Snap Removal, and TwIqbal, and Preemption-Oh My

If you are of a certain age and are presented with a trio of items, we bet you sometimes add “Oh My” to the end of the list, as in Lions, and Tigers, and Bears-Oh My.  Or, you think of other things that come in threes, such as the past and the present and the future; faith and hope and charity; the heart and the brain and the body.  That’s because Three Is a Magic Number.  Three issues were certainly magical for the defendants in Higginbottom v. Dexcom, Inc., — F.Supp.3d –, 2024 WL 3823023 (S.D.Cal. Aug. 13, 2024).

The products at issue were a continuous glucose monitoring system and an insulin pump that are used together to monitor the blood sugar of and deliver insulin to people with diabetes.  Plaintiff alleges that her son’s glucose monitor reported an inaccurate high glucose level that led to his administering himself a corrective insulin bolus.  Shortly thereafter, the pump delivered another bolus causing plaintiff’s son to become hypoglycemic while driving and led to a fatal car accident.  The delivery of boluses in close proximity is known as insulin stacking.  Id. at *3.  Plaintiff brought claims against the manufacturers of both devices for design defect, manufacturing defect, failure to warn, and wrongful death.  Defendants removed the case to federal court.  Plaintiff moved to remand and defendants moved to dismiss.  All three motions were decided in defendants’ favor.

Snap Removal:  The pump manufacturer is a forum defendant who removed the case before it was served.  Plaintiff challenged the removal on several unsuccessful grounds.  First, she argued the notice of removal was docketed by the clerk a few hours after defendant was served with the complaint.  But the time of docketing does not control.  The time of filing does, and that took place an hour before defendant was served.  Id. at *4.  Second, plaintiff took a run at asking the court to reject snap removal.  While the Ninth Circuit has not yet decided the issue, the plain language of the statute coupled with decisions by four other circuits upholding snap removals persuaded the court here.  Id. at *5-6.  Third, plaintiff argued the removing defendant did not have the consent of its co-defendant to remove.  But consent was not needed because the co-defendant had not been served at the time of removal.  Id. at *7.  Next, plaintiff tried to secure a remand because defendant did not attach the complaint and other filings from state court to its notice of removal.  However, defendant is only required to attach those documents it has been served with, and even if some were missed that is a curable defect and not a sufficient basis for remand.  Id.

Having made all the standard remand arguments, plaintiff tried a novel argument—that the case should decline jurisdiction under the Colorado River abstention doctrine.  The Supreme Court, in Colorado River Water Conservation Dist. v. United States, 424 U.S. 800, 817 (1976), held that there may be circumstances where “conservation of judicial resources and comprehensive disposition of litigation” may justify staying or dismissing a federal proceeding pending resolution of concurrent state court proceedings.  However, such circumstances are “exceedingly rare.”  Higginbottom, at *8.  Plaintiff’s abstention request is based on 42 pending California state court cases against the manufacturer of the glucose monitor.  In other words, plaintiff asked the court to hold that a federal court cannot hear a case against a defendant if a different plaintiff has brought similar claims against that defendant in state court.  Concurrent state and federal litigation is more normal than not, including in mass torts.  In fact, many federal MDLs have order and procedures in place to coordinate with state court litigations.  So, plaintiff’s abstention request was a long shot at best.    

Utilizing a multi-factor test adopted by the Ninth Circuit, the court found on balance that remand was not appropriate.  There was no convenience issue as both the federal and state forums were located in San Diego.  The possibility of piecemeal litigation is not enough.  There must be a special concern “which can be remedied by staying or dismissing the federal proceeding.”  Id.  Duplicative cases are not “particularly problematic.”  While the state court cases were filed earlier, the underlying legal claims had not yet been ruled on, making order of filing more of a net neutral factor.  Id. at *9.  Similarly, California federal courts routinely apply California state law, so this factor did not weigh against federal jurisdiction.  Federal courts should not relinquish jurisdiction if the state court proceeding “cannot adequately protect the rights of the federal litigants.”  Id. But where both forums are adequate, this factor carries less weight.  Courts also consider forum shopping in deciding whether to abstain.  Here, snap removal could be considered forum shopping, and so this factor alone leaned in favor of remand.  But the final factor was probably the most significant in this case—whether the state court proceeding “sufficiently parallels” the federal proceeding. The pump manufacturer is not a defendant in any of the 42 pending state court cases, therefore, resolution of those cases “will not resolve the claims before this court.”  Nor is plaintiff a party of any of the state court cases.  Overlapping issues are not enough four a court to invoke Colorado River abstention.   

Having decided it was keeping the case, the court next turned to each defendant’s motion to dismiss.  For the pump manufacturer, TwIqbal won the day.  Defendant argued that it should be entitled to express preemption under Riegel, but there was some ambiguity regarding whether the device was PMA approved or whether parts were Class II.  So, court decided to kick that can down the road and focus instead on the insufficiency of the pleadings.  Plaintiff conceded she had not adequately pleaded a manufacturing defect.  On design defect under a negligence theory, plaintiff alleged that the pump manufacturer knew the glucose monitor could give inaccurate readings creating a risk of insulin stacking.  But that allegation is about the glucose monitor, not the pump.  The complaint lacked any supported allegations identifying a defect in the pump or how that defect was the result of the manufacturer’s negligence.  Id.  at *15.  As to strict liability design defect, California does not recognize such a claim for prescription medical devices.  On failure to warn, while plaintiff identified a risk—insulin stacking—she did not allege it was a risk that a “reasonably prudent manufacturer would have known and warned about.”  Id. at *16.  Moreover, plaintiff failed to allege anything about plaintiff’s son’s prescribing physician.  Notably, whether his physician would still have prescribed the pump if a different warning had been given.  Id.  Under the learned intermediary doctrine recognized by California, this is a necessary piece to establish causation.  Due to the deficiencies in pleading all three defect claims, all three were dismissed without prejudice. 

The manufacturer of the glucose monitor likewise moved to dismiss all claims as expressly preempted because the monitor was approved through the FDA’s De Novo classification process “with the establishment of special controls” by the FDA to “provide reasonable assurance of the safety and effectiveness of the device for its intended use.”  Id. at *18.  If this sounds familiar, it’s because this is the second de novo preemption win for this defendant in just under one month.  We blogged about the first win here, which sets out the same rationale used by the court in Higginbottom.  Essentially it is a recognition that the PMA process is not the only circumstance in which the FDA can establish device specific requirements that satisfy the first prong of Riegel.  Because the FDA imposed device-specific labeling requirements, plaintiff’s claim that defendant is liable for failing to provide different or additional warnings is expressly preempted.  Id. at *20.

Unfortunately, plaintiff is being given an opportunity to amend her complaint to try to assert a non-preempted claim.   But as you children of the 70s know, “it takes three legs to make a tripod or to make a table stand.”  This decision strips away a couple of legs and leaves the case with a wobbly future.