We all know hindsight is 20/20.  And, it’s easy.  There are dozens of television and radio programs that thrive on Monday morning quarterbacking.  There’s no risk in saying the coach should have called for a pass when you already know the run didn’t work.  It’s also dangerous because it’s easy.  People are often too quick to point out that you should have taken path B after everyone learns path A is full of potholes.  Pointing it out is one thing, holding you liable for it is another.

What does hindsight mean in the products liability arena? Unfortunately, it can be used to demand perfection.  It can be used to allow plaintiffs to proceed on what is essentially a stop-selling theory based on the fact that in hindsight later approved treatments were safer.  That’s what happened in Holley v. Gilead Sciences, Inc., 2019 WL 2077845 (N.D. Cal. May 10, 2019).

Gilead is the manufacturer of several drugs used to treat and/or prevent contraction of the AIDS virus.  Several contain as their active ingredient tenofovir disoproxil fumarate (“TDF”).  The TDF drugs were approved by the FDA between 2001 and 2012.  Certain other of Gilead’s AIDS medications contain tenofovir alafenamide fumarate (“TAF”) rather than TDF.  The TAF drugs were approved by the FDA in 2015 and 2016.  Plaintiffs allege that defendant failed to provide adequate warnings with the TDF drugs regarding the increased risk of kidney and bone damage.  Plaintiffs also claim that defendant should be liable for “its decision to develop drugs containing TDF rather than the safer compound [TAF].”  Id. at *1.  At the heart of this claim is an allegation that the defendant was aware of TAF and that TAF was safer before it started selling TDF.  Id. at *2.

Defendant moved to dismiss all counts on federal preemption grounds.  Plaintiffs’ primary design defect claim was that there was a safer alternative available at the time defendant sought FDA-approval for the TDF drugs.  Id. at *7.  So, plaintiffs’ argument is that defendant never should have brought TDF to market.  But never-start selling claims based on allegations that the defendant should never have submitted the product to the FDA should be preempted as disguised “stop-selling” claims.  See Yates v. Ortho-McNeil Pharmaceuticals, Inc., 808 F.3d 281, 300 (6th Cir. 2015); Utts v. Bristol-Myers Squibb Co., 226 F. Supp. 3d 166 (S.D.N.Y.  2016); and Brazil v. Janssen Research & Development LLC, 196 F. Supp.3d 1351, 1364 (N.D. Ga. 2016).  But the Holley court did not see it that way.  Where Holley misses the point, however, is its focus on some hypothetical pharmaceutical product rather than the one at issue in the case.  To even state a design defect claim, plaintiffs have to identify a defect in the product they used – the one that was sold and marketed.  The court is correct that there is no federal law that prevents a manufacturer from developing a drug different from the one at issue.  Id. at *9.  That would be silly.  The fact that it did so at a later date, however, can’t be used to second guess the FDA’s approval of the drug at issue.

The danger of drawing an artificial distinction between pre and post approval is even more clearly seen in plaintiff’s argument that one of its TDF products should have contained a lower dose of TDF.  That argument could be made of almost any drug.  And post-approval, the design claim is preempted by Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013).  Pre-approval, it’s not?  We’ve argued time and again that a different product isn’t a safer alternative design.  Neither is it by-pass around preemption.

Holley doesn’t stop there, unfortunately.  To the contrary, it extends “pre-approval” claims to warnings as well as design.  To do that, it first had to discount the body of law that has interpreted Wyeth v. Levine as preempting failure to warn claims based on “information known to the FDA.” Id. at *11 (citations omitted).  That is why claims regarding the adequacy of a drug’s label at the time of approval are preempted.  That label was reviewed and approved by the FDA and the jury can’t be used to second guess that approval.  What a manufacturer can/should do with its label post-approval based on information not presented to the FDA is a different question.  So what is a pre-approval failure to warn claim anyway?  An allegation that the manufacturer should have submitted a different warning or different information to the FDA for approval?  That sounds an awful lot like fraud-on-the-FDA, which is Buckman preemption.  So, the fiction of calling plaintiffs’ claim a pre-approval failure to warn claim should not have saved it.

After allowing the pre-approval claims, the court did have to find that at least some of plaintiff’s post-approval warning claims were preempted due to lack of newly acquired evidence.  Id. at *11-12.  The “newly acquired information” requirement for CBEs wasn’t added until 2008.  So, for the older drugs, defendant could have changed the warning regardless of whether it had such new information; those claims aren’t preempted.  Id. at *12. Post-2008, plaintiffs point to different types of post-marketing information regarding the risks of TDF drugs.  But, they failed to plead whether and to what extent that information was provided to the FDA.  Therefore, the court could not determine what was “newly acquired evidence” that would support a CBE; those claims were preempted.  Id.  But dismissal is without prejudice as the court found there was a likelihood the deficiency could be cured.

Moving outside of preemption, defendant did make a few TwIqbal arguments.  First, warning causation.  Here the court said plaintiffs met the pleading standard by alleging that physicians would have “acted differently.”  Id. at *13.  So, an allegation that the prescriber would have monitored plaintiff more closely sufficed, as opposed to the prescriber would not have used the drug.  Second, consumer fraud.  Apparently, in this part of California, pleading of some consumer fraud claims doesn’t have to meet Rule 9(b).  Where plaintiff’s consumer fraud claim alleges “some fraud” and “some non-fraudulent conduct” – only the fraud is subject to Rule 9(b).  So, does that mean you can dismiss half a claim under a TwIqbal?  Here, the portion of the claim based on allegations that defendant acted “unfairly” instead of fraudulently weren’t subject to heightened scrutiny.  The court also didn’t dismiss plaintiffs’ omission based claims, but did dismiss without prejudice their misrepresentation claims.

A hindsight-oriented opinion on hindsight claims alleging that first-generation drugs should not have even been submitted to the FDA because later treatments were safer.  The logic is flawed because it’s based on Monday morning quarterbacking which should be left to sports commentators and ticked-off fans; not to judges and juries.

Just in.  United States Supreme Court rules unanimously in Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290, slip op. (U.S. May 20, 2019) (“Albrecht”), that the Third Circuit got it wrong in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017).  However, the majority opinion, by Justice Breyer, is limited and draws the support of members of the Court who are usually anti-preemption.  That says two things.  First, the Third Circuit was so far off the wall that its extreme anti-preemption position could not be stomached by anyone.  Second, if the analysis had been by a generally pro-preemption majority, rather than one with the opposite inclinations, the reasoning could have been a lot better.

Because the majority opinion has the votes of Thomas, Ginsberg, Sotomayor, Kagan and Gorsuch, it is limited to cleaning up the Third Circuit’s mess and does not decide the ultimate question of preemption on the existing facts.  Albrecht, slip op. at 17 (vacating and remanding, but not deciding the underlying preemption decision).  Once again (as with Wyeth v. Levine, 555 U.S. 555 (2009)), the “facts” are surprisingly malleable.  The majority (for reasons we’ll get into) omits a great deal of the regulatory history, and are called to task for that in Justice Alito’s concurring opinion (for Roberts, C.J., and Kavanaugh).

First, the Albrecht majority offers a more detailed definition of “clear evidence” under Wyeth v. Levine, 555 U.S. 555 (2009), rejecting the Third Circuit’s “clear and convincing” standard:

“[C]lear evidence” is evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.

Albrecht, slip op. at 1-2 (emphasis added); see also id. at 13 (satisfying this test would “show[] that federal law prohibited the drug manufacturer from adding a warning that would satisfy state law”).  This definition avoids situations where the FDA was “fully informed” (or not) by someone else, such as through a third-party Citizen’s Petition.  The majority doesn’t reach facts not before it.  See id. at 12 (emphasizing importance of “record” facts).

The dividing line for preemption in branded prescription drug cases continues to be whether the provisions of the FDA’s “changes being effected” (“CBE”) regulation are satisfied by the facts of the case.  Id. at 3-4, 14.  That regulation requires “newly acquired information” and, further, “manufacturers cannot propose a change that is not based on reasonable evidence.”  Id. at 14 (citing various parts of CBE regulation).  However, “in the interim, the CBE regulation permits changes, so a drug manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both.”  Id.  But what about what was done here – a Prior Approval Supplement (“PAS”), which is an alternative to a CBE label change?  Very little was said about that by the majority.

Second, the majority ruled that preemption – as had always been the case before Fosamax, remains a question “primarily of law” for courts, not juries, to decide.  “We here decide that a judge, not a judge, must decide the pre-emption question.”  Id. at 9.

[T]he question is a legal one for the judge, not a jury.  The question often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute.  Moreover, judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination. . . .  And judges are better suited than are juries to understand and to interpret agency decisions in light of the governing statutory and regulatory context.  To understand the question as a legal question for judges makes sense given the fact that judges are normally familiar with principles of administrative law.  Doing so should produce greater uniformity among courts; and greater uniformity is normally a virtue when a question requires a determination concerning the scope and effect of federal agency action.

Albrecht, slip op. at 16 (citations and quotation marks omitted).  Whatever factual questions might exist in a particular case are “subsumed within an already tightly circumscribed legal analysis” and decided by the judge.  Id. at 17.  So that issue’s over with.

Third, as a consequence of preemption being a legal question, the Albrecht majority also eliminated the Third Circuit’s peculiar “clear and convincing evidence” standard as superfluous:

We do not further define [Levine’s] use of the words “clear evidence” in terms of evidentiary standards, such as “preponderance of the evidence” or “clear and convincing evidence” and so forth, because, . . . courts should treat the critical question not as a matter of fact for a jury but as a matter of law for the judge to decide.

Albrecht, slip op. at 14.  Rather, “the judge must simply ask himself or herself whether the relevant federal and state laws irreconcilably conflict.”  Id. (citation and quotation marks omitted).  FDA action establishing preemption may occur by “notice-and-comment rulemaking,” “formally rejecting a warning label,” or any “other agency action carrying the force of law.”  Id. at 15 (citing, inter alia, 21 U.S.C. §355(o)(4)(A), concerning FDA acting on its own accord).

Albrecht was necessary because the Court did a lousy job in Wyeth v. Levine, 555 U.S. 555 (2009), articulating what it held about impossibility preemption.  For the last decade, courts have struggled to apply a counterfactual preemption standard requiring “clear evidence” – an undefined term − that FDA “would have” rejected a proposed warning change that in fact was never submitted.  Post-Levine decisions have been all over the lot about how strictly to apply Levine’s “would not have approved” standard.

But in Albrecht, the FDA had actually refused to allow a warning about the risk at issue.  Piling absurdity on top of absurdity, the Third Circuit had denied preemption even then – where the FDA actually rejected what plaintiffs demanded – making impossibility preemption truly impossible.  Fosamax, as it was called before reaching the Supreme Court, was awful enough that we ranked it the worst decision of the year in 2017.  Not surprisingly, the defendant sought certiorari in the Supreme Court.  The FDA agreed on how badly the Third Circuit had erred, and the Solicitor General filed supporting amicus briefs, both on the writ and on the merits.  In the Supreme Court, the Third Circuit’s rationale could not garner even one vote.

The Supreme Court also agreed (at least sub silentio) that Levine was poorly reasoned.  Albrecht spent an extraordinary four pages of the opinion just “describing [Levine],” Albrecht, slip op. at 10-13, which would hardly have been necessary had Levine made more sense.  We note that, conspicuously absent from that description is any express reference to any “presumption” (as opposed to the older “assumption”) against preemption.

In addition to the main points above, another highlight of the Supreme Court’s decision in Albrecht is express recognition of “overwarning” as a reason for the FDA’s labeling requirements:

The hierarchy of label information is designed to “prevent overwarning” so that less important information does not “overshadow” more important information.  It is also designed to exclude “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks,” that “could discourage appropriate use of a beneficial drug.”

Albrecht, slip op. at 3 (quoting 73 Fed. Reg. 49603, 49605-06 (Aug. 22, 2008) & 73 Fed. Reg. 2848, 2851 (FDA Jan. 16, 2008)).

Justice Thomas’ concurring opinion explains some of the oddities of the Albrecht decision.  Basically, he doesn’t accept an FDA “complete response letter” as a form of “law” that can be preemptive.  Albrecht, slip op. at 5 (“the letter was not a final agency action with the force of law, so it cannot be ‘Law’ with pre-emptive effect”) (Thomas, J. concurring).  We think that’s why the majority’s discussion of the regulatory history of Fosamax, compared to the concurrence, is so limited.  There is a lot of regulatory activity in between actual FDA actions.  To get Thomas’s vote, the majority omitted it.  Justice Thomas didn’t like what the Third Circuit had done, but wasn’t a pro-preemption vote either.  On that issue, Justice Thomas wrote only for himself.

Justice Alito (plus Roberts, C.J., and Kavanaugh) concurred only in the result because of “concern that its discussion of the law and the facts may be misleading on remand.”  Albrecht, slip op. at 1 (Alito concurrence).  Most of this objection has to do with the majority’s slanted version of the facts, id. at 4-5, something that also recalls Levine, and not in a good way.  However, the concurrence also highlights §355(o)(4)(A) – which as we noted was merely cited by the majority – because “if the FDA declines to require a label change despite having received and considered information regarding a new risk, the logical conclusion is that the FDA determined that a label change was unjustified.”  Id. at 2.  The concurrence would go further than the majority, addressing the “who else” question under this section:  “The FDA’s duty does not depend on whether the relevant drug manufacturer, as opposed to some other entity or individual, brought the new information to the FDA’s attention.”  Id.  Conversely, on the actual facts before the Court in Albrecht, Justice Alito was nonplussed by the majority’s failure to discuss the “Prior Approval Supplement” route of changing warnings.  Id. at 3-4.

Justice Alito agrees with the majority that Levine’s use of “clear evidence” was “merely a rhetorical flourish.”  Id. at 3.  “Standards of proof, such as preponderance of the evidence and clear and convincing evidence, have no place in the resolution of this question of law.”  Id.

So now what?

The one thing that’s definitively been put to bed by Albrecht is the notion of preemption as a question of fact to be decided by juries.  That is gone, and Albrecht’s ruling on this point will apply to all forms of implied preemption no matter what the product, since implied preemption is trans-statutory.  Also gone is the notion of a “clear and convincing” evidence standard.

If one is seeking clarity, that is as far as Albrecht will take you.  “Clear evidence” now has a new, post-Levine definition, but as Justice Alito discussed, that definition has some issues with it – most significantly with respect to the role of Citizen’s Petitions.  As for the redefined “clear evidence” standard, plaintiffs will be henceforth argue over what it means to “fully inform” the FDA.  OK, but not cited anywhere in Albrecht was Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), which has a lot to say about what plaintiffs can and can’t assert about sufficiency of submissions to the FDA.  The FDA also has to act for there to be “clear evidence,” but that’s been less of an issue historically, as Levine pretty much ended FDA inaction cases.  Another thought we have is that Albrecht has next to nothing to do with design defect claims, since there is no CBE regulations for design changes.

More than anything else, Albrecht reminds that Justice Thomas has very quirky views on preemption.  Even in a case like this one, where the anti-preemption position of the circuit court was way out in left field, there are reversals and there are reversals.  Albrecht is the kind of reversal that leaves both sides with only half a loaf.

 

To the surprise of almost nobody, the Centers for Medicare & Medicaid Services finalized their proposed direct-to-consumer advertising regulation the other day.  That’s the one that would require a statement of the promoted drug’s “list price” in all DTC advertising.  We’ve already discussed why we thought the regulation was on shaky ground in terms of CMS’s authority to issue it, and in terms of the First Amendment.  The final rule doesn’t seem to have changed anything in terms of the former, so we won’t re-examine the authority question, except to note one thing – Congress could fix that problem at any time through legislation expressly granting CMS the authority it currently seems to lack.

As to the First Amendment, we find risible the government’s position that “list price” isn’t “controversial” in the context of prescription drug pricing.  Here’s the regulation’s definition:

Wholesale acquisition cost.  Wholesale acquisition cost means, with respect to a drug or biological, the manufacturer’s list price for the drug or biological to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates or reductions in price, for the most recent month for which the information is available, as reported in wholesale price guides or other publications of drug or biological pricing data.

(Emphasis added).  This definition is facially controversial, since it demands that the advertiser “not includ[e] prompt pay or other discounts, rebates or reductions in price.”  In blunt terms, the advertiser is being expected to mislead most, if not all, of its target audience by using a product price that is too high, since most of us drug consumers benefit from “discounts, rebates or reductions in price.”  The folks currently running CMS may not like it, but most Americans still have health insurance.  Most tellingly, CMS concedes the point, admitting that “where the consumer may be insured” s/he “therefore will be paying substantially less than the list price.”

This regulation is odd in other respects than government mandated lying (we will refrain from further political comment).  In terms of enforcement, it’s essentially toothless.  Here’s the only “compliance” provision:

 403.1204 Compliance.

(a) Identification of non-compliant products.  The Secretary shall maintain a public list that will include the drugs and biological products identified by the Secretary to be advertised in violation of this subpart.

CMS will put you on a list.  Big whoop.  And even that’s not hard to avoid.  We can see it now – a DTC advertisement that ends with:

List Price:

Any Single

Price Would Be

Misleading

See our website, www.howmuchwillyoureallypay.com for full pricing and cost details.

On the referenced website, the advertiser provides every bit of actual pricing information available, perhaps offering customers assistance in navigating the healthcare system to obtain particular prices.  In a bit of delicious irony, to help consumers get the best prices, the advertiser could even choose to assist with Obamacare sign ups.  After all, if CMS can now require DTC drug advertisements to state one thing, then a different administration’s CMS could mandate that such advertisements assist the public in participating in the very programs that CMS administers.  Sauce for the goose….

The CMS rule also suggests that private Lanham Act actions could assist enforcement.  Good luck trying to convince anyone that the hypothetical above (and many other possibilities) is “misleading” so as to create liability under that statute.  It’s likely more accurate than what CMS is seeking, and in any event it’s sufficiently accurate that competitors aren’t going to waste attorney fees on Lanham Act litigation with little chance of success.

As product liability litigators, however, we are most interested in anything that preempts state-law tort suits.  This regulation comes with an express preemption clause:

(b) State or local requirements.  No State or political subdivision of any State may establish or continue in effect any requirement that depends in whole or in part on any pricing statement required by this subpart.

403.1204(b).  We’ve seen that before.  It’s patterned on 21 U.S.C. §360k(a), the preemption clause for the Medical Device Amendments.  Thus, this preemption language includes state tort suits, and being express, is not subject to any presumption against preemption.  Recognizing the above caveat concerning CMS having any authority at all in this area, if it does, then many decisions have held that administrative regulations also have the same preemptive effect as statutes.  E.g., Geier v. American Honda Motor Co., 529 U.S. 861, 872 (2000).

So the preemption clause provides that any state-law tort claim is preempted if it “depends in whole or in part on any pricing statement required by this subpart.”  We refer back to the definition of “wholesale acquisition cost” (“WAC”) we quoted above.  Under this preemption clause, it doesn’t matter what context – private tort suit, private consumer fraud suit, or state enforcement action – if a claims “depends” even a little bit on anything having to do with WAC, then preemption should whack the action.  We think the preemption clause is sufficiently broadly worded to encompass both how WAC is calculated and how it is disseminated.

To sum up, we think:

  • CMS probably doesn’t have authority to do this.
  • If it does, this exercise probably violates the First Amendment.
  • If it’s constitutional, it’s damn near toothless.
  • But, in any event, it gives us defense lawyers another preemption clause to assert.

As a young associate, we worked for a short time with then soon-to-be-Judge Harvey Bartle. We remember that, although kind and very funny, then-lawyer Bartle had a no-nonsense approach to law practice and a keen ability to discern the correct answer, sweeping aside fluff and obstacles en route to what made sense. We were excited when his appointment to the federal bench was announced. A few months later, we even asked Judge Bartle to perform our wedding (we almost said, “asked him to marry us,” but that wasn’t going to come out right) and were disappointed to learn that he would be out of town for the big day.

And so we were pleased, but unsurprised, to observe that Judge Bartle authored the decision on which we report today. We are told that a Westlaw cite will be forthcoming, but you can find the decision and order, respectively, at Documents Nos. 288 and 289 in the Zostavax MDL, In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, E.D. Pa., MDL No. 2848, Civil Action No. 2:18-md-02848-HB. We have linked the documents here and here. We have blogged previously on the Zostavax MDL, and you can read those posts here.

Today’s opinion is a decision on Merck’s motion to dismiss 173 plaintiffs’ claims for fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, violations of state consumer fraud statutes, and on a motion by co-defendant McKesson (a distributor) to dismiss the entire complaint in each of the 173 cases. As he and transferor courts had in four earlier individual cases, Judge Bartle granted Merck’s motion to dismiss the fraud-based claims, including the consumer fraud claims, with prejudice, holding that none had been pled with the particularity required by Fed. R. Civ. P. 9(b), despite several opportunities to amend. Judge Bartle stated. “Each of the 173 complaints is full of boilerplate language unrelated to the individual case and is the antithesis of how a proper federal complaint should be drafted. The one-size-fits-all approach of plaintiffs’ counsel produced allegations that are absurd on their face as to every plaintiff.” Opinion, at 2. These absurdities included allegations that plaintiffs “were induced to obtain a Zostavax vaccination by advertisements that began running years after plaintiffs were inoculated.” Id. at 3. Judge Bartle commented, “Plaintiffs’ counsel has habitually made such improper allegations, and the court has previously granted motions to dismiss nearly identical claims with prejudice,” id., and that, “[d]espite the court’s strong language chastising plaintiffs’ counsel” in those decisions, “counsel [had] continue[d] its vexatious behavior.”   Id. In light of those earlier decisions, the defendants had asked the plaintiffs’ counsel to dismiss these claims from the 173 cases, but plaintiffs’ counsel refused. The court “reiterated that such behavior can only be designed to waste the time and resources of the court and opposing counsel.

With respect to McKesson’s motion to dismiss the entire complaints in each of the 173 cases, Judge Bartle dismissed the fraud-based claims with prejudice, and the remaining counts without prejudice “on the ground that plaintiffs have failed to satisfy the requirements of Rule 8(a) of the Federal Rules of Civil Procedure,” id, by filing complaints in which the “deficiencies” were “manifest” and that did not contain “a short and plain statement of the claim showing that” the plaintiffs were “entitled to relief.” Id. The court also, sua sponte, dismissed the remaining claims without prejudice as to Merck, to avoid the “unmitigated confusion” that would result if different complaints were pending against the two defendants. Id. at 4. In closing, the court “urge[d]” plaintiffs’ counsel “not to repeat the same behavior here with respect to any future filings” in the MDL. Id. at 4-5.

But that wasn’t Judge Bartle’s final punch. In his separate Pretrial Order (the second of our linked documents), the judge ordered that re-filed amended complaints not exceed 40 pages. He then called out a plaintiffs’ firm by name, ordering that firm never to file another complaint or amended complaint longer than 40 pages and stating that any overlength pleading would be dismissed “without prejudice on [the court’s] own motion.” Pretrial Order No. 172, at 2.

We spend much of our professional life in the largely-unchecked world of MDL “master complaints” that list dozens and dozens of possible claims, and of plaintiffs’ lawyers who “incorporate” every single claim into every single short-form complaint filed on behalf of an individual plaintiff. Facilitating the MDL “cattle call” mentality in which plaintiffs’ firms assemble “inventories” of hundreds or thousands of cases without ever meeting the individual plaintiffs, this regime has never made a bit of sense and has allowed plaintiffs’ complaints to become procedural exercises lacking all significance. It has also permitted cases to remain pending for years and years during which no one – least of all the plaintiffs themselves – have any idea what the “real” claims are, let alone whether any claim has merit. We have lost track of the number of times we have expressed, in these pages, our frustration at the resulting MDL “parking lots.”

So we would love this decision even if it didn’t involve a bit of our professional history. The fact that it evokes decades-old memories of a fresh-faced associate only makes it sweeter. We are sure there is more to come in the Zostavax MDL, and we will keep you posted.

Bexis is going to have to give up saying that nothing good ever comes out of Missouri, because for the second time in just a few months we are reporting on a well-reasoned opinion from Missouri that comes to the right result for the right reasons.  In Fullerton v. Smith & Nephew, Inc., No. 1:18-cv-245, 2019 U.S. Dist. LEXIS 77350 (E.D. Mo. May 8, 2019), the district court dismissed all claims against a Tennessee-based medical device manufacturer on the basis that the Missouri-based court lacked personal jurisdiction.

There are a couple of interesting things about this order.  But first, what happened?  The plaintiff underwent a hip procedure in Arkansas using the defendant’s device, and the hardware allegedly failed, resulting in a second procedure to remove the device.  Id. at *2.  The defendant was a citizen of Delaware and Tennessee, but the plaintiff sued in Missouri.  Id. at *2-*3.  The plaintiff was a Missouri resident, so this is not a case of blatant litigation tourism that Missouri’s courts see all too often.

Regardless, because the defendant was not “at home” in Missouri and because there was no nexus between the tort and Missouri, the defendant moved to dismiss for lack of personal jurisdiction.  Id. at *3.

It was undisputed that the court did not have general jurisdiction over the defendant because Missouri was not the defendant’s home state.  Id. at *5.  The plaintiff therefore offered up two theories of specific jurisdiction:  First, the plaintiff asserted that the court had specific jurisdiction because the defendant sought to do business in Missouri by registering to do business with the Missouri Secretary of State.  Second, the plaintiff argued that although the device was implanted in Arkansas, the tort occurred in Missouri, where the device allegedly malfunctioned.  Id. at *5.

The district court rejected both arguments, and there are two points that we would emphasize.  First, although the plaintiff attempted to base specific jurisdiction on the defendant’s registration with the Missouri Secretary of State, he acknowledged that registering to do business and maintaining a registered agent alone do not create personal jurisdiction.  Id. at *8.  Corporate registration is often asserted as a basis for general jurisdiction, but the Missouri Supreme Court has already rejected that position.  The plaintiff in Fullerton therefore added that the defendant “has a long standing history of conducting business in Missouri and sells an ‘enormous amount’ of products in Missouri on a daily basis.”  Id. at *9.

Do those alleged facts sound familiar?  They should, because those were the facts in the U.S. Supreme Court’s landmark case on specific jurisdiction, BMS v. Superior Court, 137 S. Ct. 1773 (2017).  The defendant in BMS allegedly sold lots of product in California for patients other than the plaintiffs.  But according to the U.S. Supreme Court, even a defendant’s “extensive forum contacts” cannot support specific jurisdiction if they are unrelated to the plaintiff’s claims.  Id.  Any other approach would resemble a “loose and spurious form of general jurisdiction.”  Id.

The district court in Fullerton followed BMS and rejected specific personal jurisdiction based on the defendant’s allegedly “enormous amount” of unrelated business in Missouri:

Simply stating that a company marketed, promoted, and sold a product in Missouri does not establish specific jurisdiction.  Indeed, “[t]he inquiry into specific jurisdiction does not focus on Plaintiff’s contacts with the forum state, but Plaintiff’s injury must be connected to Defendant’s contacts with the forum state.”

Id. at *9-*10 (citing cases including Keeley v. Pfizer, Inc., No. 4:15CV00583 ERW, 2015 U.S. Dist. LEXIS 85282, 2015 WL 3999488, at *3 (E.D. Mo. July 1, 2015)).  That is where the plaintiff’s case for specific jurisdiction failed:  It was not relevant that the defendant sold products for other patients in Missouri.  The defendant had to have sold the plaintiff’s product in Missouri.

Bexis recently proposed a simple test to determine specific jurisdiction under BMS:  If the claimed forum contact could be asserted by any plaintiff, no matter where that plaintiff resides, was injured, etc., then it’s not the kind of contact that makes a claim “arise from” or “relate to” the forum state.  The plaintiff’s alleged forum contacts in Fullerton fail this test spectacularly.  Anyone, anywhere could assert that the defendant sells “an enormous amount” of product in Missouri.  That, however, is not relevant.  The plaintiff had to come up with “case-linked” Missouri contacts, and he could not.

That leads to the second interesting part of the Fullerton order.  This plaintiff argued also that the product was implanted in Arkansas, but that it allegedly malfunctioned in Missouri, which meant that a tort was committed in Missouri.  Nice try, but what does that have to do with the Defendant’s forum contacts?  “While Plaintiff maintains that he was a resident of Missouri when the tort occurred, the medical device at issue was manufactured in Tennessee, shipped to Arkansas, sold in Arkansas, and implanted in Arkansas.”  Id. at *10.  In other words, the complaint was devoid of any specific facts indicating that the plaintiff’s claim “arises out of and relates to the Defendant’s activities in the State of Missouri.”  Id. at *10-*11.

In the end, “[n]one of the facts alleged by Plaintiff connect [the defendant’s] conduct in Missouri to Plaintiff’s injury.”  Id. at *11.  The court therefore lacked personal jurisdiction.  As we said at the outset, the right result for the right reasons.

There are more bad fraudulent joinder decisions than good ones out there, and we typically do not like publicizing the other side’s wins. But occasionally an opinion is so weird that it merits a brief comment. Cardoza v. Med. Device Bus. Servs., 2019 U.S. Dist. LEXIS 77506 (W.D.Va. May 8, 2019), is a bit weird. The plaintiff was a Virginia resident who alleged that the liner of her hip implant fractured shortly after being implanted, requiring her to have emergency revision surgery. Because some of the fractured pieces could not be removed, she continues to have shards in her body. She sued in Virginia state court, naming five out-of-state defendants, all of whom have some relationship to the development, manufacture, or distribution of the hip implant and/or the liner, while also naming three Virginia defendants. What’s weird about any of that? It sounds like a run of the mill product liability case, doesn’t it?

Not completely. In addition to the product liability claims, the plaintiff also asserted three additional state-law claims: a “spoliation” claim; a claim for wrongful disclosure of medical information; and conversion. Those claims arose out of her allegation that, despite her surgeon’s pre-surgery assurances that he would give her the parts of the implant that were removed, those pieces were not provided to her, but were instead given to the manufacturing defendants, where they were “examined, inspected, and tested.” Although the parts have since been returned to her, she alleged that their condition and the lack of any information about the chain of custody makes it “virtually impossible for [her] to determine with reasonable certainty the root cause of her injuries and damages.”

The out of state defendants removed the case to federal court on the basis of diversity jurisdiction. The plaintiff moved to remand. Predictably, the plaintiff argued that the existence of the Virginia defendants destroyed diversity jurisdiction and required remand. Equally predictably, the out of state defendants countered that the non-diverse defendants were fraudulently joined because the plaintiff had no possibility of succeeding on the two counts in which they were named: wrongful disclosure of medical information, and conversion.

The plaintiff offered a threshold argument that remand was required because of technical violations of the removal statute, involving failures to attach copies of all process and pleadings in the case, as well as failure to give requisite notice. But no Fourth Circuit decision suggested that any such technical flaws invalidated removal, and the district court concluded that all that was afoot were de minimis violations that can be cured. We hope the defendants savored this victory, because it just gets worse after that.

The court concluded that, at least as to one claim against one of the non-diverse defendants, the conversion claim, the defendants “cannot show that there is no possibility of establishing the cause of action.” Still, the defendants did not go down without a fight. They relied on a consent form signed by the plaintiff prior to her surgery in which she consented in writing to the hospital doing what it pleased with the explanted parts. But the court held that it could not consider documents beyond the pleadings. The plaintiff claimed that she and her surgeon had a mutual intent to modify a term of the written agreement. Based on that, the court refused to say on the current record that defendants showed that the plaintiff had “no possibility” of succeeding on her claim.

The out of state defendants’ alternative argument was that, even if the non-diverse defendants were not fraudulently joined, the claims against them were improperly joined with the claims against the diverse defendants. This is a theory of “fraudulent misjoinder.” The court held that the plaintiff’s ability to prove her claims against the diverse defendants was “intertwined with her allegations regarding the conversion and spoliation of the extracted implants.” Thus, the court did not find that the claims against the non-diverse defendants were fraudulently misjoined. Lastly, as if to put a poisoned cherry on top of this rotten sundae, the court held that even if it had the discretion to sever, it would not do so here.

Anytime we start to write a post about a decision from New York, our heads start swimming in music lyrics.  Rose trees never grow in New York City…  Concrete jungle where dreams are made of…  Living just enough for the city…  Soon you will be on Sugar Hill in Harlem…  I don’t care if it’s Chinatown or on Riverside… Mom’s cookin chicken and collard greens…  Not only are there simply so many songs written about or inspired by New York, there are so many excellent songs written about or inspired by New York.  From Stevie Wonder to U2 to Paul Simon to the Beastie Boys and the list goes on . . . . Joel, Sinatra, Croce, Waits, Gershwin, Cohen . . .

As well as New York is known for its sound, our real goal today is to remind you it should also been known for its statute of limitations.  The opportunity to remind you is brought to us by the Second Circuit in Baker v. Stryker Corp., 2019 U.S. App. LEXIS 13869 (2nd Cir. May 9, 2019).  Plaintiff had a dental device implanted in August 2006 and in May 2016 filed suit alleging negligence, strict liability, and breach of warranty against the manufacturer.  Plaintiff’s sole argument was that he could not have discovered his injury until his first implant was removed in 2013.  Id. at *4.  But, that’s not the law in New York.  From the Battery to the top of Manhattan…  Actually from Tottenville to Massena since it’s the law of the state.

New York’s statute of limitations for products liability is three years and that starts to run from the date of injury.  Id. at *2-3.  That means the statute starts to run “when plaintiff first noticed symptoms, rather than when a physician first diagnosed those symptoms.”  Id. at *3.  So, it didn’t matter what the doctor diagnosed when he removed the implants.  The important facts are that plaintiff testified he started feeling pain within days of when the device was implanted in 2006.  He described the pain as “radically different from the pain he experienced” in earlier surgeries and that he also felt a choking sensation.  Id. at *3-4.  Therefore, his personal injury claims accrued in August 2006 and were time-barred.  New York where hustle’s the name of the game.

In New York, the discovery rule that plaintiff tried to rely on only applies to latent exposure cases.  See C.P.L.R. §214-c.  In other words, it was meant for toxic torts.  Baker at *5.  But even if it did apply, “discovery” is defined as “discovery of the physical condition and not . . . the more complex concept of discovery of both the condition and the nonorganic etiology of that condition.”  Id.

Plaintiff’s breach of warranty claim was similarly time-barred because that four-year statute began to run at the time of sale or entry into the stream of commerce.  Id.  So, the latest date of accrual for that claim was at the time of implant which was after the manufacturer sold the device to the hospital.  Id.   The dismissal was affirmed.  It comes down to reality…

And while it’s still a bit cold and dreary in New York right now, we’ll try to conjure up some warm thoughts by ending with — It’s not far, not hard to reach.  We can hitch a ride to Rockaway Beach…

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.