Today’s topic is something a little different. We don’t usually think of after market modifications to prescription drugs and medical devices. If this were a blog about cars, computers, or almost anything with a motor or engine that can be enhanced for speed – user modifications would be a central theme. In the drug and
Have you ever been sitting in a courtroom and wondered why you were there? We don’t mean that in a metaphysical sense, though that probably happens sometimes, too. No, we are thinking of the situation where you realize that neither the plaintiff nor the defendant are citizens/residents of the jurisdiction, and that the events in issue did not occur there either. Why are we here? This sort of thing happens to us a lot in courtrooms in New Jersey and Pennsylvania. Of course, there is an answer to the question: that is where the plaintiff filed the lawsuit. That choice of forum, so we are told by many authorities, is entitled to some respect. Okay, but how much? Forum-shopping is not one of the glories of American jurisprudence. It is a form of lawsuit arbitrage that inflicts inappropriate costs on parties and court systems. (Of course, some courts have unashamedly promoted themselves as litigation-tourist destinations.) When a plaintiff goes forum-shopping, what is being purchased? It could be plaintiff-friendly judges, jurors, laws, or procedures. It is ineluctably unseemly. Plaintiffs, being plaintiffs, sometimes push things a bit far, Forum shopping starts to look like forum-shoplifting.
If we had represented the defendant in the recent case of Kuennen v. Stryker Corp., 2013 U.S. Dist. LEXIS 1555571 (W.D. Va. Oct. 30, 2013), we would have wondered why we were in the place where the case was originally filed, the District of Columbia. The plaintiff, a resident of Virginia, underwent arthroscopic shoulder surgery in Virginia. The plaintiff received a pain pump made and sold by the defendants, to infuse a local anesthetic into the shoulder joint space. Now the plaintiff was alleging that the pain pump caused her to lose cartilage in her right shoulder joint. The defendants were both Stryker entities, which we will call “Corp.” and “Sales.” Neither was a citizen of D.C. The pain pump was not designed, manufactured, or sold in D.C. and the alleged injury occurred in Virginia. The defendants did not simply wonder why they were being hauled into a D.C. court; they successfully moved under section 1404 to transfer the case to the place where it should have been filed, Virginia. End of forum-shopping, right?
Maybe. Yeah. But not without a tussle. The defendants moved for summary judgment based on the statute of limitations. The defendants contended that the plaintiffs’ claims were barred by the Virginia two-year statute of limitations. In opposition, the plaintiffs asserted that the D.C. statute of limitations should apply with its favorable discovery role as to the accrual of the cause of action. The parties agreed that if the Virginia statute of limitations applied, the case would be dismissed, and if the D.C. statute applied, the case would continue, at least for a while. Why is it even an issue? The case is in Virginia, right? Not so fast. When an action is transferred under section 1404(a) from one district court to a district court in another state, the transferee court must apply the same law as the transferor court would have applied. The forum-shopping effect lingers.
There are several reasons we recommend taking a look at last week’s decision in Ball v. Takeda Pharmaceuticals America, Inc., 2013 WL 4040395 (E.D. Va. Aug. 8, 2013). One is that the case involves Stevens Johnson Syndrome, a rare but devastating idiosyncratic reaction which has become something of a litigation flavor du jour, with plaintiffs claiming that a great number of drugs cause this condition. After showing considerable patience (plaintiff filed 5 motions to amend), the court ruled that plaintiff finally struck out.
Most significantly, Ball was super in dismissing the plaintiff’s warning claim. The court held that the defendant’s warning about SJS/TENS was adequate as a matter of law – and dismissed the case:
The [relevant] label clearly identifies Stevens-Johnsons syndrome as a potential “adverse reaction” that could result from use of the prescription drug. Under Virginia law, a manufacturer is obligated to give a reasonable warning, not the best possible one. Courts have routinely held warnings adequate as a matter of law when they alert a party to the very injury for which the plaintiff seeks relief. [Defendant] disclosed Stevens-Johnson syndrome as a possible adverse reaction to [the drug] prior to plaintiff’s ingesting the drug. . . . The failure to disclose this risk is the sine qua non of the plaintiff’s negligence and negligence per se claims to the extent they seek to hold [defendant] responsible for plaintiff’s Stevens-Johnson syndrome. Those claims are dismissed, with prejudice.
Ball, 2013 WL 4040395, at *5 (citations omitted). A finding of adequacy as a matter of law is powerful, since warning claims are at the heart of prescription drug litigation. That this determination was made at the motion to dismiss stage, with the court taking notice of the label, is obviously even better. “A manufacturer does not insure its product’s safety, and need not supply an accident-proof product,” Id. at *6 (citation and quotation marks omitted).
Thanks to Susan Sharko of Drinker for forwarding today’s win in Hayes-Jones v. Ortho-McNeil Pharmaceutical, No. MID-L-3416-10, slip op. (N.J. Super. L.D. Aug. 3, 2012). It’s late on a Friday afternoon, and we’re trying to get out for vacation, but we liked it, so we think you will too.
Hayes-Jones is a failure to…
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 initial 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.
Over a decade ago, Bexis convinced the Fourth Circuit to predict that Virginia would reject cross-jurisdictional class action tolling – the notion that a meritless class action filed in one jurisdiction could suspend the running of the statute of limitations in another jurisdiction. See Wade v. Danek Medical, Inc., 182 F.3d 281 (4th Cir.1999). But what was won in Wade had a hard time staying won. Some federal courts, deviating from their federalist duty to construe state law conservatively, nonetheless made conflicting predictions that, maybe Virginia law (despite not recognizing class actions at all) would allow cross-jurisdictional tolling. See Torkie-Tork v. Wyeth, 739 F. Supp.2d 887 (E.D. Va. 2010); Shimari v. CACI International, Inc., 2008 WL 7348184 (E.D. Va. Nov. 25, 2008).
But not all courts. In In re Fosamax Products Liability Litigation, 694 F. Supp.2d 253 (S.D.N.Y. 2010), the court followed Wade in another multidistrict litigation (Wade had followed an MDL remand). The plaintiffs appealed, and the Second Circuit certified the question to the Virginia Supreme Court, which accepted the appeal.
Virginia’s highest court has now killed cross-jurisdictional class action tolling dead in that jurisdiction. Casey v. Merck & Co., No. 111438, slip op. (Va. Mar. 2, 2012). Good riddance, we say. It was a long enough time coming – as was the underlying Fosamax class action decision. The plaintiffs wanted over two years of tolling – just for filing a meritless complaint – because it took various courts (it was an MDL, after all) from September 15, 2005 until January 28, 2008 to dismiss the patently bogus personal injury class action.
Cross-jurisdictional class action tolling. Even though Bexis invented the phrase, we hate it. We’ve lambasted that concept many times on this blog, see here. Basically: (1) the law should not reward the filing of meritless class actions by tolling the statute of limitations; (2) lawyers and courts in one jurisdiction should not be allowed to manipulate the statutes of limitations of other jurisdictions; and (3) each state is a sovereign, and should be able to set its own tolling (and other) rules without outside interference. In fact, we’re so anti-cross-jurisdictional class action tolling that we maintain a scorecard concerning this rather arcane legal topic.
Another peeve that we’ve occasionally petted is the tendency of some courts – particularly in the Second Circuit – to assume that they know more about the law of other states than do those other states’ courts.
Those two threads come together in Casey v. Merck & Co., ___ F.3d ___, 2011 WL 3375104 (2d Cir. Aug. 5, 2011), where for once the Second Circuit decided not to play the “New Yorkers know best” card and instead certified the cross-jurisdictional class action tolling question to the Virginia Supreme Court.
Once again, the issue in dispute goes back to our Bone Screw days – when we first learned to hate cross-jurisdictional class action tolling. The Bone Screw MDL plaintiffs filed an unsuccessful nation-wide class action (which back then was a lot less futile than personal injury class actions have since become). Despite losing class certification, tardy Bone Screw plaintiffs around the country still claimed that their states’ statutes of limitations should be considered tolled by the unsuccessful MDL class action.