Child:  “Can I have ice cream before dinner?”

Parent:  “No”

Child:  “What if it’s strawberry ice cream?”

Parent:  “Still, no”

Child:  “What if my teacher told me I had to eat ice cream for homework?”

Parent: “Still, no”

Child:  “What if a monster ran in here right now and said I had to eat ice cream or he’d take me away to his evil lair forever?”

Parent:  “…..”

Child:  “Well”

Parent:  “Give me a minute, I’m thinking.”

            That’s the “What if” game.  If you’ve been a parent, you’ve played it in some form.  It’s a close cousin of the “Why” game or the “But” game.  It’s also possible that you played What If” during a late-night college cram session that led to a serious conversation about a zombie apocalypse.  Come to think of it, late-night camping, late-night tequila, or late-night horror movies are all stimuli for the zombie apocalypse “What If” game.

In the recent case of McDonald v. Schriner, 2019 U.S. Dist. LEXIS 34514 (W.D. Tenn. Mar. 5, 2019), the court allowed plaintiff to play the “What If” game on a motion to dismiss.  In this context, it’s probably more appropriately titled the “Assuming Arguendo” game.  This is how it went.

Plaintiff:  “Can I keep my claim?”

Court:  “No, you don’t have subject matter jurisdiction.”  Plaintiff’s complaint failed to allege the place of incorporation or principal place of business for any defendant, but rather only provided the address of their registered agents.  Id. at *7.  Because that doesn’t establish the residence of any defendant, the court could not determine if the parties were diverse and could not just assume they were.  Id.  Case dismissed.

Plaintiff:  “Assuming, arguendo, I fixed that and showed you there was diversity, can I keep my claim?”

Court:  “Still dismissed because you also don’t have personal jurisdiction.”  The court shot down general jurisdiction, but we don’t need to cover that since post  Daimler AG v. Bauman, 571 U.S. 117 (2014) we know “merely doing business” isn’t sufficient for general jurisdiction.  McDonald, 2019 U.S. Dist. LEXIS 34514, *10-12.  As to specific jurisdiction – jurisdiction only over claims that arise out of or relate to the defendant’s contacts with the forum – plaintiff couldn’t satisfy the first prong of the test, showing that defendant purposefully availed itself of acting in the forum.  Id. at *12.  In the Sixth Circuit, courts use a “stream of commerce plus” approach to determine purposeful availment.  Id. at *13.  The “plus” concerns things like the amount of control a defendant had over the flow of the product into the state or the quantity sold in the state.  But all plaintiff’s complaint alleged was the drug was sold in Tennessee.  Not enough.  Case dismissed.

Plaintiff:  “Assuming, arguendo, I added more allegations that satisfied the purposeful availment test, can I keep my claim?”

Court:  “Still dismissed because you’ve also failed to state a claim.”  In addition to the manufacturers of the drug at issue, plaintiff sued the pharmacy where he filled his prescriptions.  But claims against pharmacies in Tennessee are governed by the Tennessee Health Care Liability Act (“THCLA”) which requires both that plaintiff provide pre-suit notice and a certificate of good faith – neither of which plaintiff did.  Id. at *16-17.  Pharmacy case dismissed.

Plaintiff’s claims against the manufacturer are governed by the Tennessee Products Liability Act (“TLPA”).  First and foremost, the TLPA provides that FDA-approved products are “presumptively not defective or unreasonably dangerous.”  Id. at *17.  But plaintiff’s only allegation of defect was a conclusory statement that the drug used to treat his restless leg syndrome induced his gambling.  That wasn’t enough to rebut the presumption or to show that the alleged defect existed at the time the drug left the manufacturer’s control.  Id. at *18.  Plaintiff also failed to state a claim for failure to warn.  He didn’t allege any facts about the warnings.  In fact the complaint only included a conclusory allegation that his losses were caused by a failure to warn.”  Id. at *19.  Manufacturer case dismissed.

But, there was one last “What if.”  Plaintiff never bothered to respond to defendants’ motions to dismiss.  Instead, only after the magistrate issued his report and recommendations and after the time allowed for objections to the magistrate’s findings did plaintiff file an objection.  Id. at *20.  So,

Plaintiff:  “Assuming, arguendo, I had timely raised any of my responses or objections, would I get to keep my case?”

Court:  “Still dismissed.”  In fact, the only new facts plaintiff’s objections added was that he couldn’t remember any effective warnings.  What he still didn’t allege was that he read or attempted to read the warnings when they were provided to him.  Id. at *22.  So, plaintiff’s claims failed for lack of proximate cause.

Having running out of “assuming, arguendo” propositions, the Court had the last words:  “Dismissed with prejudice.”

That is the intriguing title of the latest law review article written by the “Rabbi of Torts,” Prof. Aaron Twerski (we’re not making this up, Prof. Twerski’s Wikipedia page is the fifth result when we just Googled that phrase).  Prof. Twerski, one of the ALI’s reporters for the Restatement (Third) of Torts:  Products Liability, has probably spilled as much ink as anyone in making sense of Restatement (Second) of Torts §402A, comment k (1965), one of the more opaque parts of the venerable §402A.  Indeed, in a prior article, Prof. Twerski divined fully eight different interpretations of comment k, the Second Restatement’s discussion of, among other things, design defect claims involving prescription medical products (mostly drugs and vaccines, as medical devices were much less common back in 1965).  See James A. Henderson, Jr. & Aaron D. Twerski, “Drug Design Liability: Farewell to Comment K,” 67 Baylor L. Rev. 521, 542-44 (2015).

Then there’s the Third Restatement, which sought to replace comment k’s approach to design defect claims involving “unavoidably unsafe” products with:

§6 Liability of Commercial Seller or Distributor for Harm Caused by Defective Prescription Drugs and Medical Devices

*          *          *          *

(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(c) (1998).

As we’ve chronicled on the blog, most courts still continue to grapple with comment k.  Conversely, §6(c) has received a mixed and tepid response from the courts.  Now Prof. Twerski has essentially concluded that further explication of the courts’ Talmudic approach to comment k and design defect claims in our sandbox is futile – such claims are all federally preempted.  That, of course, is something we’ve been saying on the Blog since the moment Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), was decided five years ago.  See, e.g., here, here, here, and here.  But we’re just bloggers; Prof. Twerski is an institution.  We’re flattered simply to be cited as authority on par with law reviews and other scholarly works.  See footnotes 6 & 19.

Here’s a link to Prof. Twerski’s latest article on SSRN.  Its formal citation is, 68(1) Am. Univ. L.R. 281-304 (2018).  The first thing we note about the article is that the title is limited to “drugs,” as opposed to medical devices.  Nothing in the article, however, expressly distinguishes medical devices, and Prof. Twerski concludes that the limited cause of action permitted by Restatement (Third) §6(c) – which treats prescription drugs and medical devices identically – is, indeed, preempted:

The Restatement test ultimately allows a common law design defect claim to prevail over the FDA’s approval of a drug.  The only thing that a defendant can do to escape liability is to stop selling the drug − a position that is in direct contravention of Bartlett.  Perhaps for a drug that is so egregiously dangerous, the Supreme Court might craft an exception to Bartlett.  But, otherwise, the Bartlett dissent is quite correct in predicting that the majority has rendered drug design defect immune from common law actions.

“Demise of Drug Design Litigation,” 68(1) Am. Univ. L.R. at 302 (footnotes omitted).

As we’ve pointed out on a number of occasions, most recently in our discussion of Gustavsen v. Alcon Laboratories, Inc., 903 F.3d 1 (1st Cir. 2018), the Mensing/Bartlett basis for impossibility preemption – that the FDA must pre-approve “major changes” to product designs, and therefore regulated manufacturers cannot act immediately and unilaterally to change “defective” designs, as state tort law requires − applies equally to design changes for both drugs and medical devices.

Interestingly, we also note that Prof. Twerski speculated that the Gustavsen preemption decision – then in the district court (the First Circuit decision was too recent to be in his article) – might be within “a small subset of design claims [that] may not be preempted.”  68(1) Am. Univ. L.R. at 303.  Prof. Twerski’s reasoning was “that the Supreme Court might take issue with the FDA characterization of a change in volume of the drops created by the bottle’s stopper as a ‘major change’ requiring FDA approval.”  Id.  Well, the First Circuit affirmed preemption of “major changes,” and it doesn’t seem like the plaintiffs in Gustavsen are as optimistic about their case as Prof. Twerski’s supposed they might be.  They did not bother appealing to the United States Supreme Court, and the deadline for doing so has expired.

Another interesting perspective offered by Prof. Twerski is that Bartlett was improperly decided – not on preemption, but as a matter of New Hampshire state law.  68(1) Am. Univ. L.R. at 284.  The Court in Bartlett held, as to New Hampshire product liability law:

But respondent’s argument conflates what we will call a “strict-liability” regime (in which liability does not depend on negligence, but still signals the breach of a duty) with what we will call an “absolute-liability” regime (in which liability does not reflect the breach of any duties at all, but merely serves to spread risk).  New Hampshire has adopted the former, not the latter.  Indeed, the New Hampshire Supreme Court has consistently held that the manufacturer of a product has a “duty to design his product reasonably safely for the uses which he can foresee.”

570 U.S. at 481 (string citation of New Hampshire cases omitted).  Prof. Twerski’s analysis, turning on a case Bartlett did not cite, Vautour v. Body Master Sport Industries, Inc., 784 A.2d 1178 (N.H. 2001), posits, instead, that in Vautour New Hampshire product liability became “absolute liability” based on pure risk/utility balancing, without any need for the plaintiff to assert an alternative design.

This is not the forum to rehash our strong objection to [absolute liability].  The point is that New Hampshire has embraced it.  Thus, liability was not regulatory in the sense that Justice Alito set forth in Bartlett.  New Hampshire did not impose a duty on [defendant] to develop a better warning nor did it require [defendant] to redesign [the drug].  It simply allowed a jury to find that the [drug], as designed with the warnings as given, was unreasonably dangerous.

68(1) Am. Univ. L.R. at 292-93 (footnotes omitted).

Pointing to the footnote in Bartlett (570 U.S. at 482 n.1) “sav[ing] for another day” the issue “whether a true absolute-liability state-law system could give rise to impossibility pre-emption,” Prof. Twerski suggests that Bartlett should have come to grips with the application of impossibility preemption to an absolute liability system of product liability.  68(1) Am. Univ. L.R. at 293-94.  We think that Bartlett actually did address absolute liability, perhaps back-handedly, in its discussion of the plaintiff’s claim that the defendant should never have sold its FDA-approved product.  What is that theory, if not absolute liability?  Liability, under a stop-selling theory seems pretty “absolute” to us, since the only way to avoid liability would be not to sell the product at all. Bartlett had no trouble holding that theory preempted:

The incoherence of the stop-selling theory becomes plain when viewed through the lens of our previous cases.  In every instance in which the Court has found impossibility pre-emption, the “direct conflict” between federal- and state-law duties could easily have been avoided if the regulated actor had simply ceased acting. . . .  Adopting the First Circuit’s stop-selling rationale would mean that not only [Mensing], but also the vast majority − if not all − of the cases in which the Court has found impossibility pre-emption, were wrongly decided.  Just as the prospect that a regulated actor could avoid liability under both state and federal law by simply leaving the market did not undermine the impossibility analysis in [Mensing], so it is irrelevant to our analysis here.

570 U.S. at 488-90 (detailed description of particular cases omitted).

So, did Bartlett mess up New Hampshire law?  Prof. Twerski makes a pretty convincing case as to what New Hampshire law actually is, but ultimately we don’t think it makes much difference.  First, we think that the majority in Bartlett was not interested in deciding the case based on New Hampshire having some sort of bats**t crazy tort regime, but rather wanted to emphasize preemption of more mainstream forms of product liability.  Second, nothing in Bartlett, and in particular in its affirmance of “stop-selling” preemption, indicates that absolute liability would escape the fate of other, more widely accepted, design defect liability theories.

Ultimately, Prof. Twerski concurs in that assessment.  Pure risk/utility balancing amounts to a definitively preempted stop-selling claim:

Can the state allow a common law remedy based on a finding of unreasonable danger, thus negating the FDA’s determination that the drug is reasonably safe so that it is approved for marketing? . . .  After running out of state common law duties to make the drug safer, the defendant was left with the sole option of not marketing a FDA approved drug to avoid tort liability.  This remaining option, however, is an option that Bartlett teaches flies in the teeth of preemption jurisprudence.

68(1) Am. Univ. L.R. at 300-01 (footnotes omitted).

Second, the most widely followed design defect rationale – risk/utility balancing of reasonable alternative designs (“RAD”) is precisely what Bartlett preempted:

[P]ost-Bartlett, it would seem quite clear that, for a drug that has received FDA approval, any argument that it can be modified by a RAD is federally preempted.  Justice Alito’s reasoning leaves little doubt when he said that “once a drug − whether generic or brand name- − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug.”’  If a court were to find a post-FDA approval drug to be a RAD, it would almost certainly be struck down on the same impossibility grounds set forth in Bartlett.

Id. at 295 (footnotes omitted).

Third, Prof. Twerski (like us) has only scorn for the “pre-approval design defect” theory that plaintiffs have turned to as an argument to avoid preemption.

How a court could censure a manufacturer for not developing a different drug without any assurance of its safety by the FDA is beyond comprehension.  As to preemption, the court in [Mensing] made short order of the argument that a plaintiff could challenge an FDA approved drug based on the supposition of what the FDA might do if asked to respond to a change. . . .  None of the cases opting for the “pre-approval theory” have adequately responded to either the common law or preemption arguments that negate this novel theory.

Id. at 296-97 (footnotes omitted).

Finally, as already discussed, the design defect theory enshrined in Restatement (Third) §6(c) also runs afoul of preemption.  Id. at 302 (footnote omitted).

Thus, Prof. Twerski concludes that design defect claims involving prescription drugs are preempted no matter how the plaintiffs package them.  In the end, however, Prof. Twerski sheds no tears over the demise of design defect litigation against FDA-approved drugs.  Design-based theories have never really amounted to very much:

The overwhelming majority of cases against pharmaceuticals have always been based on failure to warn. . . . Drug design, despite the fascination of scholars with this issue, has played only a minor role in drug litigation. The pillars of the republic will not fall if this questionable theory is laid to rest.

Id. at 304. That’s a sentiment with which we whole-heartedly agree.  We are always interested in reading more of Prof. Twerski’s views on design defect preemption – particularly with respect to prescription medical devices.

Back in May, 3M won the first MDL bellwether trial in In re: Bair Hugger Forced Air Warning Devices Prods. Liab. Litig. (D. Minn.). The case was Gareis v. 3M Company and at the time of trial, the only claim remaining in the case was for strict liability design defect under South Carolina law. 2018 WL 5307824 at *1 (D. Minn. Oct. 26, 2018). Plaintiff’s negligence, failure to warn, unfair and deceptive trade practices, misrepresentation, and unjust enrichment claims had all been dismissed on summary judgment. Following the defense verdict, plaintiff moved for a new trial based on dangerously thin grounds. The kind of grounds that simply crumble when even the slightest force is brought to bear. And that’s pretty much what happened. Plaintiff’s arguments just fell apart.

Plaintiff’s first argument was that the court improperly excluded evidence that would have helped him prove a design defect. Id. at *2. And the court’s first conclusion was that plaintiff “identif[ied] no prejudice” from the exclusion of the evidence. With no discussion of how the trial result would vary with the admission of the evidence, plaintiff’s motion had to be denied. Id. But the court also went on to explain why the evidence was properly excluded.

Plaintiff wanted to admit evidence of defendant’s “knowledge of risk-utility.” Id. But, “the manufacturer’s mental state is not an element of a strict liability claim for design defect.” Id. Under South Carolina law, the focus in a strict liability “centers upon the alleged defectively designed product,” not the manufacturer’s conduct. Id. Since the evidence wouldn’t go to an element of plaintiff’s claim, it was irrelevant and inadmissible. Plaintiff also argued that certain alternative design evidence was improperly excluded based solely on the argument that he should not have been limited to only alternative designs that “achieve the same function by the same mechanism.” Id. at *3. In other words, plaintiff wanted to introduce “alternatives” that were actually “different” products. That bare bones assertion didn’t move the court to go back and revisit its already correct in limine ruling on the issue.

Plaintiff then moved on to evidence it argued was improperly admitted. Testimony by defense experts that plaintiff alleged was not disclosed in the expert’s Rule 26 disclosures and therefore was inadmissible at trial. But, it you’re going to argue surprise – it really needs to be a surprise. For example, plaintiff argued that defendant’s expert did not disclose that he intended to use a video of a study used to validate his experiment and therefore plaintiff couldn’t effectively cross-examine the witness regarding the details of the experiment. Id. at *4. But, plaintiff saw the video during the MDL Science Day, referenced it in his motion to exclude defendant’s expert, knew that it was available on defendant’s website, and even question the expert about it at his deposition. Id. Not really a sneak attack. The court found no violation of the Rule 26’s disclosure requirements, but even if there had been, “the admission of the video was harmless.” Id. Plaintiff tried to make the same argument about defense expert’s testimony concerning a study cited by plaintiff’s expert. While defendant’s expert didn’t cite the study, his report did opine on the substance of the study. Id. Again, hard to be surprised about a study your own expert relied on. There are a few other similar examples in the opinion.

Finally, plaintiff tried to argue that testimony that never happened should also have been excluded. Go ahead, you can re-read that sentence. It’s accurate. Evidence of FDA clearance of the device was excluded in limine. At trial, defense counsel started to ask a question about the FDA’s examination of the device to which plaintiff’s counsel immediately objected. The objection was sustained. The question was not answered. At sidebar, plaintiff asked that the testimony be stricken. The court denied the request because there was no testimony to strike. Plaintiff argued that the failure to strike testimony that didn’t exist was grounds for a new trial. The court didn’t agree. No new trial. Id. at *6. Bair Hugger score remains 1-0 defendant.

This isn’t the first time we’ve written about the Hyde case in the Bard IVC Filters MDL.  Back in July we reported on some pretrial rulings in that bellwether case.  Get ready for more.  The decision on tap for today, Hyde v. C.R. Bard, Inc., 2018 WL 4215028 (D. Arizona Sept. 4, 2018), is sort of a man-bites-dog item, as it involves a motion in limine by the plaintiffs to exclude warnings information.  Generally, we on the defense side are the ones arguing to keep prejudicial information out, so the posture of Hyde is interesting.  Just in case you haven’t committed the facts of Hyde to memory, here’s a refresher:  Mrs. Hyde received an IVC filter implant in 2011.  Three years later, she learned that the filter had tilted, perforated the IVC wall, and fractured.  The plaintiffs brought a lawsuit sounding in various theories.

[Interlude for discovery.  Interlude for motion practice.]

Applying Wisconsin law, the Court granted summary judgment on the failure to warn claims. (As we reported back in July, the plaintiffs proffered no evidence that a different warning would have inspired the doctor to employ a different device or do anything differently.)  That ruling left claims for strict liability design defect, negligent design, negligence per se, loss of consortium, and punitive damages.  In advance of trial, the plaintiffs filed a motion to exclude the device’s instructions for use (“IFU”) and certain guidelines published by the Society of Interventional Radiologists (“SIR”).  Usually, plaintiffs love to trot out the IFU and point out offending lacunae. What’s different here?

The plaintiffs argued that because the failure to warn claims had been dismissed, the instructions and warnings set forth in the IFU were no longer relevant to any issue in the case and should therefore be excluded.  Similarly, the plaintiffs argued that the SIR guidelines, which evinced the knowledge of IVC filter complications in the medical community, were no longer relevant in the wake of dismissal of the failure to warn claims.  According to the plaintiffs, design defect must be tested against consumer expectations, and the IFU and SIR guidelines play no role with respect to such consumer expectations.   Plainly, the plaintiffs wanted the IFU and SIR guidelines out.  The defendants wanted them in.   We’re guessing the IFU warnings must be quite clear and that the SIR guidelines must be quite helpful for the defense.

Luckily for the defendants, Wisconsin law was quite clear and quite helpful for them.  In 2011, the same year as the plaintiff’s implant, the Wisconsin legislature enacted tort reform that included adoption of  section 2 of the Restatement (Third) of Torts (1998).  (We wrote about the cheesehead tort reform here.)  Section 2 employs a risk-utility balancing test and consideration of a broad range of factors, including the instructions and warnings accompanying the product.  Consumer expectations are in that broad range of factors, but no longer make up the whole ballgame. They definitely are not a basis for excluding information otherwise relevant to safety.

Under post-2011 Wisconsin law, a jury must consider not only whether there was a reasonable alternative design, but also whether a failure to adopt that design rendered the filter “not reasonably safe.”  Can the IFU and the SIR guidelines help a jury answer that question?  Almost certainly, yes.  The SIR guidelines lay out the acceptable rates of risk in IVC filters. Thus, they are relevant to the jury’s determination of whether the filter was reasonably safe.  The IFU tells physicians about risks of the filters and how to mitigate them.  That information, too, is relevant in determining whether the filter was reasonably safe.  The defendants are free to argue to a jury that the warnings provided with the filter “disclosed the risks of complications, that the medical community was aware of those risks and found them to be acceptable, and that the omission of an alternative design therefore did not render the filter ‘not reasonably safe.’”

Moreover, the IFU and SIR guidelines are relevant to the plaintiffs’ punitive damages claims.  The plaintiffs will surely try to persuade the jury that the defendants acted with “malice.”  But what the defendants, via the IFU,  told physicians about the device’s risks is relevant to whether the defendants acted with “intentional disregard for patient safety.”   The SIR guidelines are relevant to the defendants’ “awareness of filter complication rates and the extent of harm posed by filter complications, and can also inform the jury of risk levels found acceptable by interventional radiologists – a relevant fact for deciding whether Defendants ‘acted with a disregard for patient safety.”

We began this post by remarking how odd it seemed that it was the defense that wanted warnings information in, and the plaintiffs that wanted it out.  It also seems a bit odd to us that it is the plaintiffs who are insisting on a strict line of demarcation between different tort theories (failure to warn vs. design defect), and the defense who treat the line as kind of fuzzy.  But we’ve seen something like this before.  You needn’t strain your memory too much to recall how in the Bartlett case the plaintiff tried to evade preemption by arguing that the case was only about design defect and that failure to warn was out of bounds.  The defense demonstrated that there were aspects of the design defect claim that were implicated by preemption principles.  The result was a resounding defense SCOTUS victory that many of us are trading heavily on today and expect to do so for a good long while.

“Thinking out of the box” has become a hackneyed phrase, but sometimes it is perfectly accurate.



Today’s case has a little bit of everything – choice of law, statutory compliance, alternative design, warnings causation. So, the decision is a bit of “grab bag” in addition to being a “mixed bag.”

The case is Hyde v. C.R. Bard, Inc., 2018 WL 3586404 (D. Ariz. Jul. 26, 2018). To begin with, plaintiff voluntarily withdrew several claims – manufacturing defect, breach of express warranty, failure to recall, and breach of implied warranty. Id. at *2. Defendant did not move for summary judgment on negligent design defect, negligence per se, or punitive damages – so those claims remain. That left failure to warn, misrepresentation and fraud, and strict liability design defect. Of those, only strict liability design defect survived. Id.

The court first had to decide which state’s law applied. Plaintiff was living in Wisconsin when she had the IVC filter implanted but did not experience any complications until after moving to Nevada. Plaintiff argued that Nevada law should apply as the location where the injury occurred. The court disagreed. Wisconsin, the forum state, applies a two-step analysis for choice of law questions. First, are one state’s contacts so minimal that applying that state’s law would be “officious intermeddling.” Id. The court found both states to have significant contacts with the case and so moved on to step two. This consists of the analysis of 5 factors. The court found three factors (maintenance of interstate order, simplification of the judicial task, and application of the better rule of law) to be neutral. Id. at *3-4. And the remaining two favored Wisconsin. As to predictability, the IVC filter was sold in Wisconsin, implanted in Wisconsin, and defendant’s interactions with the implanting surgeon took place in Wisconsin. So, defendant could reasonably expect Wisconsin law to apply to any products liability claims arising from the use of the filter. Id. at *4. As to the forum state’s interest, Wisconsin “has a strong interest in having its laws applied to corporations transacting business with the state. Id.

 Wisconsin’s product liability statute provides a presumption that a product is not defective if it complied with relevant standards or specifications approved by a state or federal agency – such as the FDA. Defendant therefore argued that because the IVC filter was cleared by the FDA via the 510(k) process, the presumption applied. The court however, refused to apply the statutory compliance presumption because the 510(k) process is not a safety review and therefore defendant was not entitled to the non-defectiveness presumption. Id. at *6.

Another defense to strict liability claims in Wisconsin is that the harm was caused by a known and inherent risk. Defendants argued, citing to publications, FDA documents, and plaintiff’s surgeon’s testimony, that the very complication suffered by plaintiff was well known in the medical community. Id. at *7. Plaintiff countered that while the general risk may be known, the fact that defendant’s filters had a higher adverse event rate than other filters was not known. The court decided that any challenge as to incident rates is a triable issue of fact for the jury. Id.

Turning to plaintiff’s burden of proof, to maintain a claim for strict liability design or warning defect, plaintiff has to establish that the risk of harm could have been “reduced or avoided” with a “reasonable alternative design or warning.” Id.   In this case, plaintiff’s expert pointed to anchors that were added to other of the defendant’s IVC filters as a specific and available alternative design. Defendant argued that plaintiffs in the litigation claim that those other IVC filters also are defective. Essentially plaintiff relied on an allegedly defective design as the alternative to the allegedly defective design at issue. Id. That feels like it should be a non-starter. But the court said that the alternative design only has to “reduce” the risk of harm. Id. So, if the alternative is slightly less defective that appears to be enough. Again, a bit of a head scratcher.

Moving on to failure to warn, the court found plaintiff’s claim failed for lack of evidence of causation. The court skirted the issue of learned intermediary, on which the Wisconsin Supreme Court has not ruled, finding that plaintiff identified no evidence that either plaintiff or her surgeon would have changed his/her decision regarding implanting the device. Id. at *8-9. In fact, plaintiff’s surgeon testified that he didn’t recall which filter was used or who made the decision to use that filter. He further testified that he trusted the FDA, the device was meeting the expectations of the FDA, and he wouldn’t have deferred implanting the filter where it was medically necessary. Id. at *9. Put all together, there was nothing in the record to establish that a warning about greater risks would have affected either the surgeon’s or the plaintiff’s decision to use the product.

That same rationale carried over to plaintiff’s misrepresentation and fraud claims where reliance is an essential element. Plaintiff never received any independent information from the defendant nor did she point to any information from the defendant on which her surgeon relied. Id. at *10.

So, the case remains although substantially cutback. Just two quick observations from reading between and outside the lines of the opinion as to negligence per se, on which defendant did not move for summary judgment. First, if 510(k) clearance doesn’t involve “safety,” how can negligence per se apply? It would seem that following the court’s logic, the 510(k) process does not rise to the level of a substantive standard of care that can support plaintiff’s negligence per se claim. Second, back in March we reported on another partial summary judgment win in the Bard IVC Filter MDL. In that case, this same court granted summary judgment on negligence per se finding that the claim could not be based on alleged FDCA violations because there is no private right of action to enforce the Act. See prior post here. From an outsider’s perspective, it feels like negligence per se should be out of this case as well.

You’ll have to excuse us a bit today.  This post is about product liability – specifically Pennsylvania product liability.  However, it is not really focused on prescription medical products.  But what can we say?  We were provoked.


“The dark side of the Force is a pathway to many abilities some consider to be unnatural.”   – Darth Sidious (a/k/a Sheev Palpatine).

Money and the dark side share many of the same attributes.

The first footnote of a new law review article, Wertheimer & Rahdert, “The Force Awakens:  Tincher, Section 402A, & the Third Restatement in Pennsylvania,” 27 Widener Com. L.R. 157 (2018), reveals that “[t]he preparation of this article was supported in part by a research grant from the Pennsylvania Association for Justice.”  Id. at 157 n.1.  So we were not surprised in the least that “Force Awakens” read like a plaintiff litigation expert’s opinion on Pennsylvania product liability law.  The scholarship was bought and paid for, after all.

Another conclusion we reached by the end of that article was more surprising.

The Pennsylvania Association for Justice wuz robbed.  Whatever they paid, they didn’t get what they paid for.

To explain. “Force Awakens” was an obvious response to our own Bexis’ 2017 91-page opus, J. Beck, “Rebooting Pennsylvania Product Liability Law: Tincher v. Omega Flex & the End of Azzarello Super-Strict Liability,” 26(2) Widener L.J. 91 (2017).  As the PAJ engagement no doubt required, Bexis article and the propositions it contains come in for criticism.  “Rebooting,” 26(2) Widener L.J. at 204-05.  Heck, “Force Awakens” was even published in the same law review (albeit with an intervening name change) as Bexis’ article.  The point-counterpoint can hardly be more obvious.

Except Bexis didn’t get any research grants.

The first way that “Force Awakens” doesn’t stack up is simply size.  Size matters if an article is going to cover all the bases.  If the 91 pages of Bexis’ article were kilos, it would weigh in as a heavyweight.  This 57-page counter-punch is, comparatively, a featherweight.

Of course, in scholarship, length is something, but not everything.

So what else?  We think “Force Awakens” wastes precious pages discussing non-Pennsylvania law.  Granted that, given Tincher’s discussion of California precedent, see “Rebooting,” 26(2) Widener L.J. at 144-45, 163-64, 169-70, reference to California law makes sense, but the extended discussion of New Jersey law, “Force Awakens,” 27 Widener Com. L.R. at 164-65, seems odd and tangential, at best.

But most of “Force Awakens” was predictable – intended to provide something that plaintiffs could cite for arguments that Tincher didn’t change much, and (probably more importantly) in support of the embattled post-Tincher suggested jury instructions critiqued in “Rebooting.”  Thus, much of “Force Awakens” is an apologia for the SSJI and (like an expert report) reflects the position of those who purchased the scholarship:

  • “The Tincher court chose to maintain strict liability, and once again it crystallized that choice by reaffirming Section 402A, while at the same time refusing to adopt the directives of the Third Restatement.”  27 Widener Com. L.R. at 193.
  • “[P]roduct liability in Pennsylvania remains a form of strict liability.”  Id. at 194.
  • “Under Tincher the ‘blackletter’ principles of section 402A clearly remain the baseline for Pennsylvania product liability law.”  Id. at 196-97.
  • “[W]here a plaintiff succeeds in proving that a product’s dangers exceed ascertainable consumer expectations, social cost-benefit balancing of risks and utilities is not required.”  Id. at 198.
  • “Pennsylvania courts can and should utilize Barker’s fairly detailed discussion of the relevant evidentiary considerations as a guide.”  Id. at 200.
  • Tincher’s explication of risk-utility analysis carefully avoids dependence on proof of a reasonable or feasible alternative design.”  Id. at 201.
  • “The [SSJI] Subcommittee sought to change instructions that were directly in conflict with Tincher, but to leave in place all other instructions. . . . This approach strikes us as essentially correct.”  Id. at 204.
  • “[T]hirteen of fifteen distinct charges or parts of [the PDI] charges employ the phrase “unreasonably dangerous” at least once”; “its ubiquity in the proposed PDI instructions strikes us as revealing overkill.”  Id. at 204 n.165.
  • “[W]e believe that the fundamental doctrinal assumption on which these [defense side] criticisms rest is incorrect.”  Id. at 206.
  • “By reaffirming Pennsylvania’s commitment to . . . Section 402A, [Tincher] clearly signaled that product liability is and should remain . . . a doctrine firmly founded on strict liability.”  Id.
  • “Because Tincher reaffirmed the strict liability character of product liability, it remains necessary to keep product liability separate from negligence.”  Id. at 206-07.
  • “As the [SSJI] properly recognized, courts must continue to draw that dividing line in their jury instructions.”  Id. at 207.
  • “For purposes of product liability under Section 402A, a product contains relevant dangers if it ‘lacks any element that is necessary to make it safe’ for an intended or foreseeable use, or if it ‘contains a condition that makes it unsafe’ for such use.”  Id. at 208.
  • “[W]e agree with the [SSJI] Subcommittee that it would be both premature and inconsistent with Tincher’s overarching perspective to draft new warning instructions based on dicta in the opinion regarding that subject.”  Id. at 208-09.
  • “The critics’ argument that the standard jury instructions should embrace a ‘state of the art’ defense is in our opinion entirely incorrect. . . .  This is a due care defense, pure and simple, and it sounds in negligence.”  Id. at 210.
  • “The Subcommittee used Barker’s revised list on the ground that it enabled more streamlined and efficient instructions.  As a practical matter we agree with this assessment. More importantly, we think the charge that the Subcommittee ignored the relevance of the Wade factors is incorrect.”  Id. at 211.

Overall, we found “Force Awakens” recitation of these (and other) pro-plaintiff talking points quite superficial.  To take just one example, the state-of-the-art discussion utterly ignores prior Pennsylvania appellate authority recognizing that such a defense exists as to risk/utility analysis, Hicks v. Dana Cos., 984 A.2d 943, 966 (Pa. Super. 2009), and never comes to grips with the black letter of the consumer expectation test requiring plaintiffs to prove that relevant product risks are “unknowable.  Bexis covered all that in some detail.  See “Rebooting,” 26(2) Widener L.J. at 164-72 (discussing state of the art issues).

Also inexplicably absent from “Force Awakens” is the Pennsylvania Supreme Court’s treatment of the “unreasonably dangerous” of Restatement §402A in Tincher.  “[T]he notion of ‘defective condition unreasonably dangerous’ is the normative principle of the strict liability cause of action.”  Tincher v. Omega Flex, Inc., 104 A.3d 328, 400 (Pa. 2014).

[I]n a jurisdiction following the Second Restatement formulation of strict liability in tort, the critical inquiry in affixing liability is whether a product is “defective”; in the context of a strict liability claim, whether a product is defective depends upon whether that product is “unreasonably dangerous.”

Id. at 380.  The “normative” nature of the unreasonably dangerous element is nowhere found in “Force Awakens” (the word never appears), and its status as “the critical inquiry” is buried in a footnote, 27 Widener Com. L.R. at 183 n.94, while the article describes other issues as “critical.”  Id. at 183 (“defective condition”), 193 (same), 194 (failure to satisfy defect tests).  Unreasonably dangerous as “overkill”?  We don’t think so.

Assuming that “Force Awakens” is used as intended to counter defense-side arguments about Tincher, we’ve found that, on a close read, the article includes some useful concessions, should defendants need to reply:

  • “Trial courts clearly may no longer rely on the jury instructions that had emanated from Azzarello.”  27 Widener Com. L.R. at 193.
  • “The fact that a product may be dangerous . . . does not automatically mean that it is also defective.”  Id. at 195.
  • “The Tincher court acknowledged that Third Restatement materials sometimes may be helpful.”  Id. at 197.
  • Tincher recognized a negligence strand that contributed to product liability law’s formation and continues to play a role in its development.”  Id. at 206.
  • “[T]he ‘unreasonably dangerous’ language of Section 402A need not be excised in its entirety from product liability jury instructions,” id. at 207 − precisely what the pro-plaintiff SSJI did.
  • “[T]he general [SSJI] statement that ‘[a] product is defective’ if it lacks a necessary safety feature or contains an unsafe condition qualifies as an overstatement.”  Id. at 208.
  • Tincher “reaffirmed the default position that plaintiffs typically bear the burden of persuasion in civil matters.”  Id. at 212.
  • “The [SSJI] Subcommittee’s minimalist approach, while comporting with Tincher’s appeals to modesty and caution, ends up offering little by way of guidance on a range of potentially vexing product liability issues.”  Id. at 212-13.

We think that last quote is a particularly important point of departure. The SSJI subcommittee has always been slow, particularly when the law shifts in favor of defendants.  It took over 40 years, for example, for the Pennsylvania SSJIs to incorporate learned intermediary rule instructions.  As “Force Awakens” concedes, after Tincher the subcommittee’s tendency hardened to the point of Azzarello-based ossification “offering little by way of guidance.”  Id. at 213.

We on the defense side take the opposite view − recognizing the need of the bench and bar to fill in some of these post-Tincher blanks.  In sharp contrast to the retrograde approach endorsed by “Force Awakens,” the defense side’s jury instructions are being expanded and updated.  The 2018 second edition, which has just been released to the public, not only incorporates the most recent post-Tincher precedent – including the Superior Court’s 2018 holding that giving an Azzarello strict liability instruction is now “a paradigm example of fundamental error,” Tincher v. Omega Flex, Inc., 180 A.3d 386, 399 (Pa. Super. 2018) – but also has expanded beyond strictly Tincher issues to include instructions on causation (3 different situations), component parts, and post-sale duty to warn.  Suggested instructions are just that, suggestions; only the defense believes in more, not less.

Finally, our mention of post-Tincher precedent in the preceding paragraph is at the heart of why we believe that PAJ didn’t get value for whatever it paid.  Tincher was decided in late 2014.  “Force Awakens” came out halfway through 2018 – 3 ½ years later.  Bexis’ “Rebooting” article collected and reviewed every post-Tincher decision right up until that article couldn’t be edited any longer.  “Force Awakens” is just the opposite.  Remarkably, it doesn’t cite a single post-Tincher Pennsylvania decision.  Not one.  That omission, we’re pleased (but surprised) to say, leaves our opponents without any precedential support – just a law review article ex cathedra.

If we had to speculate on the reason why “Force Awakens” went radio silent on Pennsylvania precedent, we would again analogize to a litigation expert report. The available data – here post-Tincher precedent – was not supportive of the positions that the authors were being paid to advocate.  So they did what other paid experts do:  ignore it.

So, where the other side goes silent, that’s a signal for us to pour it on.  Here’s our support for our contention that almost all post-Tincher decisions disagree with the positions being asserted in “Force Awakens.”

Rejecting argument that Tincher was a narrow decision that did not change anything

Tincher v. Omega Flex, Inc., 180 A.3d 386, 401-02 (Pa. Super. 2018) (“Tincher II”)

Renninger v. A&R Machine Shop, 163 A.3d 988, 1000 (Pa. Super. 2017)

Plaxe v. Fiegura, 2018 WL 2010025, at *6 (E.D. Pa. April 27, 2018)

After Tincher an Azzarello-“any element”/”guarantor” jury charge is reversible error

Tincher v. Omega Flex, Inc., 180 A.3d 386, 399-400 (Pa. Super. 2018) (“Tincher II”)

After Tincher courts need not be bound by Azzarello-era decisions

Renninger v. A&R Machine Shop, 163 A.3d 988, 1000 (Pa. Super. 2017)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *2 (E.D. Pa. Jan. 26, 2017)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *3 (W.D. Pa. July 14, 2016)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *7 (C.P. Clarion Co. Oct. 19, 2015)

Tincher requires that the product be “unreasonably dangerous”

Tincher v. Omega Flex, Inc., 180 A.3d 386, 401-02 (Pa. Super. 2018) (“Tincher II”)

High v. Pennsy Supply, Inc., 154 A.3d 341, 347 (Pa. Super. 2017)

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 696 (M.D. Pa. 2017)

Roudabush v. Rondo, Inc., 2017 WL 3912370, at *2 (W.D. Pa. Sept. 5, 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 450 (E.D. Pa. 2016)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *6-7 (E.D. Pa. Sept. 8, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *2 (W.D. Pa. July 14, 2016)

Stellar v. Allied Signal, Inc., 98 F. Supp.3d 790, 807 (E.D. Pa. 2015)

Nathan v. Techtronic Industries North America, Inc., 92 F. Supp.3d 264, 272 (M.D. Pa. 2015)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *3 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Mattocks v. AVI Food Systems, Inc., 2015 WL 13701408, at *8 (Pa. C.P. Mercer Co. April 14, 2015)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *2 & n.4 (Pa. C.P. Allegheny Co. April 4, 2016)

Explicitly applying Wade factors/cost-benefit balancing

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 695 (M.D. Pa. 2017)

Igwe v. Skaggs, 258 F. Supp.3d 596, 610 (W.D. Pa. 2017)

Punch v. Dollar Tree Stores, 2017 WL 752396, at *8 (Mag. W.D. Pa. Feb. 17, 2017), adopted, 2017 WL 1159735 (W.D. Pa. March 29, 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 451 (E.D. Pa. 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *2-3 (W.D. Pa. July 14, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 1019534, at *13-14 & n.16 (W.D. Pa. March 15, 2016)

Lewis v. Lycoming, 2015 WL 3444220, at *3 (E.D. Pa. May 29, 2015)

Capece v. Hess Maschinenfabrik GmbH & Co. KG, 2015 WL 1291798, at *3 n.2, 7 (M.D. Pa. March 20, 2015)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *2 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

High v. Pennsy Supply, Inc., 2016 WL 676409, at *2 (C.P. Dauphin Co. Feb. 18, 2016), rev’d on other grounds, 154 A.3d 341 (Pa. Super. 2017)

Mattocks v. AVI Food Systems, Inc., 2015 WL 13701408, at *9 (Pa. C.P. Mercer Co. April 14, 2015)

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *5 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *4 (C.P. Clarion Co. Oct. 19, 2015)

Summary judgment for lack of viable alternative design in risk/utility case

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *3 (Pa. C.P. Allegheny Co. April 4, 2016)

High v. Pennsy Supply, Inc., 2016 WL 676409, at *4 (C.P. Dauphin Co. Feb. 18, 2016), rev’d on other grounds, 154 A.3d 341 (Pa. Super. 2017)

Tincher does not shift risk/utility burden of proof

Capece v. Hess Maschinenfabrik GmbH & Co. KG, 2015 WL 1291798, at *3 n.1 (M.D. Pa. March 20, 2015)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *1 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *2 n.4 (Pa. C.P. Allegheny Co. April 4, 2016)

Tincher rejects blanket exclusion of “negligence concepts” in strict liability

Roverano v. John Crane, 177 A.3d 892, 907 n.9 (Pa. Super. 2017)

Renninger v. A&R Machine Shop, 163 A.3d 988, 997 (Pa. Super. 2017)

Webb v. Volvo Cars, LLC, 148 A.3d 473, 482-83 (Pa. Super. 2016)

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Mercurio v. Louisville Ladder, Inc., 2018 WL 2465181, at *7 (M.D. Pa. May 31, 2018)

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *6 (Mag. M.D. Pa. Sept. 27, 2017)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *2 (E.D. Pa. Jan. 26, 2017)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *6 (E.D. Pa. Sept. 8, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *2-3 (W.D. Pa. July 14, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 1019534, at *13 n.15 (W.D. Pa. March 15, 2016)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *7 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *3-4 (C.P. Clarion Co. Oct. 19, 2015)

Risk/utility test is similar to, and derived from, negligence

Renninger v. A&R Machine Shop, 163 A.3d 988, 997 (Pa. Super. 2017)

Webb v. Volvo Cars, LLC, 148 A.3d 473, 482 (Pa. Super. 2016)

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *6 (Mag. M.D. Pa. Sept. 27, 2017)

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 696 (M.D. Pa. 2017)

Punch v. Dollar Tree Stores, 2017 WL 752396, at *7 (Mag. W.D. Pa. Feb. 17, 2017), adopted, 2017 WL 1159735 (W.D. Pa. March 29, 2017)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *2 (E.D. Pa. Jan. 26, 2017)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *9 (E.D. Pa. Sept. 8, 2016)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *5 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *3-4 (C.P. Clarion Co. Oct. 19, 2015)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *8 (Pa. C.P. Clarion Co. April 17, 2015)

Risk/utility test requires expert testimony

Hatcher v. SCM Group, Inc., 167 F. Supp.3d 719, 724-25 (E.D. Pa. 2016)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *2 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *3 (Pa. C.P. Allegheny Co. April 4, 2016) (risks of alternative design)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *4 (Pa. C.P. Clarion Co. April 17, 2015)

Tincher requires jury instruction on “unreasonably dangerous”

Tincher v. Omega Flex, Inc., 180 A.3d 386, 401-02 (Pa. Super. 2018) (“Tincher II”)

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620-21 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Rejecting Azzarello guarantor/any element jury instruction

Tincher v. Omega Flex, Inc., 180 A.3d 386, 399-400 (Pa. Super. 2018) (“Tincher II”)

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *3-4 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017)

Consumer expectation test held inappropriate

Igwe v. Skaggs, 258 F. Supp.3d 596, 611 (W.D. Pa. 2017) (known risk)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 452-53 (E.D. Pa. 2016) (complexity)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *8-9 (E.D. Pa. Sept. 8, 2016)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *5 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Capece v. Hess Maschinenfabrik GmbH & Co. KG, 2015 WL 1291798 (M.D. Pa. March 20, 2015) (conceded inappropriate to mechanical equipment – concrete block maker)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017) (known risk)

Mattocks v. AVI Food Systems, Inc., 2015 WL 13701408, at *9 (Pa. C.P. Mercer Co. April 14, 2015) (obvious risk)

Consumer expectation test based on objective, reasonable consumer (not plaintiff)

High v. Pennsy Supply, Inc., 154 A.3d 341, 348-49 (Pa. Super. 2017)

Igwe v. Skaggs, 258 F. Supp.3d 596, 610 (W.D. Pa. 2017)

Yazdani v. BMW of North America, LLC, 188 F. Supp.3d 486, 493 (E.D. Pa. 2016)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 450-52 (E.D. Pa. 2016)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *7 (E.D. Pa. Sept. 8, 2016)

Bailey v. B.S. Quarries, Inc., 2016 WL 1271381, at *15 (M.D. Pa. March 31, 2016), appeal dismissed, 674 F. Appx. 149 (3d Cir. 2017)

Lewis v. Lycoming, 2015 WL 3444220, at *3 (E.D. Pa. May 29, 2015)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *2 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

Strict liability only applies to a manufacturer’s own products

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 712 (M.D. Pa. 2017)

McLaud v. Industrial Resources, Inc., 2016 WL 7048987, at *7 (M.D. Pa. Dec. 5, 2016), aff’d, 715 F. Appx. 115 (3d Cir. 2017)

Schwartz v. Abex Corp., 106 F. Supp.3d 626, 653-54 (E.D. Pa. 2015)

Tincher principles apply to warning claims

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Igwe v. Skaggs, 258 F. Supp.3d 596, 609-10 (W.D. Pa. 2017)

Bailey v. B.S. Quarries, Inc., 2016 WL 1271381, at *15 (M.D. Pa. March 31, 2016), appeal dismissed, 674 F. Appx. 149 (3d Cir. 2017)

Trask v. Olin Corp., 2016 WL 1255302, at *9 n.20 (W.D. Pa. March 31, 2016)

Williams v. U-Haul International, Inc., 2015 WL 171846, at *3 n.6 (E.D. Pa. Jan. 14, 2015) (subsequently vacated in part on other grounds having to do with negligence, 2015 WL 790142)

Horst v. Union Carbide Corp., 2016 WL 1670272, at *16 (Pa. C.P. Lackawanna Co. April 27, 2016)

Product must be “unreasonably dangerous” without a warning

High v. Pennsy Supply, Inc., 154 A.3d 341, 351 (Pa. Super. 2017)

Igwe v. Skaggs, 258 F. Supp.3d 596, 612, 614-15 (W.D. Pa. 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 453-54 (E.D. Pa. 2016)

Hatcher v. SCM Group, Inc., 167 F. Supp.3d 719, 725, 727 (E.D. Pa. 2016)

Inman v. General Electric Co., 2016 WL 5106939, at *7 (W.D. Pa. Sept. 20, 2016)

Post-sale duty to warn continues to require defect at sale

Trask v. Olin Corp., 2016 WL 1255302, at *9 (W.D. Pa. March 31, 2016)

Evidence of product user’s negligent conduct admissible as relevant to risk/utility

Punch v. Dollar Tree Stores, 2017 WL 752396, at *11 (Mag. W.D. Pa. Feb. 17, 2017), adopted, 2017 WL 1159735 (W.D. Pa. March 29, 2017)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *4 (C.P. Clarion Co. Oct. 19, 2015)

Evidence of third-party’s negligent conduct admissible as relevant to risk/utility

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *5-6 (Mag. M.D. Pa. Sept. 27, 2017)

Evidence of product user’s knowledge admissible as relevant to consumer expectation

Igwe v. Skaggs, 258 F. Supp.3d 596, 611-12 (W.D. Pa. 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 452 (E.D. Pa. 2016)

Evidence of product warnings relevant to consumer expectation

Igwe v. Skaggs, 258 F. Supp.3d 596, 610-11 (W.D. Pa. 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 452-53 (E.D. Pa. 2016)

Evidence of product user’s negligent conduct admissible as relevant to causation

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *5 (Mag. M.D. Pa. Sept. 27, 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 450 (E.D. Pa. 2016)

Evidence of a product’s compliance with industry standards is relevant/admissible

Webb v. Volvo Cars, LLC, 148 A.3d 473, 482-83 (Pa. Super. 2016) (maybe, but issue was not properly preserved)

Mercurio v. Louisville Ladder, Inc., 2018 WL 2465181, at *7 (M.D. Pa. May 31, 2018)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *1-2 (E.D. Pa. Jan. 26, 2017)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *3 (W.D. Pa. July 14, 2016)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *3 (Pa. C.P. Allegheny Co. April 4, 2016)

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *2 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *6-7 (C.P. Clarion Co. Oct. 19, 2015)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *8-9 (Pa. C.P. Clarion Co. April 17, 2015)

Evidence of compliance with government standards is relevant/admissible

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *2 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017) (OSHA)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *8-9 (Pa. C.P. Clarion Co. April 17, 2015)

Evidence of technological infeasibility under current state of the art is relevant/admissible

Igwe v. Skaggs, 258 F. Supp.3d 596, 611 (W.D. Pa. 2017) (on summary judgment)

And finally, to provide at least something that is specific to prescription medical products:

Existing exclusion of prescription medical products from strict liability applies after Tincher

Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 928237, at *3 (W.D. Pa. Feb. 15, 2018)

Krammes v. Zimmer, Inc., 2015 WL 4509021, at *4-5 (M.D. Pa. July 24, 2015)

In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2015 WL 3669933, at *35 (N.D. Ill. June 12, 2015)

*          *          *          *

Is there any contrary Pennsylvania product liability precedent?  Well, we’re a defense-side blog and we don’t do the other side’s research for them.  That’s what plaintiffs’ side presumably paid for with the “research grant” that produced “Force Awakens” – and they didn’t get it.  PAJ should demand its money back.


This post comes only from the Cozen O’Connor side of the blog.

The MDL court in the Testosterone Replacement Therapy (“TRT”) litigation recently entered summary judgment in favor of a non-US manufacturer that did not distribute in the US, along with its US subsidiary. The judgment ended efforts to hold those two defendants, Besins Healthcare, S.A. and Besins Healthcare Inc., liable under a series of product liability claims for injuries allegedly caused by the use of AndroGel, a TRT product. In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, 2018 WL 2416239 (N.D. Ill. May 29, 2018).

The court knocked down each of the plaintiffs’ claims in rather short order. Plaintiff’s strict liability and negligent design defect claims fell because plaintiffs had no evidence of a defect. Plaintiffs tried to rely on allegations in the complaint. That doesn’t cut it on summary judgment. Allegations are not evidence:

As the non-moving party, it is plaintiffs’ burden to identify evidence to show why defendants are not entitled to judgment as a matter of law. Because plaintiffs have provided nothing more than quotations from their complaint and from this Court’s order denying the Besins defendants’ motion to dismiss, they have not met their burden.

Id. at *5. A lack of evidence also ended plaintiffs’ manufacturing defect claim: “Plaintiffs present no evidence or argument that AndroGel suffers from a manufacturing defect. Thus the Court considers plaintiffs to have forfeited that negligence theory.” Id. The court entered judgment against plaintiffs’ defect claims.

More interesting was the Court’s rejection of Plaintiffs’ failure to test claim. Plaintiffs relied on an email from an R&D employee at a Besins subsidiary reacting to publications suggesting an association between AndroGel and cardiovascular risks. The employee wrote that “the community should be calling for further study” and that Besins should be “very careful . . . about getting into this discussion” because it might have an “ethical obligation” to conduct such studies as a company that profited from the manufacture of AndroGel. Id. at *2. It’s not surprising that plaintiffs focused on this email.

But they did little else. In fact, plaintiffs’ evidence went no further than the email, which on its own does not establish a failure to test claim. On the other hand, the Besins defendants, who were not distributors of AndroGel in the US, presented actual evidence undermining plaintiffs’ claim. In particular, they relied on the R&D employee’s deposition testimony in which he clarified that Besins did not have the right to conduct testing in the United States. Id. This went unchallenged, and the court found it dispositive:

Plaintiffs have provided nothing to support a contention that the Besins defendants have a duty to conduct safety studies in the United States. To the contrary, the undisputed evidence shows that the Besins defendants cannot do so, and plaintiffs have not attempted to reconcile that evidence with their position.


The court found other unfixable problems with plaintiffs’ failure to test claim. Plaintiffs presented no evidence that Besins actually failed to test. The R&D employee’s email certainly doesn’t prove that. Plaintiffs also provided no evidence of a proximate causation, making no evidentiary connection between the alleged failure to test and their injuries:

[P]laintiffs have provided no evidence that the Besins defendants’ alleged failure to test proximately caused plaintiffs’ injuries. Plaintiffs’ theory is that the Besins defendants’ failure to adequately test AndroGel caused AbbVie [the company to whom Besins licensed the exclusive right to market and distribute AndroGel in the US] to lack sufficient information about AndroGel’s risks. The alleged failure to test, plaintiffs say, thus “directly contributed to AbbVie’s failure to provide an adequate warning to healthcare providers in the United States.” Plaintiffs, however, do not cite any evidence to support this theory. Their conclusory argument is insufficient to withstand summary judgment.


The court also rejected plaintiffs’ failure to report adverse reports claim. Plaintiffs described this claim as a failure to report adverse events to other manufacturers, industry experts and the FDA. Having so constructed their claim, however, plaintiffs presented no evidence or argument to establish that the Besins defendants had an enforceable duty to report adverse events to other manufacturers or industry experts. Id. at *6. For their part, the Besins defendants presented evidence that they had no duty to report AndroGel adverse events to the FDA. That responsibility instead fell solely to AbbVie, the company to whom the Besins defendants licensed the exclusive right to market and distribute AndroGel in the US. Id. With no duty, plaintiffs had no claim. Setting that aside, plaintiffs nonetheless presented no evidence that the Besins defendants failed to report any adverse event or that such failure proximately caused their injuries. Id. For all these reasons, the court entered judgment against plaintiffs’ failure to report claim.

The upshot of this opinion appears to be that the non-distributor Besins defendants are our of the Hormone Replacement Therapy MDL.

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

Today is a follow-up post on Bell v. Boehringer Ingelheim Pharms, No. 17-1153, 2018 U.S. Dist. LEXIS 90337 (W.D. PA. May 31, 2018). When we last blogged about this case back in February, the court had tossed out everything except negligence and fraud/misrepresentation claims on well-settled Pennsylvania law that prescription drug cases sound only in negligence. The court then dismissed the remaining claims for failure to satisfy TwIqbal pleading standards. Plaintiffs were afforded an opportunity to amend and re-plead the claims recognized under state law. They did. And once again, they don’t get by TwIqbal.

So, what’s missing this time around? The court starts out by noting that despite being dismissed for factual insufficiency, plaintiff made few factual revisions in the amended complaint. Id. at *4. So few that the court was able to essentially adopt its factual recitation from the first decision. Id. That’s an underwhelming start and things don’t improve for the plaintiff as the court examines each claim in turn.

Starting with plaintiff’s catch-all negligence claim, the court found “[t]he amended complaint contains a boilerplate laundry-list of alleged negligence that is virtually identical to the negligence claim in the original complaint.” Id. at *12. Since plaintiff just re-packaged his conclusory allegations from the original complaint, the amended complaint once again fails to state “any facts about how defendants breached their duty or how defendants’ conduct caused [plaintiff’s] injury.” Id. at *13. At the heart of plaintiff’s negligence claim was his allegation that defendants should have changed their label to warn about the risk of kidney injury following FDA approval. But for that claim to survive, plaintiff would have had to have pleaded what new information became available to warrant a change, what the changed warning should have said, and how any alleged breach was the cause of plaintiff’s injury. Id. at *13-14. Absent all those pieces, plaintiff’s negligence claim was dismissed.

Negligent misrepresentation was even easier to dismiss because it was an exact duplicate of the original complaint. Id. at *14. We’ve all heard the expression that the definition of insanity is doing the same thing over and over and expecting a different result. Well, same allegations equal same result. Dismissal.

Next up was plaintiff’s negligent design claim. This claim was previously dismissed for failure to plead the availability of a safer, alternative design as required by Pennsylvania law. So, plaintiff argued he satisfied that requirement in the amended complaint by pointing to other available products. But different products are just that different products – not alternative ways to design the product at issue. Saying plaintiff could have taken a different product doesn’t do anything to establish how the design of defendant’s product was defective or how it could have been designed differently. Id. at *15. Another dismissal.

Last, plaintiff based his fraud claims on allegations that defendants concealed information about the risks of the drug from the FDA, the public, plaintiff, and plaintiff’s physicians. But fraud claims don’t just have to satisfy TwIqbal, they are held to the more rigorous Rule 9(b) standard. Generality won’t suffice. Id. at *16. And plaintiff’s claim was just that, too general. The amended complaint contained no allegations about what information was concealed. It was missing the “who, what, when, where and how” of defendants’ alleged fraud, i.e., the “first paragraph of any newspaper story.” Id. at *17. So, fraud was dismissed as well.

Despite the complete lack of factual support for any of plaintiff’s claims, he once again asked for a chance to re-plead. The court, somewhat reluctantly, granted the request but made it clear that any final attempt by plaintiff to fix these pleading deficiencies would have to be a significant improvement. Specifically, plaintiff has

to clearly articulate the legal theory he is pursuing and to allege sufficient facts to make each element of the claim plausible. He must also eliminate his overbroad, conclusory “shotgun” allegations so that defendants are given adequate notice of what [plaintiff] claims they did wrong.

Id. at *18-19. Given plaintiff’s track record, this seems like a fairly high hurdle to clear. Stay tuned to see if plaintiff tees it up for strike three.


Is fear of injury the same thing as injury?  The question answers itself.  At least it should.  They are not the same, and there are strong jurisprudential reasons for courts to throw out cases alleging mere fear of injury.  We have a No Injury scorecard documenting a pretty clear court consensus that fear of injury should not be enough to get a case to the jury.  Think of diet drug cases where the claim was an increased risk of heart valve injury.  Most courts concluded that such fear did not amount to actionable injury.  Considerations of Article III case or controversy or standing or ripeness usually persuaded courts that fear of physical injury simply did not cut it.  But not always.  So it is good that today’s case, Perez v. B. Braun Medical, Inc., 2018 WL 2316334 (S.D.N.Y. May 9, 2018), gets added to the defense side of the ledger.  In 2010, the plaintiff had been implanted with an IVC filter to treat her pulmonary embolism (PE) and deep vein thrombosis (DVT).  The implant was intended to be permanent.  In subsequent years there were reports of IVC filters causing problems via misalignment and migration.  In 2014, the FDA urged doctors to remove IVC filters within one to two months after the danger of PE subsides.  The plaintiffs alleged that the defendants in this case continued to market their IVC filter for long-term use — according to the court, the complaint alleged that the defendants were “defying the FDA’s general recommendations.”  Meanwhile, no doctor recommended that the plaintiff remove the IVC filter, even though in 2016 a CT scan showed that the tip of the IVC filter possibly had tilted.  That tipping point was apparently not enough to remove the filter, but was enough to file a lawsuit.  The complaint alleged that the IVC filter was defective and increased the risk that the plaintiff would suffer a serious injury. The plaintiff also referenced unspecified economic and psychological damages. The defendants moved to dismiss the complaint for failure to state a claim upon which relief can be granted, arguing that the complaint did not adequately allege that the plaintiff had suffered any cognizable injury.  The court granted the motion to dismiss.  It analyzed the personal injury, warranty, fraud, and New York Business law claims separately, so we will do likewise.

1. Personal Injury Claims

The plaintiff alleged that her physical injuries were the post-implant likely tilting of the IVC filter, psychological trauma of living with a defective product implanted in her body, and the increased risk of future injuries due to the IVC filter.  The problem for the plaintiff was that New York law is reasonably clear that a mere threat of future harm is insufficient to impose liability against a defendant in a tort context.  To be sure, the complaint also alleged that the plaintiff “sustained serious personal injuries,” “serious physical injuries,” and “severe injuries,” that she suffered “loss of enjoyment of life, disability, and other losses,” and that she “incurred substantial medical costs and expenses to treat and care for Plaintiff’s injuries described herein.”  But those are more rote formulas than factual allegations.  The complaint certainly never described the nature of the injuries.  New York law does recognize claims for emotional distress, but such claims must be premised on truly outrageous conduct, and nothing like that resided in the complaint.  Perhaps the best thing that the plaintiff had was an allegation that the defendants marketed permanent filters even after the “FDA warnings that caution generally against long-term implantation of IVC filters.” But because those warnings, whether or not they said what the plaintiff alleged, did not happen until after the plaintiff’s implant, they could not preserve the plaintiff’s claims.

2. Breach of Warranty Claims

The defendants had a strong statute of imitations argument, because the clock on warranty claims usually starts at the time delivery, which was in 2010, more than seven years before the complaint was filed.  New York’s statute of limitations for warranty claims is four years.  The plaintiff trued to dodge the statute of limitations by arguing that the warranty explicitly extended to future performance, and that existed here because the defendants had stated that the IVC filters were safe and effective for permanent implantation.  But the complaint did not explain how the plaintiff’s particular IVC filter had fallen short.  Again, the mere tilting of the IVC filter, even with a risk of future harm, did not equate to a cognizable injury,  New York courts (like most courts on planet Earth) have acknowledged a policy of protecting court dockets from “being clogged with frivolous and unfounded claims.”  Warranty claims often seem like add-ons in product liability cases, and here they were frail add-ons to already frail claims.

3. Fraud Based Claims

Fed. R. Civ. P. 9(b) requires that fraud claims be pleaded with specificity, and the Perez complaint did not come close to meeting this standard.  Again, the plaintiff leaned on the defendants’ representations that the IVC filters were safe and effective for their intended and reasonably foreseeable use.  But the plaintiff never explained why those statements are fraudulent. After all, the the complaint admitted that IVC filters can be used to reduce the risk of PE and DVT, and it nowhere alleges that the plaintiff’s filter performed in a manner different from how the defendants describe.  Whatever the complications and injuries that the defendants failed to warn the plaintiff about, the complaint did not specifically describe them, and could not allege that the plaintiff had sustained any such complications and injuries.  Moreover, the complaint lacked any facts showing that the alleged omissions were made with an intent to deceive.  The plaintiff simply had not made out a case for fraud.

4. New York General Business Law Claim

The complaint’s final count alleged that the defendants engaged in consumer fraud in violation of New York General Business Law Sections 349 and 350<>. Section 349 prohibits “[d]eceptive acts or practices in the conduct of any business, trade or commerce or in the furnishing of any service in this state.” Section 350 prohibits “[f]alse advertising.”  As with the plaintiff’s breach of warranty and fraud based claims, the New York Business Law claims failed to show what materially misleading representations the defendants made. That there are side effects associated with IVC filters that are implanted long-term, does not mean that the plaintiff’s IVC filter “had not been effective for implantation into the IVC to prevent PE and DVT for which it was designed or that it is not safer than the alternative.”

What is interesting about the Perez case is how the lack of a real injury did not just undermine the personal injury claims (seems obvious enough), but also undermined the representational claims.  What is doubly interesting about the Perez case is that the no-injury defense worked with respect to an implanted device.  Most of the good cases on our no injury scorecard involved drugs.  Arguably, a plaintiff has a little more to work with when there is a device implanted in the body.  There is a continuing exposure.  Nevertheless, mere fear of injury could not overcome the court’s fear of frivolous claims.

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.