Thursday, February 11, 2016

Fourth Circuit Flubs Admissibility of 510k Clearance

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

             We’ve put it off long enough – time to deal with the awful decision in C.R. Bard v. Cisson, __ F.3d __, 2016 WL 158814 (4th Cir. Jan. 14, 2016).  When we posted our 2015 Top Ten, we noted that we were watching Cisson because it had the potential to be among our top or bottom 10 of 2016.  Well, the top is definitely off the table and while it’s still early, the bottom is certainly in the running.

              A quick background of the case.  Cisson is an appeal from the first trial in the massive Pelvic Mesh MDL.  Plaintiff underwent implantation of defendant’s pelvic mesh device and began experiencing pain.  Two years later, she had surgery to remove the device, but the “arms” of the device could not be removed.  Id. at *1.  In 2013, defendant won summary judgment on many of plaintiff’s claims leaving only design defect and failure to warn to proceed to trial.  Id. at *2.  The trial resulted in a plaintiff verdict, including a sizeable punitive damages award.  Id. at *1. 

On appeal, defendant challenged several of the court’s evidentiary rulings, which is a tough row to hoe given the discretionary standard of review.  Chief among those was the district court’s decision to exclude any evidence of defendant’s compliance with the FDA 510k clearance process – finding it both irrelevant and unduly prejudicial.  As we pointed out earlier, considerable precedent allowed admission of FDCA compliance into evidence, including compliance with §510k clearance procedures.  But downright irrelevant?  Really?  The process established by the industry’s primary regulator as to what the industry must do and how it must do it in order to be able to bring its product to market is irrelevant?  At least the Fourth Circuit did not go that far.  It acknowledged that the question of relevance is “more difficult,” id. at * 6; perhaps a slight nod that if it had to rule on that issue it might have disagreed with the district court.  Unfortunately, the appellate court still affirmed, holding under Rule 403’s less demanding “prejudice” standard that the district court did not abuse its discretion in excluding the 510k clearance as unduly prejudicial.

The first question in determining whether evidence is admissible under Rule 403 is whether it is probative of an issue in the case.  Here, under Georgia’s risk-utility test for design defect claims, one of the questions for the jury is whether the defendant acted reasonably in designing the product.  Id. at *3.  Certainly there should be little dispute that compliance with the 510k process goes to reasonableness.  At a minimum, the fact of compliance, clearance, and a description of that process is evidence that addresses plaintiff’s inevitable arguments of what the company did and didn’t do, and what it should and shouldn’t have done.  To omit the 510k clearance would be to present the jury with a falsehood, a void, a gaping whole – which should be filled with the truth – that the company played by the rules. 

Putting aside that sort of common sense argument, the general state-law rule is that a product’s compliance with FDA regulations is relevant, albeit not controlling, in product liability litigation.

[A] product’s compliance with an applicable product safety statute or administrative regulation is properly considered in determining whether the product is defective.
Restatement (Third) of Torts, Products Liability §4(b) (1998). 

The Fourth Circuit, however, belittled the probative value of compliance with the 510k process by mistakenly concluding that it has nothing to do with safety.  Id. at *3.  Indeed, the Fourth Circuit went so far off base as to state that the 510k clearance process allows some medical devices to “avoid” “safety testing.”  Id.  Again, we are left shaking our heads at such contrafactual conclusion.  The 510(k) process is not a complete abandonment of safety considerations. As we have written before, while the 510(k) clearance is premised on substantial equivalence, such clearance does necessarily constitute a finding of safety.   Congress enacted the 510(k) process, in part, to enable quicker clearance for new devices that are equivalent to devices that have already been on the market and have accumulated some sort of safety and efficacy record.

But the court misapplied to evidence the Supreme Court’s preemption language in Lohr v. Medtronic:

Thus, even though the FDA may well examine 510(k) applications ... with a concern for the safety and effectiveness of the device,” the agency’s clearance rests only on whether the device is “substantially equivalent to one that existed before 1976” before allowing it “to be marketed without running the gauntlet of the [MDA premarket approval] process.

Cisson, at *4 (quoting Lohr, 518 U.S. 470 at 493-94 (1996)).  But the preemption cases have nothing to do with the admissibility of evidence.  Indeed, our prior post on this topic contains a sizeable number of cases that reject preemption but are accompanied by statements affirming the admissibility of FDA compliance.  So while the Fourth Circuit was correct that the Supreme Court “found the 510k process insufficiently tied-up with safety to preempt state tort actions,” id., that court wasn’t being asked to decide preemption.  It was asked whether the jury could hear evidence of compliance with industry standards.  Juries hear evidence on industry standards all the time.  And they receive instructions from the court all the time on how to weigh that evidence.  There seems to be little reason why that wouldn’t have worked well here.  Just because 510(k) clearance doesn’t preempt a plaintiff’s claims, it doesn’t mean that evidence of such clearance should disappear from trial. 

            Moreover, things have changed since 1996, including the 510k process.  But the court ignored both the actual changes to the 510k process since Lohr and recent FDA guidance that “the principles of safety and effectiveness underlie the substantial equivalence determination that is the heart of the 510k process.”  Id. at *4.  We also point you to a guest post that explains that not all 510k clearances are premised on pre-1976 products.  This is true of pelvic mesh and its regulatory history.  We won’t repeat it here, but it is hard to imagine how anyone could argue that the current 510k process is so divorced from safety review that it is “prejudicial” even to mention it to a jury.

            Having downplayed the significance of the compliance evidence, the Fourth Circuit next examined the district court’s conclusion that admission of this evidence would create an unnecessary “mini-trial” on the 510(k) process itself and defendant’s compliance with it.  How is that different from admission of compliance – or non-compliance, for that matter − with any regulatory scheme?  It is the same drill – one side wants to highlight the importance of compliance, while the other tries to minimize it.  What is peculiar to FDCA 510k compliance, as opposed to motor vehicle OSHA standards?  Cisson held that the jury would be misled or confused and that it might improperly “inflate” the importance of the evidence.  Id. at *5.  That the jury would be distracted from the central question – whether defendant acted reasonably in designing the device.  Id.  As noted above, we can’t conceive of a discussion of reasonableness that doesn’t include compliance with FDA regulations. The 510(k) process regulates the manner in which medical devices are developed, designed, manufactured and labeled.  It’s not everything.  But it’s a big enough piece of it for the jury to hear about.  Given that, it’s hard to imagine how the jury is anything but hamstrung by not having evidence as to how that process played out with this product.  It was provided with a false version of reality.

            We think the 510k clearance process was a substantial piece of evidence that would be wrongly excluded in any case.  But in a Georgia punitive damages case, exclusion is even more egregious.  Georgia is one of the best states in the country for punitive damages not being available where relevant government regulations are complied with.  See generally Hernandez v. Crown Equip. Corp., 92 F. Supp. 3d 1325, 1356 (M.D. Ga. 2015) (discussing critical role that compliance plays in precluding punitive damages).   So in essence, when the court excluded 510k compliance it also excluded a major state law defense to punitive damages because it might be difficult to understand.  What?  When something’s “hard” you just skip it?  Defendant was robbed of a potentially complete defense to punitive damages, again based on complete misperception by the court of what the 510k process is.  That’s a bad result.  “For one thing, the Due Process Clause prohibits a State from punishing an individual without first providing that individual with an opportunity to present every available defense.”  Philip Morris USA v. Williams, 549 U.S. 346, 353 (2007).

            One final point on the compliance issue.  Does Cisson mean that, where a plaintiff is claiming some sort of violation, say a warning letter or form 483 concerning a 510k device, that non-compliance evidence remains too “prejudicial”?    Or is 510k clearance an application of the all-too-common plaintiff-side logic of “heads I win, tails you lose”?

            Other issues were raised on appeal in Cisson, most notably a hearsay challenge to a material data safety sheet (“MSDS”) pertaining to one of the materials used in defendant’s pelvic mesh product.  Defendant challenged its admission as hearsay.  The district court ruled that it was admissible as non-hearsay to show notice – that defendant was aware of it, but also went on to sua sponte rule that it was admissible hearsay under several hearsay exceptions.  The Fourth Circuit disagreed.  In particular, the MSDS failed the “generally relied upon” hearsay exception provided by F.R. Evid. 803(17).  An MSDS wasn’t sufficiently “trustworthy” because “[d]isclaimers of the sort in the MSDS are not typically so motivated, being intended instead to prevent any use of a product that might create a liability.”  2016 WL 158814, *7.  Since this MSDS was essentially the supplier’s attempt to cover its derriere, it was inadmissible hearsay.  In the end, however, the plaintiff skated again, because despite the erroneous hearsay rulings, the MSDS could be admissible for notice, and the Fourth Circuit concluded that any error was “harmless” under the indulgent abuse of discretion standard of review for evidentiary issues.  Supposedly, because plaintiff only crossed the line (presenting the MSDS for its truth rather than for notice) once.  Id. at *11-12.  All we can hope is that recognition of the untrustworthy nature of a supplier’s MSDS may be helpful in future pelvic mesh cases, which is cold comfort to the defendant assailed by bogus arguments in Cisson itself.  Perhaps conceding notice would keep the MSDS out altogether. 

            Except for the original district court decision on the issue of the admissibility of compliance with the 510k process, Cisson is the worst decision we know of on this subject.  It is based in part on excerpts of preemption decisions used out of context and in part on an excuse that it would be confusing for the jury to hear about compliance, a key defense that is almost universally recognized.  And to do so in a punitive damages case?  Either aspect would cause sufficient dismay on their own, combined it’s a gross miscarriage of justice and denial of due process.    

Wednesday, February 10, 2016

Seventh Circuit Knocks Out Claims Against Generic Manufacturer on Preemption Grounds

 It is not often that we get the opportunity to discuss an opinion from a panel of judges including two former professors from our law school.  Diane Wood is the Chief Judge of the 7th Circuit and taught us Civil Procedure at the University of Chicago Law School a long time ago.  Richard Posner is the reason we took a course in Law and Economics, and it is hard for us to think about economics, M&A, securities, or even – wait for it – tort causation without recalling some of his graphs, equations, and, most importantly, insights.  The fact that Wood and Posner were both brilliant members of the same remarkable faculty does not mean they always agree.  For instance, there was quite a judicial kerfuffle not too long ago when Wood took Posner to task for conducting his own outside-the-record experiment to determine how long it really would take a worker to change in and out of special clothing. 


But Wood and Posner, along with Judge Bauer, did agree in Houston v. United States, 2016 WL 403310 (7th Cir. Feb. 3, 2016), where the court held that failure to warn and design defect claims against a generic manufacturer were preempted. No outside-the-record experiments were required.  The plaintiff claimed that he had been permanently disfigured by Stevens-Johnson Syndrome caused by ingestion of allopurinol. Allopurinol is a generic version of Zyloprim.  It is used to treat gout by reducing uric acid in the body.  The plaintiff took the generic version and sued the manufacturer of the generic.  The plaintiff also sued various health care providers for medical malpractice. Those health care providers were federal employees under the Public Health Service Act, which explains why the lead defendant was the United States.  The claims against the federal employees were dismissed for failure to exhaust administrative remedies.


The Seventh Circuit’s application of the Supreme Court decisions in Mensing and Bartlett was straightforward, so we’ll try to make this post equally straightforward.  The opinion is in the form of an Order from the entire panel, but the clear language and absence of footnotes make us think that Posner had a hand in the drafting.  The court reasoned that the generic manufacturer's "duty of sameness" "preempts a state law claim against a generic manufacturer if, as here, that claim would require the manufacturer to redesign its drug, change its labeling, or exit the market to avoid liability."  That is a nice formulation that might find its way into more than a few defense briefs going forward.  All the claims against the generic manufacturer were dismissed.


Desperate to hang liability on someone, anyone, the plaintiff then sought permission to amend the complaint and add the brand manufacturer, even though the plaintiff had not taken the brand drug. The Seventh Circuit decided not to decide whether it would embrace or reject the Conte absurdity, instead holding that the statute of limitations had already run out against the brand manufacturer.  That is fine as far as it goes, but it also represents something of a missed opportunity.  A decision by the Seventh Circuit smacking down Conte would have overturned some lower court mischief.  In any event, the Houston Order, while not the typical one-two punch against both generic and brand liability that we often applaud, amounts to a win for both the generic and brand manufacturers, as well as for common sense.


Tuesday, February 09, 2016

Injunctive Relief Claims Lead to Defense Opportunities

It’s not all that common, but every now and then our opponents feel their oats and seek injunctive relief – usually against the continued marketing of an FDA-approved product.  A state-law plaintiff seeking such injunctive relief should bring about an almost Pavlovian response from the defense.  This is an opportunity to make headway on preemption and related issues.  Courts don’t like to be in the business of invoking state law to override an FDA approval decision.  We can think of five cases that fit the pattern:  Bernhardt v. Pfizer, Inc., 2000 WL 1738645 (S.D.N.Y. Nov. 22, 2000); In re Paxil Litigation, 2002 WL 31375497 (C.D. Cal. Oct. 18, 2002); In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015); Herazo v. Whole Foods Market, Inc., 2015 WL 4514510 (S.D. Fla. July 24, 2015); and most recently, Stevens v. Boston Scientific Corp., ___ F. Supp.3d ___, 2016 WL 328739 (S.D.W. Va. Jan. 26, 2016).

The first two of these cases, Bernhardt and Paxil, are both notable because they bothered the FDA enough that the government intervened, filing amicus curiae briefs urging preemption and primary jurisdiction as grounds for the respective courts to reject the proposed injunctions.  In Bernhardt, the plaintiffs sought injunctive relief under state law to force a manufacturer to make changes in its FDA-approved labeling and also to issue “Dear Doctor” letters that the FDA had not required.  The court agreed that the FDA had primary jurisdiction over what a drug’s labeling (and DHCP letters) should say.  “Under the doctrine of primary jurisdiction, a district court may refer a matter within its original jurisdiction to the appropriate administrative agency if doing so will promote proper relationships between the courts and administrative agencies charged with particular regulatory duties.”  Bernhardt, 2000 WL 1738645, at *2 (citation and quotation marks omitted).  Whether the results of a new study required a labeling change or a “Dear Doctor” letter are squarely within the expertise of the FDA:

[P]laintiffs ask this Court to determine, on the basis of presumably scientific and medical principles to be developed at an adversary preliminary injunction hearing, that the [study] findings warrant a notice to all [drug] users and their physicians.  The FDA, not this Court, has the relevant expertise.

Id.  For good reason, the court was uncomfortable with issuing the injunction that the plaintiffs were demanding:

[T]here is no opportunity for inconsistent interpretations of law.  There is, however, a substantial danger of a much more serious inconsistency.  An order by this Court directing [defendant] to issue the notices would not preclude the FDA from either issuing a second notice or requiring [defendant] to do so, thus creating the potential for inconsistent directions concerning a serious medical ailment and how it is best treated.

Id. at *3.

In Paxil, 2002 WL 1940708, plaintiffs actually got a little further.  On the first go-round, the court actually issued an injunction under state law against a manufacturer’s continuation of FDA-approved advertising.  In re Paxil Litigation, 2002 WL 1940708 (C.D. Cal. Aug. 16, 2002).  After the FDA itself intervened, the district court reconsidered its order and rescinded the injunction.

While the Court is unwilling to blindly accept FDA’s ultimate determination here, it has given careful consideration to the extensive fact-finding engaged in by FDA. . . .  Specifically, FDA has now presented evidence to the Court regarding not only the internal review process involved in the advertisements in question, but also its position that the advertisements are not misleading. . . .  [T]he Court finds FDA’s evidence persuasive such that it changes the Court’s evaluation of Plaintiffs’ likelihood of success on the merits to a degree dictating that the preliminary injunction be denied.

Paxil, 2002 WL 31375497, at *2.

Fast forward to last year.  In Celexa, 779 F.3d 34, another California consumer fraud class action sought (in the context of an MDL) to enjoin the defendant from selling its drug in accordance with its FDA approval.  “In its prayer for relief, plaintiffs request that the court ‘[p]ermanently enjoin[ ] [defendant] from continuing to sell or market [the drug] with its current drug label and direct[ ] [defendant] to seek FDA approval of a new [drug] label.’  Id. at 38.”  The trial court threw out the case due to the “safe harbor” for regulated activities read into the relevant California statutes.  Id. at 35.  The First Circuit didn’t go there, but went someplace even better – as we discussed here − the result being the first post-Levine appellate decision finding preemption as to a branded drug because the warning change being demanded could not be accomplished by a changes being effected (“CBE”) application to the FDA.  Because plaintiffs were only challenging the defendant’s reading of the original studies on which the drug’s approval was based, there was no “new information” on which a CBE application could have been based.  Id. at 43.  Claiming only that the underlying data originally submitted to the FDA was “questionable” and “flawed,” plaintiffs’ complaint “[e]xpress[ed] displeasure with federal law as well as the FDA.”  Id. at 38.

Once again, the injunctive allegations were such that the court did not want to go there.  Instead, it found preemption:

Our review of the Supreme Court opinions . . . makes clear that a necessary step in defeating [defendant’s] preemption defense is to establish that the complaint alleges a labeling deficiency that [it] could have corrected using the CBE regulation. . . .  The CBE procedure is only available to make changes that, among other things, are based on “newly acquired information”. . . .  “[N]ewly acquired information” could be an increasing body of data of an inherent risk with the drug.  Or it could be new data from a clinical study evincing [the drug’s] inefficacy. . . .  We have scrutinized the complaint itself to see if it might plausibly be read as relying on “newly acquired information” in contending that [defendant] could have changed its label through the CBE procedures. We find only two fleeting references to academic articles . . . [but] Plaintiffs make no claim that these two academic articles are based on new data.  They instead contend that these two studies . . . were not included in [defendant’s original] submission to the FDA.

Celexa, 779 F.3d at 41-42 (citations omitted).  Once again, an overly ambitious injunctive request led the court to adopt an FDA-friendly defense.

The same thing occurred in Herazo, 2015 WL 4514510, only this time in the context of homeopathic products.  Such products are of questionable efficacy, but as we discussed here, the FDCA declared them legal in 1938, and that hasn’t changed.  Once again plaintiffs sought to enjoin the distribution of a legal product under the FDCA on grounds of state (consumer protection) law.  This time, the court resorted to both preemption and primary jurisdiction, abstaining from deciding (most of) the merits, and shipping the thing to the FDA.  On preemption the court found a rather obvious conflict:

Plaintiffs’ suit seeking to change the labeling requirements of Defendant’s homeopathic medication conflicts with federal policy and should be impliedly preempted.  . . . [T]he Court additionally finds that allowing the claim for injunctive relief to go forward would undermine the purpose for which Congress enacted the uniformity provision and thwart the Food and Drug Administration’s ability to carry out its oversight of marketing of homeopathic products.

Herazo, 2015 WL 4514510, at *5.  Primary jurisdiction covered the rest:

Courts consider four factors when applying the doctrine of primary jurisdiction:  (1) the need to resolve an issue that (2) has been placed by Congress within the jurisdiction of an administrative body having regulatory authority (3) pursuant to a statute that subjects an industry or activity to a comprehensive regulatory scheme that (4) requires expertise or uniformity in administration.  The [FDA] has the necessary experience and expertise in regulating labeling of homeopathic medication and it is within the Agency’s purview to decide whether the labels are compliant with federal law and the comprehensive regulatory scheme it has devised. . . .  [G]iven the extensive regulatory scheme to oversee homeopathic drug marketing and the questions presented over the labels in this case, the Court finds abstention appropriate under the primary jurisdiction doctrine.  Having found the doctrine of primary jurisdiction applies, . . . [p]ending the referral to the Food and Drug Administration, the Court stays this case to avoid any prejudice to the parties.

Id. (citations omitted).  Once again, a court recoiled at the prospect of state law precluding the manufacturer of an FDA-approved product from marketing that product at all.

Stevens continues the trend.  Once again, the plaintiffs sought an injunction – this time under RICO as well as state consumer protection statutes – to prevent the defendant from selling a product that the FDA allowed to be marketed.  Plaintiffs made various allegations about how the defendant had violated and/or deviated from FDA requirements, but once again the court decided, in the face of a request that effectively would have removed the product from the market, to respect the FDA regime and let the FDA decide whether these allegations were true, and if so what to do about them.

Primary jurisdiction was the route taken in Stevens.  It was not the same as “exhaustion of remedies.”  2016 WL 328739, at *4.  Primary jurisdiction “comes into play whenever [plaintiff’s] claim requires the resolution of issues which, under a regulatory scheme, have been placed within the special competence of an administrative body,” even if the agency never had the matter submitted to it before.  Id. (citation and quotation marks omitted).  Likewise primary jurisdiction cannot be waived, and can even be raised sua sponte by a court.  Id.  Instead, “the doctrine exists for the proper distribution of power between judicial and administrative bodies and not for the convenience of the parties.” Id.  “Uniformity” is an important consideration – we can’t have some states banning products that the FDA allows to be marketed and others not.  Id.  So is “technical expertise.”  Courts are competent to decide anything that is merely an issue of law, but not the application of the FDCA to a complex set of facts.  Id.

Oddly, after having boldly made a plethora of charges and sought not only an injunction, but a temporary restraining order, the plaintiffs in Stevens essentially ran and hid from the FDA once primary jurisdiction was raised:

[T]he plaintiff completely avoids any discussion of the FDA, its regulations or statutory authority, or its control over medical device issues in her Brief on Primary Jurisdiction.  Even more, the plaintiff does not refer to any of the safety issues that so permeated the Complaint and Motion for a TRO and for a Preliminary Injunction.

Stevens, 2016 WL 328739, at *6.  The ostrich approach not only didn’t work, but probably made things worse for the plaintiffs, since they surrendered the administrative field to the defendant.  The court recognized that plaintiffs were effectively alleging product adulteration by another name.  However, “The FDA’s domain includes authority to prevent or ameliorate the introduction of adulterated or misbranded drugs and devices into the market.”  Id. at *7.

So, once again, off to the FDA these injunctive allegations go:

[M]any of the factual allegations contained in the Complaint and supporting documents are based on alleged violations of statutes and regulations over which the FDA exercises its expertise and impressive administrative dominance.  Congress established an extensive listing of prohibited acts under the FDCA. . . .  Further, the MDA, which establishes the expedited 510(k) clearance process, is enforced by the FDA − necessitating many specialized scientific determinations.  The FDA is in the best position to determine whether [defendant’s product] is in compliance with the FDA’s own statutes, regulations, and directives − particularly because the FDA was the very agency that cleared [that] device in the first place.

Stevens, 2016 WL 328739, at *7 (emphasis added).  In other words, if the FDA started this, it can damn well finish it.  Sounds good to us.

The moral of this story is this – whenever plaintiffs seek injunctive relief against the distribution of a product that has successfully cleared all relevant FDA-related hurdles to being marketed, defendants should roll out their best implied preemption and primary jurisdiction arguments.  This is prime turf for making good law.

Friday, February 05, 2016

Learned Intermediary: Arizona Supreme Court Restores Order in the Desert

We recently brought you the breaking news that the Arizona Supreme Court has adopted the learned intermediary doctrine in prescription drug cases.  The case is Watts v. Medicis Pharmaceutical Corp., No. cv-15-0065-PR, 2016 WL 237777 (Ariz. Jan. 21, 1016), and the Arizona Supreme Court’s unequivocal adoption of the doctrine allows us to check one more state off the list—the number stand at 37 states (plus D.C.) whose highest courts have adopted the LID.  (See our headcount here). 
Having now had the opportunity to take a deeper dive, we can say that the Watts opinion is a solid endorsement of the learned intermediary doctrine and an artful explanation of the doctrine’s underpinnings.  But before we get there, we note that Bexis filed an amicus brief in support of adopting the doctrine.  On the other side, the lead author of an amicus brief for the trial lawyers was former Arizona Supreme Court Chief Justice Stanley G. Feldman.  Bexis versus the former Chief?  We like those odds.  We actually worked in Phoenix for a year following law school and became acquainted with Chief Justice Feldman while we clerked in the chambers next door.  This was in the mid-1990s, and while he was a polarizing figure even then because of his background as a plaintiffs’ advocate, we came to know him as a brilliant and vigorous individual.  On the learned intermediary doctrine, however, we don’t mind saying that the former Chief is wrong and that his successors (and Bexis) got it right.
So what about the Arizona Supreme Court’s opinion?  In Watts, the plaintiff took prescription medicine for acne on two separate occasions, each time for 20 weeks, and she allegedly experienced drug-related lupus and hepatitis.  When she later sued the drug’s manufacturer, she alleged that the manufacturer failed adequately to warn her of the consequences of the drug’s long-term use.  Why did she claim that the manufacturer failed adequately to warn her, the patient, and not the prescribing physician?  We suspect it was because the drug’s prescribing information included both lupus and hepatitis under its warnings and precautions.  However, the discount card that the plaintiff herself received from her physician was less specific, stating that “[t]he safety of using [Solodyn] longer than 12 weeks has not been studied and is not known.”  Id. at *1.  The trial court granted the manufacturer’s motion to dismiss, presumably under an application of the learned intermediary doctrine.
The Arizona Court of Appeals vacated the judgment in an opinion that can be characterized as nothing short of bizarre and that we have covered extensively (here, here, and here).  The Court of Appeals ruled that the learned intermediary doctrine conflicted with the Uniform Contribution Among Tortfeasors Act (“UCATA”).  According to that court, the learned intermediary doctrine interferes with the application of comparative fault because it “preemptively limits a manufacturer’s duty” and thus conflicts with UCATA’s demand that “each defendant in a tort case is liable for his or her own respective share of fault.”  Id. at *6.  Of course, the Court of Appeal’s opinion completely confused duty and liability with the allocation of fault once liability is found, but we’re getting ahead of ourselves. 
The Arizona Supreme Court granted review, vacated the Court of Appeals’ opinion, and adopted the learned intermediary doctrine.  The Court was even so kind as to describe exactly what it was going to do at the very beginning of the opinion:

Under the learned intermediary doctrine (“LID”), a manufacturer satisfies its duty to warn end users by giving appropriate warnings to the specialized class of persons who may prescribe or administer the product.  We hold today that the LID generally applies to a prescription drug manufacturer.  We further conclude that the LID is not displaced by the Uniform Contribution Among Tortfeasors Act.

Id. at *1.  As the Arizona Supreme Court reasoned,

The premise for the LID is that certain types of goods (such as prescription drugs) are complex and vary in effect, depending on the end user’s unique circumstances, and therefore can be obtained only through a qualified intermediary like a prescribing physician, who can evaluate the patient’s condition and weigh the risks and benefits. 

Id. at *3.  Thus, the Court held that the learned intermediary doctrine applies generally to prescription drug manufacturers, and it did not stop there. 
First, the Arizona Supreme Court adopted the learned intermediary doctrine as set forth in the Restatement (Third) of Torts: Product Liability § 6.  We routinely see courts applying the learned intermediary doctrine, but it is less common (though not unprecedented) to see reliance on the Third Restatement.  Here, the Arizona Supreme Court embraced it:  “In our view, the Third Restatement properly states the LID, and therefore we adopt § 6(d) as our expression of it.”  2016 WL 237777, at *3.  The court even noted parenthetically that “[a]bsent Arizona law to the contrary, this court will usually apply the law of the Restatement.”  Id.
Second, the Arizona Supreme Court rejected the idea that the learned intermediary doctrine creates “blanket immunity” for pharmaceutical manufacturers, reasoning that a patient can still have a claim “if the manufacturer fails to provide adequate warnings to the learned intermediary.”  Id. at *4.  This states the obvious.  Warnings-based claims under the LID exist in most every jurisdiction and sometimes are the exclusive basis for liability in prescription drug and medical device cases. 
Third, the Court ruled that the learned intermediary doctrine was not in any way outdated.  The Court of Appeals had found that the rationale underlying the doctrine “was no longer viable,” but the Supreme Court ruled that its rationale is as vital as could be.  Quoting the Texas Supreme Court, the Arizona court stated,

Because patients can obtain prescription drugs only through their prescribing physicians . . . and because the “learned intermediary” is best suited to weigh the patient’s individual needs in conjunction with the risks and benefits of the prescription drug, we are in agreement with the overwhelming majority of other courts that have considered the learned intermediary doctrine and hold that, within the physician-patient relationship, the learned intermediary doctrine applies and generally limits the drug manufacturer’s duty to warn to the prescribing physician.

Id. at *4.  When we said at the outset that the opinion was artful, we had this quote in mind.  Maybe “artful,” is not the correct word, but we still think this quote captures the underpinnings of the doctrine very nicely in a nutshell.  Moreover, the Arizona Supreme Court expressly rejected the West Virginia Supreme Court’s opinion in State ex rel. Johnson & Johnson Corp. v. Karl and correctly characterized that opinion—which found that the learned intermediary doctrine to be outdated—as an outlier.  Id. at *5. 
Fourth, the Court rejected a “direct-to-consumer” advertising exception to the learned intermediary doctrine.  We have always scratched our heads at the “DTC” exception, which exists only in New Jersey.  Even when prescription drug manufacturers advertise to consumers, the product is still available only by prescription, i.e., only from a learned intermediary.  In rejecting a DTC exception, the Arizona Supreme Court held that the learned intermediary doctrine provided sufficient protection to patients under its own terms.  Id. 
Fifth, the Arizona Supreme Court dismantled the Court of Appeals reliance on UCATA, and it did so on the basis that we describe above.  The LID defines the scope of a manufacturer’s duty; UCATA governs the allocation of fault once liability is found.  As the Arizona Supreme Court put it,

Because the LID and UCATA address two distinct subjects, they are not mutually exclusive.  The LID identifies circumstances when a manufacturer has met its duty to warn and thus is not at fault.  UCATA does not identify the scope of duties or when parties are at fault; instead, given a determination that multiple parties are at fault, it specifies how liability is apportioned among them.

Id. at *6.  There you have it—apples and oranges. 
Sixth, and certainly not least, the Arizona Supreme Court rejected arguments based on the Arizona Constitution’s anti-abrogation clause, which provides that “[t]he right of action to recover damages for injuries shall never be abrogated, and the amount recovered shall not be subject to any statutory limitation . . . .”  Ariz. Const. art. 18, § 6.  Several other states have comparable constitutional provisions, and plaintiffs’ lawyers often roll them out in opposition to civil justice reform efforts.  The plaintiffs’ lawyers rolled it out here (we are told that Justice Feldman likes the argument).  The Court, however, rolled it right back in, locked the door, and threw away the key.  It held unanimously that the anti-abrogation provision has no effect on the evolution of common-law claims, and the learned intermediary doctrine does not abrogate anything anyway: 

Moreover, the LID does not abrogate a right to recover damages, but instead provides a means for a manufacturer to fulfill its duty to warn the end user by properly warning the learned intermediary. . . .  It does not prevent a plaintiff from asserting an action against the manufacturer in appropriate circumstances, such as when the full medical information and warnings are not given to the medical provider.

Id. at *7.  In other words, plaintiffs can assert a failure-to-warn claim, just not the one they want.  Nothing about that offends the Arizona Constitution, which is welcome commentary on anti-abrogation provisions generally. 
The opinion is terrific, but the result is not a complete win for the drug manufacturer.  The Arizona Supreme Court declined to reinstate the trial court’s order dismissing the case and remanded the matter for further proceedings consistent with its opinion.  Perhaps the trial court will dismiss the case again, or maybe the manufacturer will have to raise the adequacy of the warnings or warnings causation on a motion for summary judgment.  Either way, the manufacturer’s duty to warn will run to the prescribing physician, and not the patient directly, and that is way it ought to be. 

Thursday, February 04, 2016

Pecking A Blow For Chicken Preemption

            It may have been our limited caffeine intake to that point in the day, but, when Bexis asked us to do a post on a case about representations about chicken, our initial thought was of some of the songs sung a la chicken.  Like this and this.  When we read the decision and saw it was authored by Judge Fischer, we thought about how fishers (the weasel relatives) kill and eat chickens and other “farmed” birds.  (They also kill and eat porcupines, which takes rare talent.)  At that point, our self-diagnosed mild adult ADD satisfied, we proceeded to read the case.  As you would expect if you read the title or had analyzed the trends of when we post about food cases, Arnold v. Kroger Co., No. C-150291, 2016 Ohio App. LEXIS 176 (Ct. App. Ohio Jan. 22, 2016), is not just a case about representations about chicken, it is a case about preemption state law claims based on those representations.

            The plaintiffs in Arnold brought purported class action under a variety of Ohio common law and statutory theories based on chicken labeled as “raised in a humane environment” and “humanely raised,” which they said was misleading because the chicken was raised like other mass produced (raised?) chicken.  (The chicken was supplied by a non-party company, which used to have television ads proclaiming “it takes a tough man to make a tender chicken,” which could cut for or against the “humane environment” depending on your view.)  Title 21 of the United States Code is divided into 27 chapters addressing various things about food and drugs.  Chapter 10 is from the Poultry Products Inspection Act (“PPIA,” which you can squawk if you try) and it includes a familiar express preemption provision along with various provisions on inspection, labeling and marketing of poultry.  A provision that preempts “marketing, labeling, packaging, or ingredient requirements . . . in addition to, or different than, those [from the PPIA]” should be fairly easy to apply.  Id. at **4-5.  For private civil actions for damages, the express preemption inquiry starts with the duty that plaintiffs seek to impose under the state law.  “Thus, the question here is whether the legal duty upon which each damages action is predicated constitutes an additional or different marketing, labeling, packaging, or ingredient requirement imposed by Ohio.”  Id. at *6.

            Other than some perverse desire to talk about chicken, we probably would not be discussing this case if the main analysis was all that was at issue.  The PPIA gives something called the Food Safety and Inspection Service (FSIS) authority to approve labeling for chicken and it determined the label for the chicken in this case was not false or misleading.  Therefore, by contending that specific language in the label—“raised in a humane environment” and “humanely raised”—was false and misleading, “any liability the Arnolds seek to impose based on their state-law claims would attach additional or different terms to the [chicken’s] labeling.”  Id. at **6-7.  That is pretty straightforward.

            The plaintiffs did try something creative, though.  They said the PPIA’s labeling purview does not extend to anything about the chickens while they are alive, just to the carcasses or portions of carcasses that are sold.  That did not avoid preemption for three reasons.  First, the PPIA prohibits labeling that is “false and misleading in any particular,” which logically includes representations about the prior state of the chicken.  Id. at *7.  Second, the PPIA’s requirement that chicken must be “wholesome, not adulterated, and properly marked, labeled, and packaged” to be sold is tied to a public health purpose, so the “Inspection” part of the Act is not divorced from the labeling part.  Id. at *8.  Third, FSIS published notice in the Federal Register recounting its finding that “birds that have not been treated humanely” many result in adulterated chicken that is “not acceptable for human food,” indicating humane treatment is part of the decision to approve labels.  Id.

            It seems to us that this is reminiscent of some of the attempted end runs on device preemption that we see, particularly where the theory of the plaintiff is that something about the materials that went into the finished product should have been the subject of additional warnings in the label.  Even if you start with the egg or the hen who laid it—we are not taking sides on the great debate—broad preemptive effect should follow from the requirement that a federal agency assure that labeling for the finished product, whether it be a device or a pack of drumsticks, is not “false or misleading in any particular.”  In addition, like the record that the FSIS pays attention to how the chicken lived in allowing its parts to be sold as food, there tends to be a record that FDA pays attention to materials selections and a bunch of other stuff in approving (or clearing) a device and its label.  A famous fast food commercial from the 1980s declared “parts is parts” in slighting a competitor’s chicken-based menu item.  This may not be an appetizing declaration, but the parts and materials that go into a PMA device should be part of the express preemption picture.

Wednesday, February 03, 2016

New Jersey Federal Judge Says It’s Not So Easy to Preserve Confidentiality of Discovery Documents

Fifty-seven years ago the Music Died.  On Feb 3, 1959, a small aircraft carrying rock and roll legends Buddy Holly (“Everyday,” ”It’s So Easy,” “Peggy Sue,” and a whole lot of other, crucial early rock and roll tunes), Ritchie Valens (“La Bamba,” “Come On, Let’s Go”), and J.P. Richardson, aka the Big Bopper (“Chantilly Lace”) crashed in Clear Lake, Iowa.  It is the precipitating event in Don McLean's eight and a half minute 1971 pop hit “American Pie.”  (Hence, “But February made me shiver/with every paper I’d deliver/bad news on the doorstep/I couldn’t take one more step.”) The plane was a four-seater, so only three passengers could join the pilot for the short flight to the next stop, which was  Moorhead, Minnesota – through a blizzard.  One of Holly’s backing musicians, Waylon Jennings, was also supposed to be on the plane, but he gave up his seat to the Big Bopper, who was suffering from the flu.  In some versions of the story, Jennings lost a coin toss.  But that is not the story on the official Waylon Jennings website.  In any event, Jennings rode the bus.  As a result, he lived another 43 years.  Fate gave Jennings a second chance.  He didn't waste it.  Jennings had a fine career as an outlaw C&W star. His catalogue is impressive:  “Luckenbach, Texas,” “Are You Sure Hank Done it this Way, “ “Mamas, Don’t Let Your Babies Grow Up to be Cowboys,” and many more.  Jennings was also the balladeer/narrator on the Dukes of Hazzard tv show. 

Jennings was also for a while part of a supergroup called The Highwaymen, which included a few other fellas you might have heard of:  Johnny Cash, Willie Nelson, and Kris Kristofferson.  And now our little account must take a legal detour.  There was an earlier musical group called The Highwaymen.  Some Wesleyan students got together to perform folk music.  Turns out they were pretty good.  They had a hit record in 1961 with their version of "Michael, Row the Boat Ashore."  Those original Highwaymen were an impressive lot.  Several went on to graduate school.  Stephen Trott was one of the Highwaymen.  He attended Harvard Law School, became a prosecutor, and later became a Ninth Circuit Judge.  So maybe it's not much of a surprise that these original, collegiate Highwaymen filed a lawsuit against Waylon, Willie, et al. for appropriating their group's name.  Like most cases, it settled.  Unlike most cases, the settlement included a provision permitting the original Highwaymen to share the stage with the more famous folks during a 1990 concert in Hollywood.    

Back to the main branch of our story.  Maybe Jennings never quite entered the pantheon alongside Holly.  Or maybe he did.  Either way, he did okay.  He used his second chance well.   

Holly, of course, was a genuine musical genius and had attained stardom by 1959.  Jennings back then was a sometime dj and sometime musician who had been given a big break when Holly invited him along on the Winter Dance Party tour.  As the musicians gathered outside that little plane on that cold, blustery Iowa night, Holly jokingly told Jennings he hoped the bus would break down and that Jennings would freeze.  Just as jokingly, Jennings said, “I hope your ol’ plane crashes.”  Understandably, Waylon was always haunted by that near miss back in 1959.  You can see a video of Jennings telling the story here


Today’s case is about a second chance.


We are talking about the dismal topic of document confidentiality.  Many -- definitely too many -- documents are produced in mass tort litigations.  Almost all those documents are produced by the corporate defendants.  Most end up having nothing to do with the case.  If two million documents are produced in an MDL, fewer than 200 are likely ever to be marked as exhibits at trial.  But producing all those documents is wickedly expensive for the company, a lot say things that no company would want to become public, so what the hey, why shouldn’t the plaintiff lawyers have a little fun?  A lot of those documents involve proprietary information about marketing, pricing, new avenues of scientific research, etc. – all things that a competitor would enjoy reading.  (We remember a professor in law school suggesting that companies wishing to engage in joint-pricing arrangements would be smart to file bogus law suits against each other occasionally and then use document discovery as a way of learning, and then coordinating, pricing strategies.  Yes, our law school had as many cynics as scholars.) 

Any right-thinking, diligent company will mark some discovery documents as confidential so as to limit dissemination.  Parties, their lawyers, and experts might be entitled to see the documents, but discovery documents need not be fair game for other assorted nosy Nellies.   Why did we call this topic “dismal”?  Because Judges are often hostile to the notion of document confidentiality.  Maybe they truly think that any case before them is necessarily a matter of public interest.  Or maybe they simply hate the administrative difficulties of sealing documents.  This much is clear: plaintiff lawyers revel in the opportunity to hand discovery documents over to press toadies who can help poison jury pools.  We know plaintiff lawyers who spend more time holding press conferences than cuddling up with the Rules of Civil Procedure or Evidence.  Sometimes a bloviating lawyer representing the press will intervene to get access to confidential discovery documents.  The plaintiff lawyer will pretend to honor the confidentiality order that he or she signed off on, but will also do a bad job of disguising the glee at the fact that the intervenor will do its best to undo the protections bargained for in the confidentiality order.  Here’s the point: maintaining confidentiality of litigation documents is an uphill battle. 

That uphill battle was on display in In Re:  Benicar (Olmesarten) Products Liability Litigation, 2016 U.S. Dist. LEXIS 7977 (D. N.J. January 21, 2016).  The defendants sought to seal some exhibits attached to the plaintiffs’ motion to compel discovery.   As is fairly typical in mass tort litigation, the parties had agreed to a confidentiality order that permitted a party producing proprietary, trade secret and/or highly sensitive commercial information to designate the material as “protected” if disclosure of the materials being produced could cause competitive harm to the producing party.  The documents at issue here included MedWatch forms, internal emails, study summaries, presentations on foreign regulatory requirements, correspondence with licensing partners, and various other materials.  The plaintiff opposed the sealing of those documents, arguing that the documents contain no personal patient information, trade secrets, proprietary information or sensitive commercial information.  The plaintiffs also argued that the defendants had not established that there is “legitimate private or public interest which would warrant sealing” and that the plaintiffs would suffer “a clearly defined and serious injury if their requested relief is not granted.”  The defendants argued that disclosure of the materials would reveal sensitive personal information of patients and the defendants’ business practices to competitors, as well as cause harm to the defendants’ reputation in the market-place.  The defendants also argued that disclosure of at least some of the documents was barred by federal regulations.

After applying a dreaded balancing test (public’s right to know vs. company’s interests in confidentiality), the court denied the defendants’ motion.  (Local Civ. Rule 5(c)(2) lists four factors, but take our word, it adds up to a balancing test.)  We say “dreaded” balancing test because, as Justice Black said long ago, application of a balancing test is often just a fig leaf covering a court’s  determination to do what it simply wants to do.  That’s inevitable and that’s okay – just realize that most courts will end up wanting not to keep litigation documents sealed.  In Benicar, the court based its denial of the motion to seal on its conclusion that the defendants did not include a competent affidavit or certification to support the elements of confidentiality.  There was a supporting affidavit, but the court held it to be insufficient because it was too generalized.  The affidavit, which was not drafted for the purposes of this motion but rather in support of a proposed discovery confidentiality order, established that the market for hypertension drugs is competitive, that defendants would be harmed by disclosure of some information sought by the plaintiffs, and that the defendants went to great lengths to maintain security.  Nevertheless, the court found that the affidavit failed to demonstrate the affiant’s personal knowledge as to how disclosure of the exhibits in question would create a “clearly defined serious injury.”  What more was needed? One example supplied by the court was that the affidavit needed to “address how a competitor viewing defendants’ internal analysis of foreign regulatory compliance would harm defendants.”  Even aside from the lack of specific, concrete evidence of competitive harm, the court questioned whether such competitive harm could overcome the public’s “paramount interest” in learning about side effects or “the operation of public agencies.” 

We do not agree with the court's reasoning, not even a little.  For example, the FDA has taken the position that MedWatch forms should be confidential.  But the court's undervaluing of confidentiality concerns hardly arrives as a bolt from the blue. 

Anyway, that’s the bad news.  The good news is that the court denied the defendants’ motion without prejudice regarding all of the exhibits save one.  The court made it clear that this dispensation of mercy was not “prompted by meritorious arguments, but rather the Court’s abundance of caution in the face of insufficient information.”  It will be an uphill battle for the defendants.  It always is.  We’re not sure we’ll ever encounter a judge who is truly open-minded on the issue of document confidentiality.  As Buddy Holly sang, “That’ll be the day.”    

Tuesday, February 02, 2016

First Complete PMA Preemption Win of 2016

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

             Today’s mainstream media may be all about another “first” that happened yesterday, but our attention is drawn to a state to the south and west of all that hoopla, Oklahoma.  Oklahoma doesn’t wade into the presidential political process until Super Tuesday, but in the drug and device world, Oklahoma gets center stage for getting PMA preemption just right.

             The case is Nevolas v. Boston Scientific Corporation, 2016 U.S. Dist. LEXIS 9893 (W.D. Okla. Jan. 28, 2016) and it involved a spinal cord stimulator which is a Class III, pre-market approved medical device.  That means the product is subject to the express preemption provision of the Medical Device Amendments of 1976 (“MDA”).  As a reminder that provision provides that:

[N]o State . . . may establish or continue in effect with respect to a device intended for human use any requirement --  (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
21 U.S.C. § 360k(a).  With that, few if any products claims survive preemption.  See Nevolas at *5.  To do so, the claim must be a parallel violation claim.  A parallel claim is a state law claim in which damages are sought for conduct that violates a specific federal regulation – thus state and federal law are equivalent and express preemption doesn’t apply.  But the claim itself must be a recognized state law claim.  Plaintiffs cannot sue solely because defendant’s conduct violated federal regulations – that would be an impermissible attempt to privately enforce the FDCA. 

Much of the PMA preemption case law in recent years has been focused on defining parallel violation claims and much of it has developed in the context of motions to dismiss.  Therefore, plaintiffs are faced with a double specificity hurdle.  Parallel violation claims must be based on specific requirements applicable to the device at issue and the complaint must contain specific factual allegations to satisfy TwIqbal.   This means the courts are determining whether the complaint sets forth “facts pointing to specific PMA requirements that have been violated.”  Id. at *6.  The Nevolas complaint fell far short.  The allegations were “devoid of any factual support” for the contention that defendant “violated in unspecified ways” various federal requirements.  Id. at *7.  There was simply nothing specific in any of plaintiff’s allegations.  Plaintiff cited to no specific facts.  Plaintiff cited to no specific device-related requirements.  At best plaintiff used conclusory language and referenced only general manufacturing regulations – not the type that support a parallel claim.  Id. at *7-8. 

At this point plaintiff argued that she could not have pleaded “more” because information on PMA devices is kept confidential and not available to plaintiff absent formal discovery.  Id. at *9.  While the court was sympathetic, it didn’t find plaintiff’s argument persuasive because plaintiff didn’t even attempt to allege a violation of a regulation that would support a parallel claim down the road:
The Court finds plaintiff's allegations that defendant was required to follow nonspecific federal regulations and current good manufacturing practice requirements, which are applicable to all manufacturers of all medical devices, are insufficient to state a plausible parallel claim upon which relief can be granted. Allowing a plaintiff to plead non-specific regulations as a basis for a parallel claim is inconsistent with the Supreme Court's reasoning in Riegel, as well as the pleading requirements articulated in Twombly [and] Iqbal.
It’s not a ground-breaking decision and plaintiff is being given a chance to amend.  But, it does toss the entire complaint on preemption and it’s the first to do so this year.  No deadlock here.  A decisive defensive win in Oklahoma.