of the series, Clark blasts the then current era’s lack of confidence and seems to see the barbarians at the gate. That was back in 1969. By now, the barbarians seem to have made their way in and grabbed hold of the levers of power. Or perhaps as the cartoon character Pogo once famously said, “we have met the enemy and they is us.” Granted, we are growing ever grumpier and more pessimistic as we stumble toward dotage. Maybe we are the grouch yelling at millennials to get off our lawn. But to our moldy eyes, the glories of the Enlightenment are on the verge of being squandered. Voltaire and Franklin would be hooted by a talk-show audience or campaign rally crowd. Goodbye scientific method, hello idiocracy. Anti-vaxxers and climate-change deniers worry us. We seem to be sliding into a new Dark Age. The Matheson case is a brief moment where someone of sense leapt atop the pile of foolishness and called for a halt. (You should certainly take a look at Kenneth Clark’s description of Rodin’s Balzac sculpture – possibly the finest sculpture since Michelangelo — as a figure who says no to “lies, tanks, teargas, ideologies, opinion polls… the whole lot.”) With the current ascendancy of anti-fact know-nothingism, perhaps a small group of people who care more about truth than preference will hunker down on a small island (Martha’s Vineyard would be nice), and wait out the orgy of ignorance. In Civilisation, one of the places where the monks tended to their precious illuminated books while eluding chaos was Skellig Michael, a fearsomely remote and rocky crag west of Ireland. This tiny, forbidding island probably seemed hardly worth the bother to the Vikings. Skellig Michael also served as the location for Luke Skywalker’s retreat in The Last Jedi. So, yes, as always, everything comes back to Star Wars.

We’d like the answer to that question to be – most of the time.  But that’s too much to hope for.  After all, lawsuits are brought in California.  With its plaintiff-friendly laws, indeed, California is an often sought after venue by mass tort products liability plaintiffs.  But, according to a recent California appellate court decision, if the plaintiff isn’t from California or the injury didn’t occur in California, it is unlikely California law applies.

Chen v. Los Angeles Truck Centers, LLC, — Cal. Rptr. 3d –, 2019 WL 6242110 (Cal. App. Nov. 22, 2019) is not a prescription drug or medical device case.  It is a products liability action.  Plaintiffs were foreign tourists who were injured in bus accident in Arizona.  They settled their claims with the bus tour company and bus driver.  The pending lawsuit was brought against the Indiana manufacturer of the bus and the California distributor who purchased it and sold it to the tour operator.  Id. at *1.  So, in our DDL world this is analogous to non-California plaintiffs suing a non-California drug/device manufacturer and a California distributor.  Not a wild hypothetical.

Defendants asked the court to apply Indiana law, which it did.  Before trial, the Indiana manufacturer settled with plaintiffs.  Then a defense verdict was entered in favor of the distributor and plaintiffs appealed the choice of law determination.  The appellate court upheld the application of Indiana law.

California employs the governmental interest test in deciding choice of law questions.  The test has three-parts:  (1) are the laws of each state in fact different; (2) if so, what is each state’s interest in application of its own law under the circumstances of the particular case to determine if there is a true conflict; and (3) if so, which state’s interest would be more impaired if subordinated to the policy of the other state.  Id. at *3.

Question 1 – Indiana and California product liability laws are different.  Not surprisingly, Indiana law is more favorable for defendants.  It “imports a negligence standard into the definition of a defective product.”  Id. California law does not.

Question 2 – Only Indiana has a true interest in application of its law in this circumstance.  Indiana has a more “business-friendly” product liability rule which “furthers Indiana’s interest in providing an attractive environment for its manufacturers by protecting them from excessive liability or damage awards.”  Id. at *4.  The court compared that with the policy underlying California’s more plaintiff-friendly law and put it into context given the particular case circumstances:

[T]he underlying basis for the policy is the protection of California residents and other persons within its territorial jurisdiction from injury. California’s interest in imposing that policy becomes hypothetical when the injured persons are not California residents and were not injured in California.

Id. at *5.

Put another way, the policy behind California’s strict liability rule “is to ensure that the costs of injuries resulting from defective products are borne by the manufacturers . . .  rather than by the injured persons.”  Id.  However, the only California party in this case was the distributor.  So, California’s interest in protecting its citizens or passing the costs to manufacturers is at best hypothetical when the case does not involve California plaintiffs or a California manufacturer.

Question 3 – The court didn’t need to reach it having answered the second question in the negative, but it examined the issue anyway.  For basically all of the same reasons it concluded California’s interest was only hypothetical, it also concluded that Indiana’s law should not be subordinated to California’s.  Id. at *7-8.  Applying California law in this case “would not protect California residents or anyone who was injured in California.”  Id. at *8.  Nor would it “protect California residents and persons who are injured in California from having to bear the financial costs of injuries caused by defective products.”  Id.

In a drug/device case, this should mean California law does not apply to cases involving non-California plaintiffs and a non-California manufacturer.  In that situation, the court would have to use the governmental interest test to choose between the home state of the manufacturer and the home state of the plaintiff (usually also where the injury occurred).  Typically, the home state of the plaintiff wins out in those situations, with some limited exceptions (i.e. which law applies to punitive damages claims).  But what does this case mean for a suit brought in California by non-California residents against a California manufacturer.  If the primary policy behind California’s product liability laws are protection of California residents, the holding of this case should still apply.  It is a fairly sweeping holding.  Without a California plaintiff or a California-based injury, California law doesn’t apply.  And while we often say choice of law decisions are difficult to categorize as pro-defense or pro-plaintiff because they can be used to either sides’ benefit – we’re pretty sure we can say a decision limiting application of California law is a defense win.

We’ve used the phrase “one-two punch” before in the blog to describe a pair of legal decisions concerning the same product.  Usually, our clients have been on the winning side, but that’s not always true, particularly in cases coming out of Philadelphia, Pennsylvania.  In November, the Pennsylvania appellate courts, in gynecomastia litigation, dealt defendants two significant setbacks.

The first decision was from the Pennsylvania Supreme Court and dealt with an issue we don’t cover that much – due to state- and fact-specificity – the statute of limitations.  But what went down in In re Risperdal Litigation, ___ A.3d ___, 2019 WL 6139189 (Pa. Nov. 20, 2019) (“IRRL”), involves the realities of mass torts as much as any particular facts, so it’s worth discussing.  The legal press has indicated that the impact of IRRL will be the resurrection of “thousands” of gynecomastia plaintiffs’ cases, and that’s why the case is significant.

First off, Philadelphia seems to be just about the only place where this type of gynecomastia litigation has achieved any traction.  As other courts have pointed out, the FDA did not even consider this condition to be a “serious” hazard.

[A] November 2014 letter from a FDA senior official [stated] that “Gynecomastia is a common clinical manifestation of hyperprolactinemia, regardless or cause, and does not represent a serious adverse event as defined in 21 C.F.R. §312.32(a). . . .  [T]he parties’ regulatory experts both agreed (one readily and the other begrudgingly) that, according to the FDA’s own regulations, gynecomastia would not be a serious adverse event.

*          *          *          *

[I]t is undisputed that gynecomastia was not a “serious” hazard pursuant to the regulations in existence during the time in question. . . .

Byrd v. Janssen Pharmaceuticals, Inc., 333 F. Supp.3d 111, 122, 124 (N.D.N.Y. 2018).  Byrd quoted the FDA’s 2014 rejection of a citizen petition – brought by a Philadelphia plaintiff-side lawyer  That lawyer sued the FDA over the denial and lost.  Sheller, P.C. v. United States Dept. of Health & Human Services, 663 F. Appx. 150, 155 (3d Cir. 2016) (“gynecomastia is not a serious adverse event”; affirming dismissal).  See Moots v. Secretary, Dept. of Corrections, 425 F. Appx. 857, 858 (11th Cir. 2011) (“gynecomastia requires only cosmetic treatment”; it is not [a condition] that, if left unattended, poses a substantial risk of serious harm”) (citation and quotation marks omitted); D.E. v. Dept. of Public Welfare, 2008 WL 9399228, at *3 (Pa. Commw. Oct. 10, 2008) (“in most cases, gynecomastia spontaneously regresses within three years after its onset”); Schilling v. Ellis Hospital, 906 N.Y.S.2d 187, 189 (N.Y.A.D. 2010) (“a reasonably prudent patient in those circumstances would agree to take that medication despite being informed of the low risk of gynecomastia, which is a treatable, non-life-threatening condition”); Cleveland v. Janssen Pharmaceuticals, 2019 WL 6114719, at *4 (E.D. Cal. Nov. 18, 2019) (“[t]he FDA has characterized gynecomastia as a nonserious risk”); Garcia v. McLean, 2018 WL 1788072, at *11 (Mag. N.D.W. Va. Feb. 22, 2018) (“gynecomastia does not meet the standard to be recognized as a serious medical condition”), adopted, 2018 WL 1785481 (N.D.W. Va. April 13, 2018); Rankins v. Washington, 2017 WL 4364060, at *3 (W.D. Mich. Sept. 29, 2017) (“the absence of physical complications from gynecomastia is not uncommon”); Fryman v. Traquina, 2009 WL 5199257, at *6 (Mag. E.D. Cal. Dec. 23, 2009) (“gynecomastia is a benign condition that does not cause pain”; “it is not physically harmful”), adopted, 2010 WL 624389 (E.D. Cal. Feb. 19, 2010); see also Internet research in Ayoubi v. Altez, 2017 WL 773883, at *4 (N.D. Ill. Feb. 27, 2017), vacated, 729 F. Appx. 455 (7th Cir. 2018) (holding that judges are not supposed to do their own Internet research).

Because plaintiffs making these claims seem to do much better in Philadelphia than anywhere else, thousands of them – recruited almost entirely by lawyer advertising – have flocked to that jurisdiction.  Unfortunately, they can do that, because the manufacturer is a Pennsylvania corporation, making general personal available under Daimler AG v. Bauman, 571 U.S. 117 (2014).  So the jurisprudential issue is presented how to deal with all of these cases.

Mass torts present a “mass” problem with respect to the statute of limitations.  As we discussed, New Jersey law has responded to this problem with a special choice of law rule for mass tort litigation plaintiffs – New Jersey law will always apply.  In re Accutane Litigation, 194 A.3d 503, 506 (N.J. 2018).  If plaintiffs don’t like it, they can “bring suit in the state where they reside . . . and probably enjoy the benefit – if it is a benefit – of their own state law.”  Id.  Pennsylvania has not gone that route, so the trial court (later affirmed by the intermediate appellate court) chose another way to achieve a global resolution.  The court recognized a global accrual date for all gynecomastia claims, “ruling . . . that any claim filed after June 31, 2009, must be dismissed on statute of limitations grounds based upon the cumulative effect of medical literature, newspaper articles and attorney advertising present by that point in time.”  IRRL, 2019 WL 6139189, at *3.  This had been done before in other mass torts.  IRRL mentioned three of them, involving the drugs Vioxx, Seroquel and Avandia.  Id. at *14.  We would add the Orthopedic Bone Screw litigation, where “a universal date of discovery” that turned out to be “outside the applicable [one-year] statute of limitations” resulted in dismissal some 1500 plaintiffs’ suits.  Maestas v. Sofamor Danek Group, Inc., 33 S.W.3d 805, 809 (Tenn. 2000).

In IRRL, the global accrual date adopted by the lower courts closely corresponded to the advent of plaintiff-side attorney advertising.

The . . . lawyer advertisement . . . [w]ithout question it links the ingestion of [the drug] with the incidence of gynecomastia.  As it was uploaded on June 25, 2009 and the trial court set June 30, 2009 as the final accrual date for all [drug]-related gynecomastia claims, this video was apparently the straw that broke the camel’s back for the trial court, such that any potential plaintiff’s “inquiry should have been awakened.”

2019 WL 6139189, at *14 (citation omitted).

In IRRL, however, the Supreme Court disagreed with the courts below and held that the evidence for the asserted global accrual date was insufficient to toll Pennsylvania’s discovery rule in every case:

Unlike in these cases, we cannot conclude, as a matter of law, that the present case involves the degree of publicity required to place [plaintiffs] on notice of the relationship between their injury and its cause. . . .

It may fairly be questioned as to whether the national attention regarding the link between [the drug] and gynecomastia compares favorably with the extent of media coverage in the [Avandia, Vioxx and Seroquel] cases.  In the present cases, the trial court referenced three medical journal articles (all published in 2003-2004), nine newspaper articles (spread over eight years), two television news programs in 2008, and a YouTube video.  However, the FDA did not require a black box warning on the [drug’s] label, no national health organizations issued warnings to physicians and patients, no statistics regarding decreases in prescriptions have been cited in support of the extent of the media coverage into local markets, there was no national media “blitz,” and [defendants] did not issue any “Dear Doctor” letters advising prescribing physicians of the 2006 label change.

IRRL, 2019 WL 6139189, at *14-15.

The Pennsylvania Supreme Court did not state that this information was insufficient as a matter of law to satisfy the discovery rule, only that individualized adjudications would be required:

This is not to say that the publicity (including the medical journal articles) cited by the trial court in this case was insufficient to place [plaintiffs] on notice (at any particular point in time) that their ingestion of [the drug] was the cause of their gynecomastia. . . .  Rather, we conclude only that reasonable minds could differ, thus requiring that the factual issues relating to [defendants’] statute of limitations defense must be submitted to a jury for resolution.

Finally, the scope of the distribution and information linking [the drug] to gynecomastia in the medical journal articles, media reports and lawyer advertising does not cumulatively, as a matter of law, lead to the conclusion that [plaintiffs] were put on inquiry notice sufficient to establish a June 30, 2009 accrual date for their causes of action.

Id. at *15.

So, what now?  If that quantum of evidence isn’t enough globally, is it enough for particular plaintiffs?  It may well be.  “We do not suggest that [defendants’] contention that [plaintiffs] were aware of their injuries in 2002 and 1998 is incorrect.  Rather, we conclude only that given that the evidentiary record here is entirely undeveloped.”  Id. at *9.  The alternative the court seems to envision is individual discovery in all of the returning cases.  Since IRRL itself involved only two plaintiffs, and they were both Pennsylvania residents, id. at *2-3, the Pennsylvania Supreme Court didn’t have any mass tort considerations directly before it.

That obviously means a lot more work for lawyers.  The idea of a “universal” or “global” discovery date (like New Jersey’s choice of law decision) was an attempt to ameliorate this.  At minimum, this discovery will involve review of all plaintiffs’ medical records for knowledge of risks that plaintiffs would have had access too, depositions of the plaintiffs’ parents/guardians (both plaintiffs in IRRL were minors), and treaters (for what they informed the parents/guardians and when).

Also, as the Supreme Court’s repeated references indicate, attorney advertising will be a key issue.  Both of the plaintiffs’ suits in IRRL were prompted by attorney advertising.  2019 WL 6139189, at *3.  If our prior experience with tobacco litigation is any indication, the use of advertising historians to establish on exactly what media programs/internet websites drug-related advertisements ran, combined with discovery of plaintiffs’ parents/guardians viewing history of mass and Internet media, will have to be involved.  Since only the plaintiffs’ side knows precisely where they ran their advertisements, this could make for some interesting discovery.

What can’t be allowed to happen is, with IRRL precluding one attempt at managing the volume of discovery of a mass tort, the plaintiffs proposing their own shortcuts that deny defendants the right to take the individualized discovery, and to make the individualized record, that the Supreme Court envisioned.  This has happened before in Philadelphia.  Cf. Rost v. Ford Motor Co., 151 A.3d 1032, 1054 (Pa. 2016) (declaring Philadelphia practices that formerly required consolidated trials in mass tort cases to be “error”).

We also note that one way that some of the “mass” could be removed from this litigation would be by more rigorous enforcement of the standards for interstate forum non conveniens.  While the particular plaintiffs in IRRL were Pennsylvanians, we expect that most of the returnees will be litigation tourists.  Since they can’t be forced back to their states of residence by personal jurisdiction, the only alternative is discretionary forum non conveniens motions.  In a recent case involving another defendant unfortunately incorporated in Pennsylvania and a litigation tourist plaintiff, the court pointed out that, when interstate (as opposed to intrastate) forum non conveniens is raised, “[a] plaintiff’s choice of forum is entitled to deference, but to a somewhat lesser degree when the plaintiff’s residence and place of injury are located somewhere else.”  McConnell v. B. Braun Medical Inc., ___ A.3d ___, 2019 WL 5203925, at *3 (Pa. Super. Oct. 16, 2019).  The defendant lost in in McConnell, but that (like IRRL in a different context) was due to an insufficient record.  Properly supported forum non conveniens motions (if possible on sets of facts we don’t know) could find a receptive judicial audience, should “thousands” of returning cases involve litigation tourist plaintiffs having no good reasons, beyond dollar signs, for burdening Philadelphia courts and taxpayers.  Forum non conveniens motions, backed by facts providing the judges running the Philadelphia Complex Litigation Center what McConnell says they need, might accomplish what personal jurisdiction can’t in that litigation.

That’s one.

The second seriously adverse Pennsylvania decision in the same litigation occurred six days later in A.Y. v. Janssen Pharmaceuticals Inc., ___ A.3d ___, 2019 WL 6317403 (Pa. Super. Nov. 26, 2019).  While IRRL was the end of the appellate line, A.Y. can, and deserves to be, appealed further.  A compensatory-damages-only “judgment of $70 million,” id. at *1, in a case involving an injury that elsewhere in the country – including by the FDA − isn’t even considered “serious”?  Somebody needs to get real.  So, the sheer excessiveness of this verdict cries out for a new trial.  That verdict is apparently “30 times larger than the next largest compensatory verdict in Philadelphia.”  Id. at *22.

Indeed, A.Y. may well be the largest product liability verdict in Pennsylvania history to survive appeal.  A $55,000,000 crashworthiness verdict was affirmed in American Honda Motor Co. v. Martinez, 2017 WL 1400968, at *1 (Pa. Super. April 19, 2017) (unpublished), but that plaintiff was a quadriplegic, and non-economic damages were “only” $25 million.  Id.  Cf. Tuski v. Ivyland Café, 2004 WL 4962363, at *24 (C.P. Philadelphia Co. Dec. 22, 2004) ($50 million compensatory award to quadriplegic plaintiff held excessive); Harker v. Chan, 2018 WL 3599734, at *15 (W.D. Pa. July 27, 2018) ($43,750,000 compensatory award to permanently disfigured plaintiff held excessive).  The only Pennsylvania verdict we know of that is larger was $78 million for obstetrical malpractice leading to quadriplegic cerebral palsy from birth.  See Nicholson-Upsey v. Touey, 2012 WL 3067501 (Pa. C.P. Philadelphia Co. May 4, 2012).

As already discussed, gynecomastia is not even a serious injury.  Several of the cases we cited above discussed surgery as providing a permanent fix.  E.g., Rankins, 2017 WL 4364060, at *3 (“Surgical removal of excess breast tissue is effective but rarely necessary.”).  See also Schulman v. Group Health Inc., 833 N.Y.S.2d 62, 64 (N.Y.A.D. 2007) (ordering insurer to pay for gynecomastia surgery).  “Compensatory damages are to compensate for the full extent of the injury sustained, and the award should be limited to compensation alone.”  Moorhead v. Crozer-Chester Medical Center, 765 A.2d 786, 790 (Pa. 2001).  Plainly A.Y. verdict carries a punitive element, and should be reversed for that reason alone.  A new trial wouldn’t even be a significant expenditure of additional resources, since the cross-appeal already requires a second, punitive damages trial.  A.Y., 2019 WL 6317403, at *23.

A.Y. is something of a muddle and it’s not clear whether the court was applying Pennsylvania or Tennessee law.  We don’t know anything about Tennessee, but we have dealt with excessiveness issues in Pennsylvania.  In the surviving portion of Foley v. Clark Equipment Co., 523 A.2d 379 (Pa. Super. 1987) (a product liability ruling in Foley having nothing to do with excessiveness was later overturned), the Superior Court offered a formula against which excessiveness claims should be judged:

Were [we not reversing on other grounds], we would find that the $15,000,000 verdict was excessive.  If invested at the legal rate, the amount of the verdict would produce an annual income of $900,000.  This exceeded by far the plaintiff’s earning capacity, and although appellant sustained serious and incapacitating injuries, the record does not support this grossly excessive verdict.

Id. at 394-95.  The “legal rate” in Pennsylvania is 6% simple interest.  42 Pa. C.S. §8101; 41 P.S. §202.  Just the interest at the “legal rate” on A.Y.’s $70 million non-economic damages verdict is $4.2 million per year.  As in Foley, just the annual interest on the noneconomic damages dwarfs any conceivable earning capacity that plaintiff A.Y. could have.  Prior panel decisions of the Superior Court are “binding precedent,” A.Y., 2019 WL 6317403, at *23, but A.Y. doesn’t even cite Foley.  The Foley formula demonstrates how grossly excessive the verdict in A.Y. truly is.  One year’s interest on that verdict, alone, would earn that physically unimpaired plaintiff much more money than most people earn in a lifetime.  Its punitive nature shines like a beacon.

More recently, in another purely non-economic case, a “$26,600,000 jury award of damages . . . was excessive − if not punitive − and clearly beyond what the evidence warrants.”  Polett v. Public Communications, Inc., 2016 WL 3154155, at *3 (Pa. Super. June 6, 2016) (en banc) (citation and quotation marks omitted).  All of the four judges in Polett who agreed the verdict was excessive still sit on the Superior Court; only the lone dissenter has taken senior status.  Conversely, none of the Polett judges also sat on A.Y.  Since, a finding of excessiveness is appropriate “[w]here the jury’s verdict is so contrary to the evidence as to shock one’s sense of justice,” Kiser v. Schulte, 648 A.2d 1, 4 (Pa. 1994), finding some new judges with consciences that may be “shocked” by this verdict would be very good idea.

Another questionable aspect of A.Y. is its preemption ruling.  Once again, the opinion is less than pellucid, this part being mostly a succession of block quotes from this and that prior opinion, making it difficult to follow either the defendants’ arguments or the court’s rationale.  Apparently the defendants argued impossibility preemption – that “it was impossible for [defendants] simultaneously to comply with its federal and state-law obligations regarding [drug] labeling of pediatric gynecomastia risks.”  2019 WL 6317403, at *6 (internal quotation marks omitted).  There are a lot of subsidiary problems with A.Y., such as continued reliance on a “presumption” against preemption, id. at *6, after Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), demoted it back to a mere “assumption”; and substantial reliance on Hassett v. Dafoe, 74 A.3d 202, 210 (Pa. Super. 2013), an extreme outlier generic preemption decision that hasn’t been followed by a single court anywhere else in over five years.  But we’ll ignore those and try to cut straight to the chase, as we see it.

The defendants’ preemption argument to us seems like a sound one, particularly since Albrecht declared preemption to be a matter of law, rendering the court’s critical reliance on plaintiffs’ expert witness, A.Y., 2019 WL 6317403, at *8, unnecessary.  The defendants’ position is characterized as an “off-label use defense,” id., which means that the argument is undoubtedly similar to the post we wrote here, pointing out the following two FDA provisions:

A specific warning relating to a use not provided for under the “Indications and Usage” section may be required by FDA in accordance with sections 201(n) and 502(a) of the act if the drug is commonly prescribed for a disease or condition and such usage is associated with a clinically significant risk or hazard.

21 C.F.R. §201.57(c)(6)(i) (emphasis added).

A specific warning relating to a use not provided for under the “Indications and Usage” section of the labeling may be required by the Food and Drug Administration if the drug is commonly prescribed for a disease or condition, and there is lack of substantial evidence of effectiveness for that disease or condition, and such usage is associated with serious risk or hazard.

21 C.F.R. §201.80(e) (emphasis added).  The references in §201.57 to sections 201(n) (21 U.S.C. §321(n)) and 502(a) (21 U.S.C. §352(a)) of the FDCA are to general provisions relating to misbranding.

Since only the FDA can “require” warnings about off-label uses, that places the warning claims in question outside of the FDA’s CBE regulation (which does not expressly extend to off-label uses in any event), and puts them squarely within the “independence principle” enunciated by PLIVA, Inc. v. Mensing:  “when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.”  564 U.S. 604, 623-24, (2011).  Oddly, A.Y. nowhere cites to either this principle or, indeed, to Mensing itself (also absent is Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), which reinforced Mensing).  This complete failure to come to grips with contrary, controlling precedent casts serious doubt on A.Y.’s rationale.

What A.Y. does hold – albeit briefly and without analysis – is that the FDA’s regulatory scheme back in 2003 (when the minor plaintiff was first prescribed the drug) was different than it is now:

Plaintiffs[] assail [defendants’] “off-label use” defense as also being inconsistent with governing statutory law as it existed at the time. . . .  Specifically, [plaintiffs] accurately point out that 21 C.F.R. §201.57(f)(9)(i), which pertained to “pediatric care,” was in effect in 2003 and provided that any “specific hazard” associated with an unapproved pediatric use “shall be described in this subsection of the labeling. …” Id.

2019 WL 6317403, at *8.  This is the key point.  If drug companies were free to add warnings (or other information) about off-label uses at their leisure, then A.Y. would be right :  (1) the “independence principle” would be satisfied, (2) defendants would be within the scope of the FDA’s CBE regulation; and (3) the only preemption argument available would be “clear evidence” under Albrecht and Wyeth v. Levine, 555 U.S. 555 (2009), which is a “demanding defense.”  2019 WL 6317403, at *6.

We had to learn how to access the “historical” C.F.R. in Westlaw order to evaluate this argument, since A.Y. is not, in fact, “accurate.”  A.Y. both misnamed the relevant regulation (which involves “pediatric use,” not “pediatric care”), and miscited only snippets from the wrong subsections.  In 2003, §201.57(f)(9)(i), did not contain the word “hazard.”  Instead, the actually relevant section provided:

(vi) If the requirements for a finding of substantial evidence to support a pediatric indication or a pediatric use statement have not been met for any pediatric population, this subsection of the labeling shall contain the following statement: “Safety and effectiveness in pediatric patients have not been established.”  If use of the drug in premature or neonatal infants, or other pediatric subgroups, is associated with a specific hazard, the hazard shall be described in this subsection of the labeling, or, if appropriate, the hazard shall be stated in the “Contraindications” or “Warnings” section of the labeling and this subsection shall refer to it.

201.57(f)(9)(vi) (2003) (containing the word “hazard”).  This drug was approved for a number of pediatric indications in 2006.  A.Y., 2019 WL 6317403, at *2 (approval for “irritability associated with autistic disorder in children and adolescents (between the ages of 5 and 16), including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums and quickly changing mood”).  The opinion does not directly state whether the 2006 pediatric indications included the minor-plaintiff’s treatment, but we think so, given that the conduct being treated sounds similar.  Id. at *3 (“Attention Deficit Hyperactivity Disorder” and “Oppositional Defiant Disorder”); at *15 (“biting, hitting, smashing windows out with his fist, persistent fighting with other children, refusal to follow instructions at school or at home, and on one occasion breaking a chicken’s back”).  If the treatment were still off-label in 2006, it would then be governed by a different section (assuming no regulatory changes through 2006), §201.57(f)(9)(v) (2003) (governing off-label use “for a particular pediatric population”).  However, the relevant “hazard” language was identical in both subsections.

So the question becomes, is gynecomastia a “specific hazard” that would fall within either §§201.57(f)(9)(v-vi) back in 2003?  A.Y. skips right over this critical point, its parade of block quotes nowhere addressing it.  Why?  Because of what we discussed above.  The FDA has never considered gynecomastia a “serious” hazard warranting a warning.  That’s what the cases we cited at the outset are about, and that’s why a Philadelphia plaintiff-side lawyer took the extraordinary step of not only filing a citizen petition to try to change this – but also trying to sue the FDA when it denied its position.  Back in 2003, the same overall regulation limited the scope of warnings to “serious” hazards or risks:

Warnings. Under this section heading, the labeling shall describe serious adverse reactions and potential safety hazards, limitations in use imposed by them, and steps that should be taken if they occur.  The labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.

21 C.F.R. §201.57(e) (2003) (emphasis added).  The same is true of off-label use – “a use not provided for under the ‘Indications and Usage’ section of the labeling”:

A specific warning relating to a use not provided for under the “Indications and Usage” section of the labeling may be required by the Food and Drug Administration if the drug is commonly prescribed for a disease or condition, and there is lack of substantial evidence of effectiveness for that disease or condition, and such usage is associated with serious risk or hazard.

Id. (emphasis added).  Note the “required by the [FDA]” language.  Back in 2003 – as now – the FDA reserved to itself whether to require warnings about off-label uses.  The Mensing independence principle applies, and thus the claim is preempted without regard to Levine and “clear evidence.”

Thus, the defendants were correct, and the A.Y. decision was not, about whether the defendants had the ability to make a label change concerning an off-label use in 2003 without FDA prior approval.  That being the case, most of the A.Y. discussion, including the block quotes from Albrecht, are simply inapposite.  Plaintiffs could never put the defendants inside the terms of the CBE regulation in the first place.  Therefore the “clear evidence” standard, whatever it might mean after Albrecht, doesn’t apply.  Rather, the Mensing independence principle should govern A.Y. because applicable FDA regulations in 2003 mandated that an off-label warning can only be “required by” the FDA and thus the manufacturer could not act independently.  After Albrecht, moreover, all this is a question of law, not of fact for either juries to decide or for either sides’ experts to offer opinions.

So we have two aspects in which we think A.Y. was quite erroneous – liability and damages.  If we wanted to prolong this post, we could also take issue with:  (1) repeated reliance on preempted claims of fraud on the FDA (id. at *12) (Kessler fraud on the FDA testimony); *20 (“[i]nstead of submitting this information to the FDA . . . Defendants withheld and concealed the results”); (2) misreading of the Tennessee damages cap statute (id. at *20-21) (equating a state statutory spoliation exception with production of materials to the FDA governed solely by federal law), or (3) the exclusion of evidence of conduct by the minor plaintiff indicative of possible bullying behavior, while simultaneously seeking millions in damages for being “bullied.”  Compare Id. at *15 (minor plaintiff described as engaging in biting, hitting, fighting, vandalism, insubordination, and animal cruelty), with id. at 23-24 (claims of being bullied).  However, these issues are either evidentiary, and thus arguably governed by an abuse of discretion standard, or involve a Pennsylvania court misinterpreting another state’s law.  As such they are less clear-cut or significant than the glaring errors we have discussed above.

That’s number two.  So while we have to admit that Pennsylvania plaintiffs landed two stinging appellate blows within a week of each other in different aspects of the same litigation, it’s still time for the next round.

Picture this. Invitations go out for a Thanksgiving get-together and the host and expected guests together sort out who will bring what foods and how everything will be served. A sideboard is loaded up with the traditional holiday foods, along with a collection of everyone’s quirky favorite salad items to allow easy compilation of a guest-specific salad. Most of the guests arrive on time and eat their fill. The host fulfills her function with efficient seating, intercession in minor squabbles, and ample beverages. Like Thor’s goats, the traditional holiday foods magically replenish no matter how many guests have sampled them. Sated guests have retired to watch more football. In short, the gathering was as a Thanksgiving should be. Then, a guest appears at the door, is invited in, and directed toward to the sideboard with instructions on how to help herself, how to find a seat, and how to find beverages. The late-to-the-party guest says this arrangement is insufficient. She wants a plate prepared just for her, including both the general and guest-specific foods she contends the host should know how to pick for her, and brought to her at her preferred seat, which is on the sofa rather than the dining room table where everyone else ate. Mind you, she could have prepared her own plate and sat at the table, but she insists that a host must give her special treatment because she would not have had to prepare her own plate had she dined solo at a sit-down restaurant (excluding buffets and smorgasbords). Undoubtedly, this guest is being a jive turkey, if not an insufferable pig.

We think the plaintiff’s position in Williams v. Biomet, Inc., No. 3:18cv00211RLM-MGG, 2019 U.S. Dist. LEXIS 199802 (N.D. Ind. Nov. 15, 2019), is much like that of the boorish guest above. Her suit was transferred to the M2a hip implant MDL about six years after it was established and more than two years after generic discovery closed. (We have chimed in on a few decisions from this MDL over the years. See here.) The MDL had in place a vendor for easy access to documents produced by the defendants and a system for case-specific discovery that built on a Defendant Fact Sheet and production of specified case-specific documents. Rather than go forward with the typical case-specific depositions of the plaintiff, a treating surgeon, and one of defendant’s sales representatives, the plaintiff moved to compel the defendant to answer her written discovery in the way she wanted. She did not want to obtain generic or case-specific information from the MDL plaintiffs’ leadership or the third-party vendor selected by the parties years before. No, she wanted everything on a silver platter.

As to this issue, the court was not sympathetic to plaintiffs’ high maintenance demands. It noted that this motion to compel was brought after “[h]undreds of cases already have been remanded or transferred to other courts for trial, with all parties and courts understanding that most case-specific, and all non-case-specific discovery (also described as ‘general’ and ‘generic’ in past orders), has been completed in the MDL court.” Id. at *7. The defendant had “produced millions of documents and custodian-deponents early in the docket’s life”; these were available through the plaintiffs’ leadership, as was the complaint file on each plaintiff. Id. Medical records gathered on each plaintiff were available through the agreed vendor “on the same terms the records are available to [defendant].” Id. at *8. In responding to plaintiffs’ written discovery, defendant directed plaintiff to those sources, as it presumably had in hundreds of other cases in the MDL. “Ms. Williams contends that isn’t good enough, that [defendant] must produce the requested information and documents to her counsel rather than simply point her to a bucket full of discovery.” Id. Of course, this is an MDL and an MDL is supposed to promote efficient and non-repetitive discovery. We have described many issues we take with the general pro-plaintiff, pro-settlement slant in many modern MDLs, like here, here, and here, but we certainly agree with this foregoing principle and its application here.

Defendant’s approach did not deprive plaintiff of access to general or case-specific discovery or place an undue burden on her.

Biomet produced hundreds of thousands of documents in electronic form to Record Trak for the Plaintiffs’ Steering Committee, which serves as a stand-in for each plaintiff for purposes of receipt of discovery materials. The files are readily searchable. Ms. Williams says she shouldn’t have to conduct that search (which carries a cost as well as a risk that her search would miss documents pertinent to her case) because the rules of procedure place that burden on Biomet. If she’s right, a defendant in a mass tort MDL would have to search through the same electronic files thousands of times to narrow the pile of files down to those relating to a given plaintiff. Or Ms. Williams must conduct the search, but only once. Ms. Williams’s argument would defeat one of the main efficiencies of the MDL process.

Id. at *9. So, she basically gets what everyone else gets. Coming in late and asking for special treatment “just because” are not good reasons for deviating from the existing, established procedure. Any defendant in an MDL or state coordinated proceeding can appreciate this dynamic, and, while it might be nice to say a picky plaintiff should get nothing and like it, keeping the sideboard open for the late-arriving guests is better than having to make up a bunch of ad hoc plates of discovery for them.

Enjoy your giving of thanks and partaking of gluttony.

When we discuss the learned intermediary rule, it is typically in the context of protecting our drug and device manufacturer clients. If a manufacturer warned the doctor, it discharged its duties, and a plaintiff should not be able to claim that he or she was not directly warned. We do not often represent pharmacies, but we’d usually just as soon see them escape liability as well, if only to keep them out of the case and keep them from wrecking federal diversity. Thus, we have often written about cases that shut down failure to warn claims against pharmacies – see here and here, for example.

Illinois was already on the correct side of the ledger, refusing to put pharmacies on the hook for failure to warn. That same legal position was applied, and perhaps even slightly extended, in Urbaniak v. American Drug Stores, LLC, 2019 IL App. (1st) 180248 (Ill. App. March 25, 2019). In Urbaniak, the plaintiff had taken Reglan for six years to treat gastroparesis. Unfortunately, the plaintiff developed tardive dyskinesia and dystonia. The prescribing physician admitted that he was unaware of the risk that a patient might develop these movement disorders from long-term ingestion of Reglan. The plaintiff sued that doctor for medical malpractice and separately settled. One might think that is where the tale ends.

It did not end that way here. The plaintiff also sued the pharmacy, and the central issue in that case was whether the pharmacy could be liable for failing to issue an oral warning to the plaintiff about the medical risks associated with the long-term ingestion of Reglan. Why an oral warning? We’ll get to that point. It is a major weakness in the plaintiff’s case. Another weakness was that the plaintiff wanted to prove that the pharmacy should have known the risks about which the doctor was clueless, should have deduced that the doctor was clueless, and should have stepped into the breech and warned the patient.

That seems a trifle ambitious. It also seems more than a trifle wrong.

(Why did the plaintiff not sue the manufacturer? Dunno. Perhaps the plaintiff used a generic version. Or perhaps the plaintiff saw the learned intermediary rule as an insurmountable barrier against manufacturer liability. If the latter, then what happened in Urbaniak becomes even a little more interesting.)

In February 2009, after the plaintiff began taking Reglan, the Food and Drug Administration approved a black box warning for the drug. The black box warning addressed tardive dyskinesia directly. For the six years he took Reglan, the plaintiff had all of his prescriptions filled at the same pharmacy. When dispensing Reglan, the pharmacy distributed a medication guide to consumers. The medication guide for Reglan provided warnings and other information about the drug, including the warning about tardive dyskinesia. But the pharmacy never orally warned the plaintiff about the risks associated with taking Reglan longer than 12 weeks. Do you see where this is going?

Why would the pharmacy butt in and nag the plaintiff? That must be what the pharmacy thought when it moved for summary judgment on the claims against it. The pharmacy argued that it had no duty to warn the plaintiff or his doctor about the risk of developing tardive dyskinesia and dystonia as a result of taking Reglan for longer than 12 weeks. The trial court agreed and entered summary judgment in the pharmacy’s favor. The plaintiff appealed.

The Illinois appellate court reasoned that the learned intermediary doctrine obligates drug manufacturers to warn only physicians about the potential risks of a drug, and then physicians are required to use medical judgment to determine which warnings to provide to patients to whom the drug is prescribed. The duty to warn of side effects is not placed on the pharmacist, it is placed on the prescribing physician. A pharmacist owes just a duty of ordinary care in practicing his or her profession.

The issue in Urbaniak was not whether the pharmacy had a generalized duty to warn the plaintiff about the dangers of Reglan, because it did so in writing. (Remember the medication guide?). Rather, the issue is whether the pharmacy had a specific duty to advise the plaintiff orally about the risks of the prolonged ingestion of Reglan or to advise the prescribing physician about the risks of taking Reglan long term. That makes the Urbaniak case slightly different from prior Illinois cases. It makes Urbaniak weirder. We think it also makes Urbaniak easier.

The plaintiff argued that it is “highly unusual” for a black box prescription warning to have a time limitation – 12 weeks in this case – and that the pharmacy should have told both the prescribing doctor and the patient “about the 12 week warning so they could have evaluated whether to continue the drug.” The plaintiff argued that the pharmacy owed a duty “to be aware of the black box time limitation, to make sure that the refill does not exceed the limitation, and if it does, discuss that issue with the doctor or patient.”

The appellate court sensibly concluded that such a rule would require pharmacies to inquire into the doctor’s judgment about, at a minimum, the duration of prescriptions when side effects could develop from long-term use. Such a rule would run afoul of Illinois court decisions that have “consistently declined to impose upon a pharmacy, any duty to monitor patients, make medical decisions, or to warn a physician or a patient of ‘excessive’ prescribed doses.” Illinois law imposes “no duty on a pharmacist to warn the customer or notify the physician that drugs are being prescribed in dangerous amounts, that the customer is being overmedicated or that various drugs in the prescribed quantities could have an adverse effect.”

Again, the pharmacy did warn the plaintiff about the dangers of taking Reglan for longer than 12 weeks. It just did so in writing. The plaintiff argued that the pharmacy should have been done orally, as well. That is not a theory of liability the appellate court would accept. The plaintiff admitted that he never read the medication guide given to him with his prescription. The plaintiff seemed to want a nanny at every turn. He demanded that the pharmacy should have waded further into the situation. But, according to the appellate court, “the learned intermediary doctrine dictates that pharmacists stay out of the physician-patient relationship.”

(Some of you might be thinking that Urbaniak smells like assumption of the risk, contributory negligence, or a break in the failure to warn claim inasmuch as the plaintiff either 1) read the warning and accepted the tardive dyskinesia risk without any questions, 2) read the warning, discussed it with the doctor he later sued, and accepted the risk, or 3) never read the medication guide at all. All of that points to personal responsibility, which this plaintiff threw away with the medication guide.)

Moreover, the pharmacy had no reason to know that the doctor was ignorant of the effects of the drug for which he wrote a prescription. It is not as if the pharmacy was saddled with an “independent duty to inquire into the doctor’s pharmaceutical competence.” It is the doctor’s duty to know what he is prescribing and it is the pharmacy’s duty to give the patient what the doctor orders.

There is another way to style the plaintiff’s claim in Urbaniak. To fit within Illinois precedents, the plaintiff tried to make the case that Reglan should be considered contraindicated for anyone after 12 weeks of use. Consequently, per this line of reasoning, the pharmacy was required to speak up about such contraindication. But contraindications ”speak in terms of specific patients and specific treatments. Reglan was not specifically contraindicated for the plaintiff for any articulable reason. The plaintiff presented with no allergy and there was no concern about the interaction of multiple drugs in this case.”

The pharmacy simply had no duty to speak.

As we approach the end of the year, we turn to reflecting on the events of the passing year.  We do it here on the DDL blog with our best of and worst of posts.  It is often a time to consider just how much (or how little) was accomplished in the course of a year.  How much has changed (or stayed the same).  In any event, a year marks a significant passage of time.  Enough time to say – file a complaint with sufficient facts to support your claims (or not).

In Winkler v. Medtronic, Inc., 2019 WL 6052702 (D. MD. Nov. 15, 2019), the court was analyzing plaintiffs’ amended complaint.  That’s because almost one year earlier the first complaint was dismissed for lacking “sufficient detail for the Court to determine the applicable limitations period . . . or whether any of the claims are preempted.”  Winkler v. Medtronic, Inc., 2018 WL 6271055 (D. MD. Nov. 29, 2018).  Back then, plaintiffs complained that “a more robust pleading is impossible absent discovery.”  Id. at 4.  The court disagreed.  Specifically, the court noted that plaintiffs had the publicly available FDA Class III information on the device and they retained possession of the allegedly defective part of the device.  Plaintiffs, therefore, had the tools to “exercise[e] due diligence,” amend their complaint, and then allow the court to analyze the question of preemption.  Id. Well, two out of three of those things took place.

Plaintiffs filed their amended complaint.  It contained causes of action for negligent manufacture, failure to warn, breach of warranty, strict liability, and wrongful death.  Winkler, 2019 WL 6052702 at *3.  At issue was a ventricular assistive system that had been implanted in the decedent’s heart to provide ventricular function while decedent awaited a heart transplant.  A power failure caused the device to stop working and decedent suffered a fatal cardiac arrest.  Id. at *1.  The device was a pre-market approved, Class III device.  Having gone through the rigors of pre-market approval, only a parallel violation claim may survive preemption.

Therefore, as an initial matter, the complaint must allege violations of FDA regulations related to the device at issue.  The amended complaint contained only this single sentence with a vague reference to an unidentified FDA-standard:  “Defectively manufactured batteries which fail to hold a charge due to faulty cells violate the standards required by the FDA for premarket approval of the [device].”  Id. at *3.  Where’s the specificity?  Where’s the due diligence?

Simply stating that the defect you allege caused injury also violated a non-specific FDA standard, “is simply insufficient for this Court to infer plausibly that the claims are parallel, and not in addition, to the pertinent FDA regulations.  Id.  That is simply too low a bar to allow plaintiffs to escape statutory preemption.

Not in their amended complaint, but in their response to defendant’s motion, plaintiffs allege that the subsequent FDA recall “saves the claim.”  Id.  Even if that could be considered as part of the amended complaint, it still didn’t solve plaintiffs’ problem of failing to plausibly allege a violation of a specific FDA regulation.  The recall may support that the device was defective, but it “does not shed any light on the applicable FDA regulations” or how those arguably violated by defendant.  Id.

One year ago the court gave plaintiffs a roadmap.  Look at the regulations applicable to the device and look at the device itself.  Allege facts supporting that the device implanted in the decedent deviated from or violated any specific FDA standards.  Use due diligence.  Plaintiffs ignored that advice, added one vague reference to a violation, and tried to toss in the recall at the last minute.  In other words, since last year almost nothing changed.  So, neither did the result.  Case dismissed.