In honor of the Pennsylvania Supreme Court’s recent grant of an appeal on the Restatement (Second)/Restatement (Third) in Tincher v. Omega-Flex, we are republishing as a guest post a very good article (pre-Tincher, of course) that we recently read on this topic written by Dan Cummins of Foley Comerford & Cummins, who
Every now and then, an administrative law decision – usually involving the FDA – contains something that’s useful to our product liability defense practices. In that light we offer Cytori Therapeutics, Inc. v. FDA, ___ F.3d ___, 2013 WL 1164775 (D.C. Cir. March 22, 2013). The device in Cytori was a §510k “substantial equivalent” device (for extracting stem cells from
fat), except that the FDA held that it wasn’t. And that was the whole point of the decision, as the aggrieved manufacturer appealed the FDA’s not substantially equivalent (“NSE”) letter in the courts.
For a discussion of the administrative law impact of Cytori, we refer you to the FDA Law Blog. We’re only interested in the case because an NSE letter is essentially the FDA’s administrative decision that, in order to be marketed, a medical device is required to go through the PMA process rather than through §510k clearance. As we all know, the PMA process is preemptive (Riegel), whereas the §510k clearance process is not (Lohr).
Plaintiffs in product liability cases often argue that this or that piece of a PMA-approved device system was already/should be treated as a §510k device, and thus preemption should not be recognized. That’s where Cytori can come in handy. Why? Because the DC Circuit holds that deference is to be afforded to FDA decisions determining whether medical devices require either PMA or §510k clearance.Continue Reading Interesting FDA Administrative Law Holding
All multi-district litigation (“MDL”) practitioners are aware of (and many rue) the Supreme Court’s decision in Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998). That’s the decision interpreting the MDL statute, and which held that MDL judges lack jurisdiction to try themselves (through so-called “self-transfer”) cases that were transferred to them for pre-trial proceedings from other federal district courts. “Pre-trial” and “trial” meant just what the statute said, spoke the Court in Lexecon, and trials must occur after MDL cases are remanded to their original transferor districts.
Not that MDL courts haven’t tried to get around Lexecon. One way was through “Lexecon waivers,” by which the parties acquiesced in the MDL judge trying their cases, regardless of what the Supreme Court held that the statute required. We reviewed the pros and cons of that option here and here. The chief inherent drawback of a Lexecon waiver, as we saw it, was whether Lexecon involved a matter of jurisdiction, in which case the inability of the MDL court to try the action could not be waived. That would, of course, render the purported “waiver” useless – since whichever side lost the trial could then nullify that result essentially at will by asserting a subject matter jurisdictional defect. What little precedent exists on the point (we haven’t researched this thoroughly) suggests that waiver is possible, but that parties must proceed quite warily. See Armstrong v. LaSalle Bank National Ass’n, 552 F.3d 613, 619 (7th Cir. 2009) (Lexecon waiver possible but ineffective); In re Carbon Dioxide Industry Antitrust Litigation, 229 F.3d 1321, 1326-27 (11th Cir. 2000) (Lexecon waiver held valid); Solis v. Lincoln Electric Co., 2006 WL 266530, at *3–4 (N.D. Ohio Feb. 1, 2006) (finding Lexecon waivable).
Another possibility was suggested in our first Lexecon waiver post back in 2007:
Third, the Chief Justice [sic] could invoke 28 U.S.C. Section 292(d) to designate the MDL transferee judge as a judge of the home court. The MDL transferee judge could then preside over a trial in the home court.Continue Reading Lexecon Dodge Gets The Kozinski Kibosh
We like Riegel preemption because the oscillations of state tort juries should not supplant FDA regulation of medical devices. We like Twombly and Iqbal because plaintiffs should plead sensible facts before turning on the million dollar discovery machine. We do not much like the parallel claim exception to Riegel because its origin is muddy, its
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
This just in: Finally, the Pennsylvania Supreme Court has taken the Restatement Second/Restatement Third issue for products liability. Here’s the order. Here is the relevant language:
AND NOW, this 26th day of March 2013, the Petition for Allowance of Appeal is GRANTED, LIMITED TO the issue set forth below. . . .
The issue,
We’ve never been deferential to differential diagnosis – at least, not in litigation. There’s no need for a diagnostic tool when you’ve already got the diagnosis. And plaintiffs almost always come to litigation with a diagnosis. What’s generally at issue is causation, not the diagnosis. Yet, more and more, doctors serving as experts for plaintiffs
…and the claims are preempted to boot!
This just in: The Ninth Circuit has ruled that off-label use is not medical experimentation under a California statute, the Protection of Human Subjects in Medical Experimentation Act (“MEA”) (Cal. Health & Safety C. §24171). See Perez v. Nidek Corp., ___ F.3d ___, No. 10-555877, slip op.
Three days ago, the United States Supreme Court unanimously upheld the federally-backed regime in Cafastan against the latest insurgent assault in Standard Fire Insurance Company v. Knowles, ___ S. Ct. ___, 2013 WL 1104735 (U.S. March 19, 2013). The insurgents, in an attempt to avoid federal jurisdiction under CAFA, resorted to using the local populace (or at least, their purported absent class members’ claims) as a human shield. The insurgents’ ultimatum? Regardless of how much the would-be class’ claims might actually be worth, those claims will be decapitated, so that they cannot recover the minimum CAFA jurisdictional amount, which is $5 million.
The Supreme Court freed the hostages, holding, in accordance with Smith v. Bayer Corp., 131 S. Ct. 2368, 2380 (2011), that putative class representatives and their counsel were without power to bind the supposed class and decapitate their claims in this way:
The stipulation [plaintiff] proffered to the District Court, however, does not speak for those he purports to represent. That is because a plaintiff who files a proposed class action cannot legally bind members of the proposed class before the class is certified. Because his precertification stipulation does not bind anyone but himself, [plaintiff] has not reduced the value of the putative class members’ claims.
2013 WL 1104735, at *3-4 (citations omitted). Because jurisdiction – and thus, the jurisdictional amount – is determined “as of the time [the action] was filed in state court,” id. at *4, the Court held that the insurgents were subject to extraordinary rendition to Cafastan, where their own claims might be subject to decapitation by stipulation, but not those of absent class members:
[T]he stipulation at issue here can tie [plaintiff’s] hands, but it does not resolve the amount-in-controversy question in light of his inability to bind the rest of the class. For this reason, we believe the District Court, when following [CAFA] to aggregate the proposed class members’ claims, should have ignored that stipulation.
No, we didn’t attend the Bartlett oral argument, but the Supreme Court has become wonderfully efficient at providing argument transcripts. So we’ve read through the argument. Our strongest impression is, boy, is Bartlett a change from the “traditional” tort claims that the Supreme Court has previously considered in connection with FDCA preemption. See Wyeth