[Drug and Device Law] PMA Medical Device Preemption Decision - Better Late Than Never
We recently learned of Thomas v. Alcon Laboratories, ___ F. Supp.3d ___, 2013 WL 10888983 (N.D. Ga. Jan. 29, 2013), dismissing a contact lens product liability complaint as preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). We’re not alone, it appears, since Westlaw has only recently chosen to publish this 2½-year-old decision. Why it took this long to surface is anyone’s guess. We took a look at the docket for Thomas on PACER, but didn’t see anything out of the ordinary. Plaintiff did not prosecute any appeal.
In any event, better late than never.
Thomas was booted out on a motion to dismiss despite considerable bobbing and weaving by the plaintiff. First, plaintiff tried to hide the ball, refusing to acknowledge the product’s status as pre-market approved. That prompted one of the bigger fights we’ve seen about the judicial noticeability of FDA public records, in which plaintiff went down in flames:
The Court is permitted to take judicial notice of documents made publicly available by a government entity. Accordingly, courts have taken judicial notice of documents from the FDA, a government entity, when ruling on a motion to dismiss. Plaintiff has not cited, and the Court’s independent research has not uncovered, any Eleventh Circuit precedent clearly foreclosing the consideration of the FDA’s documents. In the absence of any such authority, the Court concludes that it may consider the documents from the FDA as a matter of public record.
2013 WL 10888983, at *3 (numerous citations omitted). Thus, the need to review these FDA records to establish the device’s true status did not require converting the dismissal motion to one for summary judgment – and plaintiff could not prolong the inevitable with unnecessary discovery.
Plaintiff also sought discovery even as to the defendant’s motion to dismiss, which the court also rejected. Id. at *2 n.4 (noting that motions to dismiss “should . . . be resolved before discovery begins”).
In her other ploy, Plaintiff purported to abandon all claims in her complaint except those “based exclusively on violations of federal regulations and violations of express and implied warranties,” which she claimed were not preempted. Id. at *5. The warranty claims raised the usual plaintiff-side boilerplate – “that the subject product was safe and fit for use for its intended purposes.” Id. Such purported “warranties,” based entirely on product safety, were preempted. “Courts have consistently found that state law claims for breach of warranties based on the safety or effectiveness of the device, impose requirements that ‘are different from, or in addition to’ federal regulations, and thus are preempted.” Id.
Plaintiff’s supposed “parallel claims” faired no better. First, plaintiff was sloppy, citing statutory sections of the FDCA and regulations that “do not exist.” Id. at *6. Oops. Hard to be parallel to something that’s not there. As for enactments that actually might have applied, they were vague “quality system” regulations (“QSR”). Vague regulations subject to multiple interpretations couldn’t be “parallel.”
[R]egulations contained in the QSR portion of the Code, cannot serve as the basis for a parallel claim [because] each regulation cited is nothing more than a general statement. . . . [T]hese standards are intended to serve only as an umbrella quality system providing general objectives medical device manufacturers must seek to achieve. These regulations are purposefully broad so as to apply to a broad range of medical devices. The regulations are to be tailored by each manufacturer of a device to apply to their particular safety and efficacy needs. The intentionally vague and open-ended nature of the regulations relied upon is the precise reason why they cannot serve as the basis for a parallel claim. Since these regulations are open to a particular manufacturer’s interpretation, allowing them to serve as a basis for a claim would lead to differing safety requirements that might emanate from various lawsuits.
Id. at *6 (citation and quotation marks omitted) (emphasis original). Such differeing requirements “would necessarily result in the imposition of standards that are different from, or in addition to those imposed by the MDA − precisely the result that the MDA preemption provision seeks to prevent.” Id.
Predictably with such vague regulations, the complaint alleged neither how the defendant violated them, nor how any supposed violation affected this plaintiff. This failure also supported preemption:
Plaintiff’s general and conclusory allegations that Defendant “fail[ed] to follow applicable federal law, federal regulations, and good practices” are insufficient Plaintiff has failed to set forth facts pointing to specific PMA requirements that have been violated. . . . Plaintiff's claims, which simply incant the magic words Defendant violated FDA regulations, are therefore insufficient. Hence, Plaintiff's claims are dismissed as they are preempted under Riegel.
Id. at *7 (citations, footnote and quotation marks omitted).
Thus, we alert you to Thomas, which is added ammunition on (1) judicial notice, (2) vagueness, and (3) causation in PMA preemption cases asserting “parallel violation” claims.
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Posted By Bexis to Drug and Device Law at 8/17/2015 08:00:00 AM --
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