This DDL blogger happens to have a relatively new teenager in the house. And said teen has been working on an assignment related to the novel by Lois Lowry, “The Giver.” If you are unfamiliar with the book or the more recent movie adaptation (and if you only know the movie, we recommend the book as the former doesn’t dig deep enough into the source material’s thought-provoking ideas), it is about a seemingly utopian society without war, poverty, pain, or suffering. This state of perfection is achieved through sameness. Everyone dresses the same, speaks the same, acts the same. The goal is to eliminate all conflict and for no one to feel uncomfortable. And to achieve this, free will and freedom of choice are non-existent.

The book’s themes have made for some very interesting dinner table debates about the benefits and drawbacks of sameness. While we’ve managed to identify the obvious benefits, we also always find the benefit comes at a price that we are typically not willing to pay. Sacrificing the ability to feel love to also not have to endure feeling pain. Sacrificing human life so that there is no hunger. So, in this DDL household, sameness has come under considerable attack and it is no surprise that individuality is being championed by the teen (and parent too, with some limitations).

And as we transition from home life to work life, we couldn’t help but acknowledge the parallel as we again find ourselves the advocates of individuality over sameness. This time it’s about a flawed class rather than a dystopian society.

In Andre v. Alere, 2018 U.S. Dist. LEXIS 69045, *3 (S.D. Cal. Apr. 24, 2018), putative class representatives allege that defendants’ marketing of its INRatio products was deceptive and misleading and that defendants are therefore liable under various state’s consumer protection laws. The INRatio products are handheld devices used to monitor blood clotting time in people taking warfarin. Class certification was originally denied back in December as to both a nationwide class and as to alleged state-specific sub-classes. Id. at *4-5. Plaintiffs sought reconsideration as to the six sub-class states (Colorado, Florida, Georgia, Maryland, New York, and Pennsylvania). They allege that based on new facts they can satisfy Federal Rule of Civil Procedure 23(b)(3)’s predominance requirement as to the learned intermediary doctrine, statute of limitations, and damages. The court disagreed.

For a class to be certified, Rule 23(b)(3) requires that “the question of law or fact common to class members predominate over any questions affecting only individual members.” And the court’s analysis is a “rigorous” one that can extend beyond the pleadings. Id. at *6.

Plaintiffs, for the first time in their reply brief, argued that the learned intermediary doctrine did not apply to their claims for several reasons. First, they alleged it does not apply because they are alleging a design defect claim not a failure to warn claim. But, that argument didn’t align with the allegations of their complaint which were about omissions and representations – i.e. failure to warn. Id. at *14. Nor did plaintiffs’ cite any authority for learned intermediary not applying to design defect claims. Id. Next plaintiff argued that the learned intermediary doctrine doesn’t apply where only economic injuries are sought. But again, they offered no legal support for their contention. Id. Finally, plaintiffs argued that because the INRatio product is user-operated, the doctrine doesn’t apply. On this point, it appears plaintiffs and defendants submitted competing examples of how prescribed medical devices that involve some patient operation are treated and concluded plaintiff’s argument was not persuasive. Id. at *15. Regardless of whether the patient has to be the one to use the device daily, it still had to be prescribed by his/her physician warranting application of the learned intermediary doctrine.

So, since the learned intermediary doctrine is applicable, Plaintiffs had to argue that it is subject to “common proof.” They did this by alleging that defendants “failed to warn any physicians.” Id. at *7-8 (emphasis added). But, as defendants argued, the inadequacy of the warning is only part of the equation. Plaintiffs must also show that “the inadequate or lack of warnings were the proximate cause of Plaintiffs’ injuries.” Id. at *8. The court cites at least one case from each of the six states at issue to support the proximate cause arm of the learned intermediary rule. Id. at *10-11. What all of those cases have in common is the conclusion that “proximate cause determination will ultimately lead to individual inquiries into each doctor’s experience with the product.” Id. at *12. Inquiries such as the extent of the physician’s knowledge of the risks and side effects and the source of that knowledge; and whether the physician stands by his/her prescribing decision; and the physician’s individualized medical decision based both on his/her knowledge of the product and of the patient. Id. at *12-13. While warning adequacy might be subject to common proof, individuality predominates on the issue of specific, proximate causation. Also, plaintiffs couldn’t point to a single case where class certification was granted involving the learned intermediary doctrine.

Class certification was also denied due to the lack of predominance as to damages and the statute of limitations. Again, individuality can’t be ignored.

On damages, plaintiffs put forth a full-refund model under California law and argued that it satisfied predominance and that a state-by-state analysis was not necessary. Id. at *16-17. The court, however, found that the cases plaintiffs relied on were not that black and white. See id. at *17-19 (analyzing plaintiff’s cases).      It was not enough to summarily conclude that predominance was satisfied as to all because it was satisfied as to some. The required “rigorous analysis”

is not satisfied by merely arguing that courts in some of the six states allow for a full refund model. Plaintiffs have failed to specifically demonstrate that each of the six sub-class states’ consumer protection statute and claims for implied breach of warranty in four sub-class states are connected to their theory of damages or that these state law causes of action damages provide for a full refund recovery.

Id. at *21. Plaintiffs had to show sameness among the six states, which it failed to do.

As to statute of limitations, plaintiffs argued that because each of the six states recognizes equitable tolling and/or the discovery rule, “then necessarily common proof will prevail over individualized questions” because no plaintiff knew until the product was recalled that the product was defective. Id. at *22-23. But plaintiffs ignore that both equitable tolling and the discovery rule require consideration of whether the plaintiff acted with due diligence – an individualized inquiry. Id. at *23. The court gives an example from the complaint of one of the putative class representative’s experiences with the device that should have alerted him to an issue before recall and points out that plaintiffs have not addressed how equitable tolling or the discovery rule would apply in that situation. Id. at *24. Since it cannot be determined if the statute would be tolled for all plaintiffs from the date of recall, individual issues predominate over common ones.

In “The Giver” sameness is a metaphor for the lack of truth and diversity. The destroyer of creativity, free will, joy, happiness, and love. The things that make life worth living. In DDL world individuality may not be the meaning of life, but it’s enough to ward off class actions which certainly makes us happy.

Sure, it was enjoyable to read In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, ___ F.3d ___, 2018 WL 1954759 (5th Cir. April 25, 2018) (“Pinnacle Hip”), to see plaintiffs’ counsel hoisted on their own petard of improper and prejudicial evidence and arguments.  But there’s more to Pinnacle Hip than “Lanier-on-a-spit,” as it has been described in these parts.  Indeed, blogging plaintiffs’ attorney Max Kennerly, dropped a comment to our first Pinnacle Hip post (which we published – we scrub only spam, not opposing views) asserting that “the rest of the opinion was a huge win for plaintiffs.”

We largely disagree with Max’s comment, and this post explains why.

Initially, we note that the defendant in Pinnacle Hip was swimming decidedly upstream in all of its legal arguments, since it was opposing a jury verdict entered against it and seeking entry of judgment as a matter of law in its favor.  2018 WL 1954759, at *2.  That means all the trial evidence is construed in the plaintiffs’ favor.  Id. at *3 (“JMOL is warranted only if a reasonable jury would not have a legally sufficient evidentiary basis to find for the nonmovant.”) (citations and quotation marks omitted).

Design Claims

The first claim addressed in Pinnacle Hip was design defect.  See 2018 WL 1954759, at *3-9.  The defendant raised several arguments, all unsuccessfully.  First, the defendant argued that plaintiff had failed to satisfy the Texas alternative design requirement because that alternative that the plaintiffs offered – a “metal on plastic” (“MoP”) hip implant – was really a “different product” from the defendants’ metal-on-metal design (“MoM”), and thus cannot serve as a design alternative.  This is an argument we have featured several times on the blog.  In Pinnacle Hip, the conclusion was that “based on the record, that MoP is a viable alternative design to MoM.”  Id. at *4.

While we would have liked to win this, on the facts, this distinction between alternative product and design is more difficult for the defense than in the cases we’ve discussed in our prior posts, which usually involve not using the product at all, or using some other product that is much less suited for the use in question.  Our classic example of alternative cause abuse is Theriot v. Danek Medical, Inc., 168 F.3d 253 (5th Cir. 1999), a Bone Screw case in which the supposed “alternative” was a different type of surgery not using the product at all.  That’s distinct from redesigning one part of a device system to use a different material, as indeed, Pinnacle Hip pointed out.  2018 WL 1954759, at *9.  Pinnacle Hip reaffirmed that similar-use products that “fail[] to perform the discrete kinds of functions for which the alleged defective was designed” or with a “wide disparity in price” cannot be considered alternative designs.  Id. at *4, *7.  However , the risk/utility defect test “contemplates that a proposed alternative design might reduce a product’s utility . . . without rendering the alternative an entirely different product.”  Id. at *5.  That means some variation has to exist without “moot[ing] the entire defect test.”  Id.

Construing the record to favor plaintiffs, Pinnacle Hip resulted in another point on the uncertain, “practically impossible to settle in the abstract,” id., at *4, line between different design and different product.  While we’d like to have won, Pinnacle Hip does not move the line itself in any lasting fashion prejudicial to the defense.  The ultimate holding was that a “cross-linked” MoP is not sufficiently different from the defendant’s MoP design to be considered a different product.  2018 WL 1954759, at *6 & n.13.  The underlying principle that the distinction between product and design seeks to protect is preventing automatic liability against whole classes of products – cigarettes, motorcycles, birth control pills, or pedicle screw fixation devices – for simply being what they are and having certain inherent risks.  That principle remains intact after Pinnacle Hip.

The defendants also lost a preemption argument – that design defect claims “’stand[] as an obstacle to the accomplishment and execution of the full purposes and objectives’ reflected in the MoM-related regulations of the FDA.”  2018 WL 1954759, at *7.  According to the defendants, because the plaintiffs were seeking “categorical” liability, that all MoMs should be “banned outright,” there should be preemption. Id. at *8.  But that’s not what the Fifth Circuit found was what happened:

[I]t is not the case that plaintiffs’ theory reached all possible MoMs.  All would agree that, despite the sweeping language with which plaintiffs presented their case, their claims were impliedly limited to presently available technologies and the adverse health effects they allegedly engender.

Id.  But the record showed that “[t]he FDA effectively withdrew all MoMs from the market . . . and left open a single door in the form of PMA.”  Id.  On this set of facts, it could not be said that banning something that the FDA had already essentially removed from the market, save for an alternative that has not yet produced an FDA-approved product, was an interference with “the FDA’s regulatory objectives.”  Id.

While losing a preemption argument is not something we would recommend, this particular type of preemption argument has never been successful that we are aware of, so it’s no great loss.  We’ve advocated at some length that the Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), decision be overturned.  But that argument is predicated on changes to 510(k) clearance created by Congress in 1990.  In Pinnacle Hip, “MoMs were sold before 1976 and have traditionally been treated as pre-amendment class III devices.”  2018 WL 1954759, at *8.  So Pinnacle Hip doesn’t affect even the distinctions that we draw from Lohr.  The preemption argument rejected in Pinnacle Hip would require the complete reversal of Lohr, even on Lohr’s facts, to succeed.

By far the better preemption argument, based on current law, with respect to 510(k) design defect claims, is that they amount to “major changes” that require prior FDA review, and probably an entirely new supplemental submission, before they could be implemented.  That should put design defect claims at odds with the “independence principle” in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), resulting in preemption of all design claims that could make a difference in a product liability action.  That argument, which does not depend on Lohr either way, was not addressed at all in Pinnacle Hip.

Finally, the defendants in Pinnacle Hip also lost on their Restatement (Second) of Torts §402A, comment k (1965), argument, which was that Texas law holds all prescription medical products, including medical devices, to be “unavoidably unsafe” within the meaning of comment k, so that those “unavoidable” risks can only be warned about and not treated as design defects.  Pinnacle Hip was unwilling to expand Texas’ application of comment k from prescription drugs to include prescription medical devices.  2018 WL 1954759, at *9.  That places Pinnacle Hip in a distinct minority position, since literally hundreds of cases, and the Third Restatement, apply limits on design defect claims equally to all types of prescription medical products.  Bexis’ book collects these cases.  Drug & Medical Device Product Liability Deskbook §2.02[2] at pp. 2.02-13 to -16 n.14 (for the proposition that “almost all courts have extended the unavoidably unsafe product exception to medical devices”).  However, as the Fifth Circuit correctly pointed out, not many of those opinions are under Texas law.

The further discussion of case-by-case versus across-the-board comment k application in Texas, 2018 WL 1954759, at *9, is more troubling, as the trend in Texas courts (in drug and vaccine prescription product cases) has favored the “blanket” approach.  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 *9 n.22.  There is good reason for that lack of precedent – because Texas law has not employed tests that require such inquiry.  See Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273 (5th Cir. 1974) (applying comment k without case-by-case analysis to a vaccine; holding that the only viable claim was inadequate warning); 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]); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (“Prescription drugs are not susceptible to a design defect claim where, as here, the drug is ‘accompanied by proper directions and warning.’”) (quoting comment k); Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004) (“Under 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) (“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”).  Contra: Adams v. Boston Scientific Corp., 177 F. Supp.3d 959, 965 (S.D.W. Va. 2016) (refusing to apply comment k across-the-board in medical device case) (applying Texas law).  The comment k portion of Pinnacle Hip is where we think that Max is on the firmest ground.  The decision made Texas law worse.  This issue will ultimately be won in Texas appellate courts or perhaps before the Texas legislature, where it would be quite simple to extend the warning related presumption of §82.007 to all medical devices approved or cleared by the FDA.

Warning Claims

As to warning claims (which Texas law calls “marketing defects”), the defendants lost on adequacy as a matter of law.  Pinnacle Hip, 2018 WL 1954759, at *10.  Unfortunately, defendants usually lose on this ground, so it’s big news – and trumpeted on this blog – when a defendant wins a judicial holding that its warning is adequate as a matter of law.  No surprise there.  In Pinnacle Hip, that discussion ended:

Not until after the FDA issued its proposed rule in 2013 did defendants specifically warn about the metallosis, pseudotumors, and tissue necrosis − the sorts of conditions that plaintiffs maintained caused their revision surgery.

Id. at 11.  As defense counsel, we interpret the Fifth Circuit’s observation as an invitation to seek an adequacy as a matter of law ruling as to post-2013 claims (if there are any) in the litigation.

In the causation discussion pertaining to the warning claims, Pinnacle Hip of course followed the learned intermediary rule.  It discussed the role of “objective” evidence of causation:

At the threshold, the parties debate the relevance, under Texas law, of “objective evidence” − that is, evidence “that a different warning would have affected the decision of a reasonable doctor.” . . . Here, plaintiffs proffered objective evidence in [expert] testimony that, if the full risks of MoM were known to physicians, “they would run to [a different product].”

2018 WL 1954759, at *11 (citations omitted).  As we’ve discussed before, “objective” expert testimony about what “reasonable physicians” would have done is usually disallowed in learned intermediary cases.

On this point, however, Fifth Circuit law, has not been as favorable as other courts.  In Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 812 (5th Cir. 1992), the court actually allowed expert testimony on what a “reasonable” physician might have done – but that case was under Mississippi law.  See Ackermann v. Wyeth Pharmaceuticals, Inc., 526 F.3d 203, 212 (5th Cir. 2008) (suggesting that Thomas would not apply to Texas law).  We’ve been aware of the brief Texas Supreme Court passing reference to “objective” evidence in Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 171 (Tex. 2012) (plaintiffs “presented no objective evidence”), but felt no reason to let the other side know it was there.

Now it’s been discovered, however.  The Fifth Circuit allowed such evidence to be admissible, 2018 WL 1954759, at *12 (“objective evidence is at least relevant”), but did not find it decisive in situations where the plaintiff would otherwise have suffered dismissal.  Critically, Pinnacle Hip did not allow unsupported “expert” testimony about what an objectively “reasonable physician” would have done be enough to let plaintiffs survive when they didn’t have prescriber testimony – which would have been the equivalent of allowing a heeding presumption in Texas, something the Fifth Circuit rejected outright in Ackerman, 526 F.3d at 212-13.

Relevance, however, does not imply sufficiency.  In the [learned intermediary] context, causation entails two distinct factual predicates:  first, that the doctor would have read or encountered the adequate warning; and second that the adequate warning would have altered his treatment decision for, or risk-related disclosures to, the patient.  Centocor addressed only the latter, suggesting a jury might be allowed to presume a particular physician would respond “reasonably” to fuller disclosure.  But that presumption must yield to contrary subjective testimony by the treating physician, and Centocor fails to explain how objective evidence would apply to whether that doctor would have read or encountered the warning in the first instance.  When considered for the limited purpose intimated in Centocor, objective evidence would have little bearing on any of [these] plaintiffs’ claims.

Pinnacle Hip, 2018 WL 1954759, at *12 (footnotes omitted) (emphasis original).  Thus, where the plaintiffs had no testimony from their prescribing physicians, those claims continue to fail, and some “expert” claiming otherwise cannot change the result.  Id. (granting JMOL in no-prescriber testimony cases).  Likewise, any “objective” testimony “must yield to contrary subjective testimony by the treating physician.” Id.  So plaintiffs cannot create questions of fact with expert testimony where the prescriber has affirmatively testified that a different warning would not have changed what s/he did.

Only what the Fifth Circuit described as “mixed bag” prescriber testimony (the prescriber said different things in different parts of his testimony) cases got to the jury in Pinnacle Hip, id. at *13, and those have always been harder cases for the defense anyway.  At best, for plaintiffs, paying some expert to opine that a “reasonable” physician would have heeded a warning won’t save any plaintiff who lacked a plausible warning causation case in the first place.  At worst, Pinnacle Hip means more plaintiff-side noise at trial in cases already going to trial on warning causation.  All in all, the defense side is better off after Pinnacle Hip than where it had been in the Fifth Circuit with only the Thomas precedent.  We definitely don’t agree with Max here.

Personal Jurisdiction

In Pinnacle Hip, the manufacturer’s parent corporation was held potentially liable because of the amount of guidance and control permitted by an inference from the facts (based on a “clear error” standard).  2018 WL 1954759, at *15.  Those facts allowed the court to conclude that more than a “passive parent-subsidiary relationship” existed as to this product.  Id. at *16.  To us that’s “big whoop” for two reasons.  First, the “clear error” standard does not apply at the district court level where jurisdictional motions are initially decided.  Second, and more important going forward, the plaintiffs proceeded under a “stream of commerce” theory where the Fifth Circuit had previously “embraced [the] more expansive” (Brennan) side of the 4-4 split in Asahi Metal Industry Co. v. Superior Court, 480 U.S. 102 (1987).  Pinnacle Hip, 2018 WL 1954759, at *15.  As we’ve discussed, that broad “stream of commerce” jurisdictional theory is probably toast after Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017).  Pinnacle Hip did not even cite BMS in its discussion of personal jurisdiction, so we guess that this argument wasn’t raised.  In light of the BMS precedent, the Pinnacle Hip jurisdictional holding should be treated as something of a “one-off” applicable to this MDL, but not to future litigation where BMS will stand front and center.

Miscellaneous Claims

Pinnacle Hip includes the Fifth Circuit’s full-throated reaffirmance of our favorite Erie principle:

[T]hat debate [about what a Texas court might do] is beside the point.  When sitting in diversity, a federal court exceeds the bounds of its legitimacy in fashioning novel causes of action not yet recognized by the state courts.  Here, despite ample warning, the district court exceeded its circumscribed institutional role and expanded Texas law beyond its presently existing boundary.

2018 WL 1954759, at *17 (footnote, citations, and quotation marks omitted) (emphasis added).  The court therefore threw out the spurious invention of an “aiding and abetting” cause of action that had no reasonable predicate in Texas law.  Id.

The court did allow two arguably weird theories against the parent corporation – all product liability theories imposing liability against a non-manufacturing parent under a theory not also cognizable against the manufacturing subsidiary are likely to be weird − to survive.  One of those, so-called “nonmanufacturer seller” was tied to statutory exceptions to immunity for nonmanufacturers.  Id. at*18.  The court held, instead, that the parent was only held liable for old-fashioned design or warning liability, after the record (again, construed in favor of plaintiffs as verdict winners) established one of statutory exceptions from nonmanufacturer immunity.  Id. That’s a little peculiar to non-Texas lawyers, but since Texas has this statute, it must mean something.

The other oddball claim that survived is one of those “last refuge of a scoundrel” theories, negligent undertaking” (a/k/a “Good Samaritan”) liability.

Texas caselaw reveals no precise control threshold a parent must cross before undertaking a duty to its subsidiary’s customers.  Texas courts have made clear that mere possession of “the authority to compel” a subsidiary is not enough − the parent “must actually” exercise that authority in a manner relevant to the undertaking inquiry.

Pinnacle Hip, 2018 WL 1954759, at *19 (footnote omitted).  Based on the stringent standard for interpreting record evidence, the court let this one slide.  Id.  Not good, but not likely to arise very often.

But there’s more afoot than just these three theories. Two years ago, we awarded In re DePuy Orthopaedics, Inc., 2016 WL 6268090 (N.D. Tex. Jan. 5, 2016), our ranking as the number six worst decision of that year, chiefly because of the large number of unprecedented theories under Texas law that this opinion permitted:

(1) extending negligent misrepresentation beyond “business transactions” to product liability, unprecedented in Texas; (2) ignoring multiple US Supreme Court decisions that express and implied preemption operate independently (as discussed here) to dismiss implied preemption with nothing more than a cite to the Medtronic v. Lohr express preemption decision; (3) inventing some sort of state-law tort to second-guess the defendant following one FDA marketing approach (§510k clearance) over another (pre-market approval), unprecedented anywhere; (4) holding that the learned intermediary rule does not apply whenever a defendant “compensates” or “incentivizes” physicians to use its products, absent any Texas state or appellate authority; (5) imposing strict liability on an entity not in the product’s chain of sale, contrary to Texas statute (§82.001(2)); (6) creating a claim for “tortious interference” with the physician-patient relationship, again utterly unprecedented; (7) creating “vicarious” breach of fiduciary duty for engaging doctors to serve as expert witnesses in mass tort litigation also involving their patients, ditto; and (8) construing a consulting agreement with a physician as “commercial bribery” to avoid the Texas cap on punitive damages, jaw-droppingly unprecedented.

While only item (5) was at issue in Pinnacle Hip, the Fifth Circuit’s invocation of Erie conservatism bears ill for all of the other judicial flights of fancy that have been allowed during the course of the Pinnacle Hip litigation.

Constitutionality of Punitive Damages Cap

For completeness, plaintiffs also lost their constitutional challenge to the Texas statute capping punitive damages at twice compensatory damages.  “Plaintiffs’ cross-appeal is meritless, and we dispose of it by footnote.”  Pinnacle Hip, 2018 WL 1954759, at *1 n.4.  That footnote went further, and characterized those constitutional claims as “frivolous.”  Id. at *23 n.72.  No matter what the constitutional challenge, a punitive damages cap “need only survive rational-basis review,” which it did in Pinnacle Hip “by injecting predictability into exemplary damages awards and preempting potentially unconstitutional awards.”  Id. (citations omitted).

Conclusion

When all is said and done, we view Max’s characterization of Pinnacle Hip as a “huge win for plaintiffs” as mostly overblown hyperbole, perhaps worthy of inclusion in the closing arguments that the Fifth Circuit held warranted a new trial.  The Fifth Circuit did some damage to comment k, but all the rest of the legal holdings were trivial, fact-bound, not likely to be useful in future cases, or some combination of those.  The forceful reiteration of conservative principles of Erie predictions of state law leave us hopeful that the Pinnacle Hip MDL will see some Fifth Circuit-mandated clean up – or, if not, perhaps the appellate court’s not-so-veiled Parthian, parting shot may have to be fired in earnest:

[D]efendants, despite their serious critiques of the district judge’s actions in this case and related MDL proceedings, see In re DePuy Orthopaedics, Inc., 870 F.3d 345, 351 (5th Cir. 2017) (finding “grave error”), have not asked us to require these cases to be reassigned to a different judge under “this court’s supervisory power to reassign,” United States v. Stanford, 883 F.3d 500, 516 (5th Cir. 2018).  We express no view on the issue but note that reassignment is both “extraordinary” and “rarely invoked.”  Id. (citation and internal quotation marks omitted).

Pinnacle Hip, 2018 WL 1954759, at *27, n.83.  Obviously, the Fifth Circuit in Pinnacle Hip was uncomfortable with the prospect of overruling the JPMDL’s assignment of this MDL, but this final footnote stands as a clear warning that, if further provoked (such as by continuing consolidated trials, or resort to other prejudicial evidence that the court noted but did not rule on), it will consider doing so.

The Eleventh Circuit has lately become a bit like Forest Gump’s box of chocolates—you never know what you’re going to get. The news today is positive.  The Eleventh Circuit recently issued a gem of an opinion on the learned intermediary doctrine under the law of Alabama, which also happens to be the home of the aforementioned Mr. Gump.

The Eleventh Circuit is not always so good. While the court got everything right in Tutwiler v. Sandoz, Inc., No. 17-13985, 2018 WL 1719024 (11th Cir. Apr. 9, 2018), readers of our 2017 Ten Worst post will recall that the Eleventh Circuit issued three of the ten worst drug and device opinions of 2017, making it 2017’s most noteworthy performer among the circuits.  Maybe we can read something into that.  Or maybe it was fate, like a feather floating in the wind.  After all, if Forest Gump taught us anything, it was that history is arbitrary and that sometimes bad things happen to good people.  The latter, of course, is a reference to Forest’s hard-luck childhood friend Jenny, played beautifully by a young Robin Wright in a performance that was both poignant and memorable.  (Much different, by the way, from Wright’s more recent portrayal of an Amazon warrior in 2017’s reboot of Wonder Woman, which awkwardly fell flat in what was otherwise a perfectly decent superhero film.  We have not yet binged the last season of House of Cards on Netflix, so we will withhold comment on Wright as the relentlessly power-hunger President Claire Underwood.  But we digress.)

So what flavor did the Eleventh Circuit recently give us on the learned intermediary doctrine? A good one, or two, or even three.  In Tutwiler, the plaintiff alleged that she suffered pulmonary issues as a result of taking generic amiodarone for non-life threatening atrial fibrillation.  2018 WL 1719024, at *1.  According to the plaintiff, she did not receive the patient Medication Guide that the manufacturer allegedly made available to distributors and thus did not know that her doctor prescribed the drug off label. Id.

The district court dismissed the plaintiffs’ failure-to-warn claims on two bases: (1) federal regulation of generic drug warnings impliedly preempted the state-law warnings claims and (2) the learned intermediary doctrine barred the plaintiff’s claims absent allegations that inadequate warnings to the physician proximately caused the alleged injury. Id..  The Eleventh Circuit affirmed under the learned intermediary doctrine.  This is slightly surprising, given that the Supreme Court’s opinion in PLIVA v. Mensing provides such a clear path to implied preemption in failure-to-warn claim involving generic drugs.

Regardless, the Eleventh Circuit’s opinion on Alabama’s learned intermediary doctrine is in equal parts concise and well reasoned. There are three takeaway points. First, the plaintiff alleged that her physician prescribed the drug off label.  But that did not make a difference to her failure-to-warn claims, nor should it have made a difference.  We have seen other plaintiffs try to establish or amplify failure-to-warn claims by highlighting that their physicians prescribed drugs off label.  It usually does not work, for the simple reason that a prescription drug manufacturer has a duty to warn about known and reasonably knowable risks, not uses.  Of course, some states’ laws might impose a duty to warn regarding dangers of a product’s foreseeable misuse.  Be that as it may, a bare allegation of off-label use does not an inadequate warning make.

Second, and most importantly in our view, the Eleventh Circuit rejected the argument that the learned intermediary doctrine did not apply because the drug manufacturer did not adequately warn the plaintiff’s physician—and all other physicians—of the drug’s dangers.  In other words, the physician lacked sufficient information to be considered a “learned” intermediary. Id. at *3.

We have seen this argument before too, and a small number of courts have regrettably fallen for it. It is nonsense.  The learned intermediary doctrine is not so named because drug and medical device manufacturers have a duty to create “learned intermediaries.”  The manufacturer’s duty is to warn about a product’s known and knowable risks, and the learned intermediary doctrine defines to whom that duty is owed—highly educated physicians who are already “learned.”  This in turn defines the two critical elements of a warnings claim in drug and medical device cases:  (1) whether the warnings are adequate and (2) whether any inadequacy in the warnings caused the alleged injury.  Those elements are defined by reference to a reasonable physician’s skill and knowledge (his or her “learnedness”) and the warnings’ impact on the prescribing physician’s conduct.

The Eleventh Circuit explained it this way:

[I]n Alabama, the manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the use of its product. The adequacy of the manufacturer’s warning is “measured by its effect on the physician, [ ] to whom it owed a duty to warn, and not by its effect on the consumer.”

. . . . In such a situation [where the patient alleges inadequate warnings] the patient must show that:  “[T]he manufacturer failed to warn the physician of a risk not otherwise known to the physician and that the failure to warn was the actual and proximate cause of the patient’s injury.  In short, the patient must show that, but for the false representation made in the warning, the prescribing physician would not have prescribed the medication to his patient.”

Id. at **2-3 (citations and quotations omitted).  In Tutwiler, the plaintiffs alleged that the drug warnings were insufficient, but that alone does not erase the learned intermediary doctrine.  She also had to allege causation.  That is where she failed:

On appeal Ms. Tutwiler again argues that the learned intermediary doctrine does not apply because she alleged that [the manufacturer] did not adequately warn Dr. Plumb. This argument, however, does not address Alabama’s separate requirement that she also plead proximate causation—that Dr. Plumb would not have prescribed her amiodarone had he known of its dangers.

Id. at *3.  Because the plaintiffs did not allege that different or additional warnings would have changed her physician’s prescribing physician, she failed to allege causation, and the learned intermediary doctrine barred her claim. Id.

Which brings us to our third takeaway.  The plaintiff could not avoid the learned intermediary doctrine by alleging that she would have avoided the drug had she known of its dangers.  “Regardless of what Ms. Tutwiler would or would not have done with the information, Alabama law requires a showing of what Dr. Plumb would have done with it.” Id. (emphasis in original).  Plaintiffs routinely give self-serving testimony or execute affidavits attesting that they would not taken the drug “had they known.”  That won’t work, at least not in Alabama.

The opinion’s only drawback is that it is not published. Still, the Eleventh Circuit has set a tone that we hope will continue throughout 2018 and beyond.  Run Forest Run.

Breaking news. This just in. Prescriber’s testimony linchpin in manufacturer’s victory over failure to warn claims. And the crowd gasped at this startling news. Actually, this news might be more the equivalent of an announcement that a 13 year-old boy made a snarky comment to his parents (current daily experience for this blogger). Not exactly a revelation. But we will say that the opinion entered by the magistrate in Harper v. Janssen Pharmaceuticals, Inc., 2018 U.S. Dist. LEXIS 58298 (M.D. Ala. Apr. 4, 2018) is strong and well-reasoned. A good addition to any learned intermediary library.

Plaintiff is the mother of a boy who was diagnosed with autism at the age of 4. From the age of around 5 or 6 until he was 10, plaintiff’s son was prescribed Risperdal among other medications. During that time he began gaining weight and experienced high prolactin levels. At the age of 16, plaintiff’s son was diagnosed with gynecomastia, an abnormal development of breasts in males. Id. at *5-8. Plaintiff filed suit alleging claims for failure to warn under common law and under the Alabama Extended Manufacturer’s Liability Doctrine (“AEMLD”), negligence, wanton misconduct, breach of implied warranty of merchantability, fraud, and negligent misrepresentation. Id. at *5.

At the core of all of plaintiff’s claims is an allegation that the manufacturer failed to provide accurate or complete information about the risk of gynecomastia with the use of Risperdal. So, there are two key areas of inquiry – what information did the manufacturer provide and what did the prescribing physician know. Starting with the Risperdal label, throughout the time plaintiff’s son was taking Risperdal, elevated prolactin levels and gynecomastia were included in the precautions section of the label. Further, at all relevant times, the label included a warning that “safety and effectiveness in children have not been established.” Id. at *9-10. Plaintiff focuses on studies done by the manufacturer that allegedly show that Risperdal had a greater risk of increasing prolactin levels than other anti-psychotic drugs in the same class and argue that this information was available to defendant at the time plaintiff’s son was prescribed the drug and it should have been part of the warning. Id. at *12-14.

Moving on to the prescribers – the first doctor to prescribe Risperdal to plaintiff’s son testified that at the time he prescribed he knew that safety and effectiveness had not been established for children, that he took that into consideration when prescribing, and that it was his practice to discuss with the parents of child patients that this was an off-label use. Id. at *15. He was also aware that the label called for periodic re-evaluations if the drug was used long-term and again it was his practice to do so and that he only continued patients on medications if he felt the benefits outweighed the risks. Id. at *16. And, the prescriber was aware that Risperdal was associated with weight gain and was also aware that prolactin-elevating compounds could lead to gynecomastia. He took both into account when prescribing Risperdal. Id. at *16-17. The second prescriber was likewise aware that Risperdal was not approved as safe and effective for use in children and would have considered that at the time he prescribed to plaintiff’s son. Id. at *19.

Before jumping into its legal analysis, the court made a few astute observations about the intersection between science and the law and in particular the uncertainty of medicine that are uncommon in legal opinions and so we decided to provide for you directly here:

To a significant degree, this case epitomizes the limitations of medical science, the law, and their interaction. The course of human history has seen profound improvements in our understanding of health, disease, and other afflictions. Recent advances in diagnosis and treatment of medical conditions, both physical and mental, are often little short of miraculous. Despite these advances, our understanding of maladies and their safe and effective treatment remains incomplete and imperfect. This is especially and poignantly true with respect to the broad category of mental health conditions. Doctors and the pharmaceutical industry have developed any number of powerful medicines for treatment of many of those conditions, with varying levels of effectiveness. All these medicines carry the burden of potential side effects for some or all users. Determining the origin of adverse conditions associated with certain drugs is often difficult.

Measuring the breadth and fixing the limits of legal liability for adverse drug reaction requires development and application of legal principles in an area of great medical uncertainty and conflicting economic and societal goals. Through federal and state legislation, administrative regulation and approvals, and the common law, we establish standards for patients, doctors, and pharmaceutical companies to govern their affairs. Legal concepts of proof and causation are often not readily applied where scientific knowledge is incomplete and uncertain. The twin aims of providing appropriate compensation to individuals injured by others while encouraging doctors and drug companies to advance the field of medicine frequently conflict, as in this case.

Id. at *21-22. We’ve blogged on occasion about the pitfalls of the law getting too far ahead of science and how making the two fields meet can be quite tricky – nice to see it in an opinion.

So, faced with a label that warned of the risk, and prescribers who knew and considered the risk, and imperfect scientific knowledge – what was left for the judge was to enter summary judgment. Plaintiff argued that while the Risperdal label contained some warnings, those warnings were incomplete or misleading about the extent of the risk (the studies noted above). However, the label was “not intended to be a risk profile for adolescents.” Id. at *28. The label explicitly stated the drug’s safety and effectiveness had not been established for pediatric patients and also went on to include both increased prolactin and gynecomastia in the precautions. More importantly, as noted above, the prescribers were aware of the risks. “The prescribing decisions of [plaintiff’s son’s] health care providers were made after weighing the risks and benefits of the medication. Critical to a plaintiff avoiding the learned-intermediary doctrine is a demonstration that the manufacturer failed to warn the physician of a risk not otherwise known to the physician.” Id. at *30 (citation and quotation marks omitted).

Further, as to the studies showing increased risk upon which plaintiff relies, plaintiff’s initial prescriber testified “that until a study is completed and the data analyzed, it is not available to him to rely upon in making his prescribing decision.” Id. at *29. Great support from the prescriber for keeping out science that post-dates prescription and usage of the drug. If the studies weren’t published until after the doctor stopped prescribing, they couldn’t factor into his prescribing decision and they shouldn’t factor into the court’s failure to warn analysis.  Putting all this together, the court concluded both that the defendant provided adequate warnings and that the “prescribing physicians knew use of Risperdal in children was an “off-label” use, independently knew of the risks associated with the medication or researched them prior to prescribing the medication, and chose to prescribe it anyway.” Id. at *31. Learned intermediary doctrine bars any failure to warn claim.

Plaintiff’s remaining claims fell away quickly as well. Wanton disregard requires a showing of recklessness or conscious disregard for the safety of others. Again plaintiff’s pointed to the label and argued it wasn’t enough. “The fact that the warnings could have been broader or stronger does not equate to reckless disregard or an indifference toward safety.” Id. at *33.  The label contained a warning of the very risk at issue, therefore, defendant was not indifferent to safety. Breach of implied warranty failed because (a) Alabama doesn’t recognize it for inherently dangerous products and (b) the drug served its purpose of treating mental health. Id. at *35-36. Finally, plaintiff’s fraud and misrepresentation claims fail because even if you assume all facts in the favor of plaintiff, she hasn’t established reliance by her son’s treaters or causation where the treaters knew of the risk and prescribed anyway. Id. at *38.

Learned intermediary may not be a hot new topic, but this testimony and the analysis by the court is pretty top-notch.

This post does not come from the Reed Smith side of the blog.

 

Favorable New Jersey appellate court decisions in product liability cases are almost always worthy of mention here. So we bring you Goodson v. C.R. Bard, 2018 WL 1370652 (N.J. App. Div. Mar. 19, 2018). To be truthful, we’re bringing it back to you. Bexis discussed the trial court’s decision to grant summary judgment to defendants last year.

As we discussed then, this is a case involving mesh used in hernia procedures. The particular mesh product involved in this case is not involved in the pelvic mesh MDL proceedings. And that may be reflected in the strength of the plaintiff’s expert reports, which is to say that they are not strong at all.  While the plaintiff used experts who have been involved in the pelvic mesh MDL, not one of them seemed to give the right opinions.

In particular, even though plaintiff brought a design defect claim, none of his experts gave an opinion that the design of this particular product was actually defective or that such a defect caused the plaintiff’s injuries. Id. at *4-5. Rather, his experts simply described various alleged risks of the product. This is not even close to sufficient to support a design defect claim. Id. Nor did any of the experts opine that there was a safer, feasible alternative design. Id. Similarly, even though plaintiff also brought a negligent failure to wan claim, none of the experts gave an opinion on the standard of care for issuing a warning or whether defendants met that standard. Id. at *5-6. In other words, plaintiff didn’t have a warnings expert to opine on whether the warning was adequate.

In short, plaintiff’s experts struck out looking.

To make matters worse, the treating doctor testified that he was aware of the potential risks of this mesh product and informed plaintiff of them. Id. at *6. There goes proximate causation under the learned intermediary doctrine.

Accordingly the New Jersey appellate division upheld the trial court’s grant of summary judgment to defendants. Unfortunately, it designated its opinion “not for publication.” That’s too bad. But rest assured: it happened. Westlaw already has it on-line. And the trial court’s decision, which Bexis’s post from last year lays out in considerable detail, has an excellent analysis of all the weaknesses in plaintiff’s case, an analysis that was essentially adopted by the Appellate Division. And, of course, we’ve written on it twice now. With all of that, we’re confident that you’ll find some way to make use of this appellate decision in your cases.

The district judge in the In re Zimmer Nexgen Knee Implant Products Liability Litigation MDL issued a summary judgment order in October 2016 that we called “the best Wisconsin law decision we have ever seen.”  What was the reason for our unusually unbridled enthusiasm?  The district judge debunked the idea that the learned intermediary rule does not apply in Wisconsin.  We have often heard that refrain, but we have always been skeptical.  The truth is that Wisconsin’s appellate courts have not addressed the issue, and the In re Zimmer Nexgen judge predicted that Wisconsin’s Supreme Court would adopt the learned intermediary rule if given the opportunity.

The Seventh Circuit has affirmed that order, so its opinion now inherits the mantle of “Best Wisconsin Law Decision We’ve Ever Seen.” That title is cemented not only by the adoption of the learned intermediary doctrine, but also the rejection of a heeding presumption, which is also very helpful.  We note that the three judges who issued this opinion have spent a combined 83 years on the Court of Appeals and that the author of the opinion spent five years on the Wisconsin Supreme Court.  Maybe the latter fact was considered when assigning the opinion; maybe it was not.  Regardless, it is a clear-minded and well-reasoned opinion that we commend to anyone who has grappled with warnings claims in Wisconsin.

Here is what happened. The plaintiff sued a knee implant manufacturer alleging design, manufacturing, and failure-to-warn claims after his prosthetic knee replacement loosened, which is a known complication of all joint replacement procedures. In re Zimmer Nexgen Knee Implant Prods. Liab. Litig., No. 16-3957, — F.3d –, 2018 WL 1193431, at *1 (7th Cir. Mar. 8, 2018).  Following summary judgment, the plaintiff raised only the warnings claims on appeal and argued that the manufacturer failed adequately to warn both the plaintiff and his surgeon.

Of course, an alleged failure to warn the plaintiff raises the application of the learned intermediary rule, which “holds that the manufacturer of a prescription drug or medical device fulfills its duty to warn of the product’s risk by informing the prescribing physician.” Id. at *2.  Because neither the Wisconsin Supreme Court nor the state’s intermediate appellate courts have addressed the rule, the Seventh Circuit undertook an Erie analysis. Id. at *3.

Although we would like to believe that the Seventh Circuit reviewed our frequently updated 50-state survey on the learned intermediary rule, it is more likely the court did its own research or relied on that provided by the manufacturer.  What it found was one Wisconsin trial court opinion applying the doctrine and noting its widespread acceptance. Id. at *3 (citing Staub v. Berg, No. 00-cv-0117, 2003 WL 26468454 (Wis. Cir. Ct. Jan. 6, 2003)).  The Court also found three federal district court opinions invoking the learned intermediary doctrine under Wisconsin law, and one case called Maynard v. Abbott Labs observing that “Wisconsin does not apply the learned intermediary doctrine.” Id. On this last point, the Seventh Circuit was particularly blunt:  “That statement is incorrect—the Wisconsin Supreme Court has never weighed in on the topic [and] Maynard itself is bereft of any analysis on the point.” Id.

The Seventh Circuit also relied on the learned intermediary doctrine’s “broad support in other jurisdictions,” including 48 states where the highest court or the intermediate appellate courts have adopted the doctrine in some form. Id. Finally, the rationale for the learned intermediary rule applies even more forcefully in cases involving surgical implants because “it is not reasonably conceivable that an individual could obtain and implant a device that requires a trained surgeon without the intervention of a physician.” Id. Amen.

The following holding and the reasoning upon which it is based are what make In re Zimmer Nexgen the Best Wisconsin Law Opinion We’ve Ever Seen:

In short, there is good reason to think that given the opportunity, the Wisconsin Supreme Court would join the vast majority of state supreme courts and adopt the learned-intermediary doctrine for use in defective-warning cases like this one involving a surgical implant. We predict the state high court would do so.  Accordingly, to the extent that [the plaintiff’s] defective-warnings claim is based on [the manufacturer’s] duty to warn him, it is foreclosed by the learned-intermediary doctrine.

Id. at *4.  For good measure, the Seventh Circuit held that the plaintiff’s direct warnings claim failed also because the plaintiff did not identify any danger about which that the manufacturer should have warned him and because he had no evidence of causation.  Even if the plaintiff would have heeded a different warning, “[he] didn’t select the NexGen Flex implant.”  His surgeon did.  Id.

The Seventh Circuit likewise rejected the plaintiffs’ argument that the manufacturer failed adequately to warn the surgeon.  The plaintiff cited the defense expert’s testimony that he would have used more cement to place the implant and argued that the manufacturer failed to warn about the amount of cement needed. Id. at *4.  But that was not sufficient because “no evidence supports [the plaintiff’s] contention that it was [the manufacturer’s] responsibility to instruct surgeons about the amount of cement they should use.” Id. at *5.  This surgeon relied exclusively on his education and training, not on any materials from the manufacturer, and the plaintiff offered no expert opinion that the warnings were inadequate in any event. Id.

Finally, the Seventh Circuit rejected the warnings claims on causation. The surgeon did not read the instructions for use and could not been affected by a different warning. Id. at **5-6.  The plaintiff urged the Seventh Circuit to apply a “heeding presumption,” i.e., a presumption in the absence of proof that the surgeon would have read and heeded a proper warning. Id. at *5.  But Wisconsin law squarely places the burden of proving causation on the plaintiff.  As the Seventh Circuit held,

Here again, the state appellate courts have not addressed this doctrine [the heeding presumption]. We seriously doubt that they would adopt it in this context.  [¶]  To the contrary, as we’ve already noted, the state court of appeals has recently held that “[a] plaintiff who has established both a duty and a failure to warn must also establish causation by showing that, if properly warned, he or she would have altered behavior and avoided injury.”

Id. (citing Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 876 (Wis. Ct. App. 2004)).  In other words, since Wisconsin law already places the burden of proving causation on the plaintiff, the Seventh Circuit would not alter that law by creating a presumption.

The plaintiff’s last request was to certify questions to the Wisconsin Supreme Court, which the Seventh Circuit rejected because “[n]o genuine uncertainty exists here.” We could not agree more and would not be surprised to see this opinion on our Ten Best list at year end.

We don’t often get to discuss decisions from Maine. In fact, a quick spin through the blog and you’ll see Maine really only comes up in various canvases or surveys of state law. We don’t dislike the state. We love the lobster — that they take very seriously. We can’t say we love the winters there (at least this blogger doesn’t), but the coastline is beautiful in summer. And perhaps our vision of Maine is just ever so slightly skewed by Stephen King having set so many of his horror novels there. While King’s frightening tales are set in fictional towns, avid readers and explorers have suggested that you can visit several real places in Maine that seem to have inspired King’s work. For instance, if you’re looking for Derry, you want to stop in Dexter, Maine (mind the sewers). If you are more of a Cujo or Needful Things fan, Castle Rock is supposedly based on Woodstock, ME. You won’t find a giant dome in Rumford, but you’ll probably notice its otherwise close resemblance to Chester’s Mill (Under the Dome). And finally, there is King’s hometown of Bangor which is rumored to be the inspiration for the town of Haven from The Tommyknockers.

So, we were quite pleased when Dustin Rawlin and Bill Berglund of Tucker Ellis sent us their recent, far from creepy, win from the 23rd state. The case is Novak v. Mentor Worldwide LLC, 2018 WL 893914 (D. Maine Feb. 14, 2018) and the primary issue is statute of limitations. Statute of limitations cases are also not something we spend too much time on here, but this one has a notable ruling specific to prescription medical products liability cases – the discovery rule does not apply.

In 2004, plaintiff underwent surgery during which defendant’s product, a vaginal sling, was implanted to treat stress urinary incontinence. Id. at *1. Around 8 months to 1 year after the surgery, plaintiff started to experience pain during intercourse and by the end of 2006 was experiencing vaginal leaking and bleeding. Id. at *2. Before the end of 2006, plaintiff informed her surgeon of her problems. He ordered tests, the first round of which were inconclusive and plaintiff failed to undergo furthering testing. Id. In 2013, plaintiff attributed her problems to defendant’s product which was partially removed in another surgery in 2014. Id. Plaintiff filed suit in 2016. Id. at *1.

Maine’s statute of limitations for all civil actions is 6 years from when the cause of action accrues. Id. at *3. Further, Maine follows the date-of-injury rule when it comes to accrual. “[M]ere ignorance of a cause of action does not prevent the statute of limitations from running.” Id. In other words, generally Maine does not apply the “discovery rule” to determine when the statute starts to run (in states that do, a claim does not accrue until the plaintiff discovers or should have discovered the wrongdoing or misconduct). There are, however, exceptions where Maine has expressly applied the discovery rule: legal malpractice, foreign object and negligent diagnosis medical malpractice; and asbestosis. Id. General products liability claims not included.

Maine has also acknowledged the continuing tort doctrine where the alleged tort occurs over a series or chain of incidents. In such cases, the claim would not accrue until the last act in the chain – such as cases of pollution or contamination. Id. at *4. The continuing tort doctrine does not apply in cases where plaintiff’s alleged injuries, while occurring or perhaps worsening over time, are allegedly caused by a single act of negligence. Id.

Because plaintiff filed suit in 2016, her claims are time-barred if they accrued before 2010. As we noted above, her surgery was in 2004 and her complications appear to have started within the first year thereafter. So, unless the court applied the discovery rule, her claims would be barred.

Plaintiff’s first argument was that the presence of the defendant’s medical device in her body constituted a continuing tort that didn’t end until the product was removed in 2014. Id. at *5. But the continuing tort doctrine isn’t about continuing harm. What plaintiff here, or in almost any drug or device products liability case is alleging is a “finite act or set of acts (manufacture, design, inadequate warning, or misrepresentation) that led to her injuries.” Id. Once the device was implanted, the alleged wrongful act was over.

[Plaintiff] underwent only one, readily-identifiable exposure to the [device] (her surgery), and all of [defendant’s] allegedly tortious conduct took place before that point. . . . [defendant’s] wrongful conduct may have caused the [device] to deteriorate, which in turn may have caused injuries over time. However, once those injuries had manifested, the fact that their full scope remained unknown did not stop the statute of limitations from running.

Id. at *9, n.6.

Plaintiff’s second argument was that there was a genuine dispute regarding whether her earlier symptoms, pre-2006, were caused by the defendant’s medical device. Perhaps plaintiff should have thought of that argument before submitting an expert report tying those early symptoms to the medical device. Id. at *6. Nor could plaintiff rely on her surgeon not identifying a connection between the device and her symptoms when his tests were only inconclusive and plaintiff opted not to do further testing. Id. For a jury to conclude that plaintiff’s early injuries were not caused by defendant’s product would require “complete speculation.” Id. The statute started to run when plaintiff first experienced symptoms, regardless of how minor those symptoms were. Id. at *9, n.7.

While the statute of limitations did away with almost all of plaintiff’s claims, her fraud based claims remained. On those, as well as any other claim based on a failure to warn, defendant argued plaintiff failed to meet her burden to prove causation – plaintiff had no evidence that a different warning or information would have changed her surgeon’s decision to implant the device. Id. at *7. First, it is noteworthy that the court applied the learned intermediary doctrine. Id. at *8. Maine’s high court has never discussed the rule. The court relied on other federal courts interpreting Maine law on the issue.

So, applying the learned intermediary, the court’s focus correctly shifted to plaintiff’s surgeon. Plaintiff did not dispute that her doctor was aware of various risks, including those experienced by plaintiff. Id. Instead, plaintiff’s tried to meet their causation burden by arguing that the doctor “may very well have decided” not to implant the device if he had been provided different warnings. Id. But, that is either an unsupported fact or mere speculation and neither are evidence. Id. Plaintiff next showed the court some medical literature concerning the risks of the medical device and the doctor’s deposition transcript. But offered no connection between the two.

[The doctor’s] deposition transcript reflects that [plaintiff’s] counsel failed to ask him whether additional information would have altered his decision to go ahead with [plaintiff’s medical device] surgery.

Id. at *9. While not discussed directly in the opinion, requiring affirmative evidence that the doctor would have changed his use of the product for plaintiff to survive summary judgment is certainly an implicit rejection of the heeding presumption. Nor was it defendant’s obligation to ask these questions at the doctor’s deposition. Id. at *9, n.14.

So, while Maine may more quickly bring to mind images of butter poached crustaceans or mysterious floating red balloons, it’s not a bad place for prescription medical products cases either.

This year’s Academy Award nominations came out last week. That means that we have spent the past few days setting a schedule for seeing all of the Best Picture nominees (well, most – we don’t do war movies and tend to opt out of love stories involving semi-animate objects) and scouring recipe blogs for perfect Oscar party buffet items.  We have also reminisced, with amusement, about the climactic moments of last year’s show, during which the presenters announced the wrong Best Picture winner before an Academy official shoved them out of the way and corrected the error.  As we recall, it turned out (not surprisingly) that the mistake was caused by sloppiness.  The Academy’s accountant handed the presenters a duplicate envelope for an award that had already been presented, starting the embarrassing domino cascade.  We recall that heads rolled in the ensuing days.

Today’s case also involves the consequences of sloppiness, along with a couple of interesting legal rulings. In its unpublished decision in Small v. Amgen, Inc., et al., 2018 WL 501354 (11th Cir. Jan 22, 2018), the Eleventh Circuit considered the plaintiff’s appeal of two summary judgment orders:  a grant of partial summary judgment for the defendants, and a later grant of summary judgment on all of the remaining claims.

The plaintiff was prescribed the defendants’ drug to treat her rheumatoid arthritis. She took the drug for nearly six years then suffered a perforated bowel and a diverticulitis infection, for which she underwent multiple surgeries.  She sued the drug’s manufacturers, asserting all of the usual claims. In 2014, the district court granted summary judgment on the plaintiff’s failure-to-warn claims, holding that Florida’s learned intermediary doctrine precluded the claims.  Later, when the plaintiff’s expert disclosures revealed her sloppy omissions — although she identified five treating physicians she intended to use as non-retained experts, she had no expert to testify to general or specific causation — the defendants moved for summary judgment on the plaintiff’s remaining claims.  In 2017, the district court granted the defendants’ motion.

On appeal, the plaintiff did not dispute or even address the 2017 summary judgment order. Instead, she argued that the 2014 dismissal of her warnings claims was improper because there were factual issues “regarding the district court’s treatment of [her prescriber] as a learned intermediary.” Small, 2018 WL 501354 at *2.  She also argued that “the district court incorrectly decided that the direct ‘patient labeling requirement’ in the FDA medication guidelines did not preempt Florida’s learned intermediary doctrine.” Id.

With respect to the prescriber-as-learned-intermediary argument, the court explained that the plaintiff’s prescribing physician had 22 years of experience in rheumatology and “intentionally selected [the drug] for [the plaintiff], despite the risk of possible infections, because other forms of rheumatoid arthritis therapy had failed.” Id. What’s more, the prescriber was involved in clinical trials with the drug, and the plaintiff was a participant, giving the prescriber “more reason to know of and discuss possible side-effects or concerns” associated with the drug.” Id. The prescriber “knew that infections were possible but prescribed the drug anyway . . . because the benefits outweighed the risks.” Id. As such, because “the prescribing physician had substantially the same knowledge as an adequate warning from the manufacturer should have communicated,” the plaintiff could not prove warnings causation and her warnings claims failed as a matter of law. Id. (internal punctuation and citation omitted).   In other words, “the failure of the manufacturer to provide the physician with an adequate warning . . . is not the proximate cause of a patient’s injury if the prescribing physician had independent knowledge of the risk that the adequate warning should have communicated.” Id. (citation omitted).

Next, the plaintiff argued that Florida’s learned intermediary doctrine was preempted by the FDA’s requirement that the manufacturers provide patients with a “medication guide” for the drug. The court emphasized that “the historic police powers of the State [were] not superseded unless that was the clear and manifest purpose of Congress.” Id. at *3 (internal punctuation and citation omitted).   To discern such “clear and manifest purpose” in cases of implied preemption, the court explained that it considered “the promulgating agency’s contemporaneous explanation of its objectives as well as the agency’s current views of the regulation’s preemptive effect.” Id. (internal punctuation and citation omitted).

In the case of the medication guide regulation, the FDA had specifically addressed concerns that the regulation would alter the framework for manufacturers’ liability by abrogating the learned intermediary doctrine.  In response, the agency stated that “the written patient medication information provided did not alter the duty, or set the standard of care for, manufacturers [or] physicians . . . .” Id. (citation omitted).   Given this “contemporaneous explanation” from the FDA, coupled with the reality that “courts have not recognized an exception to the learned intermediary defense in situations where the FDA has required patient labeling . . . ,” the court held that there was no preemption.  We love this holding, and we believe this is the first time that an appellate court has so held.

No preemption, no warnings causation – summary judgment on warnings claims affirmed. And, because the plaintiff did not address her inexplicable failure to identify causation experts, the court held that she had waived any appeal of the 2017 summary judgment order.   Case (tidily) dismissed, in a no-nonsense decision we like very much.  We’ll let you know if we are similarly pleased by this year’s Oscars.

We’re now into the New Year but aren’t completely done with the old one.  The name of the first month of the year, January, is conventionally attributed to Janus, the Roman god of beginnings, gates, transitions, and doorways.  (We say “conventionally” because some sources report that January is actually named after its tutelary deity, Juno.) Janus, like some of our opponents, is two-faced.  Janus looks both forward and backward.  Bexis last month took a couple of long looks backward at 2017’s best and worst cases.  We’re still scrolling through the various Ten Best of 2017 culture lists for ideas, confirmations, and occasional outrages.  An in-house lawyer we endlessly respect pointed us to The New Yorker’s  list of top tv programs.  It’s hard to quarrel with Emily Nussbaum’s choice of The Leftovers, a fever-dream about love and loss (and a lion sex boat) as the best drama.  She was also right to praise American Vandal, the show that made us laugh out loud the most.  (The Good Place came in second on that score.)  Nussbaum also gave honorable mention to Halt and Catch Fire, an AMC show that really did seem to catch fire after its first, flawed season.  HACF stopped acting like a Mad Men, difficult-guy retread, shifted focus to the female protagonists,  and successfully steered us through the digital revolution – from PC clones to gaming to community chat boards to security to the web to PayPal to Yahoo to something even sexier than a lion sex boat: the Next Idea.  In seasons 2-4, HACF managed to show us (rather than merely tell us) how “computers aren’t the thing; they are the thing that gets us to the thing.”  That ‘thing’ is human connection. But you already knew that, right? There is an episode after the death of a major character that is the best depiction of grief and its clumsy toggling between the transcendent and the quotidian that we’ve seen.  The dead leave a lot behind.  Some of it goes to Goodwill.  Some of it survives in silly stories.  Some of it gets caught in our throats and some of it squeezes our tear ducts hard.  If you are looking for something to binge, consider The Leftovers, American Vandal, and Halt and Catch Fire (and maybe Patriot, The Americans, and Mindhunter).  You might also want to set aside an hour to take in episode 8 of Twin Peaks: The Return because you need to relive your college experience of attending a midnight showing of something arresting and supremely weird. 

Today’s post takes us back to 2017 for a case that is neither particularly arresting nor even a little bit weird.  Rather, the result seems inevitable.  In Siddoway v. GlaxoSmithKline LLC (In re Avandia Mktg., Sales Practices & Prods. Liab. Litig.), 2017 U.S. Dist. LEXIS 203885 (E.D. Pa. December 12, 2007), the plaintiff alleged that he sustained a heart attack from taking Avandia, and that the label did not warn him adequately.  The facts here, both regarding the plaintiff’s use and the regulatory backdrop, lead ineluctably to the defendant’s victory on summary judgment.   The plaintiff was initially prescribed Avandia from 2001 through 2002. In 2003, the plaintiff suffered two heart attacks, and ultimately underwent a successful heart transplant operation. He blamed Avandia for those heart attacks.  Following the heart transplant, a different doctor prescribed Avandia to the plaintiff. The plaintiff continued to take Avandia from December 2003 through June 2007, and did not experience any other adverse cardiovascular condition.

Let’s go backward for a moment.  When Avandia was initially approved by the FDA in 1999 to treat Type II diabetes, the drug’s label contained no warning of an increased risk of heart attack. But in 2007 – four years after the plaintiff’s heart transplant — the FDA issued a safety alert for Avandia, notifying consumers that “data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.”  The FDA directed that a boxed cardio warning be added to the Avandia label.  So there’s your lawsuit, right?

Not quite.  Now let’s go forward.  After the label change and after the plaintiff filed his lawsuit, the manufacturer and the FDA conducted extensive research on Avandia’s safety. In 2013, the FDA ultimately concluded that there was no increased risk of heart attack associated with Avandia use compared to alternative diabetes medications. Thus, in 2014, the FDA approved an updated Avandia label that removed the boxed warning for a potential increased risk of heart attack.  Good science led to good news for patients, but not such good news for this particular patient’s lawsuit.  All of the plaintiff’s nine causes of actions essentially boiled down to failure to warn theories, and the facts on the ground had removed all support for that theory.  Even putting aside the question of whether the original label was inadequate because it lacked a warning that had now been repudiated by the FDA, the plaintiff’s case failed for inability to show that the alleged failure to warn was the proximate cause of the plaintiff’s injuries.  To the extent that specific claims bumped against the learned intermediary doctrine (Utah law governed, so the learned intermediary doctrine was alive and well), the plaintiff faced a huge problem when it came to posing the usual question to the prescriber:  knowing what you know today, would you still have prescribed this medicine to the plaintiff?  From his deposition testimony, it is clear that the prescriber’s “understanding of Avandia’s risk profile today is the same as it was when he prescribed Avandia to [the plaintiff]—that Avandia is not associated with an increased cardiovascular risk compared to other diabetes drugs.  He also testified that, if the current package insert were in place when he was prescribing Avandia to [the plaintiff], he still would have prescribed it.”  That is pretty inescapable logic.  John Adams once said that “facts are stubborn things.”  So is science.  So are label changes. 

But the plaintiff did try to escape the facts, the science, and the label changes.  He pointed to the prescriber’s testimony that he “quit using” Avandia for patients after 2007.  But that same prescriber’s testimony made clear that even when the 2007 data on which the plaintiff based his claims is considered along with the other Avandia risk data available today, he would still prescribe Avandia to the plaintiff, just as he had in 2001 and 2002, when there was no heart attack risk warning in the Avandia label. It is as if the plaintiff tried to preserve his case by seizing upon one favorable moment in time and excluding any other, subsequent facts that might prove inconvenient.  Don’t look forward, and don’t look backward.  Just look at the evidence in that nanosecond that might support a claim.  But no decent doctor would do that.  Nor would any sensible court.  Hence, the Siddoway court held that the plaintiff had failed to establish a genuine issue of material fact as to whether the prayed-for warning would have deterred the doctor from prescribing Avandia to the plaintiff before he suffered the 2003 heart attacks.  The court looked at all the evidence, forward and backward, and saw its way clearly towards complete dismissal of the case.   

 

In the mass torts world in which we find ourselves, glimmers of jurisprudential light can seem few and far between. Two things we love are good warnings causation decisions and sneaky plaintiffs getting caught at their own games.  Today’s case has both.  In Thompson v. Janssen Pharm., Inc., 2017 WL 5135548 (C.D. Cal. Oct. 23, 2017), the court considered simultaneous motions:  the plaintiffs’ motion for voluntary dismissal without prejudice and the defendants’ motion for summary judgment.

The plaintiff began taking Risperdal in 2001 after he was diagnosed with tics and other disorders, and he alleged that the drug caused him to develop gynecomastia (breast enlargement). Nevertheless, he continued – and continues – to take Risperdal (sixteen years, five doctors, and counting) because it effectively controls his tics, notwithstanding his alleged gynecomastia, his lawsuit, and his doctor’s recommendation that he stop taking the drug.

The Plaintiffs’ Motion for Voluntary Dismissal without Prejudice

The plaintiffs sued in the Central District of California, asserting the usual litany of claims. One day before the defendant moved for summary judgment, the plaintiffs moved for voluntary dismissal without prejudice so they could re-file their case in state court and park it in the already-existing JCCP, California’s version of an MDL.  They claimed that, though they had “been diligently seeking discovery” to prove their case, they were “unable to do so effectively” in federal court. Thompson, 2017 WL 5135548 at *4.

The court explained that factors relevant to its decision included: 1) the opposing party’s effort and expense in preparing for trial; 2) excessive delay and lack of diligence by the moving party in prosecuting the action; 3) insufficient explanation of the need for dismissal; and 4) the fact that the opposing party has moved for summary judgment. Id. at *5 (citations omitted).  Naturally, the plaintiff argued that all of these factors weighed in favor of granting the motion, but the court disagreed.

The court pointed out that, though the plaintiffs argued that they had been diligent in prosecuting his case, they had “failed to serve expert disclosure or expert reports.” Id. at *6.  Moreover, through the plaintiffs’ motion was “purportedly premised on their intention to join the pending state court [Risperdal litigation],” they gave “no explanation as to why they waited until . . . mere days before the summary judgment deadline” when they had notice of the state court litigation for more than a year. Id. The court concluded that this was “an insufficient explanation of the need for dismissal,” one of the factors to be considered. Id. (internal punctuation omitted).

In addition, though the defendants’ motion for summary judgment was not pending when the plaintiffs filed their motion (it was filed the next day), the defendants had notified the plaintiffs that they would be filing for summary judgment before the plaintiffs moved for dismissal. The court held that “the proximity of the two motions raise[d] the inference that that Plaintiffs’ motion might have been motivated by a desire to . . . avoid an imminent adverse ruling by way of Defendants’ summary judgment motion and also avoid the consequence of their failure to serve expert disclosures.” Id. (internal punctuation and citation omitted).

Simply put, as the court correctly perceived, the plaintiffs’ tactic was a transparent attempt to hide their meritless case in another mass proceeding on the chance that an inventory settlement would line their pockets at some point down the road.  The court concluded, “. . . Plaintiffs have not provided sufficient justification for voluntary dismissal given the untimeliness of the request and the proximity to Defendants’ motion for summary judgment.” Id.  Motion denied.

The Defendants’ Motion for Summary Judgment

It was undisputed that all of the plaintiffs’ claims were premised on the defendants’ alleged failure to warn about the rate of gynecomastia. As such, the defendants argued that all of the plaintiff’s claims failed because, inter alia: 1) the plaintiff assumed the risk by continuing to take the drug once he was aware of the alleged risk; and 2) the plaintiff could not prove “warnings causation;” in other words, he could not satisfy his burden of proving that that a different warning would have changed his doctors’ decisions to prescribe the drug for him. Id.

As to assumption of the risk, the defendants argued that the plaintiff was aware of the risk of gynecomastia but “continues to use Risperdal because he believes the benefits of the medicine in treating his condition outweigh the very risks that he has sued upon.” Id. at *7 (citation omitted).  The court disagreed, holding that the record did not clearly indicate that the plaintiff’s treating physicians discussed the risk of gynecomastia with the plaintiff.

But it was clear, on the record, that all of the plaintiff’s prescribing physicians were themselves aware of the risk of gynecomastia. And the plaintiff “provided no evidence that a different warning would have altered the physicians’ decisions to prescribe Risperdal.”  Therefore, the plaintiff could not “demonstrate the [warnings] causation required to survive summary judgment under California’s learned intermediary doctrine.” Id. at *8.

Nor were the plaintiffs’ claims saved by California’s “overpromotion exception.” As the court explained, “California courts have in the past recognized that the learned intermediary doctrine may not apply where a medication has been overpromoted to the extent that any warnings would have been nullified.” Id. at *9 (citation omitted).  But the overpromotion exception applies only in “unusual cases” (our California colleagues tell us that it is very rarely applied), and not “where a plaintiff’s prescribing physician did not rely on promotional statements when choosing treatment options.” Id. (citation omitted).  In this case, there was no evidence that any of the plaintiff’s prescribers relied on the defendant’s promotional activities, and the exception did not apply.

And so, in the absence of evidence of warnings causation, the court granted summary judgment for the defendants. The correct result, and a nice cautionary tale for plaintiffs thinking they can game the system, ignore both rules and law, and await the filling of their outstretched hands.  Does our defense heart good.