It was a Merry Christmas and a Happy New Year for Tucker EllisDustin Rawlin and his breast implant defense team – and they were considerate enough to share it with us.

Wait a minute, you might be saying, breast implant litigation?  Isn’t that passé? I n a sense, we’d agree with you.  This isn’t your father’s breast implant litigation.  Twenty or more years ago, one of the first wave of solicitation-driven medical device mass torts produced thousands of claims and multi-district litigation.  In another precursor of things to come, causation of almost all of the claimed injuries was scientifically discredited.  E.g., In re Silicone Gel Breast Implants Products Liability Litigation, 318 F. Supp.2d 879 (C.D. Cal. 2004); In re Breast Implant Litigation, 11 F. Supp.2d 1217 (D. Colo. 1998); In re Silicone Gel Breast Implant Products Liability Litigation, 1996 WL 34401766 (N.D. Ala. Oct. 31, 1996); Institute of Medicine, “Review of the Reports of the Independent Review Group and the National Science Panel on Safety of Silicone Breast Implants” (1999).  The litigation was thus 99.9% junk science, but in another portent of things to come, it was nonetheless sufficiently expensive to bankrupt some defendants and to force others to settle.

One other effect of the original breast implant litigation was to spook the FDA.  Motivated largely by fears of bad public relations – certainly not science – the FDA reclassified breast implants as Class III medical devices that required pre-market approval.  However disruptive the FDA’s action may have been on the market, and however many women might have been deprived of this product’s benefits in the interim, the FDA’s action is also why this isn’t your father’s breast implant litigation.

Product liability actions against PMA medical devices are subject to broad preemption, and that’s a new way for breast implant defendants to win such litigation.

On Christmas Eve came Cashen v. Johnson & Johnson, 2018 WL 6809093 (New Jersey Super. Law Div. Dec. 24, 2018), which granted the defendants’ motion to dismiss with prejudice on preemption grounds.  Cashen involved litigation tourists from Ohio who brought the usual strict liability, negligence, fraud, and consumer protection claims. Preemption wiped most of these out. Fraud claims “relating to the safety or effectiveness of the device” were preempted no matter how plaintiffs pitched them:

[C]laims of fraudulent misrepresentation and fraudulent concealment seek to either (1) impose different or additional requirements to those that the FDA has already determined to have been satisfied or (2) stand in the place of the FDA and enforce federal requirements.  The former would make the claims expressly preempted while the latter would be impliedly preempted.

Id. at *7.  Plaintiffs could not escape their complaint, which alleged fraud over the device’s “propensity to cause serious physical harm” and “misrepresentations and concealments regarding the safety” of the device.  Id. at *8.

In addition, the Ohio legislature, had had enough of judicial expansion of common-law product liability and enacted a statute (“OPLA”) that abolished the common law altogether and replaced it with statutorily defined causes of action.  The fraud claims also fell because they had been “abrogated.”  Id. at 8-9.

Cashen dodged the question of whether Ohio’s consumer protection statute was preempted, because “it clearly falls within the umbrella of the OPLA . . . and is appropriately dismissed.”  Id. at 9-10.

Finally, the statutory definitions of product liability claims was facially preempted, whether involving design, manufacturing, warnings, or warranty. Id. at *10-11.

Notably, Cashen appears to be the first claim of breast implant associated-anaplastic large cell lymphoma (“BIA-ALCL”) to be thrown out on a motion to dismiss.  This “new disease” isn’t related to silicone and thus wasn’t addressed by the aforementioned Independent Review Group.  It’s one way for plaintiffs to avoid the IRG’s devastating causation conclusions, thus it’s significant to see preemption stop a BIA-ALCL claim in its tracks.

Merry Christmas.

Then came Ebrahimi v. Mentor Worldwide LLC, 2018 WL 6829122 (C.D. Cal. Dec. 27, 2018).  This is the third judicial decision in this case.  We examined the other two, here and here.  This time, the plaintiff’s now third amended complaint alleged “a single cause of action for strict product liability arising out of a manufacturing defect,” since everything else had already been held preempted.  Id. at *1.  The remaining claim fared no better.

The purported manufacturing defect simply wasn’t.  Plaintiff in Ebrahimi had seized upon a descriptive sentence in the “product insert data sheet” (of which the court took judicial notice because “as it is available on the FDA’s website,” id. at 1 n.2.) and sought to convert it into a design specification.  Ebrahimi called out the plaintiff’s ruse:

The Sheet simply indicates that [defendant] conducted a laboratory test on one of its Implants, and [description of test results].  The Sheet does not state that the FDA required Mentor to manufacture a shell that [always matches those results].  In fact, the Sheet does not purport to announce the FDA’s manufacturing specifications.

Id. at *2.  That was pretty much all she wrote for plaintiff’s sole surviving claim.  It’s not easy to gin up a manufacturing defect for violating a specification without having a specification in the first place.  In judicial language, that’s “an unwarranted deduction of fact that is not entitled to the presumption of truth.”  Id. (citation and quotation marks omitted).

Since the third amended complaint’s remaining allegations were a rehash of claims that had already been dismissed, id., that was the end of the line.  Three strikes and yer out!  “As [plaintiff] has once again failed to allege such a claim, the Court shall not grant her leave to file yet another amended complaint.”  Id.

Happy New Year.  And to the plaintiffs − so long, and thanks for all the fish.

We’ve always hated the Ninth Circuit’s decision in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (applying Arizona law), holding that allegations of failure to provide adverse event reports (“AERs”) to the FDA created a viable, and unpreempted, state law claim.  Now our #2 worst case of 2013 is effectively gone.  Kaput.

Today the Arizona Supreme Court in Conklin v. Medtronic, Inc., No CV-17-0322-PR, slip op. (Ariz. Dec. 18, 2018), expressly – and unanimously − disagreed with Stengel’s misinterpretation of Arizona product liability warning law, and since the Arizona Supreme Court is “supreme” on state-law issues, Stengel is invalid.  We’ll get directly to the good stuff:

We disagree with Stengel. . . .  In Stengel, the Ninth Circuit held that the [Medical Device Amendments] did not expressly or impliedly preempt the plaintiffs’ Arizona common law failure-to-warn claim based on Medtronic’s alleged failure to submit adverse event reports to the FDA.  That holding, however, was based on the unsupported premises that “Arizona law contemplates a warning to a third party such as the FDA” and that, “[u]nder Arizona law, a warning to a third party satisfies a manufacturer’s duty if . . . there is ‘reasonable assurance that the information will reach those whose safety depends on their having it.’”  Neither premise comports with Arizona law. . . .  [E]stablished law does not recognize a claim merely for failing to provide something like adverse event reports (which may not qualify as “warnings” under Arizona law) to a government agency that has no obligation to relay the information to the patient.

Because Stengel incorrectly recited and applied Arizona law, we decline to follow it. . . .  [O]ur case law contemplates that a medical device manufacturer may satisfy its duty to warn consumers by properly warning a third party, such as a learned intermediary.  But the FDA is not a learned intermediary or other relevant third party in that analysis.  And we are not aware of any case that supports the proposition that a manufacturer is independently required under Arizona law to warn a governmental regulatory body.

Slip op. at 10 ¶¶30-31 (citations omitted) (emphasis added, except for final emphasis, which is original).  Put the red flag on Stengel.

So how did the Conklin court reach this exemplary conclusion?  The path begins with an excellent preemption ruling in the trial court, Conklin v. Banner Health, 2015 WL 10688305 (Ariz. Super. Oct. 30, 2015), in a case involving a pre-market approved infusion pump.  That decision held all negligence per se claims (including the failure to report claim at issue here), preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  The intermediate Arizona appellate court reversed preemption of the failure to report claim, following Stengel.  See Conklin v. Medtronic, Inc., 418 P.3d 912, 919 (Ariz. App. 2017).  A further appeal produced today’s opinion.

The Arizona Supreme Court first recognized that, contrary to Stengel, there is no presumption against preemption in express PMA preemption cases.  “[A]lthough federal laws are presumed not to preempt state laws, courts do not invoke that presumption when the federal statute contains an express preemption clause.”  Slip op. at 3 ¶8 (citations and quotation marks omitted).  Interestingly, though, Conklin ultimately based its decision mostly on implied, not express, preemption, id. at 7 ¶21 (finding duty-to-report claim impliedly preempted and not reaching express preemption), so the presumption against preemption didn’t really figure in the result.

Conklin also utilized the “narrow gap” metaphor to describe the interaction of express preemption and implied preemption in PMA device cases:

Read together, these two types of preemption, operating in tandem, have created a “narrow gap” for pleadings.  To make it through, a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violates that federal requirement (avoiding implied preemption).

Slip op. at 6 ¶18 (citations and quotation marks omitted).

The one aspect of the plaintiff’s duty-to-report claim that Conklin held to be expressly preempted was the assertion that the FDA was obligated to make AERs widely available to the public.  Federal law did not require that, so:

[T]o the extent [plaintiff] argues that the FDA either has or assumed a duty to convey information from adverse event reports to treating physicians, patients, or more broadly public consumers . . ., [that] claim is expressly preempted because it likewise would impose under state law a requirement that is “different from, or in addition to,” any applicable federal requirement.

Id. at 6 ¶20 (regulatory citations omitted).

The broader implied preemption ruling was based, as indicated above, on the absence of any reporting duty owed under state law.  Conklin “assume[d] without deciding” that AERs could be “warnings” under state law, but several “but cf.” citations indicated its disinclination to so rule.  Slip op. at 7 ¶22. The learned intermediary rule, which the court previously adopted in Watts v. Medicis Pharm. Corp., 365 P.3d 944 (Ariz. 2016) (we discussed Watts here and here), proved to be key.  Under Arizona law, prescription medical product warnings need only go to learned intermediaries, and the FDA didn’t qualify as a “learned intermediary.” Arizona’s learned intermediary rule “only extends . . . to prescribing and other health-care providers.”  Slip op. at 8 ¶26. There was never any state-law obligation to warn the FDA:

The FDA is not a health care provider and does not prescribe anything for patients. . . .  Accordingly, even if we assume that adverse event reports may constitute relevant warnings, Arizona law does not permit a manufacturer to satisfy its duty to warn end-user consumers by submitting adverse event reports to the FDA.  And conversely, a manufacturer does not breach its duty to warn end users under Arizona law by failing to submit adverse event reports to the FDA.  [Plaintiff] cites no authority, and we are aware of none, for the proposition that Arizona law requires a manufacturer to warn a federal agency.

Id. at 8 ¶¶26-27 (citations omitted).  The duty to warn in Arizona “has not been extended to require a manufacturer to submit warnings to a governmental regulatory body.”  Id. at 8 ¶28.  Submitting AERs to the FDA does not provide “reasonable assurance” that such information “will reach end users (or end users’ health care providers) because the FDA is not required to publicly release such reports.”  Id. at 9 ¶28 (citations omitted).

Thus, the lack of any Arizona state-law duty to report was fatal to plaintiff’s reporting-based claims.  While Conklin held that such claims don’t exist from the outset, the case was litigated and appealed on preemption grounds.  Thus followed the preemption ruling that plaintiff’s purported reporting claims were purely FDCA-related, and thus preempted under Buckman:

Because only federal law, not state law, imposes a duty on [defendant] to submit adverse event reports to the FDA, [plaintiff’s] failure-to-warn claim is impliedly preempted under 21 U.S.C. § 337(a).  Absent an independent state law duty to submit adverse event reports to the FDA, [plaintiff’s] failure-to-warn claim, at bottom, is an attempt to enforce a federal law requirement.  That claim is impliedly preempted under the MDA.

Slip op. at 9 ¶29 (Buckman citations omitted).

Then came the slicing, dicing, and pureeing of Stengel that we quoted at the outset.  Conklin closed by dispatching the other cases plaintiff relied on, thus performing the additional service of highlighting the questionable validity of Fiore v. Collagen Corp., 930 P.2d 477 (Ariz. App. 1996).  See Id. at 11 ¶33 (Fiore “adopted a minority view . . ., and in any event likely does not survive Riegel”).

On this blog, we have declared, until we are blue in the face, that it is a usurpation of state court power for a federal court sitting in diversity to make up new theories of liability under state law.  That’s what Stengel did, and thankfully, in Conklin, the state high court thereby bypassed by the Ninth Circuit’s novel ruling had both the opportunity and inclination to call out the trespassing federal court.  Once again:

We disagree with Stengel. . . . Stengel incorrectly recited and applied Arizona law.

Slip op. at 10 ¶¶31-32.

Mic drop.

Did you know that October is National Cybersecurity Awareness Month?  Neither did we, until we started poking around the FDA’s recent press release announcing that it intends to update its guidance on medical device cybersecurity within the next few weeks.  We also learned that National Cybersecurity Awareness Month has been observed each October since its inception in 2004.  Observed by whom?  We’re not exactly sure.  We picture our IT consultants walking office to office handing out hats and stickers with catchy slogans like “A password is like underwear. Change it!”  Or some lame pun involving the work “phishing.”  If it were up to us, we would default to the simple and classic “Ctrl-alt-delete before you leave your seat.”

All kidding aside, cybersecurity threats have moved in recent years from theoretical to very real, and while there remains no reported instance of anyone hacking into a medical device being used to treat a patient, the potential vulnerability is one to which we need to pay attention.

That includes the FDA.  The FDA has published guidance on cybersecurity with regard to both premarket submissions and post-market submissions.  (You can see our take on the postmarket guidance here)  Based on the FDA’s press release, updates are coming to the premarket guidance, specifically to “highlight the importance of providing customers and users with a ‘cybersecurity bill of materials,’ or in other words, a list of commercial and off-the-shelf software and hardware components of a device that could be vulnerable to attack.”  This jibes with the FDA’s general approach to cybersecurity, which is to undertake a risk-based analysis that identifies vulnerabilities, assesses the potential frequency and severity of the risk, identifies mitigations, and proceeds accordingly.  Such a risk-based analysis should be familiar to anyone who operates in the medical device space, where risks and benefits are weighed on a daily basis.

The other news of the press release is the publication of a Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, which “describes the types of readiness activities that’ll enable HDOs [healthcare delivery organizations] to be better prepared for a cybersecurity incident involving their medical devices.”  This Playbook was prepared by the MITRE Corporation, a government-sponsored research and development organization.  You can get a copy of the Playbook here, and you can that it is aimed at healthcare providers and critical healthcare infrastructure in which medical devices operate.

The purpose of the Playbook is to help HDOs get ready for cybersecurity threats affecting medical devices that could impact continuity of care and patient safety.  More specifically, the playbooks objectives are to:

  • Provide baseline medical device cybersecurity information that can be incorporated into an HDO’s emergency preparedness and response framework;
  • Outline roles and responsibilities for responders to clarify lines of communication “across HDOs, medical device manufacturers (MDMs), state and local governments, and the federal government”;
  • Describe a standardized approach to response efforts;
  • Serve as a basis for enhanced coordination activities among medical device cybersecurity stakeholders;
  • Inform decision making and the need to escalate response;
  • Identify resources HDOs can leverage as a part of preparedness and response activities; and
  • “Serve as a customizable regional preparedness and response tool for medical device cyber resiliency that could be broadly implemented.”

We put that last one in quotes because we’re not exactly sure what “cyber resiliency” means, but we assume it means the ability to fend off a cybersecurity event or at least mitigate its impact.  Toward that end, the Playbook suggests a four phase approach:  (1) Preparedness; (2) Detection and Analysis; (3) Containment, Eradication, and Recovery; and (4) Post Activity.

“Preparedness” means exactly what it says, with an emphasis on mindfulness of cybersecurity when procuring medical devices and keeping an inventory such that the HDO is always aware of what connected devices it has on hand.  HDOs should engage in “hazard vulnerability analysis” (again, a focus on risk) and plan for communicating and responding during an event.  That includes medical device manufacturers, whom the Playbook places squarely within the communication loop with the HDO and the FDA.

“Detection and Analysis” focuses on identifying when an incident has occurred and assessing its priority on a numerical scare that strangely assigns “Emergency” events to “Category 0.”  Analysis and documentation are important parts of the process, too.

The core of the response falls under “Containment, Eradication, and Recovery,” which appropriately focused on patient safety.  Is the device safe to use?  Is there a reliable way to test the device and confirm it is working correctly?  Are there spare or backup devices?  How quickly can the problem be fixed, and has there been collateral damage to the broader healthcare system?  These are the questions that HDO should be asking.

Finally, the “Post Activity.”  The Playbook recommends attention to lessons learned, including possibly retaining a digital forensics expert and updating the plan.

As we have said before, medical device cybersecurity is here to stay, and the FDA has been busy.  In addition to the Playbook (which is not an FDA document, but still, you get the gist), the FDA has entered into memoranda of understanding to form information sharing analysis organizations (“ISAOs”), which are “groups of experts that gather, analyze and disseminate important information about cyber threats.”  The Agency has participated in cybersecurity exercises and summits, and has engaged discussions with other government agencies, including the Department of Homeland Security.  It has proposed a Center of Excellence for Digital Health, which “would help establish more efficient regulatory paradigms, consider the building of new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices.”  We will keep you posted.

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

You’re likely all familiar with the phrase, “don’t look a gift horse in the mouth.” Checking out a gift horse’s teeth is like looking for the price tag of the gift to see how much it’s worth. The expression is meant to convey that upon receiving a gift you should accept it gratefully. But what happens when you don’t accept the gift at all. In many instances, politely declining a gift is completely acceptable. When the gift actually comes in the form of help, passing it up may well be to your own detriment. Sure, it looks good to stand on your own two feet. To accomplish something on your own. But sometimes offers of help are extended because they are needed. A parent offers to help a child tie his shoe. A teacher offers to guide a student through a math lesson. A young man offers to cut the grass for an elderly neighbor. Or perhaps a judge offers plaintiff an opportunity to take discovery to save her case. And that plaintiff says: No thanks. I’ll stand “on the allegations contained in [my] original complaint.” That plaintiff shouldn’t be surprised that what wasn’t good enough the first time around, isn’t good enough the second.

The case is Benyak v. Medtronic, Inc., 2018 Ill. App. Unpub. LEXIS 998 (Ill. App. Jun. 14, 2018) and involves an implanted intrathecal pump that plaintiff alleges became inverted in her body causing her pain. Id. at *2. Plaintiff alleged only negligent design and manufacturing defect and negligent education of medical providers. Id. at *2-3. The medical device underwent pre-market approval by the FDA and so defendant moved to dismiss the claims as preempted. That motion was granted but the court granted plaintiff leave to serve written discovery on the manufacturer and then to file an amended complaint. Plaintiff opted to do neither and so the court dismissed her claims with prejudice. Id. at *2. Plaintiff then appealed that dismissal arguing that her original allegations should have survived defendant’s motion to dismiss.

The Illinois Appellate Court authored a nice accounting of PMA preemption, see id. at *5-15, which we won’t completely recount here because if you are even an infrequent reader of this blog, you’re likely well-versed in PMA preemption. And if not, check out this scorecard to start your PMA preemption education. We will point out the court’s proper conclusion that because of the MDA’s express preemption provision, there is no presumption against preemption. Id. at *10. Also that the court landed where most court’s do, finding that there is only “a small window in which a state-law claim may escape express or implied preemption.” Id. at *13. Finally, before turning to the case-specific details, the court notes that “the manner in which allegations are pled guides the analysis of whether a state-law claim involves requirements different from, or in addition to, the federal requirements.” Id. at *15.

Since it was undisputed that the device at issue was a PMA device, there was also no dispute that the FDA had established requirements applicable to it. Id. So the court moved on to the next part of the PMA-preemption analysis – did plaintiff’s state law claims involve requirements related to safety and effectiveness different from or in addition to federal requirements. Because safety was at the heart of plaintiff’s claims, the only real issue was the “different or in addition to” standard. In other words, did plaintiff’s claim parallel the federal requirements established by the FDA for this device.

As for design and manufacturing defect – plaintiff’s complaint was completely silent as to whether the device was designed or manufactured differently or out of compliance with the FDA’s approval and protocols. Id. at *16-17.

Absent such factual allegations, plaintiff, in essence, posits that the [device] should have been designed and manufactured differently than what the FDA approved during the premarket approval process, which necessarily would impose a requirement for the [device] that is different from, or in addition to, the requirements already imposed by the FDA.

Id. at *17.

On appeal, plaintiff argued that “the ability of the [device] to remain upright” was a premarket requirement that defendant failed to meet. However, the complaint “never specifically identified any specific requirement resulting from the premarket approval process.” Id. at *19. And this brings us back to that gift horse:

Understandably, at the time plaintiff filed her complaint, she might not have had enough facts to support her allegations, which is why the circuit court allowed her leave to serve written discovery on defendants and file an amended complaint. Had she taken the opportunity to conduct the discovery, she could have bolstered the allegations of her complaint and perhaps, her state-law claim would not have been expressly preempted by the MDA. But she chose not to conduct the discovery nor file an amended complaint, resulting in her design and manufacturing defect claim, as pled in her complaint, being expressly preempted.

Id. at *19-20. It jumped right up and bit her.

As for plaintiff’s other claim, negligent instruction, it is not a recognized claim under Illinois law. Id. Even if it were, plaintiff didn’t allege that the instructions defendant provided deviated from those approved by the FDA during the PMA process. Id. at *21. So, that’s two grounds to affirm the dismissal. Plaintiff attempted to turn the claim into a learned intermediary claim arguing it was really a failure to warn the doctor claim. But, that’s not what plaintiff alleged in the complaint. The complaint never mentions learned intermediary and the court was unwilling to construe it as such.

Finally, plaintiff asked for the case to be remanded with leave to amend her complaint. Wow. Once you refuse a gift it’s much less likely you’ll get offered it again. The appellate court found that because plaintiff had “intentionally” chose not to take discovery and amend her complaint when that opportunity was afforded to her, “she has waived any right to a remand with leave to amend.” Id. at *22.

We often talk about giving plaintiffs second bites at trying to plead their claims. But if you’re going to toss the apple away without so much as a nibble, don’t be surprised when the gift horse you decided to ignore gobbles it up and spits it out with nothing left for you to chomp on.


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

What happens when a case involving a medical device that received Pre-Market Approval from the FDA survives, or at least some part of it survives, a motion to dismiss based on preemption? In recent years, as the law has developed and become increasingly favorable for defendants, most of our posts about PMA preemption are at the motion to dismiss stage. That’s because usually not much survives beyond that point. So when we happened upon Delfino v. Medtronic, Inc., 2018 WL 2688420 (Minn. Dist. May 18, 2018), we decided it warranted more than just a notch on our PMA preemption scorecard.

It looks like all the claims in this case were originally tossed back in 2012 but plaintiff was given an opportunity to amend her complaint to properly allege parallel violation claims. Now, almost 6 years since that decision – during which time we assume significant discovery was conducted – all of plaintiff’s claims are being dismissed again. Plaintiff’s negligence and strict liability claims are preempted for lack of evidence of a violation of a federal requirement and plaintiff’s warranty claims are barred by the express terms of the limited warranty of the device.

The device at issue is an implantable cardioverter defibrillator (“ICD”) and there is no dispute that it is a Class III, PMA medical device and therefore subject to preemption under Riegel v. Medtronic, 552 U.S. 312 (2008). Any state law tort claim must therefore parallel, rather than add to, federal requirements. Id. at *3. In other words plaintiff has to prove the violation of a federal requirement applicable to the device, violation of an identical state-law duty, and causation. Id. It is also not disputed that the device’s battery prematurely depleted and required replacement earlier than anticipated. Id. at *1.

We won’t walk through all the nitty-gritty, but section I.C of the opinion documents how Medtronic went about introducing manufacturing and testing records to refute plaintiff’s manufacturing defect claim. Via records, deposition testimony, and affidavits Medtronic was able to demonstrate “the manufacturing and inspection history” of the device which in turn proved that the device “passed all quality control inspections, and complied with the FDA-imposed requirements.” Id. at *4. Defendant also established that they learned that a subset of the ICD’s were suffering from premature battery depletion due to the copper used in certain of the electrodes in the device’s capacitors. It was found that copper from one supplier was at the root of the problem and defendant stopped using that copper going forward. Id.

Against that history, the question for the court was whether there was any violation of a federal requirement. Plaintiff first argued that by using copper in it capacitors, defendant was violating a federal manufacturing specification that the end terminations of the capacitors consist of plated tin over nickel. Putting aside that the copper was not used in the end terminations and that defendant’s end terminations were plated tin over nickel – there was nothing in the requirement that barred the use of copper. Id. at *5-6. As the court more fully explains, PMA silence doesn’t mean PMA forbiddance. The court points first to the language of the requirement at issue to show that when the FDA wanted to impose a prohibition it did so expressly. Id. at *6. And, if plaintiff’s theory were correct, no PMA would ever have to include prohibitory language because everything not expressly allowed would in fact be prohibited. If silence is going to be so all-encompassing, the result would be an even greater review burden on the FDA. Id. Otherwise the silence would almost assuredly be deafening.

Moreover, if plaintiff wants to rely on a “prohibited-unless-expressly-authorized” theory, she’s walking herself away from a parallel violation claim. “If the federal requirements are silent on a particular matter, than any state-law requirement as to that matter is necessarily ‘in addition to’ federal requirements.” Id.  That means plaintiff’s attempt to circumvent preemption actually ran her head first into it.

Finally, in opining that the ICD should have been made without copper, plaintiff’s expert neglects to explain how the capacitors could function without it. It’s a technical argument about electrodes (and that’s not this blogger’s area of expertise) but the more general takeaway is that you can’t argue a design that is non-functional. “State tort law that requires a manufacturer’s [device] to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than a state regulatory law to the same effect.” Id. at *7 (citation omitted).

Plaintiff’s next argument centered on device longevity. In its PMA submission, defendant included a projection that the ICD would generally perform for 5.1 years. Plaintiff argued that that projection became a requirement when the PMA was approved. But while the FDA could have established a performance standard for the ICD, it did not. Id. “Indeed, the mere fact that a device malfunctioned is not evidence that the device violated any federal requirement. Id. at *8 (with a lengthy list of citations to demonstrate the point). PMA approval is a “reasonable assurance” of safety, not a guarantee. In fact, PMA devices are by definition those with higher risks. That’s why they go through the heightened scrutiny and a risk/benefit analysis for approval. “If premature device failure were enough to withstand preemption, then few if any medical device claims would be preempted.” Id. The MDA and Riegel would be “dead letters.” Id.

Plaintiff’s final argument to try to establish a parallel violation claim was that at the time the ICD was returned to defendant, three years after manufacture, the capacitor leakage current measured higher than allowed. Id. But that’s an irrelevant fact. “For her claim to survive preemption, Plaintiff must offer evidence that [defendant] violated a federal manufacturing requirement during the device’s manufacture.” Id. To which we point you back to the really nice way Medtronic confirmed that its manufacturing process was fully compliant.

That left only plaintiff’s warranty claims. First, they were barred by the terms of defendant’s limited warranty, which defendant honored and under which plaintiff made no claim. Id. at *10. But, they were also impliedly preempted. To prevail on a warranty claim that implicates safety or effectiveness, plaintiff must convince the jury that the device was not safe and effective – directly contrary to the FDA’s conclusions. Juries can’t be allowed to “substitute their own cost-benefit analysis in place of that applied by the experts at the FDA.” Id. at *10-11.

Would we prefer an early out on a motion to dismiss? Sure. But, sometimes a few claims squeak by and when they do, as we’ve always opined, plaintiffs still face a daunting uphill battle to survive summary judgment scrutiny.

First, we’ve endured MDL courts messing around with Utah law and ignoring the usual congruence in the treatment of prescription drugs and prescription medical devices under Restatement (Second) of Torts §402A, comment k (1965).  We covered that kerfuffle here, here, here, and here.  More recently, the Fifth Circuit in In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, 888 F.3d 753 (5th Cir. 2018), outright refused – based on zero precedent – to predict that Texas would follow the overwhelming majority rule that comment k applies equally to both prescription drugs and medical devices.  Id. at 772.  Texas and Utah are two relatively conservative states when it comes to tort law.  Both have applied comment k “across the board” to prescription drugs.

We don’t think that it’s proper for federal courts, particularly in MDLs, to cut plaintiffs unprecedented breaks on substantive state law and apply comment k less strongly to prescription medical devices than to prescription drugs.  Practically no court has done that – treating prescription drugs and prescription medical devices differently under comment k – before.  Comment k is certainly not limited to prescription drugs.  The comment explicitly references vaccines, something which the United States Supreme Court has recognized.  Bruesewitz v. Wyeth LLC, 562 U.S. 223, 234 (2011).

Moreover, these recent MDL decisions appear to be  a pro-plaintiff one-way street.  Every time, the rulings are that an otherwise “across the board” comment k state (for drugs) would nonetheless apply comment k “case-by-case” to medical devices, even though no state court has done so.  We have yet to see an MDL court take the opposite position, that comment k “across-the-board” is proper for devices in a “case-by-case” state for drugs).  We know what we’re seeing – MDL courts seeking to increase settlement pressure by weaponizing novel state-law issues through pro-plaintiff legal rulings.

Here at the Blog, we’ve never examined how comment k is treated in medical device cases in depth.  Until these recent decisions, the precedent in favor of treating all prescription medical products the same under comment k – whether “same” means across-the-board, or the other (and majority) “case-by-case” application – was virtually unanimous, so we took congruity for granted.  Not any more.  We’re rectifying that situation now.

First, to reiterate, the proposition we’re supporting is, with apologies to generic preemption, “sameness.”  We consider decisions:  (1) applying comment k “across-the-board” to both prescription drugs and devices and, (2) applying comment k “case-by-case” to both prescription drugs and devices, as equivalent in this context – employing “sameness” in applying comment k similarly to all prescription medical products.

We start looking is the Restatement of Torts.  Comment k, obviously, is from the Second Restatement.  The Third Restatement, which was adopted by ALI in 1998, after product liability law became more developed, has a similar, but not identical restriction on design defect claims involving prescription medical products.  But one thing is clear – the same rules apply to all prescription medical products:

(a) A manufacturer of a prescription drug or medical device who sells or otherwise distributes a defective drug or medical device is subject to liability for harm to persons caused by the defect.  A prescription drug or medical device is one that may be legally sold or otherwise distributed only pursuant to a health-care provider’s prescription.

*          *          *          *

(c) A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

Restatement (Third) of Torts, Products Liability §6(a, c) (1998) (emphasis added).  Thus the Restatement provides strong support for applying the same standards for both prescription drugs and medical devices.

Second, as to whether a state is an “across-the-board” or a “case-by-case” comment k jurisdiction, we rely upon our prior analysis of that question in our 2011 “Comment K Some of the Way” post, except where noted herein (as with Washington State).


We considered Alabama to be an “across-the-board” comment k state in 2011. The same standard was applied to medical devices in Emody v. Medtronic, Inc., 238 F. Supp.2d 1291 (N.D. Ala. 2003):

According to [defendant], under [the Alabama Extended Manufacturer’s Liability Doctrine], prescription medical devices are unavoidably unsafe products, and where inherent risks are at issue, the only other permissible theory of liability is inadequate warning.  [Plaintiff] claims that the application of the unavoidably unsafe products doctrine should not apply to an implantable, prescription-only medical device.  The court agrees with [defendant]. The [product] is a prescription-only medical device that has an unavoidably unsafe characteristic.

Id. at 1296. Emody followed Stone v. Smith, Kline, & French Laboratories, 447 So.2d 1301 (Ala.1984), a prescription drug case, and was in turn followed in Cooper v. Bristol-Myers Squibb Co., 2013 WL 85291, at *10 (D.N.J. Jan. 7, 2013) (applying Alabama law), another prescription drug case.

Alabama does not distinguish between prescription drugs and medical devices in applying comment k.


Neither does Alaska, but that is because Alaska is one of the few states that – at least a long time ago – refused to adopt comment k altogether.  Shanks v. Upjohn Co., 835 P.2d 1189, 1197-98 (Alaska 1992).  Shanks was a drug case, but we don’t know of any medical device case applying comment k either.


We learned in 2011 that Arizona has applied the “case-by-case” approach to both prescription drugs and medical devices.  The first case to address comment k was Gaston v. Hunter, 588 P.2d 326, 340 (Ariz. App. 1978), a drug case.  Gaston has been followed in medical device cases applying Arizona law.  See Miller v. Stryker Instruments, 2012 WL 1718825, at *19 (D. Ariz. March 29, 2012) (prerequisites to comment k not established); Conklin v. Banner Health, 2015 WL 10688305, at *4 (Ariz. Super. Oct. 30, 2015) (prerequisites to comment k established).

However, Arizona now may well adhere to the Third Restatement’s restrictions on design defect claims involving prescription medical products, rather than to comment k.  See Watts v. Medicis Pharmaceutical Corp., 365 P.3d 944, 949 (Ariz. 2016) (adopting Restatement (Third) of Torts, Products Liability §6 (1998)) (prescription drug case); Harrison v. Howmedica Osteonics Corp., 2008 WL 906585, at *21 (D. Ariz. March 31, 2008) (applying Restatement §6 to medical device case); Gebhardt v. Mentor Corp., 191 F.R.D. 180, 185-86 (D. Ariz. 1999) (same), aff’d, 15 F. Appx. 540 (9th Cir. 2001).  Again, the same standard is applied to both prescription drugs and medical devices in Arizona.


As our 2011 post describes, Arkansas courts have adopted a “case-by-case” approach to comment k in prescription drug cases. Predicting Arkansas law, the Eighth Circuit adopted this construction of comment k in a medical device case, Hill v. Searle Laboratories, 884 F.2d 1064, 1067-68 (8th Cir. 1989).  The Arkansas Supreme Court, citing favorably to Hill, took the same approach in West v. Searle & Co., 806 S.W.2d 608, 612-13 (Ark. 1991), a prescription drug case.  Both Hill and West involved contraceptive products.  We haven’t seen an Arkansas device case addressing comment k since, but there’s no reason to believe Arkansas law would apply one way to prescription drugs, and another way to prescription medical devices.


As our earlier post discussed at length, California is the epitome of the “across-the-board” approach to comment k.  See Brown v. Superior Court, 751 P.2d 470, 475-83 (Cal. 1988).  Time and again, courts applying California law have likewise applied comment k “across the board” to medical devices.

[W]e find the important considerations underlying Brown apply with equal force to implanted medical devices which, like prescription drugs, are available only through a physician and can save lives or reduce pain and suffering.  Such products are commonly crucial to the well-being of the patient.  Some devices are so important that, as is the case with prescription drugs, the patient faces death without them.  Other devices, such as the intrauterine device, provide important family planning benefits and may have direct or indirect effects on the patient’s physical, mental or emotional health as well. Still other devices . . . serve the salutary purposes of restoring a degree of normalcy to the lives of those who suffer organic dysfunctions and an impaired quality of life. . . .

We perceive the risks attendant to implanted medical devices are akin to those of prescription drugs. Just as drugs and vaccines are injected or ingested into the body, implant devices must be “plugged in” to the individual, to work their effect upon or respond to complex systems imperfectly understood by medical science.  Just as with drugs and vaccines, the result may be dependent upon the peculiar physical characteristics of the individual, as is graphically illustrated in this case. . . .  Thus, when distinctions are made among medical products, implanted medical devices must be placed in a category with prescription drugs. . . .

The Brown court observed that even though a medical product with dangerous side effects may fairly be “characterized” as defectively designed, strict liability should apply only if it would serve the public interest.  We believe the public’s interest in development, availability and affordability of medical devices demands rejection of strict liability and adoption of the comment k standard.  As with prescription drugs, the harsher rule of strict liability may discourage manufacturers from researching and marketing new medical devices due to realistic fear of substantial adverse judgments, the high cost of strict liability insurance and the uncertainty that such insurance will even be available.  The costs involved may well place the products beyond the reach of those who need [them] most.  Public interest is served, rather than thwarted, by relieving the manufacturer of strict liability for injuries resulting from implanted medical devices that have been properly fabricated and marketed.

Hufft v. Horowitz, 5 Cal. Rptr. 2d 377, 383-84 (Cal. App. 1992) (citations and quotation marks omitted).

[T]he entire category of medical implants available only by resort to the services of a physician are immune from design defect strict liability.  There is no contention anywhere in the record of these coordinated cases that any of the [devices], the subject of the various claims, were obtained other than by the services of a physician.  Therefore, the determination that strict liability based on design defect is unavailable for all such claims is one to be made as a matter of law, and without the benefit of any factfinding, except for the sole factual determination, made without dispute in these cases, that the [devices] are all physician-directed and physician-applied.  Summary adjudication was therefore appropriate.

Artiglio v. Superior Court, 27 Cal. Rptr. 2d 589, 593-94 (Cal. App. 1994). Accord Garrett v. Howmedica Osteonics Corp., 153 Cal. Rptr.3d 693, 701 (Cal. App. 2013) (“the reasoning of Brown and Hufft applies to an implanted medical device . . .  regardless of whether, strictly speaking, it was available only by prescription and regardless of whether it is properly characterized as a ‘prescription’ implanted medical device”) (citations omitted); Plenger v. Alza Corp., 13 Cal. Rptr.2d 811, 818 (Cal. App. 1992) (“[w]e as well are unable to make any principled distinction in terms of policy considerations between prescription drugs and prescription implanted medical devices”); Paturzo v. Boston Scientific Corp., 2017 WL 8220600, at *3 (C.D. Cal. April 21, 2017) (“California law does not permit strict liability claims for design defects of implanted medical devices”; “the standard of liability in that context is the ‘comment k’ standard”) (citation omitted); Markowitz v. Davol, Inc., 2015 WL 12696031, at *2 (C.D. Cal. June 19, 2015) (“similar to prescription drugs, public interest favors the development, availability and affordability of such implanted medical devices”); Anderson v. Medtronic, Inc., 2015 WL 2115342, at *7 (S.D. Cal. May 6, 2015) (“to the extent these claims allege strict liability based on a design defect, they are barred by Comment K”); Sukonik v. Wright Medical Technology, Inc., 2015 WL 10682986, at *10 (C.D. Cal. Jan. 26, 2015) (a plaintiff may not maintain a strict liability claim against the manufacturer of an implanted prescription medical device on the basis of an alleged design defect”); Tucker v. Wright Medical Technology, Inc., 2013 WL 1149717, at *5 (N.D. Cal. March 19, 2013) (“the unavoidably unsafe defense set forth in Comment k act[s] as a complete bar to Plaintiffs’ strict liability design defect claim”); Currier v. Stryker Corp., 2011 WL 4898501, at *2 (E.D.Cal. Oct.13, 2011) (“California law prohibits strict liability claims for design defect against manufacturers of prescription implantable medical devices”); Mitchell v. Acumed LLC, 2011 WL 2433038, at *4 (N.D. Cal. June 13, 2011) (“it has long been the law that implanted medical devices are exempted from strict liability for design defects”); Rhynes v. Stryker Corp., 2011 WL 2149095, at *7 (N.D.Cal. May 31, 2011) (“California law categorically protects manufacturers of prescription medical devices from strict liability for design defects”); Adams v. I-Flow Corp., 2010 WL 1339948, at *6 (C.D.Cal. March 30, 2010) (“design defect theories of products liability . . . are unequivocally barred by California law”); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1725289, at *18 (D. Minn. June 12, 2007) (“California exempts manufactures of prescription drugs and medical devices from design defect claims”) (applying California law); Yalter v. Endocare, Inc., 2004 WL 5237598, at *4 (C.D. Cal. Nov. 8, 2004) (“prescription drugs and medical devices are considered to be unavoidably unsafe products”), aff’d, 220 F. Appx. 657 (9th Cir. 2007); Hanohano v. Uppal, 1997 WL 33426414, at *1 (Cal. Super. June 3, 1997) (“[u]nder Comment k, manufacturers of implanted medical devices cannot be strictly liable for design defects”). See also Sanchez v. Boston Scientific Corp., 38 F. Supp.3d 727, 736 (S.D.W. Va. 2014) (“California does not recognize strict liability for defective design of implantable medical devices”) (applying California law); Centeno v. Bayer Healthcare Pharmaceuticals, Inc., 2014 WL 4809565, at *4 (S.D. Ill. Sept. 26, 2014) (“To the extent that plaintiff seeks recovery in strict liability for design defects, her . . . Cause of Action is not cognizable under California law”) (applying California law).

Further, as discussed at length here, California (and other states’) law does not require an “implanted” device to apply comment k across the board.  In Armstrong v. Optical Radiation Corp., 57 Cal. Rptr.2d 763, 772 (Cal. App. 1996), a case involving “a thick, transparent jelly-like fluid” that is “a surgical aid,” the court applied comment k and held:

[W]e note that California law precludes strict liability for a design defect in a medical device. In the context of medical devices, design defects must be pursued under a negligence theory.

Id. at 772 (citation omitted).

As we complained above, the only contrary decision comes from an MDL, where state law was improperly manipulated as a settlement tool. See In re DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2016 WL 9559961, at *2-3 (N.D. Tex. Sept. 20, 2016) (ignoring “several decisions from California’s intermediate appellate courts”; creating distinction between different FDA classes of medical devices despite numerous California cases applying comment k to both Class II and Class III devices).


Our 2011 post assigned Colorado to the “case-by-case” approach.  As to medical devices, Wollam v. Wright Medical Group, Inc., 2012 WL 45106955 (D. Colo. Sept. 30, 2012), applied the same case-by-case method to medical devices:

In asserting this defense, [defendant] bears the burden of establishing that the [device’s]“utility must greatly outweigh the risk created by its use, the risk must be a known one; the product’s benefits must not be achievable in another manner; and the risk must be unavoidable under the present state of knowledge.”

Id. at *5.  Wollam relied on a couple of prior cases involving neither drugs nor devices, but blood products.  In Hawkinson v. A.H. Robins Co., 595 F. Supp. 1290 (D. Colo. 1984), involving a pre-MDA medical device, the court similarly held, “to rely on comment k, a manufacturer must show that the product was properly prepared, and properly marketed, accompanied by appropriate warnings and directions for use.”  Id. at 1308.

However, the most recent decision out of Colorado, Haffner v. Stryker Corp., 2014 WL 4821107 (D. Colo. Sept. 29, 2014), applied Restatement Third §6, rather than comment k, so it is open to question which standard is currently Colorado law.  Id. at *3.  In no instance has a distinction been drawn between prescription drugs and prescription medical devices.


While not addressing the “across-the-board”/”case-by-case” distinction directly the Connecticut Supreme Court in Vitanza v. Upjohn Co., 778 A.2d 829, 837 (Conn. 2001), held that “the policy considerations contained in comment (k) to §402A are persuasive and are in accord with this state’s product liability jurisprudence.”  In Hurley v. The Heart Physicians, P.C., 898 A.2d 777, 783 (Conn. 2006), the court applied the same policies to a prescription medical device.

In Vitanza, we adopted comment (k) to § 402A of the Restatement (Second) of Torts, concluding that the policy considerations set forth therein are persuasive and in accord with this state’s product liability jurisprudence. . . .  Numerous courts have determined that they [policy considerations] are applicable to prescription medical device cases.

Id. at 784 (citations and quotation marks omitted).  See also Breen v. Synthes-Stratec, Inc., 947 A.2d 383, 388 (Conn. App. 2008) (“under Connecticut law, comment (k) is not limited to prescription drugs but also is applicable to medical devices”).  Notably, Breen also “decline[d],

to accept the plaintiff’s invitation to draw a bright line distinction between class II and class III medical devices in determining the applicability of comment (k). . . .  The plaintiff has failed to provide any persuasive reason why a blanket rule excepting all class II medical devices from the application of these doctrines is appropriate or necessary.  Indeed, beyond the plaintiff’s mere reference to the portion of the definition of a class III device, . . . the plaintiff has failed to explicate his argument as to why only class III devices should fall within the ambit of comment (k). . . .  Moreover, the plaintiff has not cited any cases in which such a distinction has been applied, and we decline to draw a distinction here.

Id. at 390 (citations and quotation marks omitted).  For other Connecticut cases applying comment k to medical devices, see:  Allen v. Mentor Corp., 2006 WL 861007, at *7 (D. Conn. March 31, 2006) (applying comment k to medical device); Ferrari v. Johnson & Johnson, Inc., 2017 WL 6389870, at *4 (Conn. Super. Nov. 28, 2017) (observing that Hurley “extended” comment k to prescription medical devices); Wegryn v. Smith & Nephew, Inc., 2008 WL 803405, at *3 (Conn. Super. March 5, 2008) (“there is no persuasive reason to distinguish between a prescription implantable medical device and prescription drugs when raising . . . Section 402A, of the Restatement (Second) of Torts comment (k)”); see also Havanick v. C. R. Bard, Inc., 2016 WL 7116138, at *3-4 (S.D.W. Va. Dec. 6, 2016) (“Connecticut courts consider comment k as a defense against strict liability to manufacturers of medical device companies”) (applying Connecticut law).


Delaware has never adopted strict liability or Restatement (Second) of Torts §402A (1965).  Thus, the comment k question cannot arise.

District of Columbia

We put the District in the “across-the-board” category in 2011 due to the lack of any “case-by-case” adjudication in this jurisdiction’s case law.  Both then, and now, there is no medical device precedent in the District, however, the unavoidably unsafe product doctrine has been applied in the same fashion to blood products.  Fisher v. Sibley Memorial Hospital, 403 A.2d 1130, 1134 (D.C. 1979); Kozup v. Georgetown University, 663 F. Supp. 1048, 1058-59 (D.D.C. 1987), aff’d in pertinent part, vacated on other grounds, 851 F.2d 437 (D.C. Cir. 1988).  There is no basis to conclude that medical devices would be treated any differently.


We considered Florida law comment k law unsettled in 2011, but since then most of the cases have utilized a “case-by-case” approach.  One thing that is not unsettled, however, is that whatever Florida law is, it applies to prescription drugs and medical devices equally.  “Florida courts apply the basic elements of a strict liability claim with equal force to medical device and prescription drug manufacturers.” Bailey v. Janssen Pharmaceutica, Inc., 288 F. Appx. 597, 607 (11th Cir. 2008) (applying Florida law).  Bailey, a drug case, cited and followed Adams v. G.D. Searle & Co., 576 So.2d 728 (Fla. App. 1991), which involved a medical device.  Adams applied a “case-by-case” approach. Id. at 733 (“We therefore reject a blanket approach and decline to apply comment k to all prescription products.  Instead, we follow those courts which hold that comment k is an affirmative defense to a strict liability claim.”).

Other Florida law cases have applied comment k to medical devices in a similar fashion.  Tillman v. C.R. Bard, Inc., 96 F. Supp.3d 1307, 1341 (M.D. Fla. 2015) (following Adams; “[t]o receive the protection of comment k, [defendant] must show that ‘the product is as safe as current testing and research permit” at the time of distribution’”); Byrnes v. Small, 60 F. Supp.3d 1289, 1299 (M.D. Fla. 2015) (following Adams; “[c]omment k . . . has been adopted by Florida courts as an affirmative defense to a strict products liability claim for medical devices”); Ocasio v. C.R. Bard, Inc., 2015 WL 3496062, at *5-6 (M.D. Fla. June 3, 2015) (following Adams); Brady v. Medtronic, Inc., 2014 WL 1377830, at *6 (S.D. Fla. April 8, 2014) (the device “is an unavoidably unsafe product that falls within the purview of comment k”); Mardegan v. Mylan, Inc., 2012 WL 12850781, at *6-7 (S.D. Fla. Jan. 31, 2012) (following Adams; transdermal patch with attributes of both a drug and a medical device); Duncan v. Iolab Corp., 1991 WL 544617, at *1 (M.D. Fla. Nov. 18, 1991) (applying comment k to bar strict liability against medical device), aff’d, 12 F.3d 194 (11th Cir. 1994).


In 2011, we had Georgia as trending towards “case-by-case” application of comment k.  None of the cases we cited involved medical devices, and no new decision does so either.  The most in-depth discussion of comment k occurred in Bryant v. Hoffmann-La Roche, Inc., 585 S.E.2d 723, 726-28 (Ga. App. 2003), and we think it’s significant that Bryant relied on cases involving prescription drugs, prescription medical devices, and prescription vaccines, without drawing any distinctions between them.


Hawaii applied comment k on a “case-by-case” basis to a medical device in Larsen v. Pacesetter Systems, Inc., 837 P.2d 1273 (Haw. 1992), finding a device that had “many different types” on the market was “sufficiently analogous to a new and experimental drug to warrant comment k exemption from strict products liability.”  Id. at 1286.  Since 2011Larsen’s approach was likewise applied to prescription drugs under Hawaii law.  Segovia v. Bristol-Myers Squibb Co., 2016 WL 1587220, at *4-5 (D. Haw. April 19, 2016); Forsyth v. Eli Lilly & Co., 1998 WL 35152135, at *3-4 (D. Haw. Jan. 5, 1998).  Once again, there is no precedent for treating prescription drugs and prescription medical devices differently under comment k.


As we discussed at length in our 2011 post, Idaho was the poster child for the “case-by-case” approach.  The case that made it so, however, Toner v. Lederle Laboratories, 732 P.2d 297 (Idaho 1987), was not a prescription drug case, but instead involved a vaccine.  Only recently, was the first Idaho law case involving a medical device decided.  See Hepburn v. Boston Scientific Corp., 2018 WL 2275219 (D. Idaho May 17, 2018).  Not surprisingly, Hepburn applied Toner’s construction of comment k to medical devices.  Id. at *6.


In 2011, we concluded that Illinois was a “case-by-case” state for comment k purposes.  That is just as true for medical devices as for drugs.  The earliest decision to apply comment k, Greenberg v. Michael Reese Hospital, 415 N.E.2d 390 (Ill. 1980), contained a lengthy policy discussion before concluding that “public policy dictates against the imposition of strict liability in tort for injuries resulting from the administration of X-radiation treatments.”  Id. at 393-95.  See also:  Mele v. Howmedica, Inc., 808 N.E.2d 1026, 1042 (Ill. App. 2004) (Illinois . . . require[s] trial courts to determine on a case-by-case basis whether any medical device or other product qualifies as unavoidably dangerous”); Huskey v. Ethicon, Inc., 848 F.3d 151, 157-58 (4th Cir. 2017) (“under Illinois law, courts determine ‘on a case by case basis’ if a particular product falls within comment k”) (applying Illinois law).  Huskey cited an Illinois prescription drug case, Glassman v. Wyeth Laboratories, Inc., 606 N.E.2d 338, 342 (Ill. App. 1992), finding no difference between drugs and devices for comment k purposes.


In 2011, we noted confusion in Indiana comment k jurisprudence, with courts going both ways – all in cases involving prescription drugs.

Citing the “dearth” of decisions concerning “dangers in the use of medical devices,” the Seventh Circuit “f[ou]nd no principled basis for such a distinction” between the two types of prescription medical products in Phelps v. Sherwood Medical Industries, 836 F.2d 296, 299, 303 (7th Cir. 1987) (applying Indiana law).  Phelps, however, did not directly address comment k.  In Parks v. Danek Medical, Inc., 1999 WL 1129706 (N.D. Ind. June 17, 1999), the court analogized to those cases applying the “across the board” approach:

[S]trict liability design claims for “unavoidably unsafe” products are barred, pursuant to the Restatement (Second) of Torts §402A cmt. k (1965).  “The legal effect of finding a product to be ‘unavoidably unsafe’ under comment k is that a plaintiff may recover based on improper or negligent preparation or inadequate warning, but not on the basis that the design of the product was defective.”  Unavoidably unsafe products include prescription drugs.  It is undisputed that the device at issue was available only by prescription and comment k has been held to apply to prescription medical devices, as well as to prescription drugs.

Id. at *6 (citing Phelps; other citations and footnote omitted).  Cf. McAfee v. Medtronic, Inc., 2015 WL 3617755, at *3 (N.D. Ind. June 4, 2015) (plaintiff essentially conceded comment k barring strict liability warning claim), on reconsideration on other grounds, 2016 WL 2588807 (N.D. Ind. May 5, 2016).


As we pointed out in 2011, Iowa appellate authority had applied comment k without case-specific risk/benefit balancing in cases involving both prescription drugs, Moore v. Vanderloo, 386 N.W.2d 108, 116 (Iowa 1986), and vaccines, Petty v. United States, 740 F.2d 1428, 1439 (8th Cir. 1984).  In addition to those cases, Iowa law had applied the “unavoidably unsafe” principle to an over-the-counter medical device, a tampon . See Kehm v. Procter & Gamble Manufacturing Co., 724 F.2d 613, 621 (8th Cir. 1983) (“where the product is inherently unavoidably unsafe, liability hinges on the adequacy of the warning to users, an issue which, like negligence in non-products cases, turns on the reasonableness of the defendant’s responses to foreseeable dangers”) (applying Iowa law).

We still haven’t found an Iowa law case applying comment k/unavoidably unsafe to a prescription medical device, but we have no reason to believe such devices would be treated differently than the other types of medical products, prescription and otherwise, to which this principle has been applied.


In 2011, we concluded Kansas was a “case by case” jurisdiction for comment k.

Kansas courts appear to have applied this comment k standard identically to medical devices and vaccines, in addition to prescription drugs.  See Humes v. Clinton, 792 P.2d 1032, 1039 (Kan. 1990) (applying unavoidably unsafe exception to medical device); Johnson v. American Cyanamid Co., 718 P.2d 1318, 1323-24 (Kan. 1986) (same, vaccine); Graham v. Wyeth Laboratories, 906 F.2d 1399, 1406 (10th Cir. 1990) (same; vaccine) (applying Kansas law); Graham v. Wyeth Laboratories, 666 F. Supp. 1483, 1496-97 (D. Kan. 1987) (earlier ruling in same case).   We see no basis under Kansas law for disparate standards depending on the type of prescription medical product.


In 2011, Kentucky appeared to be moving away from early precedent suggesting “case-by-case” application of comment k to a broader approach.  The critical case involved prescription drugs, Larkin v. Pfizer, Inc., 153 S.W.3d 758, 761, 770 (Ky. 2004), in which Kentucky adopted both comment k and the Third Restatement’s version of the learned intermediary rule.  Since Larkin repeated the Third Restatement’s equivalence between “drugs” and “medical devices” several times, id. at 761-62, 763, taking the decision at its word indicates that these two types of prescription medical products are to be treated the same.  We’re not sure any longer about Kentucky backsliding from “case by case,” but we are pretty sure that the same standards apply to both prescription drugs and medical devices.

In Prather v. Abbott Laboratories, 960 F. Supp.2d 700 (W.D. Ky. 2013), the court answered this question affirmatively:

At issue is whether . . . a prescription medical device, is within comment k’s purview.  As stated in the comment, unavoidably unsafe products “are especially common in the field of drugs.”  Though that may be the case, comment k certainly does not foreclose the possibility of extending its reach to medical devices.  Rather, comment k operates when the product at issue is unavoidably unsafe − that is, it is both useful and desirable, but marked by a known, reasonable risk.

*          *          *          *

The Court does not discern a meaningful difference between this device and a prescription drug, and does not believe the framers of comment k would exclude such a product.  [It] is highly useful and desirable product used for postoperative pain management.  As will be discussed, to the extent scientifically knowable at the time, the risk of injury posed by the [device] was marginal.  Therefore, the Court finds that the [device is within the ambit of comment k.

Id. at 707 (numerous citations omitted).  Prather went on to apply the same “case by case” approach previously used with prescription drugs.  Id. (citing Weiss v. Fujisawa Pharmaceutical Co., 2006 WL 3533072, at *3 (E.D. Ky. Dec. 7, 2006)).  See also Clark v. Danek Medical, Inc., 1999 WL 613316, at *4 (W.D. Ky. March 29, 1999) (“Plaintiffs’ claims are most appropriately considered in that [comment k] context”).


Although Louisiana courts had not discussed comment k in such terms, their application looked like “across-the-board” to us in 2011.

The only case directly applying comment k to Louisiana law is questionable precedent indeed, since the opinion in McPheron v. Searle Laboratories, Inc., 888 F.2d 31 (5th Cir. 1989), certified the question to the Louisiana Supreme Court, but was later vacated on grounds that sounded like a settlement.  See McPheron v. Searle Laboratories, 904 F.2d 251 (5th Cir. 1990).  Bearing that in mind, the Fifth Circuit in McPheron stated:

{Plaintiff] contends that the court below erred in applying this doctrine to [a medical device that] is not a “true” prescription drug, which is taken into and absorbed by the body.  The great weight of the authority in other jurisdictions is to the contrary. . . .  The minority view is that the question of whether a prescription medical device is an unavoidably unsafe product entitled to comment k protection is a question of fact for the jury.

Id. at 33 (citations omitted).  At least, that’s what the Fifth Circuit thought in 1989.  We’ve not seen a Louisiana law case involving comment k and medical devices since.

Also indicative that there are no differences in the application of comment k to various prescription medical products is Chauvin v. Sisters of Mercy Health Systems, Inc., 818 So. 2d 833 (La. App. 2002), which “strongly agree[d] with the need to consider comment k and the ‘unavoidably unsafe’ defense” in a blood products case.  Id. at 840.   Accord Bourque v. Louisiana Health Systems Corp., 956 So. 2d 60, 65 (La. App. 2007) (“agree[ing] with . . .  the reasons enunciated in Chauvin”) (blood product case).


We viewed Maine as “wobbly” in the “case-by-case” approach back in 2011, chiefly on the discussion in Violette v. Smith & Nephew Dyonics, Inc., 62 F.3d 8, 13 n.3 (1st Cir. 1995) (applying Maine law), a medical device case.  A similar result was reached in a drug case in Doe v. Solvay Pharmaceuticals, Inc., 350 F. Supp. 2d 257, 267-68 (D. Me. 2004), aff’d, 153 F. Appx. 1, 2005 WL 2837538 (1st Cir. 2005), which also relied on the Third Restatement.  No reason exists to think Maine would apply comment k differently to prescription drugs than to medical devices.


Mostly on the basis of the Court of Appeals’ language in Miles Laboratories, Inc. v. Doe, 556 A.2d 1107 (Md. 1989), a blood products case, we concluded in 2011 that Maryland applied comment k “across the board.”  Id. at 1121 (citing “the singular medical utility” of such products generally).  See also Doe v. Miles Laboratories, Inc., 927 F.2d 187, 191-93 (4th Cir. 1991) (likewise applying comment k in blood product case).

However, several Maryland law cases since then have weighed in on the side of “case-by-case.”  Allen v. Boston Scientific Corp., 2015 WL 5838511, at *3 (S.D.W. Va. Oct. 5, 2015) (applying Maryland law); Stidham v. Boston Scientific Corp., 2015 WL 2452984, at *4 (S.D.W. Va. May 22, 2015) (applying Maryland law); Grinage v. Mylan Pharmaceuticals, Inc., 840 F. Supp.2d 862, 869 n.5 (D. Md. 2011) (generic drug).

There is no indication in any of these cases that Maryland law would apply different standards to different types of prescription medical products.


“Massachusetts court decisions have consistently hewed to the letter of comment k.”  Tersigni v. Wyeth-Ayerst Pharmaceuticals, Inc., 2014 WL 7464759, at *1 (D. Mass. June 25, 2014).  Massachusetts was another “wobbly” “across-the-board” state in 2011, based in part on Lareau v. Page, 840 F. Supp. 920 (D. Mass. 1993), aff’d, 39 F.3d 384 (1st Cir. 1994), a medical device (contrast dye) case, that applied comment k and unavoidably unsafe doctrine without individualized adjudication. Id. at 933.  The same rather wobbly approach, without case-specific adjudication, was applied to a prescription biologic in Calisi v. Abbott Laboratories, 2013 WL 5441355, at *15 (D. Mass. Sept. 27, 2013).  Cf. Nickerson v. G.D. Searle & Co., 900 F.2d 412, 422 (1st Cir. 1990) (pre-trial defense reliance on comment k was not an “admission” that medical devices were unavoidably unsafe).


Based on a very small sample of one case, we thought Michigan was an “across-the-board” state in 2011.  Since then, a similarly small sample of one case, Michigan law was applied in a manner that looks more “case-by-case” in Davis v. C.R. Bard, Inc., 2012 WL 6082933, at *8 (E.D. Mich. Dec. 6, 2012), an medical device case.

Based on more thorough investigation, we’re not sure Davis is accurate, though, since in Antcliff v. State Employees Credit Union, 327 N.W.2d 814, 821 n.10 (Mich. 1982), the Michigan Supreme Court referred prescription drugs as a class as “an unavoidably unsafe product.”  See also Dunn v. Lederle Laboratories, 328 N.W.2d 576, 579 (Mich. App. 1982) (declaring vaccine to be “an unavoidably unsafe product” without case-by-case evaluation).


Unusually, for most states, Minnesota’s comment k law developed mostly in the context of medical devices.  As the law appeared in 2011, Minnesota was a “case-by-case” state.  Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293, 1300-01 (D. Minn. 1988) (involving pre-Medical Device Amendments medical device); see Woodard v. Stryker Corp., 2012 WL 12860868, at *7 (D. Wyo. Feb. 9, 2012) (submitting comment k inquiry to the jury under Kociemba) (applying Minnesota law); Johnson v. Zimmer, Inc., 2004 WL 742038, at *8 nn.5-6 (D. Minn. March 31, 2004) (citing to both comment k and the Restatement Third).

The same “case-by-case” approach has been applied in Minnesota prescription drug product liability cases. Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 776 F. Supp.2d 907, 914 (D. Minn. 2011).  Once again, there is no reason to believe that comment k is applied differently to different types of products.


Mississippi was a “case-by-case” jurisdiction in 2011.

A very early Mississippi law case also applied this approach to vaccines.  Alman Brothers Farms & Feed Mill v. Diamond Laboratories, Inc., 437 F.2d 1295, 1302-03 (5th Cir. 1971) (applying Mississippi law).  We haven’t seen a Mississippi case on comment k and medical devices, but we see no basis for treating them differently under the law.


In 2011, we classified Missouri as a “case-by-case” state.

That includes medical devices.  Racer v. Utterman, 629 S.W.2d 387, 393 (Mo. App. 1981) (“On the record before us we find the surgical drape here to be an “unavoidably unsafe” product.  It is a highly useful product. . . .”); Joyce v. Davol, Inc., 2016 WL 775183, at *2-3 (E.D. Mo. Feb. 29, 2016) (finding comment k to be an affirmative defense in medical device case); In re NuvaRing Products Liability Litigation, 2013 WL 3716389, at *9 (E.D. Mo. July 12, 2013) (finding comment k defense not established on case-by-case analysis).  Cf. Kirsch v. Picker International, Inc., 753 F.2d 670, 671 (8th Cir. 1985) (applying learned intermediary rule to medical devices because “[p]rescription drugs and [this device] are marketed in similar fashion”) (applying Missouri law).


Back in 2011 we found only one prescription medical product/comment k case in the history of Montana law – from 1968 that applied the unavoidably unsafe defense without considering case-specific facts. Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 129 (9th Cir. 1968).

That’s still the case today.  We have no reason to believe that prescription medical devices – or prescription drugs for that matter – will be treated differently than vaccines for comment k purposes.


Nebraska is another “case-by-case” jurisdiction.  Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 835-40 (Neb. 2000).  In its lengthy discussion, Freeman cited cases from other jurisdictions involving both prescription drugs and medical devices without distinguishing between those types of products.  The unavoidably unsafe doctrine has also been employed by Nebraska courts in medical device cases.  See Uribe v. Sofamor, S.N.C., 1999 WL 1129703, at *13 (D. Neb. Aug. 16, 1999).  There’s nothing new since 2011, and no reason to expect Nebraska courts to draw such distinctions going forward.


The splintered decision in Allison v. Merck & Co., 878 P.2d 948 (Nev. 1994), as we discussed in more detail in 2011, makes it unclear whether, let alone how, Nevada applies comment k.  A footnote, citing comment k, but not discussing it in any detail, in Klasch v. Walgreen Co., 264 P.3d 1155, 1158 n.7 (Nev. 2011), provides some basis to believe that comment k could reappear, but so far that hasn’t happened.

There sure hasn’t been anything approaching a comment k discussion in a medical device case since Allison – suggesting that prescription drugs and medical devices rise or fall together on this issue.

New Hampshire

Since we wrote our post in 2011 the United States Supreme Court has declared, “New Hampshire takes a case-by-case approach to comment k.”  Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472, 505 (2013) (generic drug case).  That was essentially what we had thought before.

We haven’t seen a medical device/comment k case under New Hampshire law, but we have no reason to suspect that a different standard applies.

New Jersey

As we pointed out in 2011, by statute, it is now a complete defense (“shall not be liable”) that “[t]he harm was caused by an unavoidably unsafe aspect of the product and the product was accompanied by an adequate warning.”  N.J.S.A. 2A:58C-3(a)(3).

The statute draws no distinctions between prescription drugs and medical devices.  See Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1251 (N.J. 1999) (statute applied; using “terminology relevant to prescription drugs” even though product was “a hybrid prescription medical device”).  It has been applied in medical device cases. See In re Panacryl Sutures Product Liability Cases, 263 F.R.D. 312, 319 (E.D.N.C. 2009) (applying New Jersey law).

New Mexico

We discussed in 2011 that comment k was applied with no case-specific analysis in Jones v. Minnesota Mining & Manufacturing Co., 669 P.2d 744, 759-60 (N.M. App. 1983), and Perfetti v. McGahn Medical, 662 P.2d 646, 649-50 (N.M. App. 1983), both medical device cases.

Both of these decisions were relied on extensively in Rimbert v. Eli Lilly & Co., 577 F. Supp. 2d 1174, 1201-04 (D.N.M. 2008), a prescription drug case.  So there doesn’t seem to be any basis for applying different tests to different types of prescription products in New Mexico.

New York

As discussed in our 2011 post, New York has never required “case-by-case” adjudication of the applicability of comment k to prescription medical products.  See, e.g., Martin v. Hacker, 628 N.E.2d 1308, 1311 (N.Y. 1993) (“even though its side effects may cause injury, a prescribed drug, accompanied by adequate warnings, is ‘not defective, nor is it unreasonably dangerous’”) (quoting comment k).  The Second Circuit applied comment k to a medical device in Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 76 (2d Cir. 1993) (applying New York law):

The district court, however, was correct in dismissing [plaintiff’] product and design defect claims.  [Plaintiff] contends that the district court dismissed these claims because it had erroneously concluded that the [medical device] is an “unavoidably unsafe” product.  Unavoidably unsafe products are those that “in the present state of human knowledge, are quite incapable of being made safe for their intended ordinary use.”  Restatement (Second) of Torts § 402A cmt. k (1979).  Under New York law, unavoidably unsafe products “are not deemed defective or unreasonably dangerous so long as they are accompanied by proper directions for use and adequate warnings as to potential side effects.”

Id. at 75-75 (quoting Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 90 (2d Cir. 1980) (prescription drug case)).  See Militrano v. Lederle Laboratories, 769 N.Y.S.2d 839, 846-47 (N.Y. Sup. 2003) (applying comment k across-the-board in vaccine case), aff’d, 810 N.Y.S.2d 506 (N.Y. App. Div. 2006).

Here we run into see some slippage at the trial court level, as pro-plaintiff courts have partially subverted New York law by not enforcing comment k at the pleading stage.  Williamson v. Stryker Corp., 2013 WL 3833081, at *7-8 (S.D.N.Y. July 23, 2013) (refusing to follow Bravman; design defect claim survives because plaintiff pleaded failure to warn); Henson v. Wright Medical Technology, Inc., 2013 WL 1296388, at *7 (N.D.N.Y. March 28, 2013) (warning claim precludes comment k dismissal on pleadings); cf. Gensler v. Sanofi-Aventis, 2009 WL 857991, at *6 (E.D.N.Y. March 30, 2009) (same dodge with prescription drug).  The slippage however, is not peculiar to medical devices, just as the appellate authority applying comment k “across-the-board” comes from both prescription drug and medical device product liability litigation.

North Carolina

As discussed in 2011, comment k is not an issue in North Carolina because strict liability is statutorily barred.  N.C. Gen. Stat. §99B-6(d).

North Dakota

What little law that exists in North Dakota on comment k/unavoidably unsafe suggests that comment k is to apply on a “case by case” basis – both now, and in 2011.


As we indicated in 2011, an Ohio statute mandates application of the unavoidably unsafe doctrine to all drugs and medical devices across the board.  Ohio Rev. Code. §2307.75(D) (“An ethical drug or ethical medical device is not defective in design or formulation because some aspect of it is unavoidably unsafe, if the manufacturer of the ethical drug or ethical medical device provides adequate warning and instruction).”  “Unavoidably unsafe” means “that, in the state of technical, scientific, and medical knowledge at the time a product in question left the control of its manufacturer, an aspect of that product was incapable of being made safe.”  Ohio Rev. Code § 2307.71(A)(16).  See Aaron v. Medtronic, Inc., 209 F. Supp.3d 994, 1014 (S.D. Ohio 2016) (“Plaintiffs’ strict liability claims are barred . . . due to the fact that [the device] is an ‘unavoidably unsafe product’”); Yanovich v. Sulzer Orthopedics, Inc., 2006 WL 3716812, at *11 (N.D. Ohio Dec. 14, 2006) (“an adequate warning is a defense to design defect claims”), aff’d, 255 F. Appx. 957 (6th Cir. 2007) but see Thompson v. DePuy Orthopaedics, Inc., 2015 WL 7888387, at *15 (S.D. Ohio Dec. 4, 2015) (“not all prescription medical devices are deemed unavoidably unsafe”; requiring “no alternative design which would have as effectively accomplished the same purpose or result with less risk”).

Before the statute, Ohio common law had applied comment k in a “case-by-case” fashion.  Once again, however, it did so to all prescription medical products, without exception:

[W]e hold that a prescription drug, vaccine, or like product is not “unavoidably unsafe” per se under Comment k to Section 402A. . . .   Whether such a product qualifies as “unavoidably unsafe” under Comment k is a determination to be made on a case-by-case basis.

White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 752 (Ohio 1988) (emphasis added) (vaccine case); see Burwell v. American Edwards Laboratories, 574 N.E.2d 1094, 1098 (Ohio App. 1989) (court properly “determined that the [medical device] belonged in the category of unavoidably unsafe products”) (relying on prescription drug cases).


Several medical device cases supported our 2011 conclusion that Oklahoma was a “case-by-case” comment k state.  See Edwards v. Basel Pharmaceuticals, 933 P.2d 298, 300 (Okla. 1997) (patch); Tansy v. Dacomed Corp., 890 P.2d 881, 885-86 (Okla. 1994) (implant); McKee v. Moore, 648 P.2d 21, 24 (Okla. 1982) (IUD).  See also Littlebear v. Advanced Bionics, LLC, 896 F. Supp.2d 1085, 1092 (N.D. Okla. 2012); Reed v. Smith & Nephew, Inc., 527 F. Supp.2d 1336, 1354 (W.D. Okla. 2007); Alexander v. Smith & Nephew, P.L.C., 98 F. Supp.2d 1310, 1317 (N.D. Okla. 2000) (all applying same standard in medical device cases).

The identical standard has been applied in Oklahoma cases involving prescription drugs.  E.g., Eck v. Parke, Davis & Co., 256 F.3d 1013, 1017-18 (10th Cir. 2001) (applying Oklahoma law); Agee v. Purdue Pharmaceuticals, Inc., 2004 WL 5352989, at *4 & n.12 (W.D. Okla. Nov. 22, 2004), aff’d, 242 F. Appx. 512 (10th Cir. 2007).


We concluded that Oregon was a “case-by-case” jurisdiction in 2011.  Two of the three relevant cases involved prescription medical devices – specifically IUDs.  Coursen v. A.H. Robins, 764 F.2d 1329, 1337 (9th Cir. 1985); Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1148-49 (D. Or. 1989).  The same standard applies to vaccines. Senn v. Merrell-Dow Pharmaceuticals, Inc., 751 P.2d 215, 218 n.4 (Or. 1988).  Once again there is no reason to believe that different standards apply to different types of prescription medical products.


As discussed in Hahn v. Richter, 673 A.2d 888, 889-91 (Pa. 1996), Pennsylvania has always applied comment k “across the board” in prescription drug cases.  See our 2011 discussion for more details on other Pennsylvania appellate authority doing so.  By the way, the then “pending” Pennsylvania Supreme Court appeal continued this application.  Lance v. Wyeth, 85 A.3d 434, 442 n.11 (Pa. 2014) (some jurisdictions “including Pennsylvania, have taken a blanket approach applying comment k to preclude strict-liability design-defect claims for all prescription drugs”).

While the Pennsylvania Supreme Court has never decided a comment k case involving a medical device, the intermediate appellate court did in Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. 2006):

[Plaintiffs] challenge the trial court’s determination that their strict liability claim is barred by Restatement 2d of Torts section 402A, comment k.  Comment k excludes certain products from the definition of “unreasonably dangerous” used in section 402A on the basis that they are incapable of being made safe for their intended use, but are useful nonetheless. . . .  [comment k quotation omitted]

In this case, the trial court applied this section to the [medical device], citing our Supreme Court’s decision in Hahn v. Richter [citation omitted], in which the high court adopted comment k. . . .  In applying comment k here, the trial court reasoned that given the potential utility of the [device], no significant distinction can be drawn between the device and the drug upon which the Supreme Court based its decision in Hahn.  The court concluded accordingly that strict liability could not be a basis for liability in this case. [Plaintiffs] contend that . . . comment k does not apply to medical devices because the comment text does not mention them.  They cite no authority, however, for so restrictive an interpretation either of comment k or of Hahn, nor do they provide significant analysis of the language they seek to apply. We find no reason why the same rational applicable to prescription drugs may not be applied to medical devices.

Creazzo, 903 A.2d at 30-31 (citations omitted) (emphasis added).

Plaintiffs have tried and tried to avoid application of Pennsylvania’s “across-the-board” rule to medical devices, to no avail − the only area of significant disagreement concerns manufacturing, not design, defect claims.  See Lawrence v. Synthes Inc., 2002 WL 32747667, at *24 n.101 (Pa. C.P. July 25, 2002) (“[p]rescription medical devices must be analyzed similarly” to Hahn), aff’d mem., 860 A.2d 1142 (Pa. Super. 2004) (table); Ideluca v. C.R. Bard, Inc., 2018 WL 807158, at *3 (W.D. Pa. Feb. 9, 2018) (strict liability warning and design claims properly dismissed); Smith v. Howmedica Osteonics Corp., 251 F. Supp.3d 844, 848 (E.D. Pa. 2017) (“[w]here Comment k applies, its plain language bars strict liability claims that assert a design defect”); Wagner v. Kimberly-Clark Corp., 225 F. Supp.3d 311, 316 (E.D. Pa. 2016) (“Pennsylvania law prohibits strict liability claims based on a ‘design’ defect or a ‘failure to warn’ . . . against medical device and drug manufacturers”); Carson v. Atrium Medical Corp., 191 F. Supp.3d 473, 477 (W.D. Pa. 2016) (“the Court will apply Comment k, without exceptions, to medical devices”); McLaughlin v. Bayer Corp., 172 F. Supp.3d 804, 833 (E.D. Pa. 2016) (“Comment k’s prohibition of strict liability-design defect and strict liability-failure to warn claims for prescription drugs should also apply to medical devices”); Wilson v. Synthes United States Products, LLC, 116 F. Supp.3d 463, 465 (E.D. Pa. 2015) (comment k “has been consistently applied by Pennsylvania state and federal courts to medical device cases, leading to a finding that plaintiffs may not assert strict liability claims against medical device manufacturers”); Runner v. C.R. Bard, Inc., 108 F. Supp.3d 261, 266 (E.D. Pa. 2015) (following “the settled doctrine among our colleagues that comment k bars the imposition of strict liability against medical device manufacturers”); Cutruzzula v. Bayer Healthcare Pharmaceuticals, 2015 WL 8488670, at *3 (Mag. W.D. Pa. Nov. 17, 2015) (in face of defendant’s motion, “removing Plaintiff’s strict liability claims in light of Lance and Hahn”), adopted, 2015 WL 8492767 (W.D. Pa. Dec. 10, 2015); Kramme v. Zimmer, Inc., 2015 WL 4509021, at *4-5 (M.D. Pa. July 24, 2015) (“we predict that the Pennsylvania Supreme Court would apply comment k to prescription medical devices, as it is applied to prescription drugs”; Tincher did not change the existing jurisprudence concerning strict liability with respect to prescription drugs and medical devices”); Cogswell v. Wright Medical Technology, 2015 WL 4393385, at *3 (W.D. Pa. July 16, 2015) (“Plaintiff’s argument that exceptions be made is unpersuasive, and the Court will apply Comment k to medical devices”); Terrell v. Davol, Inc., 2014 WL 3746532, at *5 (E.D. Pa. July 30, 2014) (“in the case of prescription drugs and devices, strict liability claims based on all three defective conditions, including manufacturing defects, are barred in Pennsylvania”) (footnote omitted); Stout v. Advanced Bionics, LLC, 2013 WL 12133966, at *8 (W.D. Pa. Sept. 19, 2013) (“claims based upon strict product liability are barred by comment k”); Shelley v. Ethicon, Inc., 2013 WL 3463505, at *2 (E.D. Pa. July 10, 2013) (“Hahn has been broadly applied to both prescription drugs as well as prescription medical devices.”); Kline v. Zimmer Holdings, Inc., 2013 WL 3279797, at *6 (W.D. Pa. June 27, 2013) (“the motion to dismiss should be granted with respect to Plaintiffs’ strict liability design defect and failure to warn claims”); McPhee v. DePuy Orthopedics, Inc., 989 F. Supp.2d 451, 461 (W.D. Pa. 2012) (“agree[ing] with the prediction of our sister courts in this Circuit that the Supreme Court of Pennsylvania would extend this holding to medical device manufacturers”); Kee v. Zimmer, Inc., 871 F. Supp.2d 405, 409 (E.D. Pa. 2012) (“as a matter of Pennsylvania law, there is no strict liability for harm caused by medical devices”); Gross v. Stryker Corp., 858 F. Supp.2d 466, 481 (W.D. Pa. 2012) (courts “have continued to apply comment k to medical devices”); Killen v. Stryker Spine, 2012 WL 4498865, at *3-4 (E.D. Pa. Sept. 28, 2012) (comment k precludes strict liability design and warning claims in medical device cases); Doughtery v. C.R. Bard, 2012 WL 2940727, at *3 (E.D. Pa. July 18, 2012) (following “numerous courts in this district [that] have predicted that the Supreme Court would extend comment k to prescription medical devices”; Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420, at *2 (W.D. Pa. Nov. 10, 2011) (“[w]hile other jurisdictions might recognize caveats to Comment k’s exclusion of strict liability claims, this Court must apply Pennsylvania law, which does not recognize such caveats”); Esposito v. I-Flow Corp., 2011 WL 5041374, at *4 (E.D. Pa. Oct. 24, 2011) (“[p]rescription drugs and medical devices . . . are unavoidably dangerous products”); Riley v. Medtronic, Inc., 2011 WL 3444190, at *10 (W.D. Pa. Aug. 8, 2011) (“comment k applies to medical devices”); Geesey v. Stryker Corp., 2010 WL 3069630, at *5 (E.D. Pa. Aug. 4, 2010) (“comment k applies to medical devices”); Kester v. Zimmer Holdings, 2010 WL 2696467, at *9 (W.D. Pa. June 16, 2010) (Hahn “‘unambiguously’ denies the application of strict liability”); Halsel v. Zimmer, Inc., 2009 WL 10689768, at *3 (W.D. Pa. March 25, 2009) (“the Pennsylvania Supreme Court likely would find that comment k to §402A is applicable to prescription medical devices and would bar strict liability claims”); Giacalone v. Lacrimedics, Inc., 2008 WL 11365183, at *5 n.6 (E.D. Pa. Nov. 24, 2008) (noting the “many” Pennsylvania decisions applying comment k to medical devices); Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 750 (E.D. Pa. 2007) (“predicting, based on its reasoning in Hahn, that Pennsylvania Supreme Court would extend §402A’s comment k to exclude prescription medical devices from strict liability”); Parkinson v. Guidant Corp., 315 F. Supp.2d 741, 747 (W.D. Pa. 2004) (“the same considerations exempting prescription drugs from the ambit of §402A equally apply to prescription medical devices”); Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 442 (E.D. Pa. 2004) (“Comment k precludes application of Section 402A to prescription medical devices”); Murray v. Synthes U.S.A., Inc., 1999 WL 672937, at *7 (E.D. Pa. Aug. 23, 1999) (“the same reasoning underlying Comment k that excludes prescription drugs from Section 402A should also apply to prescription medical devices”); Burton v. Danek Medical, Inc., 1999 WL 118020, at *7 (E.D. Pa. March 1, 1999) (“the same reasoning underlying Comment k that excludes prescription drugs from Section 402A should also apply to prescription medical devices”); Taylor v. Danek Medical, Inc., 1998 WL 962062, at *7 (E.D. Pa. Dec. 29, 1998) (“predict[ing] that the Pennsylvania Supreme Court will determine, pursuant to its reasoning in Hahn, that prescription medical devices are likewise not covered by” strict liability).

Courts in other states, likewise interpreting Pennsylvania law, have also applied comment k across the board to medical devices:

Lance’s recognition that negligent design claims are available in a pharmaceutical products liability case does nothing to upset [general] rule precluding strict liability claims against pharmaceutical drug manufacturers. . . .  Pennsylvania uses a “blanket approach applying comment k to preclude strict-liability design-defect claims for all prescription drugs.”  Lance, 85 A.3d at 442 n.11.  This court concludes that Plaintiff . . . may bring negligence claims predicated on failure to warn, design defect, or other negligence-based theories, but she cannot bring strict liability claims. . . .

Plaintiffs other arguments fare no better. . . .  [C]ertain generic prescription drugs are allowed to be sold even though they do not go through the FDA’s pre-market approval process, and these drugs retain their exemption from strict liability. . . .  Simply put, Plaintiff’s arguments about the level of regulatory scrutiny brought to bear on drugs and medical devices do not satisfy the court that they fare differently under comment k of the Second Restatement.

In re Zimmer NexGen Knee Implant Products Liability Litigation, 2015 WL 3669933, at *35-36 (N.D. Ill. June 12, 2015) (applying Pennsylvania law) (citations omitted).  Accord Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009) (“Comment k of Section 402A denies application of strict liability to products considered ‘unavoidably unsafe’”; “[t]his prohibition has been extended to medical devices”) (applying Pennsylvania law).

Finally, in the one pre-Hahn case to consider a medical device, Ford v. McGhan Medical Corp., 142 Pitts. Leg. J. 201 (Pa. C.P. Allegheny Co. 1994), the court decided, again that prescription drugs and medical devices were treated the same, but applied a “case-by-case” approach.  Ford no longer accurately states Pennsylvania law, but does illustrate the principle at issue here – that whatever substantive approach that courts take towards comment k, that approach should apply to all types of prescription medical products.

Puerto Rico

Our 2011 comment, “[t]here’s no comment k law that we know of in Puerto Rico,” remains accurate today.

Rhode Island

We classified Rhode Island as “case-by-case” in 2011.  We have found no Rhode Island cases discussing comment k, one way or the other, as to any prescription medical product other than a prescription drug.

South Carolina

Based solely on Brooks v. Medtronic, Inc., 750 F.2d 1227 (4th Cir. 1984) (applying South Carolina law), a medical device case, we concluded in 2011 that South Carolina treated comment k in an “across-the-board” fashion. Id. at 1230-31 (prescription medical products ““are deemed ‘unavoidably unsafe,’ but are not defective or unreasonably dangerous if they are marketed with proper directions for use or include adequate warnings of potential side effects”).

So the reverse of the common situation has been true in South Carolina – medical device precedent has been applied in prescription drug cases.  See Carnes v. Eli Lilly & Co., 2013 WL 6622915, at *3-4 (D.S.C. Dec. 16, 2013) (applying Brooks to prescription drug case; rejecting plaintiff’s attempt to distinguish between drugs and devices).

South Dakota

In another N = 1, situation, in 2011, we concluded that the only available South Dakota comment k precedent applied it in an “across-the-board” fashion.

The number of relevant comment k cases still equals one in South Dakota.


The only comment k language out of Tennessee in 2011 sounded like “across-the-board” to us.  See also Laws v. Johnson, 799 S.W.2d 249, 252 (Tenn. App. 1990) (holding, without individualized analysis that comment k “governs the case at bar” involving prescription drug).

Since then, in Rodriguez v. Stryker Co., 680 F.3d 568 (6th Cir. 2012) (applying Tennessee law), the court agreed with the application of comment k to medical devices:

In rejecting [plaintiff’s] strict liability claim, the district court invoked comment k . . ., which insulates from liability manufacturers of unavoidably unsafe products that are properly prepared and accompanied by an adequate warning.  [Plaintiff] does not argue that the district court erred in applying comment k to his claim. . . .  Because plaintiff’s] duty-to-warn arguments fail, this argument necessarily fails as well.

Id. at 575. See Isbell v. Medtronic, Inc., 97 F. Supp. 2d 849, 861 (W.D. Tenn. 1998) (labeling  medical devices as “unavoidably unsafe products” based on prescription drug precedent); Harwell v. American Medical Systems, Inc., 803 F. Supp. 1287, 1300 (M.D. Tenn. 1992) (applying comment k to medical device without individualized application, beyond citing to another case similarly holding).


And now for one of the states that prompted this post.  As we stated in 2011:

Texas is a comment k/unavoidably unsafe product across-the-board state.  Centocor, Inc. v. Hamilton, 310 S.W.3d 476, 516 (Tex. App. 2010) (comment k “provide[s] a defense to a design defect claim”), app. pending; Schwarz v. Block Drug Co., 180 F.3d 261, 1999 WL 274409, at *1 (5th Cir. 1999) (“Under comment K of the Restatement of Torts (Second) § 402A, a drug manufacturer is responsible in damages only if it failed to warn of a defect of which it knew or should have known.”) (unpublished); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273-74 (5th Cir. 1974) (applying unavoidably unsafe standard without individualized assessment); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (“[p]rescription drugs are not susceptible to a design defect claim where, as here, the drug is “accompanied by proper directions and warning”); Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004) (“[u]nder Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law”); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (“[t]he Court thus holds that under Texas law and comment k of the Restatement, Defendants can only be held strictly liable if the drug was not properly prepared or marketed or accompanied by proper warnings”); cf. Brockert v. Wyeth Pharmaceuticals, Inc., 287 S.W.3d 760, 770-71 (Tex. App. 2009) (affirming summary judgment against design defect claim involving prescription drug on ground of lack of alternative design); Gerber v. Hoffmann-La Roche Inc., 392 F. Supp.2d 907, 922 (S.D. Tex. 2005) (same).

To these we would include the additional citations that we found when we researched our prior post discussing the legal rulings in Pinnacle Hip:

Pinnacle Hip complained, in a footnote, that “Texas caselaw offers almost no guidance on how to go about that case-by-case inquiry.”  Id. at [772] n.22.  There is good reason for that lack of precedent – because Texas law has not employed tests that require such inquiry.  See . . . Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808, 817-18 (S.D. Tex. 2013) (applying comment k to prescription drug without case-by-case analysis); Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595, at *3-4 (W.D. Tex. June 23, 2011) (holding, without further analysis, that “comment k applies to products such as [defendant’s prescription drug]”). . . .

Omitting substantially identical citations to Reyes, Holland, Carter, and Hackett.

Since 2011, the most noticeable development was the Texas Supreme Court’s reversal in Hamilton and its resounding adoption of the learned intermediary rule, which we celebrated here.  The discussion of the unavoidably unsafe doctrine in Hamilton certainly sounds “across-the-board,” since it does not draw any product-specific distinctions, and equates unavoidably unsafe with availability only by a physician’s prescription:

[A]s the official comment to the Restatement (Second) of Torts notes, the learned intermediary doctrine applies particularly to the medical field and unavoidably unsafe products like prescription drugs, which, by law, cannot go from the manufacturer to the end user except through a prescribing physician.  In other products-liability contexts, such as the sophisticated user or bulk supplier scenarios, however, the doctrine could apply to any type of product, not just those that are unavoidably unsafe, and the applicability of the learned intermediary doctrine in those contexts turns on whether the manufacturer’s or supplier’s reliance on the intermediary to warn the end user is reasonable.

Id. at 165 (comment k citation omitted) (emphasis added).

Further, with respect to the Fifth Circuit’s supposed distinction between prescription drugs and medical devices, Hamilton cited and relied on medical device (and vaccine) cases, in addition to prescription drug decisions, interchangeably throughout its discussion of learned intermediary principles.  Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 155 n.16, 159-60, 170 (Tex. 2012).  If Hamilton had thought there was some fundamental divide between types of prescription medical products, as Pinnacle Hip supposed, 888 F.3d at 772, surely the Texas Supreme Court would have included something, anything – not even a footnote – containing a caveat leaving open that possibility.  Nothing.  Instead, where Hamilton mentioned medical devices, it treated them as equivalent to prescription drugs.

  • 372 S.W.3d at 155 n.16 (including “medical device” case in string citation of Texas cases following learned intermediary rule).
  • Id. at 157 (applying Restatement §6, which as discussed above, treats drugs and devices identically).
  • Id. at 158 n.17 (including at least five medical device decisions among the “prescription drug” cases adopting rule).
  • Id. at 159 (more reliance on Restatement §6).
  • Id. at 166 (discussing as one “informational materials provided by healthcare providers, pharmaceutical and medical-device manufacturers”).

Also, since 2011, “Texas courts have applied Comment k to exempt prescription drugs from strict liability under a design defect theory.”  Anastasi v. Wright Medical Technology, Inc., 16 F. Supp.3d 1032, 1041 (E.D. Mo. 2014) (“Texas courts have applied Comment k to exempt prescription drugs from strict liability under a design defect theory”).  See Robles v. C.R. Bard, Inc., 2015 WL 11120857, at *3 (N.D. Tex. March 23, 2015 (“agree[ing] with Defendants that comment k applies to medical devices as well as pharmaceutical drugs”; only surviving claim requires inadequate warnings); Friske v. ALZA Corp., 2011 WL 13233327, at *12 (N.D. Tex. April 29, 2011) (“the Court acknowledges and agrees with the widespread interpretation that comment k provides that prescription drugs in general are unavoidably dangerous as a matter of law”; refusing to distinguish between drug and medical device attributes of drug-eluting skin patch).

So, that’s the Texas law that we have.  What law did Pinnacle Hip offer to support a different interpretation?

Zilch.  Not even a “lone federal district court decision,” 888 F.3d at 772 n.19 – which as just discussed is hardly “lone” at all.  Pinnacle Hip cites not one Texas law decision either:  (1) applying comment k on a “case by case” basis; or (2) distinguishing between medical devices and prescription drugs for comment k/unavoidably unsafe product purposes.  888 F.3d at 772.  Yet Pinnacle Hip has the gall to state that the defense position is “based on conjecture.”

Once again, we’re dealing with the improper MDL phenomenon of construing state product liability law far more expansively than any state court has ever done, in order to maximize settlement pressure. Nor is the Pinnacle Hip MDL the only source of such abuse.  See Adams v. Boston Scientific Corp., 177 F. Supp.3d 959, 965 (S.D.W. Va. 2016), and numerous similar decisions from the same MDL. Adams refused to apply comment k “across the board” to medical devices that were “neither FDA-approved nor a prescription drug.” Id. at 965.  No Texas court has ever drawn the first distinction, which appears to be between FDA “approval” and “clearance,” and the distinction is meaningless since design defect claims involving Class III medical devices are preempted.  The second point is simply bogus.  The case cited, Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 682 F. Supp.2d 662, 679 (N.D. Tex. 2010), doesn’t even involve a prescription medical product, but rather OTC medication, so it has no relevance to the reasons that real Texas law has applied comment k to all prescription medical products without distinction.  As again, the only contrary precedent to treating prescription medical products equally under comment k is a consequence of MDL abuse.  Don’t mess with Texas law.


Utah is another state where MDL abuse is threatening established across-the-board application of comment k by drawing spurious distinctions between different types of prescription medical products.  As discussed in 2011, the Utah Supreme Court emphatically adopted “across-the-board” application of comment k in Grundberg v. Upjohn Co., 813 P.2d 89, 95 (Utah 1991), a prescription drug case.  Utah decisions involving medical devices (drug-eluting patches for the most part) have mostly applied Grundberg, and thus comment k “across-the-board”).  Elkins v. Mylan Laboratories, Inc., 2013 WL 3224599, at *4 (D. Utah June 25, 2013) (“[b]ased on this clear authority [Grundberg], Plaintiff’s design defect strict liability claim must be dismissed”); Stanley v. Mylan Inc., 2010 WL 3718589, at *5 (D. Utah Sept. 17, 2010) (“allow[ing] the case to proceed on the understanding that Plaintiffs will not press for a strict-liability design-defect claim”); Lake-Alien v. Johnson & Johnson, L.P., 2009 WL 2252198, at *3 (D. Utah July 27, 2009) (rejecting distinctions between product type; “In the case of prescription pharmaceutical patches, it is nonsensical to separate the liability of the overall product and the substance that it releases.”); Grange v. Mylan Laboratories, Inc., 2008 WL 4813311 (D. Utah Oct. 31, 2008) (“Plaintiffs’ strict liability claim is dismissed to the extent that it is based on an alleged design defect”).  But see Creech v. Stryker Corp., 2012 WL 33360, at *5 n.6 (D. Utah Jan. 6, 2011) (refusing to apply Grundberg to medical devices).

The footnote in Creech was itself critiqued by a footnote in In re Wright Medical Technology, Inc. Conserve Hip Implant Products Liability Litigation, 178 F. Supp. 3d 1321 (N.D. Ga. 2016):

The Creech court’s interpretation of Grundberg overreaches. . . .  The Creech court’s footnote regarding Comment k is inconsistent with the Utah Supreme Court’s holding in Grundberg and, to the extent it concludes that, in Utah, Comment k has been found not to apply to medical devices, the Creech decision misinterprets Grundberg.

In its August 31, 2015, Order, the Court reached a conclusion consistent with the Utah Supreme Court’s decision in Grundberg, and further noted that most courts that had considered the issue have concluded that Comment k applies to medical devices. . . .  The Court concludes again that Utah state courts, when presented with the issue, will conclude that Comment k applies to prescribed medical devices.

Id. at 1350 n.17.  However, that earlier ruling, incorrectly utilized a sub rosa “case-by-case” approach to comment k.  See In re Wright Medical Technology, Inc. Conserve Hip Implant Products Liability Litigation, 127 F. Supp.3d 1306, 1357 (N.D. Ga. 2015) (“[f]or Comment K to apply, a device design ‘must be as safe as the best available testing and research permits’”) (quoting Tansy v. Dacomed Corp., 890 P.2d 881, 885 (Okla. 1994)).  As stated above, however, Oklahoma, unlike Utah, is a “case by case” state.

On appeal, in a decision we didn’t like for a variety of other reasons, the Eleventh Circuit agreed in Christiansen v. Wright Medical Technology, Inc., 851 F.3d 1203 (11th Cir. 2017) (applying Utah law), quoted extensively from Grundberg , found it error to apply what amounted to a case-by-case approach to comment k in a medical device case, but held that the error was “harmless” because the defendant had failed to establish that its device had in fact undergone FDA scrutiny. Id. at 1217 (“the record is silent as to whether that device had obtained FDA approval”).  As you might expect this whole episode also involves an MDL, and incredible pressure to affirm to avoid overturning a great deal of MDL time and effort – but at least the Eleventh Circuit called out the “error” for what it was.  Cf. Cook v. Boston Scientific Corp., 2015 WL 5842744, at *3-4 (S.D.W. Va. Oct. 6. 2015) (avoiding Grundberg by distinguishing between PMA and 510(k) devices that no Utah court has ever drawn).  The pattern of MDL abuse through novel, expansive construction of comment k is quite clear.

In any event, as we discussed recently, the issue of comment k, unavoidably unsafe products and medical devices under Utah law, has now been certified to the Utah Supreme Court, which has the opportunity to sort things out. See Burningham v. Wright Medical Group, Inc., 2018 WL 922362 (D. Utah Feb. 15, 2018).


In 2011, we wrote, “There’s nothing about comment k in Vermont.”  There still isn’t.


Likewise, what we said about Virginia in 2011 still stands:

Virginia’s never adopted any part of Restatement (Second) of Torts §402A (1965), and rejects strict liability altogether, so it’s also not adopted comment k.  Abbot v. American Cyanamid Co., 844 F.2d 1108, 1115 (4th Cir. 1988).

Virgin Islands

Three in a row.  In 2011, and now, “There’s no comment k law in the Virgin Islands that we know of.”


We discussed in 2011 how, for a long time, Washington had been an “across the board” comment k state in cases involving both prescription drugs and medical devices.  See Young v. Key Pharmaceuticals, Inc., 922 P.2d 59, 63 (Wash. 1996) (under comment k, a prescription drug manufacturer is liable “only if it failed to warn of a defect of which it either knew or should have known . . . it is liable in negligence and not in strict liability”) (prescription drug case); Terhune v. A.H. Robbins Co., 577 P.2d 975, 977-78 (Wash. 1978) (“the duty of the manufacturer to warn of dangers involved in use of a product is satisfied if he gives adequate warning to the physician who prescribes it”) (pre-Medical Device Amendments device case); Transue v. Aesthetech Corp., 341 F.3d 911, 916 (9th Cir. 2003) (“comment k provides a blanket exemption from strict liability for design defect claims on all prescription medical products”) (medical device case); Adams v. Synthes Spine Co., 298 F.3d 1114, 1117 (9th Cir. 2002) (“Washington applies this [comment k] rule not only to such medical products as vaccines for deadly diseases, but . . . much more broadly, to medical products where the physician acts as a learned intermediary”) (medical device case); Payne v. Paugh, 360 P.3d 39, 50, 53 (Wash. App. 2015) (“comment k establishes an exception to strict liability for unavoidably unsafe products’ such as prescription drugs and medical devices”; “for a design defect claim against a medical device manufacturer of an unavoidably unsafe product under comment k, . . . the standard is negligence”); Kaspers v. Howmedica Osteonics Corp., 2015 WL 12085853, at *8 (W.D. Wash. Oct. 23, 2015) (comment k precludes strict liability as “to [plaintiff’s] two remaining strict liability claims − design defect and failure to warn”). See also Rogers v. Miles Laboratories, Inc., 802 P.2d 1346, 1350-51 (Wash. 1991) (applying comment k to biological).

Most recently, in Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017), the court “h[e]ld that the comment k exception is not available to a manufacturer who fails to adequately warn.”  Id. at 528.  That starts to sound more like “case-by-case,” but it’s too soon to tell.  While the product in Taylor was a medical device, the court’s rationale for limiting comment k was not peculiar to medical devices, so we still think that however comment k is going to be applied in Washington, it will applied the same to all prescription medical products.

West Virginia

As of 2011, we found two federal district court cases in West Virginia predicting adoption of a “case-by-case” approach to comment k’s unavoidably unsafe product principle. Both involved vaccines.

Since then, another West Virginia federal district court launched a diatribe against comment k in a medical device case, calling it a “useless relic” and “redundant”:

[W]hat is a defective product must be analyzed in traditional tort terminology.  Through subsequent interpretations . . ., West Virginia has effectively rid itself of the need for the useless relic that is comment k.  Accordingly, there is no reason to apply comment k separately in this case, as its principles have become a part of West Virginia law.  I find additional support in the fact that West Virginia courts have never discussed or applied comment k.

Mullins v. Ethicon, Inc., 117 F. Supp. 3d 810, 820 (S.D.W. Va. 2015) (citations, quotation marks and footnote omitted).  As for the two contrary decisions, “[b]oth cases dealt with vaccines . . . where the quintessential example used by comment k was at issue.”  Id.  Mullins is, we believe, unique in this respect, being the only court in the nation to employ a categorical separation of vaccines from all other prescription medical products.  But that singular distinction was secondary to its main holding, which is that “the West Virginia Supreme Court of Appeals has not and would not adopt comment k” in any situation, id.,which would make West Virginia the fourth state to disregard comment k altogether (not counting those states that reject strict liability).

Whatever West Virginia does, there is little support for treating prescription drugs separately from prescription medical products.


As we observed in 2011, Wisconsin is another of the few states that does not follow comment k at all.  Collins v. Eli Lilly & Co., 342 N.W.2d 37, 52 (Wis. 1984).  Subsequent tort reform required a risk/utility approach to design defects, but did not include a unavoidably unsafe product exception. See Wis. Stat. §895.047(1)(a).


We concluded in 2011 that Wyoming did not require individual adjudication of whether products were unavoidably unsafe under comment k.  See Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 852 (10th Cir. 2003) (“Comment k to § 402A establishes that this rule [strict liability] does not apply to ‘unavoidably unsafe products’”) (prescription drug case); Tobin v. Smithkline Beecham Pharmaceuticals, 164 F. Supp.2d 1278, 1288 (D. Wyo. 2001) (“’unavoidably unsafe’ products simply refers to that area of the law regarding those products, such as pharmaceutical drugs, which despite the manufacturers best efforts and intentions contain an unavoidable risk”).  All of this sounds “across the board.”  Nothing in any of these decisions suggests that prescription drugs and medical devices would be subject to different standards.

This one comes from Alabama and it’s pretty straightforward – plaintiff’s claims are preempted and therefore dismissed with a little wiggle room left for an attempted amended complaint. But as we know, for Pre-Market Approved (PMA) devices, there is only a “narrow gap” between express and implied preemption through which a claim must fit to survive. And so far, plaintiff has been ping-ponging off the sides but hasn’t made it through the gap.

The case is Rice v. Allergan USA, Inc., 2018 WL 1618036 (N.D. Ala. Apr. 4, 2018). Plaintiff had LAP-BAND surgery to aid with weight loss. The LAP-BAND is a PMA device. After seven years, plaintiff started to experience difficulty swallowing and frequent vomiting and upon investigation it was discovered that the LAP-BAND had eroded into plaintiff’s stomach and had to be removed. Id. at *2. Plaintiff conceded several of her claims. Those that remained for ruling by the court were negligence, failure to warn, and negligent or fraudulent misrepresentation. Id. at *3. Plaintiff’s primary allegation in support of these claims was that while defendant’s label reported a 1% risk of erosion, studies revealed a higher complication rate. Id. at *2.

Because the LAP-BAND went through the PMA process, plaintiff’s claims are preempted unless they satisfy the “parallel claim doctrine.” That means plaintiff has to show that the state law duties she alleges defendant violated and for which she seeks damages are “genuinely equivalent” to the federal requirements imposed on the device. Id. at *5. Only when the state and federal duties are parallel will plaintiff’s claim not run afoul of the provision of the Medical Device Amendments (“MDA”) that a state not impose requirements that are “different from or in addition to” federal requirements. Id.

Plaintiff’s first negligence claim was for negligent design and manufacture. However, while she made several allegations about the device having significant risks, nowhere did plaintiff allege how the manufacturer’s duty of care under state law “parallels the federal requirement that the [device] be manufactured according to the approved specifications for the medical device.” Id. at *6. If the device was designed and manufactured according to its PMA specifications, then allowing a jury to find it was negligently designed or manufactured would be imposing a different or additional requirement on the manufacturer. Therefore, claim preempted.

Next up was plaintiff’s negligent failure to warn claim. The court actually broke the claim down into 5 theories on which failure to warn was premised: negligent marketing, negligent labeling, negligent failure to update labeling, negligent reporting, and negligent surveillance. Id. It’s worth noting here that the court applies all the same reasoning in concluding that plaintiff’s strict liability failure to warn claim is similarly preempted. Id. at *8.

Here plaintiff did cite federal regulations but still missed the mark. For instance, plaintiff cited 21 C.F.R. §99.101 which provides:

[a] manufacturer may disseminate written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling…provided that the manufacturer complies with all other relevant requirements under this part.

Plaintiff alleges that the defendant violated this federal regulation by failing to provide additional risk information about the device. But all this section does is provide a guideline should a manufacturer choose to disseminate additional information. Choosing not to do so doesn’t violate the provision. Id. at *6.

Plaintiff also cites to the Changes Being Effected (“CBE”) provisions arguing that the defendant violated those provisions by failing to implement a CBE warning. However, a CBE labeling-change is permission to change a label “while a manufacturer awaits a written FDA order approving the PMA supplement.” Id. at *7. But plaintiff did not allege that the defendant was awaiting an FDA order on a PMA supplement, so it is unknown if the provision even applies.

Plaintiff also tried to base her failure to warn claim on an alleged violation of defendant’s federal duties to report adverse events to the FDA and to conduct post-market surveillance. Id. But the court considered both of those claims impliedly preempted on the grounds that they were unlawful attempts to privately enforce the FDCA. The court said failure to report sounds like it could be failure to warn, but the requirement is to report to the FDA, not to plaintiff. And there simply is no state law cause of action for post-market surveillance. Id.

Finally, the court had to dismiss plaintiff’s misrepresentation claim based on plaintiff’s vague pleadings. If what plaintiff was alleging is that defendant should have disclosed additional information and such a disclosure requirement exceeded FDA’s requirements, the claim would be preempted as not parallel. If, on the other hand, plaintiff was alleging that the defendant “held its product out as meeting a higher standard than that required by the FDA,” such a claim would not be preempted. Id. Since the former is more likely, it appears that a properly pleaded claim is likely preempted.

Yesterday happened to be the deadline for plaintiff to file an amended complaint, which she did. A quick skim of the amended complaint leads us to believe it contains most of the same allegations and therefore deficiencies the court has already addressed. And, plaintiff re-pleaded the claims she conceded as insufficiently pleaded the first time around. We suspect another round of preemption briefing in this case’s future.


This is not new. PMA devices should have broad preemption against product liability claims. Not just from the express preemption provisions of the MDA, but from attempts to get around express preemption by basing claims on violations of the FDCA and running smack into implied preemption under Buckman. We have talked about the narrow gap a claim needs to squeeze through to not be subject to either version of preemption. We have, when we were feeling mythological, likened this to traversing the Strait of Messina between Scylla and Charybdis. Without overdoing the analogy, each state law claim must neither 1) impose a requirement that is “different from or in addition to” the PMA approval requirements, nor 2) have federal requirements as a “critical element,” or it will be smashed or swallowed into preemption oblivion. A good analysis of these issues starts with looking at what plaintiffs have alleged and how that fits within the cognizable causes of action under applicable state law.

In In re Smith & Nephew BHR & R3 Hip Implant Prods. Liab. Litig., No. CCB-172775, 2018 U.S. Dist. LEXIS 49021 (D. Md. Mar. 26, 2018), more than two hundred plaintiffs purported to assert fairly standard state law product liability causes of action against the manufacturer of a PMA hip implant. The actual allegations of what the manufacturer did wrong and what was bad about the device were not so standard. They were very heavy on alleged non-compliance with a range of FDA requirements. The defendant moved to dismiss under express and implied preemption and TwIqbal. We will focus on the preemption part and will resist griping about how the TwIqbal analysis should have come before the preemption analysis. We cannot, however, avoid commenting on the decision to address whether state law claims—under the law of forty-two states—are preempted without looking at state law. While the defendant may have liked the court’s willingness to address preemption on a motion to dismiss—something the plaintiffs resisted—the limited analysis helped to predict the result. The court said that “there is little need to analyze the elements of underlying state laws” and that it was “merely deciding which claims, and which arguments within those claims, would run afoul of state requirements that differ from and add to federal regulations,” but states do not impose requirements unless there is some statutory or common law claim that fits what plaintiff is complaining about in the case. Id. at **61-62.

The court started its preemption analysis by citing some cases we like, such as Mensing and the Bexis favorite Puerto Rico v. Franklin California Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016), on no presumption against preemption. It then cited some cases we do not like, such as Mink and Bausch on parallel claims. Id. at *66. When it said this, we knew where things were headed:

So, if a plaintiff may succeed on her state law claim by proving conduct that violates federal requirements, then that claim parallels federal requirements. The state law reliance on a federal regulation need not be explicit. Rather the elements of traditional state laws need only be satisfied by conduct leading to a violation of a federal regulation.

Id. Not only is that bit of bad logic eerily reminiscent of another case following Bausch that we lambasted, but you might want to look at the “elements of traditional state laws” before you declare them parallel to federal requirements. And there is that whole Scylla/Buckman part of the preemption analysis that cannot be defined away. With this background, the court’s analysis actually started out pretty well with strict liability design defect claims getting sucked down into the sea. “[P]remarket approval is FDA recognition of a particular medial device’s fitness for the market. Having received that approval, the BHR system cannot be labeled unreasonably dangerous by state law without imposing requirements on medical devices different from or in addition to federal regulations.” Id. at **67-68 (citing Reigel). Not bad.

The rest was. Claims for undifferentiated negligence, negligence per se—with no separate analysis—failure to warn, negligent misrepresentation, express warranty, and manufacturing defect were all considered parallel claims because they were based on the manufacturer’s “alleged failure to comply with duties already required by the FDA.” Id. at **69-70. Even if were not for Buckman, this is not what makes a state law claim parallel to a federal requirement. There needs to be a state law requirement that exists independent of FDA requirements and then it has to be parallel to the federal requirements. If state law required truthful communications about the risks and benefits of all products sold in the state and FDA required specific formats for communications about an approved device, but generally that communications about its risks and benefits be truthful, then that could be parallel. Those state law requirements probably apply equally to mushrooms as they do to implanted prescription medical devices.

By contrast, the purported state law requirement to train surgeons would be different than and in addition to federal requirements, because there is neither a federal requirement that surgeons be trained—states regulate the practice of medicine—nor a state law requirement that a manufacturer train surgeons before they can use its products. The court is correct that this claim is not impliedly preempted—it is not based on a federal requirement—but there needs to be a cognizable state law duty requiring training in the first place. Id. at *69 n.11. Similarly, the court held that a “failure to warn” claim based on reporting adverse events to FDA would not be expressly preempted, without considering whether state law imposes any duty to report—it does not. Id. at * 71. A claim for failure to warn “the general public or the medical community is, however, expressly preempted because there is no such parallel federal requirement”—but there is similarly no actual state law duty. Id. For negligent misrepresentation and express warranty, there are state law duties independent of any federal obligations and, here, we are not critical of the analysis. False marketing claims that a product is safer than it is or safer than a competing device can give rise to liability regardless of FDA requirements. So, we are fine with the court’s statement that “any state law claim that imposes liability for making false statements regarding the device’s relative safety parallels federal requirements,” even if we do not think the cases cited for that proposition are all good law. Id. at **72-73. We also agree that misrepresentation and warranty claims cannot be based on the alleged falsity of FDA-required statements about the device. Id. at *73. On manufacturing defect, the court reverted to an incomplete analysis, assuming that deviations from “the FDA’s approved design of the BHR device” could give rise to non-preempted state law claims, ignoring state law claims require manufacturing defects to render a product dangerous. Id. at *73.

Having found all these claims based on purported violations of FDA requirements to escape express preemption, without considering whether any state law authorized them, the court gave short shrift to implied preemption

All of the plaintiffs’ claims in the MACC fall within the states’ traditional power to regulate matters of health and safety. Not one cause of action tries to enforce a legal right held by a federal agency or relies on the statutory scheme for its existence—they all long predated modern medical devices.

Id. at **75-76. This is neither an accurate recap of what Buckman means, nor consistent with how the court had characterized plaintiffs’ causes of action as not seeking to impose liability based on violating requirements that were different from or in addition to FDA requirements. Rather than belabor the problems with this court’s analysis, we will end with pretty obvious gaffe. In returning to the purported state law claim for “failure to warn” by failing to report adverse events to FDA, the court concluded that “plaintiff’s failure to warn claims do not attempt to enforce the FDA’s right to be warned of information concerning the safety of approved medical devices” because plaintiffs claimed failing to report adverse events to FDA “violated a legal right owed to them.” Id. at *77. Presumably, that would be a right that the law of a state—or, rather, the law of 42 separate states—bestowed on private citizens based solely on federal law. To put it mildly, this is the kind of mess than can happen when preemption analyses skip steps and make unwarranted assumptions.


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

We’ve posted on two other occasions about the Shuker v. Smith & Nephew case as the Eastern District of Pennsylvania systematically dismantled the case on the grounds of preemption and pleading deficiencies. You can find those posts here and here. Unfortunately, the recent Third Circuit opinion deciding plaintiff’s appeal isn’t the full affirmance we had been hoping for. But before you get the wrong idea, the Third Circuit got the most important issue right – when you have a multi-component medical device, PMA preemption is to be addressed on a component-by-component basis. After that, however, the appellate decision does some unraveling of the district’s dismissal of the claims that survived preemption and so the case is going back to the Eastern District.

Briefly, the facts are that plaintiff underwent a hip replacement surgery in which his surgeon opted to use a Smith & Nephew device that consisted of several component parts, one of which was the R3 metal liner. Shuker v. Smith & Nephew, PLC, 2018 U.S. App. LEXIS 5160, *11 (3d Cir. Mar. 1, 2018). Unlike the other components of the device, the liner had undergone FDA Pre-Market approval. Id. And, the parties are in agreement that the surgeon’s decision to use the R3 metal liner with this particular device was an off-label use. Id. at *12. Plaintiff suffered complications that required additional revision surgeries.

In its first decision, the district court tossed out almost all claims as preempted and any non-preempted claims for being inadequately pleaded. When plaintiff filed an amended complaint attempting to correct the pleading deficiencies for the non-preempted claims, he again missed the mark and his remaining claims were dismissed with prejudice. The district court also entered a decision finding that it lacked personal jurisdiction over Smith & Nephew, PLC – a foreign parent company. Those three rulings are what the Third Circuit addressed in last week’s decision.

The question of how to apply PMA-preemption to a multi-component device was one of first impression in the Courts of Appeal. Id. at *2. And it is an important question because surgeons engaging in off-label use do mix and match parts with different regulatory backgrounds. The Third Circuit did a precise analysis that landed at the proper conclusion. However, the analysis does start up with a bit of a hiccup. Since we are talking about PMA-preemption, we are dealing with express preemption. Yet, in a footnote the court refused to follow the Supreme Court’s recent abolition of the presumption against preemption in the express preemption context set forth in Puerto Rico v. Franklin Cal. Tax-Free Tr., 136 S.Ct. 1938 (2016), because that decision wasn’t a products liability case and therefore did not directly concern the “historic police powers of the States.” Shuker, at *16n.9. We respectfully disagree with this conclusion for all the reasons we mention in our post discussing Franklin and simply point out that other courts have reached the opposite conclusion. Accord Watson v. Air Methods Corp., 870 F.3d 812, 817 (8th Cir. 2017) (following Franklin and rejecting presumption against preemption in express preemption case); EagleMed LLC v. Cox, 868 F.3d 893, 903, (10th Cir. 2017) (same); Atay v. Cty. of Maui, 842 F.3d 688, 699 (9th Cir. 2016) (same); Conklin v. Medtronic, Inc., ___ P.3d ___, 2017 WL 4682107, at *2 (Ariz. App. Oct. 19, 2017) (under Franklin courts may not invoke a presumption against preemption in PMA preemption cases); Olmstead v. Bayer Corp., 2017 WL 3498696, at *3 n.2 (N.D.N.Y. Aug. 15, 2017) (plaintiff’s assertion of presumption against preemption in PMA preemption case held “frivolous” after Franklin).

Fortunately, that did not derail the Third Circuit from ultimately concluding that plaintiff’s negligence, strict liability, and breach of implied warranty claims were all preempted under Riegel. To do that, the court had to determine to what device it was applying the preemption analysis. Plaintiff argued that you have to look at the device that was implanted as a whole. Whereas defendant, bolstered by an amicus brief filed by the FDA at the court’s request, maintained that the proper focus is on the component of the device with which plaintiff takes issue. Shuker, at *18. Agreeing with the defense position, the court anchored its decision on three findings. First, the FDCA defines “device” to include “components, parts, and accessories.” Id. at *19. Second, the FDCA’s off-label provisions specifically acknowledge that a physician can and will use components separately from the system for which the FDA approved use. Id. at *20. And despite the use to which the component is put, the FDA’s PMA-regulations for the component follow with it. In other words, “premarket approval requirements apply equally to the components, as manufacturers generally may not deviate from the requirements imposed through premarket approval regardless of how [a component] is used.” Id. (citation and quotation marks omitted). Third, the FDA’s position is that the device is not limited to the device as a whole but includes components. Further, the FDA is charged with assuring the safety and effectiveness of components as well as finished devices. Id. at *21-22.


[t]aken together, the statutory definition of “device,” the treatment of off-label uses, and the guidance of the FDA all counsel in favor of scrutinizing hybrid systems at the component-level. . . .. And the Riegel test is properly framed at Step One as “whether the Federal Government has established requirements applicable” to a component of the hybrid system.

Id. at *22-23. Because the part of the device plaintiff attacked was the R3 metal liner which was premarket-approved, any state tort claim that seeks to impose requirements that are different from or in addition to the FDA’s requirements for that component are preempted. That includes plaintiff’s negligence, strict liability, and implied warranty claims.

The appellate court next reviewed the dismissal of plaintiff’s claims that survived preemption – negligence and fraud claims based on alleged off-label promotion in violation of federal law – and found the negligence claim was adequately pleaded but that plaintiff failed again to satisfy Rule 9’s heightened standard for pleading fraud. As to negligence, the court found TwIqbal satisfied as to duty, breach, causation where plaintiff alleged:

  • the R3 metal liner was approved only for use with a different system and therefore under federal law defendant had a duty to refrain from false or misleading advertising;
  • in a press release, defendant misleadingly marketed the R3 metal liner as an option for the system used by plaintiff’s surgeon (one other than the one it was approved for); and
  • plaintiff’s surgeon “either read” or “was aware” of the press release.

Id. at *28-29. Like the district court, the Third Circuit considered and relied upon the press release cited in plaintiff’s complaint. Unlike the district court, the Third Circuit appears to only focus on the portions of the press release upon which plaintiff relied (see prior post for more details) and concludes that’s enough to get plaintiff to the discovery stage. Id. at *29n.18. Although we wonder if the court’s calling plaintiff’s allegations enough to “nudge” the claim over the threshold is a veiled acknowledgement of just how narrowly the complaint squeaked by. See id. at *30.

Meanwhile, plaintiff’s fraud claim needed more than a nudge and it didn’t get even that. The court focused on plaintiff’s failure to plead justifiable reliance on the alleged misrepresentation. The “read” or “was aware” of allegation that sufficed for negligence lacked the requisite details regarding how the press release “induced or influenced” plaintiff’s surgeon for a fraud claim. Id. at *33-34. Plaintiff has to allege the “circumstances of the alleged [influence on Mr. Shuker’s surgeon] with sufficient particularity to place [defendant] on notice of the precise misconduct with which it is charged.” Id. at *34. Despite this having been plaintiff’s second failed attempt at meeting the pleading standard on fraud, the Third Circuit decided to give plaintiff another chance and found the claim should only be dismissed without prejudice.

Finally, there was a separate finding by the district court that it did not have personal jurisdiction over Smith & Nephew, PLC, a foreign parent company. The Third Circuit agreed with the district court that specific personal jurisdiction was not conferred on a stream-of-commerce theory. Id. at *36-37. We’ve talked about this before and more recently in light of BMS v. Superior Court, and like the Third Circuit “we have no cause to revisit” the precedent on the issue (but you should feel free to). But the court did think plaintiff alleged enough in his complaint to allow some limited jurisdictional discovery on possible alter ego based personal jurisdiction. Id. at *38-40. Emphasis on the limited part. See id. at *40n.20 (“District Court should take care to circumscribe the scope of discovery . . . to only the factual questions necessary to determine its jurisdiction;” further referencing proportionality amendment to Rule 26(b)(1)).

So, on the third pass plaintiff got a little life breathed back into this case which is unfortunate, but as the first appellate decision on component preemption – we’ll put it in the win column.

Today we have a guest post from Reed Smith‘s Elizabeth Minerd discussing a PMA preemption case dealing with unusual “parallel claim” allegations involving the conduct of clinical trials.  As always our guest posters are 100% responsible for what they write and deserve 100% of the credit (and any blame) for what follows.  Take it away Liz.


Ever since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), in cases involving premarket-approved (“PMA”) devices, plaintiffs have taken to loading their complaints with allegations of violations of federal requirements in an attempt to escape federal preemption.  Fortunately, many courts have demonstrated a willingness to sort through these allegations and throw out those that do not fit through the oft-cited “narrow gap” between express and implied preemption described in In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010).  See the blog’s PMA preemption scorecard.  In Gravitt v. Mentor Worldwide, LLC, 2018 U.S. Dist. LEXIS 4822 (N.D. Ill. Jan. 11, 2018), the Northern District of Illinois once again did just that.

In Gravitt, the plaintiffs alleged that the wife plaintiff was implanted with a premarket-approved silicone breast implant (in the wake of the Breast Implant mass tort of the 20th century, such implants were required to obtain PMA, and are now protected by preemption). Id. at *8-9.  The plaintiffs asserted the usual claims against the defendant manufacturer: negligence, strict products liability (manufacturing and marketing), strict products liability (failure to warn), and loss of consortium. Id. at *10.

Obviously anticipating a preemption motion, the plaintiffs packed their complaint with allegations of violations of federal requirements—including novel theories attacking the defendant’s conduct of certain post-approval studies and patient follow-up required by the FDA’s PMA letter. Id. at *4-*6.  According to the plaintiffs, the defendant’s conduct was deficient because:

  1. Participant follow-up in one study supporting the PMA application was 6 years, instead of 10;
  2. Participant follow-up in the same study supporting the PMA application was less than 100%;
  3. A post-approval study did not have a sufficient number of participants;
  4. Participant follow-up in that post-approval study was not high enough; and
  5. The defendant did not provide sufficient detail about why study participants required additional surgical intervention.

Id. at *4-*6.

The court methodically addressed each of these alleged deficiencies to determine whether any fit through the “narrow gap” between express and implied preemption. Unfortunately for the plaintiffs, fortunately for the defense, none did.  Thus, defendants achieved a rare preemption win in a court bound by the notoriously bad decision, Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010).

First, the court analyzed each deficiency through the lens of express preemption—i.e., asking, “did this alleged deficiency actually violate a federal requirement?”  The court found that the first three deficiencies (if true) would violate specific requirements enumerated in the PMA letter. Gravitt, 2018 U.S. Dist. LEXIS 4822, at *21-*22.  However, the court found no federal requirement addressing the last two purported deficiencies because “the [PMA] letter does not require any particular follow-up rate for that study” and the plaintiffs did not even allege “that the [PMA] letter or any other federal law required [defendant] to provide more detailed reasons for re-operation than it actually provided.” Id. at *18-*19.  Thus, items 4 and 5 were expressly preempted.

Second, the court analyzed the three remaining deficiencies through the lens of implied preemption—i.e., asking “did this alleged deficiency violate a traditional tort duty under Illinois law?”  Here, the court answered “no” for every one of the remaining purported deficiencies, rendering them impliedly preempted.  The court reasoned that there was no “well-recognized duty owed to [the plaintiffs] under state law” requiring the defendant to follow up with study participants for 6 instead of 10 years, follow-up with all study participants, or enroll a specific number of study participants. Id. at *24-*25 (quoting Bausch, 630 F.3d at 558).  More generally, there simply are no state law requirements relating in any way to the methodology of FDA-mandated post-approval studies. Gravitt, 2018 U.S. Dist. LEXIS 4822, at *25.  Further, the plaintiffs made no effort to analogize these alleged deficiencies to any traditional state law failure to warn claim. Id.  Accordingly, the court dismissed plaintiffs’ novel claims based on alleged deficiencies in post-approval studies, id., creating valuable precedent in case any other plaintiff tries this type of preemption dodge.

Apart from the alleged deficiencies in the post-approval studies, the plaintiffs also alleged that the defendant had violated manufacturing standards based on allegations that the FDA had cited the defendant for non-compliance with manufacturing standards several times. Id. at *7-*8.  While the court recognized that, under Bausch, such a claim might survive express preemption (id. at *22), the court dismissed this theory as impliedly preempted because the plaintiffs failed to tie the alleged non-compliance with manufacturing standards to any state law claim that her specific device was defectively manufactured. Id. at *26.

The court did allow one narrow Stengel-type (failure to report) claim to survive based on the plaintiffs’ allegations that the defendant was aware of a higher rate of implant ruptures than it reported to the FDA. Id. at *27-*28.  The court reasoned that, were the plaintiffs to prove that the defendant concealed the true rate of implant ruptures from the FDA in violation of federal law, then the defendant “may have breached its state law duty to warn potential customers—and their physicians—of the product’s risks.” Id. at *31.

Overall, a solid win for the defense that significantly narrowed the scope of the plaintiffs’ claims going forward.