Friday, April 24, 2015

Is The Presumption Against Preemption Dead?

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 rececnt 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.  First, Oneok 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.  Second, Oneok 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331 U.S. 230 (1947), the Court noted, “the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.”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.

DDLaw, “The Presumption Against Preemption” (November 15, 2006) (emphasis added).  If the Court is no longer willing to rely upon a presumption against preemption, even in an opinion rejecting field preemption – the presumption’s heartland and origin − then one wonders if it still exists at all.

It might not.  As we also posted (only not so long ago) the 4-4 split on the presumption against preemption in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and a subsequent comment by Justice Kennedy (the missing vote in Mensing), suggest that the presumption teeters on the verge of abolition.

Maybe abolition has already occurred, sub silentio (“done silently”), since Justice Breyer, author of Oneok, was one of the presumption’s remaining adherents in Mensing, but then didn’t mention it in his dissent in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013).  If Justice Breyer now doesn’t see fit to use the presumption, even in finding against field preemption, he may have also come around to concluding that it’s simply too toxic a concept and belongs to the dustbin of history.  Oneok was 7-2, so it’s not like the presumption was a bargaining chip needed to obtain a hotly contested  result.

We look forward to a formal interment.

Still No Duty To Supply Drugs - In 22 States

Since the inception of the blog we’ve taken interest in “flip side” lawsuits in which a plaintiff sues one of our manufacturer clients making allegations diametrically opposed to what we usually see in product liability litigation – that, far from being injurious or “defective” − our client’s product is so valuable that the plaintiff can’t do without it, and is suing because of some threat to his/her supply of that product.

The first time we commented on such suits, the plaintiffs were suing the government, claiming a constitutional right to try investigational drugs.  We opposed that, knowing that, were such a right recognized, our clients would be the next targets of such constitutionally empowered plaintiffs, because our clients, not the government, had the drugs in question.  The courts ultimately said “no,” see Abigail Alliance v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), but the lawsuits followed anyway.  Most of these cases involved desperately ill people grasping at investigational straws because there was no cure (or even reliable treatment) for their conditions (muscular dystrophy, multiple sclerosis, and similarly devastating and fatal conditions).  We summed this kind of litigation up recently in reviewing the first comprehensive law review article on the subject.

Now there’s another one.

The plaintiffs’ duty-to-supply allegations in Hochendoner v. Genzyme Corp., ___ F. Supp.3d ___, 2015 WL 1333271 (D. Mass. March 25, 2015), were a little different, since the drug in question was not investigational.  The defendant was described as “the manufacturer of . . . the only treatment for Fabry disease” that had FDA approval.  Id. at *1.  Fabry disease is a rare (≈ 1 in 100,000), progressive, and life-shortening condition.

Because the condition is rare, the market is small.  Defendant was the “sole supplier” of the only approved medication.  Id.  Therefore, when manufacturing problems removed several batches from production, the resultant “shortage in the U.S. market”  forced the defendant to ration supply.  Id. at *1-2.  This rationing prevented the plaintiffs – disease sufferers (and spouses) from 22 states – from obtaining more than 30-50% of the recommended dose.  Id. at *2.  The reduced dose was allegedly less effective at treating the disease, which allegedly injured the plaintiffs.  Their core allegation was:

Because [defendant] has denied Fabry patients access to the drug in FDA-recommended doses, Fabry patients have suffered a return of the symptoms of their life-threatening disease.


Plaintiffs alleged a potpourri of theories predicated on the supposed duty:  negligence, negligence per se, strict liability, breach of warranty, third-party beneficiary contract, and various state consumer protection statutes.  Hochendoner, 2015 WL 1333271, at *4.  They alleged three kinds of “injury”:  (1) return of symptoms due to lower doses being less effective; (2) “accelerated” progression of the disease due to lower dose; and (3) exposure to “adulterated” product that should not have been sold.  Id. at *5.  The first was held to be adequately pleaded, because it was common to all plaintiffs, whereas categories 2 and 3 were not common, and thus inadequately pleaded.  Id. at *5-7

With the complaint thus reduced to only injuries allegedly attributable to rationing/reduced dose, the question of whether a drug manufacturer has a “duty” to maintain a full supply of its drug to all prescribed users, and can be liable for damages for a breach, was thus squarely presented in Hochendoner.

First to go was negligence per se, which was based on alleged violations of something called the “Bayh-Dole” (sounds like a pineapple commercial) Act, 35 U.S.C. §§200 et seq.  We divine from Hochendoner that the drug must originally have been developed with some sort of public funding, and the plaintiffs’ theory was that, because the defendant’s manufacturing problems led to a shortage, the defendant had somehow used its rights to this “publicly funded invention” unreasonably.  Sounds like BS, but the merits were never reached.  This statute did not provide an express cause of action and the court wasn’t about to imply one:

[The statute] focuses neither on the individuals protected nor even on the funding recipients being regulated, but on the agencies that will do the regulating.  Its purpose is not to protect the public or to prevent nonuse or unreasonable use of inventions, but instead to ensure that the Government obtains sufficient rights in federally supported inventions to meet the needs of the Government and protect the public.

2015 WL 1333271, at *8 (citations and quotation marks omitted).  The only remedy under Bayh-Dole was that the government could “march in” and license somebody else to produce the invention at issue.  Id.  Plaintiffs had no rights at all:

The express provision of one method of enforcing a substantive rule suggests that Congress intended to preclude others.  As with other federal statutes [that do] . . . not [] confer a private right of action, this identified remedy provides a mechanism for federal review of a potential violation of the statute, rather than leaving individuals aggrieved by such a violation without any form of redress.

Id.  “[W]ithout statutory intent, a cause of action does not exist and courts may not create one, no matter how desirable that might be as a policy matter, or how compatible with the statute.”  Id. at *9 (citation and quotation marks omitted). Sounds a lot like Buckman to us – one of the reasons such unusual claims interest us.

The third-party beneficiary contract theory fell next.  First, what was the purported contract?  The license agreement between the drug’s inventors and the defendant manufacturer.  Hochendoner, 2015 WL 1333271, at *9.  The contract – like the statute just discussed – was devoid of any intent to confer actionable rights on anybody else.  “[N]one of the operative clauses mentions Fabry patients, and, even more pertinently, that none of the operative clauses creates any obligation for [defendant] to produce sufficient medicine to meet demand.  Plaintiffs simply cannot point to any operative clause that [defendant] breached.”  Id.

The tort claims (negligence and strict liability) followed.  There is simply no duty recognized in any state that requires a manufacturer to keep on hand enough of a product to meet foreseeable demand.  “Plaintiffs fail to cite a single case establishing that [defendant] has a duty to manufacture sufficient medication to meet market demand.  I can find no such case under the law of any state implicated in these actions.” Id. at *11.  All prior precedent was to the contrary, and the opinion cited the Schubert and Lacognata cases we have blogged about previously, as well as the aforementioned law review article.

What remains are Plaintiffs’ claims that [defendant] violated the state product liability laws by failing to manufacture sufficient [product] to meet the U.S. market demand and refusing to fill physicians’ prescriptions for the FDA-recommended dosage.  These allegations fail to state a claim upon which relief may be granted, because the relevant state statutes do not render such conduct actionable.

Id. at *13.  Failure to provide enough of a product is not a “defect.”  Id. (“non-provision of a product does not fit” into the definition).  The harm was caused by the underlying disease, not by the product.  Id. at *14.  “Simply put, the claims asserted here are not for the manufacture and distribution of a defective product, as state product liability laws have developed, but are for a failure to manufacture sufficient quantity of a non-defective product.”  Id.

Adding icing on the cake, Hochendoner invokes our favorite Erie principle:

A federal court sitting in diversity cannot be expected to create new doctrines expanding state law.  It is not appropriate for this court to create the proposed duty as a new component of the common law, especially given that it is such a radical departure from the law as it exists.

2015 WL 1333271, at *11 (citation and quotation marks omitted).  Accord Id. at *14.

“For much the same reason,” Hochendoner declined to create a duty to supply under the consumer protection statutes of any of the plaintiffs’ 22 home states.  Id.  Again, there was no precedent for any such holding in any of the affected states.  “It is inappropriate for a federal court sitting in diversity to create a new doctrine under state law in this manner.”  Id.

Nor were there any express warranties concerning supply.  Certainly, nothing warranted “that a lower dosage would be as efficacious for use in the treatment of Fabry disease as the dose recommended on the packaging and by the FDA.”  Id. at *12.  That would amount to promoting an off-label use.  Nor was there any reliance on the non-statement:  “They do not allege that any Plaintiff believed that the lower dose would work as well.”  Id.  The warranty claim simply didn’t make any sense.

Plaintiffs offer no case law in support of the proposition that if a merchant has available only a limited amount of a product, the merchant is impliedly warranting that the limited amount will be as powerful or effective as a greater amount. A shop owner does not warrant that one cup of sugar (the only cup in stock) will make as sweet a cake as the two cups of sugar for which the recipe calls.

Id. at *13,  The case involved a prescription drug, not some homeopathic remedy.

Finally, in a footnote, Hochendoner disposed of plaintiffs’ contention that they could plead a constitutional tort (“Bivens action”).  Assuming everything else plaintiffs alleged, only a state actor could violate the Fifth Amendment, as Bivens requires.  No support existed for a theory that mere exercise of rights flowing from a federal patent converted a private manufacturer into a state actor.  2015 WL 1333271, at *9 n.7.

In the prior duty-to-supply litigation, the claims tended to concern termination of access to investigational products that allegedly helped the plaintiffs.  Hochendoner, involved a fully approved drug, with shortages caused by temporary manufacturing problems.  Id. at *2.  They eventually ended, and regular shipments resumed.  Thus these plaintiffs did not even have the arguable injuries of the prior cases, so it’s not surprising that they lost, too.  Plaintiffs are fond of saying (in the preemption contexts) that manufacturers don’t have to produce anything.   Yes, manufacturers don’t have to manufacture, nor do tort plaintiffs have any basis to stop them.  Nor can plaintiffs force them to do so.  Hochendoner reached the right result.

Thursday, April 23, 2015

It All Started With Caplinger

            This post is from the non-Reed Smith side of the blog.

            We’ve been reporting on the amazing success Medtronic has had in the InFuse litigation for over two years.  And, it all started with Caplinger.  Caplinger was the first (and arguably one of the best) of the lot, accepting propositions that PMA preemption applies to devices, not uses; that “off-label promotion” is not a proper parallel claim; that any claim dependent on the scope of the FDA’s label is really a disguised FDCA violation claim; and any claim premised on a PMA device’s safety and effectiveness is preempted.  What more could we have asked for?  A Tenth Circuit affirmance.  Now we’ve got it.

            In an extremely well-written decision the Tenth Circuit (2-1) affirmed the complete dismissal of Caplinger v. Medtronic, Inc., No. 13-6061, slip op. (10th Cir. Apr. 21, 2015).  It is so well-written we really could quote from most of it verbatim.  But we’ll try to resist that urge and give you an abbreviated version today (we do however recommend reading the whole thing, we think you’ll enjoy it).

            Caplinger is essentially no different than all the other InFuse cases.  Plaintiff alleges that because her surgeon opted to implant the InFuse device posteriorly (from the back) instead of anteriorly (from the front), this off-label use transforms the case from an otherwise preempted PMA medical device case into a non-preempted, off-label, parallel violation claim.  The Caplinger appellate decision carefully explains why plaintiff is just wrong.  It begins with a close examination of preemption law that starts where we always start – doesn’t §360k(a) foreclose “all private state law tort suits.” Slip op. at 5.  But then come Lohr, Riegel, and Buckman.  Reading those Supreme Court decisions together, the 10th Circuit reached the following conclusion as to the preemption analysis
it seems we aren't supposed to ask whether Ms. Caplinger wishes to use state tort law to impose on Medtronic a safety requirement that is “different from, or in addition to” a federal requirement so much as whether she seeks to vindicate a state duty that is “narrower” or “broader” than a federal duty. To the extent the state law duty is narrower than or equal to the federal duty it survives, through what seems a sort of Venn diagram approach to preemption. Still, even if the state claim fails that test because it would impose a “broader” duty than can be found in federal law, it appears we may not find the claim preempted just because it conflicts with “any” federal requirement. Instead, we may find the state law claim preempted only if there exists a device-specific federal requirement . . . Finally, should the state claim survive this far, we must ask whether it exists “solely by virtue” of the federal statutory scheme (unacceptable) or “predates” the scheme (acceptable).  It's no wonder that the difficulty of crafting a complaint sufficient to satisfy all these demands has been compared to the task of navigating between Scylla and Charybdis.
Id. at 11. 

            Using this template, the court answers question number 2 first – the easiest question – device-specific requirements apply to InFuse because it has been through the PMA process.  Id. at 12.  With that box checked, the court moves back to question number 1 – do plaintiff’s claims parallel federal requirements?  As we move on to the specific claims, we should note that the court did not decide whether plaintiff’s fraud claim was preempted, agreeing with the district court that the claim was not pleaded with the particularity required of Federal Rule of Civil Procedure 9(b).  Id. at 12n.1.

            On design defect and breach of warranty, the court found that plaintiff failed to even identify a purported parallel federal regulation.  So, they turned to failure to warn, negligence and negligent misrepresentation.   For these claims, plaintiff cited federal requirements that the device’s label not be “false or misleading” and contain “directions under which the layman can use a device safely and for purposes for which it is intended.”  Id. at 13. 

            First, the court points out that these requirements go to labeling only and plaintiff’s claims “go well beyond that,” challenging advertising and other representations.  “So as a matter of law Ms. Caplinger’s state law claims substantially exceed the potential scope of any federal regulation she’s identified.”  Id.  But the labeling claim also fails because plaintiff relies on an inapplicable federal regulation.  InFuse is a prescription only medical device and therefore, the FDCA recognizes that its directions for use won’t adequately inform a layman how to use the device safely.  So, manufacturers are absolved from compliance with this regulation “so long as they label their prescription devices in a certain manner approved by the FDA.”  Id.  Moreover, once a PMA device label is approved, “the manufacturer usually may not alter the label’s warnings without prior agency approval.”  Id. at 14.  And, plaintiff “offers no answer to the conundrum how she might impose a state tort duty on Medtronic to revise a label that federal regulation precludes it from revising.”  Id. 

            So, plaintiff failed to identify “any legally viable federal requirement that might parallel and thus permit her claims.”  Id. at 16.  But now we turn to the heart of the InFuse cases – plaintiff’s allegation that “off-label use is enough all by itself to insulate all her claims from preemption.”  Id. at 18.  In other words, plaintiff asked the court to find that parallelism isn’t the only way to avoid preemption – attacking off-label use “should be another entirely separate way around the problem.”  Id. at 19.  But the court found that route blocked as well.

            The first obstacle is §360k(a) itself.  It preempts state laws that impose “any requirement” that relates to the safety or effectiveness of [a] device that is different from, or in addition to, any requirement applicable . . . to the device.”  Id. at 19.  It’s all about the device, not uses.  The second bump was the court’s recognition that if Congress wanted to preempt claims as to uses, it knew how to do it.  Indeed Congress specifically protected off-label uses when it provided that “[n]othing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device.”  Id. at 20 (citing 21 U.S.C. §396).  Looking at preemption in this context, the court concluded:
Knowing about (even encouraging) off-label uses in § 396, Congress proceeded in § 360k(a) to preempt any state tort suit challenging the safety of a federally approved device without qualification about the manner of its use. Given that Congress well understood the difference between on-and off-label uses and exhibited its facility with those terms in § 396, the absence of any mention of them in § 360k(a) becomes all the harder to ignore, a sort of dog that didn't bark.
Id. So, off-label use alone doesn’t change a thing in the preemption world.

            But plaintiff didn’t stop there.  She next argued that preemption should only apply when a “state requirement differs from or adds to a federal regulation covering the ‘same subject.’  And because there are no federal regulations on the ‘subject’ of off-label uses . . . off-label claims should not be preempted.”  Id. at 21.  But, that reads in a pre-condition that is clearly not part of §360k(a).  This section “specifies its preemptive reach plainly and broadly:  any state requirement that adds to federal requirements and that relates to the safety or effectiveness of the device is preempted.  No other qualification exists.”  Id. at 22. 

            And finally, plaintiff’s last attempt to find some support for her position was to cite the FDA’s amicus brief in Medtronic v. Stengel (U.S. 2014).  But the court was unpersuaded:
Neither does the agency's latest brief mention—let alone seek to explain why it has deviated from—its prior litigating position. And the FDA acknowledges candidly that its (current) litigating position would require a court to reject “every [circuit] case since Riegel ” because none has suggested that § 360k(a)'s preemptive effect depends on a dichotomy between on-and off-label uses. Without any good reason to defer to the FDA's current position over its previous position—and the textual and precedential acrobatics that would be required to land there—we decline the attempt.
Id. at 24. 

            So, having undertaken this thoughtful and complete analysis, the court concluded that Congress undertook to balance the competing interests between those injured by FDA-approved devices and those who would suffer if innovation was checked, postponing access to new devices.  “[A]nd it is not for this court to revise it by beating a new path around preemption nowhere authorized in the text of the statute and nowhere recognized in any of the Supreme Court’s may forays into this field.”  Id. at 26.

            While we like to leave it there, we can’t end this post without a brief discussion of the dissenting opinion.  The dissent claims that it is not fundamentally disagreeing with the majority on the substance of federal preemption law, only on whether preemption sinks plaintiff’s claims as a matter of law at the pleadings stage of this case.  Dissent, at 19.  We think the problems with the dissent are more substantive than they want to let on; but more importantly, it is the arduous lengths the dissent goes to to find a claim that might survive beyond a motion to dismiss that we take issue with.

            If we had to sum up the biggest problem with the dissent it would be its apparent recognition of a state law claim for adulteration and misbranding.  That’s Buckman preemption 101.  The dissent goes on for pages about the labeling requirements in the FDCA and its prohibitions on misbranding and adulteration.  But these are federal requirements without a state law parallel counterpart.  Allowing a plaintiff to sue a manufacturer because a device was “adulterated” is the very definition of allowing a private right of action to enforce the FDCA.  No way says the Supreme Court. 

            Tied up in their misbranding argument, the dissent also argues that Oklahoma failure to warn law doesn’t require that “Medtronic provide additional warnings or labeling in order to escape state tort liability.”  Dissent, at 17.  Rather, Oklahoma law provides that a device can be defective due to an inadequate warning.  The focus on “inadequate” doesn’t save plaintiff’s claim.  If a something is inadequate, it is lacking.  And if something is lacking, something more is required.  “More” is both additional and different. 

            The dissent also tries to read misbranding and adulteration into a state law failure to warn claim:   
Once the specific elements of state law are apprehended, it becomes clear that Oklahoma is merely providing a mechanism for recovery if Medtronic violates federal law by introducing Infuse for an adulterated or misbranded use and the warnings accompanying Infuse are inadequate for that adulterated or misbranded use. The state duty, like the federal duty, requires that Medtronic provide adequate directions for use.
Dissent, at 17.  Isn’t this just negligence per se in disguise?  The defendant was negligent in its warning because the warning violates federal law.  And so we’re back to an unlawful private enforcement action.  Actually, if you look a little deeper, the disguise is quite thin: 
To hold otherwise would allow Medtronic to shift liability for its illegal misbranding and adulteration to patients and physicians and provide a strong disincentive for Medtronic to seek supplemental FDA approval when the intended use of a device changes.
Id. (emphasis added).  There is no civil liability for misbranding and adulteration.  The incentive for seeking supplemental approval is avoiding prosecution under the FDCA.  That’s the balance that Congress struck and as the majority found, it is not for this court (or any court) to beat a new path around preemption not recognized in the statute or by the Supreme Court.       

Wednesday, April 22, 2015

Maryland, My Maryland: Aldara Case Dismissed for Multiple Reasons


Today’s date is rich in literary history.  It is the birthday of Vladimir Nabokov, one of two writers whose prose style makes us want to snap our Pilot Varsity pens in despair, so great is the gap between those authors' mastery and our pedestrian scribblings.  Perhaps the biggest laugh-out-loud moment a book ever gave us was from Lolita, when the Humbert character travels a long way to visit a family that has at least one member he is especially, um, interested in, only to be greeted at the train station by the patriarch, who shared “the news that his house had just burned down – possibly, owing to the synchronous conflagration that had been raging all night in my veins.” 


Today is also the birthday of Henry Fielding, the great British novelist of the 18th century.  In high school we were forced to read Joseph Andrews and Tom Jones, and we grumbled about it, especially upon getting a peek at the girth of Tom Jones (we mean the book).  But the joy, wisdom, and energy of Fielding’s words, often propelling the most ribald adventures, converted our dread into a wholly unforced pleasure, indeed.  There is a sentence in Tom Jones that stopped us abruptly in our tracks.  Fielding on many occasions spoke directly to the reader, and at one point he explained his intention to “fill my pages with humour till mankind learn the good nature to laugh only at the follies of others and the humility to grieve at their own.”  Has any writer ever articulated a more noble goal?


It is also possible that today is Shakespeare’s birthday, though that is unclear.  (Shakespeare would be 451 years old - which places him squarely within the core demographic for CBS's lineup of law enforcement procedural dramas.)  Shakespeare’s birth was not officially recorded, but we know that he was baptized on 26 April.  The conventional deduction is that baptisms took place three days after birth, so that would place Shakespeare’s birthday tomorrow, on the 23rd.  But Nabokov liked to think that he shared a birthday with the Bard, and that is good enough for us.  Nobody writes like Nabokov, though many try.  It has been a long time since anyone tried to write like Fielding.  The last example we can think of was John Barth’s magnum opus, The Sot Weed Factor, written in 1960.  Sot Weed refers to tobacco.  The book is about a poet laureate of Maryland.  He was charged with writing an epic called Marylandiad.  Barth's novel recounts the poet’s journey to and through Maryland, where he gathers experiences and cobbles literature, all whilst doing his best to preserve his “innocence” (virginity).  There are so many great things about Maryland:  crab-hammering, a state song sharing the tune of “O Tannenbaum” [though it is a bit awkward that the song is a pro-Confederate ditty decrying “Northern Scum”], Frederick Douglass, Babe Ruth, Thurgood Marshall, Cal Ripken, The Wire, and a robust contributory negligence defense.  There is also H.L. Mencken, who defined a judge as "a law student who marks his own examination papers." 


Now we can add today’s decision, Morris v. Minnesota Mining and Manufacturing Co., No. BPG-13-1107 (D. Md. April 16, 2015), to that list of Maryland marvels.  Everything went right for the defendants in that case and everything went wrong for the plaintiff.  It is sort of epic.  You can find a link to the Morris decision here



Let’s start with the facts.  In October 2007, the plaintiff was prescribed Aldara cream for treatment of Bowen’s disease, a form of skin cancer.  Shortly after the plaintiff began applying Aldara to her nose, she developed burning lesions on her entire body.  The plaintiff was diagnosed with cutaneous Lupus, which she alleged was caused by the Aldara.  She was also diagnosed with Posterior Reversible Encephalopathy Syndrome, which she also alleged was caused by Aldara.  Aldara is indicated for several things, but Bowen’s disease is not one of them. Thus, the use of the Aldara for the plaintiff’s Bowen’s disease was an off-label use. 


Whether or not the Aldara actually caused the alleged injury, it certainly caused a lot of litigation here, to wit: 


•               In November 2010, the plaintiff sued her dermatologist in federal court for medical malpractice by prescribing Aldara off-label.  That case was dismissed for lack of subject matter jurisdiction. 


•               In December 2010, the plaintiff filed suit against her dermatologist in state court.  That case was dismissed for failure to comply with the Maryland Health Claims Malpractice Act.


•               In October 2011, the plaintiff once again filed suit against her dermatologist in state court.  The  Amended Complaint not only asserted that the defendant prescribed Aldara for an off-label use due to the potential for severe side effects.  The state court dismissed the plaintiff’s case in February 2012.


•               In April 2013, the plaintiff filed a case in federal court (this case) against the 3M defendants, asserting claims for negligence, negligence per se, product liability, breach of warranty, “conscious indifference,” and malice.  The central claim was that the defendants failed to provide adequate warnings concerning the risks, consequences, and side effects associated with the use of Aldara.


Usually, plaintiffs exploit off-label use by arguing that it calls off certain defenses (such as preemption) and makes the defendants’ conduct worse in various ways.  But Maryland is a bad place to try that tactic, because Maryland law is clear that a manufacturer is under no obligation to warn the patient of risks associated with an off-label use of a drug and, therefore, cannot be held liable in the event the physician prescribed a drug for such use.  The controlling case is Robak v. Abbott Labs., 797 F. Supp. 475, 476 (D. Md. 1992), and it is one you should keep in your hip pocket anytime you have a case in Maryland.  Under Roback, off label use pretty much walls off a manufacturer from any product liability theory. 


Naturally, the plaintiff attempted to distinguish Robak, arguing that the plaintiff’s injuries were not attributable to her dermatologist’s off-label prescription of Aldara, but rather the inherently dangerous design of Aldara itself.  That is, the plaintiff was saying that even an on-label prescription of Aldara would have caused her alleged injuries.  Well, then.  So what exactly is this case about?  In any event, the court ruled that the fact that an on-label use of Aldara might have caused injuries similar to the plaintiff’s alleged injuries did not negate the application of Robak to the facts presented here.  Because of Roback, the plaintiff’s case against the manufacturer was going nowhere.  End of story.


Except it wasn’t.  The court decided a couple of other issues against the plaintiff as well.  Perhaps it was a message that an appeal would be pointless.  At this point, we should mention that the decision in Morris was rendered by the magistrate judge.  The parties agreed that the magistrate judge could make the summary judgment ruling.  This case reminds us that there are many excellent magistrate judges in federal courts around the country.  They are often stuck with drudgery, such as ESL issues or privilege-log battles, but when given the opportunity to oversee larger issues they can really shine.  To this day, the best trial experience we have ever had in our home E.D. Pa. jurisdiction was in front of a magistrate judge who was smart, diligent, and patient, and who dealt with lawyers, witnesses, and jurors with efficiency, fairness, and grace.  


The defendants in Morris also argued that the claims against them were time-barred by the Maryland three-year statute of limitations.  This three-year limitations period begins when the plaintiff “knew or reasonably should have known” of the alleged wrong.   According to the defendants, the plaintiff’s claims were barred by limitations because the plaintiff had sufficient knowledge in October 2007 to suggest that she had a potential cause of action against the defendants.  And yet she waited until April 2013, nearly five and a half years later, to file this lawsuit.  According to the court, the defendants were right and the case was time-barred.  And once again, just as with the off-label issue, something that plaintiffs typically try to use against defendants ended up biting them in the posterior here.  In so many cases we see, the plaintiffs’ specific causation theory rests solely on temporal proximity.  Stop us if you’ve heard this one before:  there was no injury until after usage, so the product must have caused the injury.  But the Morris court interpreted Maryland law to mean that the temporal proximity between the use of a drug and the manifestation of injuries was sufficient to prompt a reasonable plaintiff to investigate.  Here, given the temporal proximity between the plaintiff’s use of Aldara and the appearance of the lesions, the plaintiff had sufficient knowledge in 2007 to be prompted to investigate whether Aldara was responsible for her injuries.  Indeed, she did investigate, by seeking medical treatment immediately after her symptoms appeared.  But the plaintiff argued that she was not properly diagnosed with severe cutaneous Lupus until 2011 and that her neurological symptoms were “never investigated” or “properly evaluated” until she was examined by her medical expert in 2014.  The court did not buy that argument:  “The fact that plaintiff’s symptoms, neurological or otherwise, were not properly evaluated or diagnosed from the outset does not form a basis for tolling the limitations period.” 


There was a third reason why the plaintiff’s case had to be dismissed.  The named defendants sold their pharmaceutical operations in 2006 – one year before the plaintiff used Aldara.  In product liability cases the defendant must be a manufacturer or seller of the product.  The 3M defendants were neither.  Did the plaintiff yield to this unassailable logic?  She did not.  She argued that because Aldara was defectively designed, the 3M defendants remained liable to the plaintiff as the original manufacturer pursuant to the Hatch-Waxman Amendments of the Food, Drug and Cosmetics Act.  We do not think that argument should work as a matter of law, whether the analysis is grounded in precedent, text, logic, or policy.  But the Morris court grounded its dismissal on something even simpler: the plaintiff had simply failed to offer any evidence to support the proposition that Aldara was defectively designed.  The plaintiff relied upon an expert affidavit that recited all the right conclusions.  Again, stop us if you’ve heard this one before:  the plaintiff pays some expert to spout all the elements of the cause of action and, presto, a factual dispute emerges that sends the summary judgment motion down the drain and sends the case to a jury.  But not so here.  The court actually read the expert affidavit carefully and spotted it for the litigation-driven drivel that such things usually are.  The expert report contained no specific evidence that Aldara is defective, or that Aldara caused the plaintiff’s alleged injuries.  Rather, the report merely contained the conclusory assertions, without evidentiary support, that the plaintiff’s neurological symptoms were “never investigated,” “never properly evaluated,” and “show direct causation to the drug Aldara.”  The court held that “[s]uch conclusory affidavits must be rejected by the Court when they represent nothing more than ‘an effort on the part of the plaintiff to create an issue of fact.’”   


Finally, the plaintiff argued that to respond to the defendants’ summary judgment motion, she required additional time to conduct discovery regarding her recently diagnosed neurological and neuropsychological conditions, as well as Aldara’s allegedly dangerous design.  Pursuant to Federal Rule of Civil Procedure 56(d), the Court may allow time to take discovery “[i]f a nonmovant shows by affidavit or declaration” that she cannot present facts to justify her opposition to a summary judgment motion and that discovery might remedy that deficit.  Fed. R. Civ. P. 56(d).  But a hope is not the same thing as a showing.  The plaintiff failed to identify specifically what further discovery she required, or what evidence that discovery would unveil.


*          *          *          *          *          *


In addition to being a great satirist and one of the inventors of the novel, Henry Fielding had a career in the law.  He was described  by a historian as one of the two best magistrates in London.  Based on the Morris decision, we think the magistrate who authored it also merits praise.  The opinion is clearly reasoned and concisely expressed.  Nabokov, Fielding, and Barth could hardly improve upon it.    



Tuesday, April 21, 2015

Breaking News - Caplinger Infuse Preemption Dismissal Affirmed

We thought our readers would like to know that today the InFuse preemption decision in Caplinger was affirmed by the 10th Circuit in a 2-1 opinion (here’s a link).  Our non-Reed Smith bloggers will undoubtedly have more to say in the future, but they are not available today, so you’ll have to read it for yourself.

The FDA Gets an EARful on Label Changes

We’ve blogged several times about the FDA’s pending proposal to gut preemption with respect to generic drugs, and that proposal’s numerous flaws.  We have been remiss, however, in not mentioning the industry’s 2014 counter-proposal that’s was jointly proposed by GPhA (for the generic industry) and PhRMA (for the branded/innovator drug manufacturers).  Given how intensely the generic and branded wings of the pharmaceutical industry compete with (and sue) one another, that they could join together in opposition to the FDA’s proposal says something in and of itself – like how bad the FDA’s proposal really is.

Anyway, to start, here is a link to the joint GPhA/PhARMA letter that details the industry’s solution to the problem of label-update delay in general.  That’s the key.  The industry proposal ends the disparity (identified by the Supreme Court in Mensing, among other places) between how the FDA treats generic and branded/innovator drugs.  The industry proposal thus stands in stark contrast to the FDA’s, which would both perpetuate and worsen the divergence between the processes affecting the two types of prescription drug manufacturers.

The industry fix is called “Expedited Agency Review” – or “EAR” for short.  Unlike the FDA’s pending proposal, the revisions advanced by industry ensure that label change procedures won’t run afoul of the “sameness” requirement that’s built into the statute (the Hatch-Waxman part of the FDCA) itself (a problem we discussed here).  Thus, it could take effect without lengthy litigation.  It also makes the FDA work harder, something that the Agency doubtlessly doesn’t care to do.

As detailed in the “Alternative to the Proposed Rule on Labeling” attachment to the Industry Letter, EAR procedures would start with the receipt, either by a manufacturer or by the FDA of “new safety information,” an already defined term in the statute:

The term “new safety information”, with respect to a drug, means information derived from a clinical trial, an adverse event report, a postapproval study . . ., or peer-reviewed biomedical literature; data derived from the postmarket risk identification and analysis system . . .; or other scientific data deemed appropriate by the Secretary about –

(A) a serious risk or an unexpected serious risk associated with use of the drug that the Secretary has become aware of (that may be based on a new analysis of existing information) since the drug was approved, since the risk evaluation and mitigation strategy was required, or since the last assessment of the approved risk evaluation and mitigation strategy for the drug; or

(B) the effectiveness of the approved risk evaluation and mitigation strategy for the drug obtained since the last assessment of such strategy.

21 U.S.C. §355-1(b)(3).  Alternatively, the information could be “received through the Sentinel System (see here for more details on Sentinel) and/or other databases including global sources that are suggestive of a need for a label change.”  Industry Letter at Attachment, p.1.

Rather than have individual companies guess when a label change is required, EAR takes advantage of the FDA’s central role as the repository of all post-marketing reporting information:

[N]o individual applicant holder has access to all the available data – the proprietary data from clinical studies conducted by NDA holders, and/or the data held and/or provided by each individual applicant holder. . . .  Unlike individual applicant holders, FDA possesses all the significant clinical trial data on a pharmaceutical product and all the adverse event and periodic reports from all manufacturers.

Id..  Putting all this information together, allows the FDA to “perform signal identification” – that is, to see the “red flags” that plaintiffs love to assert (inevitably with the basis of hindsight) in product liability litigation.

Expedited EAR safety review can be sought by industry “who believe data they are submitting to FDA might constitute ‘new safety information,’” or by the FDA on its own initiative, whenever  it “determine[s] that it is in possession of ‘new safety information’ from all the resources available to it.” Id. at p.2.  Once an EAR is commenced, the Agency must act quickly:  The industry proposal did not presume to specify the exact time, but it is intended to be quite short – “days,” not weeks or months:

FDA must make a decision on the appropriateness of a label change within XX days (or sooner if FDA determines the circumstances warrant more expedited action). During that XXday period, FDA engages the NDA and ANDA holders in discussions regarding the potential for a label change.  Once FDA determines whether a label change is required, FDA immediately notifies the NDA and all ANDA holders of the decision.  If the decision is to implement new labeling, NDA and ANDA holders implement the change within 30 days (or sooner if FDA determines the circumstances warrant more expedited action).


Thus, the EAR proposal sets deadlines for results as well as reporting.  It contrasts mightily with the existing Changes Being Effected process for branded/innovator drugs, where “new” is not as precisely defined and where the FDA acts, or doesn’t act, however and whenever the agency decides on a case-by-case basis.  Nor does EAR have the inherent tendency towards confusion as in the FDA’s proposal.  EAR would eliminate even the possibility of disparate labeling and different manufacturers of bioequivalent products will never have to guess (with possible “devil take the hindmost” litigation consequences) whether or when to submit changes via CBE, or what those changes should say:

If FDA determines through a review of all available safety data that a labeling change is required, FDA informs the NDA and ANDA holders of the content of the final labeling language immediately (within 15 days) and instructs the NDA and ANDA holders to update their labeling within 30 days via elabeling.


We have always been in favor of what we’ve described as a “high regulation, low litigation” model for ensuring the safety of prescription medical products.  While the FDA isn’t perfect (as its generic labeling proposal alone demonstrates), compared to the cost and uncertainty of litigation almost any type of administrative action is far preferable.  EAR would be a significant step towards this goal, as replacing the ad hoc CBE process for label changes with a single procedure for all drugs backed by FDA mandate would overturn Levine rather than Mensing and allow preemption to clear most of the lawyers (on both sides of the “v.”) out of the drug labeling process.

EAR – (1) It ensures that safety decisions are based on all available information, not just the slice that any individual company has.  (2) It’s consistent with the statute, and thus within FDA’s power to adopt, without years of legal haggling.  (3) It would eliminate discrepancies that the Supreme Court criticized between FDA generic and branded/innovator drug label change procedures.  (4) It would replace current confused and free-for-all system for branded/innovator label changes with strict deadlines and mandatory revisions.  (5) It would reduce litigation.  For all of those reasons, it should be adopted, but, for the same reasons, probably won’t be by the current FDA.

Monday, April 20, 2015

You Want to Remand? I’m Already Gone

This post is not from the RS side of the blog.

Medtronic removed today’s case, Cole v. Medtronic, Inc., 2015 U.S. Dist. LEXIS 48095 (W.D. Ky. Apr. 13, 2015, to federal court in the Western District of Kentucky.  Three and a half months later, plaintiff asked the court to remand it back to state court because a second defendant, a hospital, was a citizen of the forum state, thus triggering the forum-defendant rule and blocking removal.  We think Glen Fry can best take it from here:

Well, I heard some people talkin' just the other day
And they said you were gonna put me [in state court]
But let me tell you I got some news for you
And you'll soon find out it's true
And then you'll have to eat your lunch [in federal court]
'Cause I'm already gone
And I'm feelin' strong
I will sing this vict'ry song.  Woo, hoo, hoo.  Woo, hoo, hoo.

You see, it’s true that, under 28 USC § 1441(b)(2), an action that is otherwise removable on the basis of diversity jurisdiction can’t be removed if one of the defendants (here, the hospital) is a citizen of the forum state.  But this forum-defendant rule is procedural, not jurisdictional.  It can be waived, and it will be waived if it’s not raised within 30 days after removal.  Plaintiff’s remand motion was three and a half months later.  “Already gone.”

Plaintiff’s motion also asked the court to remand the case because not all defendants had consented to removal.  Again, it’s true that 28 U.S.C. § 1446 requires all defendants to consent to removal.  But that’s also a procedural, not jurisdictional, rule, so it is also waived if not raised in 30 days.  “Feelin’ strong.”

 Plaintiff also argued that defendant did not establish that the $75,000 jurisdiction limit was met.  But this was an Infuse bone graft case, and the Court knew better.  The jurisdictional limit was met.  “Sing this vict’ry song.  Woo, hoo, hoo.  Woo, hoo, hoo.”

Setting aside that this case offered the opportunity to hum a great song, it allows us to reference a six-year-old post that considered whether the attorneys for a defendant that misses its 30-day removal deadline could ethically remove the case nonetheless in the hope that plaintiff would then miss his or her deadline to remand.  

Now, in Cole, the situation was different.  Even though Medtronic knew that there was a forum defendant that could block removal, it also had a good faith argument that the case was still removable because that defendant had yet to be served.  So Cole didn’t pose the ethical question that we discussed six years ago.  But maybe it provides an answer.  

It’s hard to ignore that the client in Cole, Medtronic, is in a better place, quite literally, than it would have been if its lawyers chose not to remove because of the presence of a forum defendant.  Even if Medtronic had lost its argument that plaintiff’s failure to yet serve the forum defendant allowed Medtronic to remove, Medtronic would still be standing safely in federal court because of plaintiffs’ waiver of its right to seek remand.  And, so, if Medtronic’s lawyers had chosen not to remove the case, the client would still be in state court, a less advantageous position.  Similarly, the 30-day deadline to remove is not a jurisdictional requirement.  It’s procedural, and it also can be waived.  With that possibility always present, it seems that a lawyer whose client has passed the 30-day removal deadline should still be able to assess the situation and make an ethical decision to remove the case, knowing full well that plaintiff could thereafter waive the procedural barrier – just like what happened in Cole.  

Six years later, it’s still an interesting question.