What follows is a guest post from long-time friend of the blog Thomas J. Hurney, Jr. of Jackson Kelly PLLC in Charleston, West Virginia.  Tom comes to us today with news of an interesting – and favorable – federal court remand denial in one of the recently filed opioid litigation in his state.  It raises interesting legal issues in the context of litigation where the possibility of local prejudice makes the right of removal to federal court extremely important.  As always with our guest posts, Tom is 100% responsible for what follows.  He thus deserves all the credit and any blame.

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With respect (a lot) to the Drug & Device folks, removal and remand cases are pretty hard to spice up.  While these cases may cry out for humor and whimsy, this guest post with an old-school case summary will have to do the trick.

A number of governmental entities – states, counties and cities – have sued drug manufacturers, distributors, pharmacists and doctors, alleging that because of their distribution, sales and prescription practices, communities have been “flooded” with opioids, resulting in “an acute epidemic of drug use and related social problems.”  Relying on tort and nuisance theories, these governmental plaintiffs seek damages to “compensate … for sums [they] expended and will be forced to expend responding to social problems caused by the opioid epidemic.”

In County Commission of McDowell County v. McKesson Corp., ___ F. Supp.3d ___, 2017 WL 2843614 (S.D.W. Va. July 3, 2017), the County Commission sued several pharmaceutical distributors, including named-defendant McKesson, and added a local physician.  The defendant distributors were all citizens and residents of states other than West Virginia.  The defendant physician was a West Virginia resident, transparently added to destroy diversity jurisdiction, so that plaintiff McDowell County could sue in (you guessed it) McDowell County Circuit Court.

The defendants removed the action, alleging the physician was fraudulent joined, and also fraudulently mis-joined, to defeat diversity.  The defendants argued that the physician was fraudulently joined because there was no possible cause of action against him, as the plaintiffs failed to serve him with a Notice of Claim and Certificate of Merit at least thirty days before filing suit, as required by the West Virginia Medical Professional Liability Act, W.Va. Code §55-7B-6.  Because this failure required dismissal of the complaint against the doctor, there was no possible existing claim, so he was therefore fraudulently joined.

Defendants also argued fraudulently mis-joinder, because “the claims against [the physician] arise out of different transactions, involve different evidence, and rest on different legal theories than the claims against the diverse defendants.”

The Plaintiff moved for remand.

Remand was denied with a scholarly opinion that literally started at the beginning. Citing Chief Justice Marshall’s decision in Strawbridge v. Custiss, 7 U.S. (3 Cranch) 267 (1806), this to-be-published opinion reviewed the history of diversity jurisdiction, noting that “[t]he rule of complete diversity appears nowhere in the statute.” Although diversity jurisdiction has existed since the First Judiciary Act of 1789, it has “always been the subject of some controversy,” with the stated reasons for diversity jurisdiction including local prejudice and perhaps a desire to protect creditors from state legislation favorable to debtors.  “In the early days of the republic, at least in Virginia [of which West Virginia was a part before 1863], prejudice was palpable.  The state courts there were notoriously hostile to foreign merchants.”  As an example, state juries were permitted to deny interest on a debt judgment for a creditor, effectively removing the profit from the transaction.  Id. at *1.

The reference to “local prejudice” as a basis for diversity jurisdiction is telling, since McDowell Co. v. McKesson is precisely the type of litigation that, these days, highly likely to raise this concern, that being a local municipality suing in its home court seeking recovery of damages that would (among other things) be likely to reduce local jurors’ taxes.

Concerning the trend in federal courts against diversity jurisdiction, the opinion pointed out that “[i]n recent times, crowded federal dockets, a dearth of evidence showing the existence of state court prejudice, and continuing doubts about the utility of diversity jurisdiction have pushed federal courts in the direction of limiting it.”  Consciously bucking that trend, the decision defended the importance of diversity jurisdiction, stating

Nevertheless, Congress has created diversity jurisdiction and a litigant whose case comes within it has a right to be in federal court. As the Supreme Court has said:  “[T]he Federal courts may and should take such action as will defeat attempts to wrongfully deprive parties entitled to sue in the Federal courts of the protection of their rights in those tribunals.”  In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices and Prods. Liab. Litig., 2016 WL 7339811 at *3 fn.4 (D.S.C. Oct. 24, 2016) (quoting Alabama Great S. Ry. Co. v. Thompson, 200 U.S. 206, 218 (1906)).  Therefore, if diversity jurisdiction is to be assigned to oblivion, it is Congress, not the courts who should send it there.  Here, where the opioid epidemic is pervasive and egregious, there is at least a possibility of prejudice to the defendants at the hands of a jury drawn exclusively from the very county that is the plaintiff in this suit.  A federal jury casts a wider net and is drawn from a division composing several counties.  All may have an opioid problem, but not one that is specific to the plaintiff county.

Id. at *2.

Turning to the analysis of the defendants’ removal, the court provided a concise review of the fraudulent joinder and mis-joinder doctrines.  “Fraudulent joinder is applicable where a defendant seeking removal argues that other defendants were joined when there is no possible cause of action against those defendants or where the complaint pled fraudulent facts,” whereas “[f]raudulent misjoinder . . . is an assertion that claims against certain defendants, while provable, have no real connection to the claims against other defendants in the same action and were only included in order to defeat diversity jurisdiction and removal.”  Id. (citing Wyatt v. Charleston Area Med. Ctr., 651 F. Supp.2d 492, 496 (S.D.W. Va. 2009)).

Thus, “[i]n order to establish fraudulent joinder in a particular case, a removing defendant must show either (1) there is no possibility that the plaintiff can establish a cause of action against the removing defendant, or (2) that there has been outright fraud in plaintiff’s pleading of jurisdiction. Id. The claim against the doctor, therefore, requires remand “[i]f the plaintiff demonstrates a mere ‘glimmer of hope’ that its claim will succeed.  Id. at *3 (quoting Hartley v. CSX Transp., Inc., 187 F.3d 422, 424-26 (4th Cir. 1999)). However, “[t]his is the rare case that fits the ‘no possibility of recovery’ rubric.” Id.

The court agreed that the physician was fraudulently joined because McDowell County did not serve him with a notice of claim and screening certificate of merit at least 30 days before suing him as required by the Medical Professional Liability Act, W.Va. Code §55-7B-6 (MPLA).

West Virginia Code § 55-7B-6, imposes a series of procedural prerequisites for filing a medical malpractice claim.  The plaintiff, in such a case, is required, at least thirty days prior to filing suit, to service notice on the defendant of his intention to bring suit.  The notice must contain a ‘screening certificate of merit’ executed under oath by a qualified expert.’  If this requirement is not met, the case must be dismissed.

Id.  The MPLA plainly applied to the allegations of improper prescription by the doctor – “[i]t can hardly be questioned that writing prescriptions for controlled medication are acts done within the context of rendering health care services,” as defined in the MPLA.  Id.

Finding that state law requiring pre-suit requirements are jurisdictional (citing Flagg v. Stryker Corp., 819 F.3d 132, 137-38 (5th Cir. 2016) (en banc) [ed. note, we blogged about Flagg here], and Robinson v. Mon, 2014 WL 4161965, at *8 (S.D.W. Va. Aug. 19, 2014)), the court concluded “there is no possibility of recovery by the plaintiff against [the doctor] in this civil action as it presently stands” and the dismissed the county’s claim against him without prejudice.  Id.

That was not all.  Aiming to prevent a recurrence of this kind of jurisdictional subterfuge (remember the “local prejudice” point), the court further found that the local prescribing physician was fraudulently mis-joined because the claims against him for improperly prescribing some opioids were attenuated from the claim that the distributors “flooded” the market.

Fraudulent joinder assumes that the claim against the nondiverse defendant is sufficiently related to the claims against the diverse defendant to have been properly joined in the same lawsuit.  Such is not the case with the related, but distinct, doctrine of fraudulent misjoinder.  Here, the inquiry is whether claims against the diverse and non-diverse defendants are sufficiently related to be properly joined in a single case.

Id.

Upon review of cases adopting misjoinder, the court found the Fourth Circuit has “not accepted nor rejected the doctrine” but noted several District Courts had done so (commending the reader to the list of cases in In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices and Prods. Liab. Litig., 2016 WL 7339811 at *3 fn.4 (D.S.C. Oct. 24, 2016)).  Id. at *4.  Since the propriety of joinder is a state law question, the court looked to Rule 20 of the West Virginia Rules of Civil Procedure, governing joinder, and cases on its federal counterpart.  “Under Federal Rule 20 and the corresponding West Virginia rule, the claims, to be properly joined, must (1) arise out of the same transaction or occurrence, and (2) present a question of law or fact common to all defendants.”  The court declined to apply a “heightened standard” similar to fraudulent joinder adopted in In re Lipitor (“[T]o establish fraudulent misjoinder, the removing party was required to show either outright fraud, or that there was no possibility that the plaintiff would be able to join the diverse and non-diverse claims”), instead finding “[t]he prevailing standard is whether there is a ‘reasonable possibility that a state court would find that [the plaintiffs’] claims against [one set of defendants] were properly joined with [the] claims against the other defendants.’” Id.

The court contrasted Wyatt v. Charleston Area Med. Ctr., a medical device case where the court found that product liability and malpractice claims arose “out of the same occurrence – the plaintiff’s surgery ‘and the after effects of that surgery,’” with Hughes v. Sears, Roebuck and Co., 2009 WL 2877424 (N.D.W. Va. Sept. 3, 2009), where the court found that the plaintiff, who fell off a treadmill, couldn’t combine product claims against the treadmill manufacturer with malpractice claims against the emergency room physician who misdiagnosed her injuries.  “[The emergency room doctor] had no control over the allegedly defective product.”  Id. at *5.

In the case before the court, there was no basis for a persuasive argument that the medical malpractice and products liability claims arose out of the same transaction or occurrence.  Moreover, “the evidence supporting these claims will be markedly different.”  Id.  McDowell County’s claims were more like Hughes than Wyatt, since:

 In this case, the connection, if any, between the actions of the corporate defendants, who allegedly flooded the market with opioids, and the doctor, who prescribed some of them, is far more attenuated than any connection between the manufacturers and seller of the treadmill in Hughes and the subsequent misdiagnosis by the treating physician.

Id.

Thus, the McDowell opinion concluded,

Since there is no possibility of recovery against [the doctor] in this case, he has been fraudulently joined. Additionally, the court finds no common questions of law or fact in plaintiff’s claims against the corporate defendants and the claims against [the doctor].  The cases against each are separate and distinct. Accordingly, [the doctor] has also been fraudulently misjoined. The Motion to Remand is therefore DENIED.  Since the court lacks jurisdiction over plaintiff’s claims against [the doctor] this action, insofar as it relates to [him], is dismissed without prejudice.

Id.

This remand ruling eliminates one possible jurisdictional ploy to defeat diversity. There are, however, others, and we will have to see what happens next.

This post comes from the Cozen O’Connor side of the blog.

We’ve been blogging about “removal before service” since we announced it to the world in 2007.  It’s a procedural tactic that enables defendants to remove cases to federal court despite the “forum defendant rule,” which ordinarily prohibits a defendant from removing to federal court a case that, while it meets the requirements of diversity jurisdiction under 21 U.S.C. § 1332(a), is also pending in the home state of the defendant. Here’s the rule as codified in 21 U.S.C. § 1441(b) (2):

A civil action otherwise removable solely on the basis of the jurisdiction under section 1332(a) of this title may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.

(Emphasis added).

We emphasized the phrase “properly joined and served” because that’s the basis for “removal before service.” Defendants have had success, in certain courts before certain judges, arguing that this phrase should be interpreted according to its plain terms and that, therefore, a defendant who has not yet been served can remove a case on diversity jurisdiction grounds even if the case is in its home state court.

The court in Young v. Bristol-Myers Squibb Co., 2017 U.S. Dist. LEXIS 98736 (D. Del. June 27, 2017), is one of the courts that accepts this argument. Young was one of 33 cases in the Eliquis drug litigation that plaintiffs’ lawyers had filed in the Superior Court of Delaware. Each plaintiff and the two defendants, Bristol-Myers Squibb and Pfizer, were citizens of different states, suggesting that the cases were ripe for removal to federal court on the basis of diversity jurisdiction. But BMS and Pfizer are citizens of Delaware (as are so many corporations), implicating the forum defendant rule’s bar to removal of diversity cases.

But, as the Young court put it, all of this occurred “before Plaintiffs served (or, due to Superior Court procedures, could have served) their complaints on Defendants.” Id. at *2. The defendants had an opportunity. And they took it. They immediately removed the cases to the United States District Court for the District of Delaware where they had the good fortune of drawing a judge who had previously blessed “removal before service”—and did so again:

The undersigned judge has had several occasions to consider this issue. Having done so again, the Court sees no reason here to depart from its previously-adopted reasoning. See Munchel, 2012 U.S. Dist. LEXIS 128971, 2012 WL 4050072; Hutchins, 2009 U.S. Dist. LEXIS 4719, 2009 WL 192468. As in Munchel and Hutchins, the Court views the plain and unambiguous language of § 1441(b) as controlling. Section 1441(b)(2) provides that a case in which there is diversity jurisdiction “may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.” Here, there is diversity jurisdiction, but because there was no service on any defendant before removal, none “of the parties in interest properly joined and served as defendants is a citizen” of “the State in which [this] action” was brought, i.e., Delaware. 28 U.S.C. § 1441(b)(2) (emphasis added).

Id. at *5 (emphasis in original). And so we have yet another decision approving “removal of service” under the plain terms of the statute.

In this instance, the Court suggested that it had an additional reason to rule the way it did. The plaintiffs had already engaged in forum-selection tactics of their own. The cases were originally filed in California state court, not Delaware. The defendants, who were not California citizens, promptly removed the cases to a federal court in California and started the process to transfer the cases to the Eliquis MDL, a place that plaintiffs most certainly did not want to be. So—and here it comes—the plaintiffs voluntarily dismissed all 33 cases. They then re-filed the cases, the very same day, in Delaware state court, a court from which they hoped the forum defendant rule would hamstring defendants from once again removing the cases to federal court. Id. at *1-2.

This history of forum shopping clearly influenced the Court’s decision on plaintiffs’ motion to remand:

Additionally, given the history of these cases — including that Plaintiffs voluntarily dismissed cases originally filed in California state court, seemingly (at least in part) to avoid transfer to the MDL — removal is not a nonsensical result. To the contrary, the totality of circumstances strongly supports exercising discretion to deny Plaintiffs’ motions to remand.

Id. at *4-5.

So the “removal before service” option lives on, at least in some courts. And Young offers precedent for an argument that “removal before service” may be even more appropriate when the history of the case suggests that the plaintiff had already engaged in some sort of procedural maneuvering before the case was even removed.

Our day job has been keeping us busy, so busy with depositions, motions, delayed flights, and assorted drama that we have not posted in more than a month.  After such a long layoff, we had hoped to return with a vengeance, a “the North remembers” sort of vengeance.  Instead, we get fair market value, Current Procedural Terminology codes, and a Daubert challenge to a defense expert accountant.  Eh.  The decision is in a False Claims Act case about Medicare fraud and kickbacks, about which we care and have even spent some billable time.  But the reason we are writing about U.S. ex rel Lutz v. Berkeley Heartlab, Inc., No. 9:14-cv-00230-RMG, 2017 U.S. Dist. LEXIS 107481 (D.S.C. July 12, 2017), is because the rejection of opinions offered by the expert in this case undercuts the damages claims we see in other cases.

Lutz involves allegations that the defendants overbilled Medicare in connection with blood tests.  One part of the alleged scheme was that the defendant labs charged high processing and handling fees.  (We will ignore the issues of FCA materiality and causation that seem to flow from the absence of evidence of Medicare payment on processing and handling charges.) From what we can tell, the defendant’s expert opined that these fees were consistent with the fair market value—a defined term under the, aptly named, Stark Act—and did not represent kickbacks to referring physicians.  He offered a “charge-based methodology” to conclude that the fees were consistent with fair market value because physicians allegedly expected to recover for time spent on processing handling, not just for the actual blood draw.

“[I]t is no secret that the sticker price of services listed in physician bills and hospital chargemasters are totally unmoored from the reality of arm’s-length transactions actually taking place in the marketplace.” Id. at *12.  We think you can see where we are going with this.  In product liability cases, economic damages related to medical care, past and future, are typically based on amounts incurred.  The collateral source rule is often used offensively to create a windfall of the difference between the amount on the bills and the portion of that amount anybody ever paid or will pay.  We have called this “phantom damages.”  In FCA, RICO, and consumer protection cases, for instance, the plaintiff’s theory of price gouging or other impropriety sometimes relies on the list price of a drug or the amounts appearing on bills, regardless of what typically gets paid.  Although in the context of granting a challenge to an expert for healthcare providers that wanted the charges to matter, the Lutz decision supports the more typical defense position.

Actual transactions, not just bills, are a better indicator of fair market value because “physicians deliberately set their fees higher than the amount they either expect to receive or do in fact receive to ensure that no money is left on the table.” Id. at *16.  The court identified a number of decisions, from various types of cases, recognizing that “physicians’ billed charges do not necessarily reflect the market value of physician services.” Id. at **17-18 (citing cases).  So, the next time you have a case where the plaintiff says her damages include the total of all her medical bills and the only support she needs is her expert mouthing that “the charges were all reasonable and necessary,” think about whether Lutz and the cases it cites help you push back.  That was our return:  brief, a little bloody, and with the promise of more to come.

We commented last week that we were not surprised by the numerous post-BMS personal jurisdiction decisions we were seeing. Lots of courts and parties around the country were watching and waiting for this one. So, let’s add some more. This time from another of plaintiffs’ favorite “magnet jurisdictions” – Missouri. Historically, product liability plaintiffs bringing pharmaceutical and medical device cases have flocked to Missouri (the City of St. Louis in particular) among other notoriously plaintiff-friendly venues as litigation tourists. They would file multi-plaintiff complaints against drug and device companies not located in Missouri, including at least 1 Missouri plaintiff – to tie the case to the state — and at least 1 plaintiff from defendant’s home state – to destroy diversity.

So, when defendants would remove these multi-plaintiff complaints, which we always do, we would have to argue misjoinder and simultaneously move to dismiss all of the out of state plaintiffs for lack of personal jurisdiction. Previously, pre-BMS, the Eastern District of Missouri was rather hostile to such removals. Swiftly remanding case after case for lack of subject matter jurisdiction, opting to completely skip the personal jurisdiction issue altogether. Apparently, BMS is changing that – which frankly, we expected. But now we have some decisions.

The complaints in Siegfried v. Boehringer Ingelheim Pharm., Inc., 2017 WL 2778107 (E.D. Mo. Jun. 27, 2017) and Jordan v. Bayer Corp., 2017 U.S. Dist. LEXIS 109206 (E.D. Mo. Jul. 14, 2017) look pretty much as described above. Each case had 94 plaintiffs, of which only a handful were residents of Missouri (8 in Siegfried and 7 in Jordan). The remaining plaintiffs were from different states all over the country, including the states where defendants are citizens. Siegfried at *1; Jordan at *1-2. At least 1 to get personal jurisdiction and at least 1 to defeat diversity.

As do most courts when faced with competing issues of subject matter and personal jurisdiction, these courts cited Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574 (1999) for the proposition that the court has discretion to determine which to consider first. Siegfried at *2; Jordan at *5. While federalism usually tips the scales toward deciding subject matter jurisdiction first, where personal jurisdiction “turns on federal constitutional issues” and/or “judicial economy” concerns, personal jurisdiction can be prioritized. Jordan at *5. Put even more simply, post-BMS, “[p]ersonal jurisdiction is now the more straightforward inquiry.” Siegfried, at *3. That’s because BMS is “dispositive of the specific personal jurisdiction issue” regarding out-of-state plaintiffs suing an out-of-state defendant. Jordan at *9. Specific personal jurisdiction is lacking.   Therefore, reasoned the Siegfried court

Remanding this case for lack of complete diversity, only to have the case removed again later once the non-Missouri plaintiffs are dismissed, would be a waste of judicial resources.

Siegfried at *2. After BMS, neither the Eastern District of Missouri nor the original Missouri state court can exercise personal jurisdiction over the non-residents, so why remand the case to reach the same conclusion. Siegfried at *5. It would be an unnecessary extra step.

Applying a “straightforward” BMS analysis, both courts dismissed all of the out of state plaintiffs with no connection to Missouri. Siegfried at *5 (“nonresident plaintiffs did not ingest the drug in the forum, nor do they claim to have suffered resulting injuries in the forum. The personal injuries of the non-Missouri plaintiffs have no connection with Missouri. They did not arise out of, or relate to, defendants’ activities in Missouri.”); Jordan at *10-11 (“the non-Missouri plaintiffs do not allege that they acquired the [] device from a Missouri source or that they were injured or treated in Missouri . . . . And the general exercise of business activities in the state cannot create an adequate link between the claims and the Missouri forum.”). Because the dismissal of the non-Missouri plaintiffs negated any challenge to complete diversity, the motions to remand in both cases were denied. Siegfried at *5; Jordan at *11. Yet another post-BMS victory.

 

The warranty is “express.”

Before you say, “Well, duh,” this sometimes actually does matter. Here’s how.

Most complaints in product liability actions involving prescription medical products that include express warranty counts do so as one of a bunch of different causes of action, all pleaded seriatim (“one after another,” in non-lawyer speak).  Believe it or not, lawyers get tired of repeating themselves – especially those (like our adversaries) who don’t bill by the hour.  Thus, in complaints, we usually see each cause of action in multi-count complaints begin with a paragraph “incorporating by reference” facts that were pleaded earlier in the document.

That can be fatal to express warranty claims – because the warranty must be “express” – whereas other claims, such as failure to warn, can be maintained on the basis of allegedly omitted facts.  Thus, incorporation by reference (or pleaded facts) that only incorporates allegations of omitted facts isn’t enough to plead express warranty.  This is one more way to make express warranty claims go bye-bye (see our TwIqbal cheat sheet for others), and it appears that, increasingly, plaintiffs have been called out for this failing.

The only appellate prescription medical product case that we’ve seen on this point is Rite Aid Corp. v. Levy-Gray, 876 A.2d 115 (Md. App. 2005), aff’d on other grounds, 894 A.2d 563 (Md. 2006).  In Levy-Gray, an omission by the defendant pharmacist of a statement in the manufacturer’s labeling didn’t cut it as a basis for express warranty:

[I]n order to have an express warranty there must be an affirmative statement of fact by the seller about the goods.  A claim that there is a warranty by omission is at odds with the UCC definition of an express warranty.  Here, the manufacturer’s package insert . . . contained, inter alia, the following statement:  [statement omitted]  The omission of this statement, which was relevant to the negligence claim asserted by Plaintiff, and is of some relevance to the medical causation issues, is not relevant to the creation of an express warranty.

Id. at 126 (citation omitted) (emphasis added).

Several federal district courts have made the same point.  The issue arose in the Testosterone MDL, where the “plaintiffs have pointed to no statement that constitutes an express warranty.”  In re Testosterone Replacement Therapy Products Liability Litigation, 2014 WL 7365872, at *8 (N.D. Ill. Dec. 23, 2014).  “[P]laintiffs must plead more than misstatements and omissions to state a claim for breach of express warranty.”  Rather, plaintiff “must point to a specific affirmation or promise.”  Id.  In Young v. Bristol-Myers Squibb Co., 2017 WL 706320 (N.D. Miss. Feb. 22, 2017), the court raised the issue sua sponte (meaning “on its own”), pointing out:

[T]he Court notes that, while not raised by the defendants, [plaintiff’s] breach of express warranty claim must fail to the extent it is based on alleged omissions in [the drug’s] prescribing information. An omission is neither an affirmation of fact nor a promise.

Id. at *15 n.10 (citation omitted).

Non-express “express” warranty claims also failed in House v. Bristol-Myers Squibb Co., 2017 WL 55876 (W.D. Ky. Jan. 4, 2017), because allegations of omissions were insufficient:

[Plaintiff] cannot base her express warranty claim on allegations that the Prescribing Information fails to include the “true risks” of the drugs and does not contain “adequate information[.]”  An express warranty is created by an “affirmation of fact or promise,” not an omission.

Id. at *6 (citations omitted).  In Vakil v. Merck & Co., 2016 WL 7175638 (D.N.J. Dec. 7, 2016), the court disposed of a warranty claim under Virginia law (significant because Virginia doesn’t have strict liability) observing that “during oral argument” plaintiff “indicated that his theory was more akin to an omission. Therefore, summary judgment is granted to Defendants as to the breach of express warranty claim.”  Id. at *5.

We also looked outside the drug/device sphere, and were surprised by the relative paucity of precedent.  Either plaintiffs aren’t pleading omissions in express warranty claims or defendants are letting them get away with it.  There’s one citable appellate decision, and it’s almost 30 years old.  Sidco Products Marketing, Inc. v. Gulf Oil Corp., 858 F.2d 1095, 1099 (5th Cir. 1988) (“Omissions, however, are not affirmative representations of any sort and thus cannot support a warranty claim, because express warranties must be explicit.”) (applying Texas law).  Young cited Sidco.  So did the next two cases – coincidentally, both from Missouri:

Plaintiffs repeatedly allege that the press releases and advertisements all failed to disclose the defect, so, to the extent their express warranty claims are based on advertisements and promotional materials, these claims are based on omissions. A breach of express warranty claim, however, cannot be premised on an omission.

In re General Motors Corp. Anti-Lock Brake Products Liability Litigation, 966 F. Supp. 1525, 1531 (E.D. Mo. 1997), aff’d on other grounds, 172 F.3d 623 (8th Cir. 1999)

Plaintiff, therefore, bases liability not on what the documents provide, but on what they do not provide.  The law is clear that [plaintiff] may not recover under this theory because omissions are not affirmative representations of any sort and thus cannot support a warranty claim, because express warranties must be explicit.

Cambridge Engineering, Inc. v. Robertshaw Controls Co., 966 F. Supp. 1509, 1524 (E.D. Mo. 1997) (quoting Sidco).

Likewise, defendants in tobacco product liability cases have not allowed plaintiffs to pass off “warranty by omission” as an “express warranty.”  Witherspoon v. Philip Morris, Inc., 964 F. Supp. 455, 465 (D.D.C. 1997).  Omissions of this and that are “at odds with the definition of express warranty.  Plaintiff has not pleaded an express promise on the part of Defendant.”  Id.  Accord Hughes v. Tobacco Institute, 2000 WL 34004261, at *10 (E.D. Tex. May 5, 2000) (“nondisclosure . . . does not create an express warranty”), aff’d on other grounds, 278 F.3d 417 (5th Cir. 2001).

Another appellate decision actually exists, but it’s non-citable:

Essentially, [plaintiff] bases his claim not upon an express affirmation of fact or description of the goods, but instead, upon the omission of language such as simulated or imitation.  [Plaintiff] has presented no authority that an omission of fact can create an express warranty.

Pocino v. Jostens, Inc., 2006 WL 1163785, at *5 (Cal. App. May 3, 2006).

Finally, we found one other case, on point, not citing anything beyond the relevant UCC section, but reaching the same result:  “[A] failure to include information in the specification sheet is the exact opposite of an express warranty.”  “[O]missions . . . are simply insufficient to support a breach of warranty.”  Cannon Technologies, Inc. v. Sensus Metering Systems, Inc., 734 F. Supp.2d 753, 769-70 (D. Minn. 2010).

Express warranty claims deserve attention in prescription medical product liability litigation.  Some courts allow such claims to escape preemption.  Others give express warranty claims a longer (or at least different) statute of limitations.  Such claims should not be allowed to persist when there is no basis for them, so any express warranty claim based on omissions should be challenged at the first opportunity.

We just got tickets to see “Wicked” again (we think this will be the fourth or fifth time). Since we first saw it (on Broadway in 2003, featuring Idina Menzel’s Tony-winning performance), we have loved this quirky and oh-so-creative imagining of the backstory of “the Witches of Oz” – Galinda (later, without the first “a,” the “Good Witch of the North”) and Elphaba, the viridescent lass who, in Baum’s classics, grew up to achieve infamy as the “Wicked Witch of the West” – beginning with their days as schoolgirls and reluctant roommates.  We are eternally charmed by the subtle scarecrow-Toto-Dorothy references woven throughout (we notice at least one new one every time we see the show) and we never tire of the score (“Defying Gravity,” “For Good”).  We also don’t think it puts too fine a point on it to appreciate the resonance of a character whose life is shaped by a childhood in which she never “fit” and to be gratified by her unlikely happy ending.

 

And in this manner (wait ‘til you see this tie-in), the lesson diverges from unhappy ending of the plaintiff’s expert metallurgist in today’s case, whose conclusions were excluded, in part, because they did not “fit” the facts of the case and the issues the expert had considered. In its (regrettably) unpublished and (not regrettably) short decision in Redd v. DePuy Orthopedics, Inc., 2017 WL 2859536 (8th Cir. June 6 2017), which features an appearance by our beloved “sham affidavit doctrine,” the United States Court of Appeals for the Eighth Circuit reviewed the Eastern District of Missouri’s decision excluding the plaintiff’s expert’s “defect” and “causation” testimony and granting summary judgment for the defendant.

 

In Redd, the plaintiff – five feet tall, 302 pounds, and taking immunosuppressant drugs – received a total hip replacement using the defendant’s artificial hip.  Four years later, the hip stem fractured.  When it was removed, “doctors learned that it had not properly grown into the bone at the top of [the plaintiff’s] hip,” 2017 WL 2859536 at *1.  Plaintiff’s doctors were aware of this risk, heightened by the plaintiff’s marked obesity and her medications.  The plaintiff was implanted with a second hip stem, which similarly fractured less than two years later.

 

The plaintiff filed suit, asserting the usual negligence, strict liability, and manufacturing defect claims. She retained her metallurgy expert to opine about the cause of the hip stems’ fractures.  The expert “had done research in fatigue fracture initiation in metal objects but not in metal objects implanted in the human body.  His analysis considered metallurgical factors but not any biomechanical factors (such as a hip stem’s failure to grow into the hip bone . . .).” Id. He also “did not review any records related to the manufacturing process . . . .” Id. He opined that the fracture of the plaintiff’s hip stem was caused by the improper “phase” of the metal along with the “grain size” of the metal alloy (metallurgical terms of art, we assume).  He “acknowledged that environmental factors could have also contributed to the failure of the hip implant, but said that any small variation in the biomechanical forces would have been secondary in nature to the hip stem’s . . . state” in causing the failure. Id. (internal punctuation omitted).

 

The defendant moved for exclusion of the expert’s testimony and for summary judgment. In response, the plaintiff submitted an affidavit in which the expert testified, for the first time, that the “phase” of the metal in the hip stem violated the defendant’s own specifications, and that “environmental factors would be secondary in the cause of the fracture when the material is inherently defective to begin with.” Id. (internal punctuation omitted).  The defendant moved to strike the affidavit on the grounds that it impermissibly supplemented or changed the expert’s opinion after the close of discovery.

 

Throw a little Daubert on this expert, and his opinions melt away.

 

The district court held that the expert, while qualified to testify about metallurgy, lacked a scientific or factual basis for his “manufacturing defect” or “causation” testimony. The court further found that the expert had failed to consider the issue of the forces that were exerted on the implant inside the plaintiff’s body.  Finally, the court granted the defendant’s motion to strike the expert’s affidavit, noting that statements in the affidavit contradicted the expert’s earlier testimony and “a party cannot change testimony,” by submitting an affidavit, “just to avoid summary judgment or a Daubert motion.” Id. at *2.  (This is the “sham affidavit doctrine,” which we have used with glee and success in our own appeals.)  With the expert’s “defect” and “causation” testimony excluded, the plaintiff could not meet her burden of proving those claims, and the court granted summary judgment for the defendant.

 

On appeal, the Eighth Circuit affirmed all of the district court’s holdings. First, it held that the expert’s affidavit, invoking, inter alia, manufacturing specifications he earlier testified that he had not been provided, “arguably crossed the line between clarifying prior testimony and changing prior testimony,” id. (citation omitted); thus, the district court had not abused its discretion in excluding the affidavit from consideration.  The court also rejected the plaintiff’s argument that the district court had erred when it required the expert to exclude biomechanical causes of the plaintiff’s fracture.  The court emphasized that, while “an expert need not rule out all possible causes of an injury, [he] nonetheless should adequately account for obvious alternative explanations.” Id. at *3 (internal punctuation and citation omitted).  In this case, the expert failed to consider the obvious alternative cause of the plaintiff’s fracture; namely “the failure of the hip stem to grow into [the plaintiff’s] hip bone and properly distribute her weight,” id, and gave no consideration to the biomechanical forces applied to the hip stem.  As such, the court concluded, the district court had acted within its discretion in excluding the expert’s testimony on causation and defect.

 

Short, tidy, and correct on all counts. Keep ‘em coming.  As for us, we are off to see the Wizard (again).

The Supreme Court’s opinion on personal jurisdiction in BMS v. Superior Court has already made a substantial impact, despite being on the books for a mere three weeks.  That’s probably because it’s the Supreme Court and also because personal jurisdiction is an issue in every lawsuit filed, whether in state or federal court.  Another reason could be that the California Supreme Court’s opinion reaching for personal jurisdiction in BMS was so clearly swimming against the Supreme Court’s recent current that its reversal was widely anticipated and thus gained notoriety even faster than usual.  That last part is speculation, but still, we have not heard so much about personal jurisdiction since poor Mr. Burnham traveled from New Jersey to California to visit his kids. See Burnham v. Superior Court, 495 U.S. 604 (1990).

So what will we see following BMS?  We saw last week that some plaintiffs will try to stretch even the most tenuous forum contacts into specific jurisdiction, and some courts may go along with that.  We expect that most will not.  Take for example a recent opinion from the New Jersey Appellate Division, Dutch Run-Mays Draft, LCC v. Wolf Block, LLP, __ A.3d __, 2017 WL 2854420 (N.J. App. Div. July 5, 2017).  In Dutch Run, a Florida real estate developer sued a dissolved Pennsylvania law firm in New Jersey state court, and it argued that the law firm’s compliance with New Jersey’s business registration statute created personal jurisdiction “by consent.”  The New Jersey courts rejected that position.  Sure, the plaintiff was able to identify New Jersey contacts—business registration, a New Jersey registered agent, two New Jersey offices, the residency of some partners on the law firm’s dissolution committee, and three lawsuits that the law firm filed in New Jersey’s courts.

The problem for the plaintiff was that its claims had nothing to do with these New Jersey contacts. As the court put it, “[T]he negligence forming plaintiff’s cause of action did not arise from defendant’s contacts with New Jersey.  Plaintiff cannot show any relationship between the underlying matter and the business or attorneys in New Jersey.” Id. at *5.  Thus, no specific personal jurisdiction.  This is a faithful application of BMS, which requires a causal link between the defendant’s forum contacts and the plaintiff’s alleged injury.

Equally as important, the court held that the law firm’s registration in New Jersey did not imply “consent” to general personal jurisdiction under Daimler AG v. Bauman:

Plaintiff suggests Daimler’s holding is narrowed by its facts, specifically that Daimler was not registered as a foreign entity and had no registered agent or offices in California.

This limited view ignores Daimler’s definitive due process analysis. . . .  We now join the many courts that have circumscribed the view of general jurisdiction post-Daimler. . . .  In light of Daimler, we reject the application of [Allied-Signal, Inc. v. Purex Indus., Inc. 242 N.J. Super. 362 (App. Div. 1990)] as allowing general jurisdiction solely based on the fiction of implied consent by a foreign corporation’s compliance with New Jersey’s business registration statute. . . .  Importantly, the exercise of general jurisdiction requires satisfaction of the “continuous and systematic contacts” to comply with due process. Mere registration to conduct some business is insufficient.

Dutch Run, at *7 (emphasis added, citations omitted).  The court also rejected the plaintiff’s request for “jurisdictional discovery” because “[w]e remain unconvinced that permitting further discovery would have altered our conclusion.” Id. at *8.

Speaking of discovery, we also commend to you the order rejecting “jurisdictional discovery” in In re Baltimore City Asbestos Litigation (Smith v. Automotive Prods. Co.), Memorandum Opinion & Order, No. 24X13000333 (Baltimore City Circuit Ct. June 7, 2017).  In Smith, a Pennsylvania plaintiff sued multiple Pennsylvania defendants in Pennsylvania.  But after some defendants won summary judgment, the plaintiff tried to re-file his lawsuit in Maryland, which has a longer statute of limitations.  Slip op. at 2.

The Maryland court initially reserved ruling on personal jurisdiction and allowed limited “jurisdictional discovery.” This made neither side happy, resulting in dueling motions for reconsideration:  The defendants asked again for dismissal, and the plaintiffs wanted broader discovery.

The defendants won. Citing BMS, the court ruled that it lacked specific personal jurisdiction over the defendants because

this suit is unrelated to any alleged contact the Defendants may have had with the State of Maryland. Further the Defendants in this suit have conducted virtually no business in the State of Maryland and, therefore, have not purposefully availed themselves of the privilege of conducting activities in the State.  Therefore, this Court lacks specific jurisdiction over the Defendants in this suit.

Slip op. at 5. The court similarly lacked general personal jurisdiction over the defendants because they were not “at home” in Maryland, where “the only relevant inquiry is whether the defendant is either incorporated or has its principle place of business in the forum state.”  Slip op. at 6 (citing Daimler AG v. Bauman).  Like the New Jersey court in Dutch Run, the Maryland court rejected “jurisdictional discovery” because “[i]t is clear that further discovery will not uncover facts demonstrating the existence of general jurisdiction over any of the moving Defendants.  All of the Defendants are incorporated outside of Maryland.  The Defendants’ principal places of business are all in Europe.”  Slip op. at 6.

We bring you these two cases not only because they are timely, but because they confront tactics that we expect to see post-BMS—assertions of jurisdiction “by consent” and requests for “jurisdictional discovery.”  Our view on jurisdiction by consent is clear:  We don’t think it holds up; and as the New Jersey court found, a majority of courts have ruled that business registration alone does not form consent to jurisdiction.

As for discovery, these courts were correct to reject discovery where the facts already showed that jurisdiction was lacking. To this, we can add only that courts contemplating “jurisdictional discovery” should be reticent, very reticent.  As is commonly true with phased discovery, defining the phases can be challenging, leading to substantial overlap between discovery on jurisdictional facts versus discovery on all other facts.  It is a slippery slope toward full-blown discovery, in a case where the plaintiff has not yet established the court’s jurisdiction.  Look at what the plaintiff did in Smith v. Automotive Products, discussed above—the court gave them jurisdictional discovery, and their response was to ask for more.  We are not surprised.  Of course, this all assumes that a court has the power to allow discovery against a defendant contesting jurisdiction in the first place.  We don’t know the answer to that question, but the yet-to-be established nature of the court’s prerogative is another reason to tread lightly.

We depend on young associates to perform most of the legal research that supports the arguments we make on behalf of our clients.  By and large, those associates do an excellent job.  On those rare occasions when we find ourselves grousing about the quality of research, it usually has something to do with reliance on overly-specific computer searches.  Sometimes it seems as if the lawyers punch a search term into Lexis or Westlaw that would capture only cases that are precisely on point.  The problem with that approach is the possibility of missing cases that support general principles, or offer other oblique ammunition for one’s position.  Today’s case, Canale v. Colgate-Palmolive Co., 2017 U.S. Dist. LEXIS 97506 (S.D.N.Y. June 23, 2017), is an example of that kind of helpful, albeit indirect, authority.  The plaintiffs in Canale filed a class action attacking the defendant for allegedly overstating the whitening power of its toothpaste.  The toothpaste contained hydrogen peroxide, and its advertising bragged of deep whitening – more than three shades.  The plaintiffs asserted that the hydrogen peroxide was not strong enough and was not in contact with tooth enamel long enough to achieve the promised results.  The causes of action were based on breach of warranty and violations of New York’s General Business Law sections 349 and 350, which outlaw deceptive practices and false advertising.

What can this case possibly have to say for drug litigation?  To begin with, the toothpaste’s peroxide content meant that it was both a cosmetic and an over-the-counter (OTC) drug.  A product qualifying as both a cosmetic and drug is subject to the stricter requirements applicable to drugs.  Either way, such a product enjoys the preemption protections in the Food, Drug and Cosmetics Act,  21 U.S.C. sections 379r and 379s.  The FDCA forbids state law (including jury verdicts) or regulations that would impose a requirement on cosmetics or OTC drugs that are “different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable” via the FDCA.  Thus, the defendant filed a motion to dismiss the case in its entirety, and preemption was one of the grounds. The plaintiffs ultimately evaded preemption because the court found no FDA requirement regarding the tooth whitening claim, so there was nothing federal that the state laws against deceptive advertising  contradicted.

Okay, you’re still probably wondering why a drug defense hack would care about this case.  If an associate failed to find this case in her research, who cares?

There are two preemption points in Canale that are valuable:

1. The plaintiffs’ opposition to the defendant’s motion rested solely on implied preemption cases.  That is, the plaintiffs argued that there was no impossibility preemption.  That is, the plaintiffs had completely missed the point.  The defendant was not arguing impossibility preemption.  Rather, the defendant argued that Congress had expressly manifested an intent to preempt state law.  The plaintiffs had confused express preemption with implied preemption, but the Canale court kept the distinction straight.  So should you.

2.  The plaintiffs, predictably, argued that there was a presumption against preemption.  But, consistent with point 1 above, the Canale court held that “where, as here, Congress has expressly manifested its intent to preempt state law, no presumption against preemption arises.”  It is nice to have in your pocket such a clear statement on this issue from SDNY.

Still, as we mentioned, the preemption argument did not carry the day for the defendant.  So was this a win for the plaintiffs?  Not at all.  The issue of whether or not the advertising for the whitening toothpaste was deceptive had already been addressed to the Federal Trade Commission.  The issue was pending. The FTC had at least as much expertise as the court in deciding whether the hydrogen peroxide in the toothpaste had sufficient whitening power (let’s face it, the FTC has more expertise), the FTC is specifically tasked with discretion to police allegedly deceptive labeling, there was a risk of inconsistent rulings, and the FTC had gotten the issue first.  Consequently, the Canale court – after observing that “primary jurisdiction” is something of a misnomer because it isn’t , strictly speaking, jurisdictional – decided to stay the litigation to allow the FTC to do its job and determine whether the toothpaste advertising really was deceptive.

Staying a class action is definitely a good result for the defendant.  Despite the setback on the preemption front, we bet the Canale result put smiles on the faces of the defendant and its lawyers – nice, big, shiny smiles.

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

Usually when we are talking about Michigan, it’s to praise the Michigan Products Liability Act which cuts off civil liability for drug manufacturers “if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller.” M.C.L. § 600.2946(5). However, under Michigan law, the distinction between a drug and a device is significant. That is because device manufacturers are not afforded the same immunity. See M.C.L. § 600.2945(b).  Of course, device manufacturers do have the broad preemption provided by the Medical Device Amendments. See Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008). So it’s somewhat rare to get to post on a Michigan law case that isn’t focused on the statute or preemption, but we found one – Avendt v. Covidien, Inc., 2017 WL 2868487 (E.D. Mich. Jul. 5, 2017).

Avendt involves a biologic (as opposed to synthetic) mesh product that was used by plaintiff’s surgeon in plaintiff’s hernia repair surgery. Plaintiff suffered complications following surgery, including an infection and chronic non-healing wound that required multiple revision surgeries and eventual removal of the product. Id. at *1. The biologic mesh product at issue was approved by the FDA via the 510(k) substantial equivalence process. It was cleared to market for use only in “Class I/Clean wounds.” Id. at *17. Plaintiff did not dispute that his wound was Class I and clean, in other words this is an on-label use case. Id. at *19.   In addition, the product’s labeling contained a warning that the mesh could weaken or breakdown if used in a contaminated or infected wound or if exposed to “high concentrations of digestive enzymes.” Id. at *17.

Against this background, plaintiff filed suit alleging that defendant’s product was defective due to failure to test and subsequent failure to warn. Id. at *1. More specifically, plaintiff argued that defendant’s insufficient testing led it to market the product as a “biologic mesh,” when in fact it performs like a synthetic mesh which was the characteristic of the product that led to plaintiff’s injuries. Id. at *22.

In support of his claim, plaintiff disclosed only one expert, Dr. Michael J. Rosen. Dr. Rosen was plaintiff’s treating surgeon who performed the surgery removing the mesh. Plaintiff opted not to have Dr. Rosen prepare a full Rule 26 expert report, the consequences of which were that he would be limited to testifying as a treating physician and so only permitted to testify as to those opinions that were formed “for purposes of, and within the scope of, his care and treatment of [plaintiff].” Id. at *2. Most of Dr. Rosen’s opinions were not.

For example, Dr. Rosen’s opinion that the mesh was unsafe for use in Class I wound was excluded as not being related to his care and treatment of the plaintiff. That may have been an opinion he held at the time he treated plaintiff, but it was not formed for the purpose of or within the scope of his care and treatment of plaintiff. Id. at *23. He had no reason to form a safety opinion to care for and treat plaintiff and he didn’t include any such opinion in his medical records or in any discussion with plaintiff or any of his colleagues. Id. Moreover, Dr. Rosen did not report plaintiff’s case to the FDA as an adverse event. Id. Dr. Rosen’s opinions on the sufficiency of the testing and adequacy of the warning suffered the same fate – to even be considered potentially admissible Dr. Rosen needed to prepare a proper Rule 26 expert report “setting forth the scientific or experiential basis” of his theories. Id. at *25.

But that wasn’t the only fatal flaw for Dr. Rosen’s opinions. His opinions were also unsupported. Unlike his litigation opinion that defendant’s biologic mesh was unsafe for Class I wounds, Dr. Rosen had opined in numerous peer-reviewed articles that defendant’s product was acceptable in that precise situation. Id. at *23-24. The blatant contradiction was another ground for exclusion. Id. at *25. These same peer-reviewed publications also discussed the need for further study of the biologic mesh for treating Class II and III wounds, but nowhere suggested that further testing was needed regarding treatment of Class I wounds such as plaintiffs. So, Dr. Rosen’s opinions on adequate testing were also unsupported. Id. at *26.

As to the adequacy of the warning, plaintiff argued that the product’s labeling should have included a warning to remove the mesh in the event of a seroma (what plaintiff had) or an infection. Id. Dr. Rosen, however, could only opine that “there should be more information” about the types of cases for which the mesh should be used. Id.  That was not enough to clear plaintiff’s hurdle of proving as a matter of law that defendant had a duty to warn. Id. Moreover, as noted above, the label did warn about weakening and breakdown – the very side effects plaintiff suffered. Id.

Finally, Dr. Rosen also offered an opinion on causation. He testified that he saw the mesh “sitting on a bed of pus,” removed it, and concluded that the mesh caused the infection because the infection cleared up after removal. Id. at *29. The court didn’t question that Dr. Rosen knew an infection when he saw it.  But “the ability to diagnose medical conditions is not remotely the same … as the ability to deduce … in a scientifically reliable manner, the causes of those medical conditions.” Id. (citation omitted). Bottom line – nowhere in his opinion did Dr. Rosen rule out the other potential causes of plaintiff’s infection and failure to heal; such as his diabetes, obesity, blood pressure, and use of immunosuppressants. Id. *29-30.

But Dr. Rosen wasn’t the only problem with plaintiff’s case. Plaintiff’s failure to warn claim also failed for lack of causation. First, the learned intermediary doctrine applies to a medical device. Id. at *21-22. So any duty to warn ran to plaintiff’s surgeon. Second, there was no evidence that plaintiff’s surgeon read the product’s labeling. Id. at *29.   He had not met with the defendant’s representative, had not read the instructions for use, and had not read any of the literature about the product. Under this circumstance, no additional or different warning would have made a difference because the doctor wouldn’t have seen it. No failure to warn.

Defendant also had no duty to conduct a randomized prospective clinical trial before marketing the product. There was no evidence that such a clinical trial was the standard of care for 510k mesh products at the time defendant’s product was approved. Id. at *27.

Plaintiff paid dearly for failing to serve a Rule 26 expert report for their sole medical expert, although it appears that even with a report very little of what their expert was offered to opine on would have been admissible under Daubert anyway. And with no causal nexus between the doctor and the warning, plaintiff’s failure to warn claim was dubious regardless of whether the expert testimony was admissible or not. While any one of these things would have sunk the case, we’re glad the court explored them all. The opinion is loaded with good precedent.

One of the (many) things that made last year’s decision in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), so hideous that it weighed in at #3 of our worst decisions of the year was that, virtually without discussion, it held that an FDA-approved black box warning was not only inadequate but so poor as to be worthy of punitive damages.  Id. at *7.  Fortunately the Missouri Supreme Court granted a transfer (on January 5, 2017, according to Westlaw) and (we hope) will restore sanity on at least some of the issues in Barron.  However, the mere fact that a boxed warning – the strongest FDCA warning there is – could be utterly disregarded as in Barron got us thinking.

How have courts treated boxed warnings in other inadequate warning cases?

Initially, we’re not dealing in this post with claims that, in order to be adequate, a defendant’s labeling should have included a boxed warning. We’ve dealt with that kind of claim elsewhere, and our position is that, since the FDA must pre-approve all boxed warnings, all “should have added” claims are preempted.  This post deals with prescription medical products that already have boxed warnings.  Preemption becomes an issue in existing black box cases only if the plaintiff claims that the black box should have been changed – since (as discussed in the posts linked to previously) changes to black box warnings require prior FDA approval.

Looking back through our posts, we see we’ve described one decision, Hain v. Johnson & Johnson, No. ATL-L-8568-11 MT, slip op. (N.J. Super. L.D. June 20, 2013), reaching such a result. Hain recognized that “[a] ‘black box’ warning is the strongest warning required by the FDA.”  Id. at 6 (citing 21 C.F.R. §201.57(c)(1).  Regardless of what might be the case with other, similar products:

[B]y mandating each manufacturer include the strongest type of warning possible to warn of [the risk at issue], the FDA ensured each prescriber’s attention would be focused on the risk. . . .  [A] boxed warning required by the FDA existed in the package insert at the time [plaintiff] ingested [the drug].  Courts have previously held prescription warning labels containing a boxed warning, mandated by the FDA, are adequate as a matter of law.

Id. at 7.

In In re Chantix (Varenicline) Products Liability Litigation, 881 F. Supp.2d 1333 (N.D. Ala. 2012), the primary authority cited in Hain, the court determined that under the law of any state in the country, an on-point black box warning was adequate as a matter of law.  Such a warning was “the highest level warning possible, prominently displayed at the beginning of a drug’s official prescribing information.”  881 F. Supp.2d at 1339.  There could be no doubt that such a warning “was sufficient to alert to the possibility of the harm actually suffered.” Id. at 1340.  Plaintiff’s quibbles about when the drug should be used failed because they sought to tell physicians how to practice medicine.  “[T]he decision as to use [of] a medication as a first-line treatment is uniquely up to the prescribing medical professional and based on a decision concerning his or her individual patient.  Id.

Unlike the majority of cases reviewed by this court, the plaintiffs seek to pursue their failure to warn claims post the 2009 black box warning, not for failing to warn of possible complications from [the drug], but for failing to tell physicians when to prescribe it. . . .  [Even] the plaintiffs recognize that a black box warning is “the most serious warning in the FDA’s arsenal”. . . .  For the foregoing reasons, the court finds the 2009 black box warning adequate as a matter of law.

Id. at 1342-43 (citation omitted).  Accord In re Chantix (Varenicline) Products Liability Litigation, 889 F. Supp.2d 1272, 1304 (N.D. Ala. 2012) (“the court finds that [the] black box warning is adequate as a matter of law”).

Similarly, in Christison v. Biogen Idec, Inc., 199 F. Supp.3d 1315 (D. Utah 2016), the court held that a boxed warning of a usually fatal condition was adequate to warn physicians of that risk as a matter of law:

[I]t is undisputed that as a condition of [the drug’s] re-approval . . . the FDA required that the prescribing information contain a “black box” warning about [the risk] which is the strongest warning  required or permitted by FDA.  The black box warning, as the most serious warning available, can be reasonably expected to catch the attention of the consumer. . . .  [T]he intensity of the warning matched the magnitude of the risk.  The black box warning . . . was not qualified or minimized in any way because the magnitude of the risk − death or severe disability − was of the highest possible degree.

Id. at 1343-44 (footnotes omitted).  Accord Amos v. Biogen Idec, Inc., ___ F. Supp.3d ___, 2017 WL 1316968, at *5 (W.D.N.Y. April 10, 2017) (adequacy as a matter of law; the drug’s “label contained this information in a black box warning, the strongest warning available”); Gentile v. Biogen Idec, Inc., 33 Mass. L. Rptr. 607, 2016 WL 4168942, at *6 (Mass. Super. July 28, 2016) (“[t]he black box warning in effect when [the prescriber] first prescribed [the drug] to [plaintiff’s decedent] explicitly warned against the precise risk . . . that [she] ultimately suffered, and fully disclosed the serious consequences of that disease”).

In Aaron v. Wyeth, 2010 WL 653984 (W.D. Pa. Feb. 19, 2010), the product’s black box warning “advised physicians of the specific risks at issue in the instant case,” thus the court found “no evidence that [defendant] breached its duty to exercise reasonable care to inform [the prescriber] and others similarly situated of the risks associated with” taking the drug in question, even though the prescriber testified that he did not remember the warning correctly.  Id. at *10.  In Whiteside v. Johnson & Johnson, 2015 WL 11120989 (Mag. N.D. Tex. Mar. 13, 2015), adopted, 2015 WL 11120990 (N.D. Tex. July 8, 2015), the court dismissed the action with prejudice when the plaintiff abandoned ship in the face of the defendant’s summary judgment motion.  The court noted that the “Plaintiff’s prescription postdat[ing] . . . Defendants’ addition of an adequate ‘black box’ warning about the risks associated with the drug in question . . . would be fatal to Plaintiff’s claims.”  Id. at *1 n.1. See also Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *2-3 (N.D. Tex. Nov. 15, 2007) (black box warning held adequate as a matter of law; Texas presumption unrebutted); Clark v. Hoffman-La Roche, Inc., 2006 WL 1374516, at *7 (N.J. Super. May 2, 2006) (boxed warning “satisfied [defendant’s] burden under either New Jersey or Utah law to provide an adequate warning with respect to the risks” at issue); cf. In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 4364832, at *34 (W.D. La. Sept. 2, 2014) (characterizing post-prescription boxed warning as “hav[ing] full and adequate warnings”).

In a couple hours of looking we found more than a half-dozen cases where boxed warnings were held adequate as a matter of law.  Thus any court “unaware of any court holding that such a [boxed] warning is per se adequate as a matter of law,” Hutchens v. Abbott Laboratories, Inc., 2016 WL 5661582, at *6 (N.D. Ohio Sept. 30, 2016), either didn’t look very hard, or wasn’t willing to accept what it found.

In our view, the bottom line with boxed warnings is: one, the presence of a boxed warning concerning the relevant risk of a prescription medical product demonstrates that the risk is adequately warned about and sufficiently emphasized, making the warning adequate as a matter of law; and in any event two, since the FDA controls the content of black box warnings, any allegations that existing boxed warnings are inadequate are necessarily preempted.