Last week, our firm blog posted a short note about how Actos patients with bladder cancer in Kentucky, Louisiana, and Tennessee should move quickly to file because those states have a one-year statute of limitations for personal injury actions. We (and a whole bunch of other lawyers) assume that Takeda Pharmaceuticals will argue that the statute of limitations began to run on June 15, 2011, when the FDA issued an updated warning that one year of Actos use increases the risk of bladder cancer by more than 40%.

As if on cue, the next day Pfizer moved for summary judgment on a whole swatch of consolidated Chantix neuropsychiatric lawsuits (not to be confused with the SSRI birth defect lawsuits), arguing that the statute of limitations for those claims began to run on July 1, 2009, when the FDA mandated the box for the medication warn that the medicine was associated with “serious neuropsychiatric events, including, but not limited to depression, suicidal ideation, suicide attempt and completed suicide …”  On that day, Pfizer also sent out a “Dear Healthcare Provider Letter” notifying prescribing physicians about the change, and there was also some media coverage. 

Pfizer concludes:

Not only is the boxed warning adequate as a matter of law, but also the date of its institution – July 1, 2009 – is the latest possible date on which all statutes of limitations began to run for any person alleging that Chantix caused him or her neuropsychiatric injuries. The July 2009 label was provided to doctors prescribing Chantix and the July 2009 Medication Guide was provided to patients taking Chantix; the warnings contained in those documents were, moreover, the subject of extensive publicity, which followed almost two years of national publicity about reports of neuropsychiatric events in Chantix patients. Thus, by July 1, 2009, at the latest, all Chantix patients were on notice sufficient to trigger the running of all statutes of limitations applicable to claims of neuropsychiatric injury.

In support of their claim that a warning label on a drug is legally-binding “notice” to everyone with a claim, even the family members of decedents who of course have no way of knowing what’s on the new label, they cobble together a variety of District Court opinions, like:

Bunting v. Bristol-Myers Squibb Co., 2011 WL 2784101, at *3 (D.N.J. 2011) (claim time-barred because plaintiffs “should have been on inquiry notice of the connection between Plavix ingestion and stomach bleeding” given “warning label”); Burrell v. Astrazeneca LP, 2010 WL 3706584, at *6 (Del. Super. Ct. 2010) (plaintiffs “‘chargeable’ with knowledge of their claims” where “scientific community [had] discovered a possible link” and defendant “had specifically warned of the potential risk in its new label and in its ‘Dear Doctor’ letters”) …; In re Vioxx Prods. Liab. Litig., 522 F. Supp. 2d 799 (E.D. La. 2007), the court ruled that the “media blitz” surrounding the withdrawal of Vioxx – preceded by media accounts reporting on the medicine’s alleged risks and resulting lawsuits – “put the plaintiffs on notice of a potential link between their alleged injuries and the use of Vioxx.” Id. at 801-02, 808. Other, similar rulings abound in pharmaceutical MDLs and cases. See, e.g., In re Trasylol Prods. Liab. Litig., 2011 WL 5417173, at *3 (S.D. Fla. 2011)(granting summary judgment given “extensive selection of national and local news outlets, including major television programs and newspapers, providing coverage of a study … published in The New England Journal of Medicine” describing risks associated with Trasylol); … In re Mirapex Prods. Liab. Litig., 735 F. Supp. 2d 1113, 1120 (D. Minn. 2010) (rejecting claim that limitations statute tolled until scientific study established causation and noting “[n]o court” has accepted that argument).

Before we get to those bad arguments, a short refresher is in order.

As I’ve discussed before, it’s very hard to sue drug companies; in most states, the ordinary tort claims like strict liability, negligence, and breach of warranty are mostly dead when it companies to prescription drugs, so injured patients are stuck with only a “failure to warn” claim. In defense of “failure to warn” lawsuits, the drug company typically argues that the drug didn’t cause the patients’ problems, that every warning label it used was sufficient, and that the company had no duty to improve its warning label to inform patients of the real risks of taking the medicine.

I suppose this argument makes sense where the drug maker denies that the drug causes the side effect in question, but what happens when the drug maker subsequently updates their label to admit the exact same side effect the plaintiffs alleged they suffered? That’s what recently happened with both Yaz / Yasmin and Propecia, the labels of which have recently been altered to admit, to some degree, the same risk of side effects the companies deny causing in the plaintiffs.

As Pfizer would have it — and I’m sure Merck and Bayer and every other pharmaceutical company in America would like to have it — drug manufacturers have no duty to investigate and to warn patients about potential side effects, but patients have a legal duty to monitor FDA labeling changes to every drug they’ve ever taken because someday the label might be changed to admit the drug caused a medical condition the patient had in the past or has now.

Some courts accept that sort of hypocrisy, in which a patient is expected to know more about the dangers of a particular medication than the company knows itself. But most don’t. Let’s unpack what’s wrong with Pfizer’s statute of limitations argument in the Pfizer case.

First, the statute of limitations is an affirmative defense, which means the burden is on the defendant to prove the statute of limitations applies and the plaintiff’s claim is time-barred. In multi-district litigation cases (like Chantix and virtually every other drug mass tort), the MDL court guide itself says, “Where federal law borrows state statutes of limitations, the law of the transferor court applies.” Accord Menowitz v. Brown, 991 F.2d 36, 40 (2d Cir. 1993). Statute of limitations in drug cases are all determined by the state law of each transferor court, which means that Pfizer should have gone through each state on a state-by-state basis to explain how, under each state’s laws, the statute of limitations would apply. You can’t just cobble together a handful of federal district court opinions and then claim victory on issues specific to each of the 50 States. On that basis alone, Pfizer’s motion should be denied.

Second, most of the cases cited by Pfizer either aren’t applicable or don’t withstand scrutiny. In the first case cited, Bunting v. Bristol-Myers Squibb Co., 2011 WL 2784101, at *3 (D.N.J. 2011), the Court did not hold that the warning label was enough to give notice. Instead, the Court defied common sense and held that the statute of limitations began running in May 2004, when the Plaintiff suffered an internal hemorrhage in his stomach, rather than April 2005, when Bristol-Myers Squibb publicly announced that Plavix, when combined with aspirin, increases major bleeding. (This sort of dismal holding has implications for patients who developed internal hemorrhaging on Pradaxa, although it’s non-binding on any other court.)

Why did the court hold that the patient had to know about the risk of internal bleedingbefore the drug company even announced it? No good reason: the Court wrongly held the plaintiff somehow had the burden to defeat the statute of limitations in his complaint, and then wrongly denied the plaintiff leave to amend to add the obvious, indisputable part about the plaintiff not knowing his injury was caused by the drug’s side effects until, at the earliest, the company admitted it. See, e.g., Bethel v. Jendoco Constr. Corp., 570 F.2d 1168, 1174 (3d Cir.1978)(“If the bar is not apparent on the face of the complaint, then it may not afford the basis for a dismissal of the complaint under Rule 12(b)(6).”). All the court had to do was allow the plaintiff to amend one line of his complaint to point out an undisputed fact and he would have been fine, but the court said no.  The ruling had nothing to do with FDA warning labels; it was just another example of the garden-variety unfairness to which plaintiffs’ lawyers in pharmaceutical cases have become accustomed, this time on the misapplication of a procedural rule.

Third, most courts, thankfully, take a far more reasonable approach to the statute of limitations. As I discussed before, the New Jersey Supreme Court recently looked at this exact issue, i.e. when the statute of limitations begins to run in drug cases, and essentially applied the standard discovery rule: the question is whether a reasonable person in the plaintiff’s circumstances would have been aware of the claim within the statutory period. Other courts, too, have looked to the reasonableness and diligence of the plaintiff, instead of assuming plaintiffs know as much about drugs as the FDA itself: “the statute of limitations is triggered not merely by knowledge of an injury but by knowledge of facts, diligently acquired, sufficient to put an injured person on notice of the existence of a cause of action against another.” Fisher v. Pelstring, 817 F. Supp. 2d 791, 838–839 (D.S.C. 2012)(a Reglan case, adding “PLIVA’s argument would mean that a plaintiff who associated temporary side effects with a drug he or she was taking and later experienced permanent side effects could be barred from recovery if the temporary side effects occurred outside the limitations period.”).

Fourth, as I mentioned back when the New Jersey Supreme Court opinion came out, there’s no reason to apply the statute of limitations to claims filed in on-going consolidated drug litigation. To paraphrase myself,  what benefit is there to society by punishing people who are unaware they have a claim? Millions of patients have no clue that a drug they took for years has now been tied to their very illness until they see an advertisement specific to their circumstances — even their doctors tend not to know until the patients see those advertisements and ask the doctors about it. Don’t laugh: I hear it once a week. Few of my Actos clients were aware of the connection between the drug and their bladder cancer until they saw an ad on TV and then mentioned it to their doctor.

We have statutes of limitations to protect defendants from stale claims where evidence has been lost and memories have faded, but neither of those concerns are even remotely present in your typical pharmaceutical mass tort case. The vast majority of the patients’ medical records are stored for decades, and the presence of on-going mass tort litigation imposes a duty on the drug company to maintain its own records, and makes litigation of late-filed claims exceedingly easy and inexpensive, because all the major issues have been resolved.

I’m confident the Chantix motion will be denied, largely given the first reason; it’s not that much to ask a multi-billion-dollar drug company to do a state-by-state analysis, considering that aircraft accident plaintiffs are asked to do it. But the fact that we even seriously entertain denying thousands of injured victims compensation for a cheap procedure trick is outrageous. The creation of consolidated litigation like a federal MDL or a state court mass torts program should, like a class action, toll the statute of limitations for all potential plaintiffs.