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Those of you following the fortunes of COVID-19-related litigation should check out these two recently decided cases:  Garcia v. Welltower OpCo Group LLC, 2021 WL 492581 (C.D. Cal. Feb. 10, 2021), and Fields v. Brown, 2021 WL 510620 (E.D. Tex. Feb. 11, 2021).

Garcia, the older of the two (by one day),…

Most of the controversy in the recent decision, Hill v. Bayer Corp., 2020 WL 5367334 (E.D. Mich. Sept. 8, 2020), revolved around whether the plaintiff could assert a cause of action for failure to report adverse product events to the FDA.  Like the great majority of decisions (particularly since Conklin v. Medtronic, Inc.,…

Recently, largely related to the dubious pleasure of home ownership, we have had multiple occasions on which we were forced to shrug our shoulders and proclaim, “Nothing’s perfect.”  To wit, we recently noticed a small wet spot on our bedroom ceiling.  The roofing company discovered that the corresponding section of the roof was too shallow…

We update our cheat sheet devoted to ediscovery for defendants differently than the others.  Because of the broad nature of the topic – these cases arise in a wide variety of non-drug/device contexts – other personal injury, employment, civil rights, occasionally even criminal litigation.  That means we have to research them separately to find what…

As we blogged at the time, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), when it equated routine product liability inadequate warning claims with indirect third-party warning claims where the third party is a governmental agency – that is, the FDA.  Validating such allegations could have much broader implications – on everything from statements made to insurance regulators to child abuse reporting requirements – but, even limited to the FDA, it creates precisely the same perverse incentive “to submit a deluge of information that the [FDA] neither wants nor needs” that supported preemption of other tort claims challenging the accuracy/completeness of FDA submissions in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 351 (2001). But the Supreme Court denied certiorari in Stengel, so life goes on.

To the extent that Stengel had any redeeming feature, it is found in the 7-judge concurrence (a majority opinion, really, since 11 judges were sitting for the en banc decision), which recognizes that causation is particularly problematic where a federal agency with preemptive power is a middle-man in state-law litigation:

Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist.  To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the prescribing] doctors in time to prevent [plaintiffs’] injuries. But at this juncture − a request for leave to amend their complaint – [plaintiffs’] allegations of causation are adequate.

Stengel, 704 F.3d at 1234-35 (concurring opinion). Stengel cited to the causation theory described in Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011):

[Plaintiff’s] primary causation theory is that if [defendant] had reported the true number of injuries and malfunctions related to [the risk] caused by the [device], this information would have appeared on the FDA’s MAUDE internet database [of adverse events reported about medical devices] and in medical journals, and with this information [the prescriber] would not have recommended the [device] to [plaintiff] for treatment.

Id. at 776.

Continue Reading Causation Issues in Failure-To-Report Cases – Post-Stengel Precedent

This post is not from the Dechert side of the blog.

The United States Supreme Court has said it – the test for implied preemption under 21 U.S.C. §337(a) (the FDCA’s no-private-enforcement provision) is whether the purported state-law cause of action would exist even in the absence of the FDCA/FDA: Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 353 (2001) (preemption applies to “claims exist solely by virtue of the FDCA disclosure requirements” and to all claims where “existence of these federal enactments is a critical element”).  So have federal courts of appeals.

If the claim would not exist in the absence of the FDCA, it is impliedly preempted. In other words the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law − and that would give rise to liability under state law even if the FDCA had never been enacted.

Loreto v. Procter & Gamble Co., 515 F. Appx. 576, 579 (6th Cir. 2013) (citations and quotation marks omitted). Accord Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1339 (10th Cir. 2015) (“§337(a) preempts any state tort claim that exists ‘solely by virtue’ of an FDCA violation”); Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013) (preempting a “fraud by omission claim [that] exists solely by virtue of the FDCA  requirements”) (citation and quotation marks omitted); Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 379 (5th Cir. 2012) (following Buckman; “tort claims are impermissible if they existing solely by virtue of the FDCA disclosure requirements”).Continue Reading Another Make Work Project In New Jersey – Duty To Update Claims

We often report on cases that are dismissed at the pleadings stage but in which plaintiff is afforded an opportunity to “fix” his or her complaint.  And almost as often, we refer to this as plaintiff getting a “second bite at the apple.”  Not overly creative, but it conveys the point nicely.  In the InFuse cases, for instance, the large majority of plaintiffs’ claims have been dismissed as preempted.  Typically, the claims that survive preemption are for fraud and misrepresentation and more often than not those have been dismissed for pleading deficiencies. Less often do we see blogworthy decisions on the result of plaintiff’s second bite. So we were surprised to happen upon two such decisions in the InFuse litigation issued just days apart.  Plaintiff’s second attempt in one case was more well received by the court, but even that decision has some positive notes for defendants.

To start, we’ve posted a lot about the great success defendants have had in the InFuse litigation defeating off-label promotion claims.  So, we aren’t going to reiterate all the details.  You can check out all our posts on the InFuse cases here, including our post on Martin v. Medtronic which is one of our follow-up cases today.

In Martin, the court dismissed all of plaintiff’s claims.  The preempted claims (fraud based on the labeling, failure to warn based on off-label promotion, design defect, negligent failure to warn based on labeling, negligent design/manufacture, and negligence based on off-label promotion) were dismissed with prejudice.  Plaintiff was given leave to amend her remaining claims: fraud based on misrepresentations in off-label promotion, failure to report adverse events to the FDA, and breach of express warranty.  Martin v. Medtronic, Inc., 2014 U.S. Dist. LEXIS 164980 at *8-9 (D. Ariz. Nov. 24, 2014).  She didn’t fare much better on the second go-round.  First, plaintiff re-pleaded all of her preempted claims and the court quickly dismissed them again.  Id. at *11-12.Continue Reading InFuse Update

It is the Friday of Memorial Day Weekend.  Barbecues are being fired up.  Beach towels are being scattered on sandy dunes.  Pools are opening (probably still a tad early for a dip in the Mid-Atlantic/Northeast states).   Fittingly, we came across two decisions this week that warrant mentioning but don’t require much heavy lifting.  Perfect blog-material for the unofficial start of summer celebration.

First, we want to report that the Eighth Circuit has affirmed summary judgment in defendant’s favor in another Pain Pump case – Mack v. Stryker, — F.3d –,  2014 WL 1876124 (9th Cir. May 12, 2014) (Minnesota law).  That court joins the Sixth Circuit (Rodriguez v. Stryker Corp., 680 F.3d 568 (6th Cir.2012)) in finding that the defendant manufacturer could not be liable as a matter of law because the alleged risk was not scientifically knowable at the time of plaintiff’s surgery.  Similar to Rodriguez, the Eighth Circuit reviewed 12 articles relied on by plaintiffs to establish that the risk was knowable.  The court (in a 2-1 decision) concluded that these articles proved nothing about the particular device at the time in question.  This state-of-the-art issue is critical in the Pain Pump litigation and this appellate decision certainly tightens the binds on plaintiffs who had earlier pain pump surgeries.

Before our detractors start yelling Krumpelbeck is the law of the Sixth Circuit, here is what the Eighth Circuit had to say about that:

A separate panel of the Sixth Circuit decided a similar case to Rodriguez less than three months later, and it reversed a district court’s decision to grant summary judgment to a pain pump manufacturer without acknowledging Rodriguez. See Krumpelbeck v. Breg, Inc., 491 F. App’x 713 (6th Cir.2012) (unpublished). Krumpelbeck and Rodriguez directly conflict. We decline to consider Krumpelbeck because it is not the law of this circuit and likely not the law of the Sixth Circuit due to Rodriguez’s prior publication. See Rutherford v. Columbia Gas, 575 F.3d 616, 619 (6th Cir.2009) (“A published prior panel decision remains controlling authority unless an inconsistent decision of the United States Supreme Court requires modification of the decision or this Court sitting en banc overrules the prior decision.” (quotation and citation omitted)). Additionally, we do not find it persuasive.

Mack, 2014 WL 1876124 at *10 n.6.  Neither do we.Continue Reading Two Quick Updates – Mesh and Pain Pump

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