We do not care much about car racing.  Sure, we have seen some parts of some races on television, had toy racecars in our remote youth, and have craned our necks to see a few fancy “street legal” versions zooming past.  However, we have never attended a race in person and do not follow any driver or team.  When we heard a presentation last week from a Formula 1 executive, we paid it about as much attention as we pay most presentations in a room full of hundreds of lawyers.  We were not surprised by how much it costs to run a team, stage a race, or move a bunch of teams from race to race around the world.  We were mildly surprised by how teams manage a race from outside the car and serve as a laboratory for the creation of new technologies.  When we saw a video of the fastest pit stop in Formula 1 history, we uttered an expletive of praise.  Four tires were changed, adjustments were made, and other pit stop things were accomplished in 1.82 seconds from the car stopping to starting to move again.  We are sure that is less time than it takes to open the fuel door and remove the gas cap on our vehicle.  We are also sure that quite a bit of planning and practice went into shaving down the time required for that record pit stop.

Bear with us here, but we thought of this when comparing how things went for the defendants in the various pelvic mesh MDLs in the Southern District of West Virginia and how they have been going after remand to various federal district courts around the country.  We have commented a number of times about problems with the MDL system in general and in those MDLs in particular.  They were generally slow-moving, wasteful, plaintiff-leaning settlement machines.  By contrast, while not always fast moving, the remanded cases have received individual attention from judges who know the applicable state law, are not afraid to gut plaintiffs’ cases by tossing experts and claims, and are not trying to send messages across cases.  We have offered praise for a number of decisions in remand cases where the defendants won issues they were not winning in the MDL.  From our perspective, the individual focus is the big difference.  A specific remanded pelvic mesh case is just another case on the judge’s docket that needs a trial date and rulings on motions for summary judgment, to exclude experts, for reconsideration, etc.  The plaintiffs often have to deal with the impact of past decisions like which experts to name and which theories to push.  Their refusal to accept those impacts without a fight can lead to some surprising postures.

In Enborg v. Ethicon, Inc., No. 2:20-cv-02477-AWI-BAK, 2022 U.S. Dist. LEXIS 78720 (E.D. Cal. Apr. 29, 2022), the judge considered a motion to reconsider in connection with the exclusion of certain opinions from the plaintiff experts in a pelvic mesh remand case.  Rulings on motions to reconsider tend not to be blogworthy, but we think this one is.  We actually wrote previously about rulings in this case, including the rejection of the plaintiff’s argument that defense experts could not dispute the theory that polypropylene degrades in the human body because of the testimony of a corporate representative.  About a week earlier, the court had issued rulings on a few defense motions.  The ones we know about from the ruling on the motion to reconsider granted summary judgment on plaintiff’s warning claim for lack of proximate cause, excluded plaintiff’s FDA expert’s opinions that the device was misbranded according to the FDCA, excluded one of plaintiff’s urogynecology expert’s opinions about the absence of references in the device’s label to statements from an MSDS for the polypropylene resin, and excluded another of plaintiff’s urogynecology experts’ opinions on the impact of allegedly inadequate warnings on the implanting surgeon.  Id. at *2-3.  (We have posted on these issues many times before, like here and here; in the prior Enborg post, we predicted that plaintiff’s own FDA expert would inevitably open the door to the sort of FDA evidence that the MDL court had suggested should be excluded in remand cases.)

Intent on supporting her remaining “negligent design defect” claim—which can be pretty weak in cases like this where plaintiffs’ expert claim every synthetic midurethral sling is defective—plaintiff sought to reconsider the exclusion of the above-described warnings opinions.  This is where the arguments got surprising.  While there appeared to be several bases for excluding those opinions beyond that plaintiff’s warnings claim was gone, plaintiff argued that each opinion was relevant to a design defect claim under California law.  Id. at *3.  Typically, when it comes to design defect with a prescription medical product, it is defendant arguing that comment k (which California applies across the board to all prescription medical products) should apply and that adequate warnings should defeat a design defect claim.  (See here and here, among many prior posts.)  In our experience, plaintiffs prefer presenting on product or procedure risks without context of how those same risks apply to every other product.  Similarly, we are used to plaintiffs trying to talk about what is not in a label without ever showing what was actually in the label or answering the question of whether the missing information would ever be included in label.  Unexpected things can happen in remand cases, so plaintiff argued that an intermediate appellate case called Hansen v. Sunnyside Prods., Inc., 55 Cal. App. 4th 1497 (Cal. App. 1997), made “package warnings” relevant to determining every design defect claim under the applicable “risk/benefit test.”  (We are also used to plaintiffs arguing for the consumer expectation test—focused on the plaintiff’s now-jaded expectations—rather than the risk-utility test.)  Rather than argue that warnings never matter to the determination of design defect with a prescription medical product, the defendant argued that Hansen did not change the result.

Hansen was a somewhat unusual case where the plaintiff brought strict liability design defect and failure to warn claims against the manufacturer of a cleaning product for an injury to her finger (because there was a hole in the glove she wore to protect against injury from exposure to the cleaning product).  The trial court entered JNOV for plaintiff on liability and a new trial, centered for our purposes on defendant’s closing argument that the extensive warnings on the product were relevant to the jury’s inquiry on design defect.  (Having skimmed Hansen to get a little extra detail, we cannot resist saying that the trial court was clearly usurping the jury’s role as trier of fact and reverse engineering to a predetermined result.  That is the nice version.)  In reversing, the Court of Appeal issued a narrow ruling that California’s risk-utility test for design defect requires considering whether labeling in place at the time of the injury could “reduce the likelihood of [] harm if followed” in assessing whether the product’s design posed “excessive preventable danger.”  Enborg, 2022 U.S. Dist. LEXIS 78720, *7 (citing Hansen, 55 Cal. App. 4th at 1512, 1513, 1515 & 1519).  Plaintiff’s argument that this holding in Hansen should have allowed her to get in her experts’ criticisms of the device’s labeling seemed like trying to fit the proverbial square exhaust manifold into a round head gasket.

Enborg cut off the need for a deep dive with the conclusion that the case “does not involve use instructions.”  Id. at *7-8.  Each expert’s excluded warnings opinions concerned the failures to disclose alleged inherent risks of the device, rather than how to “reduce the ‘likelihood’ (or gravity) from using the [device].”  Id. at *8-9.  For once, there was a helpful MDL ruling on basically the same issue with the same device, albeit under Texas law.  Id. at *9 (citing In re Ethicon, Inc., No. 2:12-CV-4301, 2014 WL 457544, at *5 (S.D.W. Va. Feb. 3, 2014)).  That ruling rejected plaintiffs’ attempt to offer expert opinions on warnings in support of a design defect claim because they “serve[d] only to inform physicians of the risk of implanting the device” so they could decide whether to “implant[] the device or choose[] an alternative treatment.”  Id.  The proposed warnings opinions in Enborg had the same failing and the motion to reconsider was denied.

We think there is a simpler bright line test here, even if a simpler negligence equivalent to comment k does not apply to design defect claims for a prescription medical device (as we think it should):  What the label actually said about how to use or not use the product may be relevant to the risk-utility inquiry, but any proposals about what the label might have said about any subject are not.  For the cleaning product in Enborg, the label actually said things like “Use only with rubber gloves, avoid contact with skin” and what first aid steps to take in the event of contact with skin or eyes.  Those are clearly relevant to the extent of risk of using the product at the time the plaintiff actually used it because they were actually on the bottle in the plaintiff’s hands.  None of the nearly infinite combinations of what the label could, should, or might have said instead sheds light on that inquiry.  Opinions on what the label should have said—whether the same as or different than what it actually said—do not go to this inquiry.  Those opinions are for a failure to warn claim.  If the particular plaintiff cannot sustain that claim because of a failure of proximate cause, then she cannot backdoor her criticisms of the label as a way to pump up her design defect claim.