One, Two ... Three?

A couple of weeks ago we posted about the one-two punch of generic preemption and product identification disposing of most of the claims in the Darvocet MDL.  Well, that combination has since landed a third punch that sent still more plaintiffs reeling.


It seems that the original branded manufacturer of the product was also embroiled in the litigation.  That defendant had sold all its rights to the NDA in 2002 – long before the litigation began – to independent successor corporations.  In In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 2012 WL 767595 (E.D. Ky. Feb. 5, 2012), the court dismissed those claims as well.  The same rule – that the branded manufacturer owes no duty to generic-only plaintiffs – applies.  Id. at *2, 8.  Given the length of time that has passed, none of the plaintiffs could plausibly plead that they, in fact, took the original manufacturer’s product prior to 2002.  Id. at *4.

There are a couple of factual twists that make this latest Darvocet decision particularly interesting, given the manner in which drug companies can divest themselves of NDAs.  First, due to the learning curve in manufacturing drugs, it’s not unusual for the original NDA holder to continue producing the drug for a purchasing company for some time after the sale is effectuated.  In Darvocet that period was two years and some months.  2012 WL 767595, at *6.  Second, after selling off the NDA, it’s not unheard of for former branded manufacturers to keep their facilities operating by manufacturing drugs for sale by generic manufacturers.  That also was alleged in Darvocet.  Id. at *5-6.

Neither fact pattern helped plaintiffs, however.  As for the first, the former brand name manufacturer did not make all of its successor’s product, but only a declining fraction of it.  Id. at *7.  No plaintiff could allege ingestion of of product from one source versus the other.  Thus, the claim still failed product identification requirements – thanks to TwIqbal:

The plaintiffs have failed to state a plausible claim against [defendant] as a manufacturer of brand-name drugs after 2002.  Accepting the allegations as true, at most they establish a mere possibility that the medicine used could have been made by [defendant]. . . .  This is simply insufficient under Iqbal or Twombly because the allegations are too speculative to state a plausible claim. . . .  The statement that “[The NDA purchaser] may have sold” products manufactured by [defendant] is too vague to establish that this plaintiff ingested a [defendant] drug on those specific dates.

2012 WL 767595, at *7 (emphasis added).  Liability in this sort of indefinite manufacturer situation would require something along the lines of market share, but no market share theory applies where a manufacturer (here, the NDA purchaser) is in fact known.  Thus, there cannot be a viable theory of liability – even in market share states.

Nor did plaintiffs get any further with allegations that the former branded manufacturer might have produced generically-marketed drugs.  First, those claims suffered from the same fatal “maybe is not enough” product identification problems just discussed.  Id. at *6 (“nothing more than a “sheer possibility” that [defendant] is liable”).  Even more interesting, once a non-NDA manufacturer is involved, preemption comes into play.  None of the plaintiffs alleged that the product made by the former brand name manufacturer had a manufacturing defect – only warning claims were made – and we all know that warning claims are preempted under Mensing when it's impossible for the particular defendant to change warnings unilaterally:

The plaintiffs have not brought a manufacturing defect claim against [defendant] because their allegations do not assert that [it], at any time, manufactured products that were adulterated, outside of specifications, or used defective ingredients.  Additionally, any state failure-to-warn claims would be preempted by federal law because, as the plaintiffs concede, [defendant] had no power to change the labels for generic drugs, or for brand-name drugs that were made and sold by others.  Thus, it is not immediately apparent what purpose would be served by establishing that [defendant] manufactured propoxyphene products for other companies.

Id. (citations and quotation marks omitted) (emphasis added).  Once a manufacturer surrenders its NDA, it loses the ability to make warning changes.  Thus, Mensing impossibility preemption applies once the NDA is sold.  Mensing thus cuts off claims of successor liability – whether or not the end product is generic or branded.  That's a point to remember.

These plaintiffs, as well, were thus down for the count.  “[U]nder Iqbal, plaintiffs should not be permitted to conduct discovery in order to fix factually deficient complaints, even where the necessary information is within the defendant's exclusive possession.” 2012 WL 767595, at *9 (denying leave to amend).

No Bracketology for Us: Chalk Up Wins for TwIqbal and Statute of Limitations

Some of our friends suggested that we honor the NCAA basketball tournament by engaging in a little bracketology. Presumably, they want us to run some legal concepts, cases, or personalities through brackets, ultimately selecting an overall champion. For those five or six of you who did not fill out March Madness sheets, bracketology is a way of deciding a winner by pairing off items, deciding winners, with winners advancing to confront other winners until there is one ultimate winner. Theoretically, bracketology can be as useful as, say, a decision-tree in evaluating alternatives or determining a course of action. Mostly, it's a harmless diversion. Our favorite recent example was a bracketology treatment of characters from the late, lamented HBO series The Wire.

Bracketology can be fun. But it doesn't really work for our purposes. Creation of an intial bracket requires a seeding of the contestants. That is, at the outset you first make an assessment of relative value or merit. The excitement of the NCAA tournament is how reality can play havoc with the seeding. (Ask anyone who picked Duke or Missouri to make it to this year's Final Four.) Injuries, sudden and surprising ineligibilities, 19 year-olds calling timeouts when all timeouts have been used up, screwy turnovers, and miracle shots can all create improbable results. But an abstract exercise is different. It lacks the fluidities and frictions of real life. Doesn't the initial assessment pretty much predetermine the outcome? How can there be any upsets? In fact, that is what happened with The Wire bracket. Everyone knew right away that Omar would likely win as best character. President Obama picked Omar. And, indeed, Omar won.

When people practice bracketology, the major issue is the extent to which one follows or departs from the "chalk." The "chalk" means picking the favorites. It is a boring strategy, but is mostly effective. For every amazing underdog success story, such as Butler, George Mason, and VCU, there are way more Kentuckys, North Carolinas, and Michigan States. Odds are that this year's Final Four will include at least three number 1's or 2's. Maybe one surprise team will sneak in. If one followed the chalk for The Wire bracket, one simply had to pick either Omar or Stringer Bell to triumph. (If you haven't seen The Wire, shame on you. It certainly makes our Final Four of the best television dramas of all time.)

All of which is to say that we won't be doing Drug and Device Law bracketology. We would simply end up going with the chalk. Plus, we're not sure how to do the graphics for the brackets. If we were to pair off legal defenses, we're fairly sure that TwIqbal, Daubert, Preemption, and Statute of Limitations would be our Final Four. A couple of posts ago we discussed how preemption is so strong because it can preclude cases that otherwise possess substantive merit. That is also true with the statute of limitations. We like TwIqbal because it gets rid of junk pleadings, and we like Daubert because it gets rid of junk science. It would be nice if courts followed the chalk and applied these doctrines to send the bad cases away, like Kentucky dispatching an inferior opponent.

Last week we saw two cases where courts followed the chalk. First, we have a straightforward application of TwIqbal in Reed v. Pfizer, Inc., 2012 WL 859729 (E.D.N.Y. March 14, 2012). The plaintiff alleged injuries from ingesting an oral contraceptive. In an early court conference, "plaintiffs acknowledged that the complaint allowed room for further factual details." Reed, 2012 WL 859729 at *1. Leave was given to file an amended complaint. That amended complaint alleged the usual claims: failure to warn, manufacturing defect, design defect, and breach of warranty. All flunked TwIqbal. The failure to warn claim did "not plead facts indicating how the provided warnings were inadequate." Id. at *3. "In contrast with their thorough recitation of Ms. Reed's claimed injuries, plaintiffs plead nothing about the content of Lybrel's warnings. This is likely because, as defendants note by reference to the FDA's website, Lybrel's FDA-approved warning labels warn of the very injuries plaintiffs have pled." Id. The manufacturing defect claim offered mere conclusions about negligent manufacturing, violations of regulations and "appropriate standards of care," and failure to test, but without an ounce of fact or a hint as to how the product differed from its design. Id. at *5. The design defect claim did "not plead facts alleging the existence of a feasible alternative design that would make the product safer, as is required to establish a design defect, under either New York or West Virginia law." Id. Finally, the warranty claim missed the mark: "Plaintiffs' unsupported conclusions that Lybrel differed in some defective manner from what was warranted lack the required factual content identifying that difference and making its existence plausible." Id. at *6.
　
All of these rulings follow TwIqbal faithfully and are predictable. Not quite as predictable was the Reed court's allowance of another opportunity to amend the complaint. We would have thought that the court's reasoning, particularly on the failure to warn claim, demonstrated that further amendment would be futile. But the plaintiffs will now get a third chance to plead a viable complaint. At least the NCAA tournament is single-elimination. Lose and go home. Maybe folks in Durham, North Carolina right now would like another chance, but there is something to be said for finality.

In the second case, Judge Mayer in New Jersey granted summary judgment for Novartis because Virginia’s two-year statute of limitations barred the case in its entirety. Irby v. Novartis Pharm. Corp., No. MID-L-1815-08 MT, slip op. (N.J. Super. Ct. Mar. 16, 2012). It was yet another Zometa case where the plaintiff alleged that the medicine caused him to develop osteonecrosis of the jaw. Judge Mayer agreed with Novartis that the limitations period begins to run on personal injury claims in Virginia "as soon as the alleged injury occurs, not at the time of diagnosis or discovery." Id. at 8 (quotation marks omitted). The plaintiff filed his complaint approximately three months too late. Id. The court rejected plaintiff’s argument that his lawsuit had been saved and was timely because of cross-jurisdictional class action tolling. Id. at 8-10 (citing Casey v. Merck & Co., 2012 Va. LEXIS 48 (Va. Mar. 2, 2012)). We discussed the Casey case here. It's nice to see it being put to such good use so soon. The court also rejected the plaintiff’s alternative argument that New Jersey law should govern the statute of limitations issue. It was more of a desperate, rather than an alternative argument, because the parties had all along acted as if they assumed that Virginia law applied: "Plaintiff cannot argue in the alternative that New Jersey’s period of limitations governs his affirmative claims, having failed to raise that issue by way of a timely choice of law motion." Id. at 10-11; see also id. at 10 (stating that "it is unfair to [Novartis] and this court for Mr. Irby to suggest at this late juncture in the litigation that a question remains as to which state’s law governed" the statute of limitations issue"). Thanks to Joe Hollingsworth and Martin Calhoun for bringing this decision to our attention.

And now, back to college basketball. All of our Final Four picks are still alive, and only one of our Elite Eight (Kansas State) is gone. We mostly followed the chalk, and our few departures have thus far paid off well. If you don't hear further bragging from us next week, you'll know that our bracket got busted.

Kurns - Anything In It For Us?

A couple of weeks ago – yeah, that’s right, on February 29 – the Supreme Court issued a ruling preempting asbestos product liability claims in Kurns v. Railroad Friction Products Corp., 2012 WL 631857, slip op. (U.S. Feb. 29, 2012).  We’re only now getting around to posting about it because, frankly, there’s not a whole lot in it of interest to us.


The defendants won – the Court found the claims preempted – by 6-3, so that’s good.  But the result was in large part driven by the plaintiffs’ tactical choice (in retrospect unfortunate for them, although maybe the issue was waived below) not to challenge the validity of Napier v. Atlantic Coast Line Railroad Co., 272 U.S. 605 (1926) . Napier had held that the Locomotive Inspection Act (the relevant statute) imposed field preemption, wiping out all state authority, including tort claims, over, among other things, locomotive parts.  That’s because Congress provided that the statute applied to “the entire locomotive and tender and all parts and appurtenances thereof.”  Kurns, 2012 WL 631857, at *4.

T’ain’t no field preemption in prescription medical product liability litigation.  That more than anything else is why we didn’t blog about Kurns before now.  So is there anything there we can use?

A little.

First, even though the supposed presumption against preemption first got its start in field preemption cases (see our post here, citing Rice v. Santa Fe Elevator Corp., 331 U.S. 230 (1947), Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977), and Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 715-18 (1985)), there’s not a peep about the elusive presumption in Kurns.  That’s not really surprising, since Justice Thomas, who eviscerated the presumption against preemption in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), is also the author of Kurns.  So we can say, “one more nail in the coffin….”

Another thing we like about Kurns is that it describes preemption in the absence of a statutory preemption clause as “occur[ing] through the direct operation of the Supremacy Clause.”  Id. at *4 (citation and quotation marks omitted).  That’s another beef we have with the presumption against preemption – there’s no principled basis for interpreting the constitution itself as narrowly as flaky decisions like Wyeth v. Levine, 555 U.S. 555 (2009), have done.  Can you imagine a similar presumption against application of the Due Process clause?  The Equal Protection clause?  The First Amendment?  We can’t either.

We also enjoyed the Court’s rare venture into substantive tort law.  Kurns arose in Pennsylvania.  2012 WL 631857, at *3.  That the Court chose (2012 WL 631857, at *7) to discuss Pennsylvania tort principles in terms of the Restatement (Third) of Torts Products Liability §2 (1997) resonates with us because whether Pennsylvania law follows the Second (§402A) or Third Restatement in product liability actions is a matter of considerable dispute – as we discussed in our post, here.  Like the Third Circuit before it, the United States Supreme Court has come down on the side of the newer (and in most, but not all, situations better for defendants) Third Restatement.

The Court’s actual discussion of product liability law was rather arcane – are “warning defects” fundamentally different than “design defects”?  Since a “warning” claim necessarily warns about risks arising from a product’s design, the Court held that the “gravamen” of the warning claim was the design of a locomotive part, which fit within Napier field preemption:

A failure-to-warn claim alleges that the product itself is unlawfully dangerous unless accompanied by sufficient warnings or instructions.  Thus, the “gravamen” of petitioners’ failure-to-warn claims is still that [plaintiff] suffered harmful consequences as a result of his exposure to asbestos contained in locomotive parts and appurtenances.  Because [plaintiffs’] failure-to-warn claims are therefore directed at the equipment of locomotives, they fall within the pre-empted field defined by Napier.

Kurns, 2012 WL 631857, at *7 (various quotations, including to the Third Restatement, omitted).  Although the Court doesn’t phrase it as such, this is a reiteration of the fundamental principle underlying Restatement §402A, comment k – where a product has inherent risks (as do both asbestos and prescription medical products) warnings are necessary to make an unavoidably unsafe design “reasonable.”

Kurns also included a warning-specific variant of the propositions that tort claims regulate conduct and are therefore properly subject to preemption as state-law “requirements.”  The Court stated:

This duty to warn and the accompanying threat of liability will inevitably influence a manufacturer’s choice whether to use that particular design.  By influencing design decisions in that manner, failure-to-warn liability has a direct and substantial effect on the physical elements of a [product].

2012 WL 631857, at *7 n.4 (citation and quotation marks omitted).  This proposition isn’t in serious dispute anymore, see id. at *8 (rejecting for the umpteenth time an argument that the common law is diffferent) – unlike when we were starting out – but it’s nevertheless useful to have another Supreme Court case to cite, if needed.

Finally, the discussion, id. at *8, of a railroad’s right to buy (under Napier) federally compliant products being “meaningless” if the state could prevent defendants from selling them also tends to refute plaintiffs’ assertions of liability for “wrongfully marketing” FDA-approved drugs and devices.  Take the Court’s statement in Kurns, “a railroad’s ability to equip its fleet of locomotives in compliance with federal standards is meaningless if manufacturers are not allowed to produce locomotives and locomotive parts that meet those standards,” and substitute drug/device facts.  Then, one has:

[A] [hospital’s] ability to equip its[self with prescription medical products] in compliance with [FDA] standards is meaningless if manufacturers are not allowed to produce [drugs and medical devices] that meet those standards.

Id. at *8.  So Kurns is another arrow in our quiver, there, as well.

Not terribly great, but definitely better than nothing.