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.

Tuesday, November 17, 2015

The Ghost of Bendectin – Exorcized by the FDA?

Not quite two years ago, we posted about how, under Wyeth v. Levine, 555 U.S. 555 (2009), and subsequent Supreme Court cases, private plaintiffs can’t make claims that so-and-so should have warned about such-and-such with respect to the off-label use of a prescription medical product.  That’s because the FDA zealously guards its authority over warnings concerning off-label uses and does not allow such warnings unless the Agency specifically says so.  That’s crystal clear for drugs.  21 C.F.R. §§201.57(c)(6)(i), 21 C.F.R. §201.80(e).  It’s a little more roundabout for devices (which we explained in that post), but for now, we’re talking about drugs.  Bottom line − since off-label warnings aren’t something a manufacturer can do unilaterally under the CBE regulation, a la Levine, any tort claim demanding such warnings is preempted.

The remedy is to file a citizen’s petition asking the FDA to impose such a warning.

A former colleague recently passed along an example of how such a petition can crash and burn, making preemption even more likely in any civil litigation.  Earlier in the same year (2013) we wrote our post, one James P. Reichmann filed a citizen’s petition concerning the drug ondansetron asserting that it was used off-label for relief of morning sickness (“nausea and vomiting during pregnancy,” or “NVP”) and that the FDA should require warnings (and some other stuff) about birth defects.  The FDA therefore opened up Docket No. 2013-P-0048.  The FDA took its time because the petition “raise[d] complex issues requiring extensive review and analysis by Agency officials.”

Late last month the Agency acted.  It said “no.”  So now the issue is double preempted – with the FDA’s rejection as “clear evidence.”  First, the FDA stated, “[w]e are aware of the unapproved [what the FDA calls off-label] use of oral and injectable ondansetron for treatment of nausea and vomiting in pregnancy.”  FDA denial letter at 3.  The FDA looked at a bunch of scientific evidence (which goes on for pages and pages), and concluded, “[w]hen reviewed together, the totality of the available data does not support a determination that there is an increased risk of adverse fetal outcomes” for the off-label use in question.  Id. at 13.  Therefore:

[W]e find that the available data are not sufficient to conclude that there is a safety concern with regard to the use of ondansetron during pregnancy that would warrant changes at this time to the pregnancy risk category . . ., or to the [relevant] sections in labeling. . . .

Id. at 14.  The FDA went on (after more science-intensive discussion) to reject, as well, asserted risks to the pregnant women themselves who take the drug.  Id. at 17 (“our review of your Petition did not find evidence to support your concerns regarding treatment of pregnant women”).

Because nothing warranted a label change to address the risks of what was, after all, an off-label use, the FDA rejected the request to order “Dear Doctor” letters about the purported “risk”:

[W]e do not agree with the Petition that the available data reviewed by FDA . . . warrant a conclusion that ondansetron use during pregnancy poses an increased risk of fetal or maternal adverse outcomes.  Thus a notification to OB/GYNs that ondansetron may lead to adverse maternal or fetal outcomes is not necessary and could be misleading.

Id. at 19.

In what we find the most interesting part of the FDA’s discussion, the Agency reiterates that it is not in the business of evaluating the safety or efficiency of off-label uses:

[T]he Petition states that there are only a small number of studies regarding the efficacy of ondansetron in treating NVP or its relative efficacy . . . compared with other NVP treatments.  While this may be true, ondansetron is not approved for use to treat NVP.  Absent a compelling legal or public health concern, FDA generally does not comment on the number or quality of studies regarding the efficacy of a drug product for an unapproved use or provide notification to health care providers regarding its relative efficacy as compared to other drug products for such unapproved use.

Id. (emphasis added).  Nor, because of the lack of any “safety concern,” did the FDA require issuance of a “Dear Doctor” letter that pain pumps for ondansetron “may not be marketed or promoted in any way in the absence of FDA approval for [that] indication . . . and that such promotion is a violation of FDA regulations.”  Id. at 20.
The result of the FDA’s action is twofold – (1) because the FDA’s “compelling concern” standard for off-label warnings is not met, any warning-based tort claim about this particular off-label use should be preempted as “impossible,” since the manufacturer(s) of this drug have to get the FDA’s prior OK for such warnings, and (2) for these particular risks, there is “clear evidence” under Levine that the FDA would not permit any warnings.  So preemption should doubly bar any tort claims on the subject matter of the unsuccessful petition.

This is somewhat ironic.  Some of us are veterans of the Bendectin wars, in which scientifically bogus − Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), was a Bendectin case − but widespread, teratogenicity allegations forced off the market what was then the only drug FDA approved for the treatment of morning sickness.  Even now, there are very few (we think, only one) approved products intended for this use.  Not too many companies would want to run the risk of a similar avalanche of meritless, but expensive, litigation.

So off-label may well be better, from a liability standpoint, for products with therapeutic value for morning sickness.  If that use were on-label, then under Levine, the fact that label changes could be made unilaterally via “changes being effected” could let the litigation floodgates open.  With off-label use, however, FDA pre-approval (under the strict “compelling” need standard) is required.  Therefore, preemption applies because manufacturers cannot make warning changes about off-label uses independently of the FDA.  On-label:  no preemption; off-label:  preemption.  How would you prefer to defend that case?

From the moment we first read Levine, we’ve been convinced that it was wrongly decided.  The example of drugs used (mostly off-label) to treat morning sickness, and how Levine acts to discourage submission of this use to the FDA, is yet another reason why this is so.

Monday, November 16, 2015

How Easy Is It to Allege Proximate Causation in a Medical Device Case

This post comes from the Cozen O’Connor side of the blog, not the Reed Smith side.

Last July, in the Tapia v. Davol, Inc. hernia patch case, Davol won its motion to dismiss the plaintiff’s failure to warn claim.  2015 U.S. Dist. LEXIS 98521 at *16-17 (S.D. Cal. July 28, 2015).  The court was clear on why.  While plaintiff alleged facts on what was supposedly missing from the warnings, he alleged no facts suggesting that his own doctor didn’t receive a warning or that, if he had, he would not have prescribed the patch to plaintiff.  In other words, plaintiff did not allege facts to suggest proximate causation.  The court was explicit:
As to Defendant's second argument regarding causation, while Plaintiff alleges the specific defect in Defendants' product and specific warnings they failed to provide, he does not allege that Defendants failed to warn his own prescribing physician and that his own physician would not have used the Patch if warnings had been given.  

Id. at *16-17.  Allegations about “‘physicians’ in general and the ‘healthcare community’” didn’t provide facts to suggest the existence of proximate causation.  Plaintiff needed to allege “facts as to his own prescribing physician.”  Id. at *17.  

Little did Davol know how specific the court was being.  In particular, when the court wrote that plaintiff must allege a failure to warn “his own prescribing physician and that his own physician would not have used the Patch,” it meant just that.  Literally.  Invoke those words.  And no more.  

So, next time around, plaintiff’s failure to warn allegations did just that.  Plaintiff replaced “physicians” and “healthcare community” with “his prescribing physicians” and “his healthcare providers.”  Tapia v. Davol, Inc., 2015 U.S. Dist. LEXIS 151168, at *15 (S.D. Cal. November 6, 2015).  That’s it.  Voila!  Somehow those stock words made the existence of proximate causation more plausible—the TwIqbal standard—than it had been in his first complaint:  

Here, the FAC has changed the references of "physicians" and "healthcare community" to "his healthcare providers” . . . and "his prescribing physicians.”  As to a failure to warn, the FAC alleges that Defendants failed to warn his own prescribing physician and that his own prescribing physician would not have used the Patch if warnings had been given. . . . These allegations have been deemed sufficient on a motion to dismiss.  See Baker v. Bayer Healthcare Pharms., Inc., No. C13-490 TEH, 2013 U.S. Dist. LEXIS 179131, 2013 WL 6698653, at *5 (N.D. Cal. Dec. 19, 2013).  

Id. at *15-16.  

The court allowed a number of other claims to go forward (expect fraudulent misrepresentation), but our focus is the court’s treatment of these two sets of failure to warn allegations.  Had the court allowed the failure to warn claim in the first complaint go forward, we might not have loved it, but we wouldn’t have blinked.  

Together, however, these two decisions signal something different.  They suggest the days in which a plaintiff need only invoke magic words to plead key elements of a claim.  That’s something that TwIqbal eliminated.  There must be actual facts alleged that make elements of the claim plausible.  In a medical-device product-liability complaint, pleading “my physician wasn’t warned and if he had been he wouldn’t have prescribed the device” is no different from pleading the words “proximate causation exists.”  The latter phrase is deficient, and so too should be the first.  

So we’d like to think that there was more to the court’s decision than meets the eye.  Maybe the court believed that the balance of the factual allegations in the complaint made it plausible that the treating doctor was not warned and would have acted differently if he had been.  While we might disagree with that reasoning, at least its reasoning based on factual allegations, not stock phrases.  Of course, if the court had believed that, it should have upheld the failure to warn claim in the first complaint.  

Oh well.  In any event, the absence of actual facts on proximate causation suggests that this case may go away on summary judgment.  Plaintiff has exclusive access to his doctors at this point. Yet he wasn’t able to muster the type of factual allegations that should be necessary to allege proximate causation and survive a motion to dismiss, meaning that, after discovery, he still might not have those facts.  We’ll see.