It wasn’t an opinion, or a grant of certiorari, but it may be important nonetheless.  In a concurrence in the denial of certiorari the other day, Justices Thomas and Gorsuch expounded on their view of how preemption works (or doesn’t work) in the context of a decision by a federal agency (not the FDA – this wasn’t a drug case) not to regulate.  Lipschultz v. Charter Advanced Services (MN), LLC, ___ S. Ct. ___, 2019 WL 5300908 (U.S. Oct. 21, 2019).  These two justices indicated an unwillingness to ascribe any preemptive power at all to a decision not to regulate:

It is doubtful whether a federal policy − let alone a policy of nonregulation − is “Law” for purposes of the Supremacy Clause.  Under our precedent, such a policy likely is not final agency action. . . .  Even if it were final agency action, the Supremacy Clause requires that pre-emptive effect be given only to those federal standards and policies that are set forth in, or necessarily follow from, the statutory text. . . .

Giving pre-emptive effect to a federal agency policy of nonregulation thus expands the power of both the Executive and the Judiciary.  It authorizes the Executive to make “Law” by declining to act, and it authorizes the courts to conduct a freewheeling judicial inquiry into the facts of federal nonregulation.

Id. at *1-2 (citation and quotation marks omitted).

In the tort area, such a rationale is not that big a change, since the Supreme Court said as much back in 2002 in Spreitsma v. Mercury Marine, 537 U.S. 51 (2002).  In Sprietsma the Court held, “although the Coast Guard’s decision not to require [the safety device in question] was undoubtedly intentional and carefully considered, it does not convey an ‘authoritative’ message of a federal policy against” that device.  Id. at 528.  So regulatory inaction has not been much of a source of preemption of product liability cases for quite some time.

However, in Lipschutz Justice Gorsuch appears to be signing onto a number of prior lone Thomas preemption opinions, including his concurrence in Wyeth v. Levine, 555 U.S. 555 (2009), rejecting the concept of so-called “obstacle” preemption.  Lipschutz, 2019 WL 5300908, at *2.  Moreover, if agency non-regulation is not “law” for purposes of the Supremacy Clause, that raises the question of whether even an express agency decision not to regulate something – under a statute with an express preemption clause – could have express (as opposed to implied, as in Sprietsma) preemptive effect.

Given how split the Supreme Court has been recently in tort preemption cases, Justice Gorsuch’s possible adherence to some of Justice Thomas’ unorthodox preemption views bears watching.  If that is indeed where Justice Gorsuch is on preemption issues, Lipschutz also provides some insight into why the Court stopped with the procedural questions in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), and did not adjudicate the underlying preemption question itself.  See Id. at 169 (“The Supremacy Clause grants ‘supreme’ status only to the ‘the Laws of the United States.’”) (emphasis original).

Back in 2012, we published our “Distribute This!” post about In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), 2012 WL 181411 (D.N.J. Jan. 17, 2012), lauding its ruling that, under the “independence principle” of PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), implied preemption protects distributors of prescription drugs – all prescription drugs, not just generics – because they can’t change drug labeling since only the drug’s NDA (“new drug application”) holder can do that:

As a distributor of [branded] Fosamax, [defendant] has no power to change [the] labeling.  That power lies with the applicant who filed the New Drug Application (NDA). . . .  Additionally, if FDA had become aware of new safety information in connection with [the drug] that “it believe[d] should be included in the labeling,” FDA must notify the holder of the NDA to initiate the changes.  Neither of these procedures involves a distributor.

As a result of the scheme set forth by the FDCA, [the branded distributor] has no authority to initiate a labeling change of Fosamax.  That authority lies with the FDA and/or with [the NDA holder].  Even taking the allegation . . . as true, a contractual relationship between [the defendant and the NDA holder] cannot change the fact that [defendant] is not the NDA holder.  Consequently, [defendant] has no power to unilaterally change [drug] labeling.  Because [defendant] could not “independently do under federal law what state law requires of it,” the state law claims brought against it are preempted.

Fosamax, 2012 WL 181411, at *3-4 (quoting Mensing independence principle language; other citations and quotation marks omitted).

It’s been a while and there have been more good decisions (see our generic scorecard and branded preemption cheat sheet), so we thought we’d compile them.  The triggering event is Smith v. GE Healthcare, Inc., 2019 WL 4565246 (Mag. W.D. La. Sept. 4, 2019), which followed Fosamax and dismissed warning-related claims against a branded drug (we checked; gadolinium contrast agents are drugs, according to the FDA) distributor under the independence principle:

Although Mensing addressed the liability of generic drug manufacturers, [distributor] contends that the same rationale may be extended to state law claims asserted against drug distributors who, like generic manufacturers, are not at liberty to change, modify, or extend the labeling.  The court agrees.

[This] is an FDA approved product.  Federal law requires FDA approval of a New Drug Application (“NDA”) prior to marketing the drug in the United States.  The company that owns and controls the NDA is referred to as the “applicant.” Following FDA approval of the new drug “only the applicant” may propose a change or supplement to the NDA.  [Co-defendant] was the NDA applicant. . . .  Accordingly, [the distributor] has no authority to unilaterally change or add to the [drug’s] labeling.

Because federal law will not permit [the distributor] to do what state law purports to require of it, plaintiff’s incompatible state law claims are preempted. . . .

2019 WL 4565246, at *8 (citations and footnote omitted).  This magistrate’s recommendation was adopted, but in the interim the plaintiff filed a new complaint dropping all claims against the distributor, so that aspect was held to be moot.  Smith v. GE Healthcare, Inc., 2019 WL 4551622 (W.D. La. Sept. 19, 2019).

Besides Fosamax, Smith cited four other cases, Brazil v. Janssen Research & Development LLC, 196 F. Supp.3d 1351, 1365 (N.D. Ga. 2016); Amos v. Biogen Idec Inc., 249 F. Supp.3d 690, 700 (W.D.N.Y. 2017); Stevens v. Community Health Care, Inc., 2011 WL 6379298, at *1 (Mass. Super. Oct. 5, 2011); and Pierik v. GE Healthcare, Inc., No. 18-07733, 2019 WL 4686551, at *1-2 (N.D. Ill. June 18, 2019).  Of these, three (all but Stevens) likewise applied the independence principle to hold claims against distributors of branded drugs preempted.

When a company does not have the NDA, it has no more power to change the label of a drug than a generic manufacturer.  A distributor, even of a brand name drug, has no power to change labeling.  That power lies with the applicant who filed the New Drug Application (NDA).  Because [the distributor] could not independently do under federal law what state law requires of it, the state law claims brought against it are preempted.

Brazil, 196 F. Supp.3d at 1364-65 (citations and quotation marks omitted).

[P]laintiff’s claims against [the distributor] are preempted because [it] is not the holder of the approved application for [the drug] in the United States.  A distributor, even of a brand name drug, has no power to change labeling.  That power lies with the applicant who filed the New Drug Application (NDA).  In Mensing, the Supreme Court held that claims against a manufacturer of generic drugs were preempted because such a manufacturer has no authority under federal regulations to modify labeling.  The same reasoning compels the Court to find preemption here.  Federal regulations do not permit [defendant], as a distributor, to change labeling.  Any claim that state law compelled it to do so is therefore preempted.

Amos, 249 F. Supp.3d at 700-01 (citations and quotation marks omitted).

Multiple courts have done the same.  As [defendant] is alleged to be a distributor rather than a manufacturer of [the drugs], I cannot draw a reasonable inference that [it] had the ability to modify the warning labels of those drugs.  Plaintiffs’ claims against [defendant] are preempted to the extent they seek to hold it liable for failing to warn plaintiffs of the risks or defects of [the drugs].

Pierik, 2019 WL 4686551, at *1-2 (citations omitted).

Those aren’t the only branded distributor cases finding preemption under the independence principle.  See also Nelson v. Biogen Idec, Inc., 2018 WL 1960441, at *14 (D.N.J. April 26, 2018) (“Because [the distributor] was not the United States license holder, it could not effect change to the label. . . .  Thus, summary judgment is also appropriate for [it] on this ground.”); In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 2016 WL 7644792, at *2 (D.S.C. Nov. 28, 2016) (“the claims against [the distributor] based on [the drug’s] label are clearly preempted by federal law.  As a result of the scheme set forth by the FDCA, [a distributor] has no authority to unilaterally change [a drug’s] label.  That authority lies with the FDA and/or with [the manufacturer]”) (citations omitted); In re Lipitor (Atorvastatin Calcium) Marketing Sales Practices & Products Liability Litigation, 2016 WL 7335738, at *2 (D.S.C. Nov. 7, 2016) (same); Cleary v. Biogen, Inc., 2017 WL 4126240, at *7 (Mass. Super. Sept. 13, 2017) (“Federal law, however, only allows the holder of the original, approved application for a drug to modify, or seek approval to modify, its label. . . .  [T]he distributor[] did not have the ability to modify the warnings present on the label, or to add new warnings.  The failure to warn claims against [it] are preempted by federal law.”) (citations omitted)

Several cases have also recognized preemption of claims involving distributors of generic drugs.  Plaintiffs unsuccessfully attempted to distinguish between manufacturers and distributors in In re Yasmin & Yaz Drospirenone Marketing, Sales Practices & Products Liability Litigation, 2014 WL 1632149 (S.D. Ill. April 24, 2014):

The Court notes that both Mensing and Bartlett involved generic manufacturers and not generic distributors.  Thus, as an initial matter, the Court must consider whether Mensing and Bartlett are applicable to [defendant] − the distributor of a generic drug. . . .  [T]he rationale for excusing generic manufacturers from liability is that generic manufacturers do not have the ability to unilaterally effectuate a label change.  Only brand manufacturers have the ability to take unilateral action to strengthen a drug’s warning label.  This rationale is equally applicable to generic distributors.  Under applicable federal regulations, generic distributors have no more authority than generic manufacturers to alter a drug’s composition, label, or design.  Accordingly, the principles announced in Mensing and Bartlett are equally applicable to generic distributors.

Id. at (citation omitted).

Earlier this year, in Marroquin v. Pfizer, Inc., 367 F. Supp.3d 1152 (E.D. Cal. Feb. 14, 2019) (discussed here), the same purported distinction was rejected:

Outside of the context of fraudulent joinder and removal/remand, courts have extended Mensing to entities that merely distribute prescription drugs, be they generic prescription or brand-name prescription drugs.  These cases recognize that mere distributors lack the ability to make any changes to an FDA approved label, rather only the holder of a New Drug Application (NDA) or the FDA itself can make any change to an FDA approved prescription drug label.  In this respect, a mere distributor sits in the same shoes as a generic manufacturer, neither has the ability to alter or change an approved FDA warning label. . . .  [B]ecause the Court is unaware of a federally lawful way for a mere prescription drug distributor to include its own warnings or otherwise alter an FDA approved label, the Court agrees with those courts that hold Mensing applies to distributors of prescription drugs, be they brand-name or generic.

Id. at 1170 (citations omitted).  See In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 2457825, at *1 (E.D. Ky. June 22, 2012) (granting summary judgment on preemption for generic distributors), aff’d, 756 F.3d 917 (6th Cir. 2014); Gentile v. Biogen Idec, Inc., 2016 WL 4128159, at *9 (Mass. Super. July 25, 2016) (“[The manufacturer] is the holder of the original, approved application for [the drug].  Consequently, [the distributor] could not have sought modifications of the label.  Plaintiff’s failure to warn claim against [the distributor] is therefore preempted.”) (citation omitted).

Preemption has likewise been found in a couple of analogous situations.  In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 940 (6th Cir. 2014) (which we discussed here), preemption barring claims against the contract manufacturer of a generic drug (that happened to be the former branded manufacturer) was affirmed.

[P]laintiff . . . alleged . . . that she ingested a product manufactured by [the contract manufacturer] for [the generic manufacturer] beginning in 2003, after [the contract manufacturer] had divested its NDAs.  Therefore, her claims against [the contract manufacturer] are preempted, failing for the same reasons that the Plaintiffs’ other claims against the Generic Manufacturers do.  After the divestiture, [the contract manufacturer] had no more power to change the label than did [the generic manufacturer].  Because [the contract manufacturer] was no different than the other Generic Manufacturers at the point . . . plaintiff allegedly may have taken their product, the district court did not err in dismissing their claim.

Id. at 940.

Similarly, claims against a pharmacy were held preempted in In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 2016 WL 7368203 (D.S.C. Nov. 1, 2016):

Even if it were possible to state a claim under state law against [a pharmacy] for labeling of a drug, any such claim would preempted by federal law.  The U.S. Supreme Court has held that a generic drug manufacturer cannot change its label without FDA approval and, thus, any state law claims alleging that the manufacturer should have changed its label are preempted by federal law.  As a result of the scheme set forth by the Federal Drug and Cosmetic Act (FDCA), a pharmacy also has no authority to unilaterally change a drug’s label. . . .  Thus, any claims against [the pharmacy defendant] based on [the drug’s] label are preempted under Mensing.

Id. at *2 (citations omitted).

Preemption and drug distributors is one of those situations where the logic supporting dismissal is ineluctable.  No NDA = no independent ability to change label = preemption.  Most of the contrary precedent is from fraudulent joinder cases where the standard a defendant has to meet is significantly tougher, and even there the tide seems to be turning on the Mensing independence principle rationale.

Reed Smith’s annual Life Sciences CLE Day will be presented this year, live in Reed Smith’s Philadelphia office and via videoconference to our Pittsburgh office on Thursday, November 7. This is a free, full-day CLE program designed for in-house counsel at life sciences companies.

Bexis will be covering “That Was the Year That Was: Progress and Pitfalls in Preemption Practice in 2019.” Other Reed Smith colleagues will discuss:

  • Ethical Dilemmas: Reports from the Trenches
  • The UK Pharma and Medical Device Sectors and Brexit: Hopes, Fears, Challenges and Opportunities
  • HIPAA to CCPA: Data Protection Laws You Need to Know Today
  • New Technologies and AI: Predicting Risks and Liabilities
  • That Was the Year That Was: Progress and Pitfalls in Preemption Practice in 2019
  • 510k Regulatory & Litigation Developments
  • Current Trends in False Claims Act Enforcement
  • From Deference to Diagramming Sentences: Recent Administrative Law Developments with Practical Consequences

The good people at Reed Smith are also providing a networking breakfast and lunch, with a reception immediately following the CLE day in Philadelphia.

This program is presumptively approved for 5.5 general CLE credit and 1.0 Ethics credit in California, Pennsylvania, Texas and West Virginia. The program is also approved for 6.6 general CLE credit and 1.2 Ethics credit in New Jersey. It is presumptively approved for 6.5 general CLE credit and 1.0 Ethics credit under New York’s approved jurisdiction policy. Applications for general and Ethics CLE are pending in Delaware, Illinois, and Florida.

Interested? You can register here. (Please note that space is limited.)

We write as we prepare to head to the airport for a long weekend in Whitefish, Montana, a bit of paradise in in the Flathead River Valley of northwest Montana, just outside of Glacier National Park.   As we have mentioned in other posts, Whitefish is the home of beloved friends of many decades, and we find that occasional visits serve as no less than transfusions for the soul. We love to stand on the banks of the Flathead at sunset, and we always are reminded of Norman MacLean’s “A River Runs Through It.” When we teach writing seminars for associates, we cite our favorite quote from that book as an example of words creating an indelible image: “Eventually, all things merge into one, and a river runs through it. The river was cut by the world’s great flood and runs over rocks from the basement of time. On some of those rocks are timeless raindrops. Under the rocks are the words, and some of the words are theirs.”   Anyway, we are headed west, after an absence of too long, but better late than never.

And the same is true for today’s decision out of the Abilify MDL.  This MDL has been around for a long time, and we have posted about it before.   (You can see a couple of our previous posts here and here.) Today’s decision, In re: Abilify Aripiprazole Prods. Liab. Litig., Case No. 3:16md2734, Document 1170 (Sept. 24, 2019), which you can see here, nails the coffin shut on many plaintiffs’ claims.  As the court explains, the parties reached a global settlement in February of this year. To facilitate the settlement, the court issued an order requiring each plaintiff who wanted to participate to submit a claim form, including documentation of their use of the defendant’s product, along with a signed release. Plaintiffs were warned that failure to comply within the applicable deadlines could result in dismissal with prejudice. A number of plaintiffs ignored the deadline. In true MDL fashion, the court gave them another chance, ordering them, in early September, to submit the required documents and to show cause why their claims should not be dismissed. Many ignored this order, too.

The court invoked Fed. R. Civ. P. 37(b)(2), which provides for sanctions, including dismissal, for failure to comply with court orders.   Before dismissing cases, as the court explained, Rule 37 requires a court to find that a party has engaged in “a clear pattern of delay or willful contempt (contumacious conduct) . . . and that lesser sanctions would not suffice.” September 24 Order, at 3 (internal punctuation and citations omitted). The court had no trouble finding that both prongs of the test were satisfied.

First, the court explained, many plaintiffs had disregarded the court’s orders entirely. Others “responded to the show cause order but conceded that they are able to provide any evidence that they used [the] brand name [product].” Id. at 4 (emphasis in original).   The court commented, “. . . [A]t this advanced stage of this litigation, which has been pending for almost three years, it is not too much to require plaintiffs to provide proof of use in support of their claim that [the defendant’s product] caused them injury, particularly where they are seeking to be compensated for taking the drug.” Id. The plaintiffs were notified multiple times about the possibility of impending dismissal, and they still did not comply. As such, the court held that dismissal with prejudice was “the only acceptable alternative” for the 149 non-compliant plaintiffs. Duh.

Because we spend a great deal of our professional lives in the MDL space, we feel compelled to state the obvious.  Of course a plaintiff queued up for a handout should be required to prove that he or she actually used the product at issue. But we are struck by the absurdity of the fact that no one required this proof at any earlier stage.  The plaintiffs’ lawyers apparently did not condition their representation on evidence that the plaintiffs had ever used the product.  And the court allowed the claims to proceed for three years before it demanded this proof.  Forgive us, but this is the most important element of all that is “broken” about the MDL system.  This case is a start, but we are huge fans of Lone Pine orders and believe that no plaintiff should be allowed to usurp everyone’s resources without the barest evidence of a colorable claim.   Sounds obvious, right?

Meanwhile, PHL beckons.  We will talk to you soon, magically restored and, just perhaps, less cranky about issues like these.

We are writing about a case that does not involve drugs or devices because it runs through some of the very same personal jurisdiction issues we have warned about post-Bauman. Adams v. NHL, MDL No, 14-2551, Case No. 15-cv-00472 (SRN/JSM), 2019 WL 5079980 (D. Minn. Oct. 10, 2019), is a case from the NHL concussion MDL. We make a hokey hockey joke in the title not to minimize the alleged injuries in the cases in this MDL, but to harken back to the hokey titles in The Rocky and Bullwinkle Show, the titular characters of which were from Frostbite Falls, Minnesota. Frostbite Falls was fictional, as were the alleged general and specific jurisdictional ties of the Adams case to Minnesota. “Why is personal jurisdiction over a defendant being litigated in an MDL case?” you ask. Well, the plaintiff—a Canadian citizen proceeding pro se—filed directly in the MDL and the defendant reserved its right to contest jurisdiction when it accepted service for direct filed cases. That is a fine practice pointer to start us off. Another, implicit along the way, is that it is still not a good idea to go pro se even when there is an MDL and template complaints are available to use when asserting claims without much individualization of the pleading.

In the posture of a motion to dismiss on lack of personal jurisdiction, to which the pro se plaintiff did not respond, the complaint becomes close to the sole focus of the inquiry. Plaintiff alleged injuries sustained during more than a decade of playing—and fighting—in the NHL for a series of teams not based in Minnesota, but did not allege any injuries sustained in Minnesota. It does not look like he alleged much about Minnesota at all, presumably because he was unaware that he would have to establish a Minnesota court’s jurisdiction over the NHL in general or his various claims in particular. While he sued after Bauman, it looks like the complaint he used did not consider the decision’s impact or, perhaps, operated under the mistaken assumption that direct filing in an MDL would obviate the need for personal jurisdiction over the defendant in the MDL court. In any event, the NHL claims its headquarters and principal place of business are in New York—and plaintiff did not respond to contradict that claim. (For those of you wondering, the old Minnesota NHL franchise, the North Stars, headed down to Dallas before the plaintiff entered the league and the new Minnesota NHL franchise, the Wild, entered the league while the plaintiff was still playing. While it seems likely, therefore, that plaintiff played in Minnesota and maybe took a jarring hit or worse on the ice there, it was not in the record.)

With that background, the court walked through both general personal jurisdiction and specific personal jurisdiction under what are, by now, pretty familiar Supreme Court and Eighth Circuit standards. General personal jurisdiction was fairly straightforward on the unopposed record. The NHL is at home in New York not in Minnesota, something plaintiff “appears to tacitly agree with” because the complaint treats the NHL as a foreign corporation. While the complaint alleged franchises in Minnesota and a number of other states (and the District of Columbia?), it offered nothing to conclude that that the NHL was “essentially at home” in Minnesota. While T.J. Oshie and many other Minnesotans in the NHL might consider Minnesota the home of hockey in the United States, the business entity called the National Hockey League is not subject to general personal jurisdiction there.

The specific personal jurisdiction analysis was similarly determined by the lack of Minnesota-specific allegations in the complaint and the lack of a response by the plaintiff. The key thing to understand about the specific jurisdiction analysis under the current, post-­BMS landscape is that jurisdiction is supposed to be determined claim-by-claim. So, while plaintiff asserted negligence and fraud claims, claimed specific injuries and damages, and even the need for future medical monitoring, none of that was tied to Minnesota. No acts or omissions by the NHL in Minnesota were alleged to have hurt him and no injuries were allegedly sustained there. In the absence of actual ties between the claims and the state in which plaintiff sought to maintain his suit, the general considerations about the interest of the forum state and convenience of the parties were not enough to establish specific personal jurisdiction over the non-resident defendant.

The result here was dismissal without prejudice. Whether plaintiff files again somewhere with general or specific personal jurisdiction over the NHL, whether the case will end up back in the MDL again, and whether any re-filed case are (or maybe Åre, depending on the next forum) for another day. For now, the re-affirmation that personal jurisdiction principles apply to MDL defendants is potentially useful for our usual client base.

 

Diversity jurisdiction has been on our minds a lot lately. Last week, we wrote about a plaintiff who unsuccessfully tried to steer under the $75,000 amount in controversy requirement. As John Adams said, “facts are stubborn things,” and the existence of medical bills in excess of $75,000 refuted the plaintiff’s remand motion and permitted the defendants to keep the case in federal court.

Amount in controversy played only a minor role in this week’s episode of plaintiff resistance to federal diversity jurisdiction. The real issue was improper joinder of a non-diverse party in Porter v. Stryker Corp., 2019 U.S. Dist. LEXIS 135859 (W.D. La. Aug. 12, 2019). The plaintiff had undergone robotic assisted knee replacement surgery. Following the surgery, the plaintiff sustained fractures in both knees and had to undergo additional medical treatment. The plaintiff lived in Louisiana and filed a complaint in Louisiana state court against the manufacturers/distributors of the robot surgical system, as well as the hospital. The hospital was in Louisiana. The theory against the hospital was that it failed to ensure “proper care, maintenance and performance” of the surgical system. The manufacturer/distributor defendants, all of whom were citizens of states other than Louisiana, removed the case to federal court. The plaintiff moved for remand. The key issue was whether the local hospital had been properly joined.

We say that improper joinder was the key issue. And so it was. Still, the amount in controversy was addressed by the court briefly. The complaint did not specify an amount in controversy. But even without facial evidence from the pleadings, the fact that the plaintiff had two additional major reconstructive knee surgeries convinced the court, if only as a matter of “common sense,” that the removing parties easily met their burden of establishing an amount in controversy in excess of $75,000.

Back to the issue of improper joinder. The diverse defendants argued that the plaintiff could not recover against the hospital because the claims against the hospital necessarily arose under the Louisiana Medical Malpractice Act, and the plaintiff had failed to exhaust administrative remedies under the Act. For instance, the plaintiff had not presented its claim to a medical review panel, which is “judicially necessary” before filing a claim in court.

In the complaint, the plaintiff couched his claims against the hospital in negligence. He expressly stated in the complaint that it was “not the intent of this suit to assert any cause against [the hospital] which falls under the Louisiana Medical Malpractice Act.” Nice try. If facts are stubborn things, so is the law. The law in Louisiana is clear that a claim against a medical provider for negligence allegedly causing personal injury from the provision of health care services must go through the Louisiana Medical Malpractice Act.

The Porter court collected extensive case law in support of its conclusion that the plaintiff’s claims against the hospital fell “squarely” under the Louisiana Medical Malpractice Act. (Indeed, key to the defense argument was the Flagg en banc Fifth Circuit case, which we blogged about https://www.druganddevicelawblog.com/2016/03/all-was-not-lost-fifth-circuit-issues.html.) Consequently, the exhaustion of administrative remedies requirement under the Act applied. The plaintiff had not met such requirement. That meant that the plaintiff could not possibly recover against the hospital. That, in turn, meant that the hospital had been improperly joined. The remaining defendants were diverse in citizenship. The case was properly in federal court, and the plaintiff’s remand motion was denied.

A complaint is a plaintiff’s opening argument.  It has to contain enough substance to get plaintiff out of the gate.  Plaintiff doesn’t have to necessarily prove anything in his complaint, but he has to have factual support to back up what he hopes to prove.  Logically, any fact added to a complaint is intended to make plaintiff’s case stronger.  The goal in adding any particular fact is to raise the credibility of the target conclusion – such as plaintiff was injured and that injury was caused by something defendant did wrong.  But sometimes facts backfire.  That’s what happened in In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 2019 U.S. Dist. LEXIS 179691 (D. Md. Oct. 16, 2019).

Defendant had moved to dismiss several plaintiffs’ claims as barred by the statute of limitations arguing that their causes of action accrued no later than the date of their revision surgeries which took place more than two years before they filed their lawsuits.  For California plaintiffs, the court determined that the discovery rule might save their claims and afforded them an opportunity to amend their complaints to plead facts regarding the discovery of their injuries.  Id. at *64.  In their amended complaints, the California plaintiffs argued that they did not have notice that the defendant’s device caused their injuries until the product was recalled.  Plaintiffs also pleaded that they each contacted an attorney about potential legal claims around the time of their revision surgeries – before the recall – but those attorneys advised that they were not investigating BHR devices.  Id. at *64-65.  Plaintiffs’ intent in including this second fact was to support an argument that the attorneys’ “not interested” responses tolled the statute of limitations.  What they really did was plead themselves directly into a statute of limitations defense.

Under California law, the discovery rule provides that the statute begins to run when “the plaintiff learns, or should have learned, the facts essential to his claim.”  Id. at *67.  That happens when a plaintiff has suffered “appreciable harm” and knows or suspects defendant may be responsible.  Id. at *67-68.  There was no question that plaintiffs knew they had “appreciable harm” by the time of their revision surgeries.  Moreover, at that time they at least suspected that defendant may bear some responsibility because they consulted attorneys.  The response of those attorneys is of no consequence.  It certainly doesn’t toll the statute.  “Even discouraging advice from an attorney does not extend the limitations period.”  Id. at *69.  To the contrary if each plaintiff was sufficiently suspicious to have contacted an attorney, that in itself was sufficient to commence the running of the statute.  It also didn’t hurt that defendant was already defending lawsuits related to this device at the time plaintiffs consulted attorneys.  Id.

So, at least in California, contacting an attorney about potential claims demonstrates sufficient knowledge, or suspicion, of a potential cause of action to trigger the limitations period.  Plaintiffs had two years from those consults to continue investigating their claims and bring suit.  Because they didn’t, the court dismissed their suits with prejudice.

Bexis updated the Blog’s Personal Jurisdiction Cheat Sheet recently, with the able assistance of Reed Smith associate Kevin Hara.  Having just read stories about oral arguments in a the first couple appellate cases concerning application of Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), Due Process principles to class actions, we can’t say we were terribly impressed.  The argument that absent class members aren’t “parties” to a class action – a convenience developed many years ago to address unrelated class action management issues – simply can’t be used to create personal jurisdiction that wouldn’t otherwise exist over non-residents’ claims against non-resident corporations.  That runs head long into the clear command of Fed. R. Civ. P. 82:

Jurisdiction and Venue Unaffected

These rules do not extend or limit the jurisdiction of the district courts or the venue of actions in those courts.

That’s pretty stark.

Thus, if non-resident “P” would not have personal jurisdiction to sue non-resident corporation “D” in a given federal court, under recognized constitutional principles, then application of Fed. R. Civ. P. 23 (or any other federal rule, for that matter) simply cannot create such jurisdiction.  To construe Rule 23 in such a way as to confer jurisdiction on a district court where that court would not otherwise have had jurisdiction to entertain such a claim would be a direct violation of Rule 82.  Period.  Full stop.

That “we’ve done it this way for decades” doesn’t cut it either.  Before Daimler AG v. Bauman, 571 U.S. 117 (2014), personal jurisdiction was widely accepted as being available anywhere a non-resident corporation did “continuous and substantial” business – but no longer.  BMS in this respect was simply an outgrowth of Bauman.  It arose from the unconstitutional rulings of the California appellate courts as they attempted to salvage that state’s litigation tourism mass tort business after Bauman removed the original jurisdictional business model – just read the original Cal. App. decision.  See Bristol-Myers Squibb Co. v. Superior Court, 175 Cal. Rptr.3d 412, 424 (Cal. App. 2014) (pointing out that personal jurisdiction had been “based on a record created and an analysis engaged in prior to” Bauman) (lengthy subsequent history that everybody knows omitted).

Bauman corrected a pernicious and long-standing error that had crept into personal jurisdiction constitutional jurisprudence for more than half a century following International Shoe Co. v. Washington, 326 U.S. 310 (1945).  Given that history, in this instance it is no argument that “everybody’s been doing it.”  If the courts of appeals don’t get personal jurisdiction right in class actions, we fully expect the Supreme Court to set them straight again.  Given Rule 82 – and the Rules Enabling Act (more about that, here) – it isn’t even that difficult an argument.  Simply compare the existence of jurisdiction over any particular plaintiff’s action with, and without, that plaintiff being a member of a putative Rule 23 class.  If the former is claimed to be greater than the latter, Rule 82 (not to mention Due Process) cuts it off.

Anyway, given the “ostrich effect” that class action plaintiffs have pushed courts to take towards BMS and Bauman, we’re pleased to point out the three new decisions in our last update, all of which recognized that Rule 23 doesn’t create jurisdiction that would not exist under Bauman/BMS.

Andrade-Heymsfield v. Danone US, Inc., 2019 WL 3817948 (S.D. Cal. Aug. 14, 2019), was a consumer class action, filed in California, but for some reason also including a New York class representative and putative class.  Id. at *1-2.  It was yet another class action over food filed by the California food fascists who want to force everyone to become vegans.  Supposedly the class(es) relied on “nutrition in every sip” statements involving coconut milk.  Id.  The defendant was not “at home” for Bauman personal jurisdiction purposes in California.

The New York class was therefore dismissed.  “The Court agrees with the line of cases that held [BMS] should apply where, as here, non-resident class representatives assert state-law claims against non-resident defendants on behalf of multistate classes.”  Id. at *3.  Since the defendant had its principal place of business in New York, plaintiffs could bring their New York class there.  Id. at *4.  Nor was there any “pendent” personal jurisdiction in this situation.  Id. at *5.

In In re Nissan North America, Inc. Litigation, 2019 WL 4601557 (N.D. Cal. Sept. 23, 2019), “nationwide and statewide classes consisting of all persons who purchased, own, owned, lease, or leased a ‘Class Vehicle,” were alleged.  Id. at *1.  The issue was technically venue, since one of the defendants was headquartered in California, but had its principal place of business and manufacturing plant in Tennessee.  The action was transferred because nine of ten putative class representatives had no venue in California.  The venue statute, 28 U.S.C. §1391(b)(1), peculiarly treats each judicial district in a state with multiple districts as a “separate State.”  Id. §1391(d).  The defendant was not “at home” in the Northern District of California.  2019 WL 4601557, at *4.  That killed any general jurisdiction, and made BMS directly on point.  There was no specific jurisdiction either, since plaintiffs could produce no evidence of anything the defendant did in the district that had anything to do with the subject of the litigation.  Id. at *5 (“Plaintiffs present no evidence to the contrary, and therefore fail to meet their burden of establishing that [defendant’s] presence in this district is a basis for personal jurisdiction.”).  Thus, “Plaintiffs have not identified any link between this forum and the nonresident Plaintiffs’ claims, as those Plaintiffs did not purchase the vehicles in this forum, or even in California.”  Id.  The venue statutes did not allow cases to be brought where there would not be personal jurisdiction.

The Class Vehicle sales for the nine nonresident Plaintiffs did not take place in this district.  Nor is there any showing that Defendants engaged in any advertising or marketing-related activities in this forum that caused the nonresident Plaintiffs to purchase the Class Vehicles in their respective home states.  Venue for the nonresident Plaintiffs’ claims does not lie in this district.

Id. at *6.  The court therefore transferred the whole kit and caboodle to Tennessee, where all the cars in question were manufactured.  Id. at *10.

Finally, in Chavira v. OS Restaurant Services, LLC, 2019 WL 4769101 (D. Mass. Sept. 30, 2019), a class action under a federal statute, the Fair Labor Standards Act (“FLSA”) was stricken for lack of personal jurisdiction.  Since the FLSA has no separate jurisdictional provisions, actions under it are governed by the same standards that governed state-law actions.  Id. at *3 (citing Fed. R. Civ. P. 4(k)).  All opt-in class claims (the only kind the FSLA appears to allow) filed by non-resident plaintiffs were therefore stricken under Bauman/BMS.

This Court’s obligation to follow the law as set forth in controlling precedent, however, cannot overshadow even the most compelling policy arguments. . . .  The Court reaches the conclusion that [BMS] applies to this case. . . .  [I]t is difficult to come to a different conclusion given the language in [BMS], which is repeated twice in the opinion, to the effect that for each plaintiff, “there must be an ‘affiliation between the forum and the underlying controversy, principally, an activity or occurrence that takes place in the forum State.’”  The Court adopts [the] conclusion that the personal jurisdiction analysis applies to all opt-in plaintiffs in a collective action in the same way that the Supreme Court found that the personal jurisdiction analysis applies to each plaintiff in a mass tort action.

2019 WL 4769101, at *6 (citations and some quotation marks omitted).  Because non-resident class members did not collect any wages from defendant in the forum state, personal jurisdiction could not be exercised.  Id. at *7.

Thus, the cases we reviewed recently give us confidence that, ultimately, there is only one Due Process standard for personal jurisdiction – that articulated in Bauman/BMS – and that class actions under Fed. R. Civ. P. 23 do not, and indeed cannot, be subject to any other standards.  As long as the Federal Rules (and relevant federal statutes) remain in their current form, that’s our position and we’re sticking to it.

Today we offer another in our series of travel misadventures.   Last weekend, we had the pleasure of visiting the Drug and Device Law Rock Climber (and seeing Lin-Manuel Miranda’s improvisational hip-hop show) in New York City. We took the train to Philadelphia then to the regional station closest to our home.   Here we pause for some backstory. Our train station, from which we commute to work daily, used to be user-friendly. Riders could wait in the warm building until the horn heralded the train’s arrival then walk outside to the track, a few steps away. But a recent, massive construction project changed all that.   Getting on the train, or back to the parking area, now involves long flights of steps and several extra minutes. No one waiting in the station until the train approaches will make it to the platform before the train departs.

There are also elevators, for those unable or unwilling to traverse the steps. When we arrived on the platform after our New York trip, we had a suitcase in tow, so we took the elevator.   As the door closed, we reached for the button. With the hand that held our car keys. You know what comes next – cue the slow motion as our keys slip from our hand and fall into the elevator shaft, landing, audibly, far below. At midnight. At a deserted train station. Luckily, this is the era of Uber.   We arrived home, found the hidden spare key, and got in through the back door of our house.   Shaking our head all the while.

Today’s case also involves a “back door,” if only figuratively.   In Africano v. Atrium Med. Corp., 2019 U.S. Dist. LEXIS 176602 (N. D. Ill. Oct. 10, 2019), the plaintiff tried, and failed, to get untimely affirmative expert opinions in through the “back door” in the guise of rebuttal. The plaintiff had sued the defendant hernia mesh manufacturer, asserting the usual product liability claims. He submitted his expert’s report, naturally opining that the product was defective, in the normal course. In response, the defendant submitted the report of its expert.   The plaintiff informed the court that he intended to submit reports of rebuttal experts.   The court issued an order emphasizing that the rebuttal experts must “restrict themselves to the expert opinions offered by [the defendant], Africano, 2019 U.S. Dist. LEXIS at *2, and that the defendant could move to exclude the new opinions if the plaintiff did not comply. Of course, one of the plaintiff’s new experts offered opinions that were not “rebuttal,” and the defendant moved to exclude the opinions.

The court explained that, under Fed. R. Civ. P. 26(a)(2)(D)(ii), rebuttal expert reports “must be intended solely to contradict or rebut evidence on the same subject matter identified by another party.” Id. at *3 (internal punctuation and citation omitted). “Evidence that is only offered as additional support of a party’s argument and that does not contradict any evidence introduced by the opposing party is not proper rebuttal.”   Id. (citations omitted). The defendant argued that the plaintiff’s expert’s “rebuttal” report was not rebuttal at all, “but rather an untimely causation report intended to bolster and expand upon” the plaintiff’s original expert’s opinions. Id. at *3-4.

The plaintiff argued that it was not improper for the “rebuttal” report to “touch[] on the same matter” as his original expert’s report, so long as it contradicted the opinions of the defendant’s expert. The court disagreed, stating that “[t]he measure of proper rebuttal is not whether if offers support for arguments that could have been raised in the case-in-chief, but whether it directly refutes arguments offered by the opposition.” Id. at *5.   The court continued, “A party may not offer testimony under the guise of ‘rebuttal only to provide additional support for his case in chief.” Id. (internal punctuation and citation omitted).   In this case, the court held, the defendant had demonstrated that the so-called rebuttal report “[s]erved primarily to shore up [the plaintiff’s] case in chief, mentioning the defendant’s expert’s report only twice and then only to point out undisputed facts, “not any matters in contention.” Id. Moreover, the plaintiff did not attempt to argue that the violation of the court’s order was substantially justified or that it was harmless, as Fed. R. Civ. P. 37(c) requires. And so the court granted the defendant’s motion to strike the report.

We have lost this exact chess game against a plaintiff who missed an expert disclosure deadline and submitted an entire affirmative expert report in the guise of “rebuttal.” We love this opinion, and we’ll keep you posted on similar developments.

We aren’t pulling any punches.  We think Taylor v. Mentor Worldwide LLC, — F.3d –, 2019 WL 4941936 (11th Cir. Oct. 8, 2019) is a candidate to be one of this year’s DDL Blog bottom ten cases.  Not only was plaintiff’s expert allowed to change his opinion at trial, plaintiff was allowed to prevail without demonstrating a threshold level of exposure.  Both issues should have sent this case back for a new trial.  Instead, we get a lousy 2-1 decision on key expert issues.

Plaintiff’s case was selected as a bellwether trial in the In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation.  She alleged that defendants mesh tape was defective because of its small pore size and its alleged propensity to degrade.  Id. at *1.  Plaintiff’s specific causation expert witness authored a report attributing plaintiff’s injuries to defendant’s product’s small pore size and its “tightening/contraction” process.  Id. at *2.  Plaintiff’s expert’s report also stated that he was able to rule out other causes of plaintiff’s chronic inflammation injury.

At deposition, plaintiff’s expert conceded that none of plaintiff’s medical records showed any erosion of her mesh tape, that there may be other causes of plaintiff’s injury, that he could not say to a reasonable degree of medical certainty that the defendant’s product was the cause of injury, and he “expressed skepticism” about plaintiff’s other expert’s degradation theory.  Id. at *3.  Sounds like it was a good day for the defense.  Certainly makes us wonder why the case got to trial, but that’s water under the bridge.

After that change of heart, plaintiff’s expert apparently underwent a second about-face before trial.  At trial, plaintiff’s expert’s theory became that the mesh tape had “caused a thinning of [plaintiff’s] urethral tissue.”  Id. at *4.  This opinion was not previously expressed in either the expert’s report or in his deposition.  Not surprisingly, defendant moved to strike the testimony under Federal Rule of Civil Procedure 37 – which provides:

If a party fails to provide information or identify a witness as required by Rule 26(a) or (e), the party is not allowed to use that information or witness to supply evidence … at a trial, unless the failure was substantially justified or is harmless. In addition to or instead of this sanction, the court, on motion and after giving an opportunity to be heard:

(A) may order payment of the reasonable expenses, including attorney’s fees, caused by the failure;

(B) may inform the jury of the party’s failure; and

(C) may impose other appropriate sanctions, including any of the orders listed in Rule 37(b)(2)(A)(i)-(vi).

In its trial motion, defendant included an alternative request that should the court not strike the testimony, it be afforded an overnight continuance to prepare to cross-examine the expert on his new opinions.  The court chose door #2 and gave defendant an evening to prepare.  Despite what both the district court and the Eleventh Circuit believe was a superb cross examination, defendant again renewed its request to strike the testimony.  However, the district court concluded “that [defendant] had done a fine job in that cross-examination such that it was clear . . . there was no prejudice.”  Id.  Kudos to defense counsel for doing a great job, but prejudice isn’t the standard and hard work isn’t the cure.

The Eleventh Circuit starts with a sound premise that should have been its conclusion too:  “Dr. Porter’s Rule 26 report should have been supplemented to flesh out his ‘evolved’ opinion.”  Id. at *7.   It should have been and it was not.  In other words, plaintiff sandbagged the defendant and the court let them get away with it.  The Eleventh Circuit concluded that the district court did not abuse its discretion in finding the non-disclosure “harmless” because defendant was given extra time to prepare.

Honestly, we could copy and paste the entire dissenting opinion right here.  It pretty much sums up exactly what we think – the majority opinion has “serious legal errors.”  Not the least of which is “neutering” Rule 37(c)(1)’s exclusion sanction and green-lighting “ambush tactics.”  Id. at *19.  For a non-disclosure to be “harmless” it must be a mistake and information already known to the other party.  This was neither.  Plaintiff’s expert “evolved” his opinion after plaintiff’s attorneys questioned him post-deposition.  Id. at *21.  It certainly wasn’t a surprise to plaintiff’s counsel and it was not already known to defendant.  What defendant knew was what was in the expert’s report and deposition.   At trial, defendant was essentially facing “a brand new expert witness whose identity [plaintiff] had not disclosed.”  Id.  And, whose report defendant had not had an opportunity to rebut and whose opinions defendant had not had an opportunity to explore through deposition.

This is precisely the situation for which Rule 37(c)(1)’s exclusion sanction was created.  The Rule provides alternatives to exclusion where exclusion would not be a deterrent, such as nondisclosure of unfavorable information.  Non-disclosure of newly formed, favorable opinions is not such a case.  For this, exclusion is the proper and sanctioned incentive.

Even if extra time to prepare for cross-examination cured one of the harms of non-disclosure, it could not cure the harm defendant suffered of being denied an opportunity to obtain discovery of the underlying bases for the expert’s opinions.  The majority, like the district court, seems to be content that defendant conducted a strong cross-examination and therefore, there was no need for anything else.  But, as the dissent points out, given the expert’s “complete about-face,” defendant was also entitled to discovery concerning the reasons for that “last-minute reversal.”  Id. at *23.  Because it appears that reversal may have been fraudulent.  Plaintiff’s counsel stated at trial that after his deposition, they asked the expert to “thoroughly review the records and answer some of counsel’s questions.”  Id. at *28n.8(dissent).  So plaintiff’s counsel knew that defendant was relying on the previously disclosed opinions, they induced the expert to formulate new opinions, and they didn’t disclose them.  Id. at *23, *28n.7(dissent).  Given these acknowledged circumstances, defendant should have been given the chance to discover the nature of the communications between counsel and their expert.  Id. at *23.  This wasn’t something that could be remedied by an overnight continuance.  Defendant should have been afforded an opportunity to learn how the new opinions were formed, an opportunity it was denied by plaintiff’s intentional non-disclosure.

Another consequence of the Eleventh Circuit ruling is that it strips the court of its Daubert gatekeeping function.  The court has a duty “to ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable.”  Id. at *26 (quoting Daubert).

But when an expert witness changes his theory from one in his report to another at trial, he is effectively able to bypass this gatekeeping function. . . .   As a result, counsel can introduce new theories at trial—even when that move is deliberate and intended to mislead the opposing party, because apparently intent no longer matters—that would not have passed evidentiary muster at an earlier stage.

Id. There’s more good stuff in the dissent and we recommend you give it a read.

As for the concurring opinion, it seems more focused on not upsetting the apple cart.  It expresses the same concern as the others that this type of non-disclosure of an “evolving” expert opinion is problematic.  Id. at *14.  The concurrence, however, wraps itself even more tightly in defendant’s request for a continuance.  It finds that the trial court didn’t abuse its discretion because defendant asked for one of two remedies and the court awarded one of those requests.  The concurrence notes that the trial court wasn’t privy at the time of its ruling to all of the briefing that has now been done, finding that to be a factor in the court’s favor.  The concurrence also then notes that defendant during trial didn’t argue that Rule 37 mandated exclusion, but holds that against defendant.  Id. at *17.  It is okay for the court to make an on the fly decision, but counsel better not make an on the fly argument.  More telling is the concurring judge’s reference to this issue arising “in the middle of a lengthy and complex trial.”  Id.  In other words, this was an MDL bellwether and the court is under considerable pressure to affirm or waste a lot of time and effort.  What good is a bellwether mistrial in moving the litigation along?

We wholeheartedly share the dissent’s concern that this sends a horrible message to anyone who wants to conduct a trial by ambush – especially in complex cases where expert testimony is essential.  And we don’t think the concurrence’s suggestion that the dissent be read along with the majority to put parties on notice.  The ruling is the ruling.  Leaving “for another day a more dispositive ruling,” id. at *18, is not good enough.  Sometimes you have to bruise a few apples to make a good pie.

But that might not be the worst part of the decision.  That honor may go to the majority’s Daubert ruling.  Plaintiff also offered the testimony of a general causation expert on the issue of degradation and the shedding of polypropylene particles in the body.  The presence of the particles, said the expert, causes the body to release hydrogen peroxide which in turn causes tissue inflammation, erosion of tissue, and in some cases infection.  Id. at *2.  This is a substance toxicity opinion, therefore, the expert needed to also opine on the “dose-response relationship.”  How much of the shed substance needed to be released into the body to cause the described reaction.  Id. at *8.  He did not.

Defendant’s argument relied largely on McClain v. Metabolife International, Inc., 401 F.3d 1233 (11th Cir. 2005).  That case involved the effect of ephedrine and caffeine in defendant’s product and held that “a plaintiff must demonstrate both the level of exposure to the allegedly harmful chemical . . . and the amount of the chemical to which the plaintiff was exposed.”  Taylor, at *9 (citing McClain).  The court distinguishes McClain and other cases as toxic torts, not medical devices.  But, if we are talking about the release of particles from an implanted device, we see that as a distinction without merit.  Rather than follow McClain, the court allows proof of causation by what amounts to an asbestos-style “no threshold” exposure level.  But even most asbestos cases don’t go that far.  Science typically does not support a “one-hit” or any trivial exposure theory of causation.  Exposure does not equal causation, but that is what this decision seems to be suggesting.  No need to counter with low-levels or even with alternative causes.  One molecule gets plaintiff over the hump.   We’re a little surprised the Eleventh Circuit bought into this.  We have considered the Eleventh Circuit on of the better Daubert circuits, but this causation opinion is extremely damaging.

The opinion also contains a discussion of the Florida punitive damages statute and how to determine what constitutes “specific intent.”  But that part of the opinion isn’t as interesting or nearly as bad as the rest, so we note just in case the issue is of interest to you.

Watch for Bexis’ scathing review at the end of the year.  We’re sure he has a few more choice words.