Preemption in the Garden State

As we flagged for you on Friday, the New Jersey Supreme Court recently issued an opinion addressing preemption and the statute of limitations in a medical device claim.  Cornett v. Johnson & Johnson, 2012 N.J. LEXIS 831 (Aug. 9, 2012).  To say the least, it had interesting rulings and raised a number of issues to discuss. 

The case involved a drug-eluting stent that was implanted in the plaintiff for an off-label indication, and the plaintiff later suffered a thrombosis and died.  Id. at *9-11.  The plaintiff’s estate made a number of state law claims alleging improper warnings, manufacturing and design defects, improper off-label promotion and the like.  Id.  The statute of limitations and preemption issues eventually made their way to the New Jersey Supreme Court. 

Statute of Limitations

On the statute of limitations defense, the Court held that the plaintiff’s claims were barred by Kentucky’s one-year statute of limitations.  The opinion has a detailed choice of law analysis (between Kentucky and New Jersey law) that we won’t address here.  What was more interesting to us was the Court’s ruling that a plaintiff exercising due diligence should have known by December 2006 that the stent may have caused Mr. Cornett’s thrombosis.  December 2006 is when an Advisory Committee assembled by the FDA made findings related to plaintiffs’ claims, including that thrombosis from drug-eluting stents (like the defendants’) was a problem, the problem was greater when the stent was used off-label (as with the plaintiff), and drug therapy after the device is implanted should last for an extended period of time.  Id. at *28. 

With this ruling, the New Jersey Supreme Court has placed significant importance on Advisory Committee findings when considering when the statute of limitations starts to run in a product liability case.  Often the devices and drugs involved in product liability litigation have been the subject of FDA Advisory Committee meetings, and often those meetings address issues related to plaintiffs’ claims.  Now, in New Jersey, their findings may be a significant tool for weeding out time-barred claims. 

Preemption

The Cornett complaint was a consolidated complaint with over 40 other plaintiffs whose claims were not time barred.  So the Court was able to go beyond the statute of limitations to address preemption under the Medical Device Act (“MDA”) amendments to the FDCA. 

First, some general propositions about medical device preemption: Section 360k(a) of the MDA states that it preempts state law claims that address the safety and efficacy of a device and impose requirements that are “different from or in addition to” FDA regulation.  In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the US Supreme Court held that §360k(a) preemption does not apply if the FDA cleared the device under §510k.  (You may recall that we just recommended some light summer reading that reexamines whether Lohr’s reasoning should still apply.)  In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the Court held that §360k(a) preemption does apply if the device was approved under the FDA’s more rigorous Premarket Approval (PMA) process.  Finally, in Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), the Court held that – in situations in which §360k(a) express preemption doesn’t apply, such as with a device cleared under §510k – FDA regulations nonetheless implicitly preempt state law claims, in particular fraud-on-the-FDA claims, that improperly impact the balance struck by the FDA’s regulatory scheme. 

As for the Cornett case, it does not involve a device cleared under §510k.  The drug-eluting stent was approved under the PMA process.  This implicates §360k(a)’s express preemption under Riegel.  Lohr is irrelevant, as likely is Buckman and its implied preemption given that express preemption is already in play.

In its preemption analysis, the Cornett Court considered two claims, failure to warn and breach of an express warranty.  While the Court found significant portions of each of these claims preempted, it allowed limited parts to go forward. 

Plaintiffs’ Failure to Warn Claim

On the failure to warn claim, the Court held as preempted plaintiffs’ claim that the label lacked necessary information on the fact that comparative studies were not conducted on the stent and that drug therapy should be used for an extended period of time after the stent is implanted.  This was an easy one.  The claim goes to the heart of the FDA’s approval process and the Court saw through it:

This claim is nothing more than a challenge to the adequacy of the information required by the FDA during the PMA process and the label approved by the agency.  This failure to warn claim falls within the PLA rebuttable presumption [we’ll get back to this] and the Riegel express preemption rule.  We affirm its dismissal.

Id. at *45. 

The Court also properly dismissed plaintiffs’ failure to warn claim based on an allegation that “defendants obtained FDA approval for the device only after submitting fraudulent representations to or withholding material information from the FDA,” citing Buckman.  We agree that this claim is properly preempted.  But we also note that this isn’t a 510k case in which §360k(a) express preemption doesn’t apply.  It’s a PMA case, and §360k(a) express preemption does apply under Riegel.  That is likely all that’s necessary, not implied preemption under Buckman. 

Our real concern, though, is the Court’s decision not to preempt plaintiffs’ claim that the defendants (1) withheld from doctors and the public the fact that the label’s instructions for post-implementation drug therapy were not part of the PMA process and (2) made misrepresentations to doctors and the public that the stent was not pro-thrombotic.  Id. at *47-48.  The Court reasoned that this claim was not preempted because it “overcomes the PLA’s rebuttable presumption of adequacy.”  Id. at *48.  In other words, the complaint’s allegations, for pleading purposes, were enough to overcome the NJ Product Liability Act’s presumption that an FDA-approved label was adequate. 

But that doesn’t seem to be the issue.  Before the PLA’s presumption should be considered, the determination first should be made as to whether PLA can even be applied – that is, whether it is preempted.  And a claim of failure to warn doctors and the public is preempted under Riegel.  While the PLA and its presumption might eventually be relevant in a prescription drug case where there generally is no express preemption, this is a medical device case – one that involves the PMA process and Riegel’s express preemption.  What is and is not involved in the PMA process, what is said about that to doctors and the public, and what is said about post-implementation drug therapy or the dangers and safety of the product (here, it allegedly being pro-thrombotic) are all in the wheelhouse of the FDA’s regulatory scheme. 

For instance, the FDA-approved label, according to the Court, already addressed post-implementation drug therapy.  Id. at *12.  Requiring further disclosure to doctors and the public about what the FDA considered or didn’t in granting that approval is something for the FDA to determine.  The fact that is has not done so does not act to allow the plaintiffs’ claim.  It only underscores that plaintiffs’ claim is preempted as imposing requirements different from or in addition to what the FDA required.

The Court next addressed plaintiffs’ failure to warn “concerning off-label uses . . . based on a failure to warn the medical community and the general public of adverse information gathered about the device and that instructions for post-implantation therapy were not part of the PMA process.”  Id. at *48.  The Court held that, “[t]o the extent [this] claim is founded on promotion by defendants of off-label uses of the device beyond the [FDA’s] safe harbor [for off-label promotion], the claim is not preempted.”  In other words, if the defendant’s off-label statements do not fall under a safe-harbor created by the FDA for off-label statements, then it is not preempted.

We also question this decision.  The FDA has had a lot to say about off-label promotion.  The Cornett decision cites some of it.  FDA regulations require manufacturers to warn about off-label uses in certain circumstances.  Id. at *35.  There is a safe-harbor for off-label promotion that was previously codified in the United States Code and has since been adopted by the FDA in a guidance document.  It  says that the Secretary of HHS won’t consider a manufacturer’s dissemination of information on unapproved uses to be off-label promotion if certain conditions are met.  Id. at *33-35.  And, as described above, the FDA convened an Advisory Committee to address off-label use and post-implementation drug therapy for the very stent at issue in this litigation.  There is no doubt that the FDA regulates off-label promotion and was actively doing so for this device.  Even the Riegel case, which established express preemption, involved off-label use.  552 U.S. at 320.

And we don’t see how the plaintiffs alleging off-label promotion “beyond the safe harbor” somehow exempts plaintiffs’ failure to warn claim from §360k(a)’s express preemption.  Falling within the safe harbor simply means that the FDA itself will not consider the statements to be evidence of off-label promotion.  It doesn’t mean that statements outside the safe harbor are off-label promotion.  It just means that the FDA considers them evidence of off-label promotion.  The ultimate determination is for the FDA, not private litigants.  And the United States, not private litigants, enforce the FDCA and FDA regulations.  (Setting that aside, it’s not clear how, in Cornett, falling outside the safe harbor matches up with a failure to warn claim.) 

Now, plaintiffs may argue that by invoking the safe harbor they are making a parallel violation claim, which is arguably permissible under Riegel.  But that doesn’t seem to work either.  The FDA hasn’t determined that the alleged off-label promotion in Cornett violated any FDA requirements.  And, failure to satisfy the safe harbor doesn’t create a violation either.  So plaintiffs aren’t really seeking to enforce an FDA requirement.  They can’t be making a parallel violation claim.  In short, they are seeking to enforce a requirement “different from or in addition to” FDA requirements. 

Plaintiffs’ Breach of Express Warranty Claim

Plaintiffs alleged that the defendants breached express warranties that were created by the labeling and packaging.  The Court quickly dismissed this claim as preempted under Riegel:

Plaintiffs contend that the MDA does not preempt an express warranty claim based on the information contained in FDA approved product labels and packaging inserts.  We disagree. . . . [I]n order to succeed on the breach of express warranty claim, plaintiffs must show that the label provides inaccurate or insufficient information in spite of FDA approval following the rigorous PMA process. Success on this state law claim would inevitably impose greater requirements than those already established by the MDA.  This claim is, therefore, preempted.

Id. at *51-53. 

The Court, however, also held that an express warranty claim based on statements voluntarily made to third parties and that “deviated from the labeling and instructions” are not preempted.  Id. at *53.  This seems, if we understand it correctly, to be an attempt to again make a parallel violation claim.  But it doesn’t seem to be a fit, at least not based on the information in the opinion.  A manufacturer can make statements that are not in the labeling.  Now, it may be that some of those would violate FDA regulations.  But that doesn’t mean that any deviation from the labeling is a violation.  And without any particulars, it’s not clear that plaintiffs properly stated a parallel violation claim for breach of express warranty. 

                              *                   *                 *                 *                             

All this said, there is still hope for preemption of the claims that remain after the Court’s decision.  The Court more than once qualified its decision by saying that it was being indulgent to plaintiffs’ allegations on a motion to dismiss [in state court, by the way, where TwIqbal doesn’t apply].  Discovery may reveal further information establishing that plaintiffs’ remaining claims are, as we discussed above, preempted.  Id. at *49-50, 53.  We think that, come summary judgment time, Defendants will have a good chance of establishing that the remaining claims are in fact preempted too.

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.

Suspicion Starts the Clock

            Suspicion.  It is the stuff of great movies.  We could name just about any Hitchcock movie here, but why not go with the aptly titled Suspicion starring Cary Grant and Joan Fontaine (who by the way won the Best Lead Actress Oscar for her role in this film).  After a chance meeting on a train, Johnnie Aysgarth, reckless gambler and playboy, and Lina McLaidlaw, shy heiress, have a whirlwind romance and are married.  It is only after the honeymoon that Lina discovers her new husband’s true character and she starts to become suspicious that he is a murderer and she is his next intended victim.  Cue eerie music. 

It is also the stuff of great songs.  And here we could quote any of a number of country hits about cheating spouses and double-crossing gamblers.  But, again, why not go straight for the most obvious.  Suspicious Minds was Elvis Presley’s seventeenth and last number one hit single.  Written and originally recorded by Mark James (who also wrote Grammy-winning “Always on My Mind”), the song is about two people whose suspicions of one another are ruining their relationship.

Which brings us to today’s case – Messina v. Amylin Pharmaceuticals, Inc., 2011 U.S. Dist. LEXIS 153392 (W.D. Pa. Dec. 30, 2011) -- which is all about suspicions.  While we typically don’t spend much time on statute of limitations cases, we liked the message of this case which is rooted less in state law and more in general common sense. 

Plaintiff was prescribed Exenatide, commonly known as Byetta, for treatment of her diabetes.  The Byetta warning label included acute pancreatitis as a possible adverse reaction.  Id. at *3.  Plaintiff was diagnosed with pancreatitis in March 2007 and hospitalized for treatment for almost two months.  Shortly after her discharge in June 2007, she retained her attorney to investigate the matter.  Id. at *2.  Her attorney filed suit against the drug manufacturers on November 18, 2009 – more than two years after being retained.  Id.

Pennsylvania has a two year personal injury statute of limitations.  Like many states, Pennsylvania has also adopted the discovery rule – meaning the “running of the statute is tolled until the injured party is reasonably aware that her injury has been caused by another’s conduct.”  Id. at *5 (citation omitted).  A party must also exercise “due diligence” in becoming aware.  Id. at *7.   To the lay person, the answer to when someone knew something may seem fairly straightforward and due diligence can be as easy as asking your wife “what year did we vacation in the Keys?”  In the legal arena, however, what constitutes “reasonably aware” is the question most often at the heart of drug and device statute of limitations cases.  And, as with the Messina case, plaintiffs often want to argue that their own suspicions are trumped by medical certainty.  Fortunately, this court didn’t agree.

Plaintiff testified “that she believed Byetta caused her injury when she was discharged from the hospital in June, 2007.”  Id. at *7  This would be enough for us and it was enough for the court too:

Given Plaintiff's testimony that she subjectively attributed her injury to Byetta at that time, she was clearly on at least inquiry notice, i.e., her belief was sufficient to trigger running of her two-year statutory period to investigate.

Id.  Plaintiff’s counsel tried to muddy the waters with testimony from plaintiff’s mother that while her daughter was in a coma “her physicians did not tell [plaintiff’s mother] that Byetta did not cause her daughter’s pancreatitis and she did not know if [the doctors] were sure what caused it.  Id. at *8-9.  That’s a lot of double negatives.  Her doctor’s certainty wasn’t the trigger.  Plaintiff’s suspicions were.  Whether that suspicion was specifically that Byetta caused her injury or a more general suspicion that “something went wrong with her care” – the time for plaintiff to investigate started to run.  And because plaintiff had retained counsel, that duty to investigate applied equally (if not more so) to her counsel:

[Plaintiff] and [her] counsel on [her] behalf were obliged to make adequate inquiry during the two (2) year period applicable under Pennsylvania law, to form/substantiate reasonable beliefs as to the cause of Plaintiff's injuries and any resultant potential legal liability, and to file the appropriate actions in the appropriate courts. Counsel's failure to file the Complaint against Defendants within the statutory period leaves this Court no alternative but to hold the action time barred.

Id. at *9.

Pennsylvania actually has a fairly long history of cases that support the proposition that, absent an affirmative diagnosis to the contrary, the plaintiff’s subjective suspicion satisfies the discovery rule.  See Danysh v. Eli Lilly & Co., 2011 U.S. Dist. Lexis 104997 (Mag. M.D. Pa. July 13, 2011) (summary judgment granted on statute of limitations grounds, holding that knowledge of the precise cause of injury is unnecessary to the discovery rule); Debiec v. Cabot Corp., 352 F.3d 117 (3d Cir. 2003) (summary judgment affirmed in one of four consolidated cases; a definitive medical diagnosis is not necessary to start the statute running when a plaintiff suspects he or she has been injured and believes he or she knows the cause of her injury; where plaintiff did not receive a definitive negative diagnosis, he should have investigated his condition further and had additional tests);  Russo v. Cabot Corp., 2002 U.S. Dist. Lexis 12134 (E.D. Pa. Apr. 22, 2002) (summary judgment granted where decedent was suspicious and began collecting newspaper clippings about possible links to beryllium disease; suspicions obligated her to investigate her potential claim); Love v. Raymark Industries, Inc., 633 A.2d 1185 (Pa. Super. 1993) (knowledge of a “dirty lung” and a diagnosis of lung cancer, combined with the plaintiff’s suspicion that both were related to occupational exposure to asbestos, satisfies the discovery rule; even if plaintiff was not informed of the cause by his physicians, it was unreasonable as a matter of law for him not to make inquiry); McD v. Rosen, 621 A.2d 128 (Pa. Super. 1993) (the statute begins to run when the injured party possesses sufficient critical facts to put him on notice that a wrong has been committed and that he need investigate to determine whether he is entitled to redress);  Stauffer v. Ebersole, 560 A.2d 816 (Pa. Super. 1989) (while a speculative diagnosis may have been insufficient in and of itself to satisfy the discovery rule, it activated a duty on plaintiffs’ part to pursue whether the injury was caused by an outside act or otherwise a potential plaintiff with a tentative diagnosis could wait indefinitely).

          While the suspicion of movies and music makes for good entertainment, plaintiffs in products cases (at least in Pennsylvania) should take their suspicions seriously.

A Word of Caution

As people we strive to be honest and fair.  As lawyers we strive to be honest, fair and zealous.  We strive to do what is right for our clients and sometimes that can push us to take risks that lead to the development of new legal precedent.  Sometimes it can push us to make arguments that are cutting-edge and innovative.  It is one of the reasons we blog – to share those victories with a broader audience. 

Sometimes, however, our zealous advocacy can get the best of us and cause us to make arguments that in hindsight were ill-conceived.  Typically on this blog we are pointing out the not-so-sound tactics of plaintiffs’ counsel.  But, it is important to self-reflect as well.  To be aware of our own missteps.  Plaintiffs’ attorneys surely pick apart our errors looking to gain any advantage they can, so we can’t just sweep them under the rug.  Not every case is a winner. But, if there is a lesson to be learned, we should learn it so we don’t repeat it.  

Today’s lesson – don’t make arguments that make you appear “disingenuous.”  Unfortunately, that is the word the court used in Cates v. Stryker Corp., 2012 U.S. Dist. Lexis 9825 (E.D. Ten. Jan. 27, 2012).  

            The case involved a pain pump implanted in plaintiff’s shoulder following arthroscopic surgery.  The pump delivers an anesthetic to control post-surgical pain.  Plaintiff alleged that the pain medication was actually toxic to the shoulder cartilage leading to a condition known as glenohumeral chondrolysis, which causes constant pain, loss of full use of the shoulder/arm and can require a shoulder replacement.  Id. at *3-4.  The surgery took place in 2005 and plaintiff filed suit in 2010, so the defendant moved to dismiss the plaintiff’s negligence and strict liability claims as barred by Tennessee’s one year statute of limitations.  Id. at *6. 

            Because Tennessee applies the discovery rule to determine when the statute of limitations begins to run – the issue in this case is when plaintiff could have reasonably discovered that his injuries were related to defendant’s pain pump.  And here’s the rub.  In its pleadings – presumably in response to allegations about failure to warn – the defendant stated that “the [medical] literature notes that the cause of chondrolysis is multifactorial and the role of pain pumps in the development of chondrolysis has not been established.”  Id.  at *8.  And there was apparent support for this assertion:

Moreover, as recently as November 2009, the FDA issued a statement to the effect that the cause of chondrolysis in the shoulder, even when infusion pumps are prescribed, is unknown.

Id.  (citation omitted).

            With these statements on the record, the court was unpersuaded by defendant’s argument that plaintiff’s claims were time barred because the plaintiff “should have discovered his injury based on the wealth of scientific information available.”  Id.  The court went on to say: 

It is disingenuous for [defendant] to argue that the role of pain pumps in causing chondrolysis is not clear to trained medical people, yet argue that [plaintiff], a layperson with no medical training, should have discovered that the use of a pain pump may have caused his continuing shoulder problems. 

Id. at *8-9.  

Either the state of medical knowledge is in flux and therefore, defendant could not reasonably warn of an unknown risk or there was sufficient information available for plaintiff to have discovered the alleged causal link between the device and his injuries.  But, you can’t have it both ways.  So, our word of caution – if one of your defenses is that causation was scientifically unknowable, it’s not a good idea to turn around and make the opposite argument regarding the discovery rule and the statute of limitations.  Not only are you likely to lose your statute argument, you may also lose credibility with the court.

Even in Minnesota, You Can't Do That

We're involved in HT litigation, so we can't comment much, but readers will want to look at Rick v. Wyeth, Inc., ___ F.3d ___, Nos. 3354, et al., slip op. (8th Cir. Oct. 25, 2011).  Trying to take advantage of Minnesota's notoriously long statute of limitations, the plaintiffs, who had originally filed in their home state (New York), filed diversity actions in the District of Minnesota, as soon as the defendant moved for summary judgment on the original, state court action based on their home state's statute of limitations.  The defendant won the summary judgment motion in the plaintiffs' home state.  In Minnesota federal court, the plaintiff argued that the home state ruling was "procedural" and didn't require dismissal.  The district court agreed with the defendant and held that the home state ruling required dismissal on grounds of res judicata.

Well, now the Eighth Circuit has affirmed, holding that, where the defendant has obtained a final order of dismissal of a plaintiff's original action under the plaintiff's home state statute of limitations, that order also requires dismissal of any subsequent action filed in Minnesota in an attempt to take advantage of the longer statute of limitations.  Rick, slip op. at 8-9.

The Rick ruling should put an end to at least one form of shennanigans involving the Minnesota statute of limitations (now changed by statute, by the way, but only prospectively) no matter what product is involved.

Mirapex - Daubert Inapplicable To Toll Statute of Limitations

We don't generally cover statute of limitations-type issues (except for class action tolling) because they tend to be too state-specific and fact-bound to be of much general use.  We're making an exception for today's decision in Gazal v. Boehringer Ingelheim Pharmaceuticals, No. 10-3129, slip op. (8th Cir. July 28, 2011), because it decides a statute question we've seen raised in any number of jurisdictions.  That's whether a plaintiff, knowing full well what he thinks is happening, is allowed to delay suit under until the scientific proof of causation would satisfy the relevant Daubert standard of the jurisdiction.

Gazal provides a resounding "no" to that question, meaning that tardy plaintiffs can't hide behind Daubert to excuse their failure to file suit in a timely fashion.  The plaintiff in Gazal was an Australian national who was prescribed Mirapex in Texas, where he "owned property."  He proceeded to gamble away lots of his money, and he tried to blame Mirapex for not being able to stay out of casinos.

For statute of limitations purposes, the key undisputed fact is this:  "[Plaintiff] admitted that at some point in late 2005, he became aware that Mirapex was linked to, and might cause, compulsive gambling."  Slip op. at 2.  He didn't file suit, however, until June 2009.

Dead to rights under the Texas two-year statute of limitations, plaintiff tried to argue that his claim didn't "accrue" until there was scientific evidence sufficient to satisfy Texas' version of Daubert, which was imposed in Merrell Dow Pharmaceuticals, Inc. v. Havner, 953 S.W.2d 706 (Tex. 1997).  Thus, plaintiff was trying to take pro-defense rule (Havner is relatively strict about causation standards and scientific proof), flip it, and use it to his own advantage.

The Eighth Circuit (Texas is in the Fifth, but due to the marvels of MDL litigation, the Eighth Circuit handled the appeal) said "don't mess with Texas" and affirmed summary judgment.  Accrual for the statute of limitations is based upon consideration of notice, not on issues of ultimate proof:

[O]bjective verification of causation, in the form of an epidemiological study that meets the Havner standard, is not a predicate that must be established for a claim to accrue.  Havner considered what weight ought to be given to particular epidemiological studies in determining whether the plaintiffs’ causation evidence was legally sufficient under the “more likely than not” burden of proof.  It did not speak to the minimum notice a plaintiff must have before a particular claim accrues and does not bear on the particular issue before us.

Gazal, slip op. at 6.  Rather, what mattered for statute of limitations purposes was that the plaintiff admitted his own subjective notice of his allegations concerning Mirapex and compulsive gambling.  Id.

Since we've seen similarly knowingly tardy plaintiffs make the same argument in reliance upon any number of non-notice related elements of proof (from malpractice expert certifications to limited tort injury severity), we're pleased to see an appellate court affirm, in cogent fashion, just what the statute of limitations is all about.  So we thought we'd pass it along.

Snowbird Can’t Escape The Statute of Limitations She Left Behind

It’s cold here in Philadelphia and in much of the country. Really cold, your-car-makes-weird-noises-you-start-it cold. When it’s this cold up here, people start fantasizing about moving to Florida and leaving their snow shovels, rock salt, hats, coats, gloves, and all that behind.

Is there a point to this about drug and device law, you may wonder? Yes, there is. Like those constricting coats and scarves that keep us warm but limit our freedom of movement, many states in the Northeast and middle Atlantic states have two-year statutes of limitations for tort claims. But Florida, a sunnier land for tort plaintiffs, has a four-year statute. And snowbirds with potential causes of action might think that they left their home state’s restrictive statute of limitations behind with their snowblowers when they moved to Florida. Chapman v. Depuy Orthopedics, 2011 WL 149329 (M.D. Fla. Jan. 18, 2011), shows that ain’t necessarily so.

The plaintiff in Chapman had her hip replaced in 1995, when she lived in Virginia. She moved to Florida in 2000 and was treated by a Florida doctor, although he sent her x-rays back to her doctor in Virginia. In late 2006, a fatigue fracture was detected, and the injury manifested itself and was discovered in Florida. She returned to Virginia for treatment and had another hip replacement there in 2007. She sued Depuy in Florida in June 2009, more than two years, but less than four years, after detection of the problem with her replacement hip. Depuy moved for summary judgment, arguing that her claim was untimely under Virginia law. Plaintiff argued that she left Virginia’s statute of limitations behind and that Florida’s statute of limitations applied.

The court applied Florida’s choice of law rules to decide which state’s law to apply. Florida follows the “most significant relationship” test, which considers a bunch of factors. The bad news for Depuy is that the place of injury is usually considered the key factor in tort cases, and some judges stop their analysis right there.

But usually does not mean always. The Chapman court found “that the place where the injury occurred is little more than happenstance under the circumstances presented here.” Id. at *2. The court relied on the facts that plaintiff received her replacement hip in Virginia, had follow up care there from 1995 to 2000, had her x-rays sent there after she moved to Florida, and returned to Virginia for treatment when the hip failed in 2006. Id. The only factor favoring Florida was that the injury manifested itself and was discovered there, but that did not override the other factors. As a result, the court held that “Virginia, the state where the product was delivered and where all the significant medical services were rendered, has a greater interest in applying its law to determine the duties and liabilities arising from those activities than Florida.” Id. at *3.

That was the ballgame for plaintiff. The clock on her claim unquestionably started to run in December 2006, when the fatigue fracture was found, and her June 2009 lawsuit was therefore too late under the Virginia statute of limitations. Id.

A tip of the hat to David Walz of Carlton Fields, who alerted us to this little gem.