A great woman once said “When they go low, we go high.”  Apropos of nothing in particular these days, we have been thinking about the issue of tone recently.  For instance, what is the exact line between a negative political advertisement and a positive one?  Are there circumstances where a candidate might suspend negative ads and just run positive ones?  If the other side mostly runs negative ads, then will potential voters appreciate the contrast?  Are potential voters sick of overly divisive politics and negative advertising, regardless of how they might allocate blame for the divisiveness?  We pose these questions, but do not answer them.  Instead, we will try to be a little more positive in our tone when discussing another mixed bag preemption decision with a Class III device.  Will we come across as defensive hacks who are hiding behind a filmy layer of pandering that does not begin to obscure what we really think?  Maybe.

Pratt v. Bayer Corp., No. 3:19cv1310 (MPS), 2020 WL 5749956 (D. Conn. Sept. 25, 2020), should seem pretty familiar to our readers.  This is an Essure case and we have posted on a bunch of those, notably several recently on preemption (here, here, here, here, and here).  The Pratt preemption issues involve the narrow gap between express preemption and implied preemption into which allegedly parallel claims have to fall.  We have posted on those cases often and with a good dose of snarkiness (here, here, and here).  The Pratt analysis touches on § 324A of the Restatement (Second) of Torts, which has been the subject of a number of our posts, most of which have doubted the expansion of the Good Samaritan doctrine to prescription medical product manufacturers (here, here, here, here, and here).  This case even involves Connecticut law, which has been at issue in a number of recent posts (like here and here).  Several of the cases in those posts linked above are discussed in Pratt, so we will skip some of our typical lecturing on the proper order of analysis and the need for Erie restraint.  In our effort to be more positive, we will focus on the good in Pratt and not how it falls short.  (We have even restrained ourselves from using a punny title.)

In our spirit of positivity, we will start with the good part of the decision after setting out the allegations.  This is a decision on a motion to dismiss, so the court took plaintiff’s allegations as fact to see if she had stated “plausible claims” or plead herself into either express or implied preemption.  Plaintiff alleged to have developed a rash about four and a half year after the implant of her Essure, a Class II device for birth control.  She claimed that the implant had migrated and had to be removed during an apparently unrelated procedure to remove her fallopian tubes and ovaries (which would obviate the need for birth control).  Although her complaint did not even specify the name of any of her physicians, she offered a number of creative assertions about all the things the manufacturer allegedly did wrong.  Rather than assert the traditional design defect and warnings claims that are a staple of product liability cases against prescription medical device manufacturers, she asserted claims labeled as negligent training of the unnamed doctor and negligent risk management, which focused on handling and reporting Medical Device Reports.  These claims, in turn, were based on allegations about a range of FDA requirements and the content of FDA-required labeling.  While Connecticut has a product liability act that is the exclusive remedy for claims for injuries from products, plaintiff did not cite the CPLA.  Instead, plaintiff asserted her claims under (state) common law and federal (FDCA) law.  After doing the rest of its analysis, the court gave the plaintiff an opportunity to amend her complaint as to assert a claim under the CPLA as to her theory that survived preemption.

None of her theories within the amalgam negligent risk management claim did.  The court rightly identified the narrow gap through which claims concerning the Class III device would have to fit as a “state law claim must ‘parallel[] a federal-law duty under the MDA’ but also exist ‘independently of the MDA’.”  2020 WL 5749956, *4 (quoting the otherwise bad Fogel decision, which quoted the really bad Stengel decision).  This gap is defined by the statutory express preemption precept that a state requirement may not be “different from, or in addition to” the requirement imposed by the FDCA and the Buckman implied preemption principle that claims cannot be based on violations of the FDCA.  Id.  To figure out if the plaintiff’s proposed claim is properly parallel, the first step is to determine if the plaintiff has actually asserted a cognizable claim under state law in accordance with applicable pleading requirements.  To the extent that the risk management claim was based on reporting adverse events to FDA, Connecticut does not have any such claim.  So, it cannot be a parallel claim.  To the extent plaintiff was trying to recover directly for a violation of FDA’s requirements, such a claim would be impliedly preempted.  Id. at *8.  This was correct and actually cited several of the cases we linked above.

Plaintiff also lumped a sort of failure to warn claim under the risk management heading, claiming that whatever got reported to FDA should also have been reported to her and her unnamed physician.  Although Connecticut has failure to warn claims, like in the CPLA that plaintiff ignored in her complaint, the court did not determine if plaintiff’s allegations here amounted to a claim because it would have imposed a different requirement than what FDA imposes.  “Such claims are expressly preempted because there is no FDA requirement for Bayer to report consumer complaints directly to healthcare providers and consumers or to update its warnings and labeling as Bayer learns of issues with the device.”  Id. (citation and internal quotation omitted).  This was also the right result.

The third concept that plaintiff included under the category of negligent risk management was described as an “unreasonably dangerous distribution scheme,” which included a few different criticisms of the manufacturing of the device.  The court generously interpreted this set of allegations as an attempt to assert a negligent manufacturing claim.  She failed to do so, though, because she did not allege “that her device was not manufactured in conformance with the specifications approved by the FDA” or that “any manufacturing defects caused her injuries.”  Id. at *9.  The court did not specify whether this meant no state law claim had been asserted or whether whatever had been asserted clearly did not fit through the narrow gap, but it was dismissed.

That left plaintiff’s purported negligent failure to train claim.  In our attempt to stay positive, we will volunteer that our collective century of product liability litigation experience tells us that states imposing a duty on a prescription medical product manufacturer to train (or supervise) physicians is rare.  (You can scroll through more than a decade of the Blog here, here, here, and here.)  There are some basic reasons for this, like doctors practice medicine, states license doctors, hospitals give them privileges, FDA does not regulate their decisions with patients, and medical product manufacturers do none of these things.  When a novel state duty to train has been found, it has often been found to be preempted.  Of course, federal courts are discouraged from creating new state duties, something better left to state legislatures and courts.  With that constructive background, we return to Pratt, where a federal court sitting in diversity recognized that no Connecticut statute (recall, there is a state product liability act that the plaintiff omitted from her complaint) or court had ever recognized a duty for a manufacturer of any product, let alone a prescription medical device, to train all potential users.  Given the need to find that the state law duty existed “independently” of the FDCA, we were hopeful about where the analysis would lead.

When the court explained that plaintiff’s allegations focused on an alleged “failure to abide by FDA training guidelines,” that those guidelines required the physician to be informed of the FDA-required Physician Training Manual, and that the alleged failure to follow FDA guidelines allegedly resulted in a misplaced device and plaintiff’s injury, we thought we knew where this was headed.  Id. at *4.  This view was reinforced when we saw that the unnamed physician allegedly did not complete the training that the manufacturer offered (pursuant to FDA requirements) and that the label said:

Device to be used only by physicians who are knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training Manual; and have successfully completed the Essure training program, including preceptoring in placement until competence is established, typically 5 cases.

Id. at *5.  Then we read a footnote placed after the quote from the label and it said the court “assume[d]” that the label “imposes obligations” on the manufacturer.  Id. at *5 n.5.  Setting aside our surprise that the plaintiff could have a basis to allege so much about an unnamed physician, we were curious as to how a court deciding whether a novel state law duty exists could simply assume that labeling language that is clearly directed at doctors “imposes obligations” on the manufacturer.  The labeling language references that there should be an Instruction for Use, Physician Training Manual, and a training program that includes supervised placements—all federal requirements—but it is directed at physicians.  It is also advisory, contingent on the “to be used” phrase that FDA cannot enforce given that it does not regulate the practice of medicine.  Even with this start, the court still had to determine if there was an independent state law duty to carry out the duties imposed by federal law.

In finding that there was—or, rather, predicting that the Connecticut Supreme Court would find there was—the court considered that the manufacturer voluntarily “undertook a duty to render services (Essure training) to another (Pratt’s [unnamed] physician)” and tied that to Good Samaritan Rule (although not called such in Pratt) from Restatement (Second) of Torts, § 324A.  (A misuse of this provision by a state court landed one case as our sixth worst of 2013, which provides an inkling of how we feel about its proper scope.)  We do not think offering training to doctors that an unnamed doctor allegedly did not avail himself/herself of fits within either of the subsections of § 324A, both of which start with no duty on the defendant until there is a voluntary act and the latter of which is inconsistent with the fact that the duties that this doctor owed to plaintiff or other patients remained his/hers.  However, the more fundamental issue is that the duty to offer training still arose under federal law.  By contrast, the Connecticut Supreme Court case Pratt cited as adopting § 324A concerned suing a property holder’s contractor for failing to clear a sidewalk, resulting in a fall on a slippery sidewalk, which concerned only state law duties.  Id. at *6 n.6.  Nowhere in the Pratt analysis that concluded that failing to train in accordance with FDA requirements was a cognizable, non-preempted claim under Connecticut law was there a mention of the requirement that this duty had to exist independent of the FDCA.  If the duty to train existed because of the FDCA, as the court concluded, then any state law duty to exercise reasonable care in connection with the training was certainly not independent or parallel, it was derivative.

Indeed, when the court went forward and noted that plaintiff “alleges other training-related failures, however, that fall outside the FDA’s requirements,” it did so in reaching the conclusion that such claims would be expressly preempted.  Id. at *7.  This was correct, of course.  The unavoidable implication, though, was that the first set of training-related allegation were wholly within FDA’s requirement.  To us, that emphasizes that any duty to train arose solely under federal law, which means that there was either no claim to pursue or plaintiff was trying to recover based on a violation of federal law, which is impliedly preempted under Buckman.  Putting it together, if plaintiff re-pleads her surviving failure to train claim under the CPLA, gets past another motion to dismiss, and heads to discovery, she will have to adduce proof about the manufacturer’s training program, her (presumably named, by then) physician’s (non-)participation in it, that he physician misplaced the device because of some alleged non-compliance with FDA requirements on the training program, and that such misplacement caused her to develop a rash, for which she hopes to recover damages for a prescription device that was not defectively designed and was not lacking adequate warnings.  We are positive that will be a hard road to travel.

 

We love to read opinions that reach conclusions in a direct and precise manner (more so when we agree with the conclusion).  There is a certain skill in using simple language to convey complex ideas.  In this blogger’s opinion, nobody does it better than Hemingway.  That’s not really going out on a limb; using a Pulitzer Prize and Nobel Prize winning journalist and novelist as the benchmark.  Writing simply isn’t about dumbing things down.  You can’t accuse Hemingway of that.  It’s about making writing accessible and easy to read.  For instance, a statistician who analyzed authors’ writing styles found that Hemingway used less –ly adverbs per 10,000 words than any other writer other than Toni Morrison.  Not bad company to be in.

This praise for simplicity came after reading the decision in Noel v. Bayer Corp., 2020 WL 5038782 (D. Mont. Aug. 26, 2020).  It’s not Hemingway – by any stretch.  But it is simple and straightforward and so we will strive to make our report the same.

The case involves the birth control device Essure, which is a Pre-Market Approved product.  Plaintiff brought eleven causes of action ranging from failure to warn to negligent risk management.  Id. at *1.   The court took them in turn.

Design Defect:  It is “nearly impossible for a design-defect claim to survive pre-emption because such a claim would challenge the FDA-approved design.”  Id. at *3.  Therefore, “[a] claim that Essure’s design is deficient seeks to invalidate the FDA’s approval of the device and is inherently pre-empted.”  Id.  Brevity is the soul of wit.  William Shakespeare.

Manufacturing Defect:  Because plaintiff alleges defendant’s manufacturing of the device did not conform to FDA requirements, the claim is not preempted – doesn’t create a state requirement that is different than or in addition to a federal requirement.  But, plaintiff failed to allege facts establishing causation.  Id. Plaintiff is given a chance to re-plead this claim.  Id. at *10.

Failure to Warn — Traditional:  This claim is preempted because there is

no FDA requirement for [manufacturers] to report consumer complaints directly to healthcare providers and consumers or to update its warnings and labeling as [manufacturers] learn[] of issues with the device.

Id. at *4.  A state cannot make obligatory an FDA requirement that is voluntary.  Id.  Less is more.  Ludwig Mies van der Rohe

Failure to Warn – Failure to Report:  Federal law does require device manufacturers to report adverse events to the FDA.  “However, Montana law provides no such parallel duty.”  Id.  Plaintiff tried to draw an analogy to cases extending a manufacturer’s duty to warn to all foreseeable users (bat manufacturer’s duty to warn extended to other players, not just batter) or to all healthcare providers responsible for a patient’s care, not just the prescriber.  Id.  However, “[a] government regulator is not a foreseeable user or consumer of a product.”  Id.  Simplicity is the ultimate sophistication.  Leonardo da Vinci

Misrepresentation-based claims: “When a claim challenges marketing that complied with FDA-approved requirements” it is preempted “because success on those claims requires a showing that the FDA requirements themselves were deficient.”  Id. at *5.  Therefore, to survive preemption, statements and express warranties “must have gone beyond the statements the FDA approved.”  Id.  The court compared plaintiff’s allegations of misstatements and found them “functionally equivalent to FDA-approved language.”  Id. at *6.  For example, saying implanting the device was “quick and easy” is functionally equivalent to the FDA-approved language that the device is a “simple procedure that can be done in 10 minutes.”  Plaintiff’s last alleged misrepresentation is that the device is “the best alternative.”  “This is clearly an opinion and cannot be the basis for a misrepresentation claim.”  Id.  Make everything as simple as possible, but not simpler. Albert Einstein

Negligent Training:  There are FDA-training guidelines which plaintiff alleges defendant failed to adhere to.  Because Montana has adopted Restatement (Second) of Torts §324A recognizing a duty to exercise due care in rendering a service to another, “Montana law provides a parallel claim for the negligent training [plaintiff] alleges.”  Id. at *7.  But, plaintiff did not allege any facts demonstrating that defendant’s training differed from the FDA guidelines or how that deviation was a cause of her injuries.  Therefore, while the claim is not preempted, it is dismissed with leave to amend.  The same reasoning applied to plaintiff’s claims for negligent entrustment and training for hysteroscopic equipment.  This is equipment that is independent of but necessary to the implantation of the Essure device.

Negligent Distribution:  Plaintiff alleged defendant required physicians to purchase to kits per month.  But, a purchase minimum would only pose a danger if “the device itself was defective, which would require a showing the FDA requirements themselves were deficient.”  Id. at *9.  So that claim is preempted.  Our life is frittered away by detail. . .  Simplify, simplify.  Henry David Thoreau

Negligent Risk Management:  Plaintiff alleged defendant was required to have a risk management plan in place to deal with consumer complaints.  But, since Montana law doesn’t recognize a failure to report claim, this claim is preempted.  Id.

 Unfair Trade Practices:  This claim was premised on warranties and deceptive advertisements.  Since it is “founded on expressly or impliedly pre-empted claims,” it too was dismissed.  Id.

And we’ll leave it there because simplicity is the glory of expression.  Walt Whitman

Ponder the following:  A man attends an exercise class at a facility run by a local religious institution.  Assume that he belonged to this facility, wanted to attend an exercise class because his fitness was less than optimal, and was informed of the need to get medical advice before starting a new and potentially demanding exercise program.  He had a heart attack and collapsed right after leaving the class.  Assume that the heart attack was not a total surprise given his health, but that he had not had a heart attack before and had not informed the people running the class of any particular risk.  The class instructor rushed to the man’s aid while others called 911.  The instructor was certified in cardiopulmonary resuscitation (“CPR”) and did her best to help the man.  When paramedics arrived, they assumed care of the man, but he died despite their best efforts.

Based on these facts and assumptions, answer this question:

Who should the man’s estate sue over his death?

A) Nobody.  B) The class instructor.  C) The religious institution.  D) The entities that operate the 911/EMT system.

If you answered other than “A,” then you might need to examine your propensity to blame others.

Add in the following to the scenario presented above:  The class instructor tending to the man did not utilize an automated external defibrillator (“AED”) that she knew was present and was certified in using.  She brought the AED to the man’s side, but elected not to use it because, in her judgment, he was having a seizure and not a heart attack.

Based on these additional facts, answer these questions:

1.  Who should the man’s estate sue over his death?

A) Nobody.  B) The class instructor.  C) The religious institution.  D) The entities that operate the 911/EMT system.  E) The company that sold the AED and offered training to purchasers.

2.  If the man’s estate already sued the religious institution over his death, who should the defendant bring in via third-party complaint?

A)  Nobody.  B)  The class instructor.  C) The entities that operate the 911/EMT system.  D) The company that sold the AED and offered training to purchasers.

In Wallis v. Brainerd Baptist Church, No. E2015-01827-SC-R11-CV, 2016 Tenn. LEXIS 920 (Tenn. Dec. 22, 2016), the estate sued the church that ran the gym and then both turned their attention to the seller of the medical device that was not used.  It is often said that bad cases make bad law, but sometimes egregiously over-reaching cases can make good law.  Ultimately, Wallis fits into the latter category.  A contrary result, which would have allowed a negligence or contract claim against the seller of a device that was not used with the decedent, would have been bad, maybe bad enough to have been mentioned in our bottom ten post last week.

Continue Reading Decision Limiting Duties regarding Automated External Defibrillators Does Not Shock The Conscience

Samples, samples, samples. We dare you to make it through your local supermarket or bulk supply store without finding at least one table set up asking you to sample the latest offerings from peanut butter to frozen breakfast sandwiches; from hummus to pre-made meatballs; and don’t forget the cheese. And it’s usually more than one. By the time you’re done shopping you can have eaten an entire meal – from salsa to cheesecake. Shopping alone, this doesn’t really present much of an obstacle. Shopping with children, however, and it adds a whole new dimension. Children want to try every sample. In sample size, children love almost everything they taste. So, you then get to listen to “please, please, please” for ten aisles. “I loved it.” “I promise I’ll eat every last frozen pierogi you buy.” In occasional moments of weakness, you say yes. To nobody’s surprise, however, you’re throwing away a nearly full bag of pierogis that you found wedge in the back corner of your freezer 10 months later. Because, what tasted so good in a sample size, simply didn’t have enough flavor to desire an entrée-sized portion.

That’s sort of how we feel about today’s decision, overall it tosses out most of plaintiffs’ claims – we like those samples. But, the decision is long and when you get down to digesting all of it – some of it is a bit hard to swallow.

The case is McLaughlin v. Bayer Corp, 2016 U.S. Dist. LEXIS 37516 (EDPA Mar. 22, 2016). It’s actually five cases with identical complaints all alleging injury from plaintiffs’ use of Bayer’s contraceptive device, Essure. The device is a Class III, PMA device, so Riegel express preemption and Buckman implied preemption are both viable defenses and both were raised by the defendant in response to each of plaintiffs’ twelve claims. That’s part of the problem. Plaintiffs raised novel claims to try to avoid preemption. In fact, none of the specific theories that were allowed to survive preemption have ever actually been recognized by Pennsylvania. So, we’re sure you’re expecting an Erie discussion – but Erie isn’t even mentioned in the decision. Fortunately, TwIqbal was also successfully used by the defense, so plaintiffs really do have to go back to the drawing board on their claims. We hope that after the claims are both stripped down and beefed up, the court will see it left some really indigestible morsels on the table. We’ll take the claims in the order the court did.

Continue Reading A Federal Pennsylvania Decision That We Like in Small Bites

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

We’re doing our duty.  We don’t have to like it.  The subject of today’s post is distasteful, but necessary.  Here is our annual compilation of the ten worst court decisions of the year (2014) that occurred in prescription drugs and medical device products liability litigation.  These are decisions that left us shaking our heads at the colossal injustice of what all-to-often passes for civil justice in this sometimes crazy country of ours.  Occasionally, the barbarians are a lot closer than at the gates.  If this is memory lane, there may be something to be said for amnesia. But take heart, next week for we’ll be in a more festive mood with our favorites.

So, now for a few words from the Grinch:

1. Wyeth, Inc. v. Weeks, ___ So.3d___, 2014 WL 4055813 (Ala. Aug. 15, 2014).  So how does the same case make the bottom ten (also 2013 #-5) two years running?  By issuing a lousy opinion on a critical issue, then reconsidering (because – amazingly – the first opinion was issued without oral argument) and then doubling down on the same, ill-considered position.  In Weeks Alabama became the only state high court to recognize innovator liability (which we also call “Conte”), meaning that where the innovator didn’t even sell the product, received no economic benefit from the generic prescription the plaintiff took, and indeed may well have been driven out of the market by generic competition, it’s still liable if the generic labeling (and thus its own) is “defective.”  Being liable for purported defects in a competing product means, of course, that the costs of such liability can only be recouped by charging ones own customers more for other, non-defective products, but there are more plaintiff lawyers than innovator drug companies in Alabama.  This sort of liability, being open-ended and completely uninsurable, is the most thoroughly destructive, and irresponsible theory we’ve encountered since we started this blog, and that’s saying a lot.  Alabama getaway indeed.  For all these reasons Weeks richly deserves its designation as our #1 worst case of the year.  We (the non-Dechert side) chastised the decision here, but that was only a reprise of our original 2013 critique, here – all of which remains valid.

2. Lance v. Wyeth, 85 A.3d 434 (Pa. 2014).  Poor Wyeth, having the two worst decisions of 2014 inflicted on it.  The year wasn’t very old when Pennsylvania Supreme Court decided that it didn’t need strict liability to impose essentially the same thing under negligence.  After taking close to three years to decide this fen-phen case, the theory the court settled on was a real stinker.  Would you believe negligent design – with no alternative design requirement?  In so doing it all but adopted Restatement Third §6(c) in a prescription drug case, which is also unique for a state high court. We don’t know of any other decision, in Pennsylvania or elsewhere in the country, that does away with the alternative design requirement in a negligence case.  To add insult to injury, the court had the chutzpah to claim that this unique, novel result was really just an extant, but utterly unrecognized, part of negligence “duty” all along.  What really happened was the creation out of whole cloth of “negligence” liability that amounts to a failure to recall claim – that the product was “too harmful to be used by anyone,” and thus should not be marketed, notwithstanding FDA approval. Maybe the theory is limited to already-withdrawn products (footnote 33 suggests that it might), but maybe not. If not, we think that, eventually, the theory will fall to Bartlett (2013 #+1) preemption (Bartlett was decided just before Lance was decided and was not briefed to the court), for prescription medical products (but not others).  All this is bad enough, but there’s also disruptive dicta in Lance questioning (musing about, is more like it) the “underpinnings” of the learned intermediary rule.  So we’ll be dealing with that, too, for the foreseeable future.  Under the rubric “if this is negligence, who needs strict liability,” we (the non-Dechert side) lacerated Lance here.

3. In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 4364832 (W.D. La. Sept. 2, 2014).  Much could be said about this 100+ page opinion, and we said some of it here).  We slot this particular Actos decision as our #3 worst decision of 2014.  For some reason (perhaps embarrassment) the opinion fails to mention in its 52 Westlaw pages or 285 footnotes that the runaway verdict it was upholding was for $9 billion.  At trial, the plaintiff was allowed to try a blatantly preempted fraud on the FDA claim under another name.  That’s not hard to show, since the opinion states no fewer than 37 times (yes, we counted) that the defendant supposedly “concealed,” “misinformed,” “obfuscated,” “withheld,” or other-similar-verbed information from the FDA.  Neither the court nor the plaintiffs are the least bit subtle in their fraud on the FDA rhetoric, so we’re hopeful for an appellate reversal, but in the interim, this outlier verdict will waste everyone’s time and money.  That’s the opposite of what an MDL was supposed to do.

4. Mississippi ex rel. Hood v. AU Optronics Corp., ___ U.S. ___, 134 S. Ct. 736 (U.S. 2014). In this case the United States Supreme Court held that a state attorney general action (really brought by contingent fee counsel proceeding in an AG’s name), ostensibly on behalf of all the citizens of a state, did not qualify as a “mass action” under the Class Action Fairness Act (“CAFA”) so as to allow removal to federal court.  So state AG actions remain in state court where, combined with the usual “home cooking,” they can generate monstrous verdicts – practically all of which have so far been overturned (more on that next week).  Hood is it not ranked higher because, frankly, we always thought this CAFA argument was a very long shot (the Court unanimously rejected it). Since the defense position was already a distinct minority view, Hood didn’t change the legal landscape much.  Hood would have been a great victory had it gone the other way, but this result basically continued the status quo.  It’s the Supreme Court, so it belongs on the list, but we found other decisions to be worse.  We alerted readers to the adverse result here.

5. Hardin v. PDX, Inc., 173 Cal. Rptr.3d 397 (Cal. App. 2014).  Hardin has to take the cake for the weirdest liability theory held to state a claim by an appellate court in 2014.  It’s a generic drug case (no surprise there), so the plaintiff has a serious preemption problem.  When all else fails, use Restatement §324A “Good Samaritan” liability to punish somebody for doing something intended to be helpful.  Here, that somebody, or rather those somebodies, had prepared a monograph about the drug that was distributed by the plaintiff’s pharmacist.  Plaintiff did not sue the pharmacist, since California law holds that pharmacists don’t have a duty to warn about prescriptions that they properly fill.  Plaintiff sued the publisher of the monograph.  That didn’t work because of the First Amendment, which is enforced in California by an anti-SLAPP (“strategic lawsuit against public participation”) statute.  Plaintiff was as undaunted as the appellate court was credulous of new liability theories. A software manufacturer, whose program allegedly truncated the monograph’s original 8-paragraph text to 5 paragraphs, was also sued, and the court allowed that claim to proceed – despite two layers of intermediaries closer to any purported failure to warn (pharmacist and publisher) both having no duty to the plaintiff as a matter of law. This unfortunate defendant did not make the product, did not write the monograph, and never had any contact with the plaintiff.  As we said in our post criticizing Hardin, it was like holding (in pre-electronic times) a maker of white out liable for someone else’s deletion.  Another loose nut slides to the coast.

6. Payne v. Novartis Pharmaceutical Corp., 767 F.3d 526 (6th Cir. 2014).  The name says it all.  The Sixth Circuit reversed the “strong” application of warning causation principles that had made the district court opinion in Payne a #17 honorable mention last year.  The problem with this Aredia/Zometa case was the same as with most such cases – no evidence that there was any choice but to prescribe this drug, which was effective against cancer, under the circumstances (plaintiff had bone-metastasized cancer).  Yes, this drug could cause osteonecrosis, a nasty but not fatal condition, but the prescriber was trying to save the plaintiff’s life.  So, the prescribing oncologist testified that he would have prescribed no matter what, but now he gives warnings that patients should have a dental exam because of the osteonecrosis risk.  With benefit of hindsight, plaintiff was willing to testify that she would have taken her chances with cancer, and not used the drug at all, had she known about the lesser condition.  While admitting that the plaintiff’s testimony was “speculative,” the appellate court found it sufficient, drawing from malpractice and informed consent cases where the physician-patient relationship was implicated. We were pained with that result here.

7. Scott v. C.R. Bard, Inc., ___ Cal. Rptr.3d ___, 2014 WL 6475366 (Cal. App. Nov. 19, 2014). This is a dangerous case for two reasons.  First, it used “Good Samaritan” liability (a California favorite) to hold a medical device manufacturer liable for negligently undertaking to train surgeons in the use of its device.  Training doctors is a good thing, but if liability can be predicated on allegedly doing it “negligently,” companies will be less likely to do it at all, since they have no training duty (except where imposed by the FDA).  Second, it allowed subsequent remedial measures – FDA regulatory actions post-dating the plaintiff’s surgery – into evidence.  While an old, loopy California decision from the glory days of strict liability (Ault, decided in 1974) still allows such evidence for “policy” reasons, this wasn’t a strict liability case.  Strict liability is not recognized in California for design defect claims against prescription medical products.  Thus, the jury learned that the product was later removed from the market.  Harmless? No way; the court was California dreaming.  We (the non-RS side, that is) discussed that Thanksgiving turkey here.

8. Messick v. Novartis Pharmaceutical Corp., 747 F.3d 1193 (9th Cir. 2014).  This is one ugly Daubert decision, reversing a favorable district court ruling.  Sure, “fit” requires relevancy, but the “relevancy bar is low.”  How low?  How about a causation expert who wouldn’t even come out with an opinion that the drug caused the injury?  That’s poor. Daubert is supposed to exclude ipse dixit, but Messick allowed in what passed for “differential diagnosis” because the expert “repeatedly referred to his own extensive clinical experience as the basis for his differential diagnosis.”  And so the ipse dixit spider was allowed to weave its web in Messick.  Sole cause is cast into the dustbin of medico-legal history.  A supposedly scientific opinion can be based on “substantial factor” causation.  Association thereby morphed into causation.  We castigated Messick here.

9. In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 355995 (W.D. La. Jan. 30, 2014).  This terrible decision imposed discovery sanctions based on conduct that occurred many years before Actos litigation – about bladder cancer – ever existed.  Given that timing, whatever the defendant did with respect to this MDL couldn’t be worse than negligence, since nobody plausibly intends to impede unknown future litigation.  About the only good thing that could be said about this opinion is “Never again.” Fed. R. Civ. P. 37(e) is being amended to prevent this result in two ways:  (1) sanctions must be predicated on “intent” to interfere with “the litigation,” and (2) negligence (Zubulake) is no longer sufficient for sanctions. We discussed this Actos decision (and other issues relating to litigation holds) here.

10. Hornbeck v. Medtronic, Inc., 2014 WL 2510817 (N.D. Ill. June 2, 2014).  We’ve settled on Hornbeck as the worst InFuse case of the year.  There was competition, particularly from Coleman, an appellate case in California, but for sheer all-around awfulness, Hornbeck takes the cake.  Despite the status of InFuse as a pre-market approved device entitled to preemption under Riegel (2008 #+1), Hornbeck refused to preempt anything (even Coleman, bad as it was, preempted a majority of the plaintiff’s claims).  That wasn’t even Hornbeck’s most egregious failure.  The utter lack of support for its rulings was.  Hornbeck is a monument to “I don’t care what the law is, I don’t like preemption, and that’s that.”  As readers of this blog know, there are literally dozens of InFuse preemption cases on our device preemption scorecardHornbeck cites precisely none of them – not a single InFuse opinion − even those that might support aspects of its outcome.  The opinion interprets Bausch as allowing plaintiffs to call anything a “violation.”  Hornbeck also gets Illinois law 180° wrong on FDCA-based negligence per se (the Illinois Supreme Court actually rejects it), and even allows component by component analysis, effectively denying physicians any discretion to use components separately.  Some opinions simply don’t get it, and Hornbeck is one of those.  We didn’t “get” Hornbeck either, and didn’t write a post about it, except for including it in our scorecard.

We’re also sure that Bristol-Myers Squibb Co. v. Superior Court, 2014 WL 3747250 (Cal. App. July 30, 2014), would have made our bottom ten list, had a further appeal not been accepted by the California Supreme Court, thus wiping that personal jurisdiction atrocity (discussed here) from the books.  Other near misses were the OTC drug case Maya v. Johnson & Johnson, 97 A.3d 1203 (Pa. Super. 2014) (discussed here), and In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2014 WL 1632149 (S.D. Ill. Apr. 24, 2014) (discussed here), which would import “parallel claims” into generic drug preemption based on impossibility.

You can come out now, we’re done.  If you lost one of these monstrosities, you have our condolences.  If you haven’t – there, but for the grace of God….

We’re glad this is over, too.  Next week you (and we) get the fun stuff:  our thumbs up list of  the ten best drug/device decisions of 2014.

If anyone is still shocked that medical device manufacturers’ sales representatives are present during surgery – don’t be.  It’s a common practice.  If you don’t believe us, see our posts here and here.  Surgeons believe manufacturers’ representatives have an important role to play in making sure the surgical instruments and the surgical team are fully prepared.  That means that reps are in the OR to stay.

With that comes the very real possibility of sales representatives being sued by plaintiffs who believe something went wrong during surgery or the possibility of manufacturers being sued for the alleged acts/omissions of their representatives during surgery.  Our earlier posts cover both situations and today we’ve stumbled upon another example of the latter — McCartney v. U.S., No. 2:13-CV-1118 TS, slip op. (D. Utah Jul. 16, 2014). Plaintiff underwent multiple surgeries involving implantation of defendant’s spinal cord stimulator.  One or more of defendant’s representatives was present during plaintiff’s surgeries. McCartney, slip op. at 1-2.  During one of the procedures, one of these reps called the plaintiff’s wife to ask about the location of the plaintiff’s pain.  Plaintiff’s wife didn’t know which leg was afflicted.  Id. at 2.

Plaintiff brought two negligence claims against the manufacturer based on its representatives being present during his surgery.  The first claim is premised on an alleged general duty of care owed by manufacturers to ensure that their devices are properly implanted.  Id. at 4.  In support, plaintiff alleged that the manufacturer’s representatives “instructed” his surgeon as to how to implant the stimulator (an act) and failed to ensure that the device was properly implanted (an omission). Id. at 6.  The difference between an act and an omission was critical to the court’s decision on whether there was a duty.  “Acts of misfeasance typically carry a duty of care while nonfeasance generally implicates a duty only in cases of special legal relationships.”  Id.

Continue Reading No Duty for Sales Representatives in the Operating Room

We are sometime not sure what to make of pharmacy monographs.  You know what we mean.  Those sheets that pharmacists print out and give us with our prescriptions.  They are not drug labeling, and they are not medication guides.  They are summaries intended for patient perusal, with information taken from the labeling, but digested in a fashion intended for the lay reader.  Notably, the FDA has not asserted any prerogative to review and approve pharmacy monographs, leaving publishers essentially self-regulated under an FDA action plan.

From time to time, we are surprised when a plaintiff produces a pharmacy monograph in discovery, one that he or she received from the pharmacy and has saved.  (We have not seen the data, but we expect that people who save pharmacy monographs are the same people who have their utility bills from the mid 1990s and who know where the instructions and warranties are for all their household appliances.)  But even when this happens, we are unsure how the monographs help us.  The parties we represent – drug manufacturers – do not publish these things, and they generally don’t have any duty to warn patients anyway.
In a way, pharmacy monographs are more useful to the other side because they give plaintiffs someone else to sue – the monograph publishers.  We have commented on this before (here and here) and noted that lawsuits against publishers have met with virtually no success, and for good reason.  Publishers do not make prescription drugs; they do not sell or dispense prescription drugs; and they have no relationship or contact with the plaintiffs.  That is to say, they owe plaintiffs no duty of care, which is and should be enough to stop litigation.

Continue Reading Pharmacy Monographs and an Illusory Duty of Care

Today’s post contains our annual list of those court decisions concerning prescription drugs and medical devices that are so bad and ugly that they leave us talking to ourselves – or even to the furniture.  With the thirteenth year of the millennium drawing to a close, these opinions demonstrate that – yes, indeed – thirteen can be an unlucky number.  You’ll have to wait until next week for the good, because our custom is to start with the judicial Razzies and end the year with our list of judicial Oscars.  Here are the jurisprudential dross of 2013.

1. Kaiser Foundation Health Plan, Inc. v. Pfizer, Inc., 712 F.3d 21 (1st Cir. 2013), Aetna, Inc. v. Pfizer, Inc., 712 F.3d 51 (1st Cir. 2013), and Harden Manufacturing Corp. v. Pfizer, Inc., 712 F.3d 60 (1st Cir. 2013).  It was close, but due to the amount of money involved and the Supreme Court’s recent decision denying certiorari, this Neurontin Trilogy stands as the buzzard on this year’s pile of. . . .  As last year’s Bartlett decision demonstrated, the First Circuit has recently been an extreme outlier on a variety of matters having to do with pharmaceutical liability.  Nowhere has that status been more pronounced than with aggregation of economic loss claims.  Unlike just about any other jurisdiction, the Neurontin Trilogy allowed causation in these third-party payer actions to be determined on an aggregated and probabilistic fashion – according to the opinion of a statistical “expert” whose work otherwise has been almost universally excluded, both in our pharmaceutical sandbox and elsewhere.  Over $140 million in purported damages was affirmed despite every prescriber who actually testified swearing that the defendant’s conduct had no influence on his/her prescriptions.  This trilogy effectively declared an irrebuttable heeding presumption, at least in RICO cases.  That’s not all.  Another of the Trilogy (Harden) vacated and remanded a decision denying certification of a nationwide class of various TPP claims, 712 F.3d at 70, thus raising the specter of even more massive litigation of a sort not permitted by any other federal Court of Appeals.  With certiorari now denied, the most we can hope for is that the Trilogy’s fraud on the market rationale might fall with a favorable decision on that theory in the Halliburton securities case.  We explained the outlier nature of the Neurontin Trilogy here.

2. Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc).  2013 was not a happy new year very long.  The year was but ten days old when the Ninth Circuit issued this awful decision that, if allowed to stand, robs two Supreme Court opinions of much of their substantive effect.  (Full disclosure, RS was one of the defense counsel in Stengel).  The first of those is Riegel.  If a state’s general tort law on adequacy of warnings, or post-sale duty to warn, is sufficiently close as to constitute a “parallel” violation claim, then “parallel” has lost its meaning, and the Riegel dictum about parallel claims has swallowed Riegel’s holding whole. The second is Buckman.  If a claimed state-law warning or fraud claim alleging failure to notify a third person (such as the FDA) is sufficient to get around the unanimous holding in Buckman that fraud on the FDA claims are preempted, then none of the policy reasons that supported the result in Buckman matter anymore. Because the Ninth Circuit’s decision is incompatible with two Supreme Court decisions and two different forms of preemption, it comes in at #2 on our list.  There’s still hope, though, as the Supreme Court has asked the Solicitor General for his views of the certiorari petition in Stengel.  However, as the Old Perfessor once said, it’s a bad idea to make predictions, especially about the future.  We expressed our dislike for Stengel here.

3. Howard v. Zimmer, Inc., 299 P.3d 463 (Okla. 2013).  Howard is the ugliest FDCA-based negligence per se decision that we’ve seen out of any state supreme court in many a year.  The court has effectively allowed litigants to federalize Oklahoma tort law through the guise of negligence per se based on violations of essentially any federal statute or regulation.  With respect to the FDCA, Howard flies in the face of congressional intent by allowing what is really private enforcement of the statute despite 21 U.S.C. §337(a).  Most states, including Oklahoma until Howard, as a matter of inter-branch comity, decline to apply negligence per se to statutes (state or federal) where the legislature has not evinced an intent to allow private enforcement, and §337(a) is an emphatic expression of precisely that intent with respect to the FDCA.  Howard is an example of the common-law being modified by improper, extraneous factors, since the express purpose of this expansion of negligence per se is to get around the preemptive effect of Riegel. 299 P.3d at 470.  We lambasted Howard here.

4. In re Reglan/Metoclopramide Litigation, ___ A.3d ___, 2013 WL 3874905 (Pa. Super. July 29, 2013) (reconsideration pending), Hassett v. Dafoe, 74 A.3d 202 (Pa. Super. 2013), and In re Reglan/Metoclopramide Litigation, 74 A.3d 221 (Pa. Super. 2013). Another trilogy, and this year’s equivalent of the First Circuit’s Bartlett decision in terms of downright refusal to follow binding Supreme Court precedent.  Pennsylvania is saddled with a very pro-plaintiff Superior (intermediate appellate) Court, and in the Reglan Trilogy, that court  ignored what even it called a “tsunami” of contrary precedent to hold practically all (except for pre-2007 warning claims) the generic drug-related claims before it were not preempted.  Uniquely, the Trilogy allowed post-FDAAA claims to escape preemption, without bothering to identify what in those amendments could possibly make a difference.  Uniquely the Trilogy (or at least one of the cases) held that claims against a generic “reference listed drug” holder could escape preemption.  Uniquely, the Trilogy took allegations of absolute liability seriously.  Uniquely, the Trilogy let design defect claims slide after Bartlett – including a gratuitous footnote about innovator drugs.  Unlike the Supreme Court, the Trilogy applied a “presumption against preemption” in generic drug cases.  The Trilogy also makes a general hash of preemption law, thoroughly jumbling express and implied preemption cases and concepts together.  A dissenting judge aptly pointed out that the Trilogy is almost entirely lacking in legal reasoning and violates the mandate that lower courts “must adhere to extant Supreme Court jurisprudence.”  We vented our spleen at the Reglan Trilogy here.

5. Wyeth, Inc. v. Weeks, 2013 WL 135753 (Ala. Jan. 11, 2013), reconsideration granted, No. 1101397 (Ala. June. 13, 2013), even though the Alabama Supreme Court thankfully agreed to reconsider the case, Weeks was such a terrible ruling – the only state high court to recognize innovator drug liability (which we also call “Conte”) where the innovator didn’t even sell the product that the plaintiff used − that we give it our #5 spot even after the reconsideration.  But for the reconsideration, Weeks almost certainly achieved opprobrium as our #1 worst case of the year.  Product liability is just that, liability for products, and imposing liability on other people’s products turns upside down all the reasons why product liability was created in the first place.  Prior to reconsideration, we let Weeks have it here.

6. Medtronic, Inc. v. Malander, 996 N.E.2d 412 (Ind. App. 2013).  This is another example of courts distorting tort law to get around preemption.  “Good Samaritan” liability under Restatement Second §324A is one of those “last refuge of a scoundrel” theories of liability, and here it was applied to impose liability for the alleged statements of a “clinical specialist” and telephone “hot line” that the defendant voluntarily supplied to answer surgeon questions about an implantable PMA device.  No good deed went unpunished in a case where everything else was preempted.  Section 324A is supposed to be reserved for actions (like poorly performed first aid) that actually make risks worse, but that didn’t stop the court in Malander from misapplying it to a situation where risks allegedly were not revealed, rather than aggravated, and where the surgeon is necessarily the “captain” of the surgical “ship.”  We maligned Malander here.

7. Arters v. Sandoz Inc., 921 F. Supp.2d 813 (S.D. Ohio 2013).  An ugly decision from beginning to end, ignoring TwIqbal (literally, the opinion cites to Conley v. Gibson, 355 U.S. 41 (1957), which Twombly expressly “retired”), applying a presumption against preemption where it doesn’t belong, endorsing the “stop selling” argument later rejected in Bartlett, ignoring a state-law alternative design requirement, and improperly expanding state law in a diversity case by finding a heretofore elusive tort “duty” not to engage in off-label promotion.  We went through the spherical error in Arters here.

8. Neeley v. Wolters Kluwer Health, Inc., 2013 WL 3929059 (E.D. Mo. July 29, 2013).  We really don’t like it when federal courts make up new state-law causes of action.  It’s bad enough when they do it to their own states, so it’s even less justified when they do it to other states.  Then again, the other state might just ignore the loopy out-of-state prediction.  In Neeley a federal court in Missouri predicted that Kentucky would adopt publisher liability – a set of theories every state confronted with it has in fact rejected, as we pointed out hereNeeley then proceeded to mess up generic preemption as well, leaving design defect claims standing because they were based on “consumer expectations.” So what?  You can’t change the design without FDA approval, and the only way a defendant can be responsible for a physician’s “expectations” about the designs of a PMA medical devices is through the information supplied about it. For getting these two “big picture” issues wrong, Neeley lands on our bottom ten.

9. Ramirez v. Medtronic Inc., ___ F. Supp.2d ___, 2013 WL 4446913 (D. Ariz. Aug. 21, 2013). This is the ugliest off-label use case of the year.  Burdened by Stengel, the court viewed off-label promotion allegations as pretty much throwing Riegel preemption out the window – ruling that such promotion created a new “intended use” that the FDA didn’t regulate at all.  That’s totally at odds with how the FDA’s regulations actually treat warnings about risks of off-label use, but there you have it.  On top of that, Ramirez disagreed with the Second Circuit’s treatment of off-label use and off-label promotion in Caronia (2012 top ten #7).  We (or should we say the non-RS side, since RS represented the defendant) tried to avoid gagging when discussing Ramirez here.

10. McLane v. Ethicon Endo-Surgery, Inc., 2013 WL 5556147 (Mag. M.D. Fla. Oct. 8, 2013), terrible discovery result concerning “substantially equivalent” predicate devices.  McLane is our latest poster-child for why the Fed. R. Civ. P. 26 needs to be amended to eliminate its much abused “reasonably calculated to lead to admissible evidence” phrasing.  In McLane the court ordered discovery under that standard of not only other adverse events involving the actual device in question (cleared for marketing and labeling under §510k) but also about adverse events involving the device’s “substantially equivalent” predicate device – a device that in many cases could either no longer be on the market or else could be a product marketed by a totally uninvolved third party.  We carped about the fishing expedition allowed in McLane here.

So there they are. Hopefully none of these not-just-wrong-but-loud-wrong losses were yours – if so, we sympathize, since we know how it feels.  We considered several other candidates – coming closest to making the cut was Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013), but failure to update claims just aren’t likely to be all that widespread in the future.

Now we can stop holding our noses and do something that’s more fun.  Next week we’ll be listing our top ten best drug/device decisions of 2013.

We were perusing the recent GAO report on electronic drug labeling in our spare time (we’re weird like that).  We found a number of interesting points − such as what the FDA apparently told the GAO about its position on off-label promotion (“[a]ccording to FDA, if a drug manufacturer promotes a drug for off-label uses, such promotion may constitute evidence to support a violation of the [FDCA]”) (emphasis added).  But the most interesting aspect of the GAO study for some of us was its description of the non-labeling information available to purchasers of prescription drugs, mostly through pharmacies:

Patients can receive written drug information provided along with their prescription drugs in the form of CMI [“consumer medication information”].  Unlike prescribing information, Medication Guides, and [patient package inserts], CMI is not approved by FDA, and drug manufacturers do not produce this type of drug labeling.  Instead, it is produced by third parties and distributed to patients at the pharmacy when their drugs are dispensed.  CMI can include information from the prescribing information and can also include additional information not contained in FDA-approved labeling, such as off-label uses of certain drugs. According to officials from third parties that produce CMI, they also use other sources, such as peer-reviewed literature, to develop the information for their CMI.  FDA has not asserted the authority to require third parties to submit CMI for review by the agency before CMI is distributed,
according to agency officials.

GAO Report at 7.

This discussion started us thinking again about the novel – and we would add, reprehensible – assertion of product liability claims against some of the “third parties” mentioned in the GAO’s reports.  We discussed our overwhelmingly negative reaction to so-called “publisher liability” claims back in 2011.  Then, we pointed out that this sort of claim is almost always asserted by plaintiffs for ulterior motives (chiefly joining a non-diverse defendant to prevent removal to federal court), and that no state in the country has affirmatively permitted such a claim. Continue Reading Revisiting Publisher (Non)Liability