We’ve explained at length why Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), is an anachronism with respect to preemption, given the complete overhaul that Congress gave to §510(k).  Still, strange things happen when preemption meets product liability, and there seems to be a conspiracy of silence among judges with respect to current FDA §510(k) practices and Lohr’s archaic 1982 “grandfathering” process.

But not always.

Thus, today we are discussing Kelsey v Alcon Laboratories, Inc., 2019 WL 1884225 (Utah Dist. April 22, 2019).  The product in Kelsey was contact lens disinfectant, which the plaintiff (predictably) claimed was ineffective in preventing a serious eye infection.  Id. at *1.  We can essentially predict that sort of thing.  Plaintiff at risk of condition X takes something designed to prevent it, and presto, the plaintiff demands that the manufacturer effectively becomes an insurer against whatever that risk might be.

But a funny thing happened in Kelsey on plaintiff’s way to collecting on her ex post facto free insurance claim.

Preemption.

This product was not grandfathered Lohr-style.  Rather it was subject to numerous FDA-imposed “special controls” – specific to this type product.  In particular, FDA had issued “guidance” concerning the applicable FDCA-based requirements:

[T]he FDA issued the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products (Guidance).  The Guidance “sets forth the general information and special controls FDA believes are needed to assure the safety and effectiveness of contact lens care products. . . .”

Kelsey, 2019 WL 1884225, at *6.  “The Guidance ‘sets forth the special controls which have been determined at this time . . . to be necessary to provide reasonable assurance of the safety and effectiveness of class II contact lens care products.’”  Id. at *7.  We won’t recite the details, but the guidance covered the product’s design, good manufacturing practices, and labeling.  Id. at *7-8.  However, with respect to labeling, the guidance was ambiguous in certain respects:

There is nothing in the Guidance or the Appendix that defines package insert, specifically requires it to be a separate leaflet or pamphlet, or prohibits it from being printed on the inside of the carton.

Id. at *8.

Reviewing both Lohr and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), Kelsey concluded that “there is no automatic preemption” of product liability claims against §510(k) devices.  2019 WL 1884225, at *9.  Rather:

“[S]tate and local requirements are pre-empted only when the [FDA] has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device, different from, or in addition to, the specific Food and Drug Administration requirements.”

Id. (quoting 21 C.F.R. §808.1(d)).  “Special controls” imposed under the current §510(k) process can qualify as preemptive.

Special control documents may provide specific requirements that support a conclusion of preemption of state law claims if they show the federal government has weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on manufacturers or producers.

Kelsey, 2019 WL 1884225, at *9 (citations and quotation marks omitted).

In the case of contact lens disinfectant, between a device-specific regulation, 21 U.S.C. §800.10(a), and the aforementioned guidance, there were plenty of preemptive requirements applicable to this device to support preemption.  FDA regulation “forbids a manufacturer from making changes in the design specifications, manufacturing processes, labeling, or any other attribute that could significantly affect the safety or effectiveness of the solution without FDA review, comment, and permission.”  Id. at *10.

Plaintiff tried to escape preemption by arguing that the FDA guidance wasn’t mandatory and only provided “recommendations.”  Id. at *11.  Not a bad argument.  We’ve pointed out the non-binding nature of FDA guidance on numerous occasions.  But it wasn’t the guidance itself, it was the FDA requirements as to which the guidance provided compliance tips that proved preemptive in Kelsey.  “The court disagrees as they relate to the design and manufacture of multi-purpose contact lens solution.  While the Guidance permits some flexibility in how applicants go about demonstrating their solution meets the safety and efficacy requirements, the solution must meet those requirements to be labeled a multi-purpose solution.”  Id.

Who says so?

The FDA in allowing the product onto the market, that’s who:

[A]ccording to the 510(k) Summary, the FDA determined “[b]ased on the results of the comprehensive preclinical evaluations, [the product] is safe for the consumer under the recommended use conditions, as well as under conditions of reasonably foreseeable misuse.”

Id.  Kelsey based its conclusions on a pair of Ninth Circuit decisions, since neither Utah, nor the much smaller Tenth Circuit, had on-point precedent.  Id. at *11-12 (citing Degelmann v. Advanced Medical Optics, Inc., 659 F.3d 835, 838-39 (9th Cir. 2011), vacated due to settlement, 699 F.3d 1103 (9th Cir. 2012), and Papike v. Tambrands Inc., 107 F.3d 737, 740 (9th Cir. 1997)).  “[T]he Ninth Circuit determined the sterility labeling requirement was a device specific regulation because it specifically required a contact lens solution to meet standalone performance criteria to be labeled ‘disinfecting solution.’”  Id. at *11.

As to warnings, Kelsey held that, while the §510(k) requirements could be preemptive, the defendant couldn’t yet muster the record, given the pleadings-restricted nature of a Rule 12 motion to dismiss.  Id.  Plaintiff had a rather odd claim, that turned on the location – rather than the language – of  the relevant warnings:

Plaintiff does not allege that [the product’s] labeling should include different or additional warnings or instructions.  Rather, Plaintiff alleges the warnings and instructions should be included on a “package insert,” which she defines as a separate leaflet or pamphlet inserted in the carton.

Id.  Defendant had instead printed the warning in question on the inside of the package containing the product.  Id. at *3.  The defendant had a bunch of exhibits that (according to it) showed that the inside-the-box warnings satisfied the FDA’s requirements, but the court refused to take judicial notice of them.  Id. at *12.

Further, the guidance wasn’t device specific as to warnings.  “[T]he labeling section of the guideline does not mandate any particular language or warning.  Instead, it provides suggestions’ for language to assist in preparing labeling.”  Id. at *13.  However, some labeling claims might be ultimately be preempted.  Warning claims “would be preempted to the extent . . . based on the label’s inclusion of the words ‘sterile’ or ‘disinfecting,’” but not as to the “claim related to the location of the warnings and instructions.”  Id.  Presumably, plaintiff had figured that out, which is why the unusual locational claim was made in the first place.

Thus, preemption barred the design claims in Kelsey even though the product was §510(k) cleared.  Preemption also could bar some of warning claims, but not the plaintiff’s locational claim.  Preemption also barred claims covered by Good Manufacturing Practices, but not against manufacturing defect claims based on allegations of actual contamination.  Id. at *10-11 & n.73.

While Kelsey involved a product-specific regulation and FDA guidance document, the court also cited to the FDA’s “safety and effectiveness” conclusions made during the clearance process.  That’s progress.  Finally, as a procedural note, Kelsey was not an MDL.  That also means that the built-in institutional biases that make preemption arguments an uphill battle in the MDL context didn’t exist.  We think that’s an apt practice pointer.  There is a reason that we entitled our post that first laid these arguments out, “In Case of Good Judge, Break Glass – Implied Impossibility Preemption in Cases Involving §510(k) Cleared Medical Devices.”

 

Late last year we published the post “Twiqbal for Defendants? Not If We Can Help It.” on the issue of whether the “plausibility” standard of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S 662 (2009), applied to “affirmative defenses (which we prefer to just call “defenses) pleaded under Fed. R. Civ. P. 8(c).  Basically, our two responses to the proposition that Rule 8(c) defenses could be TwIqballed were “no” and “hell, no.”

In addition to amassing District Court precedent from every circuit, we relied on several opinions from federal courts of appeals, citing cases from the Third, Sixth, Seventh, and Ninth Circuits.

Well, the circuits are no longer unanimous.  To make sure nobody on our side is misled, we feel we ought to mention the new decision, GEOMC Co. v. Calmare Therapeutics Inc., 918 F.3d 92, 94 (2d Cir. 2019), which largely, but not entirely, holds that the absolute anti-TwIqbal position we took in that post is all wet.  GEOMC is not by any means a drug/device, or even a personal injury, decision (it’s a dispute over a commercial contract), so we didn’t find out about it until recently.

We don’t care about the facts, or the law, or even the procedure, except for the TwIqbal ruling in GEOMC.  So getting right to that, the question before the Second Circuit was “whether Twombly applies to the pleading of affirmative defenses.”  918 F.3d at 97.  GEOMC answered that question in the affirmative – at least “in context.”  Specifically:

We conclude that the plausibility standard of Twombly applies to determining the sufficiency of all pleadings, including the pleading of an affirmative defense, but with recognition that, as the Supreme Court explained in Iqbal, applying the plausibility standard to any pleading is a “context-specific” task. . . .  The key aspect of the context relevant to the standard for pleading an affirmative defense is that an affirmative defense, rather than a complaint, is at issue.

Id. at 98 (citations and quotation marks omitted).

The contextual issue recognized in GEOMC was the same one that we pointed out in our prior post had led most courts to opt for a more relaxed pleading standard for Rule 8(c) – what we described as “unfairness”:

the unfairness of holding the defendant to the same pleading standard as the plaintiff, when the defendant has only a limited time to respond after service of the complaint while plaintiff has until the expiration of the statute of limitations.

The Second Circuit in GEOMC viewed this concern as “context,” holding:

This is relevant to the degree of rigor appropriate for testing the pleading of an affirmative defense.  The pleader of a complaint has the entire time of the relevant statute of limitations to gather facts necessary to satisfy the plausibility standard.  By contrast, the pleader of an affirmative defense has only the 21-day interval to respond to an original complaint. . . .  That aspect of the context matters.

Id. at 98.  So difficulties in marshalling facts to support Rule 8(c) defenses are “a circumstance warranting a relaxed application of the plausibility standard.”  Id. at 98.

A second contextual matter also comes into play – whether the “facts” are accessible to the pleader within the limited time frame available:

In addition, the relevant context will be shaped by the nature of the affirmative defense.  For example, the facts needed to plead a statute-of-limitations defense will usually be readily available; the facts needed to plead an ultra vires defense, for example, may not be readily known to the defendant.

Id.

GEOMC affirmed striking two defenses:  contributory fault and failure to join a “necessary party.”  As to the first, it “lacked any indication of what conduct by [plaintiff] or others might have been a defense to the breach of contract claim.”  Id. at 99.  As to the second, it “lacked any indication of which party needed to be joined or why.”  Id.  In both instances, the pleading defendant “needed to support these defenses with some factual allegations to make them plausible.”  Id.  There was, however, something else in play − timing.  “[B]oth affirmative defenses were presented at a late stage of the litigation” and, what’s worse “sought to challenge claims made nearly a year earlier in the first amended complaint.”  Id.  Basically, the Second Circuit detected sharp practice, using an answer to an amended complaint to raise additional defenses to the original claim, as opposed to anything in the amendment.

So, what’s the upshot of GEOMC?  In practice we’re not sure there is much.  It seems like the difference is mostly in emphasis.  Our post (and most courts and commentators) took the position “no TwIqbal because of X.”  The Second Circuit has taken the position “yes, except X warrants “relaxing” the usual TwIqbal standard.”  While that doesn’t sound like much, we do have to admit, however, that the Second Circuit does apply TwIqbal, in some fashion, to Rule 8(c) defenses.  So particularly in the Second Circuit defendants would be well-advised not to go overboard with boilerplate defenses.

We’re writing a quick-hit post today on a topic that comes up often in medical device litigation, but rarely results in a court order—what happens when the plaintiffs want an “exemplar” medical device?  How do they get one and who pays for it?

We’re not talking here about the medical device that was actually used to treat the plaintiff.  That one has already been purchased and paid for, and it may still be implanted inside someone’s body.  No, we are referring here to brand new devices that have never been used and that the plaintiffs can use for expert consultation, trial exhibits, or anything else that does not involve actually using the exemplar in a human.

The plaintiffs in Ramkelawan v. Globus Medical Inc., No. 5:18-cv-100, 2019 U.S. Dist. LEXIS 67516 (M.D. Fla. Apr. 22, 2019), wanted multiple exemplars, and they wanted them “at cost.”  Id. at *9-*13.  The district court ruled, however, that there is simply no authority to compel a defendant to sell its products to opposing attorneys at a preferred price.  Id. at *12-*13.  If the plaintiffs wanted exemplars, they would have to buy them—and pay retail.

The dispute centered around Rule 34, which allows requests “to produce and permit the requesting party . . . to inspect, copy, test, or sample . . . any designated tangible things.”  Fed. R. Civ. Proc. 34(a)(1).  The rub is that Rule 34 does not address the cost that should be charged.

In Ramkelawan, the defendant device manufacturer did all that it seems a defendant ought to be required to do, plus more.  The plaintiffs’ experts had already inspected, measured, photographed and CT scanned certain parts of the subject devices, and they had tested the surface of the subject devices with Fourier Transform Infrared spectrometry.  Id. at *10-*11.  The defendants offered exemplars for additional inspection on conditions that were perfectly reasonable:  The plaintiffs had to pay for them, mark them “not for human use,” pay for transportation, promptly produce any testing reports, and return the exemplars to defendants at the end of the litigation or destroy them.  Id. at *11.  To the extent the plaintiffs wanted to inspect an “assembly block”—which we assume is used in assembling the devices—the manufacturer agreed to make one available for inspection at its experts’ facility.  Id. at *12.

All that was not good enough for the plaintiffs, who wanted a discount.  The district court nonetheless denied their motion to compel.  Cases involving ordinary products like “ladders and shopping carts” were inapposite to this case, which involved “highly specialized medical devices.”  Id. at *12.  Further, in the case that the plaintiffs cited, the requesting parties had agreed to pay retail prices.  Id. at *12-*13.  In the end,

[w]hile the undersigned acknowledges (as Defendants apparently do) that Rule 34 contemplates that Defendants make the subject device or exemplars available for inspection, there is simply no basis or authority for the Court to require Defendants to provide the exemplars for purchase at Plaintiffs’ preferred price, or “at cost.”

Id. at *13.  Bank this one away for future reference.  The next time plaintiffs’ attorneys wants an exemplar, offer to sell them one at the retail price or make one available for visual inspection.  If push comes to shove, Ramkelawan will be helpful.

In some states (we’re looking at you, California) it is frightfully hard to win on fraudulent concealment removal where the plaintiff has joined an in-state distributor of a drug or medical device. In other states, defendants have more of a shot. Today’s case, Harris v. Zimmer Holdings, Inc., 2019 U.S. Dist. LEXIS 71025 (S.D.N.Y. April 26, 2019), is one of the latter. The plaintiff was an Ohio citizen who claimed personal injury from a hip implant. He filed suit in Ohio state court alleging Ohio state causes of action against diverse manufacturer defendants and against Ohio (therefore non-diverse) distributor defendants. The presence of the latter supplied the ostensible reason why the action could not be removed to federal court. Still, the defendants removed, arguing that the Ohio defendants had been fraudulently joined and that, therefore, federal diversity jurisdiction existed. The fraudulent joinder argument rested on the notion that the claims against the Ohio defendants were implausible. The removal petition was accompanied by sworn affidavits from the Ohio distributor defendants denying that they played any role in the manufacturing, labeling, or packaging of the hip implant or had knowledge of its claimed defects.

The plaintiff initially filed a motion to remand in the Northern District of Ohio. Subsequently, the action was transferred to the Southern District of New York pursuant to an order from the Judicial Panel on Multidistrict Litigation. The MDL transferee court must apply the law of the circuit in which it is located. That means that Second Circuit law controlled. So far so good. But when a defendant’s fraudulent joinder claim is premised on a failure to state a plausible cause of action – as was the case in Harris – courts apply the relevant state pleading rules. Uh oh. Unlike the heightened federal pleading standards set forth in Twombly, Ohio applies “liberal notice pleading requirements” which simply require the plaintiff to provide fair notice of the claims and the grounds upon which they rest. Double uh oh.

But it turns out that there was no reason for those uh oh’s. What were the plaintiff’s claims against the Ohio distributor defendants? Broadly stated, the plaintiff alleged that the Ohio distributor defendants failed to convey adequate warnings to the plaintiff’s doctor, and that the distributor defendants were in the business of marketing, promoting, selling and/or distributing the unreasonably dangerous medical devices. What’s more, the distributor defendants also “negligently distributed, marketed, advertised and/or promoted the dangerous medical devices.” We’re not done yet. The plaintiff also said that the distributor defendants “made negligent misrepresentations regarding the safety and efficacy of the dangerous medical devices.” One more thing: the distributor defendants “negligently failed to provide sufficient information and instructions to Plaintiffs and/or Plaintiff’s prescribing physicians.” A bit repetitive, right? These allegations cannot reside in thin air. They must be stated in the form of legal causes of action. Here, the plaintiff joined the Ohio defendants in three causes of action: (1) defective design, in violation of the Ohio Products Liability Act (“OPLA”), (2) failure to warn, in violation of OPLA, and (3) violation of the Ohio Consumer Sales Practice Act (“OCSPA”).

At this point, the plaintiff in Harris had a couple of problems. Problem 1 is that the design defect and failure to warn claims under the OPLA applies only to manufacturers unless a statutorily defined exception applies – which was not the case here. Problem 2 for the plaintiff is that the OCSPA does not apply to claims for personal injury or death, although a plaintiff may recover damages arising from bodily injury so long as the injury itself is not the basis of the OSCPA claim. Here, the plaintiff’s OSCPA claim was clearly a claim for bodily injury. The plaintiff “cannot prove that the Device had concealed ‘defects’ and ‘serious risks’ without showing the Device caused bodily injury. Here, the predominate harm which is the gravamen of this case, is the alleged physical harm associated with the Device.” The Second Circuit concluded: “Accordingly, even under Ohio’s lenient pleadings standard, Defendants have met their high burden of showing fraudulent joinder as to the Ohio Defendants.”

The plaintiff’s remand motion was denied.

Today’s case in a nutshell is the dismissal on forum non conveniens grounds of a claim brought in the United States by a woman from a Spain.  We didn’t need to read beyond that blurb before we started hearing . . .

Farewell and adieu to you, fair Spanish ladies,

Farewell and adieu to you, ladies of Spain;

For we’ve received orders

For to sail to back to Boston

And so never more shall we see you again.

Just in case you don’t immediately hear that tune in Robert Shaw’s raspy tenor, here’s a link to enjoy.  Quint Americanized his version by referencing Boston, but it’s actually a Napoleonic era English sea ballad.  You can find more of the lyrics quoted in Moby Dick and the song pops up there and again in movies and television (often in homage or reference to Jaws), including in 2003’s Master & Commander, where we can only be thankful that it wasn’t sung by Russell Crowe.

Courage v. DePuy Orthopaedics, Inc., 2019 WL 1923311 (N.D. Ohio Apr. 30, 2019) is one of twelve essentially identical decisions sending Spanish litigation tourists back to Spain and in the process sets out a nice forum non conveniens analysis.  Plaintiff is a resident of Spain.  She underwent two hip replacement surgeries in Spain.  She underwent revision hip surgery in Spain.  All of her medical care related to her hip implants took place in Spain.  The device used in her hip replacements was designed and manufactured by DePuy International Limited, a United Kingdom company.  Id. at *2.  But, when plaintiff brought her failure to warn lawsuit, she filed it in the United States.  Id.

On a forum non conveniens challenge, the court undertakes a three step analysis: (1) how much deference to afford plaintiff’s choice of forum; (2) whether an adequate alternative forum exists; and (3) whether plaintiff’s chosen forum is unnecessarily burdensome.  Id. at *3.  On the last two issues, defendant bears the burden of proof.

Plaintiff’s choice is afforded less deference when plaintiff is resident of a foreign country.  In this instance, plaintiff was unable to demonstrate that she chose the U.S. for a legitimate reason, such as obtaining jurisdiction over defendant, rather than just a “tactical advantage.”  Id. We know American courts are attractive, but that’s not enough.

In addition, the Spanish legal system was available to plaintiff.  Spain recognizes numerous causes of action for personal injuries based in negligence as well as product liability law.  Id. at *4.  It does not matter that the alternative forum may not provide the same “range of remedies” as the original forum, it simply must provide “some potential avenue for redress.”  Id. at *3.  Spain does.  The second part of the alternative forum analysis is whether the defendant is amenable to process in that forum.  Here, DePuy International agreed to accept service of process of Spain and agreed to waive statute of limitations/repose under Spanish law.  Id. at *4.

Finally, the court has to assess the burden of proceeding in the chosen forum based on a balance of private and public interest factors.  Starting with the private interest factors – “all evidence related to causation and damages is located in Spain.”  Id.  The physicians are in Spain.  The documents are in Spain.  And, unlike in many foreign plaintiff cases, the product was also not designed or manufactured in the United States.  The only thing in the United States is the DePuy Hip Implant MDL and typically higher damage awards. But given these facts,

[a] trial in the United States will unfairly prejudice the Defendants by imposing barriers on their ability to secure crucial medical evidence, and prevent them from presenting this evidence through the live testimony of the medical professionals involved in Plaintiff’s care and treatment. Unlike Spanish courts, the United States lacks subpoena power to compel the production of Spanish witnesses for trial in this country.

Id. at *5.  The court found the “forced reliance on deposition testimony and medical records that must be translated” was too “significant a procedural hindrance” to allow the case to proceed in the U.S.  Id.

As to the public interest, Spain has the much greater interest in adjudicating the claims of alleged injury to one of its residents and in enforcing its regulatory and safety requirements for products sold within its borders.  Id.  Further, under Ohio’s choice of law rules, Spanish law would most likely apply.  The U.S. court “would have to engage in the cumbersome task of analyzing Spanish law and applying to multiple principles of U.S. law.”  Id. at *6.  Therefore, the “tenuous” connection between plaintiff’s claim and the U.S. combined with the availability of redress in Spain, warranted dismissal.  Farewell and adieu.

And, if that sea shanty wasn’t to your liking, how about a Roy Scheider, Robert Shaw, Richard Dreyfuss trio . . . Show me the way to go home . . .

 

 

 

 

Of all the one-off posts that we’ve done, our post from 2011, “Depositions – When Can You Talk To Your Own Witness?,” has probably garnered the most ongoing use by litigators generally.  Both inside or outside of our firms, we get questions or comments about it probably about once every other month.  That’s a lot, considering how many of our posts seem to vanish without a trace.

Because that post has generated so much interest, we thought we’d update it.  We’ll start with repeating our conclusions from back then:

First, conferring with the deponent (on anything other than privilege) while a question is pending is asking for trouble.  The weight of authority puts that on the wrong side of the line.

Second, taking a break during questioning for the sole purpose of conferring with the deponent has also drawn quite a bit of judicial fire.  Expect trouble if doing this, although sanctions may well be avoided if the witness testifies that no coaching occurred.

Third, conferring over lunch or other breaks during the deposition taken for unrelated reasons is more likely to be viewed as OK.  Again, if you’re willing to have the witness testify that no coaching occurred, so much the better.

Fourth, just as the weight of authority is against conferring with questions pending, once we get to overnight breaks, the weight has shifted decisively to such conferences being allowable.  There’s some contrary precedent, but not much.

Fifth, once we get into the realm of multi-day adjournments, except possibly in South Carolina (and Delaware, if less than five days), conferences between counsel and the deponent are all right.

The obvious way to start the update was to look for post February, 2011 citations to the leading (if not necessarily most followed) decision on in-deposition consultations, Hall v. Clifton Precision, 150 F.R.D. 525 (E.D. Pa. 1993).  We also point out (as we did in 2011) that there is no necessarily “pro-plaintiff” or “pro-defense” position on this issue, so we present both sides of the law equally, according the importance we perceive in the cases.

Since our earlier post, one more state supreme court, Nevada’s, has weighed in.  Coyote Springs Investments, LLC v. Eighth Judicial Dist. Court, 347 P.3d 267, 270 (Nev. 2015), was oddly postured.  No sanctions or additional discovery was sought after an attorney-requested in-deposition break between topics (but with no question pending) was quickly followed by the witness changing his testimony.  Id. at 269.  Instead, opposing counsel waited until trial (a bench trial) to inquire into what were claimed to be privileged communications.  During the trial, the lower court found the privilege waived.  Id. at 270.  The conferring party sought an extraordinary writ.  The Nevada Supreme Court found the absolute Hall rule was “unnecessarily restrictive.”  Id. at 273.  Rather, Coyote Springs drew the line between conferring during unrequested deposition breaks (OK) and requesting a break to confer (mostly not OK):

[W]e hold that attorneys may confer with witnesses during an unrequested recess or break in a discovery deposition.  Furthermore, we hold that attorneys may not request a break to confer with witnesses in a discovery deposition unless the purpose of the break is to determine whether to assert a privilege.  We additionally hold that once the deposition proceedings resume after a private conference that is requested to determine whether to assert a privilege, the attorney must place the following on the record:  (1) the fact that a conference took place; (2) the subject of the conference; and (3) the result of the conference, specifically, the outcome of the decision whether to assert a privilege.  We stress that counsel must make a record of the confidential communications promptly after the deposition resumes in order to preserve the attorney-client privilege.

Id. (citations omitted).  Because the testimony at issue involved a requested break, and did not concern a privilege issue, use of the disputed testimony about what transpired during the conference was not an abuse of judicial discretion.  Id.

Chesbrough v. Life Care Centers, Inc., 2014 WL 861200 (Mass. Super. Feb. 14, 2014), is a state trial court opinion of exceptionally high quality.  “[T]here was no artfully timed break-taking with either questions pending or clear lines of inquiry interrupted” during the Chesbrough deposition, but one “conference between [the witness] and his counsel . . ., which lasted just two minutes, [and] occurred during an unanticipated break requested by a different lawyer.”  Id. at *2.  As one might guess from that description, no sanctionable conduct was found.  The court refused to follow Hall, which was advanced for the rather extreme proposition that any conference during a deposition “amounted to impermissible coaching per se, and without more entitle[d the opponent] to pierce the attorney-client privilege that would otherwise attach to such communication.”  Id.  Instead, construing the applicable Massachusetts rule (Rule 30(c)), the court held the in-deposition conference proper:

Defendant’s counsel did nothing to violate either the provisions or purposes of Rule 30(c). . . .  She did not interrupt the examination of her client, or do anything to interfere with the flow of opposing counsel’s questioning.  The break that occurred here was requested by a different attorney, and by all accounts had nothing to do with advice-seeking on the part of the deponent.  There was no question pending at the time this break commenced, another circumstance suggestive of coaching not present in the case at bar.

Id. at *3.  Chesbrough rejected an “expansive construction” of the rule, based on Hall, that would have “equate[d] all forms of lawyer-witness communication during the course of a deposition (and appurtenant breaks) with impermissible coaching.  Id.  While Hall might be “ground zero” on this issue, Chesbrough found some of its holdings radioactive:

[While] Hall has gained a modest following in the courts since its publication in 1993 . . ., the greater weight and better reasoned authority that has evolved in the area of lawyer-client conferences during depositions has come to reject Hall as an untenable and impractical interference with the attorney-client privilege and right to counsel. In its zeal to root out witness coaching from civil deposition practice, Hall prescribes a remedy now widely regarded as more destructive than the ill it seeks to cure. . . . [T]he rules of Hall sweep too broadly to be adopted in this jurisdiction.

2014 WL 861200, at *5 (citations omitted).  Instead, Chesbrough imposed a more flexible set of rules for dealing with situations suggesting improper in-deposition witness coaching:

[I]f a deposing lawyer comes to believe in good faith that an opposing counsel has improperly coached a witness during the course of a deposition . . . then the lawyer . . . may in this circumstance inquire of the witness both as to the reason for the break and/or the change in testimony.  If the witness invokes the attorney-client privilege in response to such inquiry, deposing counsel may properly insist on the record that the deponent acknowledge the fact that a conference with counsel was held, the subject matter (but not substance) of the conference to which privilege is claimed, and the time, place and participants in the conference. . . .  The Court believes that the availability of such recourse will in most circumstances deter bad behavior by lawyers defending client depositions.

Id. at *8 (emphasis original).  The most commonly sanctioned conduct – conferring “while a deposing lawyer’s question is pending” and “initiat[ing] a break or recess for the purpose of conferring about the substance of the witness’s testimony . . . in the middle of a deposing lawyer’s line of questioning” – were prohibited, id. at *9, but all other in-deposition breaks were allowed, subject to the anti-coaching procedure outlined above.  Id.

Other cases involving the propriety of in-deposition conferences subsequent to our 2011 post are as follows:

Finding in-deposition conference improper

Demonstrably, counsel conducting depositions in federal courts in Pennsylvania, where Hall originated, should be extra careful when they elect to have conferences with deponents during the course of depositions.  See Peronis v. United States, 2017 WL 696132, at *2 (W.D. Pa. Feb. 17, 2017) (order prospectively applying Hall to deposition conduct); Dalmatia Import Group., Inc. v. Foodmatch, Inc., 2016 WL 6135574, at *6 (E.D. Pa. Oct. 21, 2016) (prospectively ordering that “Counsel will not communicate with deponents during breaks regarding the substance of their deposition testimony”); Vnuk v. Berwick Hospital Co., 2016 WL 907714, at *4 (M.D. Pa. March 2, 2016) (“speaking with [the client] about the subject matter of the deposition during lunch and other breaks, is wholly inappropriate, unprofessional, and − if it occurs again – sanctionable”; counsel also passed notes and whispered to client during questioning).  But strict application of in-deposition conferences is by no means limited to Pennsylvania.  See New Age Imports, Inc. v. VD Importers, Inc., 2019 WL 1427468, at *3 (C.D. Cal. Feb. 21, 2019) (motion to compel second deposition of witness due to in-deposition conference was “substantially justified” as to support an award of costs); Horowitz v. Chen, 2018 WL 4560697, at *3-5 (C.D. Cal. Sept. 20, 2018) (attorney and client “repeatedly left the room together while a question was pending”; costs and redeposition ordered); Bracey v. Delta Technical College, 2016 WL 918939, at *1-2 (N.D. Miss. March 9, 2016) (in-deposition conference resulted monetary sanction); Plaquemines Holdings, LLC v. CHS, Inc., 2013 WL 1526894, at *6 (E.D. La. April 11, 2013) (“counsel . . . took several ‘breaks’ during the deposition [and] . . . during one of these ‘breaks’ he spoke briefly with his client”; redeposition ordered because “the conduct is impermissible under Rule 30”); South Louisiana Ethanol, L.L.C. v. Fireman’s Fund Insurance Co., 2013 WL 1196604, at *7 (E.D. La. March 22, 2013) (“unilaterally taking a ‘break’ in the deposition, and speaking to [the deponent] outside the deposition” was “clearly inappropriate”).  And a special note about Abu Dhabi Commercial Bank v. Morgan Stanley & Co., 2011 WL 4526141, at *8 (S.D.N.Y. Sept. 21, 2011), adopted, 2011 WL 4526137 (S.D.N.Y. Sept. 29, 2011), and NXIVM Corp. v. Cote, 2011 WL 3648852, at *2 (N.D.N.Y. Aug. 18, 2011).  They also followed a strict Hall standard, but cases below discuss, the local New York federal court rules have subsequently been relaxed, and as a result of the local rules change, these two are of questionable validity.

In the middle

Pia v. Supernova Media, Inc., 2011 WL 6069271, at *3 (D. Utah Dec. 6, 2011) (deponent “may assert the attorney-client privilege concerning the conversations between [him] and his counsel that occurred while on long breaks while no question was pending, but must answer questions about conversations that occurred during breaks while a question was pending”); Pedraza v New York City Transit Authority, 2016 WL 270825, at *11-12 (N.Y. Sup. Jan. 20, 2016) (while 22 NYCRR 221.3 “prohibits the very type of interruption that plaintiff’s counsel sought,” and is not limited to breaks with a question pending, sanctions denied because no “tactical advantage” was sought).

Not finding in-deposition conference improper

Unlike the Hall-based decisions, the more liberal cases are not concentrated in certain jurisdictions, but seem to come from all over.  Pain Center, LLC v. Origin Healthcare Solutions LLC, 2015 WL 4548528, at *5 (S.D. Ind. July 28, 2015) (“conferring with a deponent during a recess . . . does not interfere with the fact-finding purpose of a deposition); Cannon v. Time Warner NY Cable LLC, 2015 WL 2194620, at *1 (D. Colo. May 7, 2015) (“there is no bar on attorney consultation with a client during the client’s deposition, as a general matter − so long as no question is pending”); Gavrity v. City of New York, 2014 WL 4678027, at *2 (E.D.N.Y. Sept. 19, 2014) (“The rules of this Court do not prohibit discussions between counsel and client during a deposition other than when a question is pending”) (citing E.D.N.Y. Loc. Civ. R. 30.4); Few v. Yellowpages.com, 2014 WL 3507366, at *2 (S.D.N.Y. July 14, 2014) (rejecting Hall rule under New York law; “The current rule . . . narrows the restriction on counsel to conferencing during the pendency of a question, a change that obviously represents a deliberate decision to alter the scope of the prohibition”); Murray v. Nationwide Better Health, 2012 WL 3683397, at *4-5 (C.D. Ill. Aug. 24, 2012) (a “blanket prohibition on defense counsel having a private conference with [his client] during the deposition is overly broad”; “defense counsel may have a private conference with [a client] during a recess that counsel did not request (and so long as a question is not pending)” and during other unrequested breaks); Ginardi v. Frontier Gas Services, LLC, 2012 WL 13028126, at *2 (E.D. Ark. Jan. 6, 2012) (in-deposition break to locate documents with no question pending not sanctionable; “Hall fails to recognize the importance of the attorney-client privilege”); Perrymond v. Lockheed Martin Corp., 2011 WL 13269787, at *3 (N.D. Ga. Feb. 18, 2011) (sanctions denied; “Plaintiff has not explained that [counsel’s] bathroom break comment thwarted her from pursuing a line of questions or otherwise interfered with her examination”).

Almost all of on-point precedent, whether inclined or disinclined to prohibit all in-deposition conferences, involved communication between attorneys and their clients.  But what about in-deposition conferences between an attorney and a paid expert witness?  Different rules apply, held Callahan v. Toys “R” Us-Delaware Inc., 2016 WL 9686055 (D. Md. July 15, 2016).  “[C]ommunications between attorneys and experts . . . are protected under an extension of the work-product doctrine.”  Id. at *3.  “Counsel’s choice to confer with [his expert] during the deposition break does not evince a conscious disregard of the advantage of keeping the defense strategy private,” so work product protection was not waived.  Id.  However:

Counsel’s continued insistence that the specific communications here are protected by the work-product doctrine essentially concedes their strategic nature, evidencing a danger for the precise type of witness coaching from which attorneys should refrain while witnesses are under oath.  The Court must thus conclude that the communications were improper under Rule 30.

Id. at *3.  Thus, Callahan imposed a different sanction – striking all of the expert’s deposition testimony that followed the in-deposition conference at issue.  Id. at *4.  While funny business during expert depositions is less likely to waive a privilege, Callahan demonstrates the ingenuity of courts in addressing in-deposition conferences that are thought improper.

Looking at all this, we think the continued development of the law only reinforces our 2011 conclusions.  Taking a break to confer with a client while an unanswered question is pending is asking for trouble.  That will almost always draw a sanction.  Requesting a break without a question pending is also dangerous, although a break at a logical point where the previous topic of questioning is completed will be looked upon more kindly.  Except in Pennsylvania, attorney-deponent consultations, at naturally occurring breaks in the deposition, have been pretty much OK.  Conferences between attorneys and deponents during overnight (or longer) breaks, are by now almost universally allowed, save an occasional, possibly anachronistically drafted court rule.

*          *          *          *

Finally, under the heading “only in California,” one party actually tried to sue the other over alleged in-deposition coaching consisting of, inter alia, conferring with the witness during questioning.  See Goodwin v. Pagano, 2015 WL 9486589, at *11 (Cal. App. Dec. 29, 2015) (affirming dismissal; “local court guideline” does not create a private cause of action).

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

This blogger is just returned from Ireland where we toured castles and abbeys, drove through amazing landscapes on tiny roads with hairpin turns (can’t say enough about Connemara except that everyone should go), sang about Molly Malone and the Fields of Athenry, visited a pub or two, drank a Guinness or two, and learned the history and distilling process of Irish whiskey from beginning to end (maybe had a glass or two of that as well).  The Irish take their whiskey very seriously – including serious rules about what can be called Irish whiskey.  Irish whiskey can only have three ingredients – grain, water, and yeast.  It can be single grain, single malt, or a blend, but you can’t add anything else.  And, Irish whiskey must be aged at least three years, not a day under.  And all of the aging must take place in the Republic of Ireland or Northern Ireland.  The result of strict adherence to the rules – a smooth, light flavor less sweet than American bourbon and less smoky than Scotch whisky.  What did our whiskey tour of Ireland teach us?  That we like rules.  That we like adherence to the rules.  That we like the result (a lot) when the rules are applied.  And the same can be said for drug and device law.

The first rule for generic drug cases – failure to warn claims are preempted.  PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).  The second rule for generic drug cases – see rule number one.  That really should be it.  Take a look at our generic drug preemption scorecard – the rules are clear.  But some plaintiffs look for a way around the rules. Like a distiller trying to adding vanilla or caramel to Irish whiskey, it cannot be allowed (they call that liqueur in Ireland).  Fortunately, there also are causation rules, and learned intermediary rules, and general warning rules.  When you apply them all, you get Sherman v. Pfizer, Inc., No. 50914-8-11, slip op. (Wash. App. Ct. Apr. 30, 2019).

Plaintiff Sherman was prescribed the generic drug metoclopramide for treatment of gastroesophageal reflux (GERD) from 2004 to 2010.  In 2010, plaintiff developed tardive dyskinesia – a neurological disorder that causes involuntary movements.  Id. at 3.  Since 1985, the package insert for metoclopramide included a warning about tardive dyskinesia.  The manufacturers of Reglan, the brand version of metoclopramide, revised the package insert’s warning regarding tardive dyskinesia in 2004 and again in 2009.  Id. at 3-4.

Presumably recognizing that a standard failure to warn to claim would be preempted – see rule number one – plaintiff tried to couch her claim in two different ways. The first we’ve seen numerous times – failure to update.  This post-Mensing contrived claim focuses exclusively on whether the generic label was the same as the brand label at all times as opposed to what a failure to warn claim is supposed to be about — whether a drug’s labeling adequately warns of known and reasonably knowable risks.  Sameness and adequacy are not equal.  This is where causation and learned intermediary rules come into play.

Rule number three – “the plaintiff must show that the failure to warn was both the cause in fact and the legal cause of the harm.”  Id. at 9.  Rule number 4 – in prescription drug cases, Washington applies the learned intermediary doctrine.  Id. at 8.  In Sherman, plaintiff’s prescribing physician was adamant that he was aware of the risk of tardive dyskinesia at the time her prescribed metoclopramide to plaintiff and that he always monitored his patients for movement disorders.  More importantly, he testified that he does not read package inserts.  Id. at 5.  He doesn’t read Dear Doctor letters, he didn’t rely on the brand or generic package insert in deciding to prescribe metoclopramide to plaintiff, and no changes to the package insert influenced his prescribing decision.  Id. at 6.  “Instead, he relied on his clinical training and experience, the experience of his colleagues and associates, and his mentors and people in the academic world who he respected.”  Id.

When you apply those facts to rules 3 and 4, you have one of this blog’s recurring issues – when a physician fails to read the package insert it breaks the causal chain under the learned intermediary rule.  We even have a 50-state survey of favorable precedent on the issue.  Washington was a trail blazer on this issue.  Douglas v. Bussabarger was one of the first state high court decisions to rule favorably on this issue back in the 1960s.  438 P.2d 829 (Wash. 1968).  According to Douglas,

[E]ven if we assume [plaintiff’s proposed] labeling should have taken place, [the prescriber] testified that he relied on his own knowledge of anesthetics and, in fact, did not read the labeling which was on the container.  Thus, if defendant-drug company was negligent in not labeling its container so as to warn of dangers, this negligence was not a proximate cause of plaintiff’s disability.

Id. at 478.  With Douglas as the controlling law, plaintiff’s failure to update claim fails for a lack of causation.  Sherman, at 12.

Plaintiff Sherman’s second claim was that defendants breached their duty to warn by failing to communicate the drug’s risks to plaintiff’s prescriber and the medical community “in ways other than the package insert.”  Id.  This failure to send Dear Doctor letters claim isn’t completely novel either.  But, it’s an interesting aspect of Washington product liability law that brings this claim down.  Rule number five – defendant’s duty to warn does not extend beyond the warnings that accompany the product.

Under the Washington Products Liability Act (WPLA), a manufacturer can be liable for failure to warn “if the claimant’s harm was proximately caused by the negligence of the manufacturer in that the product was . . . not reasonably safe because adequate warnings or instructions were not provided.”  Id. at 13.  The WPLA goes on to provide

A product is not reasonably safe because adequate warnings or instructions were not provided with the product, if, at the time of manufacture, the likelihood that the product would cause the claimant’s harm or similar harms, and the seriousness of those harms, rendered the warnings or instructions of the manufacturer inadequate and the manufacturer could have provided the warnings or instructions which the claimant alleges would have been adequate.

Id. at 14.  In other words, the WPLA limits the duty to warn to information “accompanying” the product.  The court noted that this is also consistent with comment k to Restatement (Second) of Torts §402A which states that “unavoidably unsafe products must be ‘accompanied by proper directions and warning.”  Id.  While plaintiff disagreed with this interpretation of the law, she offered no reason why the court should disregard the “provided with the product” language.  Since it is the package insert that accompanies prescription drugs, defendant’s duty to warn stopped there.  The WPLA precludes any claim of failure to send “Dear Doctor” letters, or any of the other ways plaintiff argued defendants should have communicated with the medical community (advertising, reprints, CME).

The rules work.  When you stick to the rules, you get decisions like this one which we rank at about the level of the Teeling Small Batch.

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

 

Margulis v. Stryker Corp., 2019 US Dist LEXIS 68555 (S.D. Fla. Apr. 23, 2019), is another case in which the plaintiffs filed a product liability claim in a court that did not have personal jurisdiction over the defendants. In this instance, however, the court didn’t dismiss the case. It punted.

The plaintiffs were from Argentina, where one of them had hip replacement surgery that was followed by complications and ultimately revision surgeries to remove the defendants’ hip implant products. Id. at *2. The plaintiffs then filed product liability claims against Stryker and Howmedica in a Florida federal court. Under Bauman, however, neither defendant was “at home” in Florida. Stryker is a Michigan corporation with its principal place of business in Michigan. Id. at *2. And Howmedica is a New Jersey corporation with its principal place of business in New Jersey. Id. at *2-3. There is also nothing in the court’s opinion to suggest that any of the events underlying plaintiffs’ claims occurred in Florida. So the Florida court appeared to lack general and specific jurisdiction. Defendants, accordingly, moved to dismiss for lack of personal jurisdiction. Id. at *3.

You’d think that they’d win that motion. But they didn’t.

While plaintiffs opposed it (on what basis, we don’t know), more importantly they moved to transfer the case under 28 U.S.C. §1406(a) to the United States District Court for the District of New Jersey, the home state of Howmedica. This maneuver, while having some surface-level appeal, wouldn’t seem to solve Stryker’s problem. Stryker is not “at home” in New Jersey. It’s a Michigan company.

Yet the court jumped at the opportunity to transfer the case anyway, declaring that, with their motion, the plaintiffs had “effectively acquiesce[d] to the ultimate relief” sought by the Defendants. Id. at *4. We’d wager that the defendants wouldn’t agree. In fact, as the court conceded, the defendants asked it to simply dismiss the case without prejudice for lack of personal jurisdiction. Id.

That seems like the better approach. The onus would then be on plaintiffs to decide whether to file their case in New Jersey and, if they were to do so, establish that a New Jersey court can exert personal jurisdiction over Stryker. Instead, the Florida court simply punted Stryker straight up the east coast to New Jersey into a second court that may not have personal jurisdiction over it as to these claims.

Frankly, the best approach would seem to involve the Argentinian plaintiffs suing in Argentina, where the alleged wrong occurred and where the plaintiffs allegedly suffered their damages. But that didn’t happen—at least not yet. And so we’ll now have the see what happens in New Jersey after the seemingly inevitable motion practice to come.

We used to author occasional “There’ll Always Be Posner” posts, highlighting the latest ruminations of that lively, capacious intellect. But it is doubtful whether we will ever have occasion to pen another such post, since Judge Posner stepped down from the Seventh Circuit. But Judge Danny Boggs still sits on the Sixth Circuit, and he still seems to have his fastball. We’ve mentioned a couple of times our admiration for Judge Boggs — he of the notorious clerk trivia quiz, spotty performance as a lifeline on Who Wants to be a Millionaire, host of Kentucky Derby parties, and dazzling mastery of prose and law. Last week he wrote a rather long opinion in Boling v. Prospect Funding Holdings, LLC, 2019 WL 1858506 (6th Cir. April 25, 2019), a case about whether certain litigation funding contracts were enforceable. We will, in turn, write a rather short summary. It will lack the Judge’s splendid phrase-turning, but it will give a sense of the main issues and rulings. Our summary might even inspire you to go the original opinion, especially if you have a case involving litigation funding. Call today’s effort a Boggs-post.

The plaintiff in Boling claimed injuries when a gas can ignited. He and his wife sued the manufacturer of the gas can. Over the course of the litigation, the plaintiff entered into four litigation funding agreements. The funding was in the form of loans (more on that later), but the plaintiff was not required to repay the loans unless he recovered money from the personal injury lawsuit. But if he did need to repay the loans, he would repay big-time. The interest rate was 4.99 % per month, which works out to an annual interest rate of approximately 79%. The plaintiff borrowed a total of $30,000, not including fees. After the case settled, the lender presented a bill for over $340,000. No wonder the plaintiff wanted to find a way out.

The plaintiff filed an action in the Western District of Kentucky seeking a declaratory judgment that the litigation funding contracts were unenforceable under Kentucky statutes prohibiting champerty and usury. He won. The funder appealed to the Sixth Circuit. The issues centered around where the case should have been litigated, what law applied, and whether the contracts ran afoul of champerty and usury laws.

The conundrum is that the four litigation funding contracts had inconsistent provisions regarding forum selection and choice of law. One of the four permitted the plaintiff to choose the forum. The others did not. The district court went with the plaintiff-can-choose provision, and reasoned the judicial economy would be served by dealing with all four contracts in the same place. On appeal, the funder argued that the court should have split the claims and permitted different fora for different contracts. But the funder had not argued that position below. The Sixth Circuit held that the funder had forfeited that argument and that the plaintiff’s choice of forum prevailed. That part was relatively easy.

Choice of law was not so easy. None of the four contracts selected Kentucky law to govern. But no matter what the contract said, the Kentucky federal court had to apply Kentucky choice of law based on the most-substantial-relationship test. Even so, wouldn’t the contracts’ choices of law be dispositive? The answer, somewhat surprising to our eyes, is: Nope. Kentucky’s most-substantial-relationship test trumps even an otherwise valid choice of law clause when the dispute is centered in Kentucky. The underlying lawsuit was filed in Kentucky and the plaintiff in that case was a Kentucky resident. When he executed the litigation funding contracts, he was in Kentucky. In short, the litigation funding dispute was over the proceeds of a Kentucky lawsuit and would determine how much a Kentucky resident could keep. So grab hold of glass of Buffalo Trace, find a Stephen Foster playlist on your iPod, place a bet on the ponies, put on your blue basketball jersey, and start delving into Kentucky law, because that is what is going to decide the champerty and usury issues.

It turns out that how to apply Kentucky law was a good deal simpler than whether to apply it. Kentucky’s champerty statute voids any contract where a non-party renders services in aid of a lawsuit and thereby acquires an interest in “the thing sued for or in controversy thereof.” The funder argued that it had merely acquired a contingent interest in the potential proceeds of the claim, and that should pass muster under Kentucky law. The plaintiff pointed out that Kentucky forbids assignment of claims in personal injury suits, plus the litigation funding contracts gave the funder “substantial control over the litigation” (e.g., forcing the plaintiff to execute documents or pay filing fees to protect the funder’s interest, limiting the right to change attorneys, etc.) The district court worried that the litigation funding contracts might have the effect of discouraging a reasonable settlement if the plaintiff feared all of the proceeds would go to the funder. The Sixth Circuit painstaking analyzed Kentucky precedents, and concluded that the district court correctly predicted that the Kentucky Supreme Court would deem the litigation funding contract champertous and in violation of Kentucky’s public policy.

Kentucky’s defined legal rate of interest is 8% per year, so the whopping 79% in the litigation funding contracts certainly smells usurious. The funder argued that the funding agreements were not really loans. The problem for the funder is that the Kentucky statute does not limit its scope to loans. Thus, whether the funder wants to call the arrangement a “non-recourse investment” rather than a loan, the usury restriction still applies. Moreover, the funding agreements clearly speak in terms of interest rates, not profits. Therefore, the Sixth Circuit held in Boling that the district court had not erred when it granted summary judgment to the plaintiff on the basis of the usury statute. (We should point out, just in case you wondered, that the district court granted summary judgment in favor of the funder on unjust enrichment and promissory estoppel, and awarded the funder $30,000 for the principal plus $4625 in fees. Rough justice?)

This is not the first time a court has voided a litigation funding agreement. We wrote about a Pennsylvania court holding such an agreement champertous here.

Recently we published a post, “One, Two, Three Strikes You’re Out,” about three recent (non-pelvic) mesh wins that occurred less than one week apart.  We spent the most ink on Nowell v. Medtronic Inc., ___ F. Supp.3d ___, 2019 WL 1434971 (D.N.M. March 29, 2019), which also happened to be the longest of the trio and the only one to be published.  We went on and on about Nowell’s recognition of the learned intermediary rule as New Mexico law, again in part because Nowell itself seemed to go on and on about that subject.  See 2019 WL 1434971, at *40-47 & n. 25.

As veterans of the learned intermediary rule wars over SSRIs in the (relatively) early days of the Blog, we were quite aware of Rimbert v. Eli Lilly & Co., 577 F. Supp.2d 1174 (D.N.M. 2008) – see our blogpost here.  The extensive and thoughtful analysis of rule in Nowell that we discussed seemed so much different (except for the “extensive” part) from the depressingly contrary approach taken in Rimbert.  The Rimbert discussion started with “the Supreme Court of New Mexico would not adopt the learned-intermediary doctrine” because “it is fundamentally inconsistent with New Mexico’s strict-liability jurisprudence,” and went on to predict “that the Supreme Court of New Mexico would be more persuaded by the analysis in State ex rel. Johnson and Johnson Corp. v. Karl rather than what other courts, including many state courts and the New Mexico Court of Appeals, have found.”  577 F. Supp.2d at 1215, 1217.  Karl, of course, was the notorious decision that for a time made West Virginia the only state in the nation to reject the learned intermediary rule.

Anyway, in discussing Nowell we gave Rimbert a sideswipe, that “in the past one pro-plaintiff court tried to say the rule didn’t apply” in New Mexico.  That’s where we were wrong.

Turns out it was the very same judge.

That’s right.  The same judge who found the learned intermediary rule incompatible with strict liability in 2008, and wanted to follow Karl − well, by 2019 he was writing footnote 25 in Nowell recognizing that the rule was virtually universal and predicting that New Mexico would follow suit (and citing, among many others, us, for that proposition).

That says something – and we mean something more than that we should have been more careful reading Nowell.  No, Judge Browning’s conversion from 2008 through 2019 speaks to what we called the “Renaissance of the Learned Intermediary Rule” in 2016, and the “Closing of the Learned Intermediary Frontier” in 2011.  Court after court in jurisdiction after jurisdiction has refused to drink the Kool-Aid the other side peddles about the rule supposedly being anachronistic.  Rather, they have recognized that the patient-consults-with-physician model as a prerequisite to getting a drug prescription reflects both what does happen and what should happen under the American health care model.  There’s a reason we call them “prescription” drugs.  Any contrary rule, that would reward plaintiffs for ignoring their doctors and relying on Internet-based non-professional opinions (and possibly on-line “pharmacies” that don’t require prescriptions), would be both bad law and bad policy.

That Judge Browning can come virtually full circle (he still doesn’t like DTC advertising) on the learned intermediary rule since 2008 is only the latest reminder of how far the law has come and the direction in which it is going on this issue.  The learned intermediary rule is one of the most universally-followed legal principles of American jurisprudence.  It’s more entrenched than the at-will employment doctrine or the economic loss rule.  It’s more universal than the Uniform Commercial Code.  There’s now precedent for the rule in every state, appellate precedent in every state but one, and adverse precedent practically nowhere.  Karl was overturned legislatively, and every high court to consider the rule since has adopted it.

So we apologize for being too dismissive of Rimbert, and too stereotypical in our thinking to assume that it “had to” be written by a different judge.  Judges (at least fair-minded ones) can be persuaded, and the learned intermediary rule is very persuasive.