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.

Today’s guest post is by Aggie Lee of Tucker Ellis, about a PMA preemption win that she briefed in California.  The medical device is a hemostatic matrix, which is unusual, and this type of device isn’t usually targeted in product liability litigation.  As is always the case, our guest posters are 100% responsible for their submissions, so Aggie deserves all the credit (and any blame) for what follows.

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Judge Gonzalo P. Curiel in the Southern District of California has been in the national spotlight since then-candidate Donald Trump questioned his impartiality in the then-pending Trump University lawsuits.  While now-President Trump might not number among his admirers, we like Judge Curiel’s recent contribution to Premarket Approval (PMA) preemption, where he recently dismissed with prejudice all of plaintiffs’ claims in Weaver v. Ethicon, Inc., No. 16CV257-GPC(BGS), 2017 WL 680725 (S.D. Cal. Feb. 21, 2017).

But it took a long time and many motions to get there, specifically four complaints, one personal jurisdiction-based motion to dismiss, and three preemption-based motions to dismiss. Defendant Ethicon, Inc., finally prevailed when the Court dismissed Plaintiffs’ Third Amended Complaint with prejudice.

Continue Reading Guest Post – The Matrix Preempted

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”?  Id. at 493.  In the same vein:

“[S]ubstantial equivalence determinations provide little protection to the public. These determinations simply compare a post − 1976 device to a pre − 1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.”

Id. (quoting from pro-plaintiff law review article).

Most of our readers know that this characterization, assuming it was true for the 1980s-era (implanted 1987) device that the Court considered in Lohr, was no longer true, even at the time Lohr was decided, and certainly hasn’t been the case since the FDAAA was passed a year after Lohr was decided.  Still, this anachronistic view of §510k has flourished for twenty years, affecting first preemption and now (thanks mostly to Mesh MDL rulings) admissibility of evidence.

That’s why we were interested in what the FDA had to say about today’s §510k clearance process in its recent memorandum entitled “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products,” which is available here.  One of our guest bloggers, Liz Minerd, recently discussed the First Amendment aspects of that document, here.

Continue Reading FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

Some bloggers on this site have openly admitted to being swayed by the length of an opinion in choosing whether to blog about it. Shorter decision, shorter post. Less words, less work. In all honesty, a 56-page summary judgment opinion does tend to elicit a slight groan or at least an audible sigh. But sometimes, if you can manage to push through, you find that 16,000 words can be summed up very succinctly – preemption, preemption, preemption.

That’s not to say that the 15,999 other words in Babayev v. Medtronic, Inc., 2017 WL 90403 (E.D.N.Y. Jan. 5, 2017) are not important or interesting but there is a lot of case specific detail and a fairly lengthy recitation of preemption law, including the division among the circuits and within the Second Circuit as to the scope of implied preemption in the context of parallel violation claims. Id. at *14-20. We’ve covered this history in significant detail and anyone with even a passing familiarity with our blog knows well our feeling that the Eighth Circuit’s interpretation of the interplay between Riegel and Buckman gets it right – that there is only “a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape express or implied preemption.” In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010). Babayev goes on to lay out the split in the circuits on the issue of whether Current Good Manufacturing Practices (CGMPs) are specific FDA regulations on which a parallel violation claim can be based. Babayev, at *22-23. Again, we align with the Eighth Circuit’s conclusion that CGMPs, which apply to all devices, not just PMA-devices, are too general to give rise to a parallel violation claim. Rather, a parallel claim that survives preemption must be based on an alleged violation of a PMA, device-specific requirement. Id. at *22.   While Babayev doesn’t go quite as far as the Eighth Circuit, it went far enough to reach the right result here – the federal violations alleged by plaintiff aren’t specific enough to warrant surviving preemption.

Babayev involved an implanted neurostimulator. Following surgery, a technician employed by the manufacturer assisted in testing the device and making sure it was functioning. As plaintiff prepared to leave the hospital he connected the device as instructed and received a shock that caused him to spasm and jump. Plaintiff did not fall. Id. at *6. The device was disconnected and plaintiff was sent home. He returned to the hospital in pain and the leads were removed. Over one week later it was discovered that plaintiff had a fractured hip which he alleged he suffered during the shock incident. Id. at *6-7.

Continue Reading Lengthy Decision, Simple Conclusion – Preemption Win Across the Board

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

We use products with warranties every day. There are warranties on frying pans, on light bulbs, on computers. We once saw a warranty on a pair of nail clippers that cost $1.49 that allowed the owner to send them in for repair or replacement as long as you included $3.00 for return shipping. What a bustling warranty department that company must have had. Generally speaking, we don’t pay much attention to warranties unless they are on big ticket items. If something goes wrong with your car, you’re scrambling to see whether it’s covered by a warranty. If a light bulb that’s supposed to last five years burns out in three, you most likely just toss it out and screw in a new one. You probably forgot how long it’s been since you last changed it anyway (speaking for this blogger at least).

Medical devices such as implantable spinal neurostimulators (guess what today’s case is about) don’t come with warranties of the kind alluded to above. You’re not going to see a provision on the labeling that says should this device break or malfunction within 3 years of implant, just send it back for a new one. There are many reasons for this, the most obvious of which is the device is inside someone’s body. Returning the device it isn’t always an option, because revision surgeries aren’t always the best option. Moreover, most product warranties talk about normal wear and tear or under normal conditions. There is no such thing as “normal” or “typical” when you are talking about inside the human body. There are simply too many unknowns for medical device manufacturers to guarantee their products.

But that doesn’t stop plaintiffs from including express warranty claims in their complaints. Typically the allegations in express warranty claims in drug and device cases are general statements that the manufacturer’s labeling and advertising represented that the product would be safe, effective, fit, proper, etc. When pressed for the actual representations that constitute the express warranty or for proof of reliance on such statements – well, that’s when plaintiffs’ express warranty claims often fall away. That’s because they don’t exist. And, that’s usually the focus of our discussion on express warranty. Occasionally, however, plaintiffs come armed with a little more specificity.

Continue Reading Express Warranty Claim Preempted

Today’s case is a partially published decision about a partial reversal of a plaintiff verdict in California. So, we are only going to discuss select parts of the decision. It’s a long one and there are large sections about plaintiff’s counsel’s misconduct during trial and excessive damage awards. It is also a joint medical malpractice and product liability case. So, when you strip away the rest, we get down to a handful of legal rulings that we are truly interested in.

The case is Bigler-Engler v. Breg, Inc., 2016 Ca. App. LEXIS 921 (Cal. App. Oct. 28, 2016) and involves the use of a cold therapy medical device, available only upon prescription. Plaintiff underwent arthroscopic knee surgery, following which her surgeon prescribed use of the device to aid in recovery. Id. at *5-6. Plaintiff rented the device from her surgeon’s medical practice. Id. at *7. Upon discharge after surgery, plaintiff was advised to use the device at a certain temperature “as much as possible.” Id. at *8. Plaintiff’s use of the device and the instructions she received from her surgeon are explained in more detail in the opinion, but ultimately, plaintiff developed severe skin damage that required multiple plastic surgeries and scar reduction surgeries. Id. at *9-13.

Plaintiff file suit against her surgeon, the medical practice, and the device manufacturer. The jury found against the manufacturer on plaintiff’s claims for design defect, failure to warn, and intentional concealment. Id. at *19. The jury also awarded punitive damages against the manufacturer on the intentional concealment claim. Id. On appeal, the court overturned the intentional concealment verdict, which also meant reversing the punitive damages verdict. But, the court upheld the trial court’s decision not to instruct the jury on the learned intermediary doctrine finding it did not apply to a medical device intended to be operated directly by the patient.

Continue Reading A Fraudulent Concealment Win Coupled with an Unfavorable Learned Intermediary Ruling

We (in its blog-specific singular version) are longstanding country music fans. There is backstory – call us when you are in Philadelphia and we will tell you about it over coffee. Suffice it to say that Nashville, the Grand Ole Opry, and country greats from the 1970’s and 1980’s occupy a significant and permanent place in our soul.  So we were moved by a new video making the rounds of social media today. Entitled “Forever Country,” it is features 30 Country Music Association Award winners – both modern and legendary – in a beautiful montage celebrating 50 years of the CMA awards. You can see it here. There is also some pretty cool irony in the choice of “Take Me Home, Country Roads” as the song that opens the video and winds its way throughout. In 1975, John Denver was nominated as Country Music Association Entertainer of the Year. The previous year’s winner, Charlie Rich, was a bit “in his cups,” as they say, when he read the nominations. As he announced Denver as the winner, he struck a match and lit the card on fire in protest, because he did not think Denver was truly “country.” Happy to debate that when we have coffee, but we (unashamedly) love John Denver, as our office neighbors will attest. We are happy that Denver’s signature song was used in this celebration of country music. If it wins him some new fans, better late than never.

Also better late than never to report on today’s case, which just appeared online though it was decided 2 ½ years ago. In Peterson v. Wright Medical Technology, 2014 U.S. Dist. LEXIS 189473 (C.D. Ill. Feb. 13, 2014), the United States District Court for the Central District of Illinois considered the defendant’s motion for summary judgment on the plaintiff’s failure-to-warn claim in a hip implant case. The plaintiff, who was obese, received a new modular artificial hip to address his “significant end stage osteoarthritis” caused by an earlier accident. At the time of the plaintiff’s hip implant, his surgeon “had been an orthopedic surgeon for 31 years and had seen many evolutions of hip implants. He had read several journal articles about modular implants, including the [subject implant].” He had also read the Instructions for Use (“IFU”) included with the implant. He “knew that a patient’s weight and activity level could have an effect on the ultimate outcome of the surgery but had no reason to believe that Plaintiff was not an appropriate candidate for the implantation of this device.” The surgeon explained all of these risks to the plaintiff and required him to attend a two-hour teaching session before obtaining his informed consent.  Peterson, 2014 U.S. Dist. LEXIS 189743 at *3-4.

Two years after the plaintiff’s surgery, the titanium modular neck of his artificial hip broke into two pieces. In his complaint, the plaintiff asserted the usual strict liability and negligence claims, along with a punitive damages claim that was later dropped. The defendant moved for summary judgment on the plaintiff’s warnings claims sounding in both strict liability and negligence.

Continue Reading Defendant Did Not “Fail to Warn” Where It Warned of Exactly What Happened to the Plaintiff’s Artificial Hip

We’ve always been bothered by the presumption against preemption – so much that this blog’s first major substantive post was on that subject.  Even before that, back in the Bone Screw days, we remember the presumption against preemption accompanying the death of express preemption for 510(k) medical devices in Lohr.  In Lohr, the presumption was used as a narrowing principle of statutory construction: “[W]e use[] a presumption against the pre-emption of state police power regulations to support a narrow interpretation of such an express command.”  Id. at 485.  Then along came Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), which (as we pointed out at the time) upheld preemption of pre-market approved medical devices under the same statutory provision with nary a peep about any preemption-busting presumption.  Nonetheless, even after Riegel, some lousy circuit court decisions still invoked the presumption as a way of poking holes in PMA preemption, most notoriously the en banc Ninth Circuit in Stengel v. Medtronic Inc., 704 F.3d 1224, 1227-28 (9th Cir. 2013), which fawned over the presumption at some length before deciding that a duty to provide information to a governmental agency wasn’t any different than a bog standard product liability duty to warn.

The presumption also came up in the context of the Vaccine Act, where one court (discussed here) sought to nullify statutory preemption by latching onto a statement in Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (a non-FDCA case), about there being “a duty to accept the reading [of a statute] that disfavors pre-emption,” even where there are other equally “plausible” interpretations. Id. at 449.  That view was shot down by the Supreme Court in Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011), which interpreted the Vaccine Act’s preemption clause in a pro-preemption direction with nary a mention of the erstwhile adverse presumption – something else we mentioned at the time.

Then along came PLIVA v. Mensing, 564 U.S. 604 (2011), where four justices found, if anything, a presumption in favor of presumption, id. at 621-23 (viewing the Supremacy Clause as a constitutional “non obstante” provision), four justices disagreed, and one didn’t take a position.  Mensing, of course, was an implied preemption case.

For these reasons, we speculated a little over a year ago whether the presumption against preemption might be dead.  Then a little later, we thought we might be wrong.

Turns out we’re half right.

Continue Reading The Demise of the Presumption Against Preemption in Express Preemption Cases

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s website here.  Our interest in this draft guidance, as product liability litigators defending FDA-regulated products, is primarily due to the Agency’s numerous statements about when changes to the design and warnings of 510(k) medical device obligates their manufacturers to resubmit their products for additional FDA clearance prior to marketing.

As we’ve already discussed in much more detail in our September, 2015 “In Case of Good Judge, Break Glass” post, if a product change requires prior FDA review and assent, then that change cannot be mandated by common law tort actions.  The Supreme Court stated in PLIVA v. Mensing, 564 U.S. 604 (2011), “The question for ‘impossibility’ [preemption] is whether the private party could independently do under federal law what state law requires of it.” Id. at 620.  The new FDA draft guidance is all about when product changes to 510(k) devices require prior submission and Agency clearance:

This guidance, when finalized, will aid manufacturers of medical devices subject to premarket notification requirements who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (also referred to together as “existing devices”) during the process of deciding whether the modification exceeds the regulatory threshold of 21 C.F.R. §807.81(a)(3) for submission and clearance of a new 510(k).

Draft Guidance at 3 (“Scope”) (emphasis added).

Initially, we remind everyone that this document is both a “guidance” and a “draft.” It is subject to comment and is not final.  Even when final it has no legally binding effect.  But the guidance does interpret legally binding regulations that, as we discussed in our “Break Glass” post, mandate prior FDA review and clearance of changes to 510(k) devices.  The guidance is useful in that it provides a more comprehensive explication of the regulations, and thus more useful understanding of when a requirement for prior FDA submission of a device change gives rise to implied impossibility preemption under Mensing, Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), and Wyeth v. Levine, 555 U.S. 555 (2009).

Here are the principles that we think are most important to that determination.

Continue Reading New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

It’s August and several your valiant bloggers are on vacation, so the skeleton crew manning the fort is even more grateful for reinforcements than usual.  Here is another guest post, this time from Reed Smith‘s Court Chillingworth.  This is about a topic we’ve covered sporadically, the Biomaterials Access Assurance Act.  As always Court is entitled to full credit (and any blame) for everything appearing hereafter.  Except for this:  Edgar Allen Poe wrote on both.  Don’t worry, you’ll understand what it means by the end of Court’s post.

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When is a medical device an implant? When is it not? While far more drab than anything Lewis Carroll would have written, it is still a multi-layered riddle, and one that should be of particular curiosity – and possibly concern – to present-day medical device lawyers. It derives from the Biomaterials Access Assurance Act (“BAAA”), 21 U.S.C. §§ 1601 et seq., a statute that shields from liability in all state and federal courts the manufacturers of biomaterial and component parts that are supplied “for use in the manufacture of an implant.” Id., § 1601(1)(A) (emphasis added); see also id. § 1601(2), 1603(b)(1), 1604(a).  A Connecticut trial judge recently explored the question in Nolen-Hoeksema v. Maquet Cardiopulmonary AG, No. 146049888S, 2016 WL 4203030 (Conn. Super. New Haven Dist. July 11, 2016), and in particular, the question of whether one of the statute’s definitions of an “implant” – a device that is intended be “in contact with bodily fluids or internal human tissue through a surgically produced opening” [21 U.S.C. § 1602(5)(A)(ii) (emphasis added)] – would apply to a medical device that is used during surgery, but is not designed to be in direct contact with the patient.

Ultimately, the court found its answer from an otherwise simplistic source:  the Webster’s Dictionary and its definitions of the word “through.” But its analysis, which involved principles of statutory interpretation and federal preemption, was complex: which one of two Webster’s Dictionary definitions of the word “through” should be applied – one advocated by the defendant, meaning “by way of” in the abstract, or one advocated by the plaintiff, meaning “penetrating.” The court chose the latter, which effectively would require direct contact between the device and the patient for the BAAA to apply to component parts of the device under 21 U.S.C. § 1602(5)(A)(ii).

Continue Reading Guest Post – Through the Dictionary, and What One Court Found There: Adventures in the BAAA