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Ray Charles’s musical threat of “tell your Ma, tell your Pa, gonna send you back to Arkansas” doesn’t sound so bad to us after reading Green v. Bayer Corp., 2021 WL 687024 (E.D. Ark. Feb. 22, 2021). The plaintiff alleged injuries from a permanent contraceptive device and brought claims for negligent training, negligent risk management, and breach of express warranty. The defendants moved to dismiss on the grounds that the claims were preempted and insufficiently pled. The court granted the motion to dismiss and denied the plaintiff’s motion to amend.

We are skeptical of the claim of negligent training. (Here is excellent article on that topic that is worth retrieving if you bump up against the claim: J. Eppensteiner & R. Nelson, “Failure to Train and Medical Device Claims,” For the Defense (April 2013).) In Green, that claim was especially frail because the contraceptive product was a class III medical device subject to express preemption. Any effort to impose a training requirement beyond FDA requirements was a clear no-go. The claim could survive only if it involved a valid claim under Arkansas law that ran parallel to FDA regulations. It did not. The plaintiff stretched Arkansas law in an effort to show a voluntary undertaking, but it did not matter because the plaintiff set forth no facts showing either how the physician training departed from FDA requirements or how such departure caused the plaintiff’s injuries. Goodbye, training claim.

We admit we do not even know what a claim of negligent risk management is. But whatever it is, the plaintiff in Green did not adequately plead it. The Green court was also unsure what the claim was exactly, but charitably interpreted it to assert that the defendants had not notified the FDA about problems. The complaint listed several alleged federal violations, including failure to submit certain reports. That sort of thing amounts to a fraud-on-the-FDA claim, which is preempted. In any event, the negligent risk management claim does not exist under Arkansas law. Even if it did, it suffered from the same flaw as the negligent training claim: lack of a causal link. Farewell, negligent risk management claim. We hardly knew ye. Actually, to be honest, we never knew ye.

The plaintiff alleged that the defendants falsely advertised the contraceptive product. She said she relied on representations on the defendants’ websites. But she did not specify exactly how anything on the website was false. A vague/overbroad allegation that the other side lied does not cut it. Adios, warranty claim.

The plaintiff proposed an amended complaint that did not fix the dismissed claims but added claims for negligent manufacture, strict liability defective manufacturing, and failure to warn. We do not even need to read the complaint to know the manufacturing claims were bogus. They pretty much always are. But the Green court did read the amended complaint, saw no there there, saw that the failure to warn claim was premised on the same facts as the warranty claim, and concluded that amendment would be futile.

The Green court made dismissal of the product liability claims look easy. Maybe it was.

(This not our first post on the Essure litigation. For earlier examples, see here and here.)

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Last week we posted about the Daubert decision in Lowery v. Sanofi-Aventis LLC, that tossed out both plaintiff’s medical causation expert and FDA expert.  As promised, that was just the first blow.  The knockout came in its companion decision granting summary judgement not just on medical causation but also on the grounds of preemption.

First a quick reminder that the product at issue is a Class III medical device that is a gel-like substance that is injected into the knee to reduce pain.  It is undisputed that plaintiff’s injection came from a product lot that was later found to be contaminated.  Lowery v. Sanofi-Aventis, 2021 WL 871344, *1 (N.D. Ala. Mar. 9, 2021).  So, “[o]n the surface, this claim may seem meritorious.  After all, the device was contaminated with bacteria.  But that is not the whole story.”  Id.  Indeed, it is just the beginning.  Because while “some cases seem viable upon their initial presentment, they can fall apart when the legal standards affecting expert testimony are applied and Congress’s policy choices come in to play.”  Id.  And that is the part of the story we are most interested in.

This story is told in two chapters.  First, plaintiff’s claims fail under Alabama law for lack of medical causation.  As pointed out in our prior post, plaintiff’s medical expert was not qualified to render his opinions and his opinions themselves were unreliable because they were not based on generally accepted scientific methodologies (they were largely based on temporal proximity and parroting the medical records).  So, on summary judgement plaintiff was left with no expert evidence that he actually suffered from the condition known as septic arthritis or that the contaminant causes septic arthritis generally or caused plaintiff’s septic arthritis specifically.  Id. at *8.  Instead, plaintiff tried to rely on defendant’s internal company documents and the testimony of plaintiff’s treating physician.  “Even if Defendant’s documents can be said to be a legally sufficient substitute for expert testimony to establish general causation,” at most those documents identified septic arthritis as a potential risk of the bacteria.  Id.  A mere possibility, “does not reliably establish general causation.”  Id.

As for plaintiff’s treating physician, he was asked at his deposition if a “reasonable physician [could] conclude tat this was . . .  septic arthritis from a contaminated lot of [the device].”  Id. at *9.  The assented to that statement.  That testimony does not come close to satisfying Daubert.

[The treater’s] statement that it was possible Plaintiff suffered from septic arthritis does not indicate that it is [the treater’s] medical opinion that Plaintiff had septic arthritis, much less what caused it. Nor does [the treater’s] statement that a “reasonable physician” could conclude Plaintiff suffered from septic arthritis indicate what [his] medical opinion about Plaintiff’s condition actually was. . . [N]othing supports the assertion that [the treater] concluded that Plaintiff suffered septic arthritis because of Defendant’s product—let alone that he conducted an analysis that would withstand Daubert scrutiny.

Id.  (citations omitted, emphasis in original)

This story could have ended there, but wanting to be efficient, the court wrote chapter two.

[E]ven if Plaintiff’s state-law claims were viable (and, to be clear, they are not), Plaintiff’s claims are preempted because they impose requirements in addition to, or different from, those required by the FDA under federal law.

Id. at *7.  The injection at issue here was subject to the device-specific requirements of its PMA and the generally applicable requirements of the FDA’s Good Manufacturing Practices (GMPs).  Id. at *14.  We would normally take issue with GMPs being found sufficient to form the basis of a parallel violation claim, but this is the Eleventh Circuit and therefore controlled by Godelia v. Doe 1, 881 F.3d 1309 (11th Cir. 2018), which just happens to be one of our top ten worst cases of 2018.  And it didn’t impact the court’s conclusion:

To assert a parallel claim, a plaintiff must “set forth” evidence of “specific violations” of “specific regulations.” Importantly, not only must a plaintiff show that a federal requirement has been violated but he must also “causally connect the simultaneous violations of federal and state law … to the alleged injury.”

Id. at *15 (citations omitted, emphasis in original).  Plaintiff failed to connect Defendant’s conduct to any “specific binding regulation.”  Id. at *16.  Plaintiff could not rely on the criticisms of his FDA expert because she was excluded.  He was left to point to only FDA guidance documents and regulations applicable to pharmaceuticals.  Id.  Plaintiff is correct that the FDA has offered “guidance” on certain applicable processing and testing procedures.  But guidance documents are non-binding, as stated in the documents themselves.  They are not final agency actions, but rather reflect the FDA’s “current thinking” on the given topic.  Id. at *17. While informative in some contexts, a deviation from the practices suggested in an FDA guidance, do not support a parallel violation claim.  Id.

So, while plaintiff alleged defendant violated the FDA’s GMP Guidance on Endotoxin Testing, what plaintiff failed to do was cite “a single specific GMP that the allegedly deficient endotoxin testing violated.”  Id. at *18 (emphasis in original).  Further, the one GMP that plaintiff does allege defendant violated is applicable to pharmaceuticals not medical devices.  The FDA defines and regulates pharmaceuticals and medical devices differently.  The GMPs applicable to one cannot be applied by the courts to the other. Failure to demonstrate any violation of GMPs was also fatal to plaintiff’s claim that defendant’s product was adulterated.  Id. at *20 (adulteration requires a finding of non-conformity with applicable requirements).  And plaintiff’s argument that defendant was not prohibited from doing additional testing is “of no moment.”  A state cannot make obligatory a federal requirement that is merely permissive.  Such a state requirement would be different from or in addition to federal requirements.  Id.

Even if there were evidence of a parallel violation “(and, to be clear, there is not),” plaintiff’s claims would still be preempted because there is no evidence that defendant’s conduct caused plaintiff’s injury.  Id. at *16.  For example, plaintiff offers no evidence that if the endotoxin testing had been done differently it would have led to different results that would have meant plaintiff would never have received an injection from the contaminated lot.  Id. at *19.  Without a causal link, plaintiff’s claims are preempted.

Without expert evidence, causation evidence, or a parallel violation – plaintiff’s claims went down for the count.

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A couple of years ago, we chastised a Third Circuit panel in our “Wrong Court” post, pointing out that its decision to declare an Internet marketing platform a “seller” under Pennsylvania law improperly usurped state judicial power under Erie Railroad Co. v. Tompkins, 304 U.S. 64 (1938).  That decision, Oberdorf v. Amazon.com, Inc., 930 F.3d 136 (3d Cir. 2019), was subsequently vacated, rehearing granted on precisely these grounds, and ultimately certified to the Pennsylvania Supreme Court for resolution.  See Oberdorf v. Amazon.com, Inc., 818 F. Appx. 138 (3d Cir. 2020).  That was the proper disposition under Erie because state courts, not federal courts exercising diversity jurisdiction, should decide whether to recognize novel theories of tort liability.  As the United States Supreme Court has repeatedly stated:

[A] federal court is not free to apply a different rule however desirable it may believe it to be, and even though it may think that the state Supreme Court may establish a different rule in some future litigation.

Hicks v. Feiock, 485 U.S. 624, 630 n.3 (1988); accord, e.g., Boyle v. United Technologies Corp., 487 U.S. 500, 517 (1988); Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3, 4 (1975).  For a complete discussion of related United States Supreme Court precedent, see this post.

Perhaps no circuit has been as firm in enforcing the federalist principle that federal courts applying state law should show such restraint than the Third Circuit.  In “Wrong Court” we listed over a dozen examples:  Sheridan v. NGK Metals Corp., 609 F.3d 239 (3d Cir. 2010); Travelers Indemnity Co. v. Dammann & Co., 594 F.3d 238 (3d Cir. 2010); Lexington National Insurance Corp. v. Ranger Insurance Co., 326 F.3d 416, 420 (3d Cir. 2003); Werwinski v. Ford Motor Co., 286 F.3d 661 (3d Cir. 2002); City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415 (3d Cir. 2002); Camden County Board of Chosen Freeholders v. Beretta, U.S.A. Corp., 273 F.3d 536, 541-42 (3d Cir. 2001); Northview Motors, Inc. v. Chrysler Motors Corp., 227 F.3d 78, 92 n.7 (3d Cir. 2000); Leo v. Kerr-McGee Chemical Corp., 37 F.3d 96, 101 (3d Cir. 1994) Adams v. Madison Realty & Development, 853 F.2d 163 (3d Cir. 1988); Falcone v. Columbia Pictures Industries, 805 F.2d 115 (3d Cir. 1986); Bruffett v. Warner Communications, 692 F.2d 910 (3d Cir. 1982); McKenna v. Ortho Pharmaceutical Corp., 622 F.2d 657 (3d Cir. 1980).  For a more complete discussion of this Third Circuit precedent (as of 2009), see this post.

Unfortunately, Erie has been transgressed, indeed ignored, again – this time in the MDL context, which makes the error particularly dangerous (a novel state law theory exerts settlement pressure in thousands of cases), and particularly hard to correct (judicial errors disadvantaging defendants in MDLs are notoriously hard to appeal).  The decision is In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2021 WL 222776 (D.N.J. Jan. 22, 2021), and the issue is express warranty.

The Valsartan MDL, as readers may remember from our prior posts, involves claims that certain drugs were contaminated with nitrosamines – the same class of allegedly carcinogenic compounds that anyone who eats bacon or other processed foods is already exposed to in larger doses than could exist in tiny pills.  Since it’s an MDL – which more properly stands for “Maximized and Distorted Litigation” – plaintiffs sued everyone conceivable under every conceivable theory of liability, and some that haven’t been conceived yet.

One of the latter types of theories was involved in today’s decision.  Plaintiffs were suing over generic drugs, which means they have every incentive to be creative to surmount the formidable barrier of generic preemption.  See generally our Generic Preemption Scorecard.  So they came up with an “express warranty” theory of liability that no court anywhere (federal or state) had adopted.

The drug in question is “a drug of choice in lowering high blood pressure.”  2021 WL 222776, at *5.  Further, the alleged impurities did not interfere with the drug’s anti-hypertensive activity, so every plaintiff received an effective medication.  Id. at *3-4.  It’s hard to come up with a valid express warranty claim under those circumstances.  In brief, the express warranty theory the Valsartan plaintiffs invented was:

Common Law Breach of express warranties by all defendants because inclusion of defendants’ VCDs [Valsartan containing drugs] in the U.S. Orange Book serves as a warranty that the VCDs at issue constituted a generic drug that is bio-equivalent in every way to the patented drug.

Id. at *5 (emphasis original).  Note the use of “common law” – there can be no dispute that the relevant issues involve predictions of state law to which the Erie doctrine applies.

After punting on state law notice issues (as Bexis’ book demonstrates – Beck & Vale, Drug & Medical Device Product Liability Deskbook §2.08, at nn. 16.1 to 16.2 (updated 2020) – the states vary widely on this issue), Valsartan describes plaintiffs’ warranty theory in stark detail:

Plaintiffs argue [manufacturer] defendants’ express warranties arise not from statements in the product labeling, but from the very act of naming the product by the generic active ingredient, that is, by calling their generic drug “valsartan” or “valsartan HCT”, etc., in patient information leaflets dispensed with each prescription, or on a third-party beneficiary basis.  Plaintiffs further argue that, based on the prescription alone, plaintiffs could not have bought any other generic drug but valsartan (or VCDs), and that [manufacturer] defendants’ naming their [product] “valsartan” necessarily left plaintiffs no choice but to “rely” on [manufacturer] defendants’ name of the product, which stands as the basis for the bargain between [manufacturers] and plaintiffs.

Id. at *10 (emphasis added).

We’ve litigated a few prescription medical product liability litigation cases in our days, and we’ve also read a lot of decisions from such litigation, but we’ve never seen any statute or caselaw recognizing an express warranty claim based on nothing more than the name of the product as compiled in some official publication.  Nor have we seen a state-law warranty claim based on something, like the name of bioequivalent drug (a/k/a “reference listed drug”), that the FDCA mandates be in approved drug labeling (and in the so-called “Orange Book”).  E.g., 21 C.F.R. §314.94(a)(4-6, 8).  Indeed, insofar as reliance/basis-of-the-bargain is concerned, this “warranty” theory strongly reminds us of “fraud on the FDA” – another made-up, FDCA-based cause of action which was also created to evade a reliance/causation element (a product’s mere presence in the market being because of fraud to avoid the learned intermediary rule).

Nor, apparently, did plaintiffs or Valsartan itself cite a scrap of precedent that the name of a drug, in and of itself, could be an express warranty.  The entire discussion of Valsartan’s decision that this theory could state an express warranty claim under the laws of all fifty states is as follows:

The [manufacturers’] very naming of the drug as valsartan or valsartan-containing amounted to an express warranty on which plaintiffs had no choice but to “rely” when they were prescribed the drug and bought it as a medication for their high blood pressure.  Plaintiffs did not have to “perceive” the package labelling or insert in order to create a benefit of the bargain.  All they had to know was they were buying a generic drug that contained valsartan because the very name “valsartan” or “valsartan-containing” constituted itself an express warranty that what plaintiffs were purchasing was the chemical equivalent of the Orange Book pharmaceutical.

Id. at *11 (emphasis added).  What was the authority for this you-don’t-even-have-to-be-aware-of-it version of “express warranty?”  This:

See, e.g., Gremo v. Bayer Corporation, 469 F. Supp.3d 240, 258 (D.N.J. 2020) quoting “‘A statement can amount to a warranty, even if unintended to be such by the seller, if it could fairly be understood … to constitute an affirmation or representation that the [product] possesse[s] a certain quality or capacity relating to future performance.’  Volin v. General Electric Company, 189 F. Supp. 3d 411, 420 (D.N.J. 2016) (citations omitted).”

Id.  That is all.  Nowhere does Valsartan mention that some states have product liability acts and decisions holding that common law claims for express warranty have been subsumed, see, e.g., Seavey v. Globus Medical, Inc., 2012 WL 253116, at *2 (D.N.J. Jan. 26, 2012), so the opinion’s premise of a state-law express warranty claim common to all states is invalid.

Neither of the cited cases has anything to do with the unique, hypothesized form of name-only express warranty in Valsartan.  As to express warranty, Gremo (a bad case we blogged about here), involved the usual allegation of safety-related claims (“generally safe”; “not any less safe,” “pose a risk”), and was no way based on merely the name of the product, or on anything else that the defendant has no choice under the FDCA but to include in product labeling.  469 F. Supp.3d at 258.  Volin does not involve any FDA-regulated product at all, but only an oven.  The “certain quality or capacity” at issue in Volin likewise was completely different from the name of the product.  189 F. Supp.3d at 421 (“only specific allegation of an express statement is that the owner’s manual instructs the user to ‘Push the control knob in and turn it to the LITE position’”).

We presume that, since that is all that Valsartan cites, that is the best that the plaintiffs presented in their MDL briefing in support of their name-only express warranty claim.  In other words, there appears to be no law anywhere (which is what our experience tells us is the case), recognizing an “express warranty” based on nothing more than the FD-recognized name of a prescription drug.  So Valsartan recognized a novel form of express warranty – under the “common law” (actually express product warranties are governed by state UCCs, not the common law) of all 50 states in direct violation of Erie federalism, as enunciated in multiple precedents from the United States Supreme Court and the Third Circuit.  What’s worse is that the opinion appears entirely oblivious to the constitutional ramifications of what it did.  Nowhere in the opinion is any citation made to any case involving Erie principles, nor is there any recognition that a “prediction” of state law was being made.

Nor is there any case that we’ve seen involving generic preemption that allowed any claim predicated on the purported “falsity” of a statement that the FDCA and FDA regulations require be included in generic drug labeling.  In this respect this purported “express warranty” claim is simply another disguised “stop selling” claim preempted under Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013).  As to preemption, we have three other observations:  (1) the FDA itself reviews drug names so that companies don’t use names that convey results or otherwise mislead (e.g., no antidepressants called “Happify” or “Pleasurac”); (2) the drug’s name, itself is a required part of the label; and (3) FDA approval of an ANDA is an agency determination that the generic is “comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use.”  See FDA website.  Thus, there are multiple routes to preemption of the Valsartan plaintiffs’ express warranty claim that do not involve the “Orange Book.”

We hope that the manufacturer defendants in Valsartan do not let this unprecedented (in several ways) “express warranty” ruling stand.  This ruling both makes a travesty of the Erie doctrine and should be preempted for attacking an FDA-mandated labeling statement.  It is difficult, in an MDL, to obtain appellate review of errors, no matter how egregious.

*          *          *          *

On another, less controversial, aspect of the same Valsartan opinion, we also note that Magnuson Moss claims based on FDA-regulated labeling were properly dismissed.  Valsartan, 2021 WL 222776, at *20-21.  This part of the opinion is the only part that contains a significant discussion of case authority.  This issue was also the subject of one of our recent blogposts, here.  The previous two sentences may be related.

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In addition to having Green Mountains, maple syrup, lake houses, an ice cream company run by summer camp buddies, a mitten wearing Senator, and a history of low COVID rates, Vermont has a history of being a legal outlier.  Some of its positions might be considered progressive or regressive.  The legislation discussed here is a (bad) example of the former.  The latter is exemplified by its position on the learned intermediary doctrine.  As we noted recently, there are very few states left where the high court has not adopted the learned intermediary doctrine or a federal court has not predicted that it would.  Until last week, Vermont was among the holdouts.  No longer.  (We will not weigh in on how Levine was impacted by this issue and how things might have been different if Vermont had been following the majority position back in 2004.)

Leavitt v. Ethicon, Inc., No. 2:20-cv-00176, 2021 WL 872696 (D. Vt. Mar. 9, 2021), bears some commonalities with some other cases we have been posting about recently.  It is a pelvic mesh case remanded from one of the MDLs after being there for more than six years.  (We cannot say whether it untimely filed, because the decision does not indicate the date for any revision surgery or the onset of alleged injuries, but the device at issue was implanted back in 2009 and the plaintiffs did plead a “count” for “discovery rule and tolling.)  When it was remanded, a motion for summary judgment had been pending for a year.  This is not a story about delaying justice, though.  This is one where it probably helped for the court deciding a Vermont state law issue to be in Vermont, even if it was a federal court and the task involved predicting what the Vermont Supreme Court would do.

The facts of the case are fairly simple and familiar.  The plaintiff received a prescription medical device as part of a surgery to repair her stress urinary incontinence.  On summary judgment, because of which claims were challenged and which were dropped, only those sounding in failure to warn were at issue.  The prescribing/implanting doctor did not rely on the IFU for the device.  The plaintiff (switching to singular to ignore the consortium plaintiff for the rest of the post) probably received a patient brochure, but she did not rely on it.  Instead, she relied on what the doctor told her (which was, in turn, not based on anything the defendant made).  This fact pattern sounds familiar enough that we have a whole survey on it.

The first step, though, was deciding if the learned intermediary doctrine should apply to the claims here.  The prediction of what the Vermont Supreme Court would do was based on three observations.  First, “where Vermont law is undeveloped, the Vermont Supreme Court frequently looks to the Restatement for guidance.”  Id. at *5 (citation omitted).  The Restatement (Third) of Torts, from way back in 1998, had adopted the learned intermediary doctrine for all prescription medical devices.  Second, citing the 2014 tally from the MDL court in the Tyree case, “forty-eight states have adopted, or a federal court has predicted the state’s highest court would adopt, the learned intermediary doctrine.”  Id at *5 & n.4.  The court predicted Vermont was likely to follow this “overwhelming majority.”  Id. at *5.  Third, “the learned intermediary doctrine reflects the realities of patient consultations and identifies the best source of information regarding the risks and benefits of a particular device or procedure for a particular patient.”  Id. at *6.  We like this one best.  Together with the others, there was more than enough to support a prediction that the Vermont Supreme Court would adopt the learned intermediary doctrine and we have updated our survey.  (Note that we were already citing a lower Vermont decision not cited in Leavitt.)

With that, plaintiff’s claims based on an alleged failure to warn her fell.  Her claims based on allegedly failing to warn her prescribing/implanting doctor were left, but they had major causation issues.  As we noted up front, though, Vermont can be a bit quirky.  It applies a heeding presumption to (non-learned intermediary) warnings claims.  Id. at *6-7.  But it does recognize, even with the presumption, there can be no proximate cause for failure to warning when there is proof that the user would have ignored any warning.  Id. at *7.  Applying those principles, and acknowledging the cases defendant cited where a physician’s failure to read the IFU negated proximate case, the court proceeded to analyze two versions of the failure to warn claims focused on the prescribing physician.

As to claims based on the IFU, summary judgment was granted because the prescriber did not read or rely on it.  Id. at *8.  Plaintiff’s reference to the sort of testimony often adduced—that the doctor relies on a “pool of information”—did not change the result because the testimony did not indicate the IFU she had not read was part of that pool.  Id.  Curiously, though, there was second theory based on the disclosure of risks in the patient brochure.  Based on testimony that the doctor “that she typically discussed the information in the brochure as well as the risks identified therein with her patients,” the court found a genuine issue on causation.  Id.  We are confused by this.  There was no evidence the doctor relied on a brochure written for patients for her understanding of the risks, let alone that she would have done something different in connection with the surgery with this patient.  It makes no sense that a doctor who did not read the IFU would rely on a patient brochure to make a decision on which device to use or surgery to do.  Even if there were some evidence that she would have engaged in a different discussion with plaintiff based on what the patient brochure said, the better thinking does not allow proximate cause for a claim based on a failure to warn the doctor to be based on speculative testimony about what the patient (now plaintiff) would have done with a somewhat different oral consent from the doctor.  Here, the jury would be asked to decide this issue based on the plaintiff’s self-serving testimony about how she would have done something different based on the possibility that different words might have been used in an oral conversation a dozen years earlier.  That would undercut much of the public policy the court found persuasive in predicting the adoption of the learned intermediary doctrine.  Because Vermont’s learned intermediary law is nascent, we will cut the court some slack.  In the future, this is the sort of record that should result in summary judgment on all warnings-based claims.

 

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Happy St. Patrick’s Day. We will not be talking about corned beef (which we revere) and cabbage (which we revile) today. Something different is on the menu.

A couple of weeks ago we were delighted to report on a Ninth Circuit affirmance of a decision by one of our former AUSA colleagues. This week we are equally delighted to report on a California Court of Appeal affirmance of a decision by another one of those colleagues.

This time the Judge being affirmed is John Shepard Wiley, Jr. We already knew Wiley was brilliant, but his online biography contains many high points we did not know about until just now. For example, Wiley has been published in several of the top law reviews (topmost, of course, being our alma mater’s, U.Chicago L. Rev., though having articles in the Harvard and Yale journals is also fairly impressive), was an award-winning law professor at UCLA, and then, speaking of topmost, he has climbed The Nose on El Capitan and the Northwest Face of Half Dome. No wonder we always looked up to the guy.

Wiley is now a Justice on the Court of Appeal. He was on the Superior Court when he granted summary judgment in a case involving a claim of mislabeled poultry. It was chicken, to be precise. Gallus gallus domesticus. The Court of Appeals affirmed Wiley’s ruling in Leining v. Foster Poultry Farms, Inc., 2021 687941 (Cal. Ct. App. Feb. 23, 2021). The case does not involve drugs or medical devices, but it does involve preemption, which is something we love almost as much as Buffalo wings, chicken parmigiana, and, so help us, McNuggets.

The poultry company paid a license fee to the American Humane Association (AHA) so that it could label some of its chicken as “American Humane Certified.” Packages of yardbird with that certification cost more than packages without it.

The plaintiff alleged that she purchased chicken relying on that label to mean that the chickens had been “afforded a comfortable existence and a quick and painless death.” But, according to the plaintiff, the truth was that the chickens were treated no differently from any others and she had paid a premium for nothing. The logo was misleading because “the chicken was not treated in a manner that an objectively reasonable consumer would consider humane.” She sued the poultry manufacturer for unfair competition, negligent misrepresentation, and breach of warranties. She sued the Humane Association for negligent misrepresentation.

Both defendants moved for summary judgment. The poultry manufacturer’s argument is of more interest to us because it argued that its label, including the Humane Association certification, had been approved by the federal government. Poultry products sold in the U.S. are governed by the Poultry and Poultry Products Inspection Act (PPIA). Labels on poultry products must be pre-approved by the Food Safety and Inspection Service (FSIS). The FSIS had approved the labels at issue, including the American Humane Association Certified logo.

The PPIA contains an express preemption clause. It provides that “Marking, labeling, packaging, or ingredient requirements … in addition to, or different than, those made in this [chapter] may not be imposed by any State or Territory or the District of Columbia” etc.

Does that sound familiar to you stout-hearted lawyers who labor in the fields of drug and device litigation? It should.

At the same time, the PPIA provides that a state, territory, or D.C. may, “consistent with the requirements under this [chapter] exercise concurrent jurisdiction … for the purpose of preventing the distribution for human food purposes of any such articles which are adulterated or misbranded.”

The poultry company argued that the first part of the clause meant that the plaintiff’s lawsuit was preempted, while the plaintiff argued that her lawsuit was part of the concurrent jurisdiction referenced in the second part of the clause.

The Leining court held that the poultry company had the better argument. By preapproving the label, the FSIS had determined that the label, including the Humane certification, was not misleading. In fact, when the FSIS updated its labeling guidelines, animal welfare advocates had challenged the standards used by FSIS in approving labels claiming humane treatment of animals used for food. It turns out that lots of different people have lots of different views as to what constitutes humane treatment. No single standard could reflect the diverse views associated with those types of claims. The FSIS concluded that if a claim is certified by a third-party certifying organization, FSIS will approve the label if it includes the certifying organization’s name,website, and logo address. Consumers could contact the certifying agency to see if its standards met their expectations for humane animal-raising practices. Meanwhile, the FSIS had come up with a means of assuring national uniformity of labeling, and the express preemption provision in the PPIA was intended to protect such uniformity.

What about concurrent jurisdiction? The Leining court held that “[w]hile additional labeling claims are preempted, concurrent jurisdiction permits States to impose additional remedies for violation of the PPIA.” (Emphasis in original). The plaintiff’s lawsuit sought to impose additional labeling requirements, not remedies, so it was preempted.

The claim against AHA did not hinge on preemption. Instead, the court dismissed the negligent misrepresentation claim against AHA because the plaintiff claimed no physical injury. True, there are narrow circumstances under California law where one can sue for economic loss sustained by relying on someone’s negligent misrepresentations, but those are confined to professional negligence in business advice made to a limited group of persons for whose benefit the professional advice was intended. Think of auditors whose certification of a company’s books induces someone to buy the company. The issue often comes up in cases against investment ratings agencies, with results varying depending on whether the investment vehicles were sold to the general public (no liability) or a limited set of qualified investors (possible liability).

The plaintiff in Leining argued that she was in a small segment of the public – those who care about animal welfare when buying food – and that the Humane certification targeted that group. But the representation was made to the general public and anyone could buy the chicken. Extending the narrow professional advice exception to a “standard grocery-buying transaction” would swallow the general rule and render the “limitation to physical injury meaningless.”

We admit that we have always been worried about this negligent misrepresentation exception. You might even say we were chicken. Anyway, it is gratifying to see a California court respect the limits to the exception. If the court had ruled the other way, you know we would have had to cry fowl. But because the defense position prevailed, permit us to crow: Winner winner, chicken dinner.

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It seems fitting that if we are going to talk about a one-two punch, we acknowledge the passing of boxing legend Marvelous Marvin Hagler.  The undisputed middleweight champion from 1980 to 1987 whose boxing career started in Massachusetts but who started out a New Jersey boy.  Only Jersey Understands Jersey!

From New Jersey to Alabama and Lowery v. Sanofi-Aventis LLC, 2021 WL 872620 (N.D. Ala. Mar. 9, 2021).  Today we’re going to talk about the first hit to plaintiff’s case – Daubert.  Stay tuned for the knockout blow – preemption.

The product at issue is a Class III medical device that is a gel-like substance that is injected into the knee to reduce pain.  This is the treatment that plaintiff underwent.  He experienced pain and swelling after the injection that required surgery and antibiotics.  His treaters determined he may have had septic arthritis or possibly a pseudoseptic reaction.  Id. at *1-2.  Sometime after plaintiff’s injection, the manufacturer discovered that the lot plaintiff’s device came from was contaminated and recalled it.  Id. at *1.  The basis of plaintiff’s claims is that the contaminant caused his infection and various related injuries.

Plaintiff proffered testimony from two experts – a hospitalist practicing family medicine as a causation expert and a molecular biologist with experience in product development and regulatory compliance as an FDA expert.  Id. at *2, *5.  The first failed on qualifications and both failed on reliability.

Plaintiff’s medical expert sought to assert medical opinions on infectious disease, orthopedics, and otolaryngology – but was not an expert in any of those fields.  Id. at *7.  The expert must be qualified to opine on the “specific issue before the court.”  Id.  Specifically, plaintiff’s medical expert sought to testify that plaintiff suffered from septic arthritis that was caused by the contaminant in the medical device.  However, the expert does not use the medical device at issue, does not perform any orthopedic procedures on knees, never did any training in orthopedics, never did any research in the field of orthopedics or this type of injection, or on knee infections or pseudoseptic reactions.  Id. at *8.  The expert’s lack of experience made him unsuited to determine whether plaintiff suffered from septic arthritis or to rule out alternative causes such as a pseudoseptic reaction.

The court further noted that not only was plaintiff’s expert unqualified to opine on plaintiff’s diagnosis but was also unqualified to opine as to the cause of the condition.  Plaintiff’s expert lacked the training and skills needed to determine the root cause of plaintiff’s condition.  Before being retained by plaintiff, this doctor had never even heard of the contaminant in defendant’s device, let alone treated anyone infected by it.  Id. at *9.  Plaintiff’s expert was a family doctor who by his own admission refers patients to specialists like orthopedists when faced with issues like those presented by this plaintiff.  As the court correctly concluded, he was a “Jack of all trades, expert in none.”  Id. at *11.

However, even if qualified, his testimony would have been excluded for lack of reliability.  To meet his burden of proof, plaintiff had to offer expert testimony to establish both general and specific causation.  General causation lays the “scientific groundwork” that the substance can cause the harm alleged while specific causation establishes that the substance did cause the injury in this case.  Id. at *12.  You cannot have the latter without the former.  The court discusses the issue in the terms of a differential diagnosis – the process of ruling in and ruling out possible causes of a diagnosis.

Here, plaintiff did not dispute that his expert does not offer a general causation opinion.  So, in conducting his differential diagnosis, plaintiff’s expert ruled out the pseudoseptic reaction, a known side effect of the device, as a cause of plaintiff’s injury but failed to properly rule in the contaminant as a cause.  His only basis for ruling in the contaminant was the initial impressions of plaintiff’s treating doctors as noted in the medical records and temporal proximity.  An expert cannot simply parrot what is in the medical records – otherwise, why would we need experts?  And the temporal proximity between the injection and the symptoms is inherently unreliable.  Id. at *14.  This is especially true in a case like this where the temporal proximity could also point to an alternative cause like a pseudoseptic reaction.  Neither parroting nor proximity are generally accepted scientific methodologies.  Lacking any methodology or analysis, his “conclusion is nothing more than his own assertion.”  Id. at *15.

Moving on to plaintiff’s FDA expert, the court concluded that she was qualified to offer the opinions she proffered except her opinion that the contaminated product put patients at risk of serious injury due to bacterial contamination.  That is a medical opinion, and the expert was not a medical doctor.  Id. at *18.  However, as to her remaining opinions the court found there were “significant analytical gaps” between [the expert’s] conclusions and the facts on which she bases her opinions.”  Id.

The crux of the FDA’s expert opinions was that the device would be found to be adulterated under FDA regulations, that defendant violated FDA’s Good Manufacturing Practices (GMPs) in the manufacturer and distribution of the device, and that defendant should have started testing earlier as required by the device’s PMA.  Id.  But despite the repeated reference to FDA regulations and GMPs, nowhere did plaintiff’s expert identify which GMPs or regulations defendant violated.  Id. at *19.  The closest plaintiff’s expert came was citing general regulations with multiple sub-parts covering a variety of processes from manufacturing to packaging to record keeping.  The FDA expert failed to connect the facts to the conclusion that FDA regulations were violated.  This type of opinion would be of no assistance to the jury:

where her analysis jumps from her observations of Defendant’s practices to conclusions as to its compliance without specifying which provision Defendant failed to comply with (let alone how it failed to do so), a jury would be left to perform guesswork.

Id. at *20.  Nor should opinions be admissible if they only support claims not before the jury.  Plaintiff’s FDA expert opined that defendant should have done different testing of the device – testing that is not required by the FDA.  But that only supports a claim that defendant should have done something different from or in addition to what the FDA requires which is a preempted claim.  Which feels like a logical place to transition to punch number two.  Next week – the summary judgment ruling.

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Today’s post discusses a recent implied-preemption decision that is relevant beyond the generic-drug context in which it arose.

A bit of background first.

In Buckman Company v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the Supreme Court held that 21 U.S.C. § 337(a)—which declares that all actions to enforce the FDCA “shall be by and in the name of the United States”—impliedly preempts any private suit seeking to enforce the FDCA. Thus, under Buckman, a state-law tort claim is barred by federal law if it “exist[s] solely by virtue of the FDCA.” 531 U.S. at 353.

In PLIVA, Inc., v. Mensing, 564 U.S. 604 (2011), the Supreme Court held that federal law impliedly preempts state-law failure-to-warn claims based on a generic drug manufacturer’s failure to give warnings different from those given by the drug’s brand-name manufacturer on its FDA-approved labeling. Such claims are impliedly preempted, the Court explained, because it is impossible for a generic manufacturer to simultaneously comply with a purported state-law duty to provide additional warnings and the federal requirement that generic labels be identical to their brand-name equivalents.

Ever since Buckman and Mensing were issued, the plaintiff’s bar has attempted to evade their holdings. A recently decided case, Bennett v. Teva Pharma. USA, Inc., 2021 WL 797834 (D. Del. 2021), involves one such attempt. More accurately, it involves three such attempts. The Bennett plaintiffs claimed that the defendant generic drug manufacturer was liable on three different failure-to-warn theories. The court rejected each as impliedly preempted.

In the course of doing so, the court made several statements that can be usefully cited not only by generic drug manufacturers but also by their brand-name competitors and medical-device manufacturers.

Claiming to have been injured by the generic version of a drug, the Bennett plaintiffs alleged that its manufacturer had failed to adequately warn of the risks associated with the drug. In particular, the plaintiffs alleged that the manufacturer had: (1) failed to distribute sufficient quantities of the FDA-mandated medication guides to ensure that a guide reached every patient; (2) failed to report adverse events to the FDA as required by the FDCA; and (3) misrepresented the drug as safe for a particular off-label use in purported violation of the FDCA’s misbranding prohibition.

Despite acknowledging that each theory of liability was premised on an “alleged violation[] of the FDCA,” the Bennett plaintiffs maintained that their claims were “not barred by Buckman because the claims” supposedly did “not exist solely by virtue of the FDCA.” 2021 WL 797834, at *2–3. Specifically, the plaintiffs argued that their claims were based on “pre-existing state duties” because the defendant’s alleged conduct purportedly violates Delaware’s misbranding statute and the Restatement (Second) of Torts § 388, which the state’s courts have adopted.

The court was not convinced. And rightly so.

The fact that the defendant’s alleged conduct might violate Delaware’s misbranding statute did not save the claims from preemption under Buckman because the state statute expressly incorporates the FDCA’s definition of misbranding. Thus, the duties that it imposes neither “predate nor exist independent of the FDCA.” 2021 WL 797834, at *3. Accordingly, the court concluded that even if based on a violation of Delaware’s misbranding statute, the plaintiffs’ claims were “prohibited by § 337(a) and preempted under Buckman.” Id.

That holding is relevant to all manufacturers regulated under the FDCA—whether they manufacture generic drugs, branded drugs, or medical devices.

As in Bennett, plaintiffs frequently assert negligence-per-se claims predicated on an alleged violation of the FDCA. Many courts properly reject such claims, either because state law does not recognize negligence-­per-se claims where the statute allegedly violated does not contain a private right of action or because they understand such claims to be preempted under Buckman. Other courts, however, have allowed such claims to proceed, reasoning that they are not preempted under Buckman because state negligence-per-se law does not depend on the existence of the FDCA. That of course ignores the fact that negligence per se is necessarily predicated on the violation of a statute or regulation that imposes substantive requirements. As the Bennett court recognized, when a particular negligence-per-se claim is based on the alleged violation of the FDCA, that particular claim “exist[s] solely by virtue of the FDCA” and is therefore impliedly preempted by § 337(a). Buckman, 531 U.S. at 353.

The plaintiffs’ reliance on Restatement (Second) of Torts § 388 fared no better. Although the provision requires manufacturers to give adequate warnings, it does not, the Bennett court noted, “refer[] to, let alone impose[] an obligation on drug manufacturers to distribute, Medication Guides,” which are “a creature of the FDA.” 2021 WL 797834, at *3. Similarly, “Section 388 … says nothing about an obligation to report adverse events to the FDA.” Id. at *4. Thus, the duty to distribute Medication Guides and the duty to file adverse-event reports “arise” not from § 388 but from the FDCA and its implementing regulations. Id. Accordingly, any private action based on an alleged failure to fulfill those duties is “barred by § 337(a) and Buckman.” Id. In other words, a plaintiff cannot rely on a general state-law duty to warn to impose liability for violation of the FDCA. Given that 21 U.S.C. § 337(a) applies to all aspects of the FDCA, that is true whether the claim at issue implicates a generic drug, a branded drug, or a medical device.

The final piece of the Bennett decision is limited to generic drugs, but no less welcome.

Despite the plaintiffs’ insistence that they were not seeking a labeling change, the Bennett court concluded that they did seek such a change and that their claims were therefore preempted under Mensing. Given their insistence that the alleged failure to submit adverse-event reports and alleged failure to warn against a particular off-label use constituted failures to warn under state law, the plaintiffs were, the court found, contending that the defendant’s labeling was inadequate and therefore had to be changed as a matter of state law. As recognized in Mensing, however, “[g]eneric manufactures … are prohibited by federal law from changing their labels to meet state-law warning requirements.” 2021 WL 797834, at *4. Because it was impossible for the defendant generic drug manufacturer to simultaneously comply with the purported state-law duty to change its label and the federal duty to “keep the label the same” as the corresponding branded label, the plaintiffs’ claims did not “escape preemption under Mensing.” Id.

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It may be tempting to dismiss as boilerplate the “choice of law” discussion that precedes the “standard of review” in a typical brief.  But while choice of law may not always be challenging or pivotal, just as often it is both.  Today’s case, Peterson v. C.R. Bard Incorporated, 2021 WL 799305 (D. Or. Mar. 2, 2021), is a good example.

In Peterson, the plaintiff, then a resident of Pennsylvania, received the defendant’s IVC (inferior vena cava) filter at a Pennsylvania hospital.  He moved to Oregon, where he suffered his alleged injury and underwent surgery to remove the filter.  The filter was designed and tested in Arizona and its manufacture was directed from Arizona.  The plaintiff filed suit in the District of Oregon and argued that Oregon law applied to his substantive claims and also to his claim for punitive damages. (We’ll tell you why he wanted this result in a minute.)  The defendant argued that Pennsylvania law applied to the product liability claims and Arizona law governed the punitive damages claim.  The defendant’s arguments carried the day, and here’s how the district court broke it down.

Choice-of-Law Analysis

As a federal court sitting in diversity, the court applied the choice-of-law rules of the forum state, Oregon.  Under Oregon’s choice-of-law rules, Oregon law applies if the plaintiff lived in Oregon at the time of his injury and suffered his injury in Oregon (he did), unless one of two possible exceptions applies.

First Exception

Under the first exception, Oregon law does not apply if the defendant can show that (1) “the use in Oregon of the product that caused the injury could not have been foreseen,” and (2) “none of the defendants’ products of the same time were available in Oregon in the ordinary course of trade at the time of the injury.”  Peterson, 2021 WL 799305 at *2 (citations omitted).   With respect to the first question, “the question is not whether the defendant could have foreseen that somebody would be injured in Oregon, but whether the defendant could have foreseen that the particular plaintiff before the court would be injured in Oregon.”  Id. (emphasis in original).  With respect to the second question, “a defendant may not merely show that the exact product at issue was unavailable in Oregon.  [It] must also show that products of the same type as the product at issue were unavailable in Oregon.”  Id. at *2-3.

In this case, the court found that the defendant satisfied the first requirement, as the defendant could not have foreseen that the plaintiff, who received his IVC filter in Pennsylvania, would suffer his injury in Oregon.  But the defendant could not satisfy the second test.  While it had discontinued Oregon sales of the plaintiff’s filter before the plaintiff suffered his injury, it did not provide evidence that it had discontinued all products of the same type, so this exception did not apply.

Second Exception

The second exception requires an issue-by-issue interest analysis of sorts, determining separately, for each issue, whether “the application of the law of a state other than Oregon . . . is substantially more appropriate” than the application of Oregon law.  Id. at *3.  As the court explained, “each state having relevant contacts . . . may not be equally concerned with regulating all issues in the case, but may only be concerned with those issues that actually implicate its policies in a significant way.”  Id.   Against this backdrop, the court first considered which state’s law governed the plaintiff’s product liability claims then separately considered the punitive damages claim.  With respect to the product liability claims, the court acknowledged that the plaintiff lived in Oregon at the time of his injury and still lived in Oregon, but it emphasized that the plaintiff did not sustain his injury until after the product was taken off the market in Oregon.  But because the plaintiff received his IVC filter in Pennsylvania, the court found that Pennsylvania was “directly implicated” from “a purely economic standpoint,” and also had “an interest in its citizens receiving safe products in its hospitals.”  Id. at *5.   The court concluded that “Pennsylvania would sustain the most serious legal, social, and economic consequences of the choice-of-law determination,” so Pennsylvania law applied to the product liability claims.

Punitive Damages

The court began by explaining that compensatory damages and punitive damages “serve distinct purposes.”  Id.  While compensatory damages “are intended to redress the [plaintiff’s] concrete loss . . . ,” punitive damages “operate as private fines, intended to punish the defendant and to deter future wrongdoing.”  Id. at *6 (internal punctuation and citations omitted).  This distinction affects the choice-of-law analysis for punitive damages claims. While some states “emphasize the defendant’s conduct in the state where the product was marketed and sold,” others “emphasize the defendant’s conduct in the state where the product was designed and manufactured,” reasoning that “the focus, for purposes of choice-of-law analysis, needs to be on the place where the defendant’s alleged corporate misconduct occurred.” Id. (citations omitted).  The court concluded,

Although this is a close call, I conclude Arizona law should apply to the issue of punitive damages. . . . [The defendant] designed, tested, and manufactured the product in Arizona.  [It] also developed the products instructions and marketing material in Arizona; developed written communications to physicians in Arizona; trained its sales force on how to interact with physicians in Arizona; and communicated with the FDA about the . . . filter in Arizona.  At bottom, although the [defendant’s] alleged misconduct eventually spread beyond Arizona, the foundation of that misconduct was formed in Arizona. . . . [The defendant’s] Arizona business activities form the foundation of [the plaintiff’s] claim for punitive damages, tipping the balance in favor of applying Arizona law.

Id. at *7.   So the court held that Pennsylvania law applied to the product liability claims and Arizona law applied to the punitive damages claims.  Why did this matter?   The court predicted that Pennsylvania would extend comment k’s “unavoidably unsafe products” exception, which expressly bars strict liability claims against manufacturers of prescription drugs, to bar claims against manufacturers of prescription medical devices like the defendant’s filter. (Of course it does, notwithstanding the nonsensical debate on which we reported here and here and here and here.)  This was fatal to the plaintiff’s strict liability claims, while the claims “would likely [have] survive[d] summary judgment” if Oregon law applied.  Id. at *1.  Pennsylvania has adopted the learned intermediary doctrine, while Oregon has not.  And Arizona law bars punitive damages claims against a product manufacturer that “adheres to government specifications,” while Oregon does not.  Id. 

We like nothing better than a decision that is both correctly reasoned and defendant-friendly, and Peterson is just such a decision.  We will keep you posted on the good and the bad.  In the meantime, stay safe out there.

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Last year the HHS Office of Inspector General issues a “Special Fraud Alert” (“Alert”) concerning “Speaker Programs” – more usually known as continuing medical education (“CME”).  Since we believe that truthful commercial speech is First Amendment protected, seeing “fraud” bandied about like this caused us to take a look.  We’re well aware that for years the FDA has pursued Orwellian logic to declare truthful speech (including CME) about off-label uses to be “false and misleading,” so we decided to see if the HHS OIG was going down the same regulatory primrose path.

To be clear, what this is all about is manufacturer-sponsored lectures to physicians about current medical issues at which the attendees receive free food:

[S]peaker programs are generally defined as company-sponsored events at which a physician or other health care professional (collectively, “HCP”) makes a speech or presentation to other HCPs about a drug or device product or a disease state on behalf of the company.  The company generally pays the speaker HCP an honorarium, and often pays remuneration (for example, free meals) to the attendees.

OIG Alert, at page 1.

Fortunately, this alert – unlike FDA’s activities – seems directed more at the money involved (OIG mentions $2 billion over three years, id.) than the content of the presentations.  Focus is paid to large amounts of money paid to “high prescribing” speakers.  Id.  To some extent we think this is a bad rap, when one considers the educational purpose of CME.  It’s highly likely that whatever the product might be, physicians who use it most frequently are likely to be the most familiar with its risks and benefits, and thus would be the most educational speakers.  These sorts of payments to physicians, moreover, are already reportable and publicly available.

So-called “high prescribers” are also likely to be quite busy, and since “time is money,” they must be paid to spend time away from their lucrative practices.  So what OIG portrays as “fraud” may well be nothing more than simple statistical association.  That’s why “fraud” in litigation requires “scienter.”  “Scienter,” in a fraud case, means “a mental state embracing intent to deceive, manipulate, or defraud” – “intent to defraud, reckless disregard for the truth, or knowing use of some practice to defraud is necessary in such an action.”  Ernst & Ernst v. Hochfelder, 425 U.S. 185, 193 n.12 (1976) (requiring scienter in securities fraud cases).  Indeed, the OIG alert states flatly that, “[t]he anti-kickback statute makes it a criminal offense to knowingly and willfully solicit, receive, offer, or pay any remuneration to induce or reward, among other things, referrals for, or orders of, items or services reimbursable by a Federal health care program.”  Id. (emphasis added).

The more specific the OIG’s alert gets, the less problems we have with it.  “[C]ondition[ing] speaker remuneration on sales targets,” id. at 2 – above a minimum necessary to maintain competency and familiarity, that sounds like the kind of thing the Anti-Kickback statute was intended to prevent.  Programs held “in a manner not conducive to an educational presentation,” id. – ditto, that’s not CME, albeit an issue directed more to audience than speaker behavior.  Programs held at “high-end restaurants where expensive meals and alcohol were served,” id. – we’re more supportive of OIG concerning the alcohol (again, directly detracting from CME), than the food, but at the extreme the OIG cited (“over $500” a head), the need to induce CME attendance has been overshot.  Invitees “who had previously attended the same program,” or friends and family “who did not have a legitimate business reason to attend,” id. – the purpose of CME is education, and this example also does not serve that purpose.

We do take umbrage at the Alert’s general statement that “OIG is skeptical about the educational value of such programs.”  Id. at 3.  First of all, that’s not its job.  Its job is to enforce the law with respect to federal programs – not to evaluate content.  That’s precisely where the FDA has gotten in trouble with the First Amendment.  As stated above, we have no problem with most of the red flags that its Alert identified.  But OIG is not a medical society, and its personnel are not doctors.  It should enforce the law, as it describes, but should not become a “nanny state” devoted to telling medical professionals how and where they should be obtaining their CME.  Thus we think the Alert overreaches when it purports to do just that:

There are many other ways for HCPs [health care providers] to obtain information about drug and device products and disease states that do not involve remuneration to HCPs.  HCPs can access the same or similar information provided in a speaker program using various online resources, the product’s package insert, third-party educational conferences, medical journals, and more.

Alert at 4.

OIG’s bureaucrats should resist this temptation to play doctor.  OIG should do its job and allow medical societies and state medical boards to do theirs.  If a doctor or someone else with power over prescription choices “knowingly and willfully soliciting or receiving remuneration in connection with speaker programs in return for prescribing or ordering products,” id. at 5, then prosecute them.  But the OIG’s generalized observations about how doctors should obtain CME ignore the scienter requirements of the Anti-Kickback Act, and thus exceed OIG’s authority.  For that reason we also object to two of the “suspect characteristics” that the Alert lists:

The company sponsors a large number of programs on the same or substantially the same topic or product, especially in situations involving no recent substantive change in relevant information.

There has been a significant period of time with no new medical or scientific information nor a new FDA-approved or cleared indication for the product.

Alert at 5.  Both of these items involve OIG purporting to make prosecutorial decisions based on the substantive content of CME programs.  “Topic”-based restrictions on speech are violations of the First Amendment.  E.g., Reed v. Town of Gilbert, 576 U.S. 155 (2015).  Nor is the restriction to “new” information appropriate, since there are always new doctors.  This sounds like the FDA’s “changes being effected” regulation.  Further, the focus on “new FDA-approved or cleared indications,” ignores that much cutting edge medicine – such as every extant COVID-19 treatment – involves off-label uses.  CME about off-label uses may well be more important and valuable to its intended audience than CME about labeled uses, since as OIG pointed out above, the “package insert” is a good source of information about the latter.

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When we head into a trial against a personal injury plaintiff, our client, the defendant, occupies the right side of the v. We mean that simply as a matter of word placement. It is Plaintiff v. Defendant, not the other way around (though on appeal the parties can be scrambled). By “right” side, we are not necessarily making a claim as to legal, moral, or aesthetic primacy. Nor are we asking for sympathy. If the case turns on whether tender feelings of jurors will flow toward a grievously ill plaintiff or a defendant corporation, we know that we will finish in second place. That’s okay. As Hyman Roth said, “This is the business we’ve chosen.”

But sometimes the sympathy factor can make what is already an uphill run seem nearly impossible. Consider the case of Ward v. LiNa Med. USA, Inc., et al., 2021 U.S. Dist. LEXIS 3096 (S.D.W.Va. Jan. 5, 2021). In Ward, the plaintiff had undergone a hysterectomy via a power morcellator. A morcellator uses spinning blades to mince a uterus and fibroids into smaller pieces in the abdominal cavity, permitting removal through small incisions. Unfortunately, there is a risk to this process. The spinning blades can cause cellular particles to spread. If undetected cancer cells are in the tissue, a morcellator might spread the cancer and “upstage” it (make it much, much worse). That is allegedly what happened to the plaintiff in Ward.

The story gets worse. The plaintiff’s doctor decided on morcellation but did not discuss the risks with the plaintiff. There was no real informed consent. After the arrival of the terrible news that the plaintiff had cancer, the doctor sat down with the plaintiff and her granddaughter and delivered quite a mea culpa. The granddaughter recorded the conversation. The doctor said he “screwed up,” “dropped the ball,” and that the procedure was a “swing and a miss.” He also admitted that he had failed to discuss the risks with the plaintiff, that he should have performed a biopsy before the morcellation to check for cancer, and that he would not have used the morcellator had he known of the cancer.

Can you imagine the plaintiff lawyer’s glee upon hearing that recording?

That is about as sad a case, and as strong a medical malpractice case, as we’ve seen. The plaintiff sued the doctor, who turned out to be a federal employee, thereby bringing the case within the Federal Tort Claims Act. She also sued the hospital. The hospital moved to dismiss the claim against it for failure to comply with West Virginia’s statutory requirement of pre-suit notification before suing health care providers. The hospital also argued that it could not be vicariously liable for the doctor’s malpractice. These arguments were certainly not frivolous. They might even have presented close calls. Still, the calls went in favor of the plaintiff. You’re not really surprised, are you?

That’s bad news for the med-mal defendants, but what’s that to us? We defend product liability, not med-mal, defendants.

Here it comes.

The plaintiff in Ward also sued the manufacturer of the morcellator. The causes of action were design defect, failure to warn, and breach of the implied warranty of merchantability and fitness. The manufacturer moved to dismiss all three claims. The manufacturer’s arguments all had respectable support in the law. But you can see where this going, can’t you?

According to the plaintiff, the design defect was the failure to include a containment bag that would have captured tissue and prevented it from spreading. The defendant argued that inclusion of containment bags was not the norm at the time of manufacture and was not recommended by experts, and that the complaint itself at one point seemed to acknowledge as much. But the court read the complaint generously, leaned heavily on the allegation that the containment bags were feasible, and declined to dismiss pleadings based on a defense of industry norms — at least not without discovery on the issue.

The failure to warn claim alleged that the manufacturer had not disclosed the risk of cancer spread, and had not advised physicians to conduct pre-operative screenings for cancer. The defendant pointed to the learned intermediary rule, and argued that even if additional warnings had been supplied, there was no allegation that the treating physician relied on any information from the manufacturer. Moreover, the physician never discussed risks at all with the plaintiff and there was no reason to believe he would have changed his behavior. The plaintiff won the day on this issue by arguing that the absence of warnings was a reason the doctor never had a complete discussion with his patient. As for warning causation, the court held that the plaintiff in the pleadings “need not lay out at this time exactly how she intends to prove that additional warnings would have prevented her injury.” The failure to warn claim remained in the case.

The defendant manufacturer argued that the breach of warranty claim was devoid of any factual allegations; it merely restated the elements of the cause of action. We’ve personally seen similar substance-less claims in many cases. Whether courts do anything about them varies from jurisdiction to jurisdiction and judge to judge. In the Southern District of West Virginia, courts have held the “claims for strict liability and breach of the implied warranty of merchantability are essential coextensive in products liability actions.” Since the strict liability claims passed muster, so did the warranty claim.

Obviously, any drug and device lawyer calls it a bad day at the office when all of his or her motions to dismiss are denied. But given the facts in the Ward case, one could not call it an unexpected day. Close calls are unlikely to benefit the right side of the v at this point. So the key at the summary judgment stage for the defense will be to make sure it is not a close call.

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