Photo of Rachel B. Weil

This post is from the non-Winston & Strawn side of the blog.

As we write today, we are nine days from an event, two years in the planning, that we have mentioned in these pages before.  We are taking the Drug and Device Law Dowager Countess (nearly 88) and her slightly younger sister to see Hugh Jackman and Sutton Foster in The Music Man on Broadway.  Jackman is the Dowager’s idol, and we fear we are reaching the end of such outings, so a tinge of pathos colors this much-anticipated excursion.  All that aside, The Music Man is a weird show.  It is about a con artist who sells innocent townspeople a bill of goods for something he never intends to deliver.  But love and morality (and the magic of musical theatre) triumph, and that which never was suddenly is.

No such magic resurrects plaintiff’s claims in today’s case.  Reddick v. Medtronic, Inc., 2022 WL 715494 (5th Cir. Mar. 9, 2022) an unreported decision out of the Fifth Circuit, is the affirmance of a trial court case that made both our PMI Preemption Scorecard and our Twiqbal cheat sheet.  In Reddick, the plaintiff was implanted with a total of five medical devices – a defibrillator and associated devices, all manufactured by the defendant – to treat his heart (not musical) rhythm disorder (which he was later found not to have at all).  Three of the devices were Class III devices, which meant that they underwent the FDA’s full premarket approval (PMA) process.  It also meant that common-law product liability claims related to those three devices were subject to Riegel’s express preemption analysis.  The other devices were Class I or Class II devices, cleared for marketing without the full PMA process (the class II devices were subject to the 510(k) clearance process), and, under Lohr, the MDA’s express preemption provisions did not apply to them.

The plaintiff filed suit in Louisiana state court, and the defendant removed the case to the Eastern District of Louisiana.  The plaintiff alleged that his devices began malfunctioning about four years after they were implanted and continued to malfunction until they were removed.  He asserted four claims under the Louisiana Products Liability Act (“LPLA)”—defective construction, defective design, failure to warn, and breach of express warranty.  He also alleged that the defendant had breached its contract with him.  The trial court dismissed the LPLA claims that targeted the Class III devices, holding that they were preempted under the MDA, and granted 12(b)(6) dismissals of the LPLA claims addressed to the Class I and II devices.  Separately, the court granted summary judgment on the contract issue, holding that there was no contract between the parties.  The plaintiff appealed, resulting in today’s decision.

LPLA Claims:  Class III Devices   

The plaintiff argued that his LPLA claims were not preempted as to the Class III devices.  As the court explained, Riegel requires a two-pronged analysis to determine whether claims are expressly preempted by the MDA:  first, the court must determine “whether the federal government has established requirements applicable to [the medical device].”  Reddick, 2022 WL 715494 at *2 (internal punctuation and citation omitted.)  Class III devices subject to PMA “automatically” satisfy the first prong.”  Id.  Second, the court evaluates whether the claims are “parallel” claims that escape preemption.  “A state law claim is ‘parallel’ if it provides a damages remedy premised on a violation of FDA regulations.”  Id. at *2 (internal punctuation and citations omitted).  The court emphasized that, even if a plaintiff has asserted a ‘parallel’ claim, a district court may dismiss the claim if it is “impermissibly conclusory and vague.”  Id. at *3 (citation omitted).

The court held that the plaintiff’s four LPLA claims, as addressed to the Class III devices, were not adequately-pled “parallel” claims because all were “impermissibly conclusory and vague.”  Id.  In his defective design and defective construction claims, the plaintiff alleged only that the devices were defective “upon information and belief,” without providing factual support.  While he alleged that some of the devices were subject to recalls, he did not plead that his particular devices were subject to the recalls or that the recalls were related to the particular adverse events he experienced.  He also cited evidence of a new recall and alleged that this recall supported his claims, but the court held that it could not consider evidence that was not before the district court when it made its decision.

The court held that the plaintiff similarly failed to provide sufficient factual support to save his failure-to-warn claim.  He alleged only the defendant dis not warn him “regarding [its] unreasonably dangerous and defective products,” but he did not identify any FDA-approved warnings or allege that the defendant departed from them.  Id. at *4.

Finally, the court agreed with the district court that the warranty claim was preempted.  Under the LPLA, a claim of breach of warranty must be pled with particularity.  While the plaintiff asserted that the defendant breached an oral “lifetime warranty” on the defibrillator and a separate warranty on one component, he did not “reproduce any specific warranty in his pleadings or specify its precise source, and he did not allege that he was induced to use [the] devices” by any warranties.  The court concluded, “. . . [W]e agree with the district court that all four of [the plaintiff’s] LPLA claims are too conclusory to state a parallel claim that avoids” express preemption.  Id.

 Thus, plaintiff was in big trouble – that starts with “T,” rhymes with “P,” and stands for “preempted” (h/t Bexis!).

 LPLA Claims:  Class I and II Devices

The court next turned to the district court’s 12(b)(6) TwIqbal dismissals of the plaintiffs LPLA claims addressed to the Class I and II devices.  The court explained that “[a] successful action under the LPLA requires four elements: (1) that the defendant is a manufacturer of the product; (2) that the claimant’s damage was proximately caused by a characteristic of the product; (3) that this characteristic made the product ‘unreasonably dangerous’; and (4) that the claimant’s damage arose from a reasonably anticipated use of the product by the claimant or someone else. Under the third element, a product may be ‘unreasonably dangerous’ under any one of LPLA’s four liability theories. Id. 

 As to the Class I and II devices, the plaintiff alleged only defective design.  But, under Louisiana law, a product is defectively designed only if “at the time the product left its manufacturer’s control, there existed an alternative design for the product that was capable of preventing the claimant’s damage, and the likelihood that the product’s design would cause the claimant’s damage and the gravity of that damage outweighed the burden on the manufacturer of adopting such alternative design and the adverse effect, if any, of such alternative design on the utility of the product.”  Id. (internal punctuation and citations omitted).  The plaintiff did not plead that there was a safer, feasible alternative design for any of the Class I and II devices at the time they left the defendant’s control.  There was a paragraph in the complaint headed “Facts and Alternative Design,” but that paragraph asserted that a more “conservative” external heart monitor should have been used instead of the implantable defibrillator.  As the court explained, that “concern[ed] the choice of treatment made by [the plaintiff’s] medical team, not a design decision by [the defendant].”  As such, the court held, the plaintiff had not pled the elements of his “defective design” claims, and the district court’s dismissal was proper.

Breach of Contract

Finally, the court turned to the plaintiff’s breach of contract claim.  The court agreed with the district court that the record contained no written agreement between the plaintiff and the defendant, and that the plaintiff was not a third-party beneficiary of the defendant’s contracts with the hospital where the implant procedure was performed.  Nor was there an oral agreement.  The plaintiff argued that an oral contract was formed when he read the defendant’s web site, which promised continuous service support for the devices.  Not so, according to the court:  formation of a contract under Louisiana law requires a “meeting of the minds,” and the plaintiff cited no evidence suggesting that the defendant intended to be bound by any agreement with the plaintiffs.  The court concluded, “That dooms [the plaintiff’s] claim.  With no contract, there was no breach.”  Id. at *5.

And there you have it.  No fanfare, no brass band – just a pointed and tidy affirmance of a correct decision.   We’ll talk to you soon and tell you all about the show.  In the meantime, stay safe out there.