Here’s another guest post by Reed Smith’s Dean Balaes.  This one looks into a major (but not too recent) post-Albrecht drug preemption case.  Can’t have too many of those!  As always, our guest posters deserve all the credit (and any blame) for their writings.


There is no hiding the fact that federal preemption is a sword that cuts deeply into the other side of the “v.”’s mass tort business prospects.  In the context of state-law failure-to-warn claims, such actions are sometimes held preempted under the Supremacy Clause of the U.S. Constitution, especially when the FDA acts on a manufacturer’s label and requires manufacturers to comply with the FDA’s language.  See Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019).  In other words, by virtue of the FDA approving a manufacturer’s label through its rigorous control process, state-law failure-to-warn claims are preempted by the federal agency’s judgment call as to what is and is not included.  Bad news for the coffers of the other side of the “v.” and great news for the interests of fairness.  One recent case cited in the Blog’s newly acquired information post illustrating the aforementioned tension is Mahnke v. Bayer Corp., ___ F. Supp.3d ___, 2020 WL 2048622, at *3 (C.D. Cal. March 10, 2020).  The Blog mentioned Mahnke briefly in a previous post.  It has since been designated to be published in F. Supp., so it is worth a closer look.

As many of the Blog’s readers know, one of the takeaways from Albrecht is that to bring an unpreempted state-law failure-to-warn claim about a branded drug, one must plead a labeling deficiency that the manufacturer could have corrected using the “changes being effected” (“CBE”) regulation.  To avoid conflict with federal requirements, the plaintiff would need to show that a manufacturer could have unilaterally changed its label because “newly acquired information” arose about evidence of a causal association between a drug in question and a clinically significant adverse reaction.  See Klein v. Bayer Healthcare Pharm. Inc., No. 218CV01424APGEJY, 2019 WL 3945652, at *5 (D. Nev. Aug. 21, 2019).  The newly acquired information, however, must have been available to a manufacturer after the FDA approved of the label in question, but before a plaintiff last used the drug.  See Goodell v. Bayer Healthcare Pharmaceuticals, Inc., 2019 WL 4771136, at *4 (D. Mass. Sept. 30, 2019).  Only after such facts are sufficiently pleaded will the Court turn its attention to the manufacturer and ask whether the manufacturer satisfied its burden to show by “clear evidence” that the FDA would not have approved of the labeling changeSee Wyeth v. Levine, 555 U.S. 555 (2009).

In Mahnke, the defendant defeated (once again) a state-law failure-to-warn claim related to an FDA-approved gadolinium-based contrast agent (“GBCA”) administered intravenously to enhance the quality of magnetic resonance imaging (“MRI”).  For those readers pondering the question:  what exactly is gadolinium good for?  Look no further.  Gadolinium is a rare earth material used in conjunction with an MRI exam because it is inherently opaque to magnetic resonances.  But elemental gadolinium can be toxic.  It cannot be introduced into the body without being bound to a chelator, which prevents gadolinium from having adverse interactions with tissue while preserving gadolinium’s contrast enhancing property.  The chelator also permits the kidneys to eliminate GBCAs from the body after the MRI exam.

Plaintiffs in these cases claim that GBCAs spontaneously undergo de-chelation, allowing elemental gadolinium to escape.  Think salt.  It’s essential to life, but only when the sodium and chlorine are bound to one another.  Bodily contact with either sodium or chlorine in their elemental forms is not recommended.  De-chelation allegedly increases the risk of Nephrogenic Systemic Fibrosis (“NSF”), a rare scleroderma-like cutaneous disorder.  The FDA has found no evidence of any of these problems in people with healthy kidneys – therein lies the preemptive rub.

In Mahnke, Plaintiff never alleged that gadolinium caused NSF and did not claim to have NSF – or even weakened kidneys.  Instead, it was alleged that by taking a GBCA drug to assist in MRI imaging, the Plaintiff with normal kidney function suffered gadolinium “toxicity,” a nebulous term that means whatever plaintiffs want it to mean.  Allegedly, the manufacturer should have warned of a nebulous “risk of gadolinium retention toxicity” to “individuals with healthy kidneys.”  2020 WL 2048622 at *2.

Mahnke questioned the other side’s failure-to-warn theory, observing that:  (1) the FDA tied the manufacturer’s hands from changing its label to incorporate gadolinium retention toxicity, even if the manufacturer so desired;  (2) even if the FDA permitted a manufacturer unilaterally to change its label under federal law, the FDA would not have approved this change;  and (3) any newly acquired information “must have been available to the manufacturer after the FDA approved the relevant label on August 19th, 2010, but before the plaintiff last used [the drug] on May 1st, 2015.”  Id. at *2-3.  The rationale for this nearly five-year window is simple causation:  plaintiff could not have been injured by lack of “newly acquired information” when plaintiff was injured before the information ever existed.

The other side pleaded that the “newly acquired information” was merely gadolinium being retained in the body following injection of a GBCA.  Id. at *1.  Big whoop.  That only stated the obvious.  That is, gadolinium is retained in the body before a healthy renal system removes it.  Mahnke held that the other side “did not connect the dots between gadolinium retention in [a healthy] body and a clinically significant adverse reaction,” i.e., gadolinium toxicity.  Id. at *3;  see also McGrath v. Bayer HealthCare Pharm. Inc., 393 F. Supp.3d 161, 169 (E.D.N.Y. 2019) (“[r]reports and studies that discuss the fact of gadolinium retention but do not reach any conclusions regarding the adverse effects or risks associated with gadolinium retention in patients with normal renal function do not plausibly allege the existence of newly acquired information that could have justified Defendants’ revising the drug label through the CBE regulation”;  internal quotations marks omitted).

Plaintiff pointed to two pieces of supposed newly acquired information that could have triggered use of the CBE regulation:  two review papers published in 2016 and 2018 collecting research regarding GBCAs.  Id. at *3.  But the 2016 and 2018 research papers were “published outside of the relevant time frame” (i.e., August 2010 through May 2015).  Id.  Any newly acquired information alleged by Plaintiff “must have been available to [defendant] after the FDA approved the relevant label on August 19, 2010, but before Plaintiff last used [the product] on May 1, 2015.”  Id.;  see also Goodell, WL 4771136, at *4.  Moreover, both articles failed “to establish the requisite connection in the body and a clinically significant reaction in patients with normal kidney function,” discussing only the effects of GBCAs in patients with advanced kidney disease—not normal renal function.  Id. at *4  (meaning these articles will not be enough in a case without Mahnke’s timing problems).  Thus, the Court concluded that the articles do “not constitute newly acquired information warranting invocation of the CBE regulation.”  Id.  To otherwise rule against the manufacturer would impose the unreasonable requirement that one should have “pieced together” vague research standing for a different proposition to “conclude[] that gadolinium is toxic when de-chelated in patients with normal renal function,” so accordingly the other side failed to meet their burden to plead a labeling deficiency that the manufacturer could have corrected.  Id.

Beyond their failure to warn claim, the other side also (unsuccessfully) alleged a design defect.  Application of Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013), outside of the generic context was conclusive.  Thus, the Court agreed with the defendant that plaintiffs failed to articulate a theory of liability that avoids preemption.  The bottom line is that the defendant successfully fended off inappropriate claims from the other side of the “v.” trying to gin up “newly acquired information” where none actually existed.

The only claim that survived is whatever vague piece of a warranty claim that might exist outside of the Defendant’s warnings.  But on the plus side, that fragment of a claim makes Mahnke non-appealable.


This week we are pleased to report on yet another breast implant case in which a plaintiff’s effort to circumvent preemption failed. In Diodato v. Mentor Workdwide LLC, 2020 WL 3402296 (D. Md. June 19, 2020), the plaintiff brought manufacturing defect, breach of warranty, and failure to warn claims that were typically skimpy in terms of laying out what federal law/regulation/specification the defendant allegedly violated.

The plaintiff had breast implants placed in 2014, experienced some symptoms (including a lump in her breast) in 2019, and had the implants removed at which time the left implant was found to have ruptured. Based on that concatenation of facts, the plaintiff alleged that the “hole” in the implant must have been due to a manufacturing defect and must have existed at the time the implant left the possession of the manufacturer and was simply undetected by the implanting physician because the manufacturer failed to warn the doctor to inspect the implant before surgery.

It turns out that there was a great big hole in the plaintiff’s legal theories.

In a blessedly concise opinion (we’re noticing a lot of that during this pandemic lockdown – it almost makes up for the horrible Covid dreams and Covid digestion problems) the Diodato court summarized the preemption analysis nicely: for claims against a class III medical device to survive, they must rest on conduct that both violates the federal scheme and also would give rise to recovery under state law even absent the federal violation. The court also wasted a minimum of time and ink in rejecting the plaintiff’s conclusory allegations, observing that “The Complaint does not disclose the foundation for Plaintiff’s belief that the rupture existed at the time the implant left Mentor’s possession. Likewise, the Complaint includes no discussion of Mentor’s manufacturing process or of any warnings Mentor provides.”

In concluding that the plaintiff’s manufacturing defect claim was preempted, the Diodato court held that “The Complaint alleges that a hole existed at the time the implant left Mentor’s possession, and reasons that the alleged existence of such a hole necessarily implies a manufacturing defect. However, in a case involving a Class III medical device, it is not enough that the plaintiff allege the existence of a deficiency. In addition, the plaintiff must allege ‘how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.’” So much for the manufacturing defect claim.

The failure to warn and warranty claims also flunked. Again, there was no alleged divergence between the defendant’s conduct and FDA requirements. Moreover, the Diodato court emphasized that the plaintiff entirely failed to address the product’s FDA-approved warnings, which specifically warn of rupture and notifies physicians that they should carefully inspect the MemoryGel implant before implantation for rupture or holes.

The Diodato court’s conclusion that these claims were preempted seems straightforward and inevitable, but is nonetheless important because so many breast implant claims seem to follow this same playbook. You might even call the Diodato case a gift from God. (That is what Diodato literally means.). It is hard for breast implant plaintiffs to get around preemption. Check that; it is almost always impossible.

All that being said, the dismissal in Diodato was without prejudice: “Though Plaintiff has failed to state a claim, the Court is not convinced that any amendment is certain to be futile.” Perhaps we will see an amended complaint. Perhaps (Probably?Certainly?) it will meet with an identical, preempted fate.

Congrats to the victorious defense team, which includes Dustin Rawlin, Monee Hanna, and Rachel Byrnes (all of Tucker Ellis) and Craig Thompson (Venable).

If, like this blogger, you had small children in the early 2000s, subconsciously you may have read today’s title with a Scottish brogue.  That’s because it might recall a scene from Shrek where Mike Myers (Shrek) and Eddie Murphy (Donkey) are having a philosophical conversation about the many and varied attributes of ogres.  “Ogres are like onions. . . . Onions have layers. Ogres have layers. You get it.”  We get it.  We also get that this reference might be coming to mind because having lived through the Shrek years, we recently introduced the now teenagers to So I Married an Axe Murderer.   Instead of talking about onions and layers, we are now subject to “We have a piper down” and “Look at the size of that boy’s head” butchered in a bad Scottish accent (not only by the kiddos).  It also means the teens have been introduced to the Bay City Rollers, which let’s face, everyone should be.

That’s what at least one of us here at the DDL blog thought of when we read the decision in Bayer Corporation v. Leach, 2020 WL 3118509 (Ind. S. Ct. Jun. 12, 2020).  Complaints are like onions, they have layers.  And having layers means courts have to consider each layer on its own merits.  The theories and causes of action alleged in a complaint need to be peeled back and examined independently.  You don’t get to lump it all together.  That’s what the Indiana Supreme Court said too.

The case involves the multiple claims of 36 women who allege they were injured by the medical device Essure, an implantable birth control device.  Id. at *1.  Essure is a PMA medical device and our blog is full of posts about the many preemption wins in Essure litigation (in the dozens).  Here, defendant moved to dismiss the complaint on both the insufficiency of the pleadings and on preemption grounds.  The motion was denied by the trial court who allowed an interlocutory appeal.  That appeal was decided at the end of 2019 with the court upholding the denial.  See Bayer Corporation v. Leach, 139 N.E.3d 1127 (Ind. Ct. App. 2019).  Both the trial court and the appellate court looked at the pleadings and the preemption arguments only in the context of plaintiffs’ manufacturing defect claim.  While defendant argued that other claims were not adequately pleaded and/or were preempted, both courts held that because “the manufacturing-defect claims are viable, we need not address any other legal theory.”  Id. at 1130 n.3.   Because the complaint was not completely “devoid of allegations upon which relief could be granted,” defendant was not entitled to a dismissal of anything.  Id. at 1135.

That’s an all or nothing standard and complaints aren’t an all or nothing proposition.  Complaints have layers.  Let’s just start with causes of action – of which there are often many.  Those causes of action require different allegations, are premised on different facts, and are based on different laws.  To say one was sufficiently pleaded tells you nothing about any of the others.  What about the grounds for a cause of action – there can be several.  We’ve seen many courts determine that a plaintiff could only proceed on a failure to warn claim to the extent it wasn’t premised on the product’s labeling or that a plaintiff couldn’t maintain the part of her design defect claim that was based on a stop selling argument.  Complaints have layers in part because plaintiffs make many and varied claims.  Sometimes, not all of them stick.  Whittling down the size and scope of a complaint at the pleadings stage can have a tremendous impact on the size and scope of a case overall.  If all that is left after a motion to dismiss is a manufacturing defect claim, you’ve likely drastically reduced the amount of discovery that is needed and the case may even be positioned to resolve quickly.

The Indiana Supreme Court didn’t say all that, but they did unanimously reverse and remand the case to the appellate court with instructions for it to “address the viability of each claim.”  Bayer v. Leach, 2020 WL 3118509 at *1 (emphasis added).  The court noted that this was a complex litigation in which plaintiffs “allege several sets of operative facts, amounting to several discrete claims.”  Id. at *2.  Already, we are beyond a one size fits all rationale.  Rather, “[i]n a complaint with multiple claims, the viability of a single claim does not immunize a separate, deficient claim from judgment on the pleadings.”  Id.  Nonviable claims are supposed to be disposed of and the litigation is supposed to proceed only as to those that survive.  Complaints have layers.  You can’t have one good claim propping up a load of bad ones.  That would be like balancing “an orange on a toothpick!

We’ll leave you with Eddie Murphy’s final words on the whole ogres are like onions thing – “You know, not everybody likes onions.”  So true of complaints as well.

Since we were involved in the Medtronic Infuse wars, we’ve been quite aware of Justice Gorsuch’s textualist views towards statutes since he wrote Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015).  In Caplinger he got a close look at the damage the Supreme Court had done to the plain meaning of the Medical Device Amendments’ preemption clause, 21 U.S.C. §360k(a) in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  Suffice it to say that he didn’t like it one bit, but because he was then a mere member of the Tenth Circuit, he had to attempt to apply it.  We’ve been through all the details twice, first in our February, 2017 post on then-nominee Gorsuch’s views on preemption, and again in our “Lohr Has Two Shadows” post the following October.  We’ll just jump right to the conclusion that then-Judge Gorsuch reached in Caplinger:  he couldn’t “help but wonder if perhaps some of those rules [in Lohr] warrant revisiting and reconciliation.”  Caplinger, 784 F.3d at 1340.

Then, in the interim, the Supreme Court abolished the “presumption against preemption” in express preemption cases, upon which the Lohr majority so strongly relied.  See Puerto Rico v. Franklin California Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016).

Gorsuch the textualist has shown forth bright and clear recently – in an opinion that, oddly, was joined by all the quondam defenders of Lohr in preemption cases.  In determining that “sex,” as used in Title VII of the 1964 Civil Rights Act meant exactly what it said, we had a heaping helping of the textualist principles that we hope the Supreme Court will apply whenever it finally takes another look at LohrSee Bostock v. Clayton County, Georgia, ___ S. Ct. ___, 2020 WL 3146686 (U.S. June 15, 2020).  If readers want the scoop on the substantive impact of Bostock, here’s a good link.  Our interest, as drug/device defense lawyers, is in what the Court had to say about the proper way to interpret statutes (such as §360k(a)).


When the express terms of a statute give us one answer and extratextual considerations suggest another, it’s no contest.  Only the written word is the law, and all persons are entitled to its benefit.

Bostock, 2020 WL 3146686, at *3.  Second:

You can call the statute’s but-for causation test what you will − expansive, legalistic, the dissents even dismiss it as wooden or literal.  But it is the law.

Id. at *11.  Third:

Nor is there any such thing as a “canon of donut holes,” in which Congress’s failure to speak directly to a specific case that falls within a more general statutory rule creates a tacit exception.  Instead, when Congress chooses not to include any exceptions to a broad rule, courts apply the broad rule.

Id. at *11.  Fourth:

This Court has explained many times over many years that, when the meaning of the statute’s terms is plain, our job is at an end.  The people are entitled to rely on the law as written, without fearing that courts might disregard its plain terms based on some extratextual consideration.

Id. at *14 (citations omitted).  Fifth:

[T]that a statute has been applied in situations not expressly anticipated by Congress’ does not demonstrate ambiguity; instead, it simply demonstrates [the] breadth of a legislative command. . . .  [U]nexpected applications of broad language reflect only Congress’s presumed point [to] produce general coverage − not to leave room for courts to recognize ad hoc exceptions.

Id. (citations and quotation marks omitted).  Sixth:

Ours is a society of written laws. Judges are not free to overlook plain statutory commands on the strength of nothing more than suppositions about intentions or guesswork about expectations.

Id. at *18

The preemptive language of §360k(a) is about as broad in the prescription medical product liability litigation context as “sex” is in the context of Title VII.

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement − (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

Or, as then-judge Gorsuch put it in Caplinger, “Given this expansive language one might be forgiven for thinking all private state law tort suits are foreclosed.”  784 F.3d at 1337.  Thus, we look forward to the Court taking a Bostock/Caplinger textualist approach to §360k(a) the nest time it encounters medical device preemption.

And the same goes for “snap removals” – another instance where plaintiffs (less successfully than in Lohr) have sought to induce courts to ignore the plain language of a federal statute.

Oh, and one last thing.  Here’s a Bostock quote for Wyeth v. Levine, 555 U.S. 555 (2009), and that Court’s result-oriented analysis of implied preemption and the history of the FDCA:

All we can know for certain is that speculation about why a later Congress declined to adopt new legislation offers a “particularly dangerous” basis on which to rest an interpretation of an existing law a different and earlier Congress did adopt.

Bostock, 2020 WL 3146686, at *12 (citations omitted).

People have long been fascinated by robots.  Way before the term was coined in a 1920 play or Isaac Asimov popularized it, there were stories about machines that acted like living things.  The droids of Star Wars universe are famed for the likeability and pluck.  However, there is still the specter that some of those droids, and certainly the cyborgs of the Terminator series or androids of various works of fiction, would turn on their creators.  Thus, robots can be scary.  Not as scary as clowns, of course, but still scary.

In defending drug and device product liability litigation, recalls are scary.  Judges and juries have been known to tilt the playing field in favor of the plaintiff when the medical product at issue has been recalled.  Fine issues of defect and causation can be glossed over when the recalled product gets tagged as “bad.”

It looks like that is a big part of what was going on with the summary judgment ruling in Mendoza v. Intuitive Surgical, Inc., No. 18-CV-06414-LHK, 2020 WL 3078178 (N.D. Cal. June 10, 2020).  This case involved an injury allegedly sustained in connection with a hysterectomy performed with a recalled model of an instrument used with a robotic surgical device.  The instrument, Hot Shears Monopolar Curved Scissors (called “MCS” in the decision instead of the catchier “Hot Shears”), was used to lyse adhesions and cauterize wounds in surgeries performed with the robot.  (Think of R2D2’s zapper more than a blaster IG-11 might use in The Mandalorian.)  Soon after her procedure, which involved lysing extensive adhesions with the MCS, the plaintiff had complications requiring a bowel resection.  About eighteen months later, the MCS was recalled because of the risk of potential micro-cracks that could cause unintended burns from leaked electrosurgical energy.  Id. at *2.  More than five years after the recall, plaintiff sued the company that manufactured the robot and the MCS.  We are not sure why the two-year statute of limitations in either Indiana or California was not a bar, but we do see the impact of Supreme Court personal jurisdiction decisions here.  The Indiana resident, whose surgery, injury, and care occurred in her home state, sued the defendant in federal court in its home state.  After some wrangling on pleadings and about a year of discovery, the case was teed up for summary judgment.

Along the way, plaintiff came forward with two experts and defendant’s motion to exclude them on Daubert was denied.  Plaintiff asserted her claims under California law—there was no choice of law discussion at all—and proceeded on fairly standard negligence and strict liability claims focused on alleged defects in the MCS and a tip cap accessory (“TCA”) used with it.  Plaintiff did not contest summary judgment on any claims based on the TCA or conduct related to it, so we can dispense with that part of the decision.  The court started with a cursory discussion of summary judgment standards, including the burden standards from Celotex.  Id.  That was about it for burden in the decision, which should be seen as foreshadowing, like when a robot starts to show signs of emerging self-awareness well before overt rebellion against the human overlords.  As the court started to walk through the evidence and argument on the three species of possible defect, this is where the bias against recalled products—if not robots—started to creep into the analysis.  We do not want to sound like defense hacks who think the manufacturing of medical devices should always win, but we do think a summary judgment analysis should be rigorous, with testing of plaintiff’s evidence in support of her claims, even if the device was recalled.

As to manufacturing defect, the court recognized that California law requires proof that the plaintiff’s device “differs from the manufacturer’s intended result or from other ostensibly identical units of the same product line.”  Id. at *4 (citation omitted).  The purported defect was micro-cracks on the MCS used in plaintiff’s surgery and plaintiff conceded that he had no direct evidence of it. While the court agreed with plaintiff that circumstantial evidence could be used to show a manufacturing defect under California law, there was at least one hole in the court’s analysis of what evidence plaintiff had. Plaintiff pointed to one of her experts, who opined that she had determined through “differential diagnosis” that there must have been a “thermal injury to the bowel as a result of the da Vinci System,” and the court pointed out that micro-cracks can only be seen under a microscope. Id.  However, that does not add up to sufficient proof to carry plaintiff’s burden to show a manufacturing defect in the MCS that hurt plaintiff, even if we ignored the issues with the use of a “differential diagnosis” in this fashion and the court’s failure to consider burden.  Where was the proof, circumstantial or otherwise, that plaintiff’s MCS was outside of specifications? How can an opinion about a “thermal injury to the bowel as a result of the da Vinci system” suffice to show the assumed manufacturing defect caused an injury when the MCS is designed to produce heat (and burns to plaintiff’s bowel was not documented)?  The answer to these questions may be in the court’s recitation that “it is undisputed that the MCS model used in Plaintiff’s surgery was later subject to a recall due to concerns about a manufacturing defect.” Id. at *5.  It may be that the court did not know the difference between a manufacturing defect and a design defect.  It may also be that the court did not think that matters for a recalled device.

The court’s analysis on design defect was even more conclusory. Basically, plaintiff had experts who said something about design defect and Daubert motions as to them had been denied previously.  That was enough, but along the way the court did provide something useful.  The court endorsed that California applies comment k to the Restatement (Second) of Torts applies to all prescription medical devices.  Id.  This implicitly rejected the cases that limit comment k treatment to implantable medical devices, which the robot and MCS are not.

The conclusion that strict liability did not apply meant that negligence did and plaintiff had to show a failure to warn to recover for a design defect.  Rather than address plaintiff’s evidence on those issues, the court merely concluded in a footnote that summary judgment for negligence was inappropriate “necessarily” because the court had “rejected Defendant’s argument that evidence of a defect in the MCS is lacking.”  Id. at *6 n.4.  As to showing a failure to warn, the court apparently wrapped that into its consideration of whether Defendant had disproven a failure to warn.

On that issue, the court found a question of fact, citing no record evidence (e.g., an expert saying the missing warnings were required at the time of plaintiff’s surgery) but pointing to plaintiff’s assertion in a brief that she did contend warnings should have been given.  Turning burden on its head, the court stated “To the extent that Defendant argues that no such warning was in fact required, Defendant raises a question of fact for the jury.”  Id. at *6.  As to proximate cause for failure to warn, it should have been a slam dunk because the prescribing physician was not deposed.  Yet, the court rejected the argument with a call to “a plaintiff may carry his burden of proving causation by indirect evidence” without identifying any evidence that plaintiff had in the record to support that a different warning about the MCS would have changed anything in plaintiff’s case.  Id.  That is not how summary judgment is supposed to work, at least since Celotex and the rest of the Supreme Court’s 1986 trilogy on the subject.

The court also mangled its consideration of causation, which it dealt with as a single requirement instead of something separately required for each claim (even though there had been scattered mentions of causation along the way).  Plaintiff was required to come forward with evidence that a manufacturing defect, design defect, and/or warnings defect proximately caused her injuries.  The court did not attempt to test the sufficiency of plaintiff’s evidence on those issues.  Instead, it merely looked to what one of plaintiff’s experts opined about medical causation (with the “system” as opposed to the MCS or a defect in it) and the possibility of an undocumented thermal injury.  Id. at *7.  That the court found genuine issues of material fact about whether there was a thermal injury and whether plaintiff had an expert to say thermal injury might have caused plaintiff’s injury does not matter much, because those were not the right questions to ask.  We could try to bring that back to robots, but what could possibly go wrong if the right questions are not asked by those programming robots?

The plaintiff in Blackburn v. Shire U.S., Inc., 2020 WL 2840089, at *1-2 (N.D. Al. June 1, 2020), claimed that the drug Lialda caused his kidney disease and his doctor would not have continued prescribing it to him if the warning label recommended detailed and more frequent monitoring for renal disease, instead of simply recommending “periodic” monitoring.  While some might describe this type of failure to warn claim as picky, that did not matter.  The plaintiff ran into a much, much greater problem on defendant’s summary judgment motion: proximate causation.  Plaintiff’s proximate causation problems were many and came from multiple directions.

Plaintiff’s own prescribing doctor all but eviscerated proximate causation.  He testified that he did not read the Lialda label before prescribing it to the plaintiff, *3, a significant hole in proximate causation.  Yet the doctor also knew that mesalamine drugs, like Lialda, contain a warning on “renal impairment” and that the doctor should “assess renal function at the beginning of treatment and periodically during treatment.  Id. at *4.  The doctor, however, never did that.  He did not evaluate plaintiff’s renal function before prescribing Lialda to him, and he never evaluated plaintiff’s renal function during plaintiff’s use.  Id. at *4-5.  In fact, the doctor’s office prescribed more Lialda to plaintiff a full 18 months after the initial prescription, even though the doctor had not seen him since that first prescription.  Id. at *5.

All of this testimony was bad for, in fact fatal to, plaintiff’s claim:

A drug manufacturer is entitled to judgment as a matter of law on a warnings claim when the record demonstrates that the prescribing physician would not have read or followed an alternative warning. There is no presumption in Alabama that an adequate warning would have been read and heeded by the prescribing physician.

Id. at *6 (citing multiple Eleventh Circuit and Alabama federal court decisions).

Plaintiff also created his own proximate causation problems.  Even though his doctor’s office scheduled a follow-up visit, plaintiff did not keep it.  Id. at *5.  Yet, after having missed that appointment and not seeing the doctor for 18 months, plaintiff asked for a refill, and he got it.  Id.  And then he never saw the doctor again.  Id.  This was the second half of a double-whammy to proximate causation on plaintiff’s failure to warn claim:

Even if [the doctor] had ordered a renal evaluation of [plaintiff] after prescribing Lialda, there is no evidence that [plaintiff] would have complied with the instruction.  [The doctor] scheduled an appointment with [plaintiff] in January 2014 to monitor [plaintiff’s] treatment, but [plaintiff]  did not keep the appointment.  After [the doctor] prescribed Lialda for [plaintiff] in November 2013, [plaintiff] did not return to [the doctor].

Id. at *7.

The factual history developed during discovery just did not support plaintiff’s claim enough to allow it to go to a jury.  The court found the history so compelling that it rejected the doctor’s testimony that he would have read the alternative warning proposed by plaintiff and might have altered his treatment because of it.  Rather, given the actual history of the doctor’s treatment, the Court found this testimony to be “self-interested”:

A summary judgment . . . safeguards against a jury verdict based on a non-party witness’s self-interested, speculative testimony regarding causation that is wholly contradicted by historical fact.  This is not the type of evidence that creates a question of disputed fact for a jury to resolve.

Id. at *7-8 (citing controlling Fifth Circuit precedent).

Without evidence of proximate causation, a failure to warn claim cannot go to a jury.  The court dismissed the case with prejudice.

We are not surprised that some readers dissented from our judgment last week that the Billions series is trash, albeit fun trash. We should be accustomed to this sort of thing. Friends constantly pepper us with praise for allegedly realistic depictions of our business. It used to be predominantly about Law and Order, but now our friends have moved up in the world and pay for premium cable. Those same friends overrule our demurrers that, no, what we do is actually much more straightforward, routine, and – dare we say it? – dull than the showrunners would have you think. We do not suggest that drama would be enhanced by accurate portraits of our quotidian pursuits. Reviewing cases and enduring teleconferences would be Nielsen-repellent. Our fundamental problem with Billions is that it makes the justice system in the Southern District of New York look like a lottery conducted in a snake pit. It is untrue. Mostly.

It is totally untrue in Montero v. Teva Pharmaceuticals USA Inc. et al., 2020 WL 1862593 (S.D.N.Y. April 14, 2020). In Montero, the SDNY judge addressed complex preemption principles in a clear, concise, intelligent manner that should be the model for all judges whenever Mensing and Bartlett issues arise. In Montero, those issues arose because the defendants raised them. The plaintiff ignored them, not even mentioning those cases in her brief. Practice-pointer to lawyers: the ignore-it approach seldom works.

In Montero, the plaintiff alleged that she sustained serious blood-clots, culminating in a pulmonary embolism, as a result of using an oral contraceptive. According to the complaint, the oral contraceptive was defectively designed, inadequately tested, and fraudulently marketed. Those theories came dressed up in the usual causes of action: negligence, strict liability, breach of express and implied warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, and fraud. The Montero court dismissed them all.

The oral contraceptive used by the plaintiff was a generic drug. The Montero court followed the teaching by SCOTUS in the Mensing case that failure to warn claims against generic drugs are preempted, because the sellers of generic drugs have no choice but to mimic the warning labels of the brand name drugs. So much for any failure to warn claim.

Then the Montero court got to the teachings by SCOTUS in the Bartlett case. While Mensing applied the impossibility preemption principle only to failure to warn, Bartlett extended it to design defect. Here is how the Montero court put it: “Under the state design defect law at issue in Bartlett, a drug manufacturer could avoid liability by either redesigning its drug or strengthening its warning label. However, federal law prohibits a generic drug manufacturer from doing either. The manufacturer cannot change a generic drug’s composition or its label.”

Applying this logic to Montero, the plaintiff’s design defect claim was just as preempted as the failure to warn claim. Moreover, she could not proceed with her failure to test theory, because that theory (which usually finds little to no support in state tort law, but that is a different topic for a different blogpost – see our failure to test cheatsheet here) was premised on the notion that such testing would have persuaded the manufacturer that the oral contraceptive “was too dangerous for the market.” That notion is inconsistent with Bartlett, which held that the “stop-selling rationale [was[ inconsistent with … preemption jurisprudence” because “preemption cases presume that an actor seeking to satisfy both his federal and state law obligations is not required to cease acting altogether in order to avoid liability.” Montero is a preemption triple play.

What is left is the plaintiff’s allegation that the defendant perpetrated an active fraud. And that means that nothing is left because the plaintiff did not allege the requisite facts. Any fraud grounded on some statement or omission in the label is flatly preempted, and any statement or omission beyond the label was never identified by the plaintiff — certainly not identified with the heightened specificity pleading requirements under Federal Rule of Civil Procedure 9(b). The complaint names no affirmative fraudulent statement. To plead a claim for fraud via concealment or omission, a plaintiff must set out what the omission was, which persons were responsible for the failure to disclose, the context of the omissions and the manner in which they misled the plaintiff, and what the defendant obtained through fraud. Here, the plaintiff’s fraudulent omissions theory was itself shot-through with omissions.

The Montero court dismissed the entire complaint with prejudice. For us, that outcome is sufficiently dramatic and satisfying. The decision lacks the Maseratis, ortolans, B&D chambers, Hamptons, Russian oligarchs, and political shenanigans of your favorite tv show, but we’d happily tune in for sequels.

Earlier this year we posted about the decision on defendant’s motion to dismiss in Crockett v. Luitpold Pharmaceuticals, Inc., 2020 WL 433367 (E.D. Pa. Jan. 28, 2020).  We called it a “patchwork” decision, meaning we generally liked it but it wasn’t a seamless defense victory.  Well, the court ruled on another defense motion just this month and this one we can say we like completely.

In case you’ve forgotten, or been thinking of something else for the last four months, the case involves an injectable medication used to treat iron deficiency anemia in people who are intolerant to oral medications.  This drug was first developed in Europe before being approved by the FDA in 2013.  In the United States, the drug is manufactured and marketed by two companies.  The complaint, however, also names as defendants the European companies who manufacture and sell the equivalent generic product there.  Crockett v. Luitpold Pharmaceuticals, Inc., 2020 U.S. Dist. LEXIS 102216, at *2 (E.D. Pa. Jun. 11, 2020).  One of those companies, headquartered in Switzerland, moved to dismiss based on lack of personal jurisdiction.

Plaintiffs waived any argument that the court had general jurisdiction over defendant by failing to respond to defendant’s argument on that point.  Id. at *6.  That left only the question of specific jurisdiction which requires that the defendant have “personally directed [its] activities at the forum” and “the litigation must arise out of or relate to at least one of those activities.”  Id.

Plaintiff’s first argument regarding purposeful availment was that defendant designed a product that caused injury to someone in Pennsylvania.  But, the court was quick to note that the Third Circuit has already shot down stream of commerce as a basis for exercising personal jurisdiction over a foreign defendant.  Id. at *6-7.

Plaintiff’s second argument was that one of the European companies, not the one who moved to dismiss, had a licensing agreement with one of the US manufacturers to allow it to sell the generic version of the drug in the US.  This the court found “far too attenuated.”  Id. at *7.  Not only was the agreement with a different entity, but the licensing agreement covered rights to sell the drug in the United States, not in Pennsylvania specifically.  The agreement did not support an “intent to distribute in Pennsylvania” and awareness alone that a product “may end up in Pennsylvania” is not enough to confer personal jurisdiction.  Id. at *8.

Plaintiff next tried to argue that the Swiss company’s “coordination” with the US companies provide sufficient activity to establish jurisdiction.  But, as the Supreme Court has already determined that a relationship with a third party alone is an insufficient basis for jurisdiction, plaintiff had to demonstrate “something more.”  Id. at *8-9.  Here, plaintiff argued that “something more” was the foreign defendant’s participation in things like clinical trials, adverse event reporting, and marketing.  Id. at *9.  On these “cooperative” activities, defendant put in evidence via affidavit that refuted it had any “direct engagement” in any US-based activities.  The “cooperation of a party who does no business in Pennsylvania with a third party engaged in business in Pennsylvania” does not provide “a basis for the exercise of specific jurisdiction over the first party.”  Id.  Plaintiff conceded she was not making an alter ego or piercing the corporate veil argument, and therefore had no grounds on which to impute the US defendant companies’ contacts to the foreign defendants.  Id. at *10.

To sum things up, plaintiff failed to meet her burden of proof to establish specific jurisdiction.  At best, plaintiff could show that the foreign defendant possibly directed some activity to the United States as a whole, but not that any actions were directed at any particular state, including Pennsylvania.  With that, the court denied plaintiff’s request for jurisdictional discovery and dismissed the claims against the Swiss defendant with prejudice.


We don’t see claims under the Magnuson-Moss Warranty Act, 15 U.S.C. §2301(1) (“MMWA”) much in our prescription medical product sandbox.  The MMWA is the federal statute that governs warranties for consumer products, and it was enacted around fifty years ago basically to make warranties more understandable and to limit the use of disclaimers.  Thus, if a seller of consumer products opts to include a warranty (which the law does not require), it has to follow federal guidelines calling for conspicuous warranties in readily understood language.

We thought there were two primary reasons why we don’t see the MMWA in our drug and device space..  First, the MMWA doesn’t allow recovery of personal injury damages.  15 USC §2311(b)(2) (“Nothing in this chapter . . . shall [] affect the liability of, or impose liability on, any person for personal injury. . . .”).  The second is that, such products have usually not been considered to be “consumer” products within the scope of the MMWA.  See Kanter v. Warner-Lambert Co., 122 Cal. Rptr.2d 72, 86 (Cal. App. 2002); Bates v. Monarch Dental Services, 2019 WL 5067904, at *4 (N.D. Tex. Oct. 9, 2019); Bhatia v. 3M Co., 323 F. Supp.3d 1082, 1102-03 (D. Minn. 2018); MHA, LLC v. Siemens Healthcare Diagnostics, Inc., 2017 WL 838797, at *2 (D.N.J. March 2, 2017); In re Minnesota Breast Implant Litigation, 36 F. Supp.2d 863, 876 (D. Minn. 1998); Goldsmith v. Mentor Corp., 913 F. Supp. 56, 63 (D.N.H. 1995); Kemp v. Pfizer, Inc., 835 F. Supp. 1015, 1024 (E.D. Mich. 1993); see also In re DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation, 953 F.3d 890, 896 (6th Cir. 2020) (raising, but not deciding issue).

But what about OTC drugs?

Well, there’s another provision in the MMWA that can be useful for such drugs – indeed for any and all FDA-regulated products.  The MMWA is “inapplicable to any written warranty the making or content of which is otherwise governed by Federal law.”  15 U.S.C. §2311(d) (emphasis added).  That provision – which we had never seen cited in a drug or device case until recently – is yet another solid basis for dismissing MMWA claims against FDA-regulated products:

Through the FDCA, the FDA extensively regulates the labeling, marketing, and sale of all over-the-counter medications. . . .  As such, the MMWA is inapplicable to any alleged express or implied warranty claims on [such products].

Hernandez v. Johnson & Johnson Consumer, Inc., 2020 WL 2537633, at *5 (D.N.J. May 19, 2020) (citations omitted).  Hernandez cited several cases involving other types of FDA-regulated products in dismissing the MMWA claim at issue.  Id. (citing Dopico v. IMS Trading Corp., 2018 WL 4489677 (D.N.J. Sept. 18, 2018) (pet food), Reid v. GMC Skin Care USA Inc., 2016 WL 403497, at *13 (N.D.N.Y. Jan. 15, 2016) (skin cream), and Jasper v. MusclePharm Corp., No. 14–02881, 2015 WL 2375945, at *5–6 (D. Colo. April 9, 2015) (dietary supplement)).

Seeing no other drug or device cases, we were curious to see whether §2311(d) had ever been invoked to dismiss MMWA claims involving these products before.  So we took a look.  It has.  Kanter did, pointing out that under §2311(d), “the FDCA and its implementing regulations govern the labeling at issue here.”  122 Cal. Rptr.2d at 797 (applying §2311(d) to monograph drug).  Section 2311(d) was also cited in dismissing MMWA claims against other nonprescription drugs in Dayan v. Swiss-American Products, Inc., 2017 WL 9485702, at *9 (Mag. E.D.N.Y. Jan. 3, 2017), adopted, 2017 WL 1214485 (E.D.N.Y. March 31, 2017) (suntan lotion), and Mahoney v. Endo Health Solutions, Inc., 2016 WL 3951185, at *8-8 (S.D.N.Y. July 20, 2016) (fluoride tablets).  Given the more intense FDA regulation of prescription medical products, their exclusion from the MMWA should be a fortiori from the non-prescription product cases.

So now there are three reasons (at least) that MMWA claims involving drugs and medical devices (both prescription and nonprescription) should be dismissed – and none of them involve professional wrestling.

Today’s guest post comes from Karl Neumann at Cozen & O’Connor.  He was on the team that won this case, and sent us such a detailed description that we invited him to write it up himself – and he was kind enough to take us up on that offer.  The title tells you what it’s about, so we simply remind everyone that our guest bloggers are 100% responsible for the contents of their posts, and deserve all the credit (and any blame).


About this time last year, the Blog reported on a plaintiff’s attempt to obtain exemplars at a discount.  Since then, the federal court in the Middle District of Florida has dismissed the manufacturer on summary judgment for the plaintiff’s failure to demonstrate causation.  In Ramkelewan v. Globus Medical Inc., No. 5:18-cv-100, 2019 U.S. Dist. LEXIS 229357 (M.D. Fla. Dec. 10, 2019), after the plaintiff resolved separate litigation with the implanting surgeon, the surgeon’s practice, and the surgical facility, the plaintiff attempted to piece together some viable theory of liability against the manufacturer in a subsequent lawsuit.  It was transparent that the plaintiff experts’ approach was to identify anything that purportedly looked like an imperfection, call them “manufacturing defects,” and then reverse engineer causation opinions.  The court ultimately did not buy what the plaintiff and his experts were selling.

The litigation involved a cervical disc replacement device that consists of a polyethylene core and two endplates. The plaintiff underwent a C5-C6 anterior cervical discectomy where the treating surgeon implanted the device.  Two days after the procedure, the core of the device expulsed from between the two endplates.  During discovery, the surgeon admitted his post-procedure realization that the plaintiff was not an appropriate candidate for the device due to the plaintiff’s hypermobile spine and that a fusion should have been performed instead.

In the subsequent lawsuit against the manufacturer, the plaintiff alleged a host of highly speculative manufacturing defect theories.  At its core, the complaint stated the plaintiff’s damages were caused by a defectively manufactured device that did not comply with design specifications approved by the FDA.  To support that conjecture, the plaintiff retained two experts, Drs. John Jarrell and Russell Dunn – both repeat offenders for giving unsound opinions.  Both have been excluded in prior cases for providing highly speculative opinions not backed by reliable data.  In re Mirena IUD Products Liab. Litig., 169 F. Supp.3d 396, 446 (S.D.N.Y. 2016) (excluding Dr. Jarrell’s causation opinions where he could not “identify support for the proposition that a parting line mismatch in an IUD was connected to a risk of perforation”); Bolt v. Ford Motor Co., 2019 WL 1254662, at *6 (N.D. Ala. Mar. 19, 2019 (excluding Dr. Dunn because his opinion was based on nothing more than speculation despite his inspection); see also Frankum v. Bos. Sci. Corp., 2015 WL 1976952, at *16 (S.D.W. Va. May 1, 2015) (excluding Dunn and noting his “complete lack of experience with medical devices outside of litigation”).

Dr. Jarrell alleged a laundry list of unsupported defects that could be consolidated down to three theories:  a misshapen core dome, insufficient core height, and the existence of a machining burr on an endplate.  He then opined that these defects caused the core to migrate and injure the plaintiff.  However, beyond that conclusion, there was not much more to the opinion. For example, Dr. Jarrell had no idea how or at what point during the manufacturing process the alleged core defects occurred and no testing was ever performed to determine if any one purported defect, or a combination thereof, could cause enough force to expel the core from between the two endplates.  Likewise, when asked in discovery whether the defects were causally connected, he merely stated they “could or could not” be.  It was apparent Dr. Jarrell formulated his conclusion before evaluating the facts, and there was no support for his analytical leaps.

As for Dr. Dunn, he identified two different purported issues with the core:  surface roughness and oxidation. Like Dr. Jarrell, his opinions came in kitchen-sink form, which included a whopping 22 separate conclusory opinions.  Notably, his oxidation theory was a re-hash of one of his litigation go-tos where he opines that oxidation occurs during the manufacturing process.  See, e.g., Trevino v. Bos. Sci. Corp., 2016 WL 2939521, at *21 (S.D.W. Va. May 19, 2016) (excluding Dr. Dunn’s attempts to argue the medical device was defective because it underwent oxidative degeneration).

Dr. Dunn posited the oxidation theory despite his concession that – prior to formulating his opinion for the case – he had never researched the issue of potential oxidation of medical-grade polyethylene.  Nor did he conduct any independent testing to conclude the subject core suffered oxidation during the manufacturing process.  Tellingly, Dr. Dunn conceded in discovery that oxidation could occur at room temperature and the core had been outside of the plaintiff’s body for three years and eight months by the time he inspected it.  Only then is when he allegedly discovered “some evidence” of oxidation on the core’s surface.  Like Dr. Jarrell, it was apparent that Dunn was taking a result-oriented approach to his opinions like he had done in the past.  See Bolt, 2019 WL 1254662, at *5 (excluding Dunn where he did not test his purported opinion).

During the litigation, the parties filed extensive Daubert cross-motions along with the manufacturer’s Motion for Summary Judgment.  Despite the plaintiff’s attempts to muster up some defect and causation theory, the court recognized the experts’ opinions were conclusory at best:

Dr. Jarrell’s report offers little more than a conclusion when it comes to his causation opinions. Dr. Jarrell opines, “The . . . failure was caused by the device[’]s defective condition and Globus’s improper manufacture and inspection of the device prior to distribution.” (Doc. 95-2, p. 6). Dr. Jarrell also opines, “In the absence of a manufacturing defect and Globus’s improper production . . . the implant would not have failed as it did in this case.” (Doc. 95-2, p. 14). Finally, Dr. Jarrell opines, “A properly manufactured core would not have experienced expulsion/migration during patient use as occurred in this case.” (Doc. 95-2, p. 16). While Dr. Jarrell offers these opinions, he fails to explain how he reached these conclusions, which appear to be little more than ipse dixit—especially since Dr. Jarrell did no independent testing to confirm such defects could cause the core to expel from the endplates. 

Ramkelawan v. Globus Med. Inc., No. 5:18-cv-100, 2019 WL 8267231, at *9 (M.D. Fla. Dec. 10, 2019) (emphasis added).

The court ultimately precluded Dr. Jarrell from providing any causation opinions because they were not based on sound scientific methodology.  Id.  The court reached a similar result with Dr. Dunn:

The Court agrees with Globus that Dr. Dunn’s opinions should be excluded. First, despite Dr. Dunn’s opinion that the core was oxidized and not to specification in regard to surface roughness, he fails to point to any FDA-approved specification with which these observations are inconsistent. Further, Dr. Dunn does not point to any manufacturing process with which Globus did not comply. And contrary to the [plaintiff’s] assertions, there does not appear to be any correlation between Dr. Dunn’s testimony regarding oxidation and surface roughness, and the resulting failure of the subject . . . core. So even assuming the core was defectively manufactured such that there was oxidation and an issue with the core’s surface roughness, neither Dr. Dunn nor any other expert has opined these defects caused the . . . core to explant and injure [the plaintiff].

Id. at *11.  Hours after the Daubert Order was released, the Court granted summary judgment because the Plaintiff could not “prove that any manufacturing defect caused the injury to [the plaintiff].”  Ramkelawan, 2019 U.S. Dist. LEXIS 229357, at *6.  In the opinion, the Court reiterated its concern with the expert’s reverse engineering, noting that “Dr. Jarrell admitted he had not performed testing to confirm his opinions and did not explain what caused him to conclude the defects could result in the core expelling.” Id.

Too often in medical device cases, courts permit experts to get away with this result-oriented approach–that is, large gaps between the expert opinions proffered and the underlying data. Many times, the issue is left for counsel to handle during cross examination at trial even though the opinions are not grounded in the facts.  So it is refreshing to see a court exercise its gatekeeping function and prevent such opinions from being presented to a jury in the first place.

Ending on one last positive note, there was no appeal.