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We’ve been watching for Armstrong v. Exceptional Child Center, Inc., ___ U.S. ___, 2015 WL 1419423 (U.S. Mar. 31, 2015), ever since we spotted an intriguing footnote mentioning the certiorari grant in Ouellette v. Mills, ___ F. Supp.3d ___, 2015 WL 751760 (D. Me. Feb. 23, 2015) (other aspects of Ouellette discussed here).  Ouellette noted:

The State also asserts that where the Plaintiffs have no private right of action under the FDCA, the Supremacy Clause does not create one.  This Court has already resolved that issue in favor of the Plaintiffs in light of Pharmaceutical Research and Manufacturers of America v. Concannon, 249 F.3d 66, 73-74 (1st Cir. 2001).   However, the Supreme Court has granted certiorari on a similar, potentially dispositive question.  See Armstrong v. Exceptional Child Ctr., Inc., 567 Fed. Appx. 496 (9th Cir. 2014), cert. granted, 83 U.S.L.W. 3077 (U.S. Oct. 2, 2014) (No. 14-15) (“Does the Supremacy Clause give Medicaid providers a private right of action to enforce § 1396a(a)(30)(A) against a state where Congress chose not to create enforceable rights under that statute?”). . . .

Id. at *3 n.5.

Any time courts mention private rights under the FDCA, we think back to Supreme Court’s implied preemption reasoning in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), specifically:

The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions: “[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 21 U.S.C. § 337(a).

Id. at 349 n.4, and:

In the present case, by contrast, we have clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government. 21 U.S.C. § 337(a).

Id. at 352 (distinguishing Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984)).Continue Reading Breaking News − Reinforcement For Buckman

Because we hail from San Francisco, we sometimes feel a certain hometown pride in the Ninth Circuit, whose San Francisco home is one of the most beautiful public buildings in the United States. Opened in 1905, the James R. Browning United States Courthouse underwent a spectacular renovation in the late 1990s and has survived two catastrophic earthquakes — the big one in 1906 and the one in 1989 that knocked down elevated highways and famously disrupted the World Series at now-decrepit Candlestick Park. We also frequently praise the Ninth Circuit here on the DDL blog for its sense of justice and learned contributions to drug and device law. But not today. The Ninth Circuit swung mightily and missed with McClellan v. I-Flow Corp., No. 11–35109, 2015 WL 294292 (9th Cir. Jan. 23, 2015), where the court allowed the plaintiff to proceed on a negligence per se theory based on alleged violations of the FDCA.  We have another name for claims like that—private enforcement of the FDCA, and the Supreme Court ruled that federal law impliedly preempts such claims more than ten years ago in Buckman.  In fact, this negligence per se scenario is where it seems most transparent that the plaintiff is purporting to enforce the FDCA and where Buckman should apply most strongly. Yet the Ninth Circuit somehow gave the plaintiff a green light.

How can this be?  The plaintiff underwent shoulder surgery and was prescribed continuous infusion of pain medicine through a pump, appropriately named the PainBuster.  Id. at *1.  After a second surgery, and further treatment with the infusion pump, the plaintiff experienced cartilage loss resulting in fusion of bones in her shoulder and severely restricted mobility.  Id.  Her lawsuit against the pump’s manufacturer went to trial on strict liability and negligent failure-to-warn claims, and the jury returned a defense verdict.  Id.

Continue Reading Ninth Circuit Swings and Misses with Buckman Preemption

We’ve always been of the opinion that the rationale for preemption in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), concerning:  (1) the FDA’s exclusive enforcement power, and (2) the adverse effects that common-law second-guessing of the sufficiency of submissions to the FDA would have on the Agency’s ability to do its job, should have impact well beyond cases labeled “fraud on the FDA.”  In particular, we’ve pointed out “embedded” fraud on the FDA claims of various sorts, including where plaintiffs seek to introduce fraud on the FDA evidence to support some other sort of claim and were stopped cold by preemption.

Here’s another one, In re Incretin Mimetics Products Liability Litigation, 2014 WL 4987877 (S.D. Cal. Oct. 6, 2014).  Incretin involved an MDL discovery dispute – plaintiffs sought “to compel production of adverse event source documents and databases” relating to the product in question.  Id. at *1.  Their excuse for being entitled to rummage through all of the defendant’s adverse event reporting was “all of the source documents underlying the adverse event reports are necessary to determine whether Defendants misreported or under-reported information to the FDA.”  Id.Continue Reading Buckman Preempts Adverse Event Fishing Expedition

            Don’t roll your eyes at us the way a daughter does when her mother is about to tell a story about the mother’s college years for the sixth, seventh . . . OK 100th time.  Our regular readers are all well aware of our affinity for, involvement with (Bexis and Yeary) and therefore abiding

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Everything seemed to go right for the defense in Anderson v. Abbott Labs., 2012 U.S. Dist. LEXIS 141585 (N.D. Tex. Sept. 30, 2012).  The court applied Buckman preemption, it applied TwIqbal, it dismissed the case early, and it didn’t allow an amended complaint.  Everything was good in Texas.  It’s an easy decision to

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We’re rather tired of the other side, abetted by the flawed reasoning in Desiano v. Warner Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008), attempting to distinguish Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), into oblivion as relating to nothing more than a “separate, freestanding” claim for “fraud on the FDA.”  We’ve argued until we’re blue in the face that Buckman (which was unanimous, but with a concurrence) was so much more than that; specifically an implied preemption case with broad implications.  Most courts get it, but enough don’t that we thought we’d investigate a little further.  So we’ve asked ourselves the question, What has the Supreme Court itself had to say about Buckman in the decade-plus since it’s been decided?
We ran a quick search and found that the Supreme Court has cited its Buckman decision seven times.  We’ll look at the drug/device cases first.  In PLIVA v. Mensing, 131 S. Ct. 2567 (2011), the Court cited Buckman as a “cf.” (that’s an abbreviation of the Latin “confer” meaning to compare/consult) to the plaintiffs’ “take steps” argument (which the Court rejected) that the manufacturer should have asked the FDA for help.  Id. at 2578.  Did the Mensing majority limit Buckman to a freestanding count for fraud on the FDA?  Hardly.  Instead, it described Buckman just the way we do, as “holding that federal drug and medical device laws pre-empted a state tort-law claim based on failure to properly communicate with the FDA.”  Id.  That’s how Buckman should be read − that any state-law claims purporting to intrude on a defendant’s communications with the FDA are preempted.  The quality of a regulated entity’s communications with a federal agency is simply none of state law’s business.
That’s one.
Then there’s Wyeth v. Levine, 555 U.S. 555 (2009), the case we most love to hate.  Levine also discussed Buckman, albeit in dueling footnotes, this time in the context of the “presumption against preemption.” Id. at 565 n.3.  Buckman was not, the majority noted, apt precedent for rejecting that presumption entirely in implied preemption cases, because it “involved state-law fraud-on-the-agency claims, and the Court distinguished state regulation of health and safety as matters to which the presumption does apply.”  Id.  Even in this worst case (which is what Levine is) scenario, the discussion is confined to the scope of a presumption (which later couldn’t muster a majority in Mensing) rather than addressing preemption directly.  Levine certainly is not limited to anything about freestanding claims.Continue Reading What Is Buckman?

The scope of Mensing is one of the hotter issues in drug and device law these days. (The Bartlett appeal is one example.) To our defense-hack eyes, Mensing seems perfectly straightforward: a claim is preempted to the extent it alleges that the risks of a generic drug were not adequately disclosed. But the doctrinal landscape…

Does Buckman v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), apply any time that a plaintiff raises a fraud on the FDA allegation in litigation, or is it limited to causes of action denominated “fraud on the FDA?  Most courts have agreed with the Sixth Circuit that Buckman applies across the board.  See , 385 F.3d 961 (6th Cir. 2004).  A persistent minority, however, has limited Buckman to complete “fraud on the FDA” causes of action.  See Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006).  The Supreme Court attempted, but failed, to close the split in Desiano, but failed – splitting 4-4.  See Warner Lambert LLC v. Kent, 552 U.S. 440 (2008). Garcia v. Wyeth-Ayerst Laboratories
Both Garcia and Desiano involved the “fraud on the FDA” exception to a Michigan tort reform statute that imposes a presumption of adequacy on warnings that are FDA approved – that is, just about every warning.  The Michigan statute was essentially dispositive.
Then Texas passed a similar presumption statute that is almost as dispositive in the ordinary case as Michigan’s.  It was only a matter of time before the Fifth Circuit would be called upon to decide the same question as in Garcia/Desiano.
Also in the mix is the Supreme Court’s later, extremely anti-preemption, decision in Wyeth v. Levine, 555 U.S 555 (2008).Continue Reading Fifth Circuit Breaks Buckman Tie

We’re returning to the topic of implied Buckman preemption today to discuss three recent decisions, Hughes v. Boston Scientific Corp., ___ F.3d ___, 2011 WL 184554 (5th Cir. Jan. 21, 2011); LeFaivre v. KV Pharmaceutical Co., ___ F.3d ___, 2011 WL 148730 (8th Cir. Jan. 19, 2011); and Goldsmith v. Allergan, Inc., 2011 WL 147714 (C.D. Cal. Jan. 13, 2011).  But before we get to these cases, we have to reiterate some things that we said not too long ago in our Bashing Bausch post.  These have to do with the relationship between implied preemption under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), and express preemption under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Specifically, defendants need to keep in mind what implied Buckman preemption can and can’t do.
Specifically, as a matter of express preemption, Lohr created – under the rationale that remedies don’t matter – an exception for largely undefined state-law claims that are “identical” to FDA regulatory standards.  “Nothing in §360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements.”  518 U.S. at 495.  We have to live with that.  The Supreme Court was unanimous on the point.  Then there’s the Riegel dictum that MDA preemption “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements.”  552 U.S. at 330.
Keep that in mind.  Express preemption allows “parallel” state law duties “premised on a violation of FDA regulations.”  If such a claim exists, it may well fail for other reasons, but it won’t be expressly preempted.
Now we turn to implied preemption.  We know now – even if we don’t like it – after Wyeth v. Levine, 129 S. Ct. 1187 (2009), and Altria Group, Inc. v. Good, 555 U.S. 70 (2008), that with implied preemption, we have a presumption against preemption to deal with.  That is, where, under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), there isn’t.
When isn’t there a presumption?
There’s no presumption when we’re concerned with the dealings between the FDA and the manufacturer in question.  “[T]he relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.”  531 U.S. at 348.
Keep that in mind, too.
Finally, Buckman – as a matter of implied preemption – held that preemption (akin to lack of standing) applies to bar certain types of FDCA violation claims by virtue of 21 C.F.R. §337(a), the statute’s preclusion of private enforcement.Continue Reading Buckman Preemption – The Good, The Bad, And The Ugly – And (This Just In) The Funky

It’s Labor Day, the unofficial end to what has been a long, hot Summer. (Shakespeare wrote that “thy eternal summer shall not fade,” but this sweltering season has us saying, ‘please, please, fade away.’) We’re getting ready for the family BBQ and suspect that, as is often the case, the appetizers (salmon pinwheels, buffalo mozzarella) will outshine the more pedestrian main course.
The same thing happened in the case of Yocham v. Novartis Pharmaceuticals Corp., 2010 U.S. Dist. LEXIS 90005 (D. N.J. August 31, 2010). We like the minor rulings. But the main ruling on preemption makes us gag.
The plaintiff was a Texas resident who alleged that she developed Stevens-Johnson Syndrome from Lamisil. Her complaint asserted claims of negligence, strict liability, express and implied warranty, misrepresentation, unjust enrichment, and violations of the New Jersey Product Liability Act and the New Jersey Consumer Fraud Act.
Let’s start with the good bits. Plaintiff sought application of the law of New Jersey, where Defendant was located. Plaintiff lived in Texas, took the Lamisil in Texas, and sustained the injury in Texas. But Texas “does not permit design defect claims for prescription drugs with otherwise adequate warnings.” Yocham, 2010 U.S. Dist. LEXIS 90005 at * 13. So it’s no surprise that the Texas plaintiff shunned Texas law. Following the “most significant relationship” test, the Court didn’t have much difficulty choosing Texas law. Plaintiff put up a struggle, contending that the location of the injury was “fortuitous.” Id. at * 13-14. That’s sort of silly. It reminds us of people who misuse certain words, “fortuitous” often one of them. It’s almost as irritating as the misplaced “hopefully,” lodging “only” next to the wrong adjective or verb, or writing “alot” as one word.
One’s choice of residence is not “fortuitous.” The late, great comedian Bob Schimmel said it would be weird to show up at somebody’s house and claim it was “fortuitous” to find them there. The Restatement’s “example of fortuitous place of injury involves the purchase of an airline ticket to fly from one state to another part, which route happens to overfly a second state, that state has no relationship to the parties, and the only relationship to the occurrence is mere chance.” Id. at * 14. Bottom line: “It was not fortuitous that Plaintiff was injured in Texas, her state of residence.” Id.
We also like the way the Court dealt with the express warranty claim. The Court pushed the eject button because Plaintiff “has not adduced evidence of reliance.” Id. at * 39. Rather, Plaintiff “relied exclusively on the advice of her physician in deciding to use Lamisil.” Id. at * 40.
Now for the main course, which gave us indigestion. Under Texas law, there is a statutory defense to failure-to-warn claims aimed at FDA-approved warnings. The only exception to the defense requires a showing that the defendant misled the FDA. Is that exception preempted by federal law? Do you really need to ask?
In Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), the Supreme Court “held that a state cause of action for injuries caused by misrepresentations made to the FDA was impliedly preempted by the [FDCA].” Yocham, 2010 U.S. Dist. LEXIS 90005 at * 22. Since Buckman was decided, the battleground has been state statutes, like that in Texas, providing a defense that is called off only if there was fraud on the FDA. That battle has largely turned out to be a debate between the pro-preemption position set forth by the Sixth Circuit in Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004), and the anti-preemption position set forth by the Second Circuit in Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008). We’ve written at length on this debate before and before and before that, so we won’t repeat ourselves here (at least not too much). Let’s leave it at this: the Garcia line of cases (which, thankfully, seems to be winning) is a straightforward application of Buckman, while the Desiano line tortures logic and policy.Continue Reading Barbecued Buckman

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