At times, we have given a glimpse into the sausage making that goes into our production of posts on recent interesting cases and developments.  Part of the process involves standing searches for “published” (including by the electronic services) decisions from trial courts and appellate courts.  Sometimes, the trial court decisions are unpublished but interesting, and the appellate decisions are published but not too interesting.  When we saw the Sixth Circuit decision in Agee v. Alphatec Spine, Inc., — Fed. Appx. –, 2018 WL 1020078 (6th Cir. Feb. 22, 2018), on one of our standing searches, it was not interesting enough to merit a post.  A short per curiam decision noted how awful plaintiffs’ complaint was and how they had waived their position on preemption by mixing up express preemption with the implied preemption raised by the defendant’s motion to dismiss.  We were feeling sleuthy, however, so we tracked down the district court’s decision from a year ago.  It has a nice discussion of Buckman, and will now be published, so we are going to discuss it.

Agee v. Alphatec Spine, Inc., No. 1:15-cv-750, 2017 WL 5706002 (S.D. Ohio. Mar. 27, 2017), reads like the sort of case brought when the plaintiffs are looking for someone on whom to pin liability in the absence of a claim against the most logical defendant.  The plaintiffs claimed that a surgeon used defendant’s product in connect with unnecessary spinal surgeries without proper informed consent, but the surgeon fled the country with criminal charges pending.  So, the plaintiffs asserted various product liability claims against the manufacturers of the product, PureGen.  Usually, we would state clearly what type of product is at issue, but neither decision really says, other than to say the defendants are medical device companies and the product was used to stimulate bone growth.  We did a little looking and saw that PureGen is an “osteoprogenitor cell allograft” derived from donated adult stem cells.  We also saw that there was some history with FDA over whether this was a biologic, requiring approval of a Biologics License Application, or a device that might go through the 510(k) pathway.  In any event, plaintiffs seemed to claim defendants should be liable for their injuries—it was unclear that there were any physical injuries—solely because PureGen “had never been approved by FDA for use in the spine.”  Defendants moved to dismiss.

We will skip over the TwIqbal part of this—although there are nice statements and the interesting fact that some of the plaintiffs were suing in the same court with contrary allegations about another product—and the some of the details of Ohio law to get to the Buckman part.  After reiterating the Buckman standard and the cases explaining that a court is to look at the asserted claims to see if a violation of the FDCA is a critical element, the court did just that, providing something of a roadmap on what is preempted under Buckman.  The claim for defective manufacturing alleged that the failure to obtain FDA approval made the product produce injury.  (That is not close to a manufacturing defect claim under Ohio law, which has codified the claim under ORC 2307.74.)  The design defect claim was identical (and similarly off-target from ORC 2307.75).  The warning defect claim was also predicated on lack of approval of the product, but not even that the warning misrepresented the regulatory status.  The misrepresentation claim was predicated on a representation to plaintiffs and their doctors that the product was approved or concealing from them that it was not.  A similar claim for nonconformance with representation (under ORC 2307.77) was slightly less clear, in that it referenced “representations made by defendants concerning the product and/or with applicable federal requirements.”

The court’s analysis of these claims was clear and quotable:

Each of the above-quoted claims is clearly dependent upon the FDCA to a degree that the claims would not exist but for the statute. It may or may not be the case that the promotion and distribution of PureGen for use in the surgeries references in the complaint was in violation of the FDCA and relevant FDA regulations.  However, if that is the case, it is the sole responsibility and privilege of the federal government, and not private plaintiffs, to bring a suit to enforce those violations.

Well-reasoned. And dispositive.  And now affirmed on appeal.

Earlier this week, we discussed how the presentation of the federal question of express preemption from the face of a complaint can lead to removal.  Part of why the defendant drug or device manufacturer may prefer federal court over state court is that the belief that the chances of winning on preemption are better in federal court.  On the other hand, we have described many instances where federal courts mess up their preemption analysis by presuming that state law imposes the duty that plaintiff claims does not conflict with FDA obligations or by extending state law in new directions to provide a basis for a parallel claim, Erie restraint notwithstanding.  It may be that state court judges are less likely to impose duties not recognized explicitly in higher court decisions.

Tibbe v. Ranbaxy, Inc., No. C-16o472, 2017 Ohio App. LEXIS 1139 (Ohio App. Mar. 29, 2017), is a case that stayed in state court despite the explicit claims that the defendants—the generic drug manufacturer and the non-diverse pharmacy defendant—violated the FDCA in various ways.  On its basic facts and history, the case had the hallmarks of a case pursued in disregard of controlling law.  A typical warnings claim that information in the generic drug label about the risk that allegedly befell plaintiff was insufficient should not fly post-Mensing.  A claim predicated on defrauding the FDA should not fly post-Buckman.  Claims against the pharmacy that it should be liable for nothing more than filling a prescription with the generic form of the particular antibiotic (presumably as required by plaintiff’s insurance) should not fly under Ohio law.  It should not have been enough to defeat a motion to dismiss for plaintiff to claim that discovery might help them determine if the generic drug’s label was different than the reference drug’s label.  After the Sixth Circuit’s decision in Fulgenzi v. Pliva, 711 F.3d 578 (6th Cir. 2013), discussed here, this is something that can and should be determined before suing.  Even though Fulgenzi held that there is exception to Mensing’s preemption of warnings claims for generic drugs where there has been a failure to update, the plaintiff there lost because the prescriber did not review the label.  So, you would think some pre-suit investigation into the labels of the reference drug and the generic drug and the prescriber’s practices should be done in determining if there is a good faith basis to plead a non-preempted claim.  Maybe that is just our silly defense-sided way of thinking.

Regardless, in Tibbe, the plaintiff got her discovery and the preemption issues were presented again on motion for summary judgment.  Despite plaintiff’s earlier protestations, the labels were actually the same during the relevant time periods, including the language as to the risk of the condition that plaintiff claimed to have developed from the medication, so Mensing applied and Fulgenzi did not.  2017 Ohio App. LEXIS 1139, *10.  The intermediate appellate court reviewed the grant of summary judgment de novo.  Even though the Sixth Circuit had carved out an exception for non-preempted generic drug warnings claims in Fulgenzi, later the same year it recognized in Strayhorn v. Wyeth Pharms., Inc., 737 F.3d 378, 391 (6th Cir. 2013), discussed here, that Mensing had broad application to “claims that the generic manufacturers failed to provide additional warnings beyond that which was required by federal law of the brand-name manufacturer,” no matter how the claims were couched. Id. at *18.  Faced with this law and the factual record on sameness, plaintiff came up with an argument that we do not recall seeing before.  She claimed that there was a “duty to warn consumers of the generic version of the drug that they cannot bring a state-law failure-to-warn claim when their prescriptions are filled with Ranbaxy’s generic minocycline and the labeling is that of the RLD.” Id. at *19.  In other words, the plaintiff claimed the manufacturer had to give legal advice—not just legal advice, but legal advice about Mensing that was contrary to the position plaintiff advocated.

This is where being in state court maybe helped the defendants.  The court did not have to engage in much of an analysis to see whether there was already a duty to do what the plaintiff wanted and did not even consider making up a new duty.  The duty to warn under the Ohio Product Liability Act related to “the risks associated with the product.” Id. at *20.  “There is no corresponding duty to warn a consumer of her legal rights or the prospective outcome of litigation should she decide to sue a drug manufacturer at a future point in time.  Thus, a claim based on that theory would not be available under Ohio law.” Id. at **20-21.  Any warnings claim based on actual Ohio law conflicted with federal law and was preempted.

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a branded prescription drug was preempted.  Courts were chilled for a while, but eventually the right sort of cases found their way to judges who understood preemption.  Now, we have a pretty big list of decisions finding preemption of such claims, along with decisions exhibiting supportive reasoning.  We are not yet at the point where preemption of failure to warn claims with branded prescription drugs—for a long time, the core claim in the biggest litigations in our bailiwick—is no longer news.  Preemption is still the exception—limited to cases with a strong regulatory history of FDA rejecting the warning plaintiff wanted—rather than the rule, particularly when it comes to favorable appellate decisions.

Rheinfrank v. Abbott Labs., Inc., __ Fed. Appx. __, 2017 WL 680349 (6th Cir. Feb. 21, 2017), is another favorable appellate decision on preemption.  You may recognize the name—especially if you are a blog aficionado—from our prior posts on the case.  We posted on partial summary judgment being granted as to part of the failure to warn claims being offered—on preemption—and the punitive damages claim—on lack of proof of relevant FDA fraud to meet the exception under the Ohio Product Liability Act provision generally precluding punitives for FDA-approved drugs.  We posted on the expansion of the preemption ruling on motion to reconsider to include design defect.  (These garnered an honorable mention in our list of the best decisions of 2015.)  We even posted on motions in limine rulings.  Even with all of those posts, a brief recap of the facts might help.  The minor plaintiff’s mother took the prescription anti-seizure medication at issue for fifteen years, including through four pregnancies, before she became pregnant with plaintiff.  She kept taking the medication at issue, along with another anti-seizure medication she had been taking, through the birth of plaintiff, who was diagnosed with “physical deformities and cognitive disabilities, including Fetal Valproate Syndrome.”  2017 WL 680349, *1.  The label for the medication at issue had long featured a black box warning and other warnings about birth defects, focusing on neural tube defects like spina bifida and discouraging use during pregnancy unless use of the medications “are clearly shown to be essential in the management of their seizures.” Id. at *2.  Over the course of seven years after plaintiff’s birth, FDA refused the manufacturer’s repeated efforts to revise the label to address developmental delays in offspring based on data from a study that was ultimately published in the New England Journal of Medicine. Id. at **2-4.  A revision of the labeling was ultimately submitted by CBE and accepted by FDA in 2011. Id. at *4.  The prescriber back in 2003 and 2004 testified that she was aware of the black box warning on birth defects, would have relayed it to plaintiff, and would not have relied on other materials outside the label. Id. at *2.

Somehow, on this record, the plaintiff got to trial.  Under the logic of “all’s well that ends well,” we will limit our rant on this point.  After all, we have discussed other birth defect cases that got to trial despite obvious issues, resulted in big verdicts, and got affirmed on appeal. Rheinfrank proceeded to trial under the portion of the strict liability failure to warn claim that was not preempted, a strict liability claim for failure to confirm to representations, the portion of a common law negligent failure to warn claim that was not preempted, and a common law negligent design claim.  Among the reasons why the two failure to warn claims should not have seen a court are that 1) Ohio law requires the allegedly inadequate warning to relate to the injury plaintiff claims, 2) claims relating to developmental delays (including as part of Fetal Valproate Syndrome) were preempted, and 3) the prescriber was aware of black box warnings about really serious birth defects and the recommendation against prescription during pregnancy in most situations.  It is hard to see how plaintiff mustered evidence of proximate cause—that is, that a proposed (non-preempted) alternative warning as to a risk of an injury the plaintiff had (based on evidence that existed when the prescription was written) would have changed the prescriber’s decision to prescribe—to survive summary judgment.  Based on the jury instructions that plaintiff proposed at trial, it seems like a broader discussion of risks and the impact of different warnings about risks was permitted than maybe should have been, which is often a reason why failure to warn claims get past summary judgment.  Given that the prescriber denied reliance on any representations outside the label, it is hard to see how that claim got to the jury.  As for the negligent design claim, it is hard to see how the same reasoning for preempting the strict liability design claim would not have applied or how a design of the drug—without being a different drug—that lacked the same birth defect risk could have been offered.  Anyway, the trial judge may have known what was coming, because the jury listened to the just about the best plaintiff could offer and returned a defense verdict on all counts after two weeks.

Continue Reading Sixth Circuit Affirms Branded Drug Preemption and Trial Win

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

If you’re even remotely interested in the topic of preemption in Pre-Market Approved (PMA) medical devices that were used in an off-label manner, simply search this blog for our Infuse cases. There are dozens and almost all are complete victories for the defense. What occasionally survives are fraud or misrepresentation claims, although they have a tough time meeting the heightened pleading standard of Rule 9(b), or failure to warn claims where a court recognizes failure to submit adverse events to the FDA as parallel to a state law duty to warn physicians. As you’ll easily see from our prior writings, we don’t understand that parallelism at all.

The most recent Infuse victory strikes a blow at each and every attempt by plaintiffs to circumvent, dodge, sidestep, and elude preemption and pleadings standards. And with each by-pass blocked, plaintiffs’ claims had nowhere to go.

As a quick refresher, Infuse is a medical device used to stimulate bone growth in spinal fusion surgeries. It is a multi-component device that received FDA PMA approval for use in single-level, anterior, lumbar surgeries. Aaron v. Medtronic, Inc., — F. Supp.3d –, 2016 WL 5242957, *1-2 (W.D. Ohio Sep. 22, 2016). Aaron is actually a consolidation of the claims of several hundred plaintiffs who alleged they were injured by their surgeon’s use of the Infuse device in an off-label manner. Specifically, they allege the device was either implanted without all of its component parts, implanted posteriorly, implanted at multiple levels, or implanted in their cervical or thoracic spines. Id. at *2. Plaintiffs’ causes of action are fraud/misrepresentation, strict liability failure to warn, strict liability design defect, negligence, and breach of express and implied warranties. Id. Defendants moved to dismiss all claims on several grounds, including most predominantly preemption.

Before getting to the substantive analysis, the court had to consider what pleadings standard to apply. Wait. Isn’t it TwIqbal? What’s the issue? The answer is the Seventh Circuit decision in Bausch v. Stryker. The Aaron plaintiffs alleged that they did not need to plead the specific federal law or regulations that defendant allegedly violated because medical device products liability cases should have a “more permissive” review standard. Id. at *3. Plaintiffs got that idea from Bausch which held that particularity in pleading the specific FDA regulations violated was not necessary due to much of the “critical information” being kept confidential. Id. at *3-4. Many courts disagree with Bausch, including the Sixth Circuit which held in a non-medical device case that a “natural imbalance of information” does not warrant lowering Rule 8’s pleading standards. Id. at *4. The discovery process cannot be used to find sufficient factual support for plaintiffs’ pleadings after the fact. So, Aaron applies TwIqbal, not some watered down version (although the court does state that some of plaintiffs’ claims might not have withstood application of that lesser standard).

Continue Reading Another Slam Dunk Infuse Win – Preemption and More

Not so long ago in a Circuit not so far away, the issue of whether design defect claims against branded prescription drug manufacturers are preempted was joined.  Much like the origins of the Jedi or the major end-of-year holidays as we know them, one would expect a clearer published record of how this came to be.  There can be a tendency to read back from recent experience and imbue our past selves with more knowledge or foresight that we actually had.  For preemption of design defect claims against branded prescription drug manufacturers, we know we have been arguing for it for years and we are not quite sure why it took so long for a Circuit Court to adopt it.  As we noted a few weeks ago, Yates v. Ortho-McNeil-Janssen Pharms., Inc., No. 15-3104, 2015 U.S. App. LEXIS 21428 (6th Cir. Dec. 11, 2015), did find preemption, and did it pretty definitively.  So definitively that it took our spot as top decision of 2015.  Along the way, the court declined to follow a prior decision of the same court, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010), which itself reversed decisions of the trial court in Longs v. Wyeth, 536 F. Supp. 2d 843 (N.D. Ohio 2008) (granting summary judgment), and Longs v. Wyeth, 621 F. Supp. 2d 504 (N.D. Ohio 2009) (denying motion to alter judgment), each of which included the holding that pre-approval design defect and negligence claims were preempted.  It is with the Longs/Wimbush decisions where our story starts, subject to some back story and with a healthy dose of links to past posts.

We first note, however, that it has long been our view, expressed in many posts and elsewhere, that design defect does not make much sense as a theory of liability for a prescription drug.  In most cases, what the plaintiff alleges made the drug excessively risky and thus defectively designed cannot possibly be changed without making it a different drug.  One of the principles of pharmacology is that changes to the chemical compound will typically affect both the desired and undesired effects in the body–or as the Supreme Court observed in Bartlett, “because of [a drug’s] simple composition, [it] is chemically incapable of being redesigned.”  133 S. Ct. 2466, 2475.  Rarely, a true change to the “design” of the active compound can be identified—maybe chop off this ethyl group or change it from a racemic mixture to a stereoisomer—that will plausibly reduce the pertinent risk, while maintaining benefits and avoiding new risks.  Even where that kind of proposed design change exists, the change would make the drug a different product, not a better version of the same product, which is what design defect is supposed to be about.  There may be some cases where a plaintiff claims that a different balance of a combined drug’s ingredients, or an
inactive ingredient, or the delivery system should be changed to reduce the risk without making it a different drug. Even those cases, though, seem better suited to warnings-based claims.

Continue Reading The Saga of Preempting Prescription Drug Design Defect Claims

One of the most basic prerequisites to having court rules is that the rules aren’t supposed to change substantive law.  With class action rules, like Fed. R. Civ. P. 23 and its state-law analogs, courts seem to have a hard time remembering that.  No substantive effect means that, if a plaintiff couldn’t bring the claim individually, that same claim can’t be brought on behalf of that same plaintiff via a class action.

One of the most basic attributes of almost any cause of action is injury.  That’s why we’re bringing you news of the recent Ohio Supreme Court decision in Felix v. Ganley Chevrolet, Inc., No. 2013-1746 slip op. (Ohio Aug. 27, 2015), even though it’s not a drug and device case. It’s a consumer fraud statute case brought under the Ohio version of Rule 23, and we think all defense attorneys who confront this kind of thing ought to know about it.  It’s that good.  Some choice quotes:

Plaintiffs bringing OCSPA [the Ohio statute] class-action suits must allege and prove that actual damages were proximately caused by the defendant’s conduct.

Felix ¶31.

Plaintiffs in class-action suits must demonstrate that they can prove, through common evidence, that all class members were in fact injured by the defendant’s actions.

Id. ¶33.  Note the word “all.”

The inquiry into whether there is damage-in-fact is distinct from the inquiry into actual damages:  fact of damage pertains to the existence of injury, as a predicate to liability.

Id. ¶34 (citation and quotation marks omitted).

If the class plaintiff fails to establish that all of the class members were damaged (notwithstanding questions regarding the individual damages calculations for each class members), there is no showing of predominance.

Id. ¶35.  Again, note the word “all.”

Perhaps the most basic requirement to bringing a lawsuit is that the plaintiff suffer some injury.  Apart from a showing of wrongful conduct and causation, proof of actual harm to the plaintiff has been an indispensable part of civil actions.  We agree, and we hold that all members of a class in class action litigation alleging violations of the OCSPA must have suffered injury as a result of the conduct challenged in the suit.

Id. ¶36 (emphasis added).

Here, here!  This is the only way that a class action rule can be read so that it does not improperly change the underlying substantive law, and plaintiffs get away with herding uninjured persons into class actions – indeed, bringing class actions where nobody at all has been injured − all the time.

Not in Ohio, anymore.  We thought you’d like to know.

It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they approach trial.  What’s left doesn’t strike us as a very good warnings case.  Rheinfrank involved claims that the antiepileptic drug Depakote caused the minor plaintiff’s birth defects.  Make no mistake about it, Depakote has a known association with such injuries.  First approved in 1983, it’s been a Pregnancy Category D drug since 1988, meaning, according to FDA regulations, that:

there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

21 C.F.R. §201.57(c)(9)(i)(A)(4).  Not only that, since 2003, this drug has carried a black box “teratogenicity” warning, as well as other quite explicit, and all-caps, language to the same effect.  For details, see 2015 WL 4743056, at *2-3.

Plaintiff-mother had used Depakote for years, through four previous uneventful pregnancies.  Id. at *1.  On her fifth pregnancy, even though Depakote came with all these warnings, she continued to take it.  Id.  Her allegations did try to change the subject, however.  In addition to claiming that the black box warning (more about that later) and all the other teratogenicity language were inadequate, she asserted that the defendants failed to warn altogether about “developmental delay.”  Id. at *5.

Continue Reading Preemption (and Other Things) Defanging Depakote Claims

A recent decision in the propoxyphene litigation – Schiller v. Eli Lilly & Co., No. 2:12-247-DCR (E.D. Ky. Apr. 7, 2014) – confirms a now basic premise of product liability law: if you claim to have been injured by a drug that you don’t identify, you will lose.

The plaintiff in Schiller, a resident of Ohio, claimed to have been injured by generic propoxyphene, which she claimed to have taken for almost seven years.  She didn’t – or couldn’t – identify the particular drug or its manufacturer, so she instead named as defendants a number of companies that manufactured the drug. Discovery didn’t help her. She still couldn’t identify the drug or its manufacturer.  She had a serious product identification problem:

It is well-settled that a threshold requirement of any products-liability claim is that the plaintiff assert that the defendant’s product caused the injury. . . . There is no theory of product liability under which a defendant can be held liable for an injury caused by a product that it did not sell, manufacture, or otherwise supply to the plaintiff.

Slip op. at 3.

Unable to identify the product, the plaintiff had no claim.  And so, when one of the defendants moved for summary judgment, the court granted it.

It was of some interest to us, though, that the court relied on two decisions that rejected market-share liability in the DES litigation.  Id. at 3-4 (citing Sutowski v. Eli Lilly & Co., 696 N.E.2d 187 (Ohio 1998); Kurczi v. Eli Lilly & Co., 113 F.3d 1426, 1431-32 (6th Cir. 1997) (applying Ohio law)).  For those who don’t recall, market-share liability was an attempt by DES plaintiffs who couldn’t identify which DES drug allegedly injured them to hold all DES manufacturers liable to the extent of their share of the overall DES market. That’s not too different from what the Schiller plaintiff tried to do, or from what some plaintiffs have tried to do in generic drug litigation. Ohio was one of the states to reject market-share liability in the DES litigation.  As we put it a few years ago, “[m]arket share liability is so not happening in Ohio.”

Nor is it in many other states.  Let’s see whether in the future we see more references to the DES market-share/product identification decisions in generic drug cases brought against multiple defendants by plaintiffs with product identification problems.

The pelvic-mesh plaintiff wrote this in his affidavit:  “I do not know whether mesh was implanted in my body.”  Favor v. W.L. Gore Assocs., 2014 U.S. Dist. LEXIS 17134, *6 (S.D. Oh. Feb. 11, 2014).  We lead with that admission today because we thought it would be a good day to use the old literary trick of foreshadowing – though we’ll admit that this isn’t a subtle use of it.  But then again that sure isn’t a subtle affidavit.

Not missing the obvious, W.L. Gore Associates moved to dismiss.  Now, plaintiff did allege in his complaint that a Gore mesh product had in fact been implanted in him.  But then came the affidavit.  A plaintiff with a sworn statement contradicting his own pleadings sure seems like good grounds for dismissal.

But the court was able to sidestep all that and still dismiss the complaint.  Plaintiff failed to assert his claims under the Ohio Product Liability Act (“OPLA”), instead alleging common law claims.  The OPLA abrogates common law claims, so plaintiffs had asserted abrogated claims.  On this ground alone, the court dismissed the complaint.  Id. at *14-15.  Now, we’ve often seen courts take such improperly pleaded common law claims and simply treat them as if they were stated under the particular product liability act in play.  Not this court.  Why? We can’t be sure.  But there may be a clue found in plaintiff’s affidavit.

Gore wasn’t the only defendant.  Plaintiff also sued Bard and Davol.  But, this time, plaintiff simply made no factual allegations about the products of these defendants.  Bard and Davol moved for summary judgment.  Id. at *12.  And they got it.  It seems that plaintiff, in his opposition papers as to another defendant, admitted that “his counsel simply ‘researched all makers of surgical mesh and attempted to cast the broadest possible net in order to avoid future statute of limitations problems.””  Id. at *4-5.  That certainly seems like another doozy of an admission.  Making matters worse – or better, depending on how you look at it – plaintiff didn’t respond to the Bard and Davol motions at all.  The court granted summary judgment.  Id. at *14.

We should also note that plaintiff sued the doctors and hospital.  Such claims require an affidavit of merit.  Plaintiff didn’t provide one.  He didn’t even oppose the medical defendants’ motions for judgment on the pleadings.  The court granted the motions. Id. at *7-12.  (We suspect that the weakness of the claims against the medical defendants is the reason that the court had earlier denied plaintiff’s motion to remand the case to state court.)

Not surprisingly, the medical defendants and Bard and Davol moved for Rule 11 sanctions.  They seemed warranted.  But the court denied the motions.

As to the medical defendants, the court was concerned that awarding sanctions would require it to make evidentiary determinations at the pleadings stage.  Id. at *15-20.  (We suspect, though, that the court may have been concerned that there were inaccuracy issues with the medical records.)  Regardless, you’d think that the Bard and Davol defendants had a slam dunk.  The plaintiff all but admitted that he sued them for no reason other than that they were in the same industry as Gore.  But the court seemed dead set against imposing sanctions.  Bard and Davol had failed to file an affidavit confirming that they had given plaintiff the required 21 days to withdraw or correct his pleading.  Id. at *20.  Bard and Davol told the court that they had done so, but that wasn’t enough. Id. at *20-21.

We’re not sure what else to say about this case and these types of complaints.  You’d think that awarding sanction might be the best way to stop them.  But the court wasn’t willing to do so here.

So we’ll leave you with a completely unrelated recommendation.  Watch “Drunk History” on Comedy Central.  We saw a few episodes this weekend and found it hard to breathe through all the laughing.

It’s only a small piece of what product liability claims are all about, but the Sixth Circuit in Fulgenzi v. PLIVA, Inc., No. 12-3504, slip op. (6th Cir. March 13, 2013), has ruled (creating something of a circuit split with the 5th Circuit’s nonprecedential Morris decision from last month), that “failure to update” claims are not preempted in a case involving a generic drug.  Everything else is gone, and Fulgenzi goes to great pains to state that even evidence of any other possible warning isn’t admissible, but this one claim remains.

As is typical with any court that rejects a preemption argument, Fulgenzi references a “presumption against preemption,” slip op. at 8, even though the Supreme Court majority in Mensing did not rely  on any such thing (and four justices would have eliminated it altogether).  Mensing impossibility preemption did not apply because there was nothing impossible – the updating in question had already been ordered by the FDA:

In our case, not only could PLIVA have independently updated its labeling to match that of the branded manufacturer through the CBE process . . . but it had a federal duty to do so.  As a result, compliance with federal and state duties was not just possible; it was required. Impossibility preemption is inappropriate in such a case.

Slip op. at 9 (citations omitted).

The more problematic aspect Fulgenzi is how it dealt with what we’ve always thought of as the strongest argument against failure to update, which is that under Buckman a duty to update claim is an improper disguised attempt to enforce an FDCA updating duty that doesn’t exist under federal law.  We’ve read Fulgenzi twice on this point, and we still don’t see the rationale, so we’ll let our readers noodle over it:


[T]he result of this violation does raise concerns that [plaintiff] is simply attempting to enforce a federal-law violation through state litigation.  Where, as here, the statute specifically excludes a private cause of action, 21 U.S.C. §337(a), state tort suits premised on violations of federal law may be impliedly preempted . . . if the claims “exist solely by virtue of” the regulatory scheme . . . .  Here, [plaintiff’s] suit is not even premised on violation of federal law, but rather on an independent state duty.   The alleged breach arises from the same act, but the legal basis is different. This is simply not grounds for preemption.  The federal duty of sameness is not a “critical element” in [plaintiff’s] case.  Failure to update from one adequate warning
to another would violate the FDCA, but not Ohio law.  Her suit instead relies upon the adequacy of
the warnings and the causation of her injuries.

Fulgenzi, slip op. at 12-13 (emphasis original).  But state law does not have anything to do with “sameness,” one way or the other.  That’s an entirely federal concept.  That “duty” exists only by virtue of the FDCA.  For plaintiffs to substitute that duty (the only one that survives Mensing express preemption), is to put state law in the position of enforcing federal law, which the FDCA explicitly prohibits.  As even Fulgenzi is forced to admit, “violation of the federal duty of sameness is essential to [plaintiff’s] case.  Id. at 13.  Whether or not there’s a “violation” is irrelevant to §337(a), the duty is unquestionably federal.  Only the federal government may enforce it.  Whether the “same” warning is, or is not, also “adequate” under state law amounts to nothing more than coincidence.  At least that’s how we see it.

The court also rejected “purposes and objectives” preemption, holding that no generalized congressional intent to encourage generic drugs prevented any and all product liability claims against their manufacturers.  “A vague policy of encouraging use of generic drugs, untethered from the structure of the Act, is not enough to support purposes-and-objectives preemption.”  Fulgenzi, slip op. at 11.

So what’s left?  A small piece of a claim.  Apparently, after preemption is overcome, the “duty of sameness” drops from the case altogether:

On the merits, whether [defendant] has violated its federal duties is irrelevant to the adequacy of its warnings.  A jury need not know about the duty of sameness at all.

Fulgenzi, slip op. at 13.  The FDA goes unmentioned at trial (even though it is simultaneously “essential”), but the plaintiff is forbidden from challenging the “adequacy” of the generic warning under state law with anything other than the FDA-approved “update.”  Id.

So there’s not that much left, and even the duty to update claim is factually specific to this one generic drug.  We don’t know of any other generic drug litigation where there’s any factual basis for a failure to update claim.  That’s why what bothers us the most about Fulgenzi is the mess the court made when as it tries to fit something into Ohio law that has no basis in Ohio precedent.  The opinion states: “[T]here is nothing in the Ohio product-liability law inconsistent with a claim that a defendant failed to warn, even inadequately.”  Slip op. at 13.  That litodes is just the double negative way of stating that there’s not a scrap of Ohio product liability law affirmatively recognizing a viable claim for failure to give an inadequate warning.

We go on until we’re blue in the face that federal courts sitting in diversity are not supposed to predict expansions of state law that have no support in that law.  It’s not enough that no court might have had occasion to reject a novel and bizarre theory like failure to give an inadequate warning nonetheless being a basis for liability.  There must be state-law precedent somewhere affirmatively supporting a claim for a federal court to predict its adoption.  Ohio imposes a “reasonable care” statutory standard for warning claims.  Nothing supports the proposition that a concededly “inadequate” warning nonetheless constitutes “reasonable care,” and Fulgenzi cites nothing.  This double negative approach is inconsistent with Erie.


[F]ederal courts must proceed with caution when making  pronouncements about state law. Sitting in diversity, we are not commissioned to take a position regarding the advisability or fairness of the state rule to be applied, but must determine the issue as would the highest court of the state.   This Court’s proper reluctance to speculate on any trends of state law applies with special force to a plaintiff in a diversity case. . . .  When given a choice between an interpretation of state law which reasonably restricts liability, and one which greatly expands liability, we should choose the narrower and more reasonable path.

Combs v. International Insurance Co., 354 F.3d 568, 577 (6th Cir. 2004) (citations and quotation marks omitted); see Ventas, Inc. v. HCP, Inc., 647 F.3d 291, 328 n.15 (6th Cir. 2011 (quoting and following Combs); Kurczi v. Eli Lilly & Co., 113 F.3d 1426, 1429 (6th Cir. 1997) (“A federal court in a diversity case is not free to
engraft onto … state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits”) (quoting Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)).

So completely apart from preemption, we think that Fulgenzi‘s plucking of a failure-to-give-an-inadequate-warning theory of liability from thin air is more than simply wrong – it’s a usurpation of the rights of the Ohio state courts to determine, in the first instance, what Ohio law is supposed to be.  It’s not merely a matter of causation (not being able to say “that a severely inadequate warning would never cause an injury that a moderately inadequate warning would have prevented,” slip op. at 14), it’s a matter of whether such a duty – that not giving a legally inadequate warning is required as a matter of “reasonable care” – exists in the first place.  No federal court should make that prediction in the first instance.

We’ve said it before, tort preemption makes courts do strange things; but that doesn’t make it right.

Still, what’s left, even after violence has been done to both §337(a) and Ohio law, isn’t very much.  Another “narrow gap” – this time between Mensing and Buckman must be navigated.  Slip op. at 14.

The arguments [plaintiff] makes, the proofs she offers, and the evidence she submits are all subject to limitation by preemption principles. . . .  [Plaintiff] must use the language of the 2004 FDA-approved label in her proximate-cause argument, not (or not merely) the fact of the failure to update.

Fulgenzi, slip op. at 14-15.  That’s all that’s left, and in a generic preemption case involving a different drug where there hasn’t been any failure to update, not even that.

Thus, while to some extent Fulgenzi is a hash, it’s also a tempest in a teapot – unless and until some other court in some other case involving some other product picks up that dead cat of a failure-to-give-an-inadequate-warning claim and tries to run with it.