Literally for decades plaintiffs in mass torts have employed the business model of flooding jurisdictions seen as friendly to them with more solicited plaintiffs than any court system can possibly handle.  They have employed every forum-shopping trick in the book to trap defendants in these jurisdictions, which usually have no relationship to any party.  After swamping the courts, they finish the job by advocating procedural shortcuts, such as abbreviated discovery and consolidated trials, that make it virtually impossible for defendants to undertake anything approaching an effective defense.

The result is tens, if not hundreds, of thousands of non-resident plaintiffs filing suit in favored(?) fora having nothing to do with either the parties or the supposed disputes.

Having thus sown the jurisdictional wind, however, the other side is now on the verge of reaping the jurisdictional whirlwind.  Their jurisdictional gamesmanship is circling the drain, following the United States Supreme Court’s decisions in Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”), and before that in Daimler AG v. Bauman, 134 S. Ct. 746 (2014) (“Bauman“).  Without personal jurisdiction over the defendants, plaintiffs can’t get to first base.  Let them explain to all these clients, who probably wondered about having their suits pending in far-off places to begin with, why all is for naught and they have to start over again (assuming they can at all – not every state tolls the statute of limitations) in a more logical forum they could have been in all along.

Two recent cases illustrate the yawning precipice into which so many litigation tourists find themselves staring.

The first is the Illinois Supreme Court’s decision a few weeks ago in Aspen American Insurance Co. v. Interstate Warehousing, Inc., ___ N.E.3d ___, 2017 WL 4173349 (Ill. Sept. 21, 2017), which we mentioned briefly in our recent post on Judge Herndon’s blowing up of a bunch of misjoined complaints dragged out of St. Claire County.  Aspen American wasn’t a product liability case at all – but it just as well could have been.  A litigation tourist insurance company sued on a subrogated claim in Chicago (Cook County).  The insured was a New Jersey company that claimed damages when a warehouse owned by the defendant allegedly collapsed, with the end result being that perishable goods owned by the Jersey entity … well, perished.  2017 WL 4173349, at *1.

The only trouble was that the warehouse wasn’t in Illinois either – it was in Michigan.  Id. at *1.  The defendant owned another warehouse in Illinois, as it did in many other states, but the plaintiff had never stored anything there.  Id.

After losing below, the non-resident defendant successfully argued that the non-resident plaintiff couldn’t obtain personal jurisdiction over it for litigation concerning an accident that also occurred out of state.

The Illinois Supreme Court’s decision was unanimous.

After Bauman and BMS, that the defendant conducted unrelated business – operating a different warehouse – in Illinois did not come close to a basis for personal jurisdiction.  The defendant had operated the Illinois warehouse for decades, but mere “continuous and substantial” business in a state isn’t enough anymore for general jurisdiction.  Aspen American, 2017 WL 4173349, at *3.  A warehouse wasn’t enough:

[T]o comport with the federal due process standards laid out in [Bauman] . . ., plaintiff must make a prima facie showing that defendant is essentially at home in Illinois.   This means that plaintiff must show that defendant is incorporated or has its principal place of business in Illinois or that defendant’s contacts with Illinois are so substantial as to render this an exceptional case.  Plaintiff has failed to make this showing.

Id. at *4.  If operating one warehouse was enough for jurisdiction, “then defendant would also be at home in all the other states where its warehouses are located.  The Supreme Court has expressly rejected this reasoning.”  Id.

Further, the defendant’s registration to do business in Illinois, as it had to do to operate that other warehouse, likewise was insufficient to support jurisdiction over a non-resident’s suit for out-of-state injuries.  “[T]he fact that a foreign corporation has registered to do business under the Act does not mean that the corporation has thereby consented to general jurisdiction over all causes of action, including those that are completely unrelated to the corporation’s activities in Illinois.”  Id. at *5,

So, why did Aspen American attract the attention of amici Illinois Trial Lawyers Association and the American Association for Justice, as well as several major asbestos defendants?  Id. at *2.  It all goes back to that gathering jurisdictional whirlwind.  Cook, Madison, and St. Clair counties are three of plaintiffs’ favorite litigation dumping grounds.  Indeed, as we mentioned in our other post, the same intermediate Illinois appellate court that got spanked in Aspen American decided M.M. v. GlaxoSmithKline LLC, 61 N.E.3d 1026 (Ill. App. 2016), less than two months later (Aspen on June 30, 2016, and M.M. on August 26 of the same year).  M.M. decided that a single clinical trial site was enough for jurisdiction, which means that it could be sued in “all the other states where” it recruited for such trials.  Aspen American unanimously rejected such broad jurisdictional arguments in the context of warehouses – we don’t see much difference.

Good luck with that now. The jurisdictional whirlwind is coming for the litigation tourist Rivieras of Illinois.

It’s already sweeping away the talc swamp in Missouri.

That’s the other decision we want to discuss, Fox v. Johnson & Johnson, ___ S.W.3d ___, 2017 WL 4629383 (Mo. App. Oct. 17, 2017).  Fox was an appeal from one of those gigantic talc verdicts we’ve all read about.  The plaintiff was a non-resident (we don’t know where from, and that doesn’t matter), who found her way into St. Louis by virtue of all that jurisdictional gamesmanship we mentioned earlier.  She was one of 65 plaintiffs from all over the country joined in the same complaint with one St. Louis resident.  Id. at *1.  However, after BMS, that jurisdictional subterfuge – and the boxcar verdict it produced – is for naught.

[A] non-resident plaintiff must establish an independent basis for specific personal jurisdiction over the defendant in the state. . . .  [S]pecific personal jurisdiction requires a connection between the forum state and the specific claims at issue.  “When there is no such connection, specific jurisdiction is lacking regardless of the extent of a defendant’s unconnected activities in the state.”  The fact that resident plaintiffs sustained similar injuries does not support specific jurisdiction as to non-resident claims.  The parties agree that BMS is controlling here, but they disagree on the resulting outcome.

Id. at *2 (BMS citations omitted).  Another unanimous decision.

Plaintiff in Fox wanted to scurry about to see if she could find talc-related contacts between the defendant and an in-state company with which the defendant allegedly did business.  Id.  The court in Fox refused to allow such ex post facto discovery and argument.  Id. at *3 (“we find no authority supporting [plaintiff’s] request to rewind the case so as to supplement the pre-trial record to establish jurisdiction under the new standard”).  Poof.  A half billion dollars or so in talc verdicts just went up in smoke.

Further, that kind of discovery doesn’t advance the ball under BMS.  The contacts that matter are the defendant’s own relationship with the forum – not that the defendant had a relationship with somebody else that was in turn a resident of the forum.  This point was litigated in BMS.  The BMS plaintiffs themselves (like the 63 non-resident plaintiffs in the complaint in Fox) had no contacts with California.

[T]he nonresidents were not prescribed [the drug] in California, did not purchase [the drug] in California, did not ingest [the drug] in California, and were not injured by [the drug] in California.  The mere fact that other plaintiffs were prescribed, obtained, and ingested [the drug] in California − and allegedly sustained the same injuries as did the nonresidents − does not allow the State to assert specific jurisdiction over the nonresidents’ claims.

BMS, 137 S. Ct. at 1781.  Nor did the defendant’s allegedly contracting with a drug wholesaler that was, in turn, located in California:

[Plaintiffs] contend that [defendant’s] “decision to contract with a California company to distribute [the drug] nationally” provides a sufficient basis for personal jurisdiction. . . .  [T]he requirements of [personal jurisdiction] must be met as to each defendant over whom a state court exercises jurisdiction.  In this case, it is not alleged that [defendant] engaged in relevant acts together with [the resident defendant] in California. . . .  The bare fact that [defendant] contracted with a California distributor is not enough to establish personal jurisdiction in the State.

Id. at 1783 (citations and quotation marks omitted).  “[C]ontracting with” an in-state entity doesn’t move the jurisdictional needle.

That a separately owned/incorporated in-state subcontractor was involved in some of the steps by which a product was prepared to enter the stream of commerce doesn’t cut it.  Whether it’s a frantic search for a Missouri talc subcontractor, or for some similar Pennsylvania subcontractor to try to prevent the coming whirlwind from decimating the Philadelphia litigation business, such efforts are highly unlikely to succeed.  What kind of facts are needed to circumvent the usual limits on personal jurisdiction?  Bauman told us.  Doing so requires an “exceptional case.”  134 S. Ct. at 761 n.18 (emphasis added).  Ordinary business relationships with third parties who themselves reside in the state aren’t going to be enough to support litigation tourism.  “Exceptional” cases that would expand specific jurisdiction under BMS should be about as frequent as “exceptional” cases that expand general jurisdiction under Bauman.  It takes something exceptional to make an exception to the constitutional Due Process limits to personal jurisdiction.

This is why we saw asbestos amici descend on Aspen American.  Non-resident asbestos plaintiffs aren’t going to be able, any more, to obtain personal jurisdiction over the great majority of the scores of defendants that they sue – only those few unfortunate enough to be “at home” in the forum.  The same would be true in a multi-defendant suit involving prescription medical products.  And what happens when those unfortunate few viable defendants find themselves unable to pursue cross-claims or otherwise obtain relief against absent parties, simply because the plaintiff didn’t sue in state where s/he was injured?  “For the convenience of parties and witnesses, in the interest of justice, a district court may transfer any civil action to any other district or division where it might have been brought.”  28 U.S.C. §1404(a); see, e.g., Schmidt v. Leader Dogs for the Blind, Inc., 544 F. Supp. 42, 47 (E.D. Pa. 1982) (“[d]efendant’s inability to implead or cross-claim herein against the medical defendants dismissed from this lawsuit is a determinative factor”; §1404(a) transfer of venue granted).  It took us all of two minutes to find a cross-claim-based venue transfer decision; there are undoubtedly more.

The jurisdictional whirlwind is upon us. Toto, we’re not going to be in Madison County anymore.

Once the Supreme Court’s decision in Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), definitively determined that non-resident plaintiffs can’t go suing non-resident defendants anywhere they want, attention turned to one of the primary types of forum-shopping gamesmanship that plaintiffs used to trap defendants in their preferred venues.

St. Louis – and thus the Eastern District of Missouri – were one of the first battle grounds, and as we celebrated here, here, and here, a jurisdiction that had previously been almost impervious to attempts to combat fraudulent misjoinder seems to be coming around.  See Jinright v. Johnson & Johnson, Inc., 2017 WL 3731317, at *4-5 (E.D. Mo. Aug. 30, 2017); Covington v. Janssen Pharmaceuticals, Inc., 2017 WL 3433611, at *4-5 (E.D. Mo. Aug. 10, 2017); Turner v. Boehringer Ingelheim Pharma, Inc., 2017 WL 3310696, at *3 (E.D. Mo. Aug. 3, 2017); Jordan v. Bayer Corp., 2017 WL 3006993, at *4 (E.D. Mo. July 14, 2017); Siegfried v. Boehringer Ingelheim Pharmaceuticals, Inc., 2017 WL 2778107, at *4-5 (E.D. Mo. June 27, 2017).  So far every post-BMS removal of a misjoined, multi-plaintiff action in Missouri has followed the rationale discussed in our prior posts (and below), except for those with timing issues.

So that’s one “magnet jurisdiction” seemingly on the way towards at least some degree of redemption.

Another one is the Southern District of Illinois, home to Madison and St. Clair Counties. That one started out looking a lot more doubtful.  The first court to decide a post-BMS removal case had the attitude that nothing had changed.  The court elected to ignore BMS – not even deigning to discuss it, beyond mentioning the defendant’s reliance.  Rios v. Bayer Corp., 2017 WL 3600374, at *1 (S.D. Ill. Aug. 22, 2017).  Otherwise, it appeared that the Southern District was going to continue a status quo that had allowed it to keep its docket largely free of escapees from Madison and St. Clair, no matter what:

Plaintiff’s Complaint alleges that Defendants are citizens of [numerous states and foreign countries], and that some of the plaintiffs are also citizens of [the same states].  Thus, complete diversity does not exist on the face of the Complaint.  In their Notice of Removal, Defendants state that this Court nonetheless has diversity jurisdiction because the out-of-state Plaintiffs’ claims were either fraudulently joined or procedurally misjoined, and thus the non-diverse Plaintiffs’ citizenship should be ignored for purposes of determining jurisdiction.  But because it is clear from the face of the Complaint that diversity jurisdiction is lacking, the Court need not first determine the existence of personal jurisdiction, and once again opts not to do so in this case.

Id. at *2.

And so things stood until just recently, until another jurist in the district (one who wasn’t a former member of ATLA’s board of governors), former Chief Judge Herndon, decided that he couldn’t in good conscience say that BMS changed nothing.  In a series of seven Xarelto cases, Judge Herndon recognized that there could be no more jurisdictional business as usual in the Southern District after BMS.  See Berousee v. Janssen Research & Development, LLC, 2017 WL 4255075 (S.D. Ill. Sept. 26, 2017); Douthit v. Janssen Research & Development, LLC, 2017 WL 4224031 (S.D. Ill. Sept. 22, 2017); Braun v. Janssen Research & Development, LLC, 2017 WL 4224034 (S.D. Ill. Sept. 22, 2017); Bandy v. Janssen Research & Development, LLC, 2017 WL 4224035 (S.D. Ill. Sept. 22, 2017); Pirtle v. Janssen Research & Development, LLC, 2017 WL 4224036 (S.D. Ill. Sept. 22, 2017); Roland v. Janssen Research & Development, LLC, 2017 WL 4224037 (S.D. Ill. Sept. 22, 2017); and Woodall v. Janssen Research & Development, LLC, 2017 WL 4237924 (S.D. Ill. Sept. 22, 2017).

Since they are all by the same judge on the same subject, these seven opinions not surprisingly track the same rationale.  We’ll reference the most recent decision, Berousee, in our discussion. Berousee is a typical (actually somewhat on the small side, in our experience) misjoined mishmash of “32 non-Illinois plaintiffs from 18 different states who were embedded in the lawsuit explicitly to destroy diversity jurisdiction” by making sure that at least one plaintiff was not diverse from the non-resident defendant being sued.  Id., 2017 WL 4255075, at *1.  This motley crew of plaintiffs were blatantly misjoined, having nothing to do with one another, except allegedly taking the same product and suffering similar types of injuries

Notwithstanding the facial non-diversity of the complaint, the defendant removed (from St. Clair county), citing (“draw[ing] attention to”) BMS for the proposition that “state courts lack specific jurisdiction to entertain non-resident plaintiff claims.”  Id.  The court agreed that BMS “established the Fourteenth Amendment’s due process clause did not permit the exercise of specific personal jurisdiction in state court over nonresident consumer’s claims.”  Id. at *1 n.2.

The key point in all these cases is the federal district court’s “discretion in jurisdiction.”  That is, under Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574 (1999), such courts, in determining their jurisdiction, are free to invert the usual process and consider personal jurisdiction before diving into subject matter jurisdiction where the personal jurisdiction question is “straightforward” and “present[s] no complex question of state law,” and conversely “subject-matter jurisdiction is problematic.”  Berousee, 2017 WL 4255075, at *2 (discussing Ruhrgas).

[D]istrict courts do not overstep Article III limits when declining jurisdiction of state-law claims on discretionary grounds without determining whether those claims fall within their pendent jurisdiction without deciding whether the parties present a case or controversy.  Where a straightforward personal jurisdiction issue presenting no complex question of state law is pending before the Court − and the dispute over subject-matter jurisdiction is problematic − the court does not abuse its discretion by turning directly to personal jurisdiction.

Id. at *2 (Ruhrgas quotations omitted).

Now – that is to say, after BMS – personal jurisdiction is much more “straightforward” than the subject matter jurisdictional thicket of fraudulent misjoinder and CAFA jurisdiction:

[S]everal courts [have] utilized the BMS holding [and] conclusively held personal jurisdiction − instead of subject-matter jurisdiction − is the more straightforward inquiry.  Based on the above recent legal decisions combined with lack of “unyielding jurisdictional hierarchy,” interests of judicial economy, and weight of the precautionary effect on ruling on an issue that could regress and bind the state court, the Court finds that in this matter personal jurisdiction is the more straightforward inquiry − and will analyze same before addressing challenges to subject-matter jurisdiction.

Id. at *3 (citations to E.D. Mo. decisions already cited in this post omitted).

That was the hard part, because once the court gets to the personal jurisdiction inquiry, application of BMS really is pretty cut and dried in the context of mass torts and multi-plaintiff misjoined complaints.  General personal jurisdiction was out under our old friend Daimler AG v. Bauman, 134 S. Ct. 746 (2014), as the defendant was neither incorporated nor headquartered in Illinois. Berousee, 2017 WL 4255075, at *3.

As for specific jurisdiction, “[i]n exercising specific personal jurisdiction, defendants’ contacts with Illinois must be directly related to the challenged conduct.”  Id. (citations omitted).  There must be “purposeful availment” related to litigation.  Id. at *3 n.3.  Plaintiffs claimed that “defendants purposefully targeted Illinois as the location for multiple clinical trials which formed the foundation for defendants’ [FDA new drug] application.”  Id. at *4.  That was insufficient under BMS:

It is undisputed that the non-Illinois plaintiffs do not claim injuries from ingesting [the drug] in Illinois, and all conduct giving rise to the non-Illinois plaintiffs’ claims occurred elsewhere. The instant matter is analogous to BMS where the United States Supreme Court held that California state courts do not retain specific personal jurisdiction over non-resident defendant pharmaceutical companies, for non-resident plaintiff claims not arising out of or relating to defendant’s contacts with California. . . .  [T]his Court lacks specific personal jurisdiction over defendants regarding the non-Illinois plaintiffs’ claims.

Id. (emphasis original).

The plaintiff-side jurisdictional argument that Berousee rejected was the same one allowed by an Illinois intermediate appellate court last year in M.M. v. GlaxoSmithKline LLC, 61 N.E.3d 1026 (Ill. App. 2016), which is why M.M. became our #8 worst case of the year.  While the Supreme Court recently denied certiorari, see 2017 WL 1153625 (U.S. Oct. 2, 2017), that means next to nothing.  Consider, for example, the number of denied certiorari petitions in PMA preemption cases before the Court took, and affirmed, the pro-preemption decision in Riegel.  Off the top of our heads (and it’s been a while) we can name at least four − Martin v. Medtronic; Brooks v. Howmedica; Kemp v. Medtronic (one of Bexis’); and Mitchell v. Collagen.  There are probably more.

So we wouldn’t read anything into the denial in M.M.  It’s reasoning didn’t impress us – at minimum it is another “grasping” and “exorbitant” theory of personal jurisdiction that, like those in Bauman and BMS, cannot pass Due Process muster.  More importantly, M.M. is questionable in light of the Illinois Supreme Court’s recent decision in Aspen American Insurance Co. v. Interstate Warehousing, Inc., 2017 WL 4173349 (Ill. Sept. 21, 2017), which not only decisively rejected jurisdiction by consent, id. at *4-5,  but also had this to say about a similar theory, involving warehouses rather than clinical trials:

[P]laintiff has established that defendant does business in Illinois through the warehouse. . . .  But this fact falls far short of showing that Illinois is a surrogate home for defendant.  Indeed, if the operation of the warehouse was sufficient, in itself, to establish general jurisdiction, then defendant would also be at home in all the other states where its warehouses are located. The Supreme Court has expressly rejected this reasoning.

Id. at *4.  Granted, Aspen Insurance was addressing general jurisdiction, but since we’re discussing non-resident plaintiffs and Due Process, the “grasping”/”exorbitant” principle is the same.  Substitute “clinical trials” for “warehouses” and you can see where this is going….

Nor, getting back to the focus of this post, did the clinical trials argument impress Judge Herndon.  He was so unimpressed, he didn’t even cite M.M. while rejecting its rationale.  In Berousee,“the non-Illinois plaintiffs failed to allege ingestion of [the drug] in Illinois, or suffered from injuries caused by [the drug] in Illinois.”  2017 WL 4255075, at *4.  Without such allegations, “there is no connection between Illinois and the underlying [drug] controversy, which in itself is unconnected to Illinois.”  Id.  Allegations like the plaintiffs, about clinical trials generally, merely involved “general connections with forum [that] are not enough; a corporation’s continuous activity of some sort within a state is not enough to support demand that corporation be amenable to lawsuits unrelated to specified activity.”  Id.  The same sort of conduct “took place throughout the United States.”  Id. at *4 n.4.  But the non-resident plaintiffs “were not prescribed [the drug] here, nor did they purchase the drug, suffer any injury, or receive treatment in [this state].”  Id.

There being no personal injury over non-resident plaintiffs’ claims against non-resident defendants, those plaintiffs had to be dismissed, without prejudice.  Id. at *4-5.  Dismissal of those plaintiffs’ claims meant that complete diversity existed between the lone Illinois plaintiff and the defendants, so remand of that claim to state court was denied.  Id. at *5.

The other six decisions by Judge Herndon apply the same core jurisdictional reasoning as Berousee almost verbatim.  See Douthit, 2017 WL 4224031, at *3-6; Braun, 2017 WL 4224034, at *3-6; Bandy, 2017 WL 4224035, at *3-6; Pirtle, 2017 WL 4224036, at *3-6; Roland, 2017 WL 4224037, at *2-5; Woodall, 2017 WL 4237924, at *3-6.

That is not to say that they are identical in all respects, however.  In Douthit, the plaintiffs’ back-up argument, that the removal was untimely, was rejected almost out of hand.  The Supreme Court’s decision in BMS constituted an “order or other paper” under 28 U.S.C. § 1446(b)(3) opening up a new 30-day removal period.  2017 WL 4224031, at *6.  Plaintiffs made only “a feeble attempt to persuade the Court that pleadings and orders filed in other suits, not related to the removed case” weren’t “orders or other papers” under this statute . Id.  The court decisively rejected this “erroneous[] conten[tion]”:

Correctly, defendants attest BMS conclusively established the Due Process Clause prohibits non-Illinois plaintiffs from filing claims against defendants in Illinois state courts.  The Court agrees with defendants and finds plaintiffs’ argument unfounded.  When a “different case resolve[s] a legal uncertainty concerning the existence of original federal jurisdiction[,]” removal is allowed on that basis.

Id. (quoting Wisconsin v. Amgen, Inc., 516 F.3d 530, 534 (7th Cir. 2008)). Accord Braun, 2017 WL 4224034, at *6; Bandy, 2017 WL 4224035, at *6; Pirtle, 2017 WL 4224036, at *6; Roland, 2017 WL 4224037, at *5; Woodall, 2017 WL 4237924, at *6.

We hope that Judge Herndon’s septilogy (while not as entertaining as J.K. Rowling’s) nails down post-BMS jurisdictional issues in Southern District of Illinois, just as firmly as those issues appear to be resolved in the Eastern District of Missouri.  On to California and Pennsylvania.

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

In our post earlier this week “No Causation, No ‘Parallel Claim’” we examined the enormous causation hurdle plaintiffs face in trying to prove a Stengel or Hughes type failure to warn claim in those jurisdictions where such a claim has been found not to be preempted. In that post, we commented that we “would have preferred an order finding the failure-to-warn claims preempted.” Well today, we bring you two that do just that. The first a complete preemption win, the other only a partial, but we’ll start with the good news.

Both Golden v. Brown, Case # 17CV30568, slip op. (Colo. Dist. Ct. Sep. 24, 2017) and Norabuena v. Medtronic, Inc., 2017 Ill. App. LEXIS 593 (Ill. App. Sep. 20, 2017) refused to recognize a failure to warn claim premised on a failure to report adverse events to the FDA – a Stengel claim if you’re in the Ninth Circuit and a Hughes claim if you’re in the Fifth. Now neither Colorado nor Illinois is in those circuits, but we’d like to think that regardless these state courts would have reached the same conclusion they did – neither Colorado nor Illinois law recognizes a claim for failure to warn the FDA. So, plaintiff can allege defendant violated a federal regulation by failing provide information to the FDA – but it isn’t “parallel” to any state law claim because there is no such state law claim. The Illinois appellate court summed it up nicely:

[A]lthough plaintiffs have identified a federal requirement that their complaint alleges Medtronic violated, there is no Illinois requirement that parallels it. Plaintiffs asserted claims for failure to warn. Although Illinois recognizes that a manufacturer may satisfy its duty to warn by conveying information to third-party learned intermediaries, this is not synonymous with an affirmative duty to warn a federal regulatory body. The learned intermediary doctrine states that a manufacturer has a duty to warn prescribing physicians of a drug’s known dangerous propensities” under the understanding that those physicians will use their expert knowledge in adequately warning the patient. We cannot find that this duty is parallel to the federal requirement.

Norabuena, 2017 Ill. App. LEXIS 593 at **14. The Colorado court not only found that allegations of failure to report adverse events to the FDA don’t state a parallel claim, but also concluded that Stengel and Hughes “cannot be reconciled with 21 U.S.C. §360k(a) as interpreted in Riegel or 21 U.S.C. §337(a) as interpreted in Buckman.” Golden, slip op. at 3. In other words, failure to warn a learned intermediary is different from and in addition to federal requirements regarding reporting of adverse events and a claim for failure to provide information to the FDA is an improper attempt at private enforcement of the FDCA. Just what we’ve been saying since these two awful decisions came down.

Both decisions have a little more to discuss.

In Golden, plaintiff also attempted to base a parallel claim on alleged violations of Current Good Manufacturing Processes (“CGMPs”). Noting that it was joining the majority of courts to have considered the issue, the court ruled that the CGMPs are too “vague” and “open-ended” to serve as a basis for a parallel claim. Id. at 2. The court also found plaintiff’s breach of implied warranty of merchantability claim preempted as essentially an allegation that the device was not safe and effective which would directly contradict the FDA’s PMA decision that “there is a reasonable assurance of . . . safety and effectiveness” and therefore expressly preempted. Id. at 3. And finally, the court found plaintiff’s claims impliedly preempted because plaintiff failed to explain “how Defendant’s conduct violated state law duties absent the FDCA.” Id. Simply stating that her claims were premised on Colorado common law was insufficient – “true merely in title, not substance.” Id. Instead, plaintiff’s claim exist solely under the FDCA which is not allowed.

The Golden case also suffered from some pleadings defects, such as failure to allege facts to support either a defect or causation. Id. at 2. But even if those pleading deficiencies could be cured, none of plaintiff’s claims survived preemption, so the case was dismissed in its entirety.

Switching gears to Illinois – unfortunately the court ruled that one of the bases for plaintiff’s failure to warn claim was not preempted. The FDCA contains regulations against device misbranding, which includes advertising that is false and misleading. Norabuena, 2017 Ill. App. LEXIS 593 at **15. Plaintiff alleged that defendant’s advertising was false and misleading in that it concealed known risks of using the device in an off-label manner. Id. at **16. In reaching its conclusion, the court distinguished plaintiff’s claim as not an attack on the device’s label which would be preempted as having been specifically approved by the FDA during the PMA process. But rather, plaintiff was challenging allegedly deceptive marketing practices post pre-market approval. Id. at **17. But that is a distinction without a difference where plaintiff’s allegation is that in its advertising defendant should have included a warning different from or in addition to the warning the FDA approved. The FDA-approved warning is what must accompany product advertising. Think about what the court is saying – if the warning is in the product label it must adhere to the FDA-approved language. If the warning accompanies an advertisement for the product it does not. We do not believe that is something the FDA would allow. While we can understand how a court can find that a false statement made in product promotion may be both a violation of state law and FDCA misbranding regulations, where that falsity is alleged to be a failure to include a warning not approved by the FDA, we respectfully disagree.

But, all is not lost in Norabuena. The appellate court found that plaintiff’s claims were properly dismissed on another ground – failure to plead causation. The complaint apparently was replete with allegations of “omitted” risks, “[h]owever, there are no specific factual allegations in the complaint asserting that [plaintiff’s] surgeon encountered or relied on any of the asserted promotional marketing.” Id. at **21. If a tree falls in the woods. . . . It’s not enough to plead the act or omission, the complaint was also allege facts supporting proximate cause. This pleading deficiency wasn’t enough for a dismissal with prejudice, so the case is heading back to the trial court and plaintiff will have to re-plead her remaining failure to warn claim.

The beast part may be a bit of an exaggeration, but it serves the purpose of depicting what at least on the surface are two very opposite things. But if you delve more deeply, you find a lot of similarities. So many similarities that the two things shouldn’t really be opposites at all. That’s what happens in the fairy tale. The beast is really a prince. But life’s not a fairy tale. And neither is pharmaceutical litigation. And if it were, it wouldn’t be a Disney version, it would be one of those original Grimm Brothers’ stories – the dark and twisty ones. And that’s what we have today. Two cases that come to opposite conclusions but based on the same allegations about the same failure to warn about the same drug. We should be talking about a beauty and a prince. Instead we have a beauty and a beast . . . or at least maybe a frog.

Within two days of each other, two decisions were handed down in cases involving the generic prescription drug amiodarone manufactured by the same company – Hernandez v. Sandoz Inc.,  2017 U.S. Dist. LEXIS 120938 (N.D. Ill. Aug 1, 2017) and Tutwiler v. Sandoz Inc., 2017 WL 3315381 (N.D. Ala. Aug. 3, 2017). Both were second bites of the apple. In Hernandez, defendants moved for reconsideration of the court’s prior ruling rejecting preemption and allowing a failure to warn claim premised on defendants’ failure to provide medication guides per federal regulations. We blogged about that earlier decision here. In Tutwiler, the court had previously dismissed that same claim but plaintiff included it in her amended complaint. Defendants moved to dismiss again. Both courts stuck to their prior decisions.

Our prior post on Hernandez explains how we think the court got preemption wrong – notably by applying the Seventh Circuit’s awful PMA, medical device express preemption decision in Bausch v. Stryker to a pharmaceutical drug case and finding a parallel violation claim. On reconsideration, defendants argued that the court misapplied Bausch. In response, the court cited other district courts within the Seventh Circuit to also have applied Bausch to pharmaceutical cases, including another amiodarone case that we blogged about here. Hernandez, at *5-7. The old adage two wrongs don’t make a right comes to mind.

Unable to make the court see that this is really an implied preemption case – plaintiff was seeking to enforce an FDCA requirement regarding distribution of medication guides – defendants were left to argue that the claim isn’t really parallel to a state law duty to warn. There is no Illinois state law duty to warn pharmacists so they can in turn warn consumers. In fact, in prescription drug cases, the manufacturer’s duty is to warn the prescribing physician – not the consumer. Id. at *9n.4. From the court’s description of plaintiff’s allegations, plaintiff alleges both traditional failure to warn the prescriber and failure to warn the consumer by failing to provide medication guides. Id. at *9. The court then seems to conflate all those allegations into one plausible failure to warn claim. See id. (“The court remains convinced that plaintiff has sufficiently alleged each of the elements necessary to establish a failure to warn claim under Illinois law despite focusing much of his complaint on his allegations that defendant’s actions violated the FDCA.”). By alleging both failure to comply with the FDCA and failure to warn the prescriber plaintiff got to dodge both preemption and learned intermediary. But those are two separate claims and they should both fail.

And that’s how you turn the beast/frog into a prince. You apply both preemption and learned intermediary like in Tutwiler. First, in this case the court already dismissed plaintiff’s traditional failure to warn claim – the failure to warn plaintiff’s prescriber – under Mensing. These are after all generic prescription drugs and the Supreme Court has said they don’t survive conflict preemption. Which is presumably why plaintiffs in these cases are focused on the medication guide allegation. In Tutwiler, plaintiffs argued that failure to provide the medication violated the “duty of sameness” on which Mensing rests making Mensing inapplicable. Id. at *2. As we noted above, failure to warn based on failing to adhere to an FDCA requirement should also be impliedly preempted under Buckman or the prohibition of private causes of action to enforce the FDCA.

But the Tutwiler court said it didn’t need to consider preemption because the claim is barred by the learned intermediary doctrine. In Alabama, like in Illinois, in a prescription drug the case the duty to warn runs to the physician. Id.

[I]t does not follow . . . that if the manufacturer inadequately warns the physician, it owes an independent duty to warn the patient directly. This is the reason why this Court previously stated that “it appears unlikely that Plaintiff can state a failure-to-warn claim based on Defendant’s failure to provide a Medication Guide to her pharmacy that avoids the application of both the learned-intermediary doctrine and Mensing.”

Id. And there’s the beauty.

There is one thing that both Hernandez and Tutwiler agree on – plaintiffs’ off-label promotion claims are fraud claims that must be pleaded to the heightened standard required by Federal Rule of Civil Procedure 9(b). Both plaintiffs tried to argue that these were negligent marketing claims. Hernandez, at *3; Tutwiler, at *2. But both courts were unpersuaded by those labels given the context of the allegations. Hernandez, at *4 (“Plaintiff’s complaint is a sprawling and, at times, confusing collection of largely unnecessary allegations that, for the most part, seem to attempt to assert a fraudulent misrepresentation claim as it relates to off-label promotion.”; Tutwiler, at *2 (Plaintiff “claims that Defendant engaged in a ‘concerted and systemic effort to persuade physicians’ . . . that the drug was safe and efficacious for off-label uses). Plaintiff Hernandez is getting another chance to re-plead his fraud claims with specificity. Since this was Plaintiff Tutwiler’s second attempt, and her complaint still failed “to identify a single statement in any promotional material to support [Plaintiff’s] contention that Defendant unlawfully promoted amiodarone for [an off-label use],” her claim is dismissed.

They say beauty is fleeting – and so too is a beautiful case. The beast/frog on the other hand lives to see another day.

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

There is always a level of uncertainty when a case gets remanded from an MDL. New judge; new interpretations of prior rulings; new rulings. It can be the cause of much anxiety on both sides. And the biggest question is – what’s left to be done? That might seem simple. The case was remanded for trial. But cases rarely go back completely trial ready. Legal issues that turn more on state law are often left to the remand court to decide, as are case specific evidentiary decisions. There are also often questions as to whether a particular issue was raised in the MDL or not. If so, what was the ruling? If not, was it waived? So, there is definitely wiggle room for remand judges to imprint their reasoning and conclusions on a case. And where you’ve made progress in the MDL, you certainly don’t want to lose momentum post-remand.

Which was likely the thinking of defendants in Walker v. Ethicon, Inc., 2017 U.S. Dist. LEXIS 112738 (ND IL Jun. 22, 2017) when faced with expert reports that went beyond the scope of what was deemed permissible by the MDL court in the mesh litigation. In this case, plaintiff served an expert report from Dr. Shull, a gynecologic surgeon. Dr. Shull had previously been challenged by defendants in the MDL but certain issues were reserved for the remand court. Certain issues had also been ruled on by the MDL court in the context of other cases and other experts – in defendants’ favor. Defendant here asked the court to apply those rulings. Generally speaking the remand court found plaintiff offered no justification not to.

First up was the expert’s opinion that different surgical procedures – ones not involving the use of the product — were safer alternatives to the defendant’s mesh product. Id. at *5. In addition to the vast body of case law holding that non-use is not an “alternative design” for the product, the mesh MDL court had so held in another case. Id. The remand court agreed. The remand court also considered the impact of Illinois state law because Illinois does not require plaintiff to prove the existence of a safer alternative design, but such evidence may be relevant. Id. at *7. Plaintiff tried to argue that because a product could be found unreasonably dangerous without evidence of a safer alternative design, it follows that a product could be found unreasonably dangerous with evidence of a safer alternative regardless of whether that was a different design or a different surgical procedure. Id. But that disregards that what is relevant but not required under Illinois law is evidence of a safer alternative design. Plaintiffs offered no support for interpreting “safer alternative design” in Illinois any differently than any other state. Nor did they explain how the alternative procedure was relevant to any element of any of plaintiff’s claims. Without relevance, the testimony was excluded. Id. at *8.

Next were the doctor’s opinion on the duties of medical device manufacturers – testing, pharmacovigilance, and training. The court excluded them all. Defendants challenged the opinion on adequacy of research and testing of the product on both the relevance and the doctor’s qualifications and competence. This is one of the topics on which the MDL court provided guidance but ultimately left the decision to the remand court. On relevance, the MDL court found it doubtful, but was willing to leave the call to the trial court based on nuances in state law. Id. at *10. Pertinent to defendants’ motion, the MDL court had also ruled that an expert “may not offer testimony that is solely a conduit for corporate information.” Id. On the qualification challenges, the MDL court did not exclude an expert on those grounds if the request for exclusion did not provide “specific content or context.” Id. at *11.

Applying those rulings to the specific case, the remand court found that defendants had properly challenged Dr. Shull’s qualifications with enough specificity and so that challenge was not denied, but reserved for the remand court. Id. So, on qualifications, Dr. Shull “is not qualified to testify regarding the standard of care for medical device testing.” Id. at *13. Plaintiffs, however, argued that they were only offering testimony from Dr. Shull regarding what testing defendants did or did not do – the extent of the testing rather than its adequacy. Id. at *12. The court took that as a concession, but went on to exclude that testimony as well. That is information found in company documents – don’t need the expert for that. Id.

Plaintiffs also wanted Dr. Shull to testify about how the defendants monitored adverse events. They claimed he was not offering an opinion as to what systems defendants should have been using just that what they were doing was “woefully inadequate.” The court found this was a “distinction without a difference.” Id. at *14-15. Dr. Shull’s experience as a surgeon does not give him the expertise to testify on the standard of care for adverse event reporting. Id. at *15. And, again if he planned to talk generally about adverse events, that’s company documents and not an area for expert testimony.

Finally, Dr. Shull’s report included an opinion on whether defendants appropriately trained physicians. On this point, the MDL court had already ruled that Dr. Shull could not testify about what should or should not be included in the Instructions for Use for the product – and that covers training of physicians. Dr. Shull could testify to the risks of the product and whether such risks were included in the product materials. Id. at *16. That’s it.

We’re not sure what remains in Dr. Shull’s report, but we certainly agree that the above portions were appropriately trimmed away.

Next week, we are traveling to Budapest, with a side trip to Vienna. We are visiting the Drug and Device Law Rock Climber, who is spending this semester abroad studying computer science (in Budapest) and climbing rocks (in Majorca, etc.).  Aside from the beloved visage of our only child, we are most excited about seeing the Lipizzaner stallions perform at the Spanish Riding School in Vienna.  When we were eleven years old, we read “My Dancing White Horses” by Colonel Alois Podhajsky, director of the School.  This wonderful autobiography recounts Podhajsky’s extraordinary efforts to save the Lipizzaners during World War II.  It was (and is) a compelling read, and it led us to “My Horses, My Teachers,” Podhajsky’s homage to his stunning equine mentors.  Since that time, the Lipizzaners have occupied a permanent spot atop our bucket list, and we are beyond thrilled to hold tickets to one of their performances.  Beyond that, we had to start from scratch to plan this trip.  We Googled and researched, and our takeaway was how much we didn’t know about Budapest’s history and culture.

Perhaps the plaintiff’s would-be experts in today’s case should have engaged in similar assessments of their knowledge bases. Regular readers of this blog are familiar with our ongoing rant against “experts” who aren’t, and with the cases that nonetheless ride on the “experts’’ unqualified shoulders.  In this case, the Court agreed with us.

In Hale v. Bayer Corporation, 2017 WL 1425944 (S.D. Ill. Apr. 20, 2017), the plaintiff alleged that the defendant’s product, an over-the-counter (“OTC”) non-steroidal anti-inflammatory drug (“NSAID”) caused him to develop a permanent kidney injury known as “Minimal Change Disease” (“MCD”). He asserted the usual product liability claims sounding in strict liability and negligence, and identified three experts.  The defendant moved to exclude all three – the plaintiff’s primary care physician, the plaintiff’s treating nephrologist, and a pharmacist — under Daubert, arguing that none had rendered an opinion that was “properly founded in or based upon sufficiently reliable medical, scientific, or other specialized knowledge.” Hale, 2017 WL 1425944 at *1 (citation omitted).

Plaintiff’s Primary Care Physician

The plaintiff’s primary care physician testified that he referred all kidney patients to a nephrologist and that he had never studied whether NSAIDs may cause particular kidney injuries. Naturally, the defendants moved to exclude him because he was unqualified to offer causation opinions and because he relied on the plaintiff’s treating nephrologist’s opinions and diagnosis as the basis of his opinions.  In their response, the plaintiffs stated that they would not offer the expert to testify about causation,  but only to discuss his care and treatment of the plaintiff.  The Court agreed that the doctor would be permitted to testify about his treatment of the plaintiff but would not be permitted to offer causation opinions.

Plaintiff’s Treating Nephrologist

Next, the plaintiff offered his treating nephrologist, who diagnosed the plaintiff with NSAID-induced MCD.  The defendants argued that the nephrologist’s opinions were “insufficiently supported by medical science” and that he was “not able to definitively establish by any medical or laboratory test that the plaintiff’s consumption [of the NSAID] was the cause of his MCD.” Id. at *3.  They also argued that the nephrologist’s purported “differential diagnosis” was based on insufficient scientific data.  The plaintiffs argued that the doctor had 30 years of experience as a nephrologist, that he managed the plaintiff’s case, and that he relied on scientific literature in reaching his causation conclusion.

The court cited case law confirming that, while a properly-performed differential diagnosis can constitute a reliable methodology, such diagnosis must go “beyond the mere existence of a temporal relationship” between the plaintiff’s ingestion of the defendant’s product and the onset of his symptoms. Id. at *4.  Analyzing the doctor’s methodology, the court observed that the doctor had ruled out certain diseases that can cause MCD.  He also ruled our food poisoning and some infections.  But most MCD is idiopathic.  (Idiopathic means nobody knows what causes it.)  To rule out idiopathic MCD in the plaintiff’s case, the doctor testified that he relied on the temporal relationship and on scientific literature that had acknowledged “for the last 25 years that NSAIDs can cause renal injury or renal malfunctions.” But the data the doctor cited involved prescription-strength NSAIDs, and he testified that he did not know of studies involving lower-strength OTC NSAIDs and had never read an article linking the defendant’s specific NSAID to renal injury.  The court concluded that the doctor could not “provide any scientific and/or medical data with regard to the relationship of over-the-counter NSAIDs and kidney disease,” let alone any specific data related to the defendant’s product.  As such, the doctor’s opinions were “unreliable based on the lack of supporting medical science as required by” Fed. R. Evid. 702.  Moreover, though the doctor had general knowledge about the diagnosis and treatment of kidney disease, he lacked “expert knowledge with the specific subset of over-the-counter NSAIDs” and MCD.  And so, like the PCP, the nephrologist was permitted to testify about his care of the plaintiff but was precluded from offering causation testimony.

The Pharmacist

Finally, the plaintiff offered a pharmacist to testify, as an element of Illinois’s “consumer expectation test,” that the plaintiff’s particular kidney injury was foreseeable to the defendant and that the danger of this injury went beyond that which would be contemplated by the “ordinary patient with ordinary knowledge common to the community.” The pharmacist was qualified to offer this opinion, they argued, “based on many years of educating and working with healthcare providers and providing healthcare services to patients.” Id. at *6.  He said that he “regularly interacted with [patients] and understood their level of awareness regarding OTC . . . NSAIDs and kidney injury.” Id. at *7.

The court pointed out that the pharmacist was not a physician, had never participated in clinical trials involving any NSAID, and was not aware of any cases of MCD associated with OTC use of the defendant’s product. Though he had reviewed 203 case reports, none involved MCD, and, in any event, the court had previously rejected expert opinions based on case reports.  As the court emphasized, “Because of their limitations, case reports have been repeatedly rejected as a scientific basis for a conclusion regarding causation. Such case reports are not reliable scientific evidence of causation, because they simply describe reported phenomena without comparison to the rate at which the phenomena occur in the general population or in a defined control group. . . [T]hey do not isolate and exclude potentially alternative causes . . . and do not investigate or explain the mechanism of causation.”  Id. at *8 (citation omitted).

Finally, the court held that the pharmacist “clearly [did] not have the necessary background to offer an opinion of whether the risk and danger of [the product] outweighed its benefits.”  His entire opinion was “based on the fact that there are alternative [products] that may achieve the same relief benefit.  That is like saying that an individual could safely ride the train to work and thus have avoided a car accident, [but] . . . there is no indication of a complete risk/benefit analysis being conducted by [the pharmacist] or that [he] relied on any studies” conducting such an analysis.  Id. at *7.  (We have posted on this issue before.  You can see some of the posts here.)  The court concluded that the pharmacist had “provided no support – other than his general experience – of the opinions” he had offered. As such, the court held that the pharmacist’s opinions were “unreliable based on the lack of supporting data as required by Federal Rule of Evidence 702.” Id. at *8.

And then there were none. And with no experts, the plaintiffs could not meet their burden of proof of causation.  Moreover, while the court acknowledged that Illinois had not decided whether the consumer expectation test required expert testimony, the plaintiff had not demonstrated that the defendant’s product was unsafe, because “every expert deposed stated that they believed [the product] to be safe when used as directed.” Id. at *11.  Check and mate – summary judgment granted for defendants.

Sometimes, when we write this stuff, we have trouble keeping a straight face because the plaintiffs’ arguments so lack merit as to verge on silliness. It continues to puzzle us that these experts – and these cases – even see the light of day.  But we are grateful for the sensible judges who extinguish them.

We’ll be back in a week or so, with pictures of beautiful white stallions (and one beautiful daughter) in hand. E-mail us – we’ll send you copies.

 

 

Last September we expressed our curiosity over Wisconsin cheese curd and our distaste for an order from the Western District of Wisconsin rejecting implied preemption in an amiodarone case. As we explained then, the district court allowed a claim alleging that the defendants failed to provide medication guides for distribution with amiodarone prescriptions. The basis for the claim was the federal regulation requiring manufacturers of some prescription drugs to make medication guides available either by providing a sufficient number of guides to distributors and dispensers or by providing the means to produce guides in sufficient numbers. Marvin v. Zydus Pharmaceuticals (USA) Inc., 203 F. Supp. 3d 985, 986 (W.D. Wis. 2016) (citing 21 C.F.R. §§ 208.1, 208.24(b)).

A state law failure-to-warn claim based on a violation of federal prescription drug regulations? Sounds like implied preemption to us, but the district court in Wisconsin concluded that this very federal-sounding claim was actually based on an “independent” state duty to warn.  Go figure.

That cheesy conclusion spilled over last week into an amiodarone case in Illinois, which again alleged that the defendants failed to provide medication guides. And again the district court concluded that federal law did not impliedly preempt the plaintiffs’ state law tort claims based on a failure to warn.  The case is Hernandez v. Wyeth-Ayerst Laboratories, Inc., No. 15 C 11176, 2017 U.S. Dist. LEXIS 58743 (N.D. Ill. Apr. 18, 2017), and if anything, these plaintiffs were even more forward about co-opting federal regulations that the plaintiffs were in Marvin.

The Hernandez plaintiffs alleged two violations of the FDCA:  First, that the defendants violated the FDCA by promoting amiodarone off label as a first-line anti-arrhythmic medication; and second, that the defendants failed to provide medications guides. Id. at *3.  The generic drug manufacturer defendants justifiable argued that these claims were preempted under PLIVA v. Mensing and Buckman v. Plaintiffs’ Legal Committee, but the district court rejected both arguments.

The district court’s discussion of Mensing is a bit confused.  Applying the often-misunderstood “parallel claim” exception to express preemption, the court held that because the plaintiffs were alleging a violation of federal regulations, their claim was “parallel” to federal law and thus was not preempted. Id. at **8-10.  The problem with this is that Mensing did not apply express preemption.  It was an implied preemption case, and the district court had no business applying “parallel claim” analysis to implied preemption, where a “parallel claim” exception does not exist.  The district court even concluded that the plaintiffs’ claim was “not expressly preempted.” Id. at *9.  That is fine as far as it goes.  But we would be surprised if the generic defendants argued express preemption.  And even if they did, disposing of express preemption does not dispose of implied preemption.  They are different things.

What cases did the district court cite? One was the Seventh Circuit’s opinion in Bausch v. Stryker Corp., for which we have expressed our vigorous disagreement multiple times (including here and here), and another was a district court case called Garross v. Medtronic.  Both addressed express preemption as applied to pre-market approved medical devices.  Apples versus oranges.  Or if staying with our cheese theme, cheddar versus Limburger.

The district court’s treatment of Buckman fares no better.  According to the court, the “plaintiff alleges that [the generic manufacturer defendant] violated its duty to warn under Illinois law because it violated the FDCA’s requirement to provide distributors with medication guides.” Hernandez, at *9 (emphasis in original).  Did you catch that?  The plaintiff was suing because the defendant alleged violated the FDCA.  The court even put “because” in italics.  This is a recipe for implied preemption under Buckman, and it runs directly into section 337(a) of the FDCA, which gives the government exclusive power to enforce the Act.  We have often observed that plaintiffs seeking to avoid preemption have to weave their way through a “narrow gap” by alleging that are suing for a violation of the FDCA, but not because the defendant violated the FDCA.

These plaintiffs were not even close. The district court acknowledged they were suing because the defendants violated the FDCA, but it somehow found that Buckman did not apply.  Recall that Buckman held that claims were preempted where “federal enactments [were] a critical element” in the plaintiffs’ case. Buckman, 531 U.S. 341, 352 (2001).  That seems to describe the Hernandez plaintiffs’ case to a tee.  The district court also did not discuss, or even acknowledge, section 337(a), which prohibits private causes of action to enforce the FDCA.  The district court again cited Bausch, and it observed that the generic defendant did not cite an express preemption provision.  It did not otherwise explain how these plaintiffs could so overtly purport to enforce the FDCA through a state law failure-to-warn lawsuit.

The defendants also argued statute of limitations and that the plaintiffs did not sufficiently plead their claims, but the former argument failed, and latter resulted only in leave to amend. For our part, summer is approaching, and we still have not tried Wisconsin cheese curd.  Maybe we will soon have the good fortune of attending a Midwestern county fair, where we are told cheese curd runs in abundance.  Or maybe we’ll just go to Chicago and have a hot dog.

We (in its blog-specific singular version) are longstanding country music fans. There is backstory – call us when you are in Philadelphia and we will tell you about it over coffee. Suffice it to say that Nashville, the Grand Ole Opry, and country greats from the 1970’s and 1980’s occupy a significant and permanent place in our soul.  So we were moved by a new video making the rounds of social media today. Entitled “Forever Country,” it is features 30 Country Music Association Award winners – both modern and legendary – in a beautiful montage celebrating 50 years of the CMA awards. You can see it here. There is also some pretty cool irony in the choice of “Take Me Home, Country Roads” as the song that opens the video and winds its way throughout. In 1975, John Denver was nominated as Country Music Association Entertainer of the Year. The previous year’s winner, Charlie Rich, was a bit “in his cups,” as they say, when he read the nominations. As he announced Denver as the winner, he struck a match and lit the card on fire in protest, because he did not think Denver was truly “country.” Happy to debate that when we have coffee, but we (unashamedly) love John Denver, as our office neighbors will attest. We are happy that Denver’s signature song was used in this celebration of country music. If it wins him some new fans, better late than never.

Also better late than never to report on today’s case, which just appeared online though it was decided 2 ½ years ago. In Peterson v. Wright Medical Technology, 2014 U.S. Dist. LEXIS 189473 (C.D. Ill. Feb. 13, 2014), the United States District Court for the Central District of Illinois considered the defendant’s motion for summary judgment on the plaintiff’s failure-to-warn claim in a hip implant case. The plaintiff, who was obese, received a new modular artificial hip to address his “significant end stage osteoarthritis” caused by an earlier accident. At the time of the plaintiff’s hip implant, his surgeon “had been an orthopedic surgeon for 31 years and had seen many evolutions of hip implants. He had read several journal articles about modular implants, including the [subject implant].” He had also read the Instructions for Use (“IFU”) included with the implant. He “knew that a patient’s weight and activity level could have an effect on the ultimate outcome of the surgery but had no reason to believe that Plaintiff was not an appropriate candidate for the implantation of this device.” The surgeon explained all of these risks to the plaintiff and required him to attend a two-hour teaching session before obtaining his informed consent.  Peterson, 2014 U.S. Dist. LEXIS 189743 at *3-4.

Two years after the plaintiff’s surgery, the titanium modular neck of his artificial hip broke into two pieces. In his complaint, the plaintiff asserted the usual strict liability and negligence claims, along with a punitive damages claim that was later dropped. The defendant moved for summary judgment on the plaintiff’s warnings claims sounding in both strict liability and negligence.

Continue Reading Defendant Did Not “Fail to Warn” Where It Warned of Exactly What Happened to the Plaintiff’s Artificial Hip

While some of us are naturally jacked up—have you seen Bexis in short sleeves?—others turn to supplements to build up their beach bodies.  We are not talking about the injectables favored by 1970s East German Olympians or 1980s NFL draft flops.  And certainly not the supplements advertised on late night television as more targeted enhancers.  (McConnell says that he heard they work as well as a Tarantino remake of a Kurosawa re-envisioning of a Shakespeare tragedy, whatever that means.)  No, we are talking about protein powder, which people who lift weights often shake up with water or milk to chug after a workout.  If you have ever cleaned the “shaker bottle” used by a high school athlete after his/her workouts, then you would know that the real problem with these powders is how much remains as a putrid clump in the bottle.  If you have not had that pleasure, then you probably know that they sell protein powder in tubs ranging from large to ridiculously large at a variety of retailers.  If you have glanced at the options among the protein powders on the retail shelves, then you may have noticed that they tout the number of grams of protein per serving and maybe something about the source of the protein.  If you are the plaintiff in Gubala v. CVS Pharmacy, Inc., No. 14 C 9039, 2015 U.S. Dist. LEXIS 77509 (N.D. Ill. June 16, 2015), and you paid $20 for a container of this stuff, then you bring a purported class action for purchasers of the same product in ten different states.  You also lose.

Plaintiff claims that the language on the front—a cylinder or truncated ovoid container does not really have a front, but we will let that slide—of the product he bought from his drug store was misleading because it said “Whey Protein Powder” and “26 grams of high-quality protein,” when each serving actually contains 21.8 grams of whey protein and 4.2 grams of other proteins plaintiff did not consider as high quality as the stuff left over from making cheese.  Id. at **5-6.  Based on this, plaintiff alleged violations of the ten consumer fraud acts, unjust enrichment and express warranty.  The defendant moved to dismiss on several grounds, including on preemption based on the FDCA and National Labeling and Education Act, which is why we saw the case. As we have said before, the NLEA has an express preemption provision for any state requirements for food labeling—protein powder is food—that are not identical to its own.  And the NLEA does have requirements on how protein content is to be discussed in labeling—by giving the “total protein contained in each serving size or other unit of measure.”  Id. at *9.  The regulations even say how total protein can be calculated, which appears to reject the plaintiff’s idea that the non-whey protein in the product he bought should not really count.  Plaintiff wanted the product’s labeling to “differentiate between whey protein and protein from amino acids” and that “would not be identical to the labeling requirements imposed by federal law.”  Id. at *11.  That is pretty straightforward express preemption, but there was a cherry and whipped cream on top of this frothy vanilla shake.  First, in adopting the protein labeling regulations, the FDA had considered and rejected the comment that labeling should specify how much of the protein in a food product was “high quality.”  Id. at **11-12.  Second, the same court had already rejected similar arguments in the context of labeling for fiber content and been affirmed by the Seventh Circuit.  Among the previously rejected arguments was that preemption of food labeling claims under the NLEA can apply to complaints only about the content of the Nutrition Facts portion of the food product’s labeling.  Id. at **14-16.  So, plaintiff could not base his consumer fraud claims on the disclosure of the amount of whey protein in the product.

Fighting off its lactic acid build up, the court proceeded to address the non-preemption grounds for dismissal.  Because the NLEA does provide for the possibility that the names of food products can be misleading by focusing on only one of its ingredients, there was a possibility of claim under the Illinois consumer fraud statute if the product’s name was misleading in the context of the entire labeling.  Plaintiff contended that the name “Whey Protein Powder” was misleading because the product was not all whey protein.  His problem, aside from being so litigious that he sued over allegedly overpaying for a $20 container of protein powder that had only 83% of its protein derived from his preferred source, was that the product’s name on the label was followed by “Vanilla” and “Naturally & Artificially Flavored Drink Mix.”  It also lacked any descriptor like “only whey” or “100% whey” or “absolutely, exclusively whey” or “way, way whey.”  Thus, it was “clear to any consumer upon first glance that the Product is not pure whey protein, and thus the label does not create a likelihood of deception or have the capacity to deceive based on the identifying name of ‘whey protein powder.’”  Id. at *19.  This meant the product name was not misleading as a matter of law and the non-preempted consumer fraud claim was dismissed.  The express warranty claim was pressed aside because “26 grams of high-quality protein per serving” was considered “puffing” and not a potentially actionable express warranty.  Id. at *22.  The unjust enrichment claim fared no better because it was premised on dismissed consumer fraud claims.  Id. at *23.

The one down-side to the decision is that the dismissal of all of these claims was without prejudice.  While we know that plaintiffs tend to get at least to their third set (i.e., the second amended complaint) before a dismissal under 12(b)(6) will be with prejudice, we doubt that any amount of stretching of the facts or law here will allow plaintiff to re-frame his allegations in a way to avoid preemption and state claims under state law.  Maybe he can get those noted trainers Hans and Franz to pump—clap—him up before he tries.

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

City of Chicago v. Purdue Pharma L.P., 2015 U.S. Dist. Lexis 60587 (N.D. Ill. May 8, 2015), deals with an effort by the City of Chicago to recover payments it made to drug companies on opioid prescriptions for City employees (and retirees) covered by HMO, PPO and worker’s compensation plans. Id. at *9-11.  Chicago claimed that it should get its money back because the drug companies misrepresented that the opioids were effective for more than short-term treatment of cancer pain.  The City lost—at least for the time being.

The City claimed that the drug companies had mounted a coordinated campaign to use key opinion leaders to write, speak and create guidelines on long-term opioid therapy, use professional and patient advocacy groups as marketing tools, develop and support medical journal articles on long-term opioid therapy, misuse CME programs to market such long-term therapy, and more.  In this campaign, according to the City, the drug companies overstated the effectiveness of opioids, downplayed the effectiveness of alternatives, and hid or understated risks such as addiction.  Id. at *4-9.  The City made common law fraud, conspiracy and unjust enrichment claims, and claims under certain Chicago municipal codes that, among other things, incorporated the Illinois Consumer Fraud and Deceptive Businesses Practices Act. E.g., Chicago Municipal Code § 2-25-90.  Chicago asked for its money back and, as is often the case, hired private counsel to help them get it.  Read here for our take a number of years ago on efforts by municipalities to recover these and other types of costs.

Continue Reading Another Municipality Tries to Recover Its Costs for Pharmaceuticals