Friday, November 27, 2015

Preemption 201 – Recent Cases Raising Specialized Issues

In case you haven’t noticed, we like preemption.  We’ve even called ourselves “obsessed” with it.  And with good reason.  Preemption, where it’s available, is the most powerful defense around – capable of wiping out an entire MDL with a single motion to dismiss.  Preemption is not dependent on the strength of a plaintiff’s underlying case.  It doesn’t matter how solid medical causation might be, or how much the prescribing physician has (or has not) been suborned during ex parte chats with the other side.  If preemption applies, than it’s bye-bye claim, and often bye-byeplaintiff.  No discovery necessary.

Thus, it’s not surprising that plaintiffs’ lawyers fight preemption tooth and nail.  That’s their job.  They are just as ethically bound to represent their clients zealously within the boundaries of the law as we are.  Thus they pick every preemption nit they can find.

That’s what we’re on about today.  We’re discussing some recent decisions that address some lesser-known – but equally deadly − preemption arguments. 

The first of these cases is Mink v. Smith & Nephew, Inc., ___ F. Supp.3d ___, 2015 WL 7356285 (S.D. Fla. Nov. 19, 2015), and as to Mink we’d like to give a shout out to Dave Walz of Carlton Fields, who sent us the decision, and the rest of the successful defense team, Ed Gerecke (also CFJB) and Doug Moore and Dave O’Quinn at Irwin Fritche.  Mink involved PMA medical device preemption under the rubric of Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Our PMA preemption scorecard now lists over 300 decisions, but Mink is the first one in which the plaintiff was a participant in an FDA-mandated post-approval clinical trial.

The Mink plaintiff’s status as a both a clinical trial participant and a user of a PMA device predictably produced unusual attempts to avoid preemption.  Here’s the first:  plaintiff “allege[d] that [manufacturer] breached an express or implied warranty by [] failing to honor the bargain that [plaintiff] would continue as a [post-approval] Study participant.”  2015 WL 7356285, at *2.  Here’s the second:  plaintiff brought “claims for breach of contract . . . and negligent misrepresentation,” both of which alleged that the manufacturer “failed to comply with the terms of the Consent to Participate Form by terminating him as a Study participant and declining to transfer [plaintiff] to another approved doctor to continue the Study.”  Id.

Nice try; no cigar.  As to the first claim, the court mentioned that, among the numerous preemptive FDA requirements applicable to PMA devices were that “a PMA applicant [must] produce comprehensive data from which the FDA can make a reasonable determination of the device’s safety and effectiveness, including the human clinical trials,” and that, as to such trials, “Class III devices are also subject to post-approval reporting requirements, including informing the FDA of new studies.”  2015 WL 7356285, at *4.  The presence of these FDA requirements was enough to bring the post-approval trial within the scope of the statute’s “different from or in addition to” express preemption clause, which was all she wrote:

Plaintiff contends that . . . [defendant] made negligent misrepresentations regarding the clinical study he was enrolled in.  But, he offers no facts in support of this assertion to establish a violation.  Instead, Plaintiff sets forth a laundry list of general regulations . . . that [defendant] allegedly violated.  These conclusory allegations amount to the same type of “magic words” or blanket claims that [applicable precedent] expressly prohibits.  These assertions . . . seek to impose requirements that are different from, or in addition to, the requirements imposed by the FDA.  As a result, the Court must hold that these claims are expressly preempted.

Id. at *6 (citations omitted).

The contract and misrepresentation claims based on the defendant’s alleged promise of free follow-up care to the plaintiff as a study participant fared no better.  The consent form allegedly constituting the contract was presented by the implanting physician.

[Plaintiff] cites no facts showing that . . . in obtaining Plaintiff's informed consent, [the surgeon] “was acting as [defendant’s] agent”. . . .  Plaintiff’s breach of contract claim is both insufficient under state law and also preempted by federal post-approval study requirements, which obligate the physician “investigator,” not the manufacturer, to obtain the patient's informed consent.

Id. at *6 (citing 21 C.F.R. §812.100).  The misrepresentation claim included an alleged promise of ten years of free followup care, however:

[T]his Study was dictated by federal statute.  Because this claim attempts to create requirements not imposed by federal law, it is expressly preempted. . . .  Even if federal requirements prohibited Plaintiff’s termination from the study due to relocation of his physician, a termination does not violate a Florida state law tort duty, as would be necessary to sufficiently allege a “genuinely equivalent” parallel claim.  Plaintiff does not cite to, and the Court is unaware of, any Florida law that requires a manufacturer to pay for postsurgical monitoring.

Id. at *7 (citing 21 C.F.R. §814.82(a)(2)).  Thus, it didn’t matter if plaintiff’s reading of the extensive federal regulations concerning clinical trials was right or not.  The claim fell because of the state-law side of the “parallel violation” track – where there wasn’t any pre-existing state-law duty for the alleged violation to be parallel to.  Mink stands for the proposition that participation in post-approval clinical trials doesn’t provide any extra basis for a plaintiff avoiding Riegel preemption.

In case anyone’s interested, Mink also addressed more widely seen, non-study-related claims, which were also preempted.  Id. at *8.

The second unusual preemption case was Allen v. Zimmer Holdings, Inc., 2015 WL 6637232 (D. Nev. Oct. 30, 2015), also involving PMA medical devices.  The outstanding feature of Allen was the regulatory pedigree of “one of the products at issue here, [which] was developed prior to the MDA and went through the FDA’s New Drug Application (“NDA”) process.”  Id. at *2.  The Medical Device Amendments were enacted in 1976.  After “the MDA came into effect, devices [that] had been treated as drugs prior to the amendments . . ., were automatically reclassified as Class III medical devices.  The MDA provided that these devices were deemed to have PMA approval if they had gone through the NDA approval process.”  Id. (citing 21 U.S.C. §§360j(l)(1), 360j(l)(3)(A).

Allen thus involved a device that had been used for decades.  Given its prolonged, successful use, it is not surprising that, after a while, “the FDA re-classified [it] as a Class II medical device.”  Id.

Thus, the preemption analysis in Allen involved two unusual aspects:  first, that the device was what’s called a “transitional device,” that is, dating from before 1976; and second, that the device had been downclassified from Class III to Class II.

The first issue, the device’s status as a pre-1976 transitional device, required little additional explication beyond what the Medical Device Amendments provided – that they are treated as PMA.  “Because the products at issue are deemed to have PMA approval, requirements are imposed under the MDA, and the first prong of the Riegel test is met.”  Id. at *4.  From there on out, standard preemption analysis applied – vague allegations and failure to flesh out any “parallel” claim doomed the plaintiff’s allegations.  Id.  Although Allen didn’t cite any cases for that result, it’s squarely in the mainstream, as a prior post of ours collecting transitional device preemption caselaw points out.

The court also took care of the second issue, downclassification:

This change does not affect the analysis here because preemption analysis focuses on how the product came to market, not its current classification.  Preemption necessarily looks backward (to the time of PMA) rather than forward because retroactive second-guessing on the FDA’s decision-making would interfere with the PMA process.  Thus, [the device] is still treated as having PMA approval for the purposes of MDA preemption analysis.

Allen, 2015 WL 6637232, at *2 (citations and quotation marks omitted).  That’s also the right result.  When we looked at downclassification a few years ago, every case to address it had found no effect on preemption.

Finally, the court pointed out that, in the context of this plaintiff’s surgery, the device at issue was effectively the component of the larger device system that had been implanted.  Component part status also didn’t undercut preemption:

Component parts, like the [device], are considered to have the same PMA approval as the device of which they are a component.  Thus both [devices at issue] are considered to have PMA approval for the purposes of MDA preemption analysis.

Id. at *3.

As with Mink, Allen also contains more mundane preemption analysis – pleading and a discussion of express warranties – for those interested in yet another citation on those points.

Finally, because not everything is skittles and beer, here’s a new and unfortunate twist on the generic drug preemption concept of “duty to update.”  PLIVA, Inc. v. Dement, ___ S.E.2d ___, 2015 WL 7431346 (Ga. App. Nov. 20, 2015).

We’ve said before that duty to update claims, even putting aside preemption, are lousy claims on the merits.  Medical causation is hard to prove because the period without updating is often only a fraction of total use of the drug.  Warning causation is hard to prove because prescribing physicians often don’t read generic warnings, updated or not.  The plaintiff in Dement managed to slip through preemption a duty-to-update claim tied to a “misbranding” allegation:

Similarly, Mensing does not require dismissal of [plaintiff’s] claims based on the generic drug manufacturers’ failure to suspend or withdraw sales of a “misbranded” drug.  [Plaintiff] alleged that the generic drug was misbranded because the generic drug manufacturers failed to, inter alia, include information that they were required to include, namely the 2004 update.  She alleged that Georgia law prohibits drug manufacturers from selling misbranded drugs, and that state law parallels federal law in that regard.

2015 WL 7431346, at *3.  Supposedly, this tying of misbranding to updating means that it “not impossible for the generic drug manufacturers to simultaneously comply with both state and federal law.”  Id.  This rationale is an attempt to fix at least the warning causation problems with duty-to-update claims, since if the very presence of the product on the market is the tort, then a learned intermediary’s reliance on its warnings doesn’t matter.

However, the court in Dement provided neither a rationale nor precedent for that statement, because there is none.  The plaintiff-side’s simultaneous compliance argument in an ordinary duty-to-update argument is decent, as long as one ignores that “updating” is an FDCA requirement that can’t be privately enforced under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  But, putting Buckman aside, the update-based claim described above isn’t a demand to change warnings, but a demand to “suspend or withdraw sales.”  That’s barred under Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), not because of simultaneous compliance issues, but because the so-called “stop-selling” argument simply proves too much – it would do away with preemption altogether.  “[A]dopting [a] stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court's pre-emption case law.”  Id. at 2470.

We reject this “stop-selling” rationale as incompatible with our pre-emption jurisprudence.  Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless. . . .  Adopting the . . . stop-selling rationale would mean that not only [Mensing], but also the vast majority—if not all—of the cases in which the Court has found impossibility pre-emption, were wrongly decided.  Just as the prospect that a regulated actor could avoid liability under both state and federal law by simply leaving the market did not undermine the impossibility analysis in [Mensing], so it is irrelevant to our analysis here.

Id. at 2477-78 (citations and quotation marks omitted).

So Dement took the rationale for one type of duty-to-update claim (warning-based), and applied it to a new and completely different type of claim (misbranding/stop-selling based), while totally ignoring the real reason why the Supreme Court broadly rejected the stop-selling argument as “revolutionary” in Bartlett.  It’s like adding two plus a brick and getting moldy Thanksgiving leftovers – the novel duty to update equation in Dement simply doesn’t add up.

Wednesday, November 25, 2015

The Risks of Plaintiff Lawyer DTC Advertising

We have been riding the Philly subway for years, but only recently realized how much the ads on the car walls have changed. Not so long ago there were lots of ads for vocational schools, inducing today's un- or underemployed to become tomorrow's truck drivers and beauticians.  But nowadays at least three quarters of the ads are from plaintiff lawyers hawking their ability to wring cash out of slip-and-falls or the latest mass tort.  Mass transit advertising space that formerly advised riders to get skills is now dedicated to pleas to get paid.  The same is true for daytime television advertising.  Perhaps we are not alone in seeing this evolution as further proof, along with Keeping up with the Kardashians and the ascendancy of kale salad, that our culture is headed to Hell in a handbasket.

You won't be surprised to hear defendants and their lawyers bemoan plaintiff lawyer advertising.  But we are not alone.  Recently, we heard a MDL judge express frustration about how plaintiff lawyer advertising was a blatant attempt to extend the tail of an over-mature mass tort.  Some plaintiff lawyer advertising is naked poaching of other plaintiff lawyer inventories - e.g., why pay a 40% contingency fee if you can pay only 20%?  But the most obvious aim and effect of such advertising is stirring up litigation.  What might not be so obvious is the extent to which plaintiff lawyer adverting causes adverse health outcomes.  A recent law review article looks into this issue and it is well worth reading. The article is by Elizabeth Tippett, a professor at the University of Oregon School of Law. The title is "Medical Advice from Lawyers: A Content Analysis of Advertising for Drug Injury Lawsuits," 41 Am. J. L. & Med. 7 (2015).

Tippett and her team looked at plaintiff lawyer advertising in Boston and Atlanta where the purpose of the ads was to recruit consumers for lawsuits against drug manufacturers.  About half the lawyers behind the advertising actually litigated cases, while the other half appeared to be referral or settlement mills.  Many of the ads obscured the fact, or at least delayed disclosure, that the ads were taken out by lawyers.  Some ads did a snazzy job of looking like public service announcements.  Reference to the FDA was often highlighted.  ("FDA Warning" "Consumer Alert"). The ads must work in terms of recruiting clients, given that there are so many of them.  Regulation by the relevant state bar appears to be de minimis.  The issue is whether such advertising affects consumer medical decisions.

There is a rich twist at work here.  Plaintiff lawyers harp on allegations that pharmaceutical direct-to-consumer advertising distorts patient risk perceptions and is so pernicious as to call off the learned intermediary rule and open the door for massive liability.  But it turns out that plaintiff lawyer advertising might well have a more profound effect on risk perceptions. At least if a manufacturer's ad inspires a patient to seek out a specific medicine, that patient must go through a doctor -- a learned intermediary -- who will make an informed medical decision.  By contrast, if a plaintiff lawyer ad terrifies a consumer into avoiding or ceasing a treatment, that consumer can make a very bad decision without ever consulting a doctor.  Few of the plaintiff lawyer ads advise consumers to talk with their doctors, and when they do it is typically in the fine print. Much better to talk to a lawyer, right?

And it turns out that plaintiff lawyer advertising really does distort risks.  Adverse events are described in the most alarming language: "fatal," "life-threatening," "disfiguring."  There is seldom any reference to the absolute risk rate, which is usually quite low.  There is usually no reference to the relative risk or background risk rate.  There is usually no reference to relevant subpopulations (e.g., long-term users). If a product recall is specific to one manufacturer, the plaintiff lawyer ad will likely elide past that fact and pretend that any problem is industry-wide. There is almost never a reference to the benefits of the drug.  Forget about fair balance.
And forget about everything the FDA requires to be included in manufacturer DTC advertising.

As is typical with law review articles, the portion describing the issue is more interesting and useful than the portion proposing a solution.   State bars are skittish about regulating the advertising of their members, and there is first amendment jurisprudence supporting such skittishness.  Still, the first amendment should not prevent the powers that be from reeling in speech that is as ridiculously misleading as so many of these plaintiff lawyer ads seem to be.  Model Rule 7.2 says that lawyer ads omitting material facts are misleading and forbidden.

The article is fascinating. It has the marvelous effect of confirming our prejudices and adding firepower to our arguments.  On this day before Thanksgiving, this thoughtful law review article gives us yet another reason for gratitude

Tuesday, November 24, 2015

Largely Thankful For The Second Circuit Striking A Blow Against Generalized Proof of Causation

            This being the week of Thanksgiving, we would be remiss to fail to weave in something about the great American (or ‘merican) holiday of giving thanks, eating turkey, watching football, and pondering the influence of the Pilgrims on our culture (beyond the obvious lasting fashion impact).  In the past, we offered our readers a “fun” word search for food and drink terms in a post on express preemption.  (Yes, the terms “fun” and “express preemption” are rarely linked in a single sentence, although “Today was no fun because I had to write a brief on express preemption” has probably been uttered.)  We have offered other posts at this time of year that featured food to different degrees, like this and this.  We have talked about reasons for being thankful, how football analogizes to law, and even how shopping has become a big part of this particular holiday.  Surely, we have given our readers many reasons to ponder deeply on important issues in their lives.  Why is stuffing called dressing in the South?  Why did some combination of the Civil War, Restoration, and carpetbaggers not force a gastro-linguistic solidarity?  Do elementary school depictions of Native Americans (f/k/a Indians; a/k/a indigenous peoples of North America, pre-Colombians, Amerinds, descendants of those who migrated across Beringea) send the right message?  Should second graders learn about smallpox blankets?  Was the choking risk with that third plate of food, after more than a few adult beverages, an acceptable one?  We would like to think that we have contributed to such meaningful introspection with our purportedly clever posts during this week every year since the blog started being purportedly clever.
            This year, we highlight a truly American tradition:  trying to make as much money as possible by suing a deep pocket defendant with as little proof as possible.  Recently, this has often involved combining three things.  First, use remedial federal or state statutes that are really for another purpose entirely, but allow for big damages and even fines (e.g., the False Claims Act was enacted against war profiteering, RICO was enacted to combat organized crime).  Second, seek to proceed on behalf of a class and/or some subset of the “public” to maximize the claims at issue.  Third, use only generalized proof of injury, causation, and damages, which is required for a class but does not require a class.  We could add in piggybacking on an issue with a product that has gotten attention because of other litigation or regulatory actions and outsource the work to contingency lawyers.  Such cases have been the subject of many posts, often addressing how generalized proof of causation makes no sense in the context of drugs prescribed to specific patients by specific doctors based on, hopefully, individualized clinical judgment.  High on the list of opinions that got it wrong are Kaiser Foundation Health Plan, Inc. v. Pfizer, Inc., 712 F.3d 21 (1st Cir. 2013), and the rest of the First Circuit’s Neurontin trilogy, which took the top spot in our list of worst decisions of 2013.  High on the list of opinions that got it right is the Second Circuit’s Zyprexa decision, UFCW Local 1776 & Participating Health & Welfare Fund v. Eli Lilly & Co., 620 F.3d 121 (2d Cir. 2010), which took home best decision in 2010 by reversing the second worst decision of 2008.  The Second Circuit’s in Sergeants Benevolent Assoc. Health & Welfare Fund v. Sanofi-Aventis U.S. LLP, No. 14-2319-cv, 2015 U.S. App. LEXIS 19797 (2d Cir. Nov. 13, 2015), adds to the weight of the good cases rejecting the misuse of generalized proof of causation by affirming class certification denial and summary judgment in a RICO (and state consumer protection) case over the antibiotic Ketek.

            If the case seems familiar based on that description, then you might need to broaden your non-blog interests.  We did post on the summary judgment decision last year and on the class certification decision more than four years ago.  The timing of the decisions highlights another issue with these cases:  they last a long time.  Sergeants was brought back in January 2008, was on its third complaint within five months, and stuck around the district court for six more years until summary judgment—only to then head up on appeal.  With the benefit of some of the decisions like the Second Circuit’s in Sergeants—which could have gone a little farther to close the loop—we would hope that future cases based on nonsensical generalized proof of causation do not linger so long.  We crib from our prior post on summary judgment in recapping the pertinent facts:
The basic facts underlying the various claims was that defendant’s antibiotic was approved to treat acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and community-acquired pneumonia, after FDA required a further clinical study in rejecting the initial New Drug Application.  Plaintiff claimed there was a conspiracy in relation to this further study, which was itself saddled with misconduct by multiple investigators, and defendant misrepresented the results of the study to FDA.  Thereafter, defendants allegedly marketed the drug off-label, there was a FDA public health advisory and labeling change about a risk of liver failure, FDA withdrew the sinusitis and bronchitis indications, and the defendant stopped promoting the drug in the U.S.  Within this relatively short period of time, the plaintiff Funds and Louisiana each claim they paid extra for their members’ antibiotics, although they have different methods of determining what drugs they cover and how they pay for them.  The plaintiffs, of course, do not decide whether a member should be prescribed a drug or which drug should be prescribed.  2014 U.S. Dist. LEXIS 65714, *11.
Unlike the district court, which did not even mention Neurontin, the Second Circuit spent a fair amount of time looking at the issue of whether a RICO case could ever be based on just generalized proof of causation, even though it agreed that the proof offered here was insufficient to either certify a class or get past summary judgment.

            RICO requires proof of proximate causation between the alleged fraud and the alleged injury, a showing of direct or indirect reliance for each plaintiff/claim will typically be required.  Because class actions require the predominance of common issues and generalized proof of causation, “it is quite difficult, though not impossible to certify a class in a RICO mail-fraud case.”  2015 U.S. App. LEXIS 1979, *40.  In addition to Zyprexa, the court pointed to the purchasing decisions of light cigarette smokers allegedly mislead by health claims and the decision to gamble at a particular casino based on allegedly misleading claims about odds as the sort of individualized decisions that are not amenable to class certification.  Id. at **41-43.  Rather than ending there with the conclusion that there is no way that proving why a particular prescription was written would be a less individualized inquiry—there are many soundbites about “the individualized nature of physicians’ prescribing decisions”—the court kept open the possibility of proof  that “the class members all faced ‘the same more-or-less one-dimensional decisionmaking process,’ such that the alleged misrepresentation would have been ‘essentially determinative’ for each plaintiff.”  Id. at *43 (citing a law review article).  We think this is description of a null set when it comes to a prescription drug RICO case and the type of evidence suggested that might fill it in unusual cases poses other problems.  Cases predicated on why drugs cases were prescribed to individual patients are not like the “fraudulent overbilling” cases where “payment may constitute circumstantial proof of reliance based on the reasonable inference that customers who pay the amount specified in an inflated invoice would not have done so absent reliance upon the implicit representation that the invoiced amount was honestly owed.”  Id. at *44 (quoting In re U.S. Foodservice Inc. Pricing Litig., 729 F.3d 108, 120 (2d Cir. 2013)).  The evidence offered in Sergeants, like the evidence offered in Zyprexa, was nowhere near what would allow an inference of reliance for every decision to prescribe the drug to each class member.
            Plaintiffs contended in Sergeants that “safety is the preeminent consideration in prescribing an antibiotic, so that had physicians known about Ketek’s ‘true’ risks, none of them would have prescribed it.”  Id. at *50.  This sounds quite a bit like one of the formulations of strict liability design defect.  Unlike in product liability cases where what physicians think matters to a decision to prescribe a particular drug will come from the mouth of a physician, the plaintiffs in Sergeants tried to prove their proposition through three other types of evidence:  1) the analysis of their frequent flyer statistician that drops in the number of prescriptions after additional liver warnings indicated that prior prescriptions must have been written in reliance on misrepresentations on safety; 2) the FDA’s subsequent decision to withdraw two of three indications for the drug; and 3) a study they contended showed a higher risk of liver toxicity than another antibiotic.  Each was rejected based on its merits.  The statistical analysis could not “support an inference that all pre-disclosure Ketek prescriptions were written in reliance on Aventis’s alleged fraud” because it failed to consider “significant larger changes in the market for anti-infectives” and that company stopped promoting it.  Id. at **52-54.  As such, the mere correlation to lower prescription volume was insufficient to show causation for each prescription.  FDA’s decision to withdraw two of the drug’s indication did not support plaintiff’s causation theory because it was not tied solely to safety, let alone to hepatic risks.  (It also was not a decision that the drug should be withdrawn or that the prior decision to approve the withdrawn indications had been wrong.)  The study did not support plaintiff’s causation theory mostly because it was viewed as being non-informative based on investigator fraud.  Moreover, the drug’s overall risk profile was generally in line with those of other antibiotics.  So, the plaintiffs could not prove causation for purposes of class certification or avoiding summary judgment—as they did not bother to generate individualized prove of causation for even the named plaintiffs.  That is well and good and we suspect that most RICO cases by payors for prescriptions drugs would do no better.

            Not to appear unthankful, but we find the court’s discussion of how some other case might prove causation through theoretical generalized evidence to be problematic.  First, the touchstone of plaintiffs’ case was that the manufacturer withheld material information on the drug’s safety and efficacy from FDA, “rendering Aventis’s marketing materials for Ketek misleading to the extent that those materials suggested that Ketek had ‘valid’ regulatory approval.”  Id. at **50-51.  While the court pointed out that the plaintiffs’ version of facts was off, it missed the larger point that this sort of fraud on the FDA should not be the basis of a claim.  For the state claims, this walks right into Buckman preemption.  For RICO—remember, preemption is based on the Supremacy Clause so it does not apply to conflicts between federal law—there should be a primary jurisdiction issue.  Second, setting aside fraud on the FDA, the court’s formulation that causation might be inferred for all prescriptions for “a drug so dangerous that no physician would ever prescribe it to treat a non-fatal condition if that physician were aware of its true risks” also invites the jury to second guess FDA’s decisions to approve the drug and not withdraw it.  The flip side of FDA’s unusual decision to withdraw two of Ketek’s indications is that it decided to the drug on the market based on a weighing of its risks and benefits.
            Third, whereas plaintiff’s statistician did a “simplistic” analysis in this case, the court pointed out that she had done a more rigorous regression analysis for the plaintiffs in Neurontin in trying to suggest that off-label prescriptions were due to off-label promotion.  The court stated that physician reliance on misrepresentations “can be proved to a jury with sufficiently powerful aggregate evidence, as opposed to individualized inquiries as to each prescribing physician’s actual decisionmaking.”  Id. at **68-69.  Statistics are ill-suited to answer questions of why each of thousands of prescriptions for a drug was made.  While a thorough regression analysis might quantify the impact of one variable against specific other variables, it is unlikely to consider every variable that impacts the decision to prescribe a particular drug and will never be able to identify which particular prescriptions were written because of reliance on the misrepresentation.  Even if the analysis suggested that, for example, 70% of the prescriptions were due to a misrepresentation and 30% were not, then class certification seems inappropriate.  The percentage of injury cannot be blurred across the class.  Relatedly, we do not see how “it may be possible to demonstrate classwide RICO causation in a case such as this one by adducing generalized proof from which a reasonable jury could conclude that only some prescription paid for by each class member were written based on the defendant’s alleged misrepresentations.”  Id. at *61 (emphasis in original).  The RICO requirement of an “actual quantifiable injury” to each plaintiff—or class member—makes insufficient proof that just some prescriptions were caused by the misrepresentation.  For an individual plaintiff, how many prescriptions were caused by a misrepresentation would surely turn on direct evidence about those prescriptions including some evidence from the physicians who wrote them.  The expediency of the class action mechanism should not reduce the proof needed to make out a substantive claim.  Particularly when the potential damages are so high—even without statutory trebling or fines—this can quickly become an issue of due process.  We could try to draw some link between the Pilgrims and due process, but they burned suspected witches based on proceedings that bore no hallmarks of due process.  So, we will leave it at that.

Monday, November 23, 2015

Ghostbusters – Phantom “Parallel Claim” Exorcized by Generic Drug Preemption

With claims related to warnings, design, and recall all preempted, plaintiffs seeking to sue makers of generic drugs don’t have many options.  After all, as we’ve discussed before, if state common law can’t require changing a defendant’s warnings, changing the design, or making the defendant stopping selling the product altogether, there’s not much left for a plaintiff to allege.

One straw that generic drug plaintiffs have grasped at is the footnote in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), “not address[ing]” the issue of “parallel claims” – facially dictum about something not raised in Bartlett:

We do not address state design-defect claims that parallel the federal misbranding statute.  The misbranding statute requires a manufacturer to pull even an FDA-approved drug from the market when it is “dangerous to health” even if “used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.” 21 U.S.C. § 352(j).  The parties and the Government appear to agree that a drug is misbranded under federal law only when liability is based on new and scientifically significant information that was not before the FDA.

Because the jury was not asked to find whether new evidence concerning [the drug] that had not been made available to the FDA rendered [it] so dangerous as to be misbranded under the federal misbranding statute, the misbranding provision is not applicable here.

Id. at 2477 n.4 (other citations omitted).

Plaintiffs tried to slime the defendants with that footnote in one of our favorite cases, In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), but they hadn’t pleaded anything of the sort, so the court held they couldn’t change their theories on appeal.  Id. at 930 (regardless of anything else, “the house [of cards] collapses based on their deficient pleading”).  Darvocet pointed out that the Supreme Court’s footnote musings didn’t mean either that such claims existed or that they escaped preemption:

Academics, commentators, and even the parties to this case are not clear on what precisely Footnote 4 means and what its impact might be. . . .  In Bartlett, the FDA argued in an amicus brief that . . . “pure” design defect claims . . . are preempted unless they “parallel the FDCA’s drug ‘misbranding’ prohibition”. . . .  It is not clear whether this [Supreme Court footnote] implies that an exception for “parallel misbranding” claims actually exists.

Id. at 929 (citations omitted).

We’re pleased to report that, although generic plaintiffs recently took another shot at Bartlett footnote 4 in a different MDL, they once again drew back a nub.  The decision is In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2015 WL 7272766 (S.D. Ill. Nov. 18, 2015), and while it likewise avoided a definitive pronouncement on whether a footnote four claim actually existed in the first place, it significantly narrowed the scope of any such hypothetical phantasm.

Here’s how Yasmin/Yaz busted the “parallel claim” ghost.  First, it recognized the questionable provenance of any implied preemption exception at all for “parallel claims.”  That’s express preemption terminology and “the background of Footnote 4 raises a legitimate question as to whether Bartlett indicates an exception for ‘parallel misbranding’ claims actually exists.”  2015 WL 7272766, at *4.  The court did not need to answer that question, however, because it agreed with the defendant’s “position as to ‘pure’ design defect claims.”  Id.  That position was that plaintiffs were not – and could not – assert such a “pure” version of design defect.

The problem was that Illinois design defect claims did not come in one if the pre-chosen forms.  No “pure” design defect claim was available under Illinois law because that state follows Restatement (Second) of Torts §402A, comment k (1965):

Illinois has adopted comment k of the Restatement (Second) of Torts § 402A, whereby a drug is not defectively designed if it is “unavoidably unsafe and is properly prepared and there are adequate warnings.” Accordingly, the viability of plaintiff's design defect claim necessarily turns on the adequacy of the subject drug's labeling.  The Supreme Court has held that a claim of this nature is preempted.

Yasmin/Yaz, 2015 WL 7272766, at *4.  Comment k’s “unavoidably unsafe” defense is inextricably interlinked with the the adequacy of a manufacturer’s warnings because even where a risk is unavoidable and can’t be designed out of a product, liability may still attach, regardless of design, if the warnings about that risk are inadequate.  Even if called a “design” claim, in practice under comment k the allegations depend on warnings.  Therefore, “[b]ecause the plaintiff's design defect claim necessarily turns on the adequacy of [the] product labeling, the claim is preempted.”  Id.

That’s a big deal because almost every state follows comment k in some way (the Erie-ignoring Mesh MDL notwithstanding).  Some states apply comment k on a case-by-case basis, others across the board, but they all recognize the concept of “unavoidably unsafe” products with risks that can only be warned about.  We discussed this at length back in 2011, and our 50-state survey concluded that only Alaska, Wisconsin, and maybe Nevada outright reject comment k.  A few other places (Delaware, Puerto Rico, Vermont, Virginia, and the Virgin Islands), haven’t ruled one way or another about comment k – in the case of Delaware and Virginia because they never adopted §402A strict liability in the first place.

Every other state follows comment k in one way or another (and we’re not sure what’s going to happen in Wisconsin post-tort reform).  Thus, under the Yasmin/Yaz rationale, even the ghostly cause of action hinted at in Bartlett’s footnote four can’t even haunt preemption in the vast, vast majority of generic drug cases.

That’s the big news about Yasmin/Yaz.  There’s some little news, too.  For the sake of completeness, we’ll also go through that.  Negligent misrepresentation, fraud, express warranty, and consumer fraud were “all premised on alleged misrepresentations or inaccuracies in [the drug’s] labeling.”  Id. at *5.  Cue the electric shocks, they’re preempted.  Id.  Plaintiffs didn’t have a scrap of evidence of any manufacturing defect, so the court refused plaintiff’s request for a fishing expedition.  Id. at *6.

Barring supernatural activity, this decision should sound the death knell for generic drug-related claims in the Yasmin/Yaz.  Preemption came, saw, and you know…. prevailed.

Friday, November 20, 2015

J & J Files Cert Petition in Massachusetts Supreme Court’s Unsupportable Rejection of Preemption Defense in Reckis TEN/Children’s Motrin Case

Back in April, we blogged about the Massachusetts Supreme Court’s head-scratching rejection of defendants’ preemption defense in Reckis v. Johnson & Johnson, 471 Mass. 272, 2015 Mass. LEXIS 169 (Mass. April 17, 2015).  As that post described in detail, Reckis involved devastating injuries to a 7-year-old child whose toxic epidermal necrolysis (“TEN”) was allegedly caused by Children’s Motrin   The jury awarded $50 million in compensatory damages, and awarded $6.5 million in loss-of-consortium damages to each of the child’s parents. 

After trial, defendants moved for JNOV, arguing, inter alia, that they were entitled to judgment as a matter of law because plaintiffs’ warnings claim was preempted, under principles of implied conflict preemption.  Under Wyeth v. Levine, defendants’ argument seemed airtight. Under Levine, 555 U.S. 555, 571 (2009), there is “impossibility preemption” – preemption because it is impossible to comply with both state and federal requirements – when there is “clear evidence that the FDA would not have approved” the labeling change the plaintiffs seek.  Plaintiffs’ failure-to-warn claim argued that the Children’s Motrin label should have contained certain specific language related to TEN.  But the FDA had already rejected identical language when that language was the subject of a Citizen Petition.   Could there be any clearer evidence than an FDA decision rejecting the very language plaintiffs identified?   The Reckis court apparently thought so, since “actually did not” wasn’t “clear” enough for that court.  Even though the substantive FDCA standards were identical, the court speculated that it could have made a difference if the FDA had considered a manufacturer’s request instead of a third party’s petition, 471 Mass. at 290, a rationale that impermissibly assumes that the FDA doesn’t always adhere to its own evidentiary standards.  The Reckis court’s refusal to recognize preemption under any set of facts was so blatant that we concluded, “If the Supreme Court meant what it said in Levine, evidently it will have to say so again.”

And the Court will have that opportunity, if it chooses to seize it.  On August 18, defendants filed their Petition for a Writ of Certiorari, posing this question:  Whether the Massachusetts Supreme Judicial Court erred when it held, in direct conflict with the Seventh Circuit, that FDA's rejection of warning language proposed in a Citizen Petition is not “clear evidence” sufficient to preempt state tort claims that the manufacturer was obligated to add the FDA-rejected language to its drug's labeling.” Johnson & Johnson v. Reckis, 2015 WL 6083499 (U.S.) at *i.

Defendants pointed out that, “[f]aced with the same allegations targeting the precise drug warnings at issue here, the Seventh Circuit held that FDA's prior rejection of a so-called Citizen Petition proposing additional warnings constituted the “clear evidence” [Levine] said was needed to preempt such claims.” Id., at *3 (citing Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010)).  That’s a direct conflict between a federal court of appeals and a state court of last resort on a question of federal law– something squarely in the Supreme Court’s job description. In declining to follow Robinson, defendants argued, the Massachusetts court “erected hurdles so high that it is hard to imagine any case satisfying the “clear evidence” standard it articulated,” creating a rule that has no “basis in [Levine] or common sense.” Id.  

Defendants concluded, “Particularly given the record here, this case is an ideal vehicle for providing much-needed guidance to the lower courts and restoring content to the “clear evidence” standard.”  Id. at *5.  We agree, and so do a host of advocacy groups – PLAC, the Chamber of Commerce of the United States, the Washington Legal Foundation , and the Biotechnology Industry Organization, the Consumer Healthcare Products Association, and the Pharmaceutical Research and Manufacturers of America -- that have filed amicus curiae briefs.  We recommend them.  They say practically everything that can be said about Levine and implied FDCA preemption.

And so it is up to SCOTUS to determine whether Levine’s legacy is to be anything other than complete evisceration of the doctrine of impossibility preemption (at least as to branded prescription drugs). We will keep you posted. 

Thursday, November 19, 2015

Incretin Preemption Part II – California Tosses Failure to Warn Claims Too

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

Last week we posted about the decision in In re Incretin-Based Therapies Products Liability Litigation (S.D. Cal.) dismissing plaintiffs’ failure to warn claims as preempted based on the Wyeth v. Levine  “clear evidence” standard.  That is “clear evidence” that the FDA would have rejected the warning sought by plaintiffs, which leads to implied preemption based on impossibility.

At that time we had heard that the judge presiding over the consolidated incretin litigation in state court in California would be issuing a similar ruling.  That turned out to be correct.   Here is a link to the decision, In re: Byetta Cases, Case No. JCCP 4574 (Cal. Super. Nov. 13, 2015).  The ultimate conclusion is the same:  the evidence demonstrates that on multiple occasions the FDA considered and rejected a causal association between incretin and pancreatic cancer and likewise concluded that the drug’s labeling did not require revision.  In re: Byetta Cases, slip op. at 15-18. 

We aren’t going to re-hash the impossibility preemption analysis again; we think the federal court decision handled the issue more than well enough.  But, we will point out a few interesting points made in the state court decision.

First and foremost, the court spends a significant amount of time dealing with the issue of whether impossibility preemption, at least in this context, is a question of law for the court or a question of fact for the jury.  Id. at 18-26.  While the court found no other case that directly answered the question, they did note that the U.S. Supreme Court in deciding Levine and every court to have considered the Levine clear evidence standard since have treated the issue as a question of law.  Id. at 19-20.  Citing things like the need for consistency on a defense “equally operative to all similarly situated plaintiffs,” and the difference between analyzing legislative facts as opposed to adjudicative facts, the court concluded that deciding the federal preemption issue was “an analytical process where legal training and experience add value and where a jury’s unique ability to test credibility is not as useful or material.”  Id. at 24. 

Having decided that it could decide the question, the court moved on to the substantive analysis, starting with a discussion of what the “clear evidence” standard really means.  The court reasoned that “clear evidence” is something more than a preponderance but less than indisputable – meaning it is closest to a “clear and convincing” standard.  Id. at 27-28.  To our knowledge this equation of “clear” to “clear and convincing” is a unique finding among the courts to have considered/applied the Levine test.  Does it make the standard any “clearer” to apply?  Questionable.  But we like the position that “clear” doesn’t mean “indisputable.”   

Not only did the court define the standard, it also put a finer point on the actual question to be answered:

It should be clearly noted that the question posed by Wyeth v. Levine is NOT to second guess whether the FDA should have allowed such a CBE, NOR whether or not the FDA of its own accord should have required a label change to add such a warning.  Further, the question presented is not whether or not there is admissible scientific evidence that one of these drugs causes pancreatic cancer, which is a different question.
Id. at 10-11.  All valid points and all things that plaintiffs use to distract the court from the real preemption question. 

So, the court answered the very specific question of whether there was “clear and convincing” evidence that the FDA would have rejected the warning plaintiffs allege should have been given.  The state court answered the question affirmatively – for essentially all the same reasons the federal court did.  Notably, the state court like the federal court would not consider plaintiffs’ arguments regarding information allegedly withheld from the FDA as those are preempted fraud-on-the-FDA claims.  Id. at 29.  The state court decision also rejected the plaintiffs’ notion that defendants were required to seek a label change and be rejected for there to be preemption:

The one piece of the puzzle arguably lacking is the fact that there was never a CBE request for a manufacturer seeking to add a pancreatic cancer warning, but plaintiffs and their advocates expect too much when they make the assumption that a manufacturer would make an insincere, factually unsound request for a CBE to add an otherwise unjustified warning . . . just to obtain a denial letter.  There is no cognizable legal obligation on the defendants to do so as a predicate to invoking impossibility preemption under Wyeth. 
Id. at 30-31. 

            As both the federal and state court decisions demonstrate, the facts of the incretin FDA story are hardly equivocal.  If this set of facts and statements by the FDA didn’t warrant Levine preemption, we aren’t sure what else other than an outright rejection of a CBE would be “clear evidence.”  Fortunately, that’s not what happened here and even though the facts were incredibly favorable, the legal analysis is also defense-friendly and hopefully helpful to those of you fighting a Levine battle of your own. 

Wednesday, November 18, 2015

Medical Device Manufacturers as "Health Care Providers"

We’ve read a fascinating new case out of Texas, Verticor, Ltd. v. Wood, ___ S.W.3d ___, 2015 WL 7166024, No. 03-14-00277-CV, slip op. (Tex. App. Nov. 13, 2015), posing the question whether a medical device company can be a “health care provider” within the meaning of that state’s pretty restrictive laws regarding medical malpractice.  While rejecting the manufacturer’s appeal on the record before it, the court in Venticor didn’t flatly say “no.”  Instead, it held:

As the issue is framed here, [[manufacturer’s] license authorizes it “to provide” (at least in the sense of manufacturing and selling) the [device] − and nothing more.  Consequently, [manufacturer] can be “licensed . . . by the State of Texas to provide health care” only if the [device] is, in itself, “health care” as the [statute] defines that term. . . .  Under it, “health care” is distinguished by either of two nouns − “act” or “treatment” − that is “performed or furnished,” or should have been, “for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement.”  The first alternative, an “act,” denotes some sort of deed or activity.  As an inanimate object, [the device], in itself, could not be an “act,” although it might be utilized in acts that qualify as “health care,” such as surgery.  Similarly, the other alternative, “treatment” also denotes some form of activity that is performed or furnished for or to a patient. Consequently, the [device] would not, in itself, be a “treatment,” although it might be utilized in a “treatment.”

Verticor, slip op. at 10 (footnotes omitted).  All this manufacturer submitted was that it was licensed to manufacture medical devices.  That wasn’t enough.  Texas medical malpractice tort reform was separate from that state’s product liability tort reform.  Id. at 11-12.  Further, the “common usage” (how such statutes are construed) of the term “health care” denoted something different from manufacturing:

In common usage, one associates “health care” with medical intervention, assistance, or other acts − e.g., one’s family doctor performing an annual physical or a nurse administering a flu shot − as opposed to the mere making or selling of a product used in providing such services.  Focusing as it does on acts and treatment provided to patients, the [statute’s] definition of “health care” does not clearly depart from this basic notion.

Id. at 13.

OK, but the court didn’t shut the door all the way:

That is not to say, however, that the acts or treatments distinguishing “health care” or “health care providers” under the [statute] cannot ever encompass some element of product manufacture or sale that would implicate [the product liability statute], or vice versa. In [the product liability statute], for example, the Legislature contemplated that the defendants in a “products liability action alleging that an injury was caused by a failure to provide adequate warnings or information with regard to pharmaceutical products” may potentially include “a health care provider”. . . .  And some of our sister courts have held that persons or entities operating under licenses similar to [the manufacturer’s] can, in some circumstances, fall within “health care providers” under the [statute].

Id. at 13-14 (footnotes and citations omitted).  The two cases cited involved manufacturer’s employees who custom fit prosthetics for individual patients (Strobel v. Marlow, 341 S.W.3d 470 (Tex. App. 2011)), or set up an administration system for a prescription drug at an individual patient’s residence (San Antonio Extended Medical Care, Inc. v. Vasquez, 327 S.W.3d 193 (Tex. App. 2010)).  They went beyond simply manufacturing a product.  Verticor, slip op. at 16-17.  “Without more,” than just manufacturing, a medical device company could not take advantage of the Texas medical malpractice statute’s restrictions – chiefly the expert opinion requirements.

Here’s where we see this going.  Ordinary product liability cases are probably covered by the holding in Verticor, and there are a number of reasons why, such as the learned intermediary rule, prescription medical product manufacturers would often resist being characterized as health care providers.  So the result in Verticor is likely to be the general rule, and for good reason.

But there are some cases where that may not be so.  Verticor was a medical device case, and when we think medical devices, we think preemption (at least as to PMA devices).  One of the avenues some plaintiffs have used to escape preemption is to include allegations that the defendant’s sales representatives said things or did things with respect to a particular plaintiff’s prescribers/treaters that adversely affected the result.  The poorly reasoned Malander case – discussed here − is an example of that.  We’ve discussed a number of these cases, which often assert Good Samaritan liability, and these posts are collected under our “manufacturer’s representatives” topic.  Given what the court had to say in Verticor, we believe that there’s a pretty good shot (depending on the particular sales rep conduct alleged) that these allegations about reps supposedly giving advice to doctors would fit within the “health care provider” definition used in the Texas statute, and quite possibly in other states that have enacted medical malpractice reform.  Thus, we recommend that defense counsel confronted with manufacturer’s representative allegations – usually, but not necessarily, in a preemption context – consider whether those allegations, which are separate from the manufacturing function, might subject the plaintiff making them to various limitations imposed by medical malpractice statutes.