Happy birthday, Christopher Plummer.   The great Canadian actor turns 88 today, and seems as vibrant as ever.  What a marvelous career Plummer has had.  He is a preeminent Shakespearean actor.  We saw him play Iago to James Earl Jones’s Othello on Broadway 35 years ago.  Of course, most people remember Plummer as Captain Von Trapp in The Sound of Music (1965), a film for which Plummer reserves enormous contempt, referring to it (if at all) as “The Sound of Mucus.” Much more recently, we enjoyed Plummer’s flinty interpretation of Ebenezer Scrooge in The Man Who Invented Christmas.  And there has been abundant publicity over Plummer’s replacement of Kevin Spacey in House of Cards.  It seems a thankless task to succeed someone in such scandalous circumstances.  But we’ll thank Plummer, if only because he supplied a (strained) segue into today’s post, which is about successor liability.

 

More specifically, we have a pro-defense decision on successor liability with respect to a bankrupt medical device manufacturer. The court holds that there is no liability for design and manufacturing claims under either NY or PA law – including PA’s peculiar product line liability theory. The court concludes as a matter of law that product line liability applies only to manufacturers, not to distributors. But there is a fly in the ointment: the court’s conclusion on the failure to warn claim is rather muddled – to the point where that cause of action is not concluded at all.

 

In Deluca v. Portland Orthopaedics Ltd., et al., 2017 U.S. Dist. LEXIS 198962 (E.D.N.Y. Dec. 2, 2017), a husband and wife sued for injuries relating to a failed hip implant. The husband and wife lived in New York. That is where the 2009 implant operation took place. That is also where the injury – the 2012 failure of the implant – took place. The implant was manufactured by Portland, an Australian company that had entered into receivership shortly before the plaintiff’s implant operation and that had sold off its assets before the implant failed three years later. The plaintiffs sued Portland, as well as the Singapore successor company and its manufacturing and distributing affiliates, which were incorporated in Pennsylvania (not something we’d ever recommend doing). The complaint included claims for strict liability (failure to warn, manufacturing defect, and design defect), negligence, and breach of warranty – the usual. Portland never appeared on the case and was dismissed. One presumes it would be judgment-proof. The remaining defendants moved for summary judgment, and their arguments centered around successor liability – or, to be precise, absence of successor liability. The court sensibly held that New York law governs because that is where the injury occurred, but the court also treats us to an analysis under Pennsylvania law, where it arrives at the same destination, albeit via a slightly more complicated route.

 

The successor corporation purchased certain assets of Portland. There was no purchase of stock or any formal merger. Under those circumstances, the successor typically does not acquire prior tort liabilities. That is the law in both New York and Pennsylvania. There are some exceptions to this general rule, but none applies here.

 

New York recognizes four possible exceptions, none of which saved the plaintiffs’ design or manufacturing defect claims:

 

First, the successor did not expressly or impliedly assume prior liabilities. In fact, those liabilities were expressly excluded.

Second, the de facto merger exception does not apply. There was no continuity of ownership, management, or physical locations. In addition, the seller continued to exist, even if only in gossamer form.

Third, the “mere continuation” exception does not apply. Again, the seller lingered, and there was no hint of overlapping owners or managers.

Fourth, there is no evidence that the asset sale was a fraudulent effort to evade liability.

 

Pennsylvania adds another factor – whether the transfer was made without adequate consideration and without provisions for creditors of the selling corporation. That factor also does not apply here. More significantly, or problematically, some Pennsylvania courts have announced a “product line” exception, an extreme pro-plaintiff doctrine left over from the 1980s. The Deluca court is not persuaded that this exception has been endorsed by the Pennsylvania Supreme Court. And remember that the Deluca court has chosen New York law to govern this case. Nevertheless, just in case some appellate court might get dodgy, the Deluca court goes through the motions of measuring the evidence in the case against the product line exception and concludes that it does not help the plaintiffs here. The factors animating the product line exception are pretty fuzzy: (1) whether the purchase of the product line caused the “virtual destruction of the plaintiff’s remedies against the original manufacturer,” (2) does the successor have the ability to assume the original manufacturer’s “risk-spreading role,” and (3) the fairness of requiring the successor to assume responsibility insofar as the successor was enjoying the original manufacturer’s good will.

 

The Deluca court easily dispensed with these factors by pointing to some important facts:

 

  1. Portland’s insolvency preceded the asset sale, and was certainly not caused by it.
  2. The asset sale was not prompted by any scheme to evade product liability claims. At the time of the sale, the problem of implant failures was not on the radar screen.
  3. The purchase agreement explicitly excluded goodwill as well as related liabilities.

 

Further, the Deluca court held that the product line exception could not be used against the defendants who were never involved in manufacturing. Thus, even if someone wanted to shape the gooey product line factors so as to preserve claims against a successor, the distributor defendants would still be off the hook.

 

The plaintiffs requested additional discovery on the successor liability question. The Deluca court refused that request on both procedural and substantive grounds. The procedural problem for the plaintiffs was that they failed to submit a Rule 56(d) affidavit documenting what discovery would be sought and why it wasn’t obtained earlier. The substantive ground was futility. Even from the face of the plaintiff’s’ arguments, it was clear to the court that the request was a mere fishing expedition, with no justification for the delay and no expectation that anything reeled in would make a difference.

 

So far so good for the defense. But the court also kept the failure to warn claim alive, at least for now. New York law recognizes that successor corporations sometimes have an independent duty to warn. That duty arises not from succession of the prior manufacturer’s duties, but from the successors’ relationship with customers. Here, the plaintiffs alleged that a sales representative working for one of the defendants was in a position to provide additional warnings to the treating doctor. We do not know what those warnings would be, and are not sure how they would fit into the chronology of the case. The defendants pointed to the Instructions for Use as containing ample warnings. The Deluca court responded that it is unclear whether the physician received the IFU or whether the warnings were in fact adequate.

 

To our eyes, those questions should not be enough to stave off summary judgment. How could the doctor not have access to the IFU? Is there any suggestion that the defendants did something to make the IFU unavailable? Seems unlikely. How is the adequacy of the warning not an issue of law? And is there any open issue of warning causation? That is, did the plaintiffs proffer any evidence that a different warning – whatever that might be – would have changed the doctor’s mind in such a way as to avoid the alleged injury? On these points, the court’s reasoning is full of holes.  We suspect that the plaintiffs will ultimately be unable to fill those holes with evidence.  Then the defendants will be in a position to borrow a title from the Bard: all’s well that ends well.

 

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.

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

Do as I say, not as I do. A crutch used by parents worldwide to justify their own bad habits while trying to ensure their children don’t repeat them. Technically, it’s being a hypocrite. Sure, parents should strive to set an example through behavior. But frankly, sometimes we’ll settle for hypocritical. Well, a federal court in Massachusetts just said the same applies to the FDA. We’ll explain.

A group of plaintiffs brought a putative class action against a group of pharmaceutical companies alleging that their prescription eye drops were intentionally designed to dispense more liquid than the human eye is capable of absorbing. Gustavesen v. Alcon Laboratories, Inc., — F. Supp.3d –, 2017 WL 4374384, at *1 (D. Mass. Sep. 29, 2017). Plaintiffs allege that therefore, medication is wasted and they are required to more frequently re-fill their prescriptions than is necessary to the financial benefit of the defendants. Id. Plaintiffs sought recovery under various states consumer protection statutes as well as for unjust enrichment and “money had and received.” Id. at *2. Defendants filed a motion to dismiss alleging multiple reasons why plaintiffs’ claims fail as a matter of law. The court opted not to consider anything beyond preemption finding that that precluded all of the alleged claims.

To begin its analysis, the court did a nice walkthrough of what it calls the Supreme Court’s trilogy of impossibility preemption decisions. First, of course, is Wyeth v. Levine, where the Court said failure to warn claims are not preempted because of a manufacturer’s ability to make certain labeling changes without prior approval of the FDA, unless there is clear evidence that the FDA would have rejected the change. Id. at *4. Next up was Pliva v. Mensing. A generic drug is required to have the same labeling as the brand-name version. Therefore, a generic drug manufacturer does not have the same ability to change its label as the brand manufacturer. Id. at *5. And, finally came Mutual Pharmaceutical v. Bartlett. Here the Supreme Court said that plaintiff’s design defect claim was preempted because any attempt by the manufacturer to change the design of the drug would have resulted in a new, unapproved drug that the manufacturer would have been prohibited from marketing. Id. Moreover, the court rejected plaintiff’s claim that defendant could have simply stopped selling the drug – defendant is not required to “cease acting altogether to avoid liability.” Id. Put the three cases together and you have the following framework. If FDA regulations allow a manufacturer to make a change without prior approval, no preemption unless clear evidence change would have been rejected. If “a party cannot satisfy a state law without first obtaining the discretionary approval of a federal agency, the state law is preempted.” Id. at *5.

Against that legal backdrop plaintiff’s argued that they had 2 theories of liability that were not preempted. First, they alleged that defendants could have changed the eye dropper tip to deliver a smaller drop and that this would have been prohibited by the FDA. Id. at *7. There are 3 categories of changes for approved drugs – major, moderate, and minor. Moderate changes are the type of labeling change discussed in Wyeth that do not need pre-approval. Major changes on the other hand must be submitted to the FDA before the drug is distributed. Id. To determine whether something is a major change, the court looked to FDA regulations and FDA guidances interpreting those regulations. In this case, that would include a guidance that for sterile products, like eye drops, any change to the container closure system is a major change. Id. The opinion goes more in depth on these regulations – but the conclusion is what is important. Plaintiff’s proposed design change would be a major change that would require prior FDA approval – therefore, the claim is preempted.

Now we come to the “do as I say” part. In response to defendants’ argument that the design change suggested by plaintiffs would be a major change, plaintiffs cited to three occasions where they claim the FDA allowed a container change without prior approval. As to 2 of the events, the documents relied on by plaintiffs don’t support their position. Id. at *9. As to the third:

At most, this is evidence of the FDA’s failure to follow strictly its own guidance. It does not cast doubt on the plain language of the 2004 Guidance deeming all changes to the size or shape of a sterile product’s container to be major changes requiring preapproval.

Id. Also:

[P]laintiffs cite no law indicating that particular actions by an agency—as opposed to the agency’s official position—are relevant to interpreting a regulation. In fact, the Supreme Court has rejected invitations to apply the standards an agency follows in practice rather than the standards it officially promulgates.

Id. In sum, do as the FDA says, not as it does. The regulations and official guidances control over individualized instances where the FDA chose not to apply them. The court can’t be guided by internal decision-making processes in one-off situations.

Having found that a post-approval change of the eye drop container would have been a major change and therefore claims premised on that preempted, the court examined whether plaintiff could sustain a claim for a “pre-approval” design change. Meaning, could/should defendants have design the dropper tips differently before seeking FDA approval. This question was decided in defendants’ favor by the Sixth Circuit in Yates v. Ortho-McNeil-Janssen Pharm, Inc., 808 F.3d 281 (6th Cir. 2015) (see post here). After examining some other district court authority cited by plaintiffs, the court in this case decided Yates was more consistent with Mensing and Bartlett.

Going back to the trilogy – if a manufacturer can’t satisfy its state law duties without FDA permission, the claim is preempted. Well, it’s not possible for a manufacturer to market a re-designed drug because that drug “would require its own NDA to be marketed in interstate commerce.” Id. at *11. So, arguing that the defendant should have changed the design pre-approval runs straight into the same impossibility preemption as a post-approval design change. Moreover, arguing that the defendant should never have sold the product is virtually the same thing as arguing that it should have stopped selling the product – the theory rejected in Bartlett.

A nice preemption decision, especially the use of Mensing and Bartlett outside the generic realm.

We write this in the first minutes of the eclipse, about 75 minutes from whatever “totality” will be visible here in southeastern Pennsylvania. We have our certified safety glasses at the ready, we have instructed the midday dog-walker to keep the Drug and Device Law Little Shaggy Rescues indoors (lest they unwittingly look skyward), and we have a continuous loop of the Fifth Dimension’s “Age of Aquarius” going around in our head. (Parenthetically, we accidentally typed “Fifth Amendment” just then for the name of the band.) The song has nothing to do with the eclipse, but it talks about the moon. And about Jupiter aligning with Mars. Appropriately thematic, we thought.

And, while “love steering the stars” may be a little strong to describe recent activity in Risperdal litigation, we have been pleased by a recent spate of positive developments. Last week, Bexis reported on two favorable decisions out of federal courts, one a post-BMS personal jurisdiction denial and the second a refusal to consolidate dissimilar cases for trial. Today we round out the triumvirate with a nice summary judgment decision from Pennsylvania’s state court system.

In In re: Risperdal Litigation: P.D. v. Janssen Pharmaceuticals, Inc., 2017 Phila. Ct. Com. Pl. LEXIS 231 (July 26, 2017), the (male) plaintiff allegedly developed gynecomastia – excessive breast tissue – when he was prescribed Risperdal (beginning when he was eight years old). He sued, including claims for design defect, failure to warn, and fraud. The defendant won summary judgment. The published decision occurs in a peculiar posture that is a creature of the Pennsylvania Rules of Appellate Procedure. Under Pa. R.A.P. 1025, when a grant of summary judgment is appealed, the trial judge prepares a written opinion in support of affirmance, arguing that there were adequate grounds for the summary judgment decision.

Design Defect

First, the court addressed the plaintiff’s design defect claims sounding in both strict liability and negligence. Because there were unresolved choice-of-law issues, the court considered these claims under the laws of both North Carolina, where the plaintiff was prescribed Risperdal and developed gynecomastia, and Pennsylvania, the forum state. Both states prohibit strict liability design defect claims against pharmaceutical manufacturers. While Pennsylvania, since Lance v. Wyeth, permits claims for negligent design defect, “a drug manufacturer can shield itself from liability for the design of drugs by including appropriate warnings; however, when it becomes known that a drug should not be used in light of the relative risks, the manufacturer can only avoid liability by removing it from the market.” P.D., 2017 Phila. Ct. Com. Pl. LEXIS 231 at *8-9. Here, the plaintiff did not offer “any evidence that Risperdal was so dangerous no warning could mitigate the relative risk of gynecomastia.” To prevail on a negligent design defect claim under North Carolina law, the plaintiff was required to submit evidence of a safer alternative design, and he had not “even address[ed] this requirement . . . , let alone submit evidence of a safer alternative design for Risperdal.” Id., at *9. As such, the court held, the plaintiff’s negligent design defect claims also failed under either body of applicable law.

Failure to Warn

The court’s dismissal of the plaintiff’s warnings claims rested on a finding that the plaintiff had not met his burden, under either North Carolina law or Pennsylvania law, of proving “warnings causation;” in other words, he had not proven that any alleged inadequacy of the product’s warnings was causally related to the his injury. We love this doctrine, because a successful argument can turn on the opportunistic exploitation of a plaintiff’s lawyer’s failure to ask a single question when deposing the plaintiff’s prescribing physicians.

The plaintiff’s warnings expert opined that the 2006 Risperdal label, in effect when the drug was prescribed for the plaintiff, should have included: 1) a recommendation for physicians to monitor prolactin levels; and 2) an indication that there was a statistically significant association between Risperdal use and gynecomastia. Id. at *12. But, as the court explained, “[a]lthough the parties deposed Plaintiff’s prescribing physicians, neither party elicited any testimony from [the doctors] concerning whether [the expert’s] proposed warnings . . . would have affected their prescribing decision.” Id. And so, the court concluded, “In light of the dearth of testimony from his prescribing physicians that [the expert’s] proposed warnings would have changed their prescribing decision, Plaintiff failed to establish proximate causation.” Id. (citation omitted).

The plaintiff attempted to save his warnings claim by arguing that the defendant engaged in illegal off-label promotion. The court held that, because the plaintiff was in an indicated population and was prescribed the drug for an indicated use, any discussion of off-label promotion was irrelevant to the case.

Fraud

Finally, the plaintiff argued that the court erred in dismissing his fraud claim. Again the court considered this claim under both North Carolina law and Pennsylvania law. Federal courts have interpreted Pennsylvania law as ‘barring [fraud claims]against pharmaceutical manufacturers.” Id. at *18 (citations omitted). Pennsylvania appellate courts have not addressed this issue. North Carolina law permits such claims, but not “where the purported misrepresentation was made solely to a third party.” Id. (citations omitted). “Because . . . neither Plaintiff nor Plaintiff’s mother relied on any representation” from the defendant in deciding whether to use the drug, “Plaintiff’s fraud claim must fail under North Carolina law.” Id.

The parties agreed that, where a true conflict of law existed, North Carolina law would apply, as that state, where the Plaintiff ingested the drug and developed gynecomastia, had a greater interest in the application of its law than did Pennsylvania, the forum state. “Ultimately,” the court held,

[I]t is immaterial whether Pennsylvania law permits a fraud claim in pharmaceutical cases. Assuming, arguendo, that Pennsylvania permits [such a claim], then Pennsylvania law conflicts with North Carolina law and North Carolina law would apply. Conversely, if Pennsylvania law prohibits such a claim, then Pennsylvania law applies. In either scenario, Plaintiff’s fraud claims would be dismissed.

Id. at *19.

We love a good summary judgment decision.  P.D. is sound and well-supported, and we trust that it will be affirmed on appeal. We will keep you posted. In the meantime, the [very cool] eclipse has come and gone. In the words of the Fifth Dimension, “let the sun shine!”

 

 

We have offered our view that cases seeking to impose liability based on well-known risks found with an entire class of prescription medications tend to be weak.  We think design defect claims usually are clearly preempted in this context and warnings claims will often be preempted too, even with Levine’s high “clear evidence” hurdle.  Cases about thrombotic risks with hormonal contraceptives have featured prominently in such posts, like this opus, precisely because design is not the issue and FDA has long been intimately involved with labeling of these products.

Another obvious fertile ground for preemption has been with gastrointestinal bleeding with anticoagulants, something of the therapeutic flip side to the risk of thrombosis.  First, it is a well-known issue.  Our quick PubMed searches easily got us to articles about this from the 1950s.  Second, this risk has been described in drug labels for a long time.  We easily found this as the first warning in prescription labels as early as 1998, although we suspect they had been around for a few decades by that point.  Third, this risk has been seen with every anticoagulant since there have been anticoagulants.  We have no doubt that any anticoagulant drug coming to market gets a thorough review of its bleeding risk and its labeling about that risk by FDA.  This surely includes attention to any differences in the labeling of the different anticoagulants and whether any post-approval studies or adverse events merit changes.  These facts should make it hard to articulate, let alone prove, a design defect claim that gets by Bartlett or a warning claim that gets by Levine, unless Buckman gets ignored.

We say “should,” but, in all fairness, it certainly depends on where the case is and who is deciding it.  Even in the nascent era of drug and device product liability litigation where cases should pretty much be in federal court unless they are in state court in the defendant’s true home state, the court can be all but determinative of the decisions on litigation-altering issues.  The selection of court can, in turn, depend on the selection of the MDL’s home in litigations where the lawyer advertising drums up enough cases to get the JPML’s attention.  We were going to contrast cases decided by different MDL courts overseeing product liability litigation over the bleeding risk of relatively new prescription anticoagulants.  Instead, we will be discussing one decision addressing allegations we think are pretty typical of what is getting offered up elsewhere and our dear readers can draw their own conclusions.

Fortner v. Bristol-Myers Squibb Co., No. 17cv1562 (DLC), MDL No. 2754, 2017 U.S. Dist. LEXIS 117030 (S.D.N.Y. July 26, 2017), comes out of the Eliquis MDL.  Based on the JPML’s statistics, when decided, there were 23 pending cases out of a total of 69 ever-filed cases in this relatively young MDL.  The drug was approved in 2012 with extensive warnings about the risk of bleeding.  Plaintiffs in the MDL offered various allegations about how the drug was defectively designed because it had a clotting risk, was not accompanied by a drug-specific clotting test, was not accompanied by an “antidote,” and was to be taken twice a day.  These same criticisms were offered as warnings claims, but there were no allegations that the manufacturer had received post-approval safety information triggering some alleged duty to try to change any aspect of the label through the CBE process.  The manufacturers challenged whether these allegations stated any state law claim that was not preempted and, before there was even an MDL established, dismissed a number of cases without prejudice in Utts I, which we discussed here.  After the MDL was established, the plaintiffs got another shot with amended complaints and still came up short in Utts II, this time with prejudice.  The court, in an exercise of magnanimity, invited the remaining plaintiffs to see if they could come up with complaints that stated a non-preempted claim.  That is how we get to Fortner, who alleged a variety of claims under Tennessee law based on the same allegations about the drug, manufacturers, and FDA that most of the remaining plaintiffs apparently offered.

As is often the case with pleading around statutes of limitation—complaints with dates for everything but when plaintiff’s alleged injury occurred—it looks like the fourth attempt at a complaint was modified to be vague, repeating allegations “in less detail and without identifying or appending the specific studies from which these allegations are drawn.” Id. at *7.  The Fortner court saw through this “pleading tactic” of “masking the basis for her claim”:  The complaint’s “claims do not become more plausible simply because the plaintiff has omitted from the FAC the sources upon which her conclusory factual allegations are based.” Id. at **7-8.  Well stated and clearly correct, but many courts let uncertainty work to the plaintiff’s advantage in this posture, despite TwIqbal’s requirement of factual allegations that plausibly state a claim.

The critical aspect of Fortner’s approach is that the court required the plaintiff to plead a warning claim based on “sufficient factual content to support a plausible inference that there exists newly acquired information such that the defendants could unilaterally have changed the Eliquis label to include additional warnings.” Id. at *8.  This, in turn, flowed from the court’s prior decisions holding that “post-approval failure to warn claims are preempted unless the plaintiff can plausibly allege that there existed ‘newly acquired information’ such that, pursuant to the Changes Being Effected (‘CBE’) regulation, the defendants could independently have updated the Eliquis label to include such warnings.” Id. at *5.  There is no such thing as a pre-approval warning claim—absent an allegation that the launch label resulted from fraud-on-the-FDA that side-stepped Buckman—so this is a pretty good statement of what a non-preempted prescription drug warnings claim should allege.

By contrast, under the court’s prior analysis, there is no such thing as a non-preempted post-approval design defect claim because “FDA regulations prohibit a change of the type implicated by the claim.” Id. Here, the first urged defect was twice daily dosing—which is a design issue if the plaintiff alleges the product should have been designed to deliver the effective dose by taking it once a day, for instance, and something that clearly cannot be changed without a new NDA.  The other urged defects are things we see as more labeling than design issues—lack of a drug-specific clotting test or an “antidote” to the drug that could be recommended or sold with the drug.  Even if such a test or antidote existed, it could not be sold with the drug based on anything the manufacturer could have done independent of FDA action.  In reaffirming its prior decision on the preemption of pre-approval design defect claims, the Fortner court noted that Yates was the only appellate court to address the issue and no binding authority disagrees with its analysis.

Based on a trio of preemption rulings at the pleading stage, it looks like the Eliquis MDL will be short lived.  That is not always the case with MDL proceedings based on dubious claims, where the burden of one-sided discovery and the weight of the docket tend to dictate the result more than anything approaching the merits.  In terms of issues that seem as obvious to us as preemption of pre-market prescription drug design defect—we note that “duh” and “no duh” mean the same thing, like “regardless” and “irregardless” or “flammable” and “inflammable”—it will help to have more appellate courts follow Yates.

 

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.

Finally, some good news out of California – at least when personal jurisdiction isn’t the issue.

Design and warning defects were the questions presented in Trejo v. Johnson & Johnson, ___ Cal. Rptr.3d ___, 2017 WL 2825803 (Cal. App. June 30, 2017), and the result, particularly on the design side, was much more to our liking.

Indeed, there may well not have been post-BMS personal jurisdiction in Trejo either, since the plaintiffs were Hondurans injured in Honduras.  It’s not clear from the opinion where the drug at issue – an over-the-counter (“OTC”) ibuprofen-based pain relief medication – was purchased.  Somewhere in the United States, we gather, and it was then sent as a “care package” to the purchaser’s Honduran relatives.  Trejo, 2017 WL 2825803, at *2.

The drug was eventually taken, in Honduras, by someone other than its intended user, and that person, the eventual plaintiff, subsequently suffered Stevens-Johnson Syndrome (“SJS”), a nasty condition that we’ve encountered frequently on this blog.  This particular exercise in litigation tourism was quite initially successful.  A jury awarded over $50 million (including $15 million in punitive damages), finding for plaintiff on negligent failure to warn, negligent design, and strict liability design defect under the so-called “consumer expectation” test and the risk-benefit test.  The defendant “won” (if you could call it that) on strict liability warning defect and design defect under the “risk/utility” test. Id. at *5.  California not only allows plaintiffs two bites at the warning apple on separate negligence and strict liability theories, but three bites at the design apple under separate negligence, strict liability/consumer expectation design defect, and strict liability/risk/utility design defect theories.  No wonder plaintiffs flock to the state.

On appeal, however, the plaintiff in Trejo lost it all.

The design defect rulings are the most significant for the rest of us.

First, Trejo becomes the fourth appellate court to hold that the impossibility preemption rationale of Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), applies generally, and it not limited to generic drugs – the others being Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 703-04 (3d Cir. 2016) (airplanes); Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281, 298 (6th Cir., 2015) (branded drugs), and In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34, 41 (1st Cir. 2015) (branded drugs). Trejo joins Sikkelee and Yates in applying Mensing/Bartlett to design defects.  And Trejo is the first appellate decision to apply Mensing/Bartlett specifically to OTC drugs.

This is a good direction for the law to be moving. No appellate court has held that Mensing/Bartlett is limited to design defects in generic drugs.

Here’s what the unanimous Second District Cal. App. panel in Trejo had to say about preemption:

While the FDCA contains an express preemption provision concerning OTC drugs (21 U.S.C. §379r) – with a great big exception that exempts “product liability” claims from preemption – express and implied preemption operate independently.  Thus the savings clause for “product liability” doesn’t preclude implied preemption where product liability claims are in conflict with federal law.  Trejo, 2017 WL 2825803, at *23 (“[t]he savings clause does not foreclose the possibility that conflict preemption may arise from federal sources other than . . . §379r”).

Plaintiff’s design defect claim was that the defendant shouldn’t have used ibuprofen at all, but rather dexibuprofen, an isomer of the drug in question, “even though the FDA has not approved dexibuprofen for sale in the United States.” Id. at *5.  That’s right – plaintiff articulated a blatant stop-selling claim of the sort Bartlett had held preempted, and the Court of Appeal called “barnyard expletive” on plaintiff’s tortured argument otherwise:

[Plaintiff] asserts that he did not argue that defendants “should have withdrawn [the drug] from the marketplace, or should have never sold it in the first place.”  This argument is merely a matter of semantics. No matter how plaintiff words his argument, the claim that defendants failed to sell dexibuprofen instead of ibuprofen requires the claim that defendants should have withdrawn [the drug] from the market because defendants could not have changed the active ingredient of [the drug] without undergoing an entirely new FDA drug application process.

Trejo, 2017 WL 2825803, at *21 n.20 (emphasis added).

The Bartlettindependence principle” also required preemption.  It was impossible for the defendant to do what plaintiff contended state law required (materially change the drug’s design) immediately because material design changes to OTC (and all) drugs (and medical devices) require the prior review by and approval of the FDA.  “[F]ederal law prohibited the manufacturer from taking the remedial action required to avoid liability under [state] law.”  Trejo, 2017 WL 2825803, at *25 (quoting Bartlett, 133 S. Ct. at 2476).  That ruling applied to all drugs:

Consistent with our conclusion that the savings clause . . . does not prevent the applicability of ordinary preemption principles in the nonprescription drug context, we agree . . . that Bartlett’s holding is not limited to prescription drugs.

Trejo, 2017 WL 2825803, at *25 (emphasis added).  The FDCA did not permit the defendant to substitute freely one active ingredient for another.  “Dexibuprofen therefore would be a new drug, requiring a new drug application.”  Id.

[F]ederal law prohibited defendants from changing the design of [the drug] by selling dexibuprofen without prior FDA approval.  Defendants accordingly could not have avoided design defect liability without violating federal law.  “FDA regulations provide that once a drug, whether generic or brand-name, is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product.”

Id. (quoting and following Yates, 808 F.3d at 298).

Preemption applied because the defendant could not have acted “unilaterally” to make the design change purportedly required by state product liability law – whether design defect is measured by consumer expectation or risk/utility:

Thus, under federal law [citations omitted] defendants could not unilaterally change the chemical composition of [the drug] from ibuprofen to dexibuprofen in order to satisfy consumer expectations or to increase the benefits or decrease the risks of [the drug].  Nor could they be required to stop selling [the drug] in order to avoid state liability.  Plaintiff’s design defect claim accordingly is preempted.

Id. at *26 (Bartlett citations omitted) (after quoting from a half-dozen cases listed in our post-Levine drug preemption cheat sheet).

Moreover, after trying the case as a straight-forward “you should have designed the product differently” claim, plaintiff could not attempt to convert it to some kind of quasi-warning-based case.  Plaintiff had a real warning claim (which we’ll get to) and couldn’t convert one possible design related factor (presence of warnings) into the whole design ball of wax to avoid preemption after having tried a different case to the jury.  Id.

But there’s more on design first.

Second, as we mentioned, California allows plaintiffs generally to prosecute design defect claims on either a consumer expectation or risk/utility theory of liability.  Not anymore in prescription medical product cases after Trejo.  Trejo also held, quite apart from preemption, that the consumer expectation theory was inapplicable to complicated products such as OTC drugs – and thus, we would argue, a fortiori would be inapplicable to prescription medical products.

The consumer expectation test is only appropriate for products that “everyday experience” allows consumers generally to have safety expectations about:

[T]he consumer expectations test is reserved for cases in which the everyday experience of the product’s users permits a conclusion that the product’s design violated minimum safety assumptions, and is thus defective regardless of expert opinion about the merits of the design.

Trejo, 2017 WL 2825803, at *27 (quoting Soule v. General Motors Corp., 882 P.2d 298, 308 (Cal. 1994)) (emphasis original).  OTC drugs – let alone prescription products – aren’t that.  Plaintiff tried the case with expert witnesses, which is a no-no under the consumer expectation theory.  That plaintiff did so demonstrated the theory’s inapplicability.

The circumstances of [the drug’s] failure involve technical details and expert testimony regarding the effect of the product upon an individual plaintiff’s health, and the ultimate question of whether [the drug] was defectively designed calls for a careful assessment of feasibility, practicality, risk, and benefit.

Id. at *30 (citations and quotation marks omitted).  SJS was an “unusual reaction” to the drug, thus “expert testimony was required to explain plaintiff’s theory.”  Id.  “Accordingly, we conclude that the consumer expectation test should not have been applied.”  Id.

In light of this complexity, plaintiff’s excuse for consumer expectations fell in the same barnyard as his argument against stop selling preemption.  Simply testifying that “I didn’t expect to get hurt” didn’t cut it:

Plaintiff here contends that the consumer expectation test applies because the ordinary consumer does not expect to contract SJS/TEN from taking OTC [ibuprofen].  However, it could be said that any injury from the intended or foreseeable use of a product is not expected by the ordinary consumer.  If this were the end of the inquiry, the consumer expectation test always would apply and every product would be found to have a design defect.

Trejo, 2017 WL 2825803, at *29 (emphasis added).  A consumer cannot, by playing dumb, bootstrap himself into a consumer expectation claim.  “[T]he consumer expectation test does not apply merely because the consumer states that he or she did not expect to be injured by the product.”  Id. Admittedly, we haven’t seen that many California plaintiffs audacious (or desperate) enough to utilize consumer expectation theories against FDA-approved products; nonetheless we’re beyond pleased now to have explicit appellate authority precluding this theory of liability against our clients.

After Trejo, it becomes a lot harder for any plaintiff to pursue a design defect claim against a prescription medical product in California.  If the design considerations that go into OTC drugs are too complex and involved to allow use of the consumer expectation theory of liability, than that theory is even less available to more sophisticated prescription products whose risks and benefits are so esoteric that the FDA has concluded that they should be dispensed only after evaluation by medical doctors.  Likewise, the Mensing/Bartlett preemption rationale against design defects is equally applicable to all FDA regulated products.  Can a branded drug manufacturer change its product’s active ingredient – or any other aspect of the product that materially affects product safety?   No.  And neither can a medical device manufacturer.  Effectively, all design defect claims that could make a difference in a product liability action (that materially affect “safety”) require prior FDA review, and thus should be preempted under Trejo and the Mensing/Bartlett independence principle.

That’s still not all.  We still have Trejo’s disposition of the warning-related aspects of the verdict to discuss.

Third, the Court of Appeal unanimously held that the jury’s verdict for the defendant on strict liability warning defect was fatally inconsistent with its verdict for plaintiff on negligent failure to warn.  Trejo, 2017 WL 2825803, at *8-14.  From a national perspective, this result is less important than the design defect aspects we just finished with, because disposition of the warning claim has to do with the interaction of California’s peculiar warning-based legal doctrines, which still attempt to maintain a difference between negligence and strict liability in the warning context.  Most other states treat them interchangeably.

It’s still important in Trejo, however.  $50 million is $50 million.

Briefly – because the whole thing reeks of hair-splitting to us – “both the strict liability and negligence theories were premised on a single alleged defect.”  Id. at *8.  “[U]nder either a negligence or a strict liability theory of products liability, to recover from a manufacturer, a plaintiff must prove that a defect caused injury.”  Id. at *6.  However, “strict liability, which was developed to ease a claimant’s burden of proof, requires proof of fewer elements than negligence.”  Id.  Thus, negligence requires “an additional element, namely, that the defect in the product was due to negligence of the defendant.”  Id.  Where (as here) the claimed defect under both theories is the same, that means that strict liability simply eliminates an necessary element, so that “a positive verdict on the latter [negligence, is] difficult to explain if strict liability cannot be found.”  Id.

Exactly that happened in Trejo, and it cost plaintiff $50 million.  It wasn’t the first time, either.  A previous decision, Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr. 2d 252, 262-64 (Cal. App. 1999), was directly on point, forthrightly holding that “[a]s a practical matter then, the difference in the two concepts [negligence and strict liability] is so small as to make no difference.”  Id. at 263.  The jury’s finding for the defendant on the “easier” warning defect claim was necessarily inconsistent with its finding for plaintiff on the “harder to prove” negligent warning claim.  Trejo, 2017 WL 2825803, at *14 (“The jury’s special verdict on negligent failure to warn is fatally inconsistent with its verdict on strict liability failure to warn and must be reversed.”).

Who knows what would have happened if this plaintiff had not insisted on more than one bite at the apple?  That’s what we’ll find out on retrial.  We have no idea when that might be however, since further appellate review in Trejo is certainly possible.  In this respect, we are reminded that Bartlett, like Trejo, was also an SJS case.

It’s a fairly well known double standard. If you ask your child why he or she did that rotten, terrible, awful thing and he or she responds “just because” – that’s never good enough. When a parent is faced with the question “why,” however, “because I said so” is a fairly standard, albeit a bit of a crutch, response. If your child happens to have a litigator as a parent, the lesson that “just because” won’t cut it is learned very early. Litigators like to practice their cross-examination skills. Litigator-parents get that opportunity when faced with broken windows, missed curfews, and dented bumpers. DDL Blog litigator-parents not only cross-examine, we TwIqbal (actually seems to work well as a verb). We want supporting facts and they better be sufficient to “nudge” whatever explanation is being offered “across the line from conceivable to plausible.” Ashcroft v. Iqbal, 556 U.S. 662, 680 (2009).

That’s exactly what the judge was looking for in Staub v. Zimmer, Inc., 2017 U.S. Dist. LEXIS 89109 (W.D. Wash. Jun. 9, 2017). Try as he might, however, he couldn’t find it. Plaintiff filed suit in Washington state alleging injury from the implantation of a prosthetic hip. Id. at *1. Following removal to federal court, defendant moved to dismiss.

In Washington, all products liability claims are subsumed under the Washington Product Liability Act (“WPLA”). Id. at *4. The WPLA allows a plaintiff to seek recovery for defective design; failure to warn; defective manufacture; or breach of express or implied warranty. Id. at *4-5. While a plaintiff does not have to specify in the complaint which precise theories he or she is pursuing, the complaint has to “contain sufficient non-conclusory factual allegations to support at least one avenue of relief.” Id. at *5. So, the court combed the Staub complaint to see if it met that basic requirement.

First, the court could find no indication anywhere in the complaint that plaintiff was alleging either failure to warn or breach of warranty. Id. at *5-6. The court was unwilling to read into the complaint claims that plaintiff appears to have failed to assert. As an aside the court pointed out that should plaintiff wish to pursue a failure to warn claim, it may be barred by the learned intermediary doctrine. Id. at *6n3. Perhaps a little foreshadowing?

The WPLA recognizes both the risk utility test and the consumer expectations test as bases for a design defect claim. So plaintiff’s complaint better have support for at least one of these theories. Plaintiff Staub, however, failed to adequately plead either. On risk utility, plaintiff only alleged that the product was “not reasonably safe.” Id. at *7. On consumer expectations, plaintiff only alleged that the device “failed to meet consumer expectations of safety.” Id. at *8. These are the pleading equivalent of “just because.” Parroting back the words of the elements of the claim do not suffice. Nowhere did plaintiff allege how a design element led to his alleged injury, whether there was a feasible alternative design, or how the product didn’t meet expectations. Id. at *7-8.

On his manufacturing claim, plaintiff failed to allege any facts showing that the device at issue deviated in any way from the intended design. Id. at *9. Once again, a bare bones allegation that the product was “defective and unreasonably dangerous” was far from satisfactory. Id. Plaintiff apparently made some attempt to save his manufacturing defect claim by alluding to the fact that the product had been voluntarily recalled. But without any allegations connecting the recall to plaintiff’s alleged injuries, the recall alone offers no support. Id. at *10n5.

Plaintiff is getting a do-over; he has 20 days to file an amended complaint. It’s sort of like, go to your room and when you come back you better having something better than “just because.”

When last we wrote, we were about to embark on a journey to Budapest and Vienna to visit the Drug and Device Law Rock Climber. We mentioned that we were thrilled to hold tickets to see the Lipizzaner stallions perform at the Spanish Riding School in Vienna, as we had wished for this since we were very small. And in the phrase “hold tickets” lies the rub.  Though our companion warned us, as we locked the door and departed for the airport, to be sure we had the tickets, we somehow arrived in Europe without them and descended into panic.  For, unlike virtually every other admission credential we had used in the past five years, these were not e-tickets or pdfs but were actual, cardboard tickets, mailed to us in a postal envelope.  And they were missing.  Luckily, in this age of e-mailed confirmations and of people everywhere speaking perfect English, we were able to secure duplicate tickets and to see the stunning white horses of our dreams.  But we were warned, so we would have had no one to blame if the outcome had been different.

As was the case in today’s decision. Ford v. Riina, et al., 2017 N.Y. Misc. LEXIS 1649 (N.Y. Sup. Ct. May 2, 2017), is an unpublished opinion out of the Supreme Court of New York County. The facts are quite tragic.  The plaintiff was being treated for a brain aneurysm by the physician defendant when “a coil escaped” and migrated further into the plaintiff’s brain. Ford, 2017 N.Y. Misc. LEXIS 1649 at *1.  The doctor attempted to retrieve the coil using the manufacturing defendant’s device after another method failed.  “Retrieval of foreign bodies misplaced during interventional radiologic procedures in the neuro . . . vasculature” was one of the indications in the device’s Instructions for Use (“IFU”), which contained warnings about, inter alia, using the proper size of the device (available in a range of sizes) and not performing more than six retrieval attempts in the same vessel using the device.   The IFU also reported that one fracture of the retriever had occurred during clinical trials and provided instructions for reducing the risk of fracture.

The doctor first tried one size of the retriever in the plaintiff. He captured the errant coil, but the retriever fractured when he attempted to retract it.  He tried a larger retriever, which also fractured.  Ultimately, the doctor was able to capture one of the fractured retrievers with a snare but was unable to capture the second retriever or the coil.  The plaintiff was taken for an emergency craniotomy and suffered a major stroke that left him severely brain-damaged.  He sued the doctor and the device manufacturer, and stipulated that claims against the manufacturer would be limited to design defect and failure to warn, and the manufacturer moved for summary judgment on both claims.

In support of its motion, the manufacturer submitted four affidavits.   The first was the affidavit of an engineer employed by the manufacturer’s successor.  The engineer stated that he was able to determine the lot number of each device opened by the doctor and that he was able to determine that there were no reported fractures of any devices in the relevant lots except the fractures to the devices used in the plaintiff.  The second affiant was a bioengineer, who stated that the retriever was the state-of-the-art medical device for foreign body removal from the time of the plaintiff’s procedure up to the present time.  He also stated that fracture was exceptionally rare in the device in question and that the benefits of the device outweighed the risk of fracture, which is inherent in all retrieval devices. The third affiant, a neurologist, opined that the retriever’s IFU expressly warned of the risk of fracture and of vessel damage, that the warnings – including the warning of the precise event that occurred in the plaintiff – were clear an adequate, and that the risks of fracture and vessel damage were “generally known and accepted in the relevant medical community.” Id. at *13-14.  Finally, a registered professional engineer opined that “no other commercial engineering or biomedical alloy can come close” to the elasticity and shape memory of the alloy used in the defendant’s device, id. at * 15-16, that there is no other material commercially available to manufacture the device for its intended use. Id. at *17.

In opposition, the plaintiff submitted the affidavits of two witnesses. The first, a materials scientist, claimed that he tested the retrieval device under a variety of conditions, that the testing confirmed that cracks and fractures could occur with much greater ease and frequency than the IFU suggested and under conditions of which the IFU did not warn, and that, as such, the IFU did not contain adequate warnings related to the potential for fracture. The second witness, a biomedical engineer, opined, inter alia, that the IFU did not adequately warn of the potential for the device to become entangled or stuck in a vessel and of the difficulty of disengaging it once it was stuck.  He also claimed that there were feasible alternative design features that would have prevented the plaintiff’s injury.

The court held that the manufacturer had “establishe[d] prima facie that the IFU conveyed to physician-users the most current knowledge concerning the potential risk of fracture associated with the [device], which is all the law requires.” Id. at *33 (citation omitted).  In addition, the IFU “set forth various steps which the physician-user could take to reduce that risk.” Id. Finally, the manufacturer “establishe[d] its prima facie entitlement to summary dismissal of plaintiff’s design defect claim by establishing that the [device] was state of the art for removing . . . foreign bodies from the neurovasculature, that the device was properly designed and manufactured . . . and . . . incorporated changes made to the [device’s predecessor] as well as other modifications that minimized the risk of fracture.” Id. at *34 (citations omitted).

Once the manufacturer made its prima facie showing, the burden was on the plaintiff to identify a triable issue of fact. And the court held that the plaintiff did not satisfy this burden.  The court stated, “An expert’s affidavit – offered as the only evidence to defeat summary judgment – must contain sufficient allegation to demonstrate that the conclusions it contains are more than mere speculation and would, if offered alone at trial, support a verdict in the proponent’s favor.” Id. at *35 (citations omitted).  In this case, the plaintiff’s experts made “repeated reference to various tests and experiments they performed which they contend[ed] replicated the foreseeable event of the [device] being ‘fully stuck’ within a patient’s cerebral vasculature.  However, noticeably absent . . . is any description . . . of the actual tests and experiments they performed or the conditions under which they performed them . . . [including whether] the tests and experiments . . . were based on accepted industry standards. Id. at *36 (citations omitted).  The court concluded, “Simply stated, there is nothing in the experts’ affidavits from which the validity of their ultimate conclusions about the design of the [device] and the adequacy of the IFU can be inferred. . . .In the absence of any reference to a foundational scientific basis for their conclusions, [the plaintiff’s experts’] opinions lack sufficient probative value to raise a triable issue of fact” as to design defect or the adequacy of the warnings.”  Claims dismissed, summary judgment for the manufacturer.

Ford is a well-reasoned and correct decision that fits nicely into our self-styled crusade against the opinions of experts who should never darken the courthouse steps.  We will keep our eyes open for similar holdings in published, precedential opinions, and we will keep you posted.