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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.