We have a guest post today, from Luther Munford of Butler Snow.  He’s been doing some thinking about how something analogous to the “two schools of thought” medical malpractice doctrine should apply to medical product liability cases.  As always with out guest posts, our posters deserve 100% of the credit, and any blame, for their posts.

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When the law addresses medical judgment directly, it allows room for reasonable physician choice.  It is ironic then, that a product liability suit over design defect may not allow any such room.  In order to protect physician choice, courts need to resist the temptation to turn product liability disputes into a contest in which reasonable physician choice has no place.

In medical malpractice litigation, where the standard of care is directly in issue, there is room for diversity of opinion.  The jury focuses on the doctor’s choices.  And if, in the light of a diversity of medical opinion, the doctor’s conduct was reasonable, there is no liability.  Steven. E. Pegalis, 1 Am. Law Med. Malp. § 3:3 (2017) (“reasonably applicable alternative methods of diagnosis or treatment” allowed).  As it is phrased in Pennsylvania, if there are “two schools of thought,” the doctor is free to pick one over the other.  Jones v. Chidester, 610 A.2d 964, 969 (Pa. 1992) (“school of thought” means “a considerable number of recognized and respected professionals”).  See also Velazquez ex rel. Velazquez v. Portadin, 751 A.2d 102, 107-108 (N.J. 2000) (allowing practice with “substantial support as proper practice by the medical profession”) (quoting Schueler v. Strelinger, 204 A.2d 577, 585 (N.J. 1964)).

But in a product liability case over defective design, there may be no room for reasonable choice.  Design defect law may ask a jury whether there is any “safer alternative” to a defendant’s device, and, if the jury believes there is, the defendant’s device may be found defective and presumably unsuitable for sale to anyone.  In fact, this question can arise whether or not there is a specific “safer alternative design” requirement in state law because the plaintiff may simply offer such a design as evidence of unreasonable risk. In answering the question, the jury will be asked to choose which expert witness is “most credible” without any allowance for reasonable differences of opinion.

If the law is going to protect a doctor’s ability to exercise reasonable medical judgment in choosing among available devices and surgeries, the question is what needs to be done to keep the unsuitable instrument of design defect litigation – where the doctor may not even be a witness and there is no pre-suit screening panel — from taking away those choices.  Only if the doctor has a choice can the doctor have the ability to determine the best method of treating the patient.

There are at least five ways design defect law can be shaped to protect doctor choice.

First, there is the question of actual doctor choice.  Where the surgeon has chosen not to employ an alternative, perhaps because of the surgeon’s education, training and experience, the jury should not be allowed to find the manufacturer liable because a choice the surgeon rejected might be deemed by the jury to be  “safer.”  See Anderson v. PA Radocy & Sons, Inc., 865 F. Supp. 522, 531 (N.D. Ind. 1994) (manufacturer not liable for employer’s decision to purchase uninsulated fiberglass bucket rather than insulated one); James. A. Henderson & Aaron. D. Twerski, Optional Safety Devices: Delegating Product Design Responsibility to the Market, 45 Ariz. St. L.J. 1399, 1417 (2013) (delegation to learned intermediary defeats design liability).

Second, a court should apply established product liability law principles and exclude from any list of “safer alternatives” those alternatives that present different advantages and disadvantages that require doctor choice, such as a different treatment or different surgery.

This is consistent with the way product liability generally protects consumer choice.  It is generally accepted that, to be a “safer alternative design,” the design must be for the same product, not a different one.  A different product may be safer in one respect, but if it serves different distinct purposes, it cannot provide a basis for finding the less safe product defective.  Informed consumers remain free to choose, and manufacturers are allowed to innovate.  The issue comes up in a variety of product liability contexts.

For example, the Fourth Circuit held in an early negligence case that, given the “peculiar purposes of [the] design” of a Volkswagen bus to provide room for passengers and cargo by placing the driver in front of the engine, a plaintiff could not argue that the design was unsafe because it was not as crashworthy as that of a passenger sedan.  The court granted judgment as a matter of law for the defendant.  Dreisonstok v. Volkswagenwerk, A.G., 489 F.2d 1066, 1074 (4th Cir. 1974), followed in Restatement (Third) of Torts: Product Liability § 2, cmt. f, illus. 9 (1998).  Similarly, a safer bullet proof vest does not make a bullet proof vest with less coverage unreasonably dangerous when the vest allows a greater range of motion.  Linegar v. Armour of Am., Inc., 909 F.2d 1150, 1154 (8th Cir. 1990); see also Hosford v. BRK Brands, Inc., 223 So.3d 199, 208 (Ala. 2016) (smoke alarm not defective just because a more expensive dual-sensor alarm was sold).

This principle is particularly apt in the field of medical devices where different products offer different sets of benefits and complications and whose “safety” depends on professional judgment and, in the case of devices, surgical skill.  Like the learned intermediary doctrine, device defect law should recognize that the doctor relies not only on what the manufacturer has supplied, but also “other medical literature, and any other source available to him, and … the personal medical history of his patient.”  Lebowitz v. Ortho Pharmaceutical Corp, 307 A.2d 449, 457 (Pa. Super. 1973).  The Texas Court of Appeals so held in a hormone therapy case:

[A] plaintiff cannot prove that a safer alternative design exists by pointing to a substantially different product, even when the other product has the same general purpose as the allegedly defective product . . .  Thus, a safer alternative design must be one for the product at issue . . . [Plaintiff] does not explain how [the drug] could have been modified or improved . . .  In essence, [plaintiff] argues that the [drug] should have been a different product . . .  But, as the supreme court has explained, Texas law does not recognize this sort of categorical attack on a product.

Brockert v. Wyeth Pharm., Inc., 287 S.W.3d 760, 770-71 (Tex. App. 2009). See also In re Propulsid Prod. Liab. Litig., No. MDL 1355, 2003 WL 367739, at *3-4 (E.D. La. Feb. 18, 2003) (alternative or different methods of treatment insufficient to prove alternative design).

In medical device cases, courts have held that different devices which perform in different ways cannot be treated as safer alternatives. The principal authorities come from the pedicle screw cases where the courts refused to accept other fixation devices, such as those involving hooks and wires, as presenting safer alternative designs.  The Fifth Circuit explicitly gave doctor choice as a primary reason for its holding.  It said:

[Plaintiff] therefore argues that other products that do not use pedicle screws should be considered as alternative designs . . .  Underlying this argument is the assumption that all pedicle screws are defective and there can be no system using pedicle screws that would be an acceptable product.  The problem with this argument is that it really takes issue with the choice of treatment made by [plaintiff’s] physician, not with a specific fault of the pedicle screw sold by [defendant].

Theriot v. Danek Med., Inc., 168 F.3d 253, 255 (5th Cir. 1999).

Similarly, in other device cases it has been held that a treatment that uses no device at all cannot be considered as a safer alternative.  As the United States District Court for the District of Nevada explained:

Neither is the Court swayed by Plaintiff’s argument that the testimony of [the expert] to the effect that Plaintiff’s [surgery] could have been accomplished without use of [the product].  The fact that an alternative method of [surgery] was potentially available does not support Plaintiff’s design defect claim.  As argued by Defendants, non-mesh repair is not an alternative design and does not meet Plaintiff’s burden to support this particular claim.

Schmidt v. C.R. Bard, Inc., No. 2:11-CV-00978-PMP, 2013 WL 3802804, at *2 (D. Nev. July 22, 2013).

While this rule would have its most direct application in states with a safer alternative design requirement, it would not be limited to those states.  It should apply wherever alternative design is used as a basis for declaring a device unreasonably dangerous.  In Driesenstock, the Fourth Circuit’s Volkswagen bus case, the issue was whether the alternative could be used to prove the defendant’s negligence.  And in Linegar, the Eighth Circuit’s bullet-proof vest case, the question was whether the vest was unreasonably dangerous.  In neither case was there a specific safer alternative design requirement.  See James Beck (“Bexis”), On Alternative Design, Take Two – Negligence, Drug and Device Law Blog (Feb. 27, 2017) (use of alternative design in negligence cases).

[Editorial note:  The Massachusetts Niedner decision (discussed here) is also an excellent example of this application]

Third, even where the products might be very similar, the jury should not be asked to choose between two products where either one is supported by a “school of thought” or “substantial medical opinion.”  From the “doctor’s choice” perspective, it is error for a court to intervene in the diagnosis and treatment of a patient in order to dictate the treatment of a patient when reasonable medical professionals could disagree.  For example, one court recognized the “same product” requirement but nevertheless said a jury could find that an alternative was safer if it did not alter “a fundamental and necessary characteristic of the product.”  Hines v. Wyeth, No. CIV. A. 2:04-0690, 2011 WL 1990496, at *8 (S.D.W. Va. May 23, 2011) (citing Torkie-Tork v. Wyeth, 739 F. Supp. 2d 895, 900 (E.D. Va. 2010)).  In that case the court said it was for the jury to decide whether natural progestin and synthetic progestin were different products. Id. at *9.  But if either choice would be within the doctor’s standard of care, that difference should not matter.

Fourth, the principle of reasonable doctor choice could also be used to interpret comment k to the Restatement (Second) of Torts §402A.  That comment rules out design defect liability for medical products if a proper warning is given and the device is “unavoidably unsafe.”  This has sometimes been incorrectly said to simply import a risk-utility test.  Mullins v. Ethicon, Inc., 117 F. Supp. 3d 810, 818-819 (S.D.W. Va. 2015).  But a better reading would be to say that a medical product is “unavoidably unsafe” and so qualifies for comment k protection if its use, within the professional standard of care, presents a risk of injury to the patient.  That would, for example, be true of nearly all implantable medical devices. See James Beck (Bexis), Unavoidably Unsafe PMA Medical Devices, Drug and Device Law Blog (Nov. 30, 2017).

Finally, the principle of doctor choice might be a basis for excluding from evidence actions of the federal Food and Drug Administration based on a comparison of one treatment to another if both treatments were considered to be within the doctors’ standard of care.  Congress has told the FDA that it is not to “limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient….”  21 U.S.C. § 396 (2009).  Nevertheless, the FDA does take regulatory actions based not on independent judgments about safety and effectiveness but rather upon comparisons among methods of treatment.  A negative comparison that failed to recognize reasonable doctor choice should be just as inadmissible as expert testimony that failed to apply the correct liability standard.  See, e.g., United States v. Wintermute, 443 F.3d 993, 1001 (8th Cir. 2006).

If the principle of doctor choice were applied in design defect law, it would be necessary to decide what theories of design defect liability would survive.  Certainly a device not considered to be within the standard of care would face liability if it were so egregiously dangerous as not to have any justifiable therapeutic use.  Or if scientific testing proved a way to design the same product so that it was both safer and equally effective, that might be considered in some jurisdictions.

And none of this would directly affect liability for failure to warn, because any rule that rests on doctor’s choice has to assume that doctors are aware of the complications that may arise out of use of the device.

When it comes to design defect claims and FDA pre-market approved (“PMA”) medical devices, “preemption” is our reflexive reaction. That’s entirely reasonable, given the many decisions that preempt state-law design-related claims since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  We collect then all here.

Nevertheless, there are some judges, particularly (but not all) in state court, who react negatively to the very concept of preemption.  Thus, a word to the wise is not to put all your dismissal eggs in one basket.  One logical alternative argument starts with the same premise as preemption – that “the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application.”  Riegel, 552 U.S. at 323.

The “almost no deviations” limitation, of course applies to device design.  E.g., Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012); Blunt v. Medtronic, Inc., 760 N.W.2d 396, 409 (Wis. 2009); McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804, 810 (E.D. Pa. 2016); Kitchen v. Biomet, Inc., 2014 WL 694226, at *3 (E.D. Ky. Feb. 21, 2014); Miller v. DePuy Spine, Inc., 638 F. Supp. 2d 1226, 1229 (D. Nev. 2009).

Which brings us to Restatement (Second) of Torts §402A, comment k (1965), “which insulates from liability manufacturers of unavoidably unsafe products that are properly prepared and accompanied by an adequate warning.”  Rodriguez v. Stryker Corp., 680 F.3d 568, 575 (6th Cir. 2012) (applying Tennessee law).  Putting aside the separate (albeit important) issue whether comment k applies to prescription medical products generally or only on a case-by-case basis, courts on both sides of that question equate “unavoidably unsafe” with the absence of an alternative design:

[N]umerous state and federal courts ha[ve] interpreted comment k to mean that a product is “unavoidably unsafe” when, given proper manufacture and labeling, no feasible alternative design would reduce the safety risks without compromising the product’s cost and utility.

Bruesewitz v. Wyeth LLC, 562 U.S. 223, 256 (2011) (Breyer, J. concurring) (footnote containing string citation omitted) (emphasis added).  In other words, “a defendant seeking to invoke the [comment k] defense must first show that the product is highly useful and that the danger imposed by the product could not have been avoided through a feasible alternative design.”  Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2487 (2013) (applying New Hampshire law).  To avoid a claim of “unavoidable risk, there must be, at the time of the subject product’s distribution, no feasible alternative design which on balance accomplishes the subject product’s purpose with a lesser risk.”  Toner v. Lederle Laboratories, 732 P.2d 297, 306 (Idaho 1987).  “The purpose of comment k is to protect from strict liability products that cannot be designed more safely.” Grundberg v. Upjohn Co., 813 P.2d 89, 92 (Utah 1991).  Grundberg and Toner don’t agree on much when it comes to comment k, but they agree on the importance of alternative design.

Thus, that a PMA-approved device must be made with “almost no deviations” from its specified design means (in addition to preemption) that there is no legal alternative design that would allow the plaintiff to avoid a manufacturer’s comment k defense.  To use a non-approved alternative design would be illegal – and illegal designs cannot serve as “feasible” alternative designs.  See Lewis v. American Cyanamid Co., 715 A.2d 967, 981 (N.J. 1998} (“plaintiff may not succeed on an alternative design theory that would have required the defendant manufacturer to violate the law”); White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 753-54 (Ohio 1988) (alternative design not feasible where “it was not possible for [defendant] to have legally marketed a [product] design using [the alternative design] at the time [plaintiff] was inoculated”); Ackley v. Wyeth Laboratories, Inc., 919 F.2d 397, 401 (6th Cir. 1990) (following White; alternative designs did not “exist[]” where it was “indisputable” that “[w]ithout an FDA license to produce another design, [defendant] was legally prohibited from distributing” those designs) (applying Ohio law); Wolfe v. McNeil-PPC, Inc., 773 F. Supp.2d 561, 572 (E.D. Pa. 2011) (when “[t]here exists no FDA-approved alternative form of [the product],” “there is no available alternative design”); Militrano v. Lederle Laboratories, 769 N.Y.S.2d 839, 847-48 (N.Y. Sup. 2003) (where plaintiff proposed a non-FDA-approved alternative, defendant “could not have marketed a reasonable alternative”), aff’d, 810 N.Y.S.2d 506 (N.Y.A.D. 2006); In re Alloderm Litigation, 2015 WL 5022618, at *12 (N.J. Super. Law Div. Aug. 14, 2015 (no feasible alternative where design plaintiff advocated “was not approved by the Food and Drug Administration until” after plaintiffs’ surgeries); Totterdale v. Lederle Laboratories, 2008 WL 972657 (W.Va. Cir. Mar. 19, 2008) (where FDA approval not until after plaintiff’s injury plaintiff did “not provide[] any new material facts to raise a genuine issue as to whether [the product] was avoidably unsafe”).

Thus, in Gross v. Stryker Corp., 858 F. Supp.2d 466 (W.D. Pa. 2012), comment k applied to “a Class III medical device which received FDA approval pursuant to the PMA process.” Id. at 481 (footnote omitted).

Moreover, the inherently rigorous nature of the premarket approval process and the contraindications, warnings, and precautions described in the [device’s] Summary of Safety and Security Data all suggest that [it] is an “unavoidably unsafe” product to which strict liability does not apply.

Id. at 482.  “As a result, the [device] can be considered a prescription medical device that falls within the scope of comment k to § 402A.”  Id.

Similarly, the court employed the non-preemption path of comment k in Aaron v. Medtronic, Inc., 209 F. Supp.3d 994 (S.D. Ohio 2016).  While Ohio (at the relevant time, this has now changed, Ohio Rev. Code Ann. §2307.75(D)) was a case-by-case comment k state, the PMA approved nature of the device, and the constraints the FDA’s approval placed on alternative designs, meant that comment k had to apply:

Defendant argues . . . that [the device’s] classification by the FDA as a Class III medical device inherently means that it is unavoidably unsafe and that Comment K’s prohibition of strict liability claims therefore applies. Defendant’s argument is well taken.  Class III devices . . . are, as relevant here, defined as devices that are “for a use which is of substantial importance in preventing impairment of human health, or…present[] a potential unreasonable risk of illness or injury.”  21 U.S.C. §360c(a)(1)(C)(ii). . . .

[T]here is no alternative design for [the device] that could lawfully be marketed.  “Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications…that would affect safety or effectiveness.” There is therefore no basis for an in-depth evidentiary inquiry into alternative designs.

Aaron, 209 F. Supp.3d at 1013-14 (quoting Riegel, 552 U.S. at 319) (other citations omitted).

So while preemption should do the trick with design defect claims involving PMA approved medical devices, courts may sometimes have an easier time with alternative, non-constitutional arguments such as the lack of any legal alternative design under Restatement §402A, comment k.  Consider giving judges this other way to the end result that we all want – dismissal of design defect claims.

About two years ago, in our post “How Does a Bad Idea Get Implanted,” we discussed what at the time seemed a California peculiar argument that the “unavoidably unsafe” product doctrine epitomized by Restatement (Second) of Torts §402A, comment k (1965) was somehow limited to implantable – as opposed to non-implantable – medical devices.  While most medical device litigation has historically involved implants, in that post we saw nothing in comment k, or the broader concept that prescription-only products have inherent risks (why their availability requires a doctor’s prescription in the first pace), that is logically limited to implantable devices.

We pointed out in that post that this rather weird argument apparently originated in ill-considered dictum in Chandler v. Chiron Corp., 1997 WL 464827, at *4 (N.D. Cal. July 28, 1997), a case which ultimately dismissed the plaintiff’s design defect claim on causation grounds (and was affirmed on that basis, see 176 F.3d 481 (9th Cir. 1999)), and was directly refuted by controlling California appellate authority: Armstrong v. Optical Radiation Corp., 57 Cal. Rptr.2d 763, 772 (Cal. App. 1996), which applied the comment k unavoidably unsafe rationale to intraocular fluid, a non-implanted surgical aid.  As we put it then:

The issue is not whether the device is implanted, it is whether the device unavoidably poses risks even as it must be used by physicians to “save lives or reduce pain and suffering.”

Quoting Brown v. Superior Court, 751 P.2d 470, 479 (Cal. 1988)).

We were recently contacted by fellow defense counsel about a similar argument being made by plaintiffs in a Pennsylvania case, since Pennsylvania, like California, also applies comment k across the board.  We took a look at the case law and let them know that Pennsylvania precedent likewise has not recognized any artificial distinction between implanted and non-implanted prescription medical devices.  Rather, in Wagner v. Kimberly-Clark Corp., 225 F. Supp.3d 311, 315 (E.D. Pa. 2016), a Pennsylvania court applied comment k/the unavoidably unsafe doctrine to bar strict a liability claims involving a prescription device that wasn’t an implant. Wagner involved a temporary feeding tube used while the plaintiff was in intensive care, and the court dismissed strict liability design and warning defect claims, but not manufacturing defect claims, under Pennsylvania’s broad reading of comment k.  225 F. Supp.2d at 315 & n.4.  Indeed, Wagner essentially took the application of the unavoidably unsafe doctrine to design and warning claims as a given, as 9/10 of the opinion was about whether or not strict liability manufacturing defect claims could survive (which is a different issue we addressed here).  Id. at 316-18.

Maybe a feeding tube, although not technically an implant, still seems “close enough,” since such tubes do extend inside the body, albeit quite temporarily.  OK, but there’s plenty of precedent out there about devices that don’t even temporarily penetrate the body.

In Racer v. Utterman, 629 S.W.2d 387 (Mo. App. 1981), the plaintiff was injured when “a disposable drape manufactured by defendant . . . caught on fire resulting in serious burns.”  Id. at 391.  “The purpose of the surgical drape is to provide a sterile field and to serve as a barrier to prevent bacteria from reaching the operation site.”  Id. at 391-92.  The appellate court affirmed application of comment k to this product:

Comment k to the Restatement recognizes that “unavoidably unsafe” products achieve protection despite their danger “when accompanied by proper directions and warning”. . . .  On the record before us we find the surgical drape here to be an “unavoidably unsafe” product.  It is a highly useful product which affords substantially increased protection against infection during surgical procedures.  Its water-repellant attributes increase these protections.  In the state of knowledge at the time of the injury no method of making the product fire-resistant was available which did not adversely affect its barrier against infection or create potential injury to the patient from allergy or disease.

Id. at 393.  The defendant still lost, but on warnings, id. at 395, not because comment k didn’t apply to the drape because it wasn’t implanted.

The Illinois Supreme Court applied comment k’s unavoidably unsafe rationale to therapeutic x-ray radiation equipment in Greenberg v. Michael Reese Hospital, 415 N.E.2d 390, 394-95 (Ill. 1980).

The possibility that in certain cases protection of human life and health might be diminished by the imposition of liability has been recognized in section 402A of the Restatement. Comment k indicates that certain products, though dangerous, are necessarily so and do not warrant the imposition of liability. . . .  [C]omment k presume[s] in their treatments that the denomination “product” has already been applied to the matter in question.  Nevertheless, imposition of strict liability is a question of policy, and often the same policy concerns are involved in discussions which are ostensibly diverse, for example: the meaning to be given such terms as “product,” “defective,” “unreasonably dangerous,” and “business of selling.”  For the reasons stated we conclude that public policy dictates against the imposition of strict liability in tort for injuries resulting from the administration of X-radiation treatments by a hospital.

Id. at 394-95 (citations and quotation from Prosser’s On Torts omitted).

Two other cases have applied comment k’s analysis to external patches that release drugs that are absorbed through the skin.  In Edwards v. Basel Pharmaceuticals, 933 P.2d 298 (Okla. 1997), the court cited and quoted comment k (“the law regarding such products appears at Comment k”) in a case involving nicotine patches.  These were products “incapable of being made safe, but are of benefit to the public dispute the risk.  Id. at 300.  Likewise, in Mardegan v. Mylan, Inc., 2012 WL 12850781, at *6-7 (S.D. Fla. Jan. 31, 2012), a fentanyl “pain patch” was considered to be within the scope of comment k.  The court refused to grant summary judgment, but only because it found “genuine issues of material fact . . . as to whether the patches at issue were incapable of being made safe,” not because comment k was categorically inapplicable to non-implanted products.  Id. at *7.

Most recently, in Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017), the court applied comment k to a surgical robot – a piece of equipment that assists in the conduct of surgery and is never implanted in the body.  The court applied comment k analysis to the liability questions.  Id. at 526-28.  As in Racer, Taylor found that the comment k exception did not apply on the facts of the case, because it could not be said that the product warnings were adequate as a matter of law.  Id. at 528 (“[e]xemption from strict liability under comment k is expressly limited to products accompanied by adequate warnings”).  Once again, there was not a hint in Taylor that the fact that the robot was not an implant made comment k ipso facto inapplicable.  Washington law “safeguard[ed] the public to the greatest extent possible without discouraging the development and marketing of unavoidably unsafe products.”  Id.

The great majority of product liability litigation involving prescription medical devices happens to involve implants.  However, that descriptive fact is of no legal consequence to the applicability, or not, of the comment k/unavoidably unsafe product doctrine.  That doctrine is interpreted in a variety of different ways – most notably case-by-case versus across-the-board application to prescription medical products.  But no matter which way the doctrine is interpreted, its application is not dependent upon whether or not a medical device is implanted in the body.  At least three state high courts, two state intermediate appellate courts, and a couple of federal district court agree.  There is no contrary precedent, only the aforementioned dictum in Chandler, a 20-year-old district court case, the reasoning of which has never been adopted by any subsequent decision, and (as we already discussed) is refuted by the Cal. App. Armstrong decision.

A funny thing happened on the way to a defense verdict last year—after the jury decided that the defendant’s product was not defective, the MDL judge told the jurors that perhaps they did not “fully understand” and instructed them to try again. So the jury went back into the jury room, and having been duly admonished by the court, the jury changed its mind and returned a verdict for the plaintiff.  We commented fully on the proceedings here, and while we will not repeat all the gory details, trust us, the proceedings were odd.

The Eleventh Circuit has now affirmed the plaintiff’s verdict, and the defendant has valid reasons to be unhappy. Not only did the Eleventh Circuit place its stamp of approval on the do-over verdict, it applied a hopelessly muddled view of comment k.

The case is Christiansen v. Wright Medical Technology, Inc., No. 16-12162, 2017 WL 1046088 (11th Cir. Mar. 20, 2017).  The plaintiff alleged that a defect in the defendant’s metal-on-metal hip replacement device caused him an injury, and he asserted product liability claims governed by Utah law. Id. at *1.  As luck would have it, the case was selected as a “bellwether” trial case in the Conserve Hip Implant MDL, and after a trial that lasted about a week, the jury returned a verdict finding that the product was not defectively designed. Id. The jury also found that the defendant had made negligent misrepresentations and awarded compensatory and punitive damages. Id.

Under Utah law, this is a defense verdict. The Utah Products Liability Statute covers all claims for injuries allegedly caused by defective products, and it requires proof of a product defect.  As a result, once the jury found that the product was not defective, nothing else mattered.  The defendant won.  The court, however, ruled that the verdict was “inconsistent” because the jury found no defect on the one hand, but also found negligent misrepresentation on the other. Id. That is why the court re-instructed the jury, resulting in the second verdict finding a product defect. Id.

The Eleventh Circuit affirmed this result, and its opinion relies on the assumption that the first verdict was “inconsistent.” Id. at **5-7.  But what inconsistency?  The jury made two core findings—no defect and negligent misrepresentation.  Maybe the evidence supported those findings and maybe it did not, but it is very possible for a defendant to make a misrepresentation and also sell a product that is free from design defects.  (There were no manufacturing or warning-based defect claims, in case you were wondering.)  The finding of no defect makes the misrepresentation finding meaningless under Utah law.  They are not “inconsistent.”  The former just deprives the latter of any legal consequence.

For whatever reason, the district judge saw an “inconsistency,” and the Eleventh Circuit deferred. The Eleventh Circuit tries to explain the proceedings in the district court, but in the end, it really did not explain why the initial verdict called for further deliberation.  It seems to have taken that for granted.

There is a second problem with the Eleventh Circuit’s opinion—it declined to apply Utah’s adoption of Comment k and gave a reason that simply does not hold up. Comment k to section 402A of the Restatement (Second) or Torts provides protection against strict liability claims involving “unavoidably unsafe products.”  Nearly all states have adopted some version of Comment k—some apply it on a case-by-case basis; some treat it as an affirmative defense; some apply Comment k as a matter of law in all cases involving prescription medical products, recognizing that all drugs and medical devices have both benefits and risks.

Utah has adopted Comment k, but has placed the burden on the defendant to prove certain elements to invoke Comment k as a defense. However, in cases involving prescription medical products, the Utah Supreme Court has “rejected the case-by-case approach and adopted Comment k as a categorical bar against strict liability.” Id. at **7-8 (quoting Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991)).  Comment k therefore applies in Utah across the board, and the Defendant justifiably argued to the Eleventh Circuit that Comment k applied and that it should result in a judgment for the defense.

The Eleventh Circuit “predicted” Utah law differently. According to the Eleventh Circuit, the Utah Supreme Court applied Comment k to prescription drugs because they are FDA approved. Id. at *8.  It therefore held that the Utah Supreme Court would not apply comment k categorically to medical devices. Id. at **8-9.  It further held that, even if Comment k applied to “FDA-approved medical devices,” the defendant had not carried its burden of proving that the product was FDA approved. Id. at **8-9.

There is so much wrong with this holding. To start, with the Utah Supreme Court having decided that Comment k applies to prescription drugs, there is no basis on which to predict that Utah law would be different for prescription medical devices.  The rationale for applying Comment k is the same—no matter how you design a drug or medical device, there will always be risks. (See here for our research post on comment k, including a 50-state survey.)  In addition, the Eleventh Circuit’s fixation on FDA approval to distinguish prescription drugs from prescription medical devices ignores that the FDA regulates medical devices, too.  It also ignores that drugs are approved for marketing in different ways—some through full-blown new drug applications, some under pre-NDA rules, some through a showing of substantial equivalence, etc.  Comment K applies to all of them, and the Utah Supreme Court has never drawn a distinction.  There is no reason to believe it would draw a distinction between drugs and medical devices because of their respective regulatory pathways either.

Finally, the Eleventh Circuit held that Comment k would not help the defendant in any event because the defendant did not prove that the product was approved by the FDA. This is wrong.  Utah’s version of Comment k requires the defendant to prove certain elements, but FDA approval is not one of them.  Neither the Utah pattern jury instruction nor the instruction given by the district court called for the defendant to prove FDA approval.  Yet, the Eleventh Circuit based its opinion on this purported failure of proof.

We can’t help but consider the possibility that this plaintiff’s judgment had more staying power because it came out of an MDL “bellwether” trial. Maybe.  Maybe not.  It seems to us that if you assume that “bellwether” verdicts actually help the parties value other cases, a defense verdict is as useful as a plaintiff’s verdict.  Both have dollar amounts attached to them, and the number attached to the defense verdict is zero, plus the defendant’s costs.  That should have been the result in Christiansen.

Bexis, who took some lumps in probably the worst Wisconsin product liability decision ever (he filed PLAC’s amicus brief in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005)), just read what we believe is the best Wisconsin law decision ever – at least in the drug/medical device sandbox that we inhabit. The decision is In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2016 WL 6135685 (N.D. Ill. Oct. 21, 2016) (since the caption is a mouthful, we’ll call it “ZNKI“).

Here’s why ZNKI is favorable on Wisconsin legal issues.

First, as our longstanding 50-state survey on the learned intermediary rule points out, Wisconsin is one of nine states in which only federal courts predicting state law have had occasion to adopt the learned intermediary rule.  Looking more closely at these nine, Wisconsin is one of only two states (South Dakota being the other) where only federal district courts have reached this holding.  What isn’t there, but is discussed in ZNKI, is that some courts have (without much reasoning) refused to predict Wisconsin’s adherence to the rule.  Refusing to dodge the issue, ZNKI forthrightly examines both Wisconsin precedent and the general state of the law and concludes that Wisconsin would join the nationwide learned intermediary consensus:

[F]ederal courts applying Wisconsin law have reached different conclusions about the doctrine’s applicability.  The vast majority of states, however, do employ some version of the doctrine.  In addition, this court’s research suggests that those courts that have declined to apply the doctrine under Wisconsin law have done so in cases involving prescription drugs, not medical devices, and those courts offer no reason to believe that the Wisconsin Supreme Court would not adopt this majority rule if presented with the issue.

In the context of . . . surgery, a patient must rely on the experience and judgment of his or her surgeon, who selects the appropriate implant and educates the patient about the particular risks − based on the patient’s particular circumstances and physiology. . . .  Given that context, and given the widespread acceptance of the doctrine throughout the country, the court believes it is likely that the Wisconsin Supreme Court would apply the learned intermediary doctrine in this case.

ZNKI, 2016 WL 6135685, at *19-20 (numerous citations omitted).  As we’ve pointed out recently, the learned intermediary rule is, if anything, enjoying a renaissance, with thirteen straight state high court adoptions since the infamous Karl case (since overruled by statute) was the only supreme court to go the other way.

Continue Reading Probably the Best Wisconsin Law Decision We’ve Ever Seen

This post is from the non-Reed Smith side of the blog.

We found it strange that last month’s decision in Jenkins v. Boston Scientific Corp., 2016 WL 1448867 (S.D.W. Va. April 12, 2016), held – almost as a throw-away point – that Texas law wouldn’t apply Restatement (Second) of Torts §402A, comment k (1965) to medical devices as it does to prescription drugs. That’s a notable, indeed almost unprecedented, result.

Jenkins did recognize that Texas law has, for a long time, applied comment k across-the-board to bar design defect claims against all prescription drugs. Id. at *5, citing Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *5 (W.D. Tex. Nov. 2, 2004) (“Under Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law.”). Carter is hardly the only Texas case for applying comment k generally to bar design defect claims. We collected that law in our 2011 Comment K,Some of the Way post: Centocor, Inc. v. Hamilton, 310 S.W.3d 476, 516 (Tex. App. 2010) (comment k “provide[s] a defense to a design defect claim”), rev’d on other grounds, 372 S.W.3d 140 (Tex. 2012); Schwarz v. Block Drug Co., 1999 WL 274409, at *1 (5th Cir. 1999) (“Under comment K of the Restatement of Torts (Second) § 402A, a drug manufacturer is responsible in damages only if it failed to warn of a defect of which it knew or should have known.”) (unpublished, in table at 180 F.3d 261); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273-74 (5th Cir. 1974) (applying unavoidably unsafe standard without individualized assessment); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (“[p]rescription drugs are not susceptible to a design defect claim where, as here, the drug is “accompanied by proper directions and warning”); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (“[t]he Court thus holds that under Texas law and comment k of the Restatement, Defendants can only be held strictly liable if the drug was not properly prepared or marketed or accompanied by proper warnings”).

However, after recognizing Texas law with respect to comment k and prescription drugs, Jenkins declined to apply comment k in the same fashion to medical devices:

I reject [defendant’s] contention that Texas’s absolute bar for FDA-approved prescription drugs, applies here, given that the products are neither FDA-approved nor prescription drugs. See Lofton v. McNeil Consumer & Specialty Pharm., 682 F. Supp.2d 662, 679 (N.D. Tex. 2010) (refusing to “take a leap not taken by Texas courts” in applying comment k categorically outside the prescription drug context).

2016 WL 1448867, at *5 (citation omitted).

That’s it. The entire extent of the discussion of Texas law on this point is one sentence and one citation. Absent is any discussion of why the policy reasons that have led Texas courts to apply comment k in every prescription medical product case over the last forty years don’t apply to prescription medical devices.

But what about Lofton?

Continue Reading Don’t Mess With Texas

In Hawaii, from whence today’s case comes, tourists are encouraged to try poi, mashed up taro root, which looks like purple wallpaper paste and tastes like, well, purple wallpaper paste. The term is also used as a friendly descriptor of ethnically ambiguous looking people, whose roots have been mashed together to form something not readily identifiable by traditional visual stereotypes. (At least it seemed friendly when we heard it applied to our own offspring.) Personally, we think it is a nice concept and the less that categorizing people to determine their rights, opportunities, and expectations happens, the better. For a number of aspects of product liability law, however, the decision on whether to proceed categorically or case-by-case is still hotly contested. This is particularly true for comment k to the Restatement (Second) of Torts, § 402A, which forms the meat of the decision in Segovia v. Bristol-Myers Squibb Co., CV. No. 15-00519 DKW-RLP, 2016 U.S. Dist. LEXIS 52405 (D. Haw. Apr. 19, 2016).

Segovia involves a fatal hemorrhagic stroke with an anticoagulant prescribed and used for atrial fibrillation. We are not sure what was different from the first complaint, but the second try made vague allegations about misrepresentations to FDA and others that it was “tested and found to be safe and effective for its indicated uses” and that FDA and others had not been told of the drug’s “defects” in support of allegations of strict liability and negligent failure to warn and design defect theories. While it seems like this complaint asserted claims based on non-existent duties and clearly preempted claims, the only issues addressed by the court on the motion to dismiss were whether Hawaii law took comment k to preclude design defect claims for all prescription drugs categorically and whether any fraud-based claims had been pleaded with sufficient particularity.

As to the first question, the court did not look to our relatively recent discussions on this issue, but generally looked to older cases to find the public policy rationale for taking a case-by-case approach for prescription drugs—which was essentially determinative on a motion to dismiss. But we are getting ahead of ourselves. The first step was determining what Hawaii case law already said about comment k and only two cases were discussed. Larsen v. Pacesetter Sys., Inc., 837 P.2d 1273, 1286 (Haw. 1992), involved a pacemaker—not a drug—and concluded that summary judgment based on comment k was inappropriate where there was evidence that the “pacemaker was demonstrably capable of being made safe for its intended use.” Forsyth v. Eli Lilly & Co., 1998 WL 35152135, **3-4 (D. Haw. Jan. 5, 1998), involved a prescription drug, but did not decide the issue of categorical or case-by-case because a genuine issue as to the adequacy of warnings was sufficient to preclude summary judgment. Rather than view these cases are leaving the issue open, the Segovia court found “neither Larsen nor Forsythe create a blanket rule of design defect immunity for pharmaceutical manufacturers, and the Court declines to extend comment k in a fashion that the Hawaii courts themselves have thus far declined to do.” 2016 U.S. Dist. LEXIS 52405, *11. We think this misconstrues comment k, which does not provide “immunity,” and what it means to conclude that all prescription drugs are “unavoidably unsafe.”

Continue Reading Some Case-by-Case Comment K Mixed with Some Insufficient Pleading of Fraud

We aren’t going to mince words today. We don’t like Christiansen v. Wright Medical Technology Inc., MDL 2329, 2016 U.S. Dist. LEXIS 46409 (N.D. Ga. Apr. 5, 2016). It is an opinion on post-trial motions in a case that went to trial in the Conserve Hip Implant Products Liability Litigation. It’s a beautiful spring day here in the Mid-Atlantic and we hope that’s true where you are. If it is, and if anything in this post makes you interested in the greater details and nuances of the decision, we recommend taking it outside, sitting under a tree, and enjoying some fresh air. You should at least have pleasant surroundings while you try to get through it. It’s long, and tedious, and frankly, muddled. So, we are going to try to focus in on the key parts – so that we might also try to get out and enjoy some of this fine weather.

Christiansen is a hip implant case. It went to trial on 5 theories of liability: strict liability design defect, negligent design defect, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. Id. at *2-3. Apparently the court had dismissed plaintiff’s failure to warn claim on summary judgment. Id. at *69 n.18. The jury ultimately returned a verdict finding the hip implant was defectively designed and caused plaintiff’s injuries and awarded $550,000 in compensatory damages. The jury also found in favor of the defendant on the fraudulent misrepresentation and concealment claims, but awarded another $450,000 to plaintiff on his negligent misrepresentation claim and $10 million in punitives. Id. at *18.

But that wasn’t the jury’s first verdict. It’s first verdict, delivered days earlier, answered the first question on the Verdict Form – do you find the hip implant was defectively designed – in the negative. Id. at *6. While that should have been the end of the inquiry, the jury didn’t understand the instruction to not go any further and they kept answering the verdict form. So, they went on to find that defendant had made negligent misrepresentations and awarded plaintiff $662,500 in compensatory damages and $2.5 million in punitives. Id. at *7.

Continue Reading Georgia MDL Court Muddles Utah Law

When we examined Restatement (Second) of Torts §402A, comment k (1965), in our 2011 research post “Comment K, Some of the Way,” we remarked about how it said “a lot of things,” including: (1) that one can’t design away unavoidable risks, (2) that unavoidably unsafe products aren’t considered “unreasonably dangerous” for purposes of strict liability, and (3) that such products are “especially common” in the prescription medical product area. The first proposition suggests that design defect liability is incompatible with unavoidably unsafe product characteristics. The second indicates that unavoidably unsafe products shouldn’t be subject to strict liability. The third raises the issue of whether all prescription medical products should be considered unavoidably unsafe products – since their inherent risks are why they require a prescription in the first place.

We pointed out that some states, like California and Utah, prohibit design defect liability altogether, following that aspect of comment k. Others, like Pennsylvania, reject strict liability in the context of prescription medical products. Often, as is the case in Massachusetts, the status of negligent design liability is uncertain.

However, the most striking divide has always been between those states following a case-by case approach to determining whether a given product was “unreasonably dangerous” and those states that followed an “across-the-board” approach to comment k in the prescription medical product area. After adding everything up, we had to conclude in our blogpost that, despite its inherent inefficiency and tendency to second-guess the FDA, the case-by-case approach to comment k remained the majority rule.

Continue Reading Comment K Case by Case – Falling Out of Favor?

Happy Birthday, Eric Clapton. (Today is also the birthday of painters Goya and Van Gogh. Is there something about March 30 that breeds people who turn their blues into art?) Clapton has been around so long it is easy to take him for granted. He has built up a formidable body of musicianship. He is the only three-time inductee in the Rock and Roll Hall of Fame, for his solo work as well as his stints with the Yardbirds and Cream. We remember how, in the late 1960s, one of our sisters would scribble on her school notebooks that “Clapton is God.” That sister later married a very nice, very hip guy, who was also a Clapton fan. A couple of years ago Clapton’s autobiography came out. Our brother-in-law summarized the book thusly: “I made a lot of music, took a lot of drugs, caused a lot of damage to relationships and health, but in the end, everything was pretty cool.” Just so.

In the early 1990s, we were working at a law firm representing the Robert Stigwood Organization (RSO). You might remember RSO as the force behind the soundtracks for Grease and Saturday Night Fever. RSO also managed the careers of the Bee Gees, Andy Gibb, Yvonne Elliman, and Clapton. In our case, RSO, along with Eric Clapton, was being sued by Jim Gordon, the drummer in the short-lived rock group Derek and the Dominos. Gordon claimed he had been denied writing credit and money for the long piano coda in the all-time great song, “Layla.” By the time he filed the lawsuit, Gordon was a resident of the Atascadero Prison for the criminally insane. Somewhere along the way, Gordon had started hearing a voice. That voice told him to kill his mother. With a hammer and butcher knife. He obeyed that voice. Needless to say, the deposition of Gordon behind prison walls was odd. Earlier in the case, our firm sent a representative to London to meet with our co-defendant, Mr. Clapton. That assignment went to another associate – one who didn’t even like Clapton’s music that much – certainly not as much as we did. Our bitterness and envy were complete. We insisted that the lucky associate (a close friend of ours, but his musical tastes ran more toward c&w and happy pop than toward guitar gods) relay a message to Clapton that, of all the versions of “After Midnight,” the best was the slow one that ran on the Michelob beer commercials. Imagine our delight when we were told that after Clapton listened to that opinion, he paused thoughtfully, nodded, and gently assented: “Yes. That one is the most soulful.”

It would be hard to list all of the great songs that Clapton worked on, but here is a start:

  • “For Your Love” (with the Yardbirds. Clapton hated the poppy-ness of the song and left the group just before the song climbed the charts)
  • “White Room” (listen to that solo and try arguing that the Drug and Device Law Sister was wrong all those years ago about deifying Clapton – go ahead, we dare you!)
  • “Sunshine of Your Love”
  • “Badge” (written with George Harrison. On the track credits, the rhythm guitarist is listed as L’Angelo Misterioso- that’s Harrison, who couldn’t use his real name for legal reasons. Damn lawyers.)
  • “Crossroads”
  • While My Guitar Gently Weeps” (we read somewhere that John Lennon contemplated replacing Harrison with Clapton, but Clapton wasn’t interested in becoming a Beatle)
  • “Layla” (the title song of rock’s greatest double album. Like most of the songs on that magnum opus, it is about Clapton falling in love with Harrison’s wife, Patti Boyd. Ms. Boyd, by the way, was one of the screaming, predatory schoolgirls in the Hard Day’s Night movie)
  • “Why Does Love Got To Be So Sad”
  • “Bell Bottom Blues”
  • “I Shot The Sheriff” (Maybe the original version by Bob Marley is better, but Clapton’s is also superb)

[The founder of this blog wants us to include “Wonderful Tonight” on our list of Clapton favorites. Who are we to refuse? But who knew there was a softer side of Bexis?]

Another one of Clapton’s hits was “Cocaine.” And thus we have an introduction to today’s case, Tersigni v. Wyeth, 2016 U.S. App. LEXIS 5393 (1st Cir. March 23, 2016). Tersigni was a diet drug case, and the alleged injury was Primary Pulmonary Hypertension (PPH). PPH is a very bad disease. The claims were brought under Massachusetts law for negligent design and negligent failure to warn. The trial court dismissed the negligent design claim. The negligent failure to warn claim went to the jury, which returned a defense verdict. On appeal, the plaintiff raised these issues:

  • The negligent design defect claim should not have been dismissed
  • The court should not have admitted evidence at trial that the plaintiff had been incarcerated
  • The court should not have admitted evidence at trial of the plaintiff’s cocaine use

Continue Reading First Circuit Upholds Defense Verdict in Diet Drug Case