[Drug and Device Law] You Say Durata, We Say Riata . . . Let's Call the Whole Thing Off
This is from the non-Reed Smith side of the blog only.
The George and Ira Gershwin classic, first introduced to the world through the talented voices and feet – on roller skates no less -- of Fred Astaire and Ginger Rogers. While the difference between pronouncing it to-may-to versus to-mah-to (or if you’re Larry the Cable Guy in Pixar’s Cars – tow-mater) doesn’t seem like enough to call off a marriage – the difference between Riata and Durata defibrillator leads should have been enough to end the case of Teixeria v. St. Jude Medical S.C., Inc., 2015 U.S. Dist. LEXIS 25657 (W.D.N.Y. Mar. 3, 2015).
Plaintiff was implanted with a cardiac defibrillator but one of the wires (or leads) had to be replaced only 14 days after implantation. Id. at *3. The lead at issue is a Durata lead. The Durata lead is a later version of the Riata lead in which the insulation material was changed. Id. at *4. Plaintiff alleges that the insulation on Durata wires/leads erodes, exposing the wire and causing it to malfunction. Id. at *8. Plaintiff appears to base this theory of defect on allegations almost exclusively focused on a different lead – the Riata lead – which has a different insulating material. Po-tay-to/Po-tah-to. So the defendant moved to strike all of the unrelated allegations – which would have essentially stripped the complaint of the facts needed to sustain a claim:
St. Jude is simply requesting the Court to not accept as true, or to strike, these made up allegations that St. Jude violated non-existent PMA requirements related to the manufacture of Riata leads--which allegations Plaintiff has copied from another case to challenge the Durata lead at issue in this case. St. Jude asserts that the Riata and Durata leads for the defibrillator are different products approved separately by the FDA and containing different materials. St. Jude asserts further that "there is no evidentiary basis for Plaintiff's allegation that his Durata lead suffered from the alleged product defect. Plaintiff neither includes nor attaches any medical report, device inspection or testimony from a physician or other expert. Plaintiff has no evidentiary support that his Durata lead suffered a Riata-like externalization lead failure.
Id. at *36-37. The case from which plaintiff allegedly copied his allegations is Pinsonneault v. St. Jude Medical, Inc., 2014 WL 2879754 (D. Minn. June 24, 2014) – a great win for defendants that we posted about here in which plaintiff couldn’t prove his manufacturing allegations against the Riata lead. Begging the question – if plaintiff’s allegations had no evidentiary support to sustain a claim against Riata, how can those same allegations sustain a claim about Durata. Ee-ther/Igh-ther?
Rather than relying on Pinsonneault or that plaintiff’s case was based on allegations about a different product, the court here seems to be more focused on the fact that the case is still at the pleadings stage. So, the court concludes that plaintiff should be afforded an opportunity to conduct some discovery to determine if his contention that the Durata lead is simply “a modification of an existing product with a history of defects” is true. Teixeria at *41. Isn’t it equally plausible that the “modification” eliminated the defects allegedly present in the other device? Should this type of "maybe" allegation be enough to subject the defendant to the millions of dollars in discovery costs? Allegations about a defect in another product – regardless of whether in the same family or made by the same manufacturer – shouldn’t be enough to sustain a claim even at the pleadings stage.
The court did caution plaintiff that in light of the Pinsonneault decision he was on notice of the evidentiary obstacles in his way. But only suggested that if discovery in this case proves the same thing it proved in that case – that there were no case specific federal regulations violated – and that plaintiff doesn’t at “some later time” withdraw those assertions, he may have to compensate defendant. There seem to be some teeth missing from this pronouncement, but we’ll take what we can given the denial of the motion to strike.
Turning to defendant’s motion to dismiss based on preemption, plaintiff brought six causes of action: negligent and strict liability manufacturing; negligent and strict liability failure to warn; negligent misrepresentation to plaintiff, his doctor and the FDA; and breach of warranty. Id. at *9-10. Since the leads are Class III, PMA approved devices – they are subject to the rigors of both Riegel and Buckman preemption. Which means, to survive, plaintiff’s claims need to fit through the narrow gap left after the court applies both types of preemption. This has proven to be an uphill battle for most plaintiffs – not an insurmountable obstacle, but very difficult.
Where PMA preemption is a hands-down winner is on failure to warn. This case is no different. The court explains the differences between the duty under New York law to warn end users and the duty under the FDCA to warn the FDA and finds the two significantly different so as to not be parallel. Id. at *21-25. So plaintiff’s bread-and-butter claim is gone.
The difference between state law and FDA regulations also sunk plaintiff’s negligent misrepresentation claim. Under New York law, such a claim requires privity. Id. at *25. First, plaintiff didn’t plead privity. Id. at *26 (“the word privity does not appear at all in the claim”). Second, what plaintiff did plead was that defendant had a requirement to provide information to the FDA as part of the PMA process. Id. Smells like Buckman preemption to us. While the court didn’t go in that direction, it did find those allegations weren’t sufficient to establish privity because there is “nothing in the PMA process or other FDA regulations require[ing defendant] to have a direct relationship with specific potential patients before those patients make a final decision to acquire a defibrillator.” Id. at *27. No privity requirement under the FDCA, no claim that parallels New York law.
But now the opinion takes a downhill turn. On manufacturing defect, the court found that to the extent plaintiff’s claims were based only on alleged violations of federal regulations, they survived preemption. Id. at *16-21. Sounds like the court was trying to allow a parallel violation claim, but as we’ve explained in the past, the FDA’s Good Manufacturing Practices (GMPs) are not the type of device specific regulations on which a parallel claim can be based. GMPs “contain systems-oriented requirements for quality control and compliance” and provide “guidance” to manufacturers. Id. at *6. Because the GMP regulations were designed to be flexible and are intentionally vague, they cannot serve as the basis for a parallel claim.
That aside, we think the court missed an important fact about the alleged GMP violations – the inspection and warning referenced occurred in 2012 and 2013 – well after the plaintiff’s device was implanted and hence well after it was manufactured. Id. at *6-7. We don’t see any allegations that the alleged manufacturing violations were occurring at the time the device at issue was manufactured. Granted we are only privy to the allegations cited in the complaint, but we find the absence of that particular allegation quite troubling if the 2012 violations are the basis for plaintiff’s claim escaping preemption.
Unfortunately, the court applied its reasoning on design defect to breach of implied warranty as well:
So long as an eventual jury in this case receives instructions that only a deviation from FDA standards can equate to a lack of fitness for intended purposes, a finding of liability and an award of damages would not add anything to [defendant’s] federal responsibilities.
Id. at *34. On breach of express warranty, the court split the claim into two parts. Allegations that pertained to the content of the device’s packaging and labeling were preempted – like failure to warn claims. Id at *35. But to the extent the breach of express warranty claim was based on allegations that defendant’s sales representatives made “direct, personal representations to [plaintiff] and his physicians,” those representations were “voluntary” and outside the scope of any federal regulatory scheme. Id. Debatable. Certainly plaintiffs have had no problem in the past arguing that what a sales representative says to a doctor is regulated by the FDA. It appears however that the complaint lacked any specificity about those direct representations. That type of deficiency we would hope would require at least an amended complaint – but that wasn’t the case here.
While not a slam dunk on preemption, St. Jude has successfully litigated these types of manufacturing claims before. So while we quibble with the preemption decision, we are more disheartened that a case based extensively on allegations of defect in a different product was allowed to survive. We would have settled for dismissal with permission to amend so long as it was clear plaintiff needed to plead facts about the actual product at issue. Oh, Nee-ther/Nigh-ther – let’s call the whole thing off.
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Posted By Michelle Yeary to Drug and Device Law at 3/11/2015 03:12:00 PM --
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