Tuesday, March 26, 2013

Life After Stengel . . . There’s Hope

            This year started off a little scary.  But that was winter – dark, cold, dreary.  With spring we look forward to brighter skies, warmer weather, blooming flowers – things that generally put is in a better mood (OK, so it snowed in New Jersey yesterday but we are choosing to think positively).  Things like a PMA preemption win in California federal court post the Ninth Circuit’s decision in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144 (9th Cir. Jan. 10, 2013).  You can read what we think about Stengel here.     And with that hanging out there, we were happy to learn about Simmons v. Boston Scientific Corp., No. 12-7962 PA (FFMx), slip op. (C.D. Cal. Mar. 25, 2013) (Simmons II).  So, a quick congratulations and thank you to Shook, Hardy & Bacon L.L.P’s  Mike Carroll for the win and for bringing it to our attention.
           
            The device at issue was a defibrillator that allegedly malfunctioned causing plaintiff injury.  There is no question that the device is a Class III PMA device.  So, there is also no question that plaintiff’s state law claims are preempted under Riegel v. Medtronic, Inc., 522 U.S. 312 (2008).   Slip op. at 3-4.  And, it is also not surprising that plaintiff tried to overcome Riegel preemption by alleging she was bringing parallel violation claims.  The Simmons court recognized that ordinarily, parallel violation allegations do not save failure to warn claims from preemption because they would “require a defendant to give warnings to patients or physicians different from or broader than those required by FDA regulations.”  Slip op. at 4.  But, being in the Ninth Circuit, the court also had to recognize Stengel’s newly created failure to warn the FDA cause of action.  Id.   But just because the court acknowledged the existence of the cause of action doesn’t mean plaintiff has a claim – she still had to plead it sufficiently.  Which she didn’t.

            And this was plaintiff’s third strike.  The court had already dismissed plaintiff’s second amended complaint back in January, but decided to give plaintiff another opportunity on a few of her claims – such as failure to warn the FDA – to allege a sufficient factual basis.  See Simmons v. Boston Scientific Corp., No. 12-7962 PA (FFMx), slip op. (C.D. Cal. Jan. 14, 2013) (Simmons I).  Despite some additional specificity about what the alleged defect was, plaintiff’s third amended complaint remained wholly deficient.  In fact, the court found that her failure to warn allegation was “identical to that contained in the [second amended complaint], which the Court determined was insufficient.”  Simmons II, slip op. at 5.  Three attempts and plaintiff alleged nothing more than bald assertions that defendant failed to report adverse events.  Id.  So, even if Stengel gave credence to the claim, with nothing to back it up, the court dismissed it.  Id.   While Twombly and Iqbal are highly important to all defendants, they are the greatest weapons we currently have to fight off Stengel claims in the Ninth Circuit (and Hughes claims in the Fifth Circuit).  So wins like this are significant and focus us on the need to be focused on the details – that’s where we win – in the facts, the specifics, the details.      

            The lack of specificity also sunk plaintiff’s manufacturing and design defect claims.  As to design defect, plaintiff’s third amended complaint again was simply a repeat, no new allegations.  The court dismissed it for the same reasons it did back in January: 
As to Plaintiffs’ claim that the device as designed violated the PMA specifications imposed by the FDA, Plaintiffs again fail to point to any precise PMA specifications allegedly violated by the design . . . .  Indeed, unless Plaintiffs altered the device in some way without approval from the FDA (a fact which plaintiffs do not allege in even a conclusory manner), this claim fails, as the design . . . was granted PMA by the FDA.

Simmons I, slip op. at 6-7.  Well, that wraps up design defect claims nicely.  As to manufacturing defects, plaintiff had previously relied on FDA’s Current Good Manufacturing Practices (“CGMPs”), but like other courts, the Simmons court found CGMPs “too generic” to overcome preemption.  Simmons I, slip op. at 4.  So this time around, plaintiff focused on alleged PMA violations.  The allegation was that the device violated its PMA because it “served no therapeutic benefit.”  Simmons II, slip op. at 4.  Not nearly enough:

Such an allegation is, without more, insufficient to overcome §360k preemption. . . . Plaintiffs must do more than baldly assert that the device violated federal standards.  Rather, Plaintiff must provide some allegations regarding the nature of the alleged . . . defect as it related to the FDA approval process.

Id. (citations and quotation marks omitted).  The Simmons complaint failed to state “what PMA specifications were imposed on the [device], let alone which specifications the [device] failed to satisfy.”  Id. at 5.   The only thing it did allege was information about recalls and FDA advisories regarding other defibrillator models – not the one implanted in plaintiff.  Id.  Easy to dismiss those allegations as irrelevant on that ground alone, but the court went on to find that even if they had involved the device at issue, plaintiff failed to link them to the alleged malfunction and “that product recalls do not create a presumption that FDA requirements have been violated.”  Id. at 5.

            Since this was plaintiff’s third attempt at stating her claims, the court also denied any further leave to amend as futile and dismissed all claims with prejudice.  As if that wasn’t reason enough to celebrate, the court awarded defendant its costs.  A banner day in California and a good way to shake off the winter blues.


No comments: