The Defendant/Petitioner has filed its merits brief in the U.S. Supreme Court in BMS v. Superior Court.  This is the case where the California Supreme Court expanded specific personal jurisdiction beyond recognition by basing specific jurisdiction on a pharmaceutical company’s forum contacts involving different products and people other than the plaintiffs.  We wrote about the opinion and its problems here, here, and here, and the opinion came in at number one on our 2016 worst ten list.

As expected, the Petitioner pharmaceutical company has put forth compelling arguments that the California Supreme Court’s version of specific jurisdiction runs against binding precedent and is an all-around bad idea. The Petitioner is also joined by a number of amici, most notably the United States of America.  (You can view all the briefs on the SCOTUSblog here.)  If we have been critical of the Solicitor General in the past, we will voice no concern this time around.  The SG hit the nail on the head, and the United States’ brief reinforces the Petitioner’s very strong arguments—and adds another, which we will get to in a minute.

First, the briefs. The general thrust of both briefs is that the California Supreme Court’s “sliding scale” approach to specific jurisdiction impossibly contradicts binding precedent.  A court simply court cannot base specific jurisdiction on a defendant’s forum contacts involving other individuals and other products, no matter how intense those contacts are.

For the Petitioner, it comes down mainly to one concept—proximate causation. That is to say, for a claim to “arise from or relate to” a defendant’s forum contacts, the defendant’s activities in the state must be a proximate cause of the plaintiff’s lawsuit.  Take, for example, this opening salvo:

The [California Supreme Court] concluded that Bristol-Myers could be haled into California on respondents’ claims merely because Bristol-Myers sold Plavix to other persons and developed other products in the State.

            That is not how specific jurisdiction works.  Since International Shoe Co. v. Washington, 326 U.S. 310 (1945), this Court has made clear time and again that “specific or case-linked” jurisdiction requires a causal connection between the defendant’s forum conduct and the litigation. Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 919 (2011).  That bedrock requirement ensures that a common connection links the defendant, the forum, and the litigation; that States do not assert jurisdiction over matters occurring and directed entirely outside their borders; and that any litigation to which a defendant is subject is a direct and foreseeable consequence of its in-state activities.  Courts cannot dispense with this causation requirement because a defendant has wide-ranging contacts with a State.  Only general jurisdiction allows that, and then only where the defendant is at home.

Petitioner’s Br. at 2. This is (or at least should be) an uncontroversial description of specific jurisdiction, and the Petitioner draws from it that specific jurisdiction requires a “causal connection” between the defendant’s forum contacts and the plaintiff’s claims. Id. at 14.

Continue Reading Solicitor General Urges Supreme Court to Reverse California’s Ill-Conceived Version of “Specific Jurisdiction”

When we heard about Judge Neil Gorsuch being nominated for the United States Supreme Court, our first move was to enter his name in Westlaw along with the term “preemption.” That’s the constitutional doctrine most important to our medical device, generic drug, and (unfortunately to a lesser extent) innovator drug clients.  It’s also a doctrine more likely to get less attention in what promises to be the upcoming brouhaha.

By far the most important Gorsuch preemption decision is Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015), cert. denied, 136 S. Ct. 796 (2016), the very favorable PMA medical device preemption decision that we discussed previously here and named as our #2 best case of the year for 2015.  We’re not reprising those posts here.  Rather, we’re examining Caplinger for what it might tell us about Judge Gorsuch’s broader views of FDCA preemption.  His dissatisfaction with the Supreme Court’s tortured approach to express preemption in medical device product liability cases is very clear.

Caplinger begins with the strong statement that, in enacting the Medical Device Amendments, Congress “[e]xercis[ed] its authority under the Supremacy Clause” in enacting 21 U.S.C. §360k(a). 784 F.3d at 1336.  Before looking at relevant Supreme Court authority, Caplinger comments:

At first glance the answer to this appeal might appear easy enough.  Section 360k(a) preempts “any requirement” imposed by states on manufacturers that differs from or adds to those found in the FDCA.  Given this expansive language one might be forgiven for thinking all private state law tort suits are foreclosed.  After all, a “requirement” usually means a request, need, want, or demand.  And an adverse tort judgment seems to involve just that: a demand that a defendant appear to answer for its conduct and pay damages for failing some state law duty.

Id. at 1337 (dictionary citation omitted).  A string citation about the lower courts’ “struggles” to make sense of medical device preemption followed.  Id. at 1337-38.

The problem was, when the Supreme Court got involved, rather than interpreting Congress’ “expansive” preemptive language according to its terms, the Court “issued a number of opinions that embody ‘divergent views’ about the proper role of the MDA’s preemption provision, a fact that has yielded considerable ‘uncertainty’ among the lower courts.”  Id. (citation omitted).

Continue Reading Gorsuch Looks Pretty Good On Preemption

The United States Supreme Court today granted certiorari in Bristol-Myers Squibb Co. v. Superior Court.  Here is a link to the order.  The California Supreme Court decision in this case was our worst case for all of 2016.  Here is our description of what the Supreme Court has just agreed to review:

Bristol-Myers-Squibb v. Superior Court, 377 P.3d 874 (Cal. 2016). Ultimately (and fortunately) there was not much contest for the worst drug/device product liability decision of the year.  The highest court of the largest state in the country – check.  Direct defiance of United States Supreme Court precedent on a significant constitutional issue – check.  Significant impact on the litigation of mass torts – check.  In Bauman, the Supreme Court condemned “exorbitant exercises” of general jurisdiction that do not “permit out-of-state defendants to structure their primary conduct with some minimum assurance as to where that conduct will and will not render them liable to suit.”  Such “unacceptably grasping” “[e]xercises of personal jurisdiction [are] so exorbitant” that they “are barred by due process.”  The paradigm of such overly “grasping” jurisdiction is that which “would presumably be available in every other State in which a [defendant’s] sales are sizable.”  So the California Supreme Court promptly fashions a theory of “specific” jurisdiction that allows masses of plaintiffs, anywhere in the country, to sue a drug company (and presumably any other large corporation), as long as one Californian (or, here, 86 of 678) is suing over the same conduct.  The reason?  Because the defendant does significant general business in California.  If your reaction is that BMS simply shifted the pre-Bauman “continuous and substantial” jurisdiction standard from general jurisdiction to specific jurisdiction, you would be right.  We haven’t seen such blatant defiance of Supreme Court precedent in our bailiwick since the First Circuit in Bartlett (2012-1), and that one headed up our bottom ten, too.  Here’s hoping for a similar result in the Supreme Court.  We chronicled California sliding to the bottom of the slippery slope here and here.

If our side wins this, then we’ll see a significant reduction in both the size and reach of litigation in all those places where we don’t want to be. We’ll be following this closely.

We’ve always been bothered by the presumption against preemption – so much that this blog’s first major substantive post was on that subject.  Even before that, back in the Bone Screw days, we remember the presumption against preemption accompanying the death of express preemption for 510(k) medical devices in Lohr.  In Lohr, the presumption was used as a narrowing principle of statutory construction: “[W]e use[] a presumption against the pre-emption of state police power regulations to support a narrow interpretation of such an express command.”  Id. at 485.  Then along came Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), which (as we pointed out at the time) upheld preemption of pre-market approved medical devices under the same statutory provision with nary a peep about any preemption-busting presumption.  Nonetheless, even after Riegel, some lousy circuit court decisions still invoked the presumption as a way of poking holes in PMA preemption, most notoriously the en banc Ninth Circuit in Stengel v. Medtronic Inc., 704 F.3d 1224, 1227-28 (9th Cir. 2013), which fawned over the presumption at some length before deciding that a duty to provide information to a governmental agency wasn’t any different than a bog standard product liability duty to warn.

The presumption also came up in the context of the Vaccine Act, where one court (discussed here) sought to nullify statutory preemption by latching onto a statement in Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (a non-FDCA case), about there being “a duty to accept the reading [of a statute] that disfavors pre-emption,” even where there are other equally “plausible” interpretations. Id. at 449.  That view was shot down by the Supreme Court in Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011), which interpreted the Vaccine Act’s preemption clause in a pro-preemption direction with nary a mention of the erstwhile adverse presumption – something else we mentioned at the time.

Then along came PLIVA v. Mensing, 564 U.S. 604 (2011), where four justices found, if anything, a presumption in favor of presumption, id. at 621-23 (viewing the Supremacy Clause as a constitutional “non obstante” provision), four justices disagreed, and one didn’t take a position.  Mensing, of course, was an implied preemption case.

For these reasons, we speculated a little over a year ago whether the presumption against preemption might be dead.  Then a little later, we thought we might be wrong.

Turns out we’re half right.

Continue Reading The Demise of the Presumption Against Preemption in Express Preemption Cases

We can’t stand no-injury class actions – brought by plaintiffs who allege only that “I got exactly the product I paid for, and wasn’t hurt, but for X reason I paid ‘too much’ for it.” Such litigation is a waste of time and money, and is inevitably driven by class action lawyers looking for fees, not by any real injury, which is why they’re called ‘no injury” to start with.  We see them in our sandbox, mostly in connection with third-party payor actions, although some FCA cases also spout similar damage theories.  They’re usually based on some sort of technical violation of the FDCA.  But our clients are hardly the only defendants burdened by this kind of senseless litigation for litigation’s sake.

Statutory violations – otherwise not causing harm to anyone – are widely asserted as the basis for classwide relief in many areas of the law. Such violations were at issue in Spokeo, Inc. v. Robins, 136 S. Ct. 1540 (2016), decided last month. Spokeo came to the Court on the question of whether certain alleged violations of the Fair Credit Reporting Act (“FCRA”) could suffice to create the Article III standing needed to proceed in federal court.  The Court gave the defense community some relief, at least rhetorical, from no-injury class actions – but ultimately remanded the action without making a definitive ruling on the claims before it.

In a nutshell, sufficient for our purposes here, FCRA imposes penalties for (among other things) false reporting of credit-related information. The defendant, Spokeo, operated an internet search engine that, for a fee, allowed anybody to conduct web searches on anybody else.  136 S. Ct. at 1546.  Given that the Internet (present company excepted) often seems to be a giant garbage can, the plaintiff claimed that some of the information about him was false.  Since the information on file was (or could be) used for determining credit, he brought a FCRA class action.  Id.   He sought statutory damages ($100-$1000 per “violation”), without any showing that he had ever actually been denied credit.  Id.  The district court dismissed for lack of standing, but the court of appeals (the Ninth) reversed.  Id.

Continue Reading Spokeo – Half a Loaf, Maybe More, from the Supreme Court

Today’s guest post is courtesy of Reed Smith’s Lindsey Harteis. She’s been following the big-deal UHS v. Escobar False Claims Act that the Supreme Court could decide any day now (or could wait until the end of June), which involves the existence and (perhaps) extent of the so-called “implied certification” theory of FCA liability.

As always our guest posters deserve all the credit, and any blame, for the contents of their posts.

Finally – be sure to read the IMPORTANT ANNOUNCEMENT at the end of this post. DDLaw blog is getting ready to move, and that means you’ll have to resubscribe to continue getting our posts. But don’t worry, it’s easy.

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We spent this past weekend chasing our ten-week old Samoyed puppy around the backyard, where he ventured “down in the weeds” more than a few times. This caused the OCD in us to go over him multiple times with a fine-toothed comb: We reasoned that he was bound to pick up some ticks. Lucky for us, he didn’t. But it got us thinking that when courts go down in the weeds like our dog did, they are bound to pick up a few nasty buggers themselves. In the oral argument for the appeal in United Health Services v. Escobar, 780 F. 3d 504 (1st Cir. 2015), the Court definitely took a run through the weeds. (We blogged briefly on the case here). We’re taking our fine tooth comb through the oral argument to look for ticks, and we fear we’re bound to find in this ruling another “corpus juris festooned with various duties.”

That’s a quote from a Justice we missed dearly while listening to the oral argument in this case. Justice Scalia used it in his concurring opinion in Skilling v. United States, 561 U.S. 358 (2010), which limited a fraud statute in the criminal context due to vagueness and via the 5th Amendment Due Process route.

Skilling reminds us of United Health Services for a couple of reasons: (1) It dealt with defining the contours of a sort of fraud – honest services fraud – for which the lower courts took an expansive view that wasn’t foreseeable based on the plain language in the statute; (2) Scalia was accusing the Courts of Appeals of invention of law rather than interpretation in their rulings on what constituted honest services fraud; and (3) the case involved a fusion of Restatement and black letter law in an unrelated area (Agency and Trusteeship) but was a criminal case.

Continue Reading Guest Post − Implied Certification: An Eradicated Pest or Here to Stay?

Earlier this month the United States Supreme Court agreed to hear Universal Health Services, Inc. v. United States ex rel. Escobar (No. 15-7), in which the Court will decide whether a False Claims Act claim can succeed under the so-called “implied certification” theory, and if so whether that theory goes beyond situations where compliance is an express precondition to payment.  We’re not FCA lawyers, but other folks at Reed Smith are, so rather than sorting through all this ourselves, we’re linking (a first for us) to a Reed Smith client alert that has what we think is a good explanation of why this case – and this FCA theory – is important to our clients and to our readers generally.

In addition to being on the warpath about cy pres class action settlements, we try to keep an eye on various other issues related to the much-abused Fed. R. Civ. P. 23.  First, we’re pleased as punch to let you know that all the really awful things that the Federal Judicial Conference’s Rule 23 Subcommittee was contemplating doing (rejecting/watering down ascertainability, recognizing issue classes, writing cy pres into Rule 23, and eliminating offers of judgment) have all been dropped.  You can read about it here.  Only comparatively minor settlement-related issues (opt-outs, notice, objectors, approval) remain on the Subcommittee’s agenda.

There are also two recent, and pending, petitions for certiorari of note raising class action-related issues.  One of them, Wal-Mart Stores, Inc. v. Phipps, No. 15-597 (U.S., filed Nov. 6, 2015), is a spin-off of the employment-related litigation that produced Wal-Mart Stores, Inc. v. Dukes, 131 S. Ct. 2541 (2011).  Having lost Dukes, plaintiffs have tried to regroup by filing separate, smaller class actions.  Given how long the Dukes litigation was pending, the statute of limitations becomes a serious problem for these newer, still quite large class actions.  Hence the issue of “stacking” the tolling effect of successive class actions under American Pipe & Construction Co. v. Utah, 414 U.S. 538 (1974), is a major issue.  We’ve been aware of stacking attempts for some time, but the courts had largely gotten it right – until now.  The Phipps petition is from the first court of appeals decision ever to allow stacking as a general rule.  Hence, the question presented is:

Whether the Sixth Circuit erred in concluding, in conflict with the decisions of seven other Circuits, that statutory limitations periods applicable to the claims of absent and unknown persons can be extended indefinitely by filing successive (or “stacked”) class actions.

More information, including links to all filed documents, is available on SCOTUSBlog, here.  Full disclosure – Bexis and his firm are filing an amicus brief for the Product Liability Advisory Council (“PLAC”)  in the Phipps matter.

Continue Reading Class Action Issues at the Supreme Court (and Elsewhere)

On May 26, 2015, the Solicitor General’s office responded to the United States Supreme Court’s Oct. 14, 2014 invitation for the government’s views on the certiorari petition filed in Athena Cosmetics, Inc. v. Allergan, Inc., No. 13-1379.  The brief is on Westlaw at 2015 WL 2457643, and is also referenced (although not yet with a link) at the SCOTUSblog page for the case, here.  We discussed the opinion being appealed from, Allergan, Inc. v. Athena Cosmetics, Inc., 738 F.3d 1350 (Fed. Cir. 2013), here, and noted the cert. petition here (item #5).  As we pointed out, the question presented is of potentially great interest, even though Athena is not a product liability case:

The question presented is whether, under Buckman [Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001)], the FDCA impliedly preempts a private state-law claim for unfair competition premised on a party’s purported failure to obtain FDA approval, where FDA itself has not imposed any such requirement.

Under the current administration, we’ve grown accustomed to the Solicitor General taking anti-preemption positions in prescription medical product cases that we consider extreme – even to the point of claiming that every appellate court in the country had misapplied Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Needless to say, we were not expecting a pro-preemption result in Athena, and we were right.  However, this time the SG’s arguments were surprisingly temperate, although (we would argue) still incorrect.

Briefly, Athena is a dispute between two competing manufacturers of a vanity product, eyelash thickeners.  Thus, the Court is being asked to take another look at Buckman preemption in the context of a product that is about as far away from the life-saving/improving prescription products that our clients make as it is possible to be, yet staying (arguably) within the bounds of FDA jurisdiction.  Robin Williams once said that “cocaine is God’s way of telling you you have too much money.”  The same could just as easily be said about eyelash thickeners.  But we digress….

Anyway, the plaintiff (Allergan) went through the time and effort to get its eyelash thickener approved as a drug.  The defendant (Athena) did not, taking the position that its eyelash thickener was a cosmetic.  As the SG pointed out, “[i]n
contrast to drugs, cosmetics may be marketed without FDA approval.”  2015 WL 2457643, at *2.  The FDA had never taken
any enforcement action against the defendant, although it had against other eyelash thickeners containing similar (or identical) active ingredients.  Id. at *5.  The difference between a “drug” requiring FDA approval and a “cosmetic,” which does not, is that a drug is “intended to affect the structure or any function of the body.”  Id. at *1 (quoting 21 U.S.C. 321(g)(1)(B)).

In our experience, most companies, when faced with a competitor that they believe is violating the FDCA (such as by off-label promotion) will tip off the FDA and watch as the Agency comes down upon the miscreant like a ton of bricks.  Whether the plaintiff tried that here, we don’t know.  What we do know is that it tried, successfully, to take matters into its own hands.  Rather than wait for the FDA to act, plaintiff sued under the California UCL, which due to the quirks of California law, discussed here, allowed a private right of action under California’s “little FDA Act” (called the “Sherman Act”), which mirrors the FDCA.  See SG br., 2015 WL 2457643, at *9 (“California directly incorporates the federal new-drug application regulations”).

Thus, as we explained in much greater detail in our earlier Athena post, the result was an injunction against selling an unapproved “drug,” even though the FDA had never determined that this product was a “drug” that required pre-marketing approval in the first place.  As we argued in that post, and as the defendant-petitioner argued to the Supreme Court, that runs afoul of Buckman’s holding that private enforcement of the FDCA is impermissible under 21 U.S.C. §337(a).

So how did the Solicitor General get around Buckman? Primarily, the government argued that the FDA didn’t act at all – the Agency never approved, or disapproved, the defendant’s product, since that product wasn’t ever submitted in the first place:

As respondent notes and petitioner essentially concedes, FDA has never approved [the product] to be marketed as a drug, nor has the agency taken any other affirmative step to authorize (or forbid) the sale of the product as a matter of federal law.

2015 WL 2457643, at *10.  Thus, according to the SG, a finding under the California UCL (allowing suit under the Sherman Act’s FDCA-identical standards) that the defendant was selling an unapproved “drug” rather than a “cosmetic,” didn’t conflict with anything the FDA did, because the FDA hadn’t done anything.

This discussion of FDA inaction is not what we usually see, because our clients’ drugs and medical devices are always subject to some form of FDA approval/clearance/whatever.  We know of Supreme Court implied preemption precedent, Spreitsma v. Mercury Marine, 537 U.S. 51 (2002), that an agency’s “decision to take no regulatory action left the law applicable to [the product] exactly the same as before the [agency] began.”  Id. at 65.  So Spreitsma found no preemption, even where an agency considered doing something and decided against it.  Id.  Cf. Geier v. American Honda Motor Co., 529 U.S. 861, 881-82 (2000) (deliberate, policy-driven decision to not require certain action can constitute preemptive agency action).  In a situation where a product was never even brought before an agency, Spreitsma’s no-preemption rationale would seem to apply even more strongly.

But, oddly, the SG’s brief never even cites Spreitsma.  Rather, it argues against preemption because there is no “direct and positive conflict” with any FDA action, citing an uncodified 1962 savings clause that essentially restates the definition of implied conflict preemption.  2015 WL 2457643, at *13-14.  That, we think is wrong, because it mixes express (the 1962 language) and implied preemption, when the Supreme Court has repeatedly – and in Buckman itself – held that the two types of preemption operate independently of each other.

Respondent also suggests that we should be reluctant to find a pre-emptive conflict here because Congress included an express pre-emption provision in the MDA.  To the extent respondent posits that anything other than our ordinary pre-emption principles apply under these circumstances, that contention must fail in light of our conclusion last Term in Geier v. American Honda Motor Co., 529 U. S. 861 (2000), that neither an express pre-emption provision nor a saving clause “bar[s] the ordinary working of conflict pre-emption principles.”  Id., at 869.

Buckman, 531 U.S. at 352.  As Buckman observed, Geier also confirms that even express savings clauses cannot prevent implied preemption where “an actual conflict with a federal objective is at stake.”  529 U.S. at 871.

So the SG takes the position that, as long as the FDA hasn’t actually done anything, the state of California can enforce
standards identical to what the FDA would have considered, should the Agency ever have decided to act.  “[Plaintiff’s] claim thus does not supplant any regulatory determination by FDA regarding the product’s status as a cosmetic or a new drug.  No conflict is presented between the federal and state standards in this regard.”  2015 WL 2457643, at *11.  See also Id. at *14 (“capacity to police the vast marketplace of consumer products that have never been submitted to FDA for pre-market review is even more constrained”); *16 (defendant “never submitted a marketing application to FDA, and FDA never approved [defendant’s] product for marketing. Thus, unlike in Buckman, [plaintiff’s] suit does not require a court to evaluate the propriety of submissions to FDA”).  Be that as it may with a product that is arguably a cosmetic requiring no FDA action at all, for our drug and device clients the SG’s arguments suggest a different result where “the propriety of submissions to the FDA” is placed at issue in a state-law action:

Whether false statements have been made to a federal agency, and what sanction to impose if they were, are matters to be decided by the federal government, the sovereign that established that administrative forum.

Id. (citation omitted).

Buckman, the SG argued, found a common-law claim preempted for three reasons:

  • “First, the putative state-law claims sought to police fraud on a federal agency by entities the agency itself regulated, a matter of an exclusively federal character over which the federal agency at issue − the FDA − possessed ample direct authority.”
  • Second, “the claims in Buckman, which were directed at a defendant that was not the manufacturer of the devices and therefore did not have a manufacturer’s duty to warn purchasers of safety risks, did not “rely[] on traditional state tort law.” 531 U.S. at 353. Rather, the plaintiffs relied on a theory that “exist[ed] solely by virtue of the FDCA,” ibid.
  • Third, “allowing plaintiffs to pursue a “fraud-on-the-FDA” claim under state law could compromise FDA’s “flexibility” to pursue “difficult (and often competing) objectives” under the FDCA’s medical device provisions. 531 U.S. at 349.”
2015 WL 2457643, at *12-13.  We’re not so sure about #2, since Buckman turned on the type of conduct (false statements to the FDA) rather than the source (a non-manufacturer).  Assuming arguendo that such a distinction exists, has nonetheless has some positive preemption attributes.

Item one should preempt any claims concerning informationtually given to (or withheld from) the FDA by those that “the agency itself regulate[s].”  We’ve always thought (as recently as a couple of days ago) that alleged failures to report/inaccurate reporting of adverse events to the FDA were preempted, and the SG’s brief doesn’t disagree.

Item two supports additional implied preemption – beyond fraud on the FDA − of claims brought against “a defendant that was not the manufacturer.”  So does Mensing/Bartlett, since as we discussed here, non-manufacturers can’t change labels (or anything else) unilaterally.  Inability to act independently = impossibility = implied preemption.

Item three not only reconfirms the FDA’s primacy over off-label use and promotion, which is what the quoted portion of Buckman was discussing, but gives the Court’s analysis potentially broader effect.  The FDA pursues a lot of “difficult” and “competing” objectives and strikes a lot of balances.

There are several other places where we find helpful nuggets – intended or not − in the SG’s brief.  These occur in the SG’s discussion of other courts of appeal’s decisions involving implied preemption under Buckman.  The same office that had been so quick to denounce cases as wrongly decided in prior briefs did not do so in Athena.  Most importantly, the SG’s brief endorsed preemption of “claims that defendant failed to provide the FDA with sufficient information and did not timely file adverse event reports, as required by federal regulations” as being “in accord with this Court’s decision in Buckman.”  2015 WL 2457643, at *22 (describing In re: Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200 (8th Cir. 2010)).

The SG also had no problem with preemption of statutory state-law liability-creating-exceptions based on fraud on the FDA:

In cases involving claims of fraud against a federal
agency, courts of appeals have concluded that federal law does bar plaintiffs’ suits.  See Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 381 (5th Cir. 2012) (state-law claim of fraud on FDA preempted by the FDCA).  These outcomes are faithful to this Court’s decision in Buckman.

2015 WL 2457643, at *21-22 (non-FDCA citation omitted).
We’ve discussed Lofton here and here.  Thus, it appears that even the current anti-preemption SG’s office is on our side (and not on the side of Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d mem. by equally divided court, 552 U.S. 440 (2008)), concerning the preemption of  express state statutory “fraud on the FDA” exceptions.  Remember that if the SG ever tries to change his/her tune.

The SG’s brief also agreed that off-label use claims were properly preempted where “FDA was aware of the defendant’s off-label use, had actively taken steps to halt abuses, and ultimately approved the device for the relevant procedures.”  2015 WL 2457643, at *19-20 (discussing Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013)) (citations and quotation marks omitted).  To the SG it was an unobjectionable application of preemption to dismiss a claim that, contrary to an actual FDA determination, the defendant had violated the FDCA.  Id. at *19 (discussing PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010)). The SG likewise did not dispute the preemption of claims that a product (or a defendant’s conduct) involved something that was “illegal” under the FDCA.  Id. at *18 (discussing Loreto v. Procter & Gamble Co., 515 Fed. Appx. 576 (6th Cir. 2013)).

As we discussed in our earlier posts, we think that preemption was appropriate in Athena because the distinction between “state” and “federal” is evanescent where, as in California, purported state law simply adopts the FDA’s regulatory standards wholesale.  We don’t think that the congressional intent embodied by §337(a) can be so easily nullified.  Obviously, the SG disagrees, and is unwilling to look behind the California fig leaf. We also disapprove of the unnatural conjoining of express and implied preemption, since they operate independently. Beyond that, however, we find the Athena SG’s brief surprisingly helpful, since the fields in which we labor are planted by positive FDA decision-making, and the SG seems to find Buckman preemption a proper means of weed control for protecting our clients’ drug and device bounty.

We’ve got the expression “the dog that didn’t bark” stuck in our heads today, and it’s not just from that phrase being used in the recent Caplinger decision. See Caplinger v. Medtronic, Inc., ___ F.3d ___, 2015 WL 1786742, at *9 (10th Cir. April 21, 2015) (blogged about here). No, it’s also our reaction to another preemption decision handed down almost simultaneously with Caplinger – by the Supreme Court – in Oneok, Inc. v. Learjet, Inc., 2015 WL 1780926 (U.S. April 21, 2015).  Both Oneok and the majority’s opinion in Caplinger share something in common beyond being decided on the same day and being about preemption.  Neither so much as breathes a word about the embattled “presumption against preemption.”

That the Caplinger majority doesn’t mention any presumption (or assumption, or whatever) against preemption isn’t really surprising, since it affirmed preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), in which the Supreme Court majority did likewise.  It is surprising that Oneok didn’t rely, or even reference, such a presumption.  FirstOneok found no preemption, and we’ve noted elsewhere, the presumption against preemption is one of those result-oriented things that tends to pop up when consistent with a no-preemption result and vanish where preemption is found.  SecondOneok is a field preemption case (one reason why nothing else in it is terribly pertinent), and field preemption is where the presumption against preemption originated.  As we said in one of our very first posts:

The presumption asserted by the Lohr plurality originated in preemption discussions involving neither express nor conflict preemption – but rather “field” preemption.  Thus, in Rice v. Santa Fe Elevator Corp., 331 U.S. 230 (1947), the Court noted, “the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Id. at 230 (citations omitted). . . .  Rice involved the most sweeping form of preemption – field, not conflict preemption.

The Rice assumption became a presumption in Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 715-18 (1985), and Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977) (cases also cited in Lohr).  Both of these cases rejected field preemption before turning to additional preemption arguments raising actual conflicts with federal regulation.  Both courts invoked a “presumption” against preemption solely in their discussions of field preemption.

Continue Reading Is The Presumption Against Preemption Dead?