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In a significant PMA preemption win, the Ninth Circuit rejected a plaintiff’s attempt, in a breast implant case, to base a “parallel” violation claim on nothing more than a res ipsa loquitur inference. Weber v. Allergan, Inc., ___ F.3d ___, 2019 WL 5090757 (9th Cir. Oct. 11, 2019).  Weber involved a Class III breast implant that allegedly suffered “gel bleed.”  The plaintiff tried to turn a factual statement in the product’s labeling – that in lab tests such bleed was under 1% − into a guarantee that none of the defendant’s products would ever bleed more than that.  Id. at *2.  That argument failed, as an attempt to convert an “aspirational” statement about what testing had shown into a mandatory guarantee was “different from” the FDA’s requirements for the device:

To the extent [plaintiff] interprets the implant label’s statement “as a guarantee of performance, she seeks to impose a more demanding standard than that of the FDA, rather than a parallel one.”

Id. at *5.  Weber quoted and followed Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012), a case we discussed here, which had rejected a very similar argument about whether a description of test results concerning dosage variability could be read as a guarantee that the device would never vary by a greater amount.

“To the extent that [the plaintiff] interprets the plus or minus 15 percent specification as a guarantee of performance, she seeks to impose a more demanding standard than that of the FDA, rather than a parallel one.”

Walker, 670 F.3d at 580 (as quoted in Weber, 2019 WL 5090757, at *4).

This holding in Weber disposed of plaintiff’s only attempt at a specific “parallel” claim.  Since, “for a state law claim regarding a Class III medical device to survive express preemption by the MDA, a plaintiff must establish that the defendant violated an FDA requirement,” id. at *3, the only argument plaintiff had left was that the “malfunction” of the device allowed the inference of some sort of defect.  Id. at *5.  This claim also failed.  While “res ipsa loquitur,” as Weber accurately described the gist of plaintiff’s argument, may allow the inference of a product defect in some non-preemption circumstances, it could not support any further inference that a violation of the FDCA was responsible for the malfunction.  “Res ipsa loquitur is not enough to survive MDA preemption.”  Id.

[T]o survive MDA preemption, a plaintiff cannot simply demonstrate a defect or a malfunction and rely on res ipsa loquitur to suggest only that the thing speaks for itself.  Instead, for a state law claim to survive express preemption under the MDA, a plaintiff must show that the defendant deviated from a particular pre-market approval or other FDA requirement applicable to the Class III medical device.

Id. at *4 (citations and quotation marks omitted).

Res ipsa doesn’t work because FDA approval is not a guarantee that each and every unit of each and every approved product will always function as intended.

[T]he FDA’s pre-market approval of the process by which a Class III device is manufactured does not guarantee that every device manufactured in that process will work.  Rather, the FDA performs a cost-benefit analysis and may approve devices knowing that they sometimes will fail.  When it enacted the MDA, Congress struck a balance . . . that the benefit to the many of bringing potentially lifesaving, but risky, medical devices to the public following the rigorous process of FDA approval outweighed the cost to the few of preempting common law claims based on different standards.

Id. (citations and quotation marks omitted).

The same was true of plaintiff’s attempt to base a claim on purported violation a general FDCA requirement “to put in place processes to test products for compliance with product specifications.”  Id.  Again, a regulatory violation simply cannot be inferred from a mere device malfunction.

Here, even if more general FDA requirements are sufficient, [plaintiff] has not shown a violation of the FDA’s Current Good Manufacturing Practices.  Again, the mere evidence suggesting that her particular [device] was defective does not show that [defendant] failed to comply with the FDA’s Current Good Manufacturing Practices.  Likewise, evidence that some other implants produced by [defendant] were defective does not demonstrate noncompliance.

Id. at *6 (citation omitted).

Weber thus adds to the overwhelming weight of precedent against allowing proof of “parallel” violation claims by means of a res ipsa-like inference in the absence of actual evidence.  See Walker, 670 F.3d 569, 580-81; Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011); Williams v. Bayer Corp., 541 S.W.3d 594, 612-13 (Mo. App. 2017); Reed v. St. Jude Medical, 2018 WL 4293146, at *4 (Mag. D. Minn. July 24, 2018), adopted, 2018 WL 4251872 (D. Minn. Sept. 6, 2018); McAfee v. Medtronic, Inc., 2015 WL 3617755, at *6 (N.D. Ind. June 4, 2015); Knoppel v. St. Jude Medical, Inc., 2013 WL 12116393, at *7 (C.D. Cal. Sept. 24, 2013); Smith v. St. Jude Medical Cardiac Rhythm Management Div., 2013 WL 1104427, at *4 (D. Md. March 13, 2013); Burgos v. Satiety, Inc., 2013 WL 801729, at *7 (E.D.N.Y. March 5, 2013); Kallal v. Ciba Vision Corp., 2013 WL 328985, at *3 (N.D. Ill. Jan. 28, 2013), aff’d, 779 F.3d 443 (7th Cir. 2015); Gross v. Stryker Corp., 858 F. Supp.2d 466, 483 (W.D. Pa. 2012); Ali v. Allergan USA, Inc., 2012 WL 3692396, at *11 (E.D. Va. Aug. 23, 2012); Cafferty v. Cayuga Medical Center, 2011 WL 541809, at *5 (N.D.N.Y. Feb. 8, 2011); Williams v. Cyberonics, Inc., 654 F. Supp.2d 301, 306 (E.D. Pa. 2009), aff’d, 388 F. Appx. 169 (3d Cir. 2010); Cenac v. Hubbell, 2010 WL 11537934, at *2 (E.D. La. April 16, 2010); Rankin v. Boston Scientific Corp., 2010 WL 672135, at *4 (E.D. Ky. Feb. 19, 2010); Banner v. Cyberonics, Inc., 2010 WL 455286, at *4 (D.N.J. Feb. 4, 2010); Clark v. Medtronic, Inc., 572 F. Supp.2d 1090, 1094 (D. Minn. 2008); Delfino v. Medtronic, Inc., 2018 WL 2688420, at *8 (Minn. Dist. May 18, 2018), aff’d, 2019 WL 2415049, at *10 (Minn. App. June 10, 2019); Golden v. Brown, 2017 WL 3272368, at *2 (Colo. Dist. June 27, 2017); contra, Sumpter v. Allergan, Inc., 2018 WL 4335519, at *2 (E.D. Mo. Sept. 11, 2018); Raab v. Smith & Nephew Inc., 150 F. Supp.3d 671, 694-95 (S.D.W. Va. 2015).