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JAMES M. BECK is Counsel resident in the Philadelphia office of ReedSmith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LiinkedIn page is here.

The Supreme Court decided “the big one” today – and not to keep anyone in suspense [the big one is a major earthquake in California mass tort litigation], the result is that the California Supreme Court finding of personal jurisdiction despite neither the plaintiff nor the defendant residing in the state has been reversed. Here is a link to the slip opinion in Bristol-Myers Squibb Co. v. Superior Court, No. 16-466 (U.S. June 19, 2017) (“BMS”).  It’s an 8-1 opinion, not a close decision, with Justice Alito writing for the Court.  Only Justice Sotomayor (predictably, from her prior positions) dissented.

After BMS, a lot of the litigation industry in California will go sliding into the sea.

This is one of the most important mass tort/product liability decisions ever, because expansive notions of personal jurisdiction – that large companies can be sued by anyone anywhere – are behind the growth of “magnet jurisdictions” (ATRA calls them something else) that attract litigation tourist plaintiffs from all over the country, suing companies from all over the country, without regard for whether any such defendant is incorporated or does business in the state.  Get rid of any personal jurisdiction basis for doing so, and we, if not end, at least put major limits on plaintiffs’ ability to forum-shop in this manner.

In our sandbox, product liability plaintiffs, suing manufacturers of FDA-regulated products, have flocked to what they view as their most favorable venues, certain notorious counties in Missouri, Illinois, Pennsylvania, New Jersey, New York – and yes, California. That’s what BMS rejected.  For several decades, plaintiffs’ litigation tourist strategy relied on expansive interpretation of “general” personal jurisdiction – that any defendant that conducted “continuous and substantial” business in any state could be sued in that state by anyone.  This theory was damaged by Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (2011) (which we call “Brown”), and then demolished altogether in Daimler AG v. Bauman, 134 S.Ct. 746 (2014) (which we call “Bauman”).

After Bauman, mere “continuous and substantial” business in a jurisdiction could not support general personal jurisdiction.  Rather only corporate defendants “at home” in the particular jurisdiction could be sued there. Bauman, 134 S. Ct. at 757; Brown, 564 U.S. at 919.  With no “exceptional” exceptions that apply to mass torts, Bauman limited general personal jurisdiction to those states where a corporation is incorporated or has its principal place of business. Bauman, 134 S. Ct. at 760-61.  “Exorbitant” and “grasping” jurisdictional allegations that would expand jurisdiction to “every other State” where large corporations do business, violate Due Process. Id. at 761-62.  “A corporation that operates in many places can scarcely be deemed at home in all of them.” Id. at 761 n.19.

Bauman thus threatened the viability of litigation tourism the litigation industry in numerous plaintiff-friendly venues, since 90%+ of the plaintiffs in such venues are typically non-residents.  Plaintiffs fought back.  The ink on Bauman was barely dry when they started trying to import the same expanded “continuous and substantial” rationale into the other major basis for personal jurisdiction, “specific” personal jurisdiction, which heretofore had been limited to suits “related to” the forum state – that is suits brought by in-state residents or persons injured in a state.  By a 4-3 margin, the California Supreme Court in Bristol-Myers Squibb Co. v. Superior Court, 377 P.3d 874 (Cal. 2016) (which we’ll call “BMS II”), conferred specific personal jurisdiction on litigation tourist plaintiffs from all over the country suing over a prescription drug.

No more.

As reiterated by the United States Supreme Court in BMS, the “primary consideration” of personal jurisdiction  is “the burden on the defendant.”  Slip op. at 6 (quotingWorld-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286, 292 (1980)).  While general jurisdiction is governed by Bauman’s “at home” requirements as to corporate defendants, “[s]pecific jurisdiction is very different.” Id. at 5.  “The suit” itself – not just some other aspect of litigation – “must arise out of or relate to the defendant’s contacts with the forum.” Id. (emphasis original) (citation and quotation marks omitted).

[S]pecific jurisdiction is confined to adjudication of issues deriving from, or connected with, the very controversy that establishes jurisdiction.

Id. at 6 (quoting Brown, 564 U. S. at 918).

The California Supreme Court’s BMS II ruling that any “substantial connection” between a corporate defendant’s activities and California, whether or not causally related to a litigation tourist plaintiff’s claimed injuries, would suffice to support jurisdiction failed miserably.  Personal jurisdiction reflects a concern with “submitting to the coercive power of a State that may have little legitimate interest in the claims in question.”  BMS, slip op. at 6.  That would be California in this case, where the litigation tourist plaintiffs did not reside in the state and did not sue over a drug that they purchased in the state.  When there is no “affiliation between the forum and the underlying controversy, . . . specific jurisdiction is lacking regardless of the extent of a defendant’s unconnected activities in the State.”  Id. at 7 (emphasis added).  We believed from day one that the California Supreme Court had improperly imported the general jurisdiction test rejected in Bauman into specific jurisdiction. In BMS the Supreme Court agreed:

[T]he California Supreme Court’s “sliding scale approach” is difficult to square with our precedents. Under the California approach, the strength of the requisite connection between the forum and the specific claims at issue is relaxed if the defendant has extensive forum contacts that are unrelated to those claims.  Our cases provide no support for this approach, which resembles a loose and spurious form of general jurisdiction.

Id.  “Loose and spurious” – that’s a good description of the basis for most litigation tourism in mass torts.

The State Supreme Court found that specific jurisdiction was present without identifying any adequate link between the State and the nonresidents’ claims. . . .  [T]he nonresidents were not prescribed [the drug] in California, did not purchase [it] in California, did not ingest [it] in California, and were not injured by [it] 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.

Id. at 8 (citing Walden v. Fiore, 134 S. Ct. 1115, 1123 (2014)).  Nothing related solely to other plaintiffs matters in specific jurisdiction.  As we suspected it would be, Walden was the critical precedent here. BMS, slip op. at 8-9.  The cases plaintiffs relied upon, Keeton v. Hustler Magazine, Inc., 465 U. S. 770 (1984), and Phillips Petroleum Co. v. Shutts, 472 U. S. 797 (1985), were “amply” distinguishable and “had no bearing on the question presented here.”  BMS, slip op. at 10-11.

Nor did the presence of a California distributor – equally uninvolved with the plaintiffs who brought the suit – change the result one iota.  Repeated prior precedents have held that personal jurisdiction “must be met as to each defendant over whom a state court exercises jurisdiction.”  Id. at 11 (citations and quotation marks omitted).  “The bare fact that BMS contracted with a California distributor is not enough to establish personal jurisdiction in the State.”  Id. at 12.  This ruling, while something of a side show in BMS, should be critical in other types of cases, such as asbestos, where dozens of defendants are typically joined together without regard for where either the defendants or plaintiffs are located.

Thus, unfortunately for litigation tourists, “a defendant’s general connections with the forum are not enough.”  Id. at 7.  Plaintiffs’ unrestricted forum shopping days are over.  “[S]traightforward” application of fundamental personal jurisdiction principles means that plaintiffs may “join[] together in a consolidated action in the States that have general jurisdiction over BMS.”  Otherwise, “the plaintiffs who are residents of a particular State . . . could probably sue together in their home States.”  Id.  Finally, while the Court did not address “whether the Fifth Amendment imposes the same restrictions on the exercise of personal jurisdiction by a federal court, ” id. as we mentioned above, Walden v. Fiore was probably the single most important prior precedent in BMS.  As our post on Walden pointed out, Walden was a federal (Bivens) action filed in federal court.  We thus don’t see that caveat as being a meaningful one.

The result in BMS means that the era of big mass torts, filed by plaintiffs anywhere against anyone over anything, is (to paraphrase Bill Clinton) over.  There will be still be mass torts, but as BMS pointed out at the end of the opinion, they will either be defendant-specific − filed in the target defendant’s state of incorporation or principal place of business – or limited to plaintiffs from the state where the litigation is situate.  San Francisco (as in BMS), Los Angeles, Philadelphia, St. Louis, Chicago, Madison County, wherever….  These jurisdictions can only assert jurisdiction over in-state plaintiffs, or else defendants that are (unfortunate enough to be) “at home” in those respective states (subject, of course, to state venue requirements).

A very good day for the right side of the “v.” – and not very good for those on the wrong side.  Plaintiffs will have to get used to the radical proposition that defendants have constitutional rights, too.

The only remaining personal jurisdiction theory available to the great majority of litigation tourist plaintiffs is the so-called “jurisdiction by consent” theory that posits that mere registration to do business/appointment of an agent for service of process – something that all 50 states require – constitutes “consent” to be sued even by non-residents in any state where a corporate defendant so registers. Of course, a lot of states (including California since way before Bauman) do not interpret their personal jurisdiction statutes in that manner (see our discussions here and here).  Critically, as we’ve also pointed out before (including in our post-Bauman personal jurisdiction cheat sheet, which we will be now be converting to a consent cheat sheet), that consent theory would be just as expansive, and thus just as  violative of Due Process, as the general and specific jurisdiction theories rejected in Bauman and BMS, respectively.

Remember, the basis for all of the Court’s jurisdictional jurisprudence is Due Process. “[A] state court’s assertion of jurisdiction exposes defendants to the State’s coercive power,” so that assertion “is subject to review for compatibility with the Fourteenth Amendment’s Due Process Clause.”  BMS, slip op. at 5 (citation and quotation marks omitted).  Plaintiffs should not expect to achieve the same unconstitutional result by other means, such as expanding state corporate registration statutes beyond recognition.  Plaintiffs in BMS could not escape Bauman in that fashion.  Future plaintiffs should not expect to escape both Bauman and BMS with yet another subterfuge.  Under Due Process, there must be “a connection between the forum and the specific claims at issue.”  BMS, slip op. at 8.

Finally, we’d also like to point out one more implication of today’s BMS decision – it affects available venues for a large number of federal causes of action.  The general federal venue statute, 28 U.S.C. §1391, provides that, “[f]or all venue purposes,” a corporation “shall be deemed to reside, if a defendant, in any judicial district in which such defendant is subject to the court’s personal jurisdiction.”  Thus, by the terms of §1391, the scope of personal jurisdiction recognized in BMS (subject to the Court’s final caveat in BMS about federal personal jurisdiction) also becomes the template for the permissible venue choices available to federal plaintiffs bringing suit under any federal statute that does not contain its own statute-specific venue provisions.

We have two posts on innovator liability that we update on a consistent basis: our innovator liability scorecard, and our “Innovator Liability at 100” state-by-state collection of materials that we originally compiled when the one-hundredth judicial opinion on this topic was decided.  Well, not too long ago the Fourth Circuit, in McNair v. Johnson & Johnson, ___ F. Appx. ___, 2017 WL 2333843 (4th Cir. May 30, 2017), did what no court of appeals had done since the innovator liability first reared its ugly head in 1994 – it certified the question to the relevant state high court – in this case, the West Virginia Supreme Court of Appeals:

Whether West Virginia law permits a claim of failure to warn and negligent misrepresentation against a branded drug manufacturer when the drug ingested was produced by a generic manufacturer.

2017 WL 2333843, at *1.

At least a dozen federal court of appeals decisions have rejected innovator liability under the laws of some two dozen states. Ironically, the first to do so was the Fourth Circuit itself, in Foster v. American Home Products Corp., 29 F.3d 165, 168, 171 (4th Cir. 1994), under Maryland law.  Plaintiffs did not begin resorting to the delaying tactic of requesting state court certification until relatively late in the game.  Courts of appeals were not accommodating, refusing to certify what they saw as an outlier issue in Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605, 614-15 (5th Cir. 2014); Strayhorn v. Wyeth Pharmaceuticals, 737 F.3d 387, 406-07 (6th Cir. Dec. 2, 2013). See also In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 3610237, at *3 (E.D. Ky. Aug. 21, 2012), aff’d, 756 F.3d 917 (6th Cir. 2014); Mosley v. Wyeth, Inc., 719 F. Supp. 2d 1340, 1351 n.9 (S.D. Ala. 2010) (district courts refusing certification motions).  But plaintiffs got lucky (for a few months) in Wyeth, Inc. v. Weeks, 159 So. 3d 649, 653 (Ala. 2014), with a certified question, and with nothing left to lose they’ve been trying it ever since.

McNair is not only an outlier procedurally, but is troubling substantively.  First, the Fourth Circuit’s certification opinion seems more concerned with preemption rather than state law – addressing preemption before even bothering with state-law causation principles, and finishing that section with the observation, “while a state law failure-to-warn claim against a generic manufacturer is preempted, such claims are not preempted as to the warnings on a brand-name drug distributed by a brand-name manufacturer.”  2017 WL 2333843, at *3 (emphasis original).  Ordinarily, the existence of a recognized state law claim precedes any decision on whether that claim is preempted.  We always find it troubling when a federal court views principles of state law more through the lens of a preemption dodge than on their merits.

Although pointing out (as could hardly be denied) that even in the current preemption environment, “overwhelming” precedent rejects innovator liability, McNair, 2017 WL 2333843, at *4, the certification order makes it appear as if there is no prior West Virginia law on this subject.  That is simply not so.  As we state in our Innovator Liability at 100 post:

In In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917 (6th Cir. 2014), the Sixth Circuit concluded that West Virginia “has rejected claims attempting to impose liability on brand manufacturers where plaintiffs ingested only generic drugs.”  Id. at 953.  Darvocet relied upon Meade v. Parsley, 2009 WL 3806716 (S.D.W. Va. Nov. 13, 2009).

[Innovator defendants] are not responsible for the damage resulting from a product that they did not manufacture, distribute or sell. . . .  Product liability law in West Virginia allows for recovery when the plaintiff can prove that “a product was defective when it left the manufacturer and the defective product was the proximate cause of the plaintiff’s injuries.”  Because neither [innovator defendant] manufactured the product that injured plaintiffs, there is no proximate cause.

Id. at *2-3 (quoting Dunn v. Kanawha County Board of Education, 459 S.E.2d 151, 157 (W. Va. 1995)).

That the Fourth Circuit would decide to omit all of the most directly on-point West Virginia law-based precedent – including a published court of appeals decision − from its certification order is simply inexplicable.  Certainly, ignorance cannot be claimed, as both the Darvocet and Meade decisions were relied upon by the district court in McNair itself.  McNair v. Johnson & Johnson, 2015 WL 3935787, at *6 (S.D.W. Va. June 26, 2015).  We can only hope that the West Virginia high court (docket available here) will not be misled by these omissions.

 

This is our quasi-annual update to our cheat sheet about ediscovery for defendants.  Essentially that means using discovery to obtain access to what plaintiffs have said about themselves, and their supposed injuries, on social media.  Such material can be critical to defeating a plaintiff’s case. See Zamudio-Soto v. Bayer Healthcare Pharmaceuticals, Inc., 2017 WL 386375, at *11 (N.D. Cal. Jan. 27, 2017) (summary judgment on statute of limitations granted because plaintiff’s “Facebook post is even more indicative of suspicion [of causation]” than evidence that sufficed to defeat the discovery rule in binding Ninth Circuit decision).

However, we once again implore defendants – be reasonable.  Don’t do what we complain about the other side doing.  Don’t make unbounded requests for all social media at all times about everything.  Having just read a bunch of ediscovery cases about social media, we can state with confidence that such open-ended discovery is the quickest way to make bad precedent, the kind we don’t put on our cheat sheets, in this area.

Since discovery issues involving social media can arise in a many types of non-drug/device litigation – and even outside of personal injury altogether (think employment-related suits, for one thing) – this is a different kind of cheat sheet.  Instead of collecting cases as they come down via our weekly prescription medical product-related searches, we have to go out and research this issue specifically.  We’re lazy, so that doesn’t happen more than once a year or so.  The summaries below have been added to the cheat sheet itself, but we’re presenting them here as well.  As always with cheat sheets, we compile only those favorable to our side, which means those cases that allow all, or substantially all, of the discovery being sought.

  • Baxter v. Anderson, 2016 WL 4443178 (Mag. M.D. La. Aug. 19, 2016). Ordering plaintiff to identify every social networking website used or accessed since her accident, and where she posted photographs or other information, as well as usernames and the last date of access. Plaintiff must also produce all postings, including photographs, since the accident about the claims and defenses of the litigation, as well as postings about her alleged physical injuries and her physical capabilities.
  • Zamora v. GC Services, LP, 2016 WL 8853096 (Mag. W.D. Tex. Aug. 19, 2016). Plaintiff ordered to respond to discovery demand for all social media postings, recordings, and text messages, that concern the factual allegations plaintiff is making in the lawsuit.
  • McDonald v. Escape the Room Experience, LLC, 2016 WL 5793992 (Mag. S.D.N.Y. Sept. 21, 2016). Motion to compel granted ordering plaintiff to produce postings about plaintiff’s socializing, her attendance at parties or other social outings, and her participation in performances or other employment activities. Plaintiff’s production must include her complete postings, during the relevant time period, on any electronic social media or internet sites, including dating sites.
  • Jacquelyn v. Macy’s Retail Holdings, Inc., 2016 WL 6246798 (Mag. S.D. Ga. Oct. 24, 2016). No threshold showing is necessary before a defendant can seek discovery of social media evidence. Such a rule would shield from discovery Facebook users who do not share information publicly. Where a plaintiff puts physical condition and quality of life at issue, Facebook postings reflecting physical capacity and inconsistent activities are relevant and discoverable. Plaintiffs must produce: (1) all photographs posted by plaintiffs or in which they are tagged; (2) all comments to those photographs; (3) all posts by plaintiffs relating to activities in which plaintiffs contend they could not participate due to the incident; and (4) any posts referencing their claimed injuries, damages, or loss of enjoyment of life since the incident.
  • Scott v. United States Postal Service, 2016 WL 7440468 (Mag. M.D. La. Dec. 27, 2016). Where plaintiff has put her physical condition and activities at issue by filing a lawsuit, social media concerning those matters is discoverable. Defendant came forward with evidence that relevant social media existed. Plaintiff can also be required to identify all social media used since the accident and all postings related to any type of physical or athletic activities since the accident. To ensure completeness, plaintiff must retain historical data for all social media and review for responsive information. If such information is unavailable, plaintiff must describe the steps she took to locate and review responsive information.
  • Brown v. City of Ferguson, 2017 WL 386544 (E.D. Mo. Jan. 27, 2017). Social media discovery is no different than any other discovery. Social media is neither privileged nor protected by a right of privacy. Plaintiffs must produce all social media content with any relevance to the case, for five years prior to the incident, including private messages sent through Facebook messenger.
  • Gee v. Citizens Insurance Co., 2017 WL 694711 (Mich. App. Feb. 21, 2017) (unpublished). Affirming dismissal of plaintiff’s complaint as a sanction for deliberately deleting social media information to evade discovery.
  • Gordon v. T.G.R. Logistics, Inc., ___ F. Supp.3d ___, 2017 WL 1947537 (D. Wyo. May 10, 2017). Plaintiff required to produce all social media history about her significant emotional turmoil, any mental disability or ability, or significant events which reasonably could result in emotional distress. Plaintiff also required to produce all Facebook postings which reference the accident, its aftermath, and any of her claimed physical injuries. Plaintiff must produce Facebook history and photos which relate or show her level of activity after the accident. Pre-accident social media need not be produced without a showing of relevance.
  • Matthews v. J & J Service Solutions, LLC, 2017 WL 2256963 (Mag. M.D. La. May 23, 2017). Plaintiff ordered to comply with document requests for all social media communications with defendant’s current or former employees and for archived Facebook material. Social media is discoverable.

These case have also been added to the cheat sheet itself, where we have collected over 100 favorable ediscovery for defendant cases that go back over a decade.

This guest post comes courtesy of Jonathan Hoffman, a Senior Partner at MB Law Group LLP, in Portland, Oregon.  Jon, a long-time member of the Product Liability Advisory Council (“PLAC”), originally circulated a version of this post to PLAC members.  Bexis, also a long-time PLAC member, saw it, thought blog readers would be interested, and successfully importuned Jon to submit a longer version here.  Access to these kinds of alerts are one reason, among many, why we encourage drug and medical device manufactures confronted with product liability litigation to join PLAC.

As always our guest bloggers deserve 100% of the credit (and any blame) for their posts.  Onward to the Hague Convention.

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Although most drug and medical device litigation is purely among domestic individuals and defendants, many manufacturers of these products are based outside the United States or are domestic subsidiaries of overseas companies.  In recent years, the US Supreme Court has trimmed many excessive impositions of personal jurisdiction in suits brought against foreign and other non-local defendants, most recently, in BNSF Ry. Co. v. Tyrrell, No. 16-405, 2017 WL 2322834 (U.S. May 30, 2017).

[editor’s note − see our BNSF post here]

However, it may have become easier for plaintiffs to invite foreign manufacturers to the party here in the US based on the Court’s recent liberal interpretation of the Hague Service Convention, 20 U. S. T. 361, T. I. A. S. No. 6638 (1965), which governs service of process on foreign entities.  Until now, effecting service upon a defendant based in another country has been an inconvenience, if not an outright impediment.  Many US courts held that the only proper means of service under the Convention was to serve the complaint upon the “central authority” of that country, requesting that central authority to then serve the complaint upon the defendant in the manner under which service is customarily performed under that country’s laws.  The Convention also provided that the Convention “shall not interfere with—(a) the freedom to send judicial documents, by postal channels, directly to persons abroad.”  Many US courts concluded that this provision, Article 10(a) of the Convention did not authorize service of process by mail because it only referred to the right to “send” documents, not to “serve” them.

But the Supreme Court disagreed late last month.  Water Splash, Inc. v. Menon, No. 16-254, 2017 WL 2216933 (U.S. May 22, 2017), arose from a seemingly simple dispute between the manufacturer of playground equipment and a former employee.  The employee was allegedly working for one of Water Splash’s competitors while still employed by Water Splash.  Water Splash sued in Texas state court, but the former employee lived in Canada.  Water Splash served her by mail, in accordance with Texas law.  She did not appear.  The trial court entered a default judgment.  She then moved to set aside the judgment, but the court denied her motion.

The Supreme Court held that, as long as service by mail is performed in compliance with the forum’s law, Article 10(a) of the Hague Service Convention permits such service by mail on foreign defendants unless the country in which service was made has objected to this type of service.  Article 10(a) provides that the Convention will not interfere with “the freedom to send judicial documents, by postal channels, directly to persons abroad,” but does not expressly refer to “service.”  For decades, the lower courts had split over whether this provision extends to service of process or is limited to service of other documents and pleadings.  Compare, e.g., Bankston v. Toyota Motor Corp., 889 F. 2d 172, 173-74 (8th Cir. 1989) (holding that sending summons and complaint to defendant in foreign country does not constitute valid service under Hague Convention) with Brockmeyer v. May, 383 F. 3d 798, 802 (9th Cir. 2004) (holding that the meaning of “send” in Article 10(a) includes “serve.”).

The question whether the Hague Convention permits service by mail has now been answered.  The answer is a qualified “yes,” as long as such service complies with the forum’s service requirements and that the country where the defendant is located did not object to Article 10(a).  This broader acceptance of international service via mail may, by lowering procedural barriers to entry, have the unfortunate effect of haling more foreign manufacturers or foreign parent companies into US Courts.

Water Splash does not eliminate all opportunities for defendants to avoid claims brought against foreign manufacturers, however.  A variety of other remedies are still available to a foreign defendant.  Most notably, Plaintiffs may mistakenly try to extend this ruling to effect mail service on a defendant in a country that has not ratified the Convention, or that has objected to such service.  Or, the plaintiff may fail to effect mail service in compliance with forum law.  The Hague Convention does not render such service sufficient.

Moreover, even if a US Court upholds service against a foreign defendant under the US’s liberal interpretation of the Hague Service Convention, a judgment might be unenforceable in the courts of the foreign defendant’s domicile.  Foreign courts may refuse to enforce a judgment entered in the US by deciding that the American court lacked personal jurisdiction over the local defendant.  Or, in some signatory countries (most notably Japan), that did not object to the Hague Service Convention, courts may not enforce a foreign judgment where service did not comport with the Hague Service Convention by including a copy of the summons and complaint in Japanese.

More traditional errors, too, can still render mail service on foreign companies ineffective to sustain a lawsuit in the US.  For example, a plaintiff serving a foreign entity may underestimate the time required to serve that entity, even if the service is performed by mail.  If the complaint is not properly served within the time provided by the forum state’s state statute of limitations and whatever state-law tolling provision allows for relation back of service, the claim can be dismissed.  See Walker v. Armco Steel Corp., 446 U.S. 740, 750 (1980); Bancorp Leasing & Fin. Corp. v. Agusta Aviation Corp., 813 F.2d 272, 274 (9th Cir. 1987).

But in significant cases, where the stakes are high and the plaintiffs’ counsel is more competent, the Water Splash decision suggests that more foreign manufacturers may have to learn to swim in American waters.

With the Phillies stinking the joint out – off to their worst start since World War II – and both of Boranian’s local teams in last place, too (not as deeply buried as the Phillies), use of baseball imagery might seem a bit painful right now.  Only our DC-based blogger has had anything worth cheering about lately, and with what’s going on there recently….  Baseball must be a welcome distraction.

But a one-two-three inning was what came to mind in looking at the new decisions that turned up last week. We were struck by three relatively easy wins for defendants.  Individually, they would not warrant separate post, but under a “totality of the evidence” standard, when added together, we found them worth discussing

The first is N.K. v. Abbott Laboratories, 2017 WL 2241507 (E.D.N.Y. May 22, 2017), a Depakote/birth defects case.  There are a number of these cases around, and we have already commented on several.  But we have to say, if the other side’s experts are as poor as they were in N.K, this litigation deservedly isn’t going anywhere.  N.K. went away on summary judgment after all of the plaintiff’s “experts” – and the term deserves to be in quotes – were excluded from testifying.  The first purported expert was the minor-plaintiff’s treating pediatrician, who was totally out of her depth:

[The witness] has never conducted research on Depakote or valproic acid. Nor has she researched the effects of in utero exposure to valproic acid (“valproate exposure”).  Prior to [minor plaintiff’s] first visit, her knowledge of Depakote was limited to refilling prescriptions for epileptic patients.  Since that initial visit, she has conducted little to no additional research on Depakote, valproic acid, or valproate exposure.

2017 WL 2241507, at *2 (record citations omitted).  Unsurprisingly, the court found this witness “not qualified to testify that Depakote caused [minor-plaintiff’s] injuries.”  Id. at *3.  She possessed no applicable medical experience nor had she bothered even to review the relevant literature.  Id. (she “did not perform any research or make any additional investigation that might qualify her as an expert on valproate exposure”).  Instead, “[h]er attempts to understand the cause of [minor-plaintiff’s] injuries were limited to a single review of a single medical book, the day of his first visit.”  Id.  This is hardly the kind of expert we would expect to see in litigation where a strong causation case is present.

The second expert in N.K. “ha[d] a more substantial background” – it could hardly have been less – but was not even a medical doctor.  Id. at *4.  Again, we would not expect to see this kind of “expert” in a strong case.  Lack of a medical degree is a problem.  “[C]ourts have consistently drawn a distinction between the qualifications of medical and non-medical doctors, noting that non-medical doctors who are qualified to diagnose a medical condition may be unable to reliably determine its cause.”  Id.  This witness was a “teratologist and toxicologist,” but had no relevant diagnostic expertise.  “[B]y his own testimony he has never evaluated children, has never been called upon to diagnose dysmorphic features or autism in a child, and is not a clinician.”  Id.

Nor did these unqualified “experts” use proper methodology.  They both purported to engage in the last refuge of a Daubert scoundrel – differential diagnosis.  The pediatrician “viewed [minor plaintiff’s] condition as either genetic or the result of prenatal valproate exposure.”  Id. at *5.  Which one didn’t she investigate?

She reached this conclusion before eliminating any genetic causes. . . .  Not only did [she] fail to eliminate alternative causes before reaching her initial conclusion, she lacked the knowledge to independently rule out genetic causes.

Id.  Genetics were a serious alternative  “[A]t least four other treating physicians have recommended further genetic testing to determine the cause of [minor plaintiff’s] injuries.”  Id.  The court could hardly be faulted for wondering what these plaintiffs were hiding in not having this testing done.

The other expert – the one that wasn’t even a doctor – was, if anything worse.  He “did not conduct his own independent investigation,” rather “[h]is opinion is based entirely on reviewing existing reports provided to him by Plaintiffs.”  Id. at *7.  Having to spoon-feed an expert is another indicator of a weak case.  Beyond that, his “attempt to rule out potential alternative causes of [minor plaintiff’s] condition is plagued by the same problems as” the pediatrician’s.  Indeed, “[h]e relied on [her] flawed report in ruling out genetic causes.”  Id.

Finally, plaintiffs failed to slip the pediatrician’s opinions in the back door, as “factual” testimony by a treater.  A treater’s testimony was equally subject to Daubert:

Even if such an opinion could be read into her records, classifying [her] as a fact expert does not relieve this Court of its duty to ensure she utilized reliable methods in reaching her opinion.  Courts in this district have found that when a treating physician seeks to render an opinion on causation, that opinion is subject to the same standards of scientific reliability that govern the expert opinions of physicians hired solely for the purposes of litigation.

Id. at *8 (citations and quotation marks omitted).  To us, this is the most significant legal ruling in N.K.

Summary judgment granted.  One away on a dribbler to the mound.

Next up, Rincon v. Covidien, 2017 WL 2242969 (S.D.N.Y. May 22, 2017). Rincon failed on a motion to dismiss, because of TwIqbal.  Rincon involved hernia mesh, and an alleged injury suffered more than six years after implantation.  Id. at *1.  Plaintiff’s complaint had a rather fundamental – and fatal – flaw.  It failed to allege that a defect caused the alleged injuries:

[Plaintiff] fails to allege any facts that plausibly establish such causation. . . .  Taken together, these facts − even liberally construed (not that there is a basis for liberal construction here) − fall far short of demonstrating that [defendant’s] mesh was a “but for” cause of [her] later injuries. . . .  Nothing in the Amended Complaint even endeavors to explain why the mesh is a more likely, let alone proximate, cause of [plaintiff’s] alleged harms.

Id.  One would have thought that, with an obvious serious timing issue, the plaintiff would have tried harder in Rincon to allege the sort of critical facts supportive of causation.  The absence of these facts is another marker of a weak case.

But not only did the plaintiff in Rincon fail to allege causation; she also failed to allege defect:

Under New York law, Rincon must prove the existence of a defect. . . .  But [plaintiff] fails to allege a defect except in the most conclusory terms:  that [defendant] manufactured the PCO mesh, that the mesh was used during her hernia surgery in 2006, that she needed subsequent medical procedures in 2012 and 2013, and thus [defendant] must not have “properly manufactured, tested, inspected, packaged, labeled, distributed, marketed, examined, sold, supplied, prepared and/or provided [ ] the proper warnings” regarding the mesh.

Id. at *2.  To make matters worse, plaintiff tried to make up her pleading defects in her brief opposing dismissal.  The court was not impressed.  Those assertions “serve only to illustrate the deficiencies in her Amended Complaint − namely, that it does not identify any actual defect in the coating and says nothing about how the coating, even if defective, caused [her] specific injuries.”  Id.

On top of that, plaintiff only “suggest[ed],” but did not actually seek, leave to amend.  Id.  Plaintiff’s notably poor pleading resulted in dismissal with prejudice.   “[E]ven if [she] were to add her new ‘facts’ . . ., her claims would all still fail for the reasons discussed above.”

Called third strike.  Two down, and add one to our TwIqbal cheat sheet.

The final out was made by Merancio v. Smith & Nephew, Inc., 2017 WL 2257124 (E.D. Cal. May 23, 2017), where summary judgment was granted after the plaintiffs failed to retain the allegedly defective implant.  The complaint itself was a mess, which certainly did plaintiffs no favors.  “[N]either factual details concerning plaintiffs’ claimed injuries nor specific legal theories of liability have been alleged in any detail.”  Id. at *1.  Having lost the device that supposedly failed plaintiffs “presented no substantive evidence concerning the merits of their claims.”  Id.  Instead, they pursued another all too common “last refuge of a scoundrel” tactics – attempting to litigate the defendant’s supposed discovery lapses.

That didn’t work this time.  Whatever deficiencies (if any at all) in the defendant’s initial disclosures were irrelevant by the time summary judgment rolled around.  Even if the identity of the affiant who supported the summary judgment motion was disclosed too late, it was disclosed “well prior to the close of discovery,” and the witness “was ultimately deposed by plaintiffs.”  Id. at *4.  Like too much pine tar on a bat, the violation, if it existed at all, was harmless.  Or, to mix sports metaphors, “no harm, no foul.”  “Plaintiffs have made no showing that they were prejudiced by the timing of defendant’s disclosures.  Indeed, plaintiffs have made no allegations of any harm − not even general, vague, and conclusory ones − flowing from defendant’s allegedly belated disclosures.”  Id.

So plaintiffs tried again, arguing that the court should ignore the defendant’s affidavit, which was factually undisputed, because the affiant “failed to include a list of cases in which he has appeared as an expert.”  Id. at *5.  The court was having none of plaintiffs’ trivial pursuit.  If plaintiffs thought this deficiency was so important, they should have done something about it earlier, rather than pursue a nitpicking litigation strategy:

[P]laintiffs’ counsel never asked defense counsel or the expert for this list and never filed a motion to compel with the court seeking the information or the imposition of sanctions. . . .  Again, plaintiffs do not even generally suggest how they have been harmed as a result of these minor deficiencies in [defendant’s] expert report.  Indeed, when asked at the hearing on the pending motion, plaintiffs’ counsel suggested he purposefully did not pursue any further efforts to obtain the list of cases in which [the affiant] had appeared as an expert because, in counsel’s view, it made defendant’s expert “attackable.”

Id. (emphasis added).

With plaintiffs’ discovery smokescreen blown away, summary judgment was inevitable.  “It [was] undisputed on summary judgment that, at the time the parts used in [plaintiff’s] knee replacement left the control of defendant, they had been inspected, passed quality control inspections, and were in compliance with all applicable FDA regulations.”  Id. at *7.  Defect at sale is a “necessary element” of strict liability.  Id.  Further, California simply does not recognize strict liability design defect claims involving prescription medical products.  Id.  Negligence failed because of a “complete failure of proof” that the device failed when it shouldn’t have.  Id. at *8.  Finally, plaintiffs’ warranty claim was dismissed (in addition to the above grounds) on an interesting legal ruling − that the personal injury damages were not available for alleged breach of contract:

Here, plaintiff seeks general damages for pain, suffering, and inconvenience, and special damages for medical expenses, future medical expenses, loss of earnings, [plaintiff] seeks here are generally not cognizable in claims sounding in contract in California.

Id. (citations omitted).  Finally, with no evidence “that the defendant negligently injured” her spouse, that wife-plaintiff’s consortium claim bit the dust. Id. at *9.

Side retired on a (very) foul popup.

Weak claims all in N.K., Rincon, and Merancio. Daubert, TwIqbal, and simple failure to prove the claim defeated these actions, and did so fairly expeditiously.   Which is as it should be.  Weak claims have no business being brought, and where plaintiffs are unable to hide weak claims in MDLs, these cases demonstrate that (at least in the federal courts), the civil justice system still works.

 

We pointed out earlier that Bristol-Myers Squibb Co. v. Superior Court, No. 16-466 (“BMS”), was not the only personal jurisdiction matter on the Supreme Court’s docket this term.  Argued the same day as BMS was BNSF Railway Co. v. Tyrell, a Federal Employees Liability Act (“FELA”) personal injury case raising some similar personal jurisdiction questions – but not the unprecedented expansion of “specific” personal jurisdiction presented by BMS.  We opined in our prior post that for all the difficulties that the plaintiffs in BMS encountered at oral argument, the plaintiffs in BNSF (there were two consolidated cases) had it even worse:

[W]e frankly can’t see a path to affirmance for the plaintiff in BNSF.  It could well be a unanimous reversal of the Montana Supreme Court, albeit with at least one concurrence offering a different rationale (similar to Bauman).

For the full post, go here.

BNSF was just decided, here’s the link to the opinion, and that’s pretty much what happened – reversal with only one justice (Sotomayor) concurring in part and dissenting in part – as was the case in Bauman.  Also as in Bauman, Justice Ginsburg authored the opinion of the Court.

Briefly, since we discussed the facts in BNSF before, two plaintiffs sued the defendant for personal injuries under FELA in Montana state court despite:  (1) neither plaintiff being a Montana resident; (2) neither plaintiff being injured in Montana; and (3) the defendant being neither a Montana corporation nor headquartered in Montana.

By 8-1 the Court held no personal jurisdiction. The first part of BNSF was about issues peculiar to the FELA statute.  We’ll skip that – except to point out that the Court once again cautioned – as it did in Bauman – that personal jurisdiction decisions predating International Shoe Co. v. Washington, 326 U.S. 310 (1945), were of doubtful validity:

[A]ll these cases [cited by plaintiffs] were decided before this Court’s transformative decision on personal jurisdiction in International Shoe.  See Daimler, [which we call Bauman] 571 U.S., at ___, n.18 [134 S.Ct. 746, 761] n.18) (cautioning against reliance on cases “decided in the era dominated by” the “territorial thinking” of Pennoyer v. Neff, 95 U.S. 714 (1878)).

BNSF, slip op. at 9 (citations rejiggered).

After disposing of the FELA issues, BNSF turned to the Montana law issues.  The Montana Supreme Court had relied on the Montana “Long Arm” statute, which provided for the exercise of general jurisdiction over all persons “found within” the state.  Id. The terms of the statute didn’t matter much since the correct question was “whether the Montana courts’ exercise of personal jurisdiction under Montana law comports with the Due Process Clause of the Fourteenth Amendment.”  Even though it was undisputed that the defendant was “found within” Montana under the statute, there was no jurisdiction for the rather transparently obvious reason that no state statute could go beyond what constitutional Due Process permitted:

[T]he business [defendant] does in Montana is sufficient to subject the railroad to specific personal jurisdiction in that State on claims related to the business it does in Montana. But instate business, we clarified in [Bauman] and Goodyear, does not suffice to permit the assertion of general jurisdiction over claims like [plaintiffs’] that are unrelated to any activity occurring in Montana.

Id. at 11-12 (footnote omitted).

For DDLaw’s purposes, not specific to railroads, that’s the most significant aspect of BNSF.  Some courts, most notably Bors v. Johnson & Johnson, 208 F. Supp.3d 648 (E.D. Pa. 2016), which we discussed here, seem to have overlooked the point that a peculiarly worded state statute simply cannot override the Due Process constraints enforced in BNSF and Bauman.  Thus, that the unusual language of a state enactment (Pennsylvania’s corporate registration statute) in Bors could be read to allow personal jurisdiction (in Bors “consent” jurisdiction) beyond the Due Process limits of Bauman means nothing.  State statutes cannot extend personal jurisdiction to unconstitutional extremes – as BNSF held with respect to the “found within” language in Montana’s Long Arm statute.

Thus, although BNSF did not reach the issue of jurisdiction by consent, slip op. at 12, its rationale should be fatal to decisions like Bors that purport to hold that a state statute can authorize an otherwise unconstitutional scope of personal jurisdiction.

While we are waiting for the Supreme Court to rule in Bristol-Myers Squibb Co. v. Superior Court, No. 16-466 (“BMS”), an interesting thing happened.  Last week in TC Heartland LLC v. Kraft Foods Grp. Brands LLC, ___ S.Ct. ___, 2017 WL 2216934 (U.S. May 22, 2017), the Court interpreted the federal venue statute peculiar to patent litigation, 28 U.S.C. §1400(b), to restrict the ability of patent plaintiffs to bring their cases anywhere in the country.  2017 WL 2216934, at *7.  Reaffirming the viability of a 60-year- old decision, Fourco Glass Co. v. Transmirra Products Corp., 353 U.S. 222 (1957), the Court held that patent infringement actions could only be brought where the defendant “resides,” which in the case of corporations meant only where they were incorporated.  2017 WL 2216934, at *7.

A lot has been written already about how TC Heartland means the demise of the Eastern District of Texas as the equivalent of Madison County, Illinois for patent litigation.  That is not our sandbox, and we’re not here to discuss that.  For our purposes, we’re intrigued by the Court unanimously restricting – albeit under a federal venue statute, not the Due Process Clause of the Constitution – widespread plaintiff-side forum shopping leading to suits piling up in particular magnet jurisdictions.  From a policy standpoint, that’s also what BMS is about.

Indeed, we tangentially encountered patent-based forum-shopping before. In this post, we discussed a decision of the Federal Circuit in a patent case, Acorda Therapeutics Inc. v. Mylan Pharmaceuticals, Inc., 817 F.3d 755 (Fed. Cir. 2016), which involved a related question of personal jurisdiction − that a defendant’s “plans to market its proposed drugs” in a jurisdiction were enough to support jurisdiction under minimum contacts/specific jurisdiction analysis in patent cases. Id. at 762-63.  We weren’t concerned with that patent-specific proposition.  Rather, we were interested in the alternative argument – ultimately avoided in Acorda – that sought to assert general jurisdiction under Delaware law simply because the defendant had registered to do business in the state and thereby supposedly “consented” to be sued there for anything by anyone.  The only reason expansive personal jurisdiction arguments were being made in Acorda was to support the equally expansive notions of venue in patent cases that TC Heartland has just consigned to the dustbin of legal history.

In any event, that alternative argument in Acorda is now moot because only a month later (to the day), the Delaware Supreme Court rejected jurisdiction by consent under state law in Genuine Parts Co. v. Cepec, 137 A.3d 123, 147 (Del. 2016) (holding that Bauman “indicates that such a grasping assertion of state authority is inconsistent with principles of due process”).  The Acorda situation does demonstrate, however, the relationship between the expansive notions of personal jurisdiction before the Supreme Court in BMS and the expansive notions of venue that bit the dust in TC Heartland.

There is one other interesting point that we learned reading TC Heartland.  We had never had much occasion to consider the general federal venue statute, 28 U.S.C. §1391(c), that was the principal basis for the expansive venue arguments that the Court rejected in TC Heartland.  The Court quoted that statute:  “[f]or purposes of venue under this chapter, a defendant that is a corporation shall be deemed to reside in any judicial district in which it is subject to personal jurisdiction at the time the action is commenced.” TC Heartland, 2017 WL 2216934, at *6 (emphasis added).

Thus, the general federal venue statute – applicable to all federal question actions where (unlike the patent statute) the applicable statute does not contain its own venue provisions – is dependent on where a corporation is “subject to personal jurisdiction.” That’s what is before the Supreme Court in BMS.  Thus an unremarked upon (at least by us) aspect of BMS is that the Court’s decision will also determine the scope of available venues available to federal plaintiffs in any number of situations having nothing to do with product liability.  That may be of interest to corporations, particularly if personal jurisdiction was waived in a particular case, but a motion challenging venue is still appropriate.  It may also be of interest for other reasons peculiar to federal claims that we’re not familiar with.  In any event, we invite our readers, in-house and otherwise, to think about this possible aspect of BMS for a moment.

Now that Dr. Scott Gottlieb is safely installed as FDA Commissioner, we at DDLaw can end our moratorium on blogposts about First Amendment issues. There was no way we wanted to give his opponents any ammunition by saying nice things about Dr. Gottlieb before his confirmation.

Not so now.

Given what Dr. Gottlieb has said – and is saying – we doubt that the FDA’s absolutist ban on truthful industry speech about off-label uses (pejoratively called “promotion”) will continue much longer in its current form.  For instance, on the FDA’s website, Dr. Gottlieb is quoted here as giving a speech saying:

The question we need to ask ourselves is this: Should a patient receive one or even two-year-old care just because the wheels of my government institution and its meticulous work may take longer to turn than the wheels of clinical science?  Some people believe that patients should be treated only according to the clinical evidence included in a drug’s approved indications.  Yet this evidence may be two or maybe three years old, especially in a fast-changing field like cancer, where off label use of medicines provide important opportunities for patients to get access to the latest clinical practice and for doctors to tailor their patients’ treatment plans based on medical need and personal preferences.

*          *          *          *

Efforts to limit prescription and scientific exchange to indications only specified on a label could retard the most important advances in 21st century medicine.  The development and deployment of drugs is becoming more and more closely linked to understanding of mechanism of action, which means that physicians can use drugs in more sophisticated ways that cannot all be anticipated on a label, or easily or quickly studied in prospective studies. . . .  More important, medicine is becoming more personalized as tools like genomics make it possible to tailor treatments on an individual basis. Physicians will not be able to always wait for FDA to approve a new label for every one of their patients, and drug companies will not be able to conduct a trial to explore every possible contingency.  In the future, personalization of care could mean that we will have much more off-label use of new medicines, guided by the latest literature, at least until our regulatory approaches are able to fully adapt to a different paradigm where treatment is highly specific to individual patients.  Yet policy forces are tugging in exactly the opposite direction by placing restrictions on the exchange of some of the most pertinent information.

(Emphasis added).  Defendants in cases involving off-label-use-related allegations should consider having their FDA experts review and, if appropriate, rely upon the current FDA Commissioner’s positions – particularly to rebut contrary views offered by former FDA officials.

Dr. Gottlieb’s non-FDA writings show similar solicitude for scientific speech – whether or not that speech originates with FDA-regulated manufacturers.  In an article for the American Enterprise Institute, Dr. Gottlieb criticized FDA policies that “prohibited” a manufacturer with a drug undergoing supplemental FDA approval for a new use from “distributing the findings or educating doctors on the new use through sponsored medical education.”  “[A] more measured approach to the regulation of promotion” would allow “sharing of useful information that falls within the bounds of appropriate clinical care.”

Those who pursue a rigid adherence to restrictions on the exchange of off-label information, and who fail to recognize that the sharing of scientific evidence can sometimes have important public health benefits, are guilty of pursuing a rigid standard that does not take measure of the consequences. . . .  [E]stablishing the FDA label as the only determinant for acceptable scientific speech loses sight of the fact that these labels are slow to incorporate important medical results about the effectiveness of medical products. They are not the sole basis for medical practice.

In another AEI article a few years later – shortly after the government lost United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) − Dr. Gottlieb’s criticism of the FDA’s prohibition of truthful speech about off-label uses was even more pointed.

When this [off-label] speech is truthful, nonmisleading, and promulgated in an educational context, it is quite possible that the speech would be deemed constitutionally protected by the courts under doctrines that recognize commercial speech as being subject to First Amendment considerations.

(Footnote omitted).  Basically, Dr. Gottlieb took issue with whether scientific speech concerning off-label uses could ever be considered illegal “promotion”:

A core principle of America’s constitutional speech protections is that the government should not establish what is orthodox, especially when it comes to politics, the arts, religion, and science.  The founders recognized that these matters are by their nature iterative, and that it would be dangerous in a democratic society for the government to use its resources to pick a side in these debates.  Matters that are subject to their own evolution − a core feature of how new science unfolds − are better addressed by adding voices to the debate, not suppressing them.

Dr. Gottlieb even urged FDA regulated manufacturers to stand up and challenge the constitutionality of off-label informational restrictions promulgated by the FDA – the agency he now leads:

[T]he drug industry needs to be willing to take the prerogative to challenge the facts in some of these cases and have that day in court. When investigations turn on the sharing of truthful, nonmisleading information about widely accepted uses of drugs, in fast moving fields like cancer, there is a legitimate question about whether public health is being served by suppressing this sort of information.  However, until these cases are challenged in court, there will remain ambiguity around where the appropriate lines rest, what speech is constitutionally protected commercial speech or clearly violative, and how public health is best served.

(Emphasis added).  Not long after that, a company took up Dr. Gottlieb’s challenge, and the result was Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015).

To some extent, where one stands depends upon where one sits, but Dr. Gottlieb has enough of a track record on truthful manufacturer speech about off-label uses of drugs and medical devices, and the constitutional and medical implications of suppressing it, that we are more hopeful now than we have ever been that the FDA will see reason, respect the First Amendment, trust physicians, and change its science-suppressing ways.

With that in mind, we examine the newest First Amendment precedent rejecting governmental prohibition of a manufacturer’s truthful speech about its product, Ocheesee Creamery LLC v. Putnam, 851 F.3d 1228 (11th Cir. 2017).  Ocheesee is a food (skim milk) case, but doesn’t involve the FDA – it doesn’t even involve the federal government.  Instead, Ocheesee is a demonstration that, when given the chance, state regulators are still equally capable of behaving just as badly towards the First Amendment as the feds, albeit on a smaller scale.

It may be that Ocheesee doesn’t involve interstate commerce, see 851 F.3d at 1231 n.1, or it may be that there is something peculiar about milk regulation that we don’t know, but the State of Florida (not the FDA or any other federal entity) came down on the plaintiff, described as “a small dairy creamery located on its owners’ farm” that “sells all-natural dairy items,” like a ton of bricks.  Id.  Apparently, the process of “skimming” the cream from whole milk “depletes almost all the vitamin A naturally present in whole milk because vitamin A is fat-soluble and is thus removed with the cream.”  Id.  Thus Florida agricultural regulations require vitamin A to be added to skim milk before it can be sold as “skim milk.” Id.

That was a problem for the plaintiff because, as a matter of philosophy, this business “prides itself on selling only all-natural, additive-free products.”  Id.  It therefore “refuse[d] to replace the lost vitamin A in its skim milk” with a vitamin A additive as Florida law required.  Id.  The State of Florida thus prevented the plaintiff from calling its product “skim milk,” even though that “product contains no ingredients other than skim milk.”  Id.  Instead (and ironically) the state sought to require the plaintiff to call its product “imitation milk.”  Id. at 1232.  Not surprisingly, the plaintiff refused and sued instead.

Readers attuned to the First Amendment no doubt see the problem already.  Calling such a product “skim milk” is truthful.  The State of Florida – like the FDA with truthful off-label speech – sought to suppress the plaintiff’s truthful speech in a commercial context, using the public health (vitamin A is not just good for you, but essential to health) as its reason for doing so.  Who wins – the First Amendment right to engage in truthful commercial speech, or the state’s public-health-based rationale for suppressing such speech?

In Ocheesee, freedom of speech prevailed.  851 F.3d at 1233 (“The sole issue on appeal is whether the State’s actions prohibiting . . . truthful use of the term ‘skim milk’ violate the First Amendment.  We hold that they do.”).

First, the lay of the constitutional land.  Ocheesee applied the now-venerable “Central Hudson” intermediate scrutiny test for constitutionality of governmental restrictions of commercial speech.  851 F.3d at 1233 (citing Central Hudson Gas & Electric Corp. v. Public Service Comm’n, 447 U.S. 557, 563-64 (1980)).  Thus, Ocheesee did not apply the more speech protective tests enunciated in Sorrell v. IMS Health Inc., 564 U.S. 552 (2011) (“heightened scrutiny”) (see our discussions here, here, here, and here); and Reed v. Town of Gilbert, 135 S.Ct. 2218 (2015) (“strict scrutiny”) (see our discussion here).  That doesn’t mean that the Eleventh Circuit was unaware of these cases – quite the contrary:

There is some question as to whether under the Supreme Court’s decisions in Sorrell and Reed an analysis to determine if the restriction is content based or speaker focused must precede any evaluation of the regulation based on traditional commercial speech jurisprudence, and if so, whether this would alter the Central Hudson framework.  In Sorrell, the Supreme Court found the restriction at issue to be content based but nevertheless cited, articulated, and applied the Central Hudson test.  And in Reed, the Court arguably broadened the test for determining whether a law is content based. . . .  We need not wade into these troubled waters, however, because the State cannot survive Central Hudson scrutiny, and in any event the [plaintiff] does not argue the State’s restriction was content based or speaker focused.

851 F.3d at 1235 n.7.  Thus, the favorable First Amendment decision in Ocheesee sets a floor for the protection of truthful commercial speech in the Eleventh Circuit that parties arguing Sorrell and Reed may exceed.

Under the Central Hudson criteria, as a “threshold question,” the government (which always has the burden of proof) had to establish that the suppressed speech either concerned “unlawful” conduct or was “false or inherently misleading.”  851 F.3d at 1235-36.  It failed because selling the plaintiff’s product was not unlawful – the state would have allowed its sale under the “imitation” description.  Id. at 1237.  Note the parallel to off-label speech – doctors are free to engage in off-label use, and products so used may be lawfully sold.  “[T]he only difference between the two courses of conduct is the speech.”  Id.

Nor could the speech be considered false or misleading.  The state could not simply “define” a product in whatever way it chose, and declare anything not meeting that definition “misleading.”  The court rejected such “self-evidently circular” reasoning:

Such a per se rule would eviscerate Central Hudson, rendering all but the threshold question superfluous.  All a state would need to do in order to regulate speech would be to redefine the pertinent language in accordance with its regulatory goals.

Id. at 1238.  Again, any resemblence to the FDA’s salami slicing of “intended uses” is entirely intentional.  Consumer “unfamiliarity is not synonymous with misinformation.”  Id. at 1239 (citation and quotation marks omitted).

Next up in Ocheesee was the three-pronged “intermediate scrutiny” Central Hudson test:  (1) was the asserted governmental interest substantial? (2) did the regulation directly advance the that substantial governmental interest? And (3) was the restriction on speech more extensive than is necessary to serve that interest?  851 F.3d at 1235-36.

As in off-label promotion cases, the “substantiality” of the government’s “interest in combating deception and in establishing nutritional” – that is to say product safety and effectiveness – “standards” was concededly “substantial.”  Id. at 1240.  Ocheesee jumped over the second prong and went right to the third, “because the measure is clearly more extensive than necessary to achieve its goals.”  Id.

In all commercial speech cases, “the preferred remedy is more disclosure, rather than less.”  Id. (Supreme Court citation omitted).  Florida’s flat ban on use of the term “skim milk” failed because a disclaimer would serve the same purpose in a “less restrictive” and “more precise” way.  Id.  “[A]llowing skim milk to be called what it is and merely requiring a disclosure that it lacks vitamin A” was sufficient “to serve [the state] interest in preventing deception and ensuring adequate nutritional standards.”  Id.

The First Amendment thus prevailed where the speech is truthful – without the court going even having to go to the trouble of relying on heightened (Sorrell) or strict (Reed) scrutiny, both of which would be argued in truthful off-label speech cases.  Visions of shattered backboards come to mind.  We don’t think Dr. Gottlieb wants the FDA to end up like Bill Robinzine, so we’re looking for a more reasonable off-label speech policy to emerge from the FDA, before a court has to do so for the agency.

Late last year we happily blogged about Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449 (S.D.N.Y. Dec. 23, 2016), chiefly because it held that design defect claims against a branded prescription drug (Eliquis) were preempted under the impossibility preemption reasoning in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013).  However, as we noted in that post, dismissal of the non-design aspects of complaint was with “leave to amend.” See also Utts, 2016 WL 7429449, at *1.

Of course, plaintiffs amended.

Now, they probably wish they hadn’t.

In a second opinion, issued earlier this month, the Utts litigation was dismissed a second time, this time with prejudice. Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2017 WL 1906875 (S.D.N.Y. May 8, 2017) (“Utts II”).  Preemption was once again front and center, but this time an excellent preemption result was accompanied by a variety of equally pleasing common-law – California law – rulings.

Impossibility Preemption

First, preemption. Design defect claims had already been preempted under Mensing/Bartlett, as plaintiffs were reminded whenever they crossed the line into design-type claims. Id. at *1, 9, 10 n.10, 13 n.15, 16, 19.  But the major preemption issue this time around involved warnings – and whether any of the information that plaintiffs claimed required some kind of “better” warnings involved “newly acquired information” of the sort that a defendant could unilaterally add given the scope of the FDA’s “changes being effected” exception to preemption recognized in Wyeth v. Levine, 555 U.S. 555 (2009). See 21 C.F.R. §314.3(b) (known as the “CBE” regulation for drugs – note, there are similar CBE regulations for devices and biologics; we’ve discussed the device regulation here).

For a more detailed discussion of the “newly acquired information” aspect of preemption, see our post here about In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015), which was the first appellate decision finding preemption where plaintiffs failed to come forward with any “new” information to support their warning claims. Utts II explained that, in the preemption context, “if the plaintiff can point to the existence of ‘newly acquired information’ to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by ‘clear evidence’ that the FDA would not have approved the labeling change made on the basis of this newly acquired information.”  2017 WL 1906875, at *9.

Plaintiffs threw a lot of mud at the drug and its manufacturer, but nothing they heaved against the wall stuck – everything plaintiffs cited all old information that did not go beyond what the FDA had before it when it approved the drug in the first place.

Why is that?

Basically, Eliquis is a next-generation anticoagulant, very effective at what it does, and not requiring the kind of dietary restrictions and constant blood testing that older blood thinners such as warfarin – originally sold as rat poison – do.  Utts II, 2017 WL 1906875, at *2 & n.4.  Unfortunately, the plaintiffs’ bar has decided that anybody needing anticoagulation therapy should be should only have such older drugs available, and has launched an ongoing litigation assault at practically every next generation anticoagulant (others include Xarelto and Pradaxa) – because of risks of serious and sometimes fatal bleeding inherent in what these drugs are supposed to do.

The FDA was well aware of the risks that Eliquis, like any other anticoagulant, could cause uncontrollable bleeding when it approved it. Indeed, the “label warns about the risk of serious bleeding no less than five times.” Id. at *3.  It “specifically warns about the risk of bleeding” during concomitant therapy “in conjunction with antiplatelet agents, such as aspirin.”  Id. at *4.  The labeling also “twice warns about the fact that there is no specific antidote” should serious bleeding occur.  Id.

That’s why plaintiffs lost in Utts II.

Basically, the well-known fact that anticoagulants carry with them serious bleeding risks is why none of the information that the plaintiffs in Utts II brought forward qualified as “new.”  “New” is defined in the FDA’s CBE regulation as “studies, events, or analyses [that] reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.  21 C.F.R. §314.3(b) (quoted at 2017 WL 1906875, at *8).  In the preemption context, “

  • “The table and the description from the ISMP report do not suggest − nor do the plaintiffs allege − that the real-world signal data for [the drug] shows a greater severity or frequency of bleeding events or deaths than previously disclosed in [defendant’s] submissions to the FDA. Accordingly, the information contained in this table does not constitute newly acquired information. Utts II, 2017 WL 1906875, at *13.
  • Plaintiffs argue “that the guidance regarding concomitant use of antiplatelet agents is inadequate because the label does not advise how or when to use combination therapy . . . or how commonly bleeding events will occur. This omission . . . was evident to the FDA when it approved the label and the plaintiffs have not identified any newly acquired information.” Id. (quotation marks and footnote omitted).
  • This observation does not constitute newly acquired information, as it simply speculates whether [drug] safety could be further improved. Id. at *14 (as to “improved dosage guidance”).
  • [E]mbolic-thrombotic events are . . . not bleeding events. Nor do the plaintiffs argue that any of this data comparing the incidence of embolic-thrombotic events . . . constitutes newly acquired information. Id. (footnote omitted).
  • [T]he findings directed towards the risk of ischemic stroke for [the drug] users do not constitute newly acquired information. Id. at *15.
  • [P]laintiffs do not allege, however, that this expert guidance contains, or is founded upon, any newly acquired information regarding reversal agents or the treatment of excessive bleeding.” Id.
  • “[P]laintiffs do not allege that this statement contains newly acquired information about what constitutes a safe residual drug level.” Id. at *16.
  • “[T]his article does not refer to any new information that would have permitted the defendants to amend the [drug’s] label. And, in their opposition to this motion, the plaintiffs do not argue that it does.” Id.
  • “[P]laintiffs do not contend that any of the five remaining documents . . . contains newly acquired information regarding an undisclosed risk of bleeding. Several of these articles merely express a desire for further investigation. Id.

Thus, although plaintiffs loaded up their amended complaint with no fewer than “34 warnings that the defendants allegedly failed to provide,” 2017 WL 1906875, at *11, there was no safety in numbers. None of their supposedly missing warnings was based on “newly acquired information” as defined and required by the FDA’s CBE regulation.

Because, plaintiffs could not point to any “newly acquired information” to support their warning-related allegations, those allegations fell outside the scope of the Levine CBE exception and were preempted, because under Mensing/Bartlett such warnings could not be added without prior FDA approval.  2017 WL 1906875, at *9.

Next, in accordance with practically all law, Utts II held that preemption could be decided on a motion to dismiss.  A “determination regarding preemption is a conclusion of law.” Id. at *19 (pointing out that Mensing had been decided on a motion to dismiss).  To the extent that the Third Circuit’s aberrant Fosamax decision was pertinent, it was distinguishable.  Fosamax was limited to “clear evidence” determinations, and in Utts II, because plaintiffs offered no “new” information, clear evidence was never at issue.  Id. at *19-20.  Finally, plaintiffs were “not entitled to discovery on preempted claims.”  Id. at *20 (discussing TwIqbal).

In a way, the new evidence requirement discussed in Utts II resembles the so called “public disclosure” requirement that is a defense to False Claims Act claims (see here for more discussion), except that the “newness” of the information in preemption of state-law warning claims is measured against the evidence presented to the FDA, as opposed to the public.

Buckman Preemption

Utts II also found fraud-on-the-FDA preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  Plaintiffs ran from their blatant fraud-on-the-FDA allegations, asking that they “be read merely as evidentiary background.”  2017 WL 1906875, at *26.  The court read them as they were written (and no doubt intended), and found preemption:

Each of the statements on which the fraud claim is premised depends on statements made to and approved by the FDA. There is no newly acquired information that required or suggested that the allegedly fraudulent statements should be altered to remain truthful and non-fraudulent.  Accordingly, the fraud claims are preempted.

Id.

Other FDCA-Related Issues

On other FDCA-related issues, Utts II ends up on our Adverse Drug/Device Event cheat sheet because of its discussion of how voluntarily reported adverse events aren’t legitimate proof of causation:

Federal regulations advise that a report submitted by a manufacturer “does not necessarily reflect a conclusion by the [manufacturer] or FDA that the report or information constitutes an admission that the drug caused or contributed to an adverse effect.” 21 C.F.R. § 314.80(l).  As the FDA Website explains:

FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. Further, FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.

The Supreme Court has similarly warned that “[t]he fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug caused that event.” Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 44 (2011). I n sum, “the mere existence of reports of adverse events . . . says nothing in and of itself about whether the drug is causing the adverse events.” Id.

Utts II, 2017 WL 1906875, at *12.

In addition, Utts II contains an excellent discussion of the harmful effects of overwarning.  The need to prevent overwarning is the reason that the CBE regulation does not apply to all information, new or old, that could in some way “strengthen” existing warnings:

The FDA has recognized that “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks, could discourage appropriate use of a beneficial drug . . . or decrease the usefulness and accessibility of important information by diluting or obscuring it.” Indeed, “labeling that includes theoretical hazards not well-grounded in scientific evidence can cause meaningful risk information to lose its significance.” For this reason, the CBE regulation requires that there be sufficient evidence of a causal association between the drug and the information sought to be added.

Utts II, 2017 WL 1906875, at *8 (all quotes from “Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices,” 73 Fed. Reg. 2848 (FDA Jan. 16, 2008).

Another notable FDA-related aspect of Utts II has to do with so-called “comparative claims” – claims that one medication is better than another in some respect.  Plaintiffs often claim (as they did in Utts II) that there is some sort of duty to warn that ones product is less safe than its competition.  However, Utts II points out that the FDA does not permit such claims except when supported by specific types and amounts of scientific evidence.  “[A]ny claim comparing the drug to which the labeling applies with other drugs in terms of frequency, severity, or character of adverse reactions must be based on adequate and well-controlled studies.”  2017 WL 1906875, at *7 (citing 21 C.F.R. §201.57(c)(7)(iii)).  Further, “federal regulations do not require a manufacturer to include information about a competitor’s product or progress.” Id. at *16 (citing 21 C.F.R. §§201.56, 201.57, 201.80).

State-Law Warning Issues

Beyond its preemption and other FDCA-related aspects, Utts II has a load of other helpful holdings, mostly about California law.  The decision contains an excellent discussion of the state of the art defense.  2017 WL 1906875, at *10.  It also points out that, the California Supreme Court’s holding – quite apart from preemption – that as a matter of federal/state comity, warning liability does not exist as a matter of state law where the purported duty flies in the face of FDA regulation:

Even where a risk is “known” or “knowable” at the time of distribution, under California law, a manufacturer “may not be held liable for failing to give a warning it has been expressly precluded by the FDA from giving.” Thus, if the manufacturer disclosed to the FDA “state-of-the-art scientific data concerning the alleged risk” and the FDA determined, after its review, “that the pharmaceutical manufacturer was not permitted to warn − e.g., because the data was inconclusive or the risk was too speculative to justify a warning,” then the manufacturer could not be held strictly liable for failure to warn. “[T]he FDA’s conclusion that there was, in effect, no ‘known risk’ is controlling.”

2017 WL 1906875, at *11 (all quotations from Carlin v. Superior Court, 920 P.2d 1347 (Cal. 1996)).  Thus, the same grounds that support preemption as a matter of federal law – where, as here, the FDA says “no” – also preclude liability as a matter of state law.

In tandem with preemption, Utts II also holds that the defendant’s drug labeling was adequate as a matter of California law on the bleeding issues raised by plaintiffs – just as our prior post thought it should.  In general, the label “clearly discloses that there is a risk of excessive bleeding and that there is no known antidote if that occurs.”  2017 WL 1906875, at *21.  Nor could plaintiffs prevail with any of the usual nitpicking that goes on in this type of litigation.

  • Monitoring – “The label provides, in unambiguous terms, all of the scientifically reliable information that physicians may need to determine how to monitor their patients.” Id.
  • Bleeding Reversal – A “recommendation is to discontinue [the drug] and apply ‘standard supportive treatment and other local measures’ . . . does not supply a basis for a plausible claim that the label needed to add further guidance.” Id. at *22 (quoting medical article).
  • Dosage – Plaintiffs do “not identify any research or data that undermines or contradicts the dosing guidance” and “speculation about information that the defendants may possess is insufficient to plausibly plead a claim.” Id. (citing TwIqbal).

Similarlly, plaintiffs other warning-based claims failed due to the adequacy of the warning.  Id. at *24 (implied warranty), *26-27 (fraud); *29 (consumer fraud)

Finally, here are some other California warning-related nuggets we can use:  (1) Under the learned intermediary rule, “a manufacturer discharges its duty to warn if it provides adequate warnings to the physician about any known or reasonably knowable dangerous side effects, regardless of whether the warning reaches the patient.”  2017 WL 1906875, at *11. (2) “[P]harmaceutical manufacturer[s] may not be required to provide warning of a risk known to the medical community.” Id. (quoting Carlin).  (3) “[W]arnings relevant to any breach of warranty claim are those directed to the physician rather than the patient.” Id. at *22 (quoting Carlin) (emphasis original).  (4) The opinion notes that the learned intermediary rule applies to California consumer fraud claims.  Id. at *28 n.32.

Looking Forward

Utts II contains by far the most detailed discussion to date of the interplay between preemption and the “newly acquired evidence” requirement of the FDA’s CBE regulation.  It would be notable for that reason alone.  However, it also finds the labeling adequate as a matter of law, which is second highly significant ruling in any prescription medical product litigation.  What’s more, since the entire Utts amended complaint is now dismissed with prejudice, not only Utts II, but also the original Utts design defect preemption ruling, is now appealable.

Any appeal would be interesting.  Every ruling in Utts II is double-breasted, in that preemption is bolstered by independent state law grounds.  That is not the case with design defect preemption in the original Utts decision, where preemption is the sole basis for dismissal.  Utts, 2016 WL 7429449, at *12.  So, if plaintiffs were to appeal, their only clean shot at preemption would involve their design claim.  In any event, the preemption rulings in both Utts (Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015)), and Utts II (Celexa, 779 F.3d 34) are supported by court of appeals decisions, as our preemption cheat sheet demonstrates.  At best, in a hypothetical appeal, we would get an affirmance and reinforcing appellate precedent supporting preemption in innovator drug cases.  At worst, there would be a circuit split, which would offer the further (double-hypothetical) possibility of additional Supreme Court review of what Utts II called the Levine “trilogy.”  2017 WL 1906875, at *9.  While we always prefer to win, whenever, however, and as quickly and as thoroughly as possible, we certainly would find another shot at innovator drug preemption in the Supreme Court an interesting proposition.

One of the issues that the federal Civil Rules Committee’s discovery subcommittee considered, but that eventually fell by the wayside, on the way to the 2015 discovery rules amendments, were proposals to convert to a “requestor pays” discovery system.  That would be a very significant change, and one of the criticisms that the other side leveled at such a system was that only rich people (or at least only rich plaintiff lawyers) could afford to bring suit, given the prospect of having to pay for expensive discovery that current system now gives plaintiffs for free.

Well, not for free.  Nothing is free.  The current “producer pays” discovery system gives plaintiffs a windfall by allowing them to demand production of millions of dollars’ worth of documents – and as importantly, electronically stored information (“ESI”) − and to impose those costs almost entirely on defendants.  As any economist will tell you, any system that provides access to something for free or at greatly below-market cost, be it health care, “dumped” imports, or discovery, creates greater demand for whatever the below-cost item is than would exist otherwise.

It’s worse in the legal system, because the other side’s heightened demand for “free” discovery has the concomitant effect of increasing the nuisance (that is to say, settlement) value of all litigation in which such demands are made – since one’s opponent is stuck with the bill.

All our side got out of the 2015 rules amendments cycle on requestor pays is a provision more clearly recognizing the authority of courts to shift discovery requests.  See Fed. R. Civ. P. 26(c)(1)(B).  As we’ve mentioned, a couple of courts have done this during prescription drug/device MDL litigation.  See In re Bard IVC Filters Products Liability Litigation, 317 F.R.D. 562 (D. Ariz. 2016); In re Benicar (Olmesartan) Products Liability Litigation, 2016 WL 5817262 (D.N.J. Oct. 4, 2016).  Both of those cases involved what the courts viewed as excessive and unnecessary MDL discovery targeted at the defendants’ overseas activities.

Now we’ve found a third case – it took a little longer because it didn’t involve prescription medical products – that also invoked the new cost-shifting provisions in a very familiar (and frustrating) situation.  McClurg v. Mallinckrodt, Inc., 2016 WL 7178745 (E.D. Mo. Dec. 9, 2016), wasn’t an MDL, but it could have been, except for a limited geographic scope.  Many hundreds of plaintiffs were all seeking recovery for alleged radiation-induced injuries from the same two defendants.

A situation depressingly familiar to any defense counsel in mass tort litigation developed.  Although plaintiffs are nominally responsible under the rules for collecting (and paying for the collection of) their own medical and related records in response to discovery requests, they botched the job so badly that the defendants – in whose interests it was to have these records – had to step in and do it themselves on their own dime.  Plaintiffs did produce “a list of known health care providers and a signed authorization for the release of medical records.”  Id. at *1.  “Because Plaintiffs did not timely and fully produce all of their records, Defendants contracted with a third-party vendor . . . to collect records directly from Plaintiffs’ health care providers and employers.”  Id.  Also, “the parties in this matter could not agree to a reasonable scope of record collection and allocation of costs.”  Id. at *4.

So things stood until bellwether plaintiffs were selected (interestingly, by random selection, id. at *2).  All of a sudden the plaintiffs became very interested in the additional records that the defendants had been collecting at their own expense.  So they served discovery requests seeking those records – only for the bellwether plaintiffs – for free.  Id. (“Plaintiffs served document requests seeking ‘all documents and records’ that Defendants had collected regarding each of the 16 Bellwether Plaintiffs”).  Somewhat ironically, they also claimed that the defendants had engaged in excessive records gathering, and therefore also demanded access to the defendant’s records database (also set up at defendants’ sole cost) so they could select which records they wanted.  Id. (“Plaintiffs assert that they, too, wish to access [defendants’] secure portal free of charge, in order to decide which records they want”).

The two McClurg defendants’ response was “hell, no; not without you sharing the cost equally – that is shouldering one-third of the expense along with the defendants each sharing a third.  Id. (subject to a credit for whatever records plaintiffs had actually collected and turned over).

The McClurg court shifted costs, not 33% but 18%, to plaintiffs under Rule 26(c)(1)(B).  2016 WL 7178745, at *3.  Cost-shifting was necessary so that the plaintiffs did not become free riders:

The Court finds . . . that good cause exists to order some amount of cost-sharing before Plaintiffs may obtain the records collected by Defendants here.  Plaintiffs would ordinarily have been, and pursuant to the Court’s order were, responsible for gathering and producing their own records.  But while Plaintiffs appear to have produced some records as new complaints were filed, they did not do so in a complete and timely manner.  Indeed, Plaintiffs apparently produced records for a few of the Bellwether Plaintiffs just one or two days before their scheduled depositions.

Id.  That “Plaintiffs [were] seek[ing] access to the portal establish and maintained at Defendants’ expense” further justified a cost allocation order.  Id.

Although it was “unfortunate” that the parties never sought court intervention after failing to reach a records production protocol, id. at *4, giving plaintiffs free access to records collected and maintained at the defendants’ expense was unfair.  Id. (“it would be unfair to allow Plaintiffs to gain the benefit of Defendants’ early record collection and creation of the portal, which helped move the case forward, without contributing a fair share of the overall costs of such collection”).  Crediting plaintiffs’ complaints about excessive collection, McClurg reduced the percentage to 18%.  Id. (eliminating records collected concerning plaintiffs that the defendants knew could not be in the bellwether pool).  Plaintiffs also received a credit for the comparatively small amount of timely produced records they had collected.  Id.

Since the same failure by plaintiffs to collect their own records competently is endemic to prescription medical product MDLs, the cost-shifting in McClurg is of significant interest to us.

In fact, the results in all three of these cases – Bard IVC, Benicar, and McClurg – are also of interest to us because they provide pointers to where the requestor pays debate might reasonably go.  We certainly don’t agree with the other side’s largely bogus argument that across-the-board requestor pays discovery might shut the courthouse doors on the “poor” plaintiffs in the litigation-funded, advertising-driven mass tort industry.  In such litigation, there “does not appear to be a significant financial disparity in the parties’ ability to finance these putative litigations.  Thus, what this Court and other courts similarly situated are faced with is ‘Goliath versus Goliath.’”  Arch v. American Tobacco Co., 175 F.R.D. 469, 496 (E.D. Pa. 1997).

However, since the federal rules are supposed to be transubstantive, we will accept for the sake of argument that some deserving plaintiffs in some types of litigation might be excluded by a blanket requestor pays regime.  As an alternative, we think that the rules should include a presumption that the requestor pays for certain types of unduly burdensome, or otherwise unfair, discovery.  While such discovery might nonetheless be “proportionate,” were it to uncover something significant, these types of discovery are expensive and not particularly likely to produce evidence usable at trial.

Here are some examples of discovery that we have encountered that we think deserve to be presumptively discoverable only at the requestor’s expense – there are undoubtedly more:

  • Discovery into a defendant’s overseas activities, particularly if the documents are not in English (Bard IVC and Benicar both involved this kind of discovery);
  • Discovery into information independently gathered by the defendant for purposes of the litigation, excepting witness statements, and other items specified by the rules as peculiarly relevant (that’s McClurg);
  • Discovery into products manufactured by defendants other than those used by plaintiffs;
  • Discovery into product risks other than those suffered by plaintiffs;
  • Discovery into information in the possession of third parties, including government agencies;
  • Discovery into time periods where recovery is barred by relevant statutes of limitations;
  • Discovery into post-litigation information, after the alleged conduct has ceased;
  • Subjects of Rule 30(b)(6) depositions where the entity faced with deposition has no available percipient witnesses, and any witness would only have reviewed the same documents available to the deposing party;
  • ESI discovery into information located on inactive legacy/obsolete computer systems; and
  • Other similarly burdensome discovery, not of a type likely to produce significant evidentiary benefit, as determined by research commissioned by the Federal Judicial Center.

None of this kind of information is ordinarily essential to the hypothetical impecunious plaintiffs who would otherwise be shut out of court by having to pay for what are almost always expensive wild goose chases.

And if one of these categories turns out to be of particular importance in a given lawsuit, the requestor pays directive is only presumptive.  The party requesting the discovery would be able to go to the judge – either before or after the discovery takes place − and explain why a category of discovery, presumptively disfavored under the new regime, should be exempted from the requestor pays rule on the facts of the case in question.  Likewise, if the requestor is able to overcome the presumption beforehand, and the supposedly important discovery turns out to be a wild goose chase anyway, then the producer should be entitled to file a motion to shift those costs back to the requestor.

Implementing across-the-board requestor pays is a long shot right now, and such a dramatic change in the system could well have unintended and unforeseeable litigation consequences.  We think our proposal is not only a way to discourage types of discovery that are peculiarly prone to abuse, but might also be a way of trying out requestor pays on a smaller scale to see whether it is indeed a desirable change to the system generally.

If anybody out there is interested in this idea, have at it. Unlike discovery, our blogging is free to all readers.