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).

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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.