Thursday, December 31, 2009

Them's The Breaks

A recent case, Koger v. Synthes North America, Inc., 2009 WL 5110780 (D. Conn. 2009), underscores what should be a simple fact of life in product liability litigation involving orthopedic implants in particular, and implanted medical devices in general – plaintiffs shouldn’t expect to get anywhere with nothing more than a broken device.

That’s because the environment inside the human body is really hostile. For an orthopedic implant, the repetitive stress of everyday movement will inevitably cause anything metal to give way to metal fatigue over time – particularly if the implant is weight bearing, and especially if there’s a medical complication such as non-union of a fracture. For any electronic implant, being inside the body is like constantly being submerged in salt water. If you’ve ever dunked a camera or a non-water-resistant watch in the ocean, then you know how well that’s likely to turn out. Trying to maintain device integrity against not only salt water, but the combined assault of bodily immunity and other defenses against foreign objects is a constant, uphill battle against the best that billions of years of evolution have been able to come up with.

To put this all in legal terms, we think that the various stresses of bodily environment should always be – as a matter of law – a “reasonable secondary cause” of device failure in any implant case that would preclude using any form of res ipsa loquitur or "malfunction" theory.

That’s pretty much what Koger did. The case involved orthopedic bone screws used for internal fixation of a fracture that the plaintiff received in a motor vehicle accident. Almost two years after the screws were inserted, an x-ray showed that they had broken. Other medical tests indicated a “non-union” – that is, that the fracture had failed to heal. 2009 WL 5110780, at *1. That’s not good. People can disagree over whether non-union is beneficial in the workplace, but there’s no disagreement that non-union’s a bad thing for a bone fracture.

Plaintiff sued the manufacturer of the broken screws. For whatever reason – not wanting to invest money in a lousy case, inability to find an expert willing to offer a defect opinion in a two-year non-union case, sheer lassitude – the plaintiff in Koger tried to get by summary judgment without any expert at all. The plaintiff’s argument was simple: the device broke, therefore a jury could find it defective. That’s res ipsa loquitur.

And it's a bunch of hooey.

The court, quite correctly, concluded that the plaintiff’s theory was simply wrong. Res ipsa loquitur isn’t available in a “complex” situation, such as the performance of an implanted medical device. Koger, 2009 WL 5110780, at *3. The effects of the non-union was a possible alternative cause that could not be eliminated:

[P]aintiff’s case requires complex medical and technical expert testimony to determine whether the breakage occurred as a result of a defect or a nonunion. According to the record, it appears more probable than not that a nonunion occurred. Thus, absent expert testimony, plaintiff cannot adduce sufficient proof of her claim to survive summary judgment.
Id. That’s it, short and sweet.

And not only short and sweet, but in accordance with the great weight of well-reasoned precedent. For instance The Wyoming Supreme Court reached essentially the same decision in Rohde v. Smiths Medical, 165 P.3d 433, 438 (Wyo. 2007) (our prior post here), where the plaintiff claimed a defect could be “inferred because a medical device fractured while implanted in his body.” The court held that it was plaintiff’s burden to eliminate all reasonable secondary causes for a device failure, and that if the case was so bad that the plaintiff couldn’t find an expert – too bad. Allowing mere device failure to create a jury submissible case would “unduly expand” product liability:

[Plaintiff] suggests that products liability plaintiffs should not be required to present evidence that secondary causes did not cause the product’s malfunction because, in any given case, there are innumerable possible causes and it is unduly burdensome for plaintiffs to disprove all of them. He claims it should be enough to establish that the device malfunctioned. . . . [Plaintiff] overstates the burden imposed on plaintiffs by the inference of defect rule. In this case, [defendant] presented evidence of a reasonable secondary cause. . .[thus plaintiff ] was not required to disprove numerous or vague secondary causes. . . .

We recognize it may have been difficult for [plaintiff] to meet the challenge of showing a specific defect. . . . Nevertheless, if the [device] was defectively designed making it prone to fracture then, presumably, he could have located an expert to analyze the design and provide his opinion. . . . [Plaintiff’s] failure to meet his burden to establish a specific defect or an inference of defect. . .does not justify expanding the inference of defect rule to allow a plaintiff to proceed to trial simply because the product failed. Such a holding would unduly expand product liability jurisprudence without justification.
165 P.3d at 440. An appellate court in Tennessee reached the same conclusion over a decade earlier. Fulton v. Pfizer Hospital Products Group, Inc., 872 S.W.2d 908, 911-12 (Tenn. App. 1993) (“the product in dispute is a technically complex medical device”; although it broke, “res ipsa loquitur is not a substitute for proof of defect”); see King v. Danek Medical, Inc., 37 S.W.3d 429, 435 (Tenn. App. 2000) ("the failure or malfunction of the device, without more, will not make the defendant liable"). See Guillory v. Employers Mutual Liability Insurance Co., 411 So.2d 504, 506 (La. App. 1982) (res ipsa loquitur inapplicable, given other possible causes for broken device, including misuse and use of wrong sized product).

Similarly, in Stilwell v. Smith & Nephew, Inc., 482 F.3d 1187, 1193 (9th Cir. 2007), the plaintiff “ask[ed the court] to blindly accept the [product’s] failure before her fracture healed as prima facie evidence that they were defective.” The court (as might be expected from its use of the adverb “blindly”) refused. Even with an expert, the plaintiff had nothing to establish any definite “duration of [the device’s] use” as a weight-bearing implant. Id. at 1194.

[Plaintiff] failed to explain the defect that formed the basis for her claim. She seemed to suggest that, at a minimum, the second [implant] should have performed for longer than it did, but she did not rely on any record evidence to support that contention. She has repeatedly reminded us that her treating physicians testified that [implant] failure is rare, yet rarity does not indicate infallibility. [Plaintiff’s] vague arguments regarding the expected life of the [implant] thus do not refute [defendant’s] evidence that the [implant] performed as intended in this case.
Id. at 1195-96 (also citing patient smoking as a secondary cause). See White v. Howmedica, Inc., 490 F.3d 1014, 1016 (8th Cir. 2007) (fragmentation of device after six years of implantation “not something that is so generally recognizable as to qualify under the so-called common knowledge exception”) (applying Nebraska law); Rolon-Alvarado v. Municipality of San Juan, 1 F.3d 74, 79-80 (1st Cir. 1993) (res ipsa loquitur not applicable broken medical device situation) (applying Puerto Rico law).

One of our favorite cases – Riegel itself – also rejected a claim that the fact that the now-famous catheter burst was sufficient circumstantial evidence of a defect – given that the physician both overinflated the device and put it to a contraindicated use:

We agree with the district court that [plaintiffs] did not come forward with competent evidence excluding [defendant’s] proffered causes as the origin of the [failure. It is undisputed that [the prescriber], in performing [surgery], inflated the balloon catheter. . .beyond the maximum rated burst pressure explicitly specified on the device label. . . . Although it may well be that inflating the balloon catheter up to ten atmospheres was the best decision under the circumstances, this does not indicate that the inflation was not the cause of the catheter’s rupture. It is similarly undisputed that [plaintiff] had heavily calcified arteries, and that the label for the [device] contraindicated its use in such an instance . . . . [T]his does not mean that in this particular instance, we can exclude the calcified nature of [plaintiff’s] artery as a cause for the catheter’s rupture.
Riegel v. Medtronic, Inc., 451 F.3d 104, 125-26 (2d Cir. 2006), aff’d on other grounds, 552 U.S. 312 (2008) (you know what).

Likewise, a break did not equate to a defect in Reed v. Biomet Orthopedics Inc., 318 Fed. Appx. 305, 307 (5th Cir. 2009) (applying Louisiana law), in the absence of any expert testimony “that would suggest a material deviation from [defendant’s] production standards or identical products.” The same argument – “the fact that the [implant] failed is significant evidence of a defect” – was rejected in Yanovich v. Zimmer Austin, Inc., 255 Fed. Appx. 957, 966 (6th Cir. 2007) (applying Ohio law). “Circumstantial evidence” (another way of saying res ipsa loquitur) was unavailing, because an implantable medical device isn’t the same as a tire. Given that the plaintiff couldn’t say that other devices would have failed under the same circumstances (plaintiff’s “biometrics” and implant technique), he “failed to eliminate other potential causes for the. . .breakage.” Id.

Harrison v. Howmedica Osteonics Corp., 2008 WL 906585 (D. Ariz. March 27, 2008), produced a similar result even though that plaintiff had an expert. The expert didn’t give any real opinions – he didn’t opine exactly how much longer a “nondefective” device should have remained intact, only that it would have been longer than what happened in this case. Id. at 11. The device was defective because of “the fact that it broke.” Id. at *12. Essentially this wasn’t any opinion at all, just res ipsa parroted by an expert, and it was thrown out on Daubert grounds. Id. at *15-18. The court then granted summary judgment, observing that there was no evidence either of how long the device was intended to last, or how long bony union would have taken. Because “[i]nferences cannot be drawn out of thin air,” summary judgment was appropriate.  Id. at *26.

And we've got lots more (that's why anybody who's still reading this is still reading it).

A raft of other district court opinions agree that a medical device is not defective just because it broke or otherwise malfunctioned. Hare v. Hoveround Corp., 2009 WL 3086404, at *7 (N.D.N.Y. Sept. 23, 2009) (“the fact that a product does not operate properly does not by itself mean that the product was defectively designed”) (wheelchair); Harrington v. Biomet, Inc., 2008 WL 2329132, at *5 (W.D. Okla. June 3, 2008) (“circumstantial evidence [eleven dislocations] does not support an inference that a defect in the. . .[device] was probable”); Mead v. Synthes Spine Co., 2007 WL 1530114, at *4 (E.D. Mo. May 22, 2007) (“plaintiff has not presented sufficient circumstantial evidence”; “it is well-known that the devices will fail if fusion does not occur”); Hall v. Johnson & Johnson, 2006 WL 1096940, at *3-4 (D.N.J. April 25, 2006) (“premature failure" of device did not excuse need for expert testimony on defect; “[w]ithout expert testimony, the average lay juror has no grounds to know if an implant should last two, five, or twenty years”); Evans v. Mentor Corp., 2005 WL 1667661, at *2-3 (E.D. Va. June 28, 2005) (“circumstantial evidence that a product defect may have caused the [failure] is speculative at best and cannot establish that plaintiff's injuries were probably caused by a product defect”); Enlow v. St. Jude Medical, Inc., 327 F. Supp.2d 738, 743 (W.D. Ky. 2003) (“res ipsa loquitur analysis is ill-suited to this and most product cases involving the use of medical devices”); Webster v. Pacesetter, Inc., 259 F. Supp.2d 27, 32 (D.D.C. 2003) (“one cannot presuppose the existence of a defect solely on the basis that unintended or undesirable results have occurred”); Muller v. Synthes Corp., 2002 WL 460827, at *8 (N.D. Ill. March 26, 2002) (“[t]he mere fact plaintiff’s [devices] both cracked does not lead to an obvious conclusion of defective design”); Prohaska v. Sofamor, S.N.C., 138 F.Supp.2d 422, 443 (W.D.N.Y. 2001) (broken device case; “a design defect claim cannot be established simply on the basis of a product's inherent risks”); Minisan v. Danek Medical, Inc., 79 F. Supp.2d 970, 977 (N.D. Ind. 1999) (“[i]t is a known fact in the medical community that [a device] may break due to a number of factors unrelated to any defect”; “if this Court assumes as fact that the fracture of the [device] did directly cause continuing pain and discomfort that necessitated further surgery, this does not mean that ipso facto the device was defective”); Samarah v. Danek Medical, Inc., 70 F. Supp.2d 1196, 1203 (D. Kan. 1999) (“plaintiff essentially requests the court to infer the existence of a defect in defendants’ product solely from the fact that plaintiff sustained an injury. . . [S]uch proof is inadequate to establish a viable products liability claim”); Menges v. Depuy Motech, Inc., 61 F. Supp.2d 817, 827 (N.D. Ind. 1999) (that three surgical screws broke “does not mean that ipso facto the device was defective”); Sita v. Danek Medical, Inc., 43 F. Supp.2d 245, 257 (E.D.N.Y. 1999) (“the fact that a medical device broke is not proof of a defect”); Savage v. Danek Medical, Inc., 31 F. Supp.2d 980, 983 (M.D. Fla. 1999) (the “conclusion reached by Plaintiffs, however – that because the [device] is loose. . .[it] is a fortiori defective – is a faulty one”); Ontiveors v. Danek Medical Group, Inc., 1999 WL 1129651, at *4 (D. Utah Aug. 3, 1999) (“fact that [the device] broke, in the absence of other evidence, is not sufficient to establish a defect”); Carter v. Danek Medical, Inc., 1999 WL 33537317, at *8 (W.D. Tenn. June 3, 1999); (“a device failure or malfunction will not, without more, render a manufacturer liable”) (there are over a dozen more identical cases for this point in Tennessee); Clark v. Danek Medical, Inc., 1999 WL 613316, at *3 (W.D. Ky. March 29, 1999) (“[s]imply because non-union occurs in this case does not tend to suggest that the device is defective”); Mozes v. Medtronic, Inc., 14 F. Supp.2d 1124, 1129 (D. Minn. 1998) (“res ipsa loquitur is clearly inapplicable” where one or more causes for which defendant is not responsible” is responsible for device failure); Minda v. Biomet, Inc., 1998 WL 817690, at *3-4 (E.D.N.Y. Feb. 5, 1998) (rejecting argument that “the device had to be defective because it failed”; res ipsa loquitur inapplicable where device could have failed due to plaintiff’s weight); Moeller v. Danek Medical, Inc., 1997 WL 1039333, at *3-4 (W.D. Pa. Dec. 1, 1997) (“plaintiff has not eliminated the realistic possibility that the [device] broke while he attempted to lift the bench in contravention of his doctor’s instructions”); Cather v. Catheter Technology Corp., 753 F. Supp. 634, 638-39 (S.D. Miss. 1991) (“mere conclusory allegation that, because the catheter broke, there must have been some defect in its design or in the materials with which it was produced” insufficient to avoid summary judgment).

There are also some cases where preemption is available as a defense, and plaintiffs have tried to stretch an already invalid inference even further – arguing that because a device failed, it must have been manufactured, or designed, or somethinged in violation of the FDCA. This unwieldy pile of inferences upon inferences has uniformly been rejected. Funk v. Stryker Corp., ___ F. Supp.2d ___, 2009 WL 4281389, at *8-9 (S.D. Tex. Dec. 1, 2009) (“one may not infer a defect in the product simply because a patient encountered negative side effects in using it”) (our prior post here); Williams v. Cyberonics, Inc., ___ F. Supp.2d ___, 2009 WL 2914414, at *5 (E.D. Pa. Sept. 10, 2009) (argument “that the medical device failed to function according to its design because it simply stopped working” was “absolutely no reason to believe that [the device] failed to meet all of the FDA’s requirements”); Clark v. Medtronic, Inc., 572 F. Supp.2d 1090, 1094 (D. Minn. 2008) (medical devices “can fail for a variety of reasons, including medical complications, body rejection phenomena, allergic reaction, and surgical techniques, all of which occur without someone acting in a negligent manner”); Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 438 (E.D. Pa. 2004) (claim that “the [devices] should not malfunction as it did unless [they] were defective” rejected; plaintiff “cannot simply point to the malfunction itself to prove that the [devices] were not manufactured in accordance with the FDA/PMA specifications”); Enlow, 327 F. Supp.2d at 743 (finding an “unwarranted leap of faith from the malfunction of the valve. . .to the conclusion that [defendant] failed to adhere to FDA requirements”).

Finally, no discussion of broken device cases would be complete without mention of Adams v. Synthes Spine Co., 298 F.3d 1114 (9th Cir. 2002) (applying Washington law). In Adams the plaintiff creatively tried to repackage the device-was-defective-because-it-broke claim as a warning defect. Creative, yes; successful no. There was a risk of breakage, but most surgeons elected to leave the plate in because that risk was less than the inherent risks of explantation surgery. Thus a warning of the obvious – that the implant could break – was not defective just because doctors didn’t follow it:

That the surgeons usually did not remove the device does not show that they didn’t understand the warning, just that they generally didn't agree with the recommendation. [Plaintiff’s surgeon] explained why-the risk of the surgery to remove the plate exceeded the risk of leaving it in, because in most cases it wouldn't break. A second surgery could safely be left for the rare cases when it broke. Even the rarest events happen sometimes, to someone. It is extremely unfortunate that [plaintiff] was that someone . . . . That doesn't show anything inadequate about the warning, just that breakage was rare. Whenever a rare event occurs, the occurrence is surprising. People often choose to bear the risk of a rare event in order to avoid a certain and unattractive alternative, which in this case would be a second surgery, unnecessary in most cases.
Id. at 1118. That a risk of breakage happens in a particular case, in and of itself, doesn’t make a warning defective any more than the break itself is sufficient evidence of a design or manufacturing defect.

It may be a tough break for plaintiffs (particularly those with cases that are so lousy that they won't spring for/can't get an expert) – but the law has to require more than device failure to make out a prima facie case. Otherwise, as the court recognized on Rohde, we’ve turned product liability into a form of absolute insurance against all risks.

Wednesday, December 30, 2009

It All Depends On The Judge

Don’t look now, but things have gotten a bit weird for Third-Party Payor (TPP) lawsuits in the District of Minnesota. It all started way back in 2006: Judge James Rosenbaum, presiding over the Medtronic Implantable Defibrillators MDL, denied a motion to dismiss a bevy of state-law claims brought by TPPs, including the usual litany of “economic loss” claims (sounding in consumer fraud, warranty, and unjust enrichment), all of which related to the recall of Medtronic’s implantable defibrillators. Of course, law geeks like us didn’t know what to make of the decision, since Judge Rosenbaum denied this motion without comment.


Fast forward a year, and Judge Donovan Frank, presiding over the Guidant Implantable Defibrillators MDL, granted a motion to dismiss similar state-law claims brought by TPPs relating to the recall of Guidant’s implantable defibrillators. See In re: Guidant Corp. Implantable Defibrillators Prods. Liab. Litig., 484 F. Supp. 2d 973 (D. Minn. 2007). The court agreed with Guidant that the TPPs lacked standing to bring state-law economic-loss claims, because the TPPs’ insureds were the persons who suffered direct injury. In a “don’t-blink or you’ll miss it” footnote, the court acknowledged “that its colleague in the Medtronic MDL recently denied a motion to dismiss the third-party payer claims in that MDL on the basis of standing.” Id. at 983 n.5. But the Guidant court declined to follow this previous decision and instead ruled that dismissal was appropriate “on the record before the Court in this MDL.” Id.  Round two to the Guidant MDL, and a result that warmed the hearts (no pun intended) of defendants in TPP cases across the country.

But our story doesn’t end there. Just a few weeks ago, Judge Rosenbaum responded with round three in the TPP standing war. It seems that after the initial Medtronic decision way back in 2006, one TPP, the Kinetic Co., sued Medtronic on behalf of itself and a putative class of TPPs, seeking reimbursement of medical expenses resulting from the recall of the cardiac defibrillators.  Kinetic Co. v. Medtronic, Inc., 2009 U.S. Dist. LEXIS 112918 (D. Minn. Dec. 4, 2009). The case was consolidated into the Implantable Defibrillator MDL, but later dismissed without prejudice and refiled as a stand-alone class action. Medtronic moved to dismiss plaintiff’s state-law claims, which sounded in – you guessed it – consumer fraud, misrepresentation, warranty, and subrogation. In moving to dismiss these claims for lack of standing, guess which recent decision Medtronic cited? Yup, the Guidant MDL decision. And guess which decision Judge Rosenbaum blew off in denying Medtronic’s motion to dismiss? Yup, the Guidant MDL decision. To be fair, Judge Rosenbaum “acknowledge[d]” the Guidant decision – by simply citing it – and then, “with great respect to its colleague,” Judge Rosenbaum declined to follow Guidant. Instead, the court launched into a two-page riff, heavy on policy and light on caselaw, explaining why, in the court’s view, denying standing would be unfair.  In a nutshell:

because this Nation’s present health care regime almost always requires third-party payors to shoulder a significant portion of the employees’ costs of medical services. To deny this fact, and to extract legal conclusions from this denial, denies reality, and real financial injuries occurring in the real world.
Kinetic, 2009 U.S. Dist. LEXIS 112918, at *9.

Umm, ok – but isn’t any economic loss suffered by a TPP the result of its contractual obligations to its insureds, and derivative of (and far more indirect than) the more direct injury suffered by those insureds? And when a putative class of TPPs is allowed to run alongside a personal injury MDL and seek damages that seem at least partially duplicative of the damages sought by the individual plaintiffs in the MDL, aren’t you creating a big administrative headache, or otherwise running the risk of double recovery? The Kinetic court didn’t really address these concerns – instead, it seemed content to merely defend on policy grounds its earlier unexplained decision in the Medtronic MDL, and then trot out the old, flawed war-horses of TPP standing that are the familiar refrain of plaintiffs’ lawyers in this field – Desiano, Zyprexa, Marshfield Clinic, and K Dur (some of our favorite cases - can't you tell?)

The Kinetic court also struggled to address a huge problem that vexes (or should vex) all TPPs seeking to recover these types of damages – causation. In the Guidant MDL, the court concluded that the TPPs failed to show a direct causal connection between Guidant’s alleged conduct and the alleged harm suffered by the TPPs. In a passage that is music to the ears of anyone who deals with TPP consumer fraud claims on a regular basis, the court found:

Here, the named TPP Plaintiffs’purported standing rests on the independent choices of the doctors who recommend the devices to their patients and on the patients who decide to receive the devices, in lieu of other treatment options….Without a more direct connection, these claims are too speculative to establish a causal link between the alleged injury and the alleged misconduct.
Guidant, 484 F. Supp. 2d at 984.

The Kinetic court, by contrast, found “[t]he alleged causative chain is not complicated.”  2009 U.S. Dist. LEXIS 112918, at *16. In reaching this conclusion, the Kinetic court sidestepped the intractable causation problems highlighted by Guidant even as it acknowledged that the decisions of insureds’ medical providers are, in fact, intervening decisions. Id.

There are a host of other inconsistencies between Kinetic and Guidant – not least of which is whether these are “Third-Party Payors” or “Third-Party Payers,” a problem which, we confess, confuses even us. In the end, though, round three of the TPP standing dispute leaves us feeling a bit cold. We’re concerned that the decision has made litigating TPP cases in the District of Minnesota more confusing – at least if you’re not before Judge Rosenbaum or Judge Frank.

And we’re also eagerly waiting to see if there will be a fourth round of the TPP standing war in the Land of 10,000 Lawsuits - as in the Eighth Circuit - to straighten out this mess.

Tuesday, December 29, 2009

Depecage, Punitive Damages, and Mass Torts

Plaintiffs usually allege that decisions regarding marketing, distributing and selling a drug or device - as well as interactions with the FDA - were made by the manufacturer at the corporate level. Of course, they argue that these corporate decisions then impacted the prescribers and plaintiffs at their home locales.  As lawyers who defend mass torts, including putative class actions, we are used to litigating choice-of-law issues - and using the heavily lex loci-oriented outcome (no matter what rule applies, tort cases heavily lean toward having plaintiff's home jurisdiction's law apply) -- to disaggregate cases, defeat class actions, or even return cases to their proper fora.  Will wonders never cease.


But one size does not necessarily fit all – especially in the law. Punitive damages can be one example of this point. "The law governing the right to [punitive] damages need not necessarily be the same as the law governing the measure of compensatory damages," because one state may have “the dominant interest with respect to the issue of compensatory damages and another state ha[ve] the dominant interest with respect to the issue of [punitive] damages.” Restatement (Second) of Conflict of Laws § 171 comment d. There are also territorial aspects of due process that restrict states' ability to punish out of state conduct, something we addressed here. These are similar to the due process issues we've discussed before that (we think) also preclude use of class actions in the punitive damages context - regardless of any choice-of-law considerations.

But back to the point.  When different parts of a case are controlled by different states' law we lawyers call this "depecage." That's more jargon, so we looked it up. It's legal French (and you thought we only dealt with legal Latin) and comes from some art form involving layering - like ogres, we guess.  Actually, that's not particularly bad etymology - even though our French is pitiful - since mass torts certainly lend themselves to layering, and to the consequent need to parse claims and choice of law inquiries.

Because punitive damages are designed to deter and punish improper conduct, rather than to compensate an injured plaintiff, there are arguments to support application of the law of the defendant's principal place of business to punitive damages issues. One of them is that, since the imposition of punitive damages is meant to alter a defendant's expectations, rather than the plaintiffs', applying the defendant's home state's law may better serve the parties. See Restatement (Second) of Conflict of Laws § 145 comment c (“If the primary purpose of the tort rule involved is to deter or punish misconduct. . .the state where the conduct took place may be the state of dominant interest and thus that of most significant relationship”). At least the defendant has some reason to expect that its conduct - which eminates from its home state - will be held to the punitive standards of its home state. Plaintiffs, on the other hand, don't expect anything along these lines, assuming they expect anything at all.

Interestingly, Indiana rejected the use of depecage. In 2004, answering a certified question from the U.S. Court of Appeals for the Third Circuit (it was an air crash case) as to whether Indiana law permits depecage, the Indiana Supreme Court stated that depecage "may also produce unfair results because the hybrid law may be more favorable to one party than another, allowing a result that could not be reached if the laws of any one state were applied. As Brainerd Currie said, a party 'should not be allowed to put ‘together half a donkey and half a camel, and then ride to victory on the synthetic hybrid.’” Simon v. U.S., 805 N.E.2d 798, 802-03 (Ind. 2004) (citations omitted).

We like the donkey and camel line, and wish we came up with it. But the analysis arguably starts to break down in the context of a complex mass tort where caravans of plaintiffs come plodding in from almost every state this side of Timbuktu and choose to file in defendant's home state in order to stay out of federal court. In response to such blatant forum-shopping, some courts have seen fit to readjust the balance by applying more sophisticated choice of law concepts, including depecage.

While the injuries are alleged to span multiple states, the alleged misconduct allegedly occurred in the defendant's home state. That can become important, especially when the defendant is located in a state with exceptionally favorable (yay, depecage!) or exceptionally unfavorable (forget depecage) punitive damages law – exactly why we're not going to be pinned down to a particular position

But it can be argued that the relationship between the parties centers on defendant's home jurisdiction - even though the place of injury may properly lay claim to the compensatory damage claims - and applying the defendant's home jurisdiction's law violates neither the interests of the states nor the hypothetical expectations of the parties. Practical notions come into play as well. Utilizing a single state's punitive damages rules within a mass tort allows court (or courts) applying a single state's punitive damages law to better ensure that punitive awards do not overlap - preventing a defendant from getting hit over and over with awards where the first was already deemed sufficient to deter under that state's law. Then there's Lexecon…. Which is probably a good place to stop.

Monday, December 28, 2009

Zyprexa Pathetic Plaintiff Cases Pulverized

Last week we surprised even ourselves by including Judge Weinstein's December 1 Zyprexa decision as one of top ten best decisions of 2009. That opinion concluded, albeit reluctantly, that Mississippi's claims could not be adjudicated on a mass basis. Even Judge Weinstein acknowledges that sometimes (we would say more than sometimes) issues of causation, injury, and reliance need to be considered on an individual basis.


 
In a pair of newer summary judgment decisions, Judge Weinstein considered these types of issues on an individual basis.  These show how incredibly weak plaintiffs' claims can be in the Zyprexa litigation. Both plaintiffs claimed that the company had failed to warn that the drug could cause weight gain and diabetes. Both cases were thrown out on summary judgment. And it wasn't even close.

 
In both decisions -- 2009 U.S. Dist. Lexis 117777 (E.D.N.Y. Dec. 10, 2009) and 2009 U.S. Dist. Lexis 117778 (E.D.N.Y. Dec. 10, 2009) - Judge Weinstein begins (as usual) by furnishing his stock summary of the course of the Zyprexa litigation. That summary highlights many of the problems inherent in mass tort MDLs, such as:
  • complexity and expense
  • massive, asymmetrical discovery
  • "quasi-class actions"
  • opportunistic, parasitic actions
  • ample, one-sided press coverage
  • settlements that don't end the case but, rather, invite endless dumping of new cases into the MDL
  • etc. (And there's a lot in that "etc.")

 The opinions then recite some common facts, such as:  the original 1996 Zyprexa label listed the relevant adverse events; in 2003 the FDA announced that it would require a hyperglycemia and diabetes warning; the American Diabetes Association and other groups in 2003 held a conference and issued a consensus statement on antipsychotic and weight gain and diabetes; and a Dear Doctor Letter went out in March 2004.
 
The court once again concluded that March 2004 is the latest possible date that doctors are deemed to be aware of the risks. Depending on the facts, such as diabetes diagnosis and particular knowledge, the date could be sooner, and the statute of limitations clock starts ticking that much sooner.

 

 Then we get to the facts of the particular cases, and they are truly pathetic (as in weak, not as in evoking sympathy).
 
Plaintiff Gove (2009 U.S. Dist. Lexis 117777) had bipolar disorder and had attempted suicide multiple times. She started taking Zyprexa in 1998. She tolerated it, but was concerned about weight gain. (Red flag.) She stopped taking any antipsychotics at all for a couple of years, but went back on Zyprexa in 2002 after another suicide attempt. To put it in plain terms, Zyprexa worked for her. Gove's treater certainly thought so. Gove had been obese for a long time, so it couldn't have been too surprising when she was diagnosed with diabetes in 2002. (Redder flag.) The treater was aware of the association between Zyprexa and diabetes, but kept prescribing it because the benefits were worth the risks. In March 2003 the treater discussed with Gove the potential for Zyprexa to elevate blood glucose. But she didn't want to switch to another agent. (Where are we now on the color spectrum? Crimson?  Fuchsia?) In May 2004 Zyprexa started working less well (it happens) and Gove was taken off of Zyprexa because of concerns regarding -- wait (weight?) for it -- weight gain and diabetes. In short, the treater was actively engaged in making well-informed risk-benefit decisions.

 

 Judge Weinstein had several independent bases for issuing summary judgment against this plaintiff. First, by August 2003 at the latest, Gove knew that Zyprexa might have played a role regarding her diabetes. Since she didn't file her case until well after the limitations period ran, she was out of luck (and out of court).  Second, plaintiff couldn't show that different (stronger, clearer, faster, higher, etc) warnings would have made any difference. The treater had been deposed and said that different warnings would not have affected the prescription decision. Third, the learned intermediary doctrine is alive and well in Arizona (which supplied the substantive law) and the treater in this case was pretty darned learned on the potential risks of Zyprexa. So much for the Gove case.

 

 If anything, the other case was even weaker. Plaintiff Broderick (2009 U.S. Dist. Lexis 117778) had a history of obesity, hyperlipidemia, heart disease, depression, schizoaffective disorder, and multiple suicide attempts. She began taking Zyprexa in December 1999. Plaintiff's expert witness submitted a report indicating that Broderick's diabetes post-dated her Zyprexa use, but Judge Weinstein actually read the medical records and found that Broderick had been diagnosed with diabetes in 1998 and was taking insulin in June of 1999. (Aaah, plaintiff experts - it's so refreshing when they play true to form!) Just as with Gove, the treaters were well-informed. Just as in Gove, the treaters thought that Zyprexa worked well for the patient and that the benefits were worth the risks. And, just as in Gove, Judge Weinstein had no difficulty concluding that the statute of limitations had run and that the learned intermediary doctrine (this time under California law) ended the case. There was also a causation dimension to Broderick, but now it involved medical injuries. Unless plaintiff's expert was also going to discuss the possible role of a time-machine (don't laugh, could happen with some of those experts), it was not possible for a jury to conclude that Zyprexa caused a case of diabetes that was diagnosed before the plaintiff ever took the drug. Nor was there any evidence that Zyprexa had exacerbated the condition.

 

 And there you have it. A couple of nice, well-reasoned summary judgment opinions. Reassuring, isn't it?

 

 Well ... not entirely. Because this pair of frail cases is just the tip of the iceberg. For anybody who labors in the fields of mass tort, it is not at all unusual for plaintiff lawyers to cobble together inventories of thousands of cases, many of which involve plaintiffs:

 

  • who never used the drug or device
  • whose usage was so de minimus as to preclude any rational finding of causation
  • who are not injured at all
  • who had the injury before they ever used the drug or device
  • who knew or should have known of the bases of their claims so long ago that every statute of limitations in the country has run
  • whose treaters were learned intermediaries making a conscious risk-benefit decision, and such decision would be unaffected by whatever purple prose the plaintiff thinks should have been crayoned into the warnings
  • who are homicidal, prone to serial child-molesting, or already in jail. (You probably think we just threw that in to see if you were really following along. But no, that's something we've actually seen in MDLs.)

Anybody who works on drug and device litigation - the extra-strength MDL versions - knows that (often well) over 90% of the cases filed would never be filed as individual actions. Plaintiff lawyers exploit the overwhelming numbers of cases in MDLs knowing that the forest hides the (Charlie Brown Christmas) trees:  that it's just too hard to discover the gnarly facts of all the cases
 
Defendant-companies know it too, and that makes settlement considerations rather difficult to swallow. It's hard to justify paying for cases when most are pure bilge.
 
Even though some courts don't believe it, it really, really makes sense to devise methods for testing the cases and making sure that the specious cases get tossed aside. If plaintiff lawyers won't do it (and one would think that things like Rule 11 would concentrate one's mind on such things, but alas ...) then judges need to employ mechanisms such as Lone Pine orders (how about a Lone Pine-type procedure for the statute of limitations?) or bundling, or pilot discovery programs to ensure that cases like Gove and Broderick are teed up for dismissal sooner rather than later.  

 
In the end, we like these December 10, 2009 decisions. We just wish they could have come a couple of years earlier, and without all the need to waste discovery resources on cases that never should have been filed in the first place.

 

Thursday, December 24, 2009

Top Ten Best Prescription Drug/Medical Device Decisions Of 2009

Good tidings and great cheer. Merry Christmas, Happy Hanukkah, Kool Kwanzaa, Super Solstice – whatever holiday you’re celebrating. What is there to celebrate? Well, for the moment we can all celebrate our top ten favorite drug and medical device decisions of 2009. While we don’t have a Supreme Court star at the top or our tree this year (Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009), isn’t drug/device), there are still quite a few well-reasoned and useful 2009 decisions for those of us on the right side (in more ways than one) of the “v.” to rely upon in the years to come.


So here are the best – those decisions that had us rushing to the keyboard during the year to bang out those congratulatory posts – the kinds we like to write most. We’ll be starting with some state supreme court decisions, and working our way down from there.

1. AstraZeneca LP v. State, ___ So.2d ___, 2009 WL 3335904 (Ala. Oct. 15, 2009). It’s not really “product liability,” but in terms of sheer impact and dollar value, this one belongs on top. For years the Alabama Attorney General has been using gullible juries and questionable “fraud” claims to extract large settlements and even larger judgments from out-of-state pharmaceutical companies. Only trouble was that the supposedly defrauded party, the Alabama Medicaid Agency, knew perfectly well what was going on, and didn’t rely upon the purported misrepresentations. In a gutsy move, because over $250 million in verdicts were involved, AZ and two other defendants appealed rather than knuckle under. While the rationales differed, eight of nine justices of the Alabama Supreme Court agreed that reliance was completely absent and that AZ and the others should receive judgment n.o.v.  As a result, Alabama will have to go back to raising revenues the old fashioned way – through legislatively imposed taxes. We (Bexis) blogged about the case here, while sitting in an airport in San Diego coming back from a PLAC meeting.

2. DePriest v. AstraZeneca Pharmaceuticals, L.P., ___ S.W.3d ___, 2009 WL 3681868 (Ark. Nov. 5, 2009). It gets tougher after number one. We’ve decided to go with DePriest in the second spot because of it’s potential long-term impact. A lot of state consumer fraud statutes have “safe harbor’ provisions that exempt activities that the government allows and regulates (exact language varies) – which means FDA-approved labels, among other things. The blog has promoted wider use of these safe harbors as a defense here (listing every state that had a “safe harbor” provision), here, and here. DePriest is the first state supreme court decision to apply one of these safe harbor provisions and hold that a consumer fraud claim attacking FDA-approved labeling cannot proceed. Your state’s law may vary, but we’re hoping that DePriest becomes the first of many. We blogged about DePriest here.

3. De Bouse v. Bayer, ___ N.E.2d ___, 2009 WL 4843362 (Ill. Dec. 17, 2009). A recent entry, but a very good one. How far off-track product liability has gotten? Well, our three top cases all involve consumer fraud/economic loss, rather than what we studied in law school as “product liability.” Anyway, Illinois is a big state with a history of questionable class action practice in “Hellhole” counties. De Bouse throws out two more dangerous class-action-friendly theories: (1) there can’t be recovery when the defendant never communicated, directly or indirectly, with the plaintiff; and (2) the mere offering for sale of a prescription drug isn't any sort of actionable “implied representation” that the product is safe for its intended use, so that any injury could give rise to a consumer fraud claim. Extreme theories, both. And both rejected. But, the scariest thing is that an intermediate appellate court gave these crazy theories credence, and the case had to go all the way to the Illinois Supreme Court before common sense prevailed. The good news, of course, is that in the end, it did, so the case ends up on the good list, rather than the bad one. We posted about De Bouse earlier this week when it came down.

4. Blunt v. Medtronic, Inc., 760 N.W.2d 396 (Wis. 2009). The Wisconsin Supreme Court, not known as overly friendly to defendants, rejected an argument that could have blown a rather large hole in PMA medical device preemption under Riegel. Instead, the court held that PMA supplements – basically every medical device improvement after the FDA’s initial PMA approval – have just as much preemptive effect as the original device approval. That’s as it should be, since PMA supplements are subject to the same stringent review standards as the initial PMA. Since most devices are upgraded regularly after approval, failure to accord preemptive weight to the supplements would have limited the scope of preemption significantly. For PMA device manufacturers, Blunt has nationwide implications. We blogged about Blunt here.

5. Bruesewitz v. Wyeth, Inc., 561 F.3d 233 (3d Cir. 2009). This is the good half of a yin/yang combo concerning express preemption under the Vaccine Act. Its evil twin – a case out of Georgia called Ferrari that made last year's bottom ten – got killed off this year when the plaintiff took a non-suit (despite winning below) to avoid review by the U.S. Supreme Court.  Bruesewitz holds that Congress plainly intended the Act to preempt vaccine-related design defect claims and to impose stiffer standards on vaccine warning claims. While we think that anybody who reads the legislative history fairly would agree, since its preemption, it may take the Supreme Court to enforce what congress wanted, or it may not. Although we wouldn’t be surprised if Bruesewitz gets high court review (both sides have told the Court that certiorari should be granted, and the Court's been taking its time considering the petition), the opinion as it stands is important enough to make our list. We discussed the Bruesewitz affirmance here. Stay tuned for possible future developments.

6. In re Vioxx Class Cases, ___ Cal. Rptr.3d ___, 2009 WL 4806197 (Cal. App. Dec. 15, 2009). This is another recent edition to our list. We only posted about it the other day. What this decision demonstrats is that even in California – notoriously the home of probably the broadest consumer fraud laws in the country – a plaintiff can’t state a claim without some plausible basis for damages. Here, the plaintiffs alleged that the class would have en masse migrated to a cheaper generic had it only known the “truth.” That was garbage.  In truth, they didn’t. Thus, plaintiffs’ latest shot at a fraud-on-the-market theory of recovery in a prescription drug case came a-cropper. The case only gets a #6 ranking because, while California is a big state, it’s also a peculiar one, so impact elsewhere will be slight.

7. In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009). This is the best trial court PMA medical device preemption case of the year, bar none. It contains the best analysis of the interplay between express preemption under Riegel and fraud-on-the-FDA/faux-private-FDCA-right-of-action preemption under Buckman. Sprint Fidelis is the best place for defense counsel to start (other than this blog, which explained all six months before Sprint Fidelis was decided) when trying to figure out what’s an unpreempted “parallel violation” claim and what’s really a disguised private FDCA cause of action that won’t pass muster as a state-law claim under Buckman. How good is Sprint Fidelis? So good that plaintiffs responded by trying (unsuccessfully) to force the recusal of the judge. And so good that the judge in the state-court side of the same litigation followed it. The case is now on appeal to the Eighth Circuit. We ecstatically blogged about the Sprint Fidelis win here.

8. Guinn v. AstraZeneca, 598 F.Supp.2d 1239 (M.D. Fla. 2009). How does a defendant go about winning multi-district litigation? Well, here’s one way – let the plaintiffs pick their best triable case (under Lexecon, that will be limited to cases filed in the MDL court’s district), then let the plaintiffs pick their first-string experts, and finally, despite all that, blow out the plaintiffs’ best case and experts on Daubert grounds. That’s what happened in Guinn.  It’s the best drug/device Daubert decision of 2009. Diabetes is a disease with lots of pre-existing risk factors, and just about every plaintiff will have a slew of them. The Seroquel plaintiffs’ best case sure did, and their experts couldn’t account for those factors in their opinions. So they fell back on temporal association (also known as the post hoc ergo prompter hoc fallacy) – a big Daubert no-no. We’ll leave it at that, since it’s a Dechert case and Bexis is on that team (although he doesn’t claim any credit for this win). We (well, Herrmann) blogged about Guinn here. The case is now on appeal, and we’re hoping for a repeat performance on next year’s list.  It's also the third AZ case on this list; that's one company that had a good year, result-wise.

9. In re Neurontin Marketing, Sales Practices & Products Liability Litigation, 618 F. Supp.2d 96 (D. Mass. 2009) and In re Neurontin Marketing, Sales Practices & Products Liability Litigation, 257 F.R.D. 315 (D. Mass. 2009). There aren’t many cases that have had anything nice to say about purported class actions seeking recovery of the cost of effective off-label use just because there might also have been some illegal off-label promotion going on. However, early on in the now-quite-extended Neurontin litigation, that judge did suggest there might be some “there there.” See Neurontin (the caption's just too long), 244 F.R.D. 89, 113-14 (D. Mass. 2007). Well, in these more recent 2009 decisions, the judge carefully walked those earlier comments back, in light of the torrent of more recent precedent in the good guys’ favor, and then ended up dismissing the claims outright. There were a number of similar decisions in 2009, but we go with this one because having to change the judge’s mind increases the degree of difficulty. We blogged about the first Neurontin win here.

10. In re Zyprexa Products Liability Litigation, ___ F. Supp.2d ___, 2009 WL 4260857 (E.D.N.Y. Dec. 1, 2009). What? Judge Weinstein on our good list – after making our bad list last year with another decision in the same MDL? Yup, that’s right. He’s a judge, and a smart one, thus he could see the handwriting on the wall with the increasingly widespread rejection of statistical shortcuts in class action/mass action litigation concerning supposedly “defective” products. This case is where all that precedent finally caught up. As is Judge Weinstein’s wont, he wrote a cogent and thorough opinion explaining the development of what he calls the “individualized proof rule.” And that’s not all. This was another overreaching attorney general action (see Alabama, above) compounded by contingent-fee, outside counsel making exorbitant demands. Thus, Judge Weinstein let the state have it for pursuing “slash-and-burn-style of litigation” that didn’t serve the best interests of the participants (the off-label uses helped their medical conditions) of the very healthcare plans on whose behalf the state purported to be suing. We might have ranked this decision higher, but for the obvious reluctance Judge Weinstein showed in having to follow precedent at odds with his personal preferences. Still, preferences or no, he ended up doing the right thing. We blogged about the decision here.

But we can’t stop at this point. Judicial Santas put so many shiny new gifts under our tree in 2009 that we can’t keep ourselves from opening a few more. Thus, here are another ten honorable mentions:

Honorable mentions: (11) Kovach v. Caligor Midwest, 913 N.E.2d 193 (Ind. 2009) (the Indiana Supreme Court reverses a really bad device design defect ruling on precisely the grounds that we suggested in our own commentary); (12) In re Actimmune Marketing Litigation, 614 F. Supp.2d 1037 (N.D. Cal. 2009)/In re Actimmune Marketing Litigation, 2009 WL 3740648 (N.D. Cal. Nov. 6, 2009) (excellent one-two punch demolishing another off-label promotion class action – where the company had been prosecuted; see our posts here and here); (13) Ashley County, Ark. v. Pfizer, Inc., 552 F.3d 659 (8th Cir. 2009) (the 8th Circuit puts a decisive end to the first attempt at bringing public nuisance claims in prescription drug litigation; we discussed it here) (14) Riley v. Cordis Corp., 625 F. Supp.2d 769 (D. Minn. 2009) (another really well-reasoned device preemption case, and the first one involving a combination device; we discussed it extensively here); (15) Longs v. Wyeth, 621 F. Supp.2d 504 (N.D. Ohio 2009) (there hasn’t been a whole lot to cheer about since Levine on the drug preemption side, but Longs was a bright spot; it didn’t hurt that the plaintiff’s argument was that an FDA-approved drug was too dangerous under state law ever to have been marketed at all; see our coverage here); (16) Hughes v. Boston Scientific Corp., ___ F. Supp.2d ___, 2009 WL 3817586 (S.D. Miss. Nov. 12, 2009) (this is a good device preemption case - and an outstanding fraud-on-the-FDA preemption case; we covered it here); (17) Iacangelo v. Georgetown University, 595 F. Supp.2d 87 (D.D.C. 2009) (the plaintiff’s purported “state” claims were really disguised FDCA violation claims; the court threw them out in an excellent decision; we were all over it, here), (18) Southern Illinois Laborers’ & Employers Health & Welfare Fund v. Pfizer Inc., 2009 WL 3151807 (S.D.N.Y. Sept. 30, 2009)/In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2009 WL 2043604 (D.N.J. July 10, 2009) (you pick ‘em; two good decisions blowing out third-party payer economic loss class actions; we covered them here, here, and (together) here); (19) Frey v. Novartis Pharmaceuticals Corp., 642 F. Supp.2d 787 (N.D. Ohio 2009) (Twombly/Iqbal really came to our neighborhood in this case; we think it's the best application of Rule 8 to a drug/device personal injury case in 2009; we sang its praises here); (20) Mensing v. Wyeth, Inc., ___ F.3d ___, 2009 WL 4111209 (8th Cir. Nov. 27, 2009) (you saw right – the same opinion simultaneously makes both our top and bottom ten lists; Mensing appears here because it’s the first appellate to consider and reject the infamous Conte decision on brand-name drug liability in a generic case; Mensing essentially held, “give me a break,” and followed the majority rule; we covered it all, the good, bad, and ugly, here).

Looking ahead to next year, the Supreme Court could take the Bruesewitz appeal – setting up yet another FDCA-related preemption smackdown – or it could take the Abdullahi foreign tort claims case that made our worst decisions list. Also on the preemption front, we’ve got a trio of post-Levine SSRI suicide implied preemption appeals that should be decided in the coming year by the federal courts of appeals. Those will give us a better idea whether Levine did much damage to implied preemption in cases where there are really good administrative records. One of them (Dobbs) was Herrmann’s case, although he won’t be around to argue it. There are also cases teed up in the Pennsylvania and California Supreme Courts challenging state hiring of outside contingent fee counsel to sue our clients. Bexis has been involved in amicus efforts in both of these. Finally, there are pending appeals in (at least) Zyprexa (2008 worst decisions list), Guinan (2009 worst decisions list), Oxycontin II (ditto), Sprint Fidelis, Guinn, Riley, and Longs. All of these are good candidates for repeat-player status in 2010.

Wednesday, December 23, 2009

Iqbal Four

The fourth and final installment of the great Bloggers versus Burbank debate over whether Congress should act to nullify the Supreme Court Twombly/Iqbal pleading decisions has been posted at PENNumbra.  That would be Prof. Burbank's closing argument - or should we say closing shots - because he says we "set[] up and knock[] down strawmen," "throw[] sand in the air," and generally act "[l[ike law students misled by course materials."  In short, those of you who already think that we don't know what we're talking about will love it.

Those of you who think we have a point (and are at least a certain age) will read the latest Burbank piece and wonder "where's the beef?"

First, he essentially abandons under fire both of his main prior arguments - that the right to jury trial is being impinged ("issues include. . .access to court, the right to a jury trial"), and that discovery really isn't all that expensive ("not[hing] demonstrated[s]that it has been a problem in more than a small slice of litigation").  He now admits:  (1) that there's "no doubt that this Court would reject a Seventh Amendment challenge to plausibility pleading" and (2) pleading "absence of systematic empirical evidence" to the latter - sort of denying that cats purr because we don't know how they do it.

Second, he argues that he should prevail because of who he is ("[e]ven if that [hearing the same old arguments] were true, they have not heard them from the scholar [that is, Prof. Burbank] who wrote the definitive history of the Rules Enabling Act"), rather than what he says.  That's called "ex cathedra," and it went out of fashion back when we figured out that Aristotle was wrong and that the Sun really didn't orbit the Earth.  Like Aristotle, it's possible to be both "definitive" and incorrect.

Anyway, read it for yourselves and see if Prof. Burbank's got any reason (other than liking plaintiffs more than defendants) for why it was proper for the Court to interpret Rule 8 one way in Conley, but somehow becomes improper for the Court to interpret the same rule another way in Twombly/Iqbal.  A Curt Flood rule for rules, perhaps?

In any event, thanks to Prof. Burbank and all the folks at PENNumbra for putting this together.  Who knows, if we get the time, we may put together a more thorough critique of Prof. Burbank's latest piece - maybe on PENNumbra (if they let us), or failing that, here.

A Good Week For Forum Non in New York

Defendants went two for two sending forum-shopping non-resident plaintiffs back where they came from in New York this week.  First, the Second Circuit, in a summary order, told bunch of Austrian plaintiffs from a ski train fire to take their lawsuits back across the Atlantic.  Ferk v. Omniglow Corp., slip op. (2d Cir. Dec. 21, 2009).  Austrians injured in an Austrian accident suing in the United States were not entitled to "very little deference" (we'd say none at all) in their choice of forums.  Id. at 3.  Allegations of corruption weren't any of a US court's business ("I] is not the business of our courts to assume the responsibility for supervising the integrity of the judicial system of another sovereign nation”).  Id.  And these plaintiffs blew their statute of limitations argument (just like they blew the statute itself) with poor lawyering - they failed to raise the argument in the lower court.  Id. at 4.

We're particularly gratified to say auf wiedersehen to the Kaprun litigation because it was the the only legal basis for a rather questionable section of the ALI's Principles of the Law of Aggregate Litigation Project (§2.10) that would allow for opt-in class actions brought by foreign plaintiffs in US courts over things that happened overseas.  Now, not only was the attempt at an opt-in class class reversed (Kern v. Siemens Corp., 393 F.3d 120 (2d Cir. 2004), but the whole kit and caboodle's been shipped back to Austria where it belonged in the first place.  Thus, we'd have to say that this section is pretty much dead on arrival.

That's one.

In some ways, we like the other one even better - even though it's even shorter.  In Avery v. Pfizer, Inc., slip op. (N.Y.A.D. Dec. 22, 2009), the First Department (don't ask, this gets confusing even to us), put a dozen or so squatter Lipitor plaintiffs back on a midnight train to Georgia - also on forum non conveniens grounds.  In the words of the court, the test plaintiff "lives in Georgia," ingested the drug in Georgia," suffered his injuries in Georgia," "all [plaintiff's] treating physicians are in Georgia," and "all of {plaintiff's] witnesses are in Georgia.  Id. at 88-89 (the page numbering confuses us, too - here in Pa, we start our opinions with page 1).

But plaintiffs filed suit in New York state court.  Bet it wasn't just so plaintiffs' counsel could see the Mets play the Braves at Shea (or wherever's the scene of the Mets' annual collapses these days).

We're particularly gratified for the result in Avery because, on appeal, the plaintiffs argued for the same benighted "mass torts exception" that another New York judge had seen fit to create out of whole cloth.  We criticized that prior decision here when it first came down, and more recently bestowed upon it the distinction of being one of the ten worst drug/device decisions of 2009.  The Appellate Division in Avery said "thanks, but no thanks" to that bit of judicial tort activism:

We decline to disregard the traditional forum non conveniens factors in favor of a "mass torts litigation" approach.
Slip op. at 89 (citing and refusing to follow Matter of Oxycontin II, 23 Misc.3d 974 (N.Y. Sup. 2009)).

Unfortunately, the Appellate Division's disapproval in Avery doesn't kill the Oxycontin II decision outright.  The folks from Skadden Arps who were nice enough to send this baby along were also good enough to explain to us not only that New York organizes its intermediate appellate courts by geographic region, but that New York City is such a busy place, legally (and every other way), that a trial court in Staten Island (Oxycontin) isn't even in the same appellate department as a trial court in Manhattan (Avery).  But since the Oxycontin II decision is also on appeal (you can appeal just about anything in New York state court), here's hoping that the appellate court there will find persuasive the Avery rejection of some sort of "mass tort exception" from the normal rules of civil procedure .

Tuesday, December 22, 2009

California Vioxx Class Action Slides Into The Sea

The endless see-saw that is the battle to impose reason on California consumer fraud class actions, just took a “see” (or is that a “saw”) in the direction of the good guys. Last week, in a to-be-published opinion, the California Court of Appeal affirmed the denial of class certification for Vioxx-related consumer and third party payor actions. In re Vioxx Class Cases, 2009 WL 4806197, Slip op. (Los Angeles County Super. Ct. No. JCCP 4247).
The class plaintiffs here weren’t very original. We’ve heard these allegations before, but California’s always been a more dicey jurisdiction than most. The class plaintiffs claimed that Vioxx was no more effective than a cheaper generic alternative, and that it was less safe – and therefore, they would not have paid the price they paid for Vioxx but for Merck’s having deceived them. In short, it’s your typical “price inflation” allegations that most courts have rejected.

Merck used discovery to inquire just what drugs the plaintiffs would have purchased instead of Vioxx, but plaintiffs maintained that this level of specificity was not relevant; they just claimed they overpaid for Vioxx. Good for them. Merck turned their intransigence against them. Good for Merck. For plaintiffs, the facts turned out to be a most inconvenient truth.

Plaintiffs’ proposed measure of damages was the price they paid for Vioxx minus the price of the general comparator (that’s lawyerspeak for “alternative”) medication. Oops, didn’t happen. Evidence (critical to the win) showed that after the Vioxx withdrawal, most patients did not switch to the alternative generic comparator as alleged in the complaint. Instead, their doctors changed them over to other brand name products.

In a ruling that puts some of the sunshine back into sunny California (at least when there’s not an El NiƱo) the Court of Appeal affirmed the trial court’s well-reasoned denial of class certification.

One of the things that makes California so difficult is that there’s not just one consumer fraud statute. There’s a bunch, and each one’s a little different. The first claim the court dispatched was brought under the Consumer Legal Remedies Act (“CLRA”). Fortunately, the section of the CLRA that allows private citizens to recover damages has “as a result of” causation language that requires a showing that the alleged deception was “material.” The Court of Appeal agreed that, because materiality varied from person to person – based on his or her medical condition, severity of pain, reason for prescription, other medical issues, etc. – a class action would not be appropriate. Slip op. at 24. Seems logical enough to us, but since it’s California consumer protection law, we take nothing for granted. The ruling on this issue should be broadly applicable to cases under other states’ consumer fraud statutes which share the “as a result of” formulation.

Two other California consumer fraud statutes are the unfair competition law (“UCL”) and the false advertising law (“FAL”). These are even scarier because they require causation to be proven by the named plaintiff(s) only. See In re Tobacco II Cases, 46 Cal.4th 298 (2009). Once the named plaintiff shows harm “as a result of” violations of the UCL and FAL (don’t these make you think of Latin American communist groups?), plaintiffs assert that restitution can be granted to the entire class without a showing of reliance as to these class members – because of the language permitting restitution where monies “may have been acquired through means of unfair competition.” Despite this language, the Court of Appeal reasoned that “may have” only gets you so far – even if you need not prove individual injury, you must have appropriate class-wide proof as to the fact and extent of injury:

“While the ‘may have been acquired’ language . . . is so broad as to allow restitution without individual proof of injury, it is not so broad as to allow recovery without any evidentiary support.” Slip op. at 19. Plaintiffs’ theory was that restitution amounts could be measured solely by the price paid for Vioxx minus the price of the generic alternative medication – but the generic alternative wasn’t really an alternative at all, since the evidence showed it wasn’t the replacement for a majority of putative class plaintiffs. Thus the Court of Appeal said, “[w]hen the plaintiff seeks to value the product received by means of the market price of another, comparable product, that measure cannot be awarded without evidence that the proposed comparator is actually a product of comparable value to what was received.” Id. The inconvenient truth that the majority did not use the alternative that the plaintiffs alleged – not coincidentally the one that also would have maximized their recovery – sunk the class action. Because each person would have his or her own individualized alternative, there was no viable class-wide measure of damages. Splash; into the sea it goes.

A lot of the times, it’s hard for damages issues to be class-busters, but the Court of Appeal’s logic is dead on. For everybody who already tried and failed on the purported generic alternative, their measure of damages could not be ‘price of Vioxx minus price of purported comparator’. And for those whose doctors would never prescribe the purported comparator at all, the plaintiff’s simplistic damage calculation is simply irrelevant.

Evidence is good. The court rejected plaintiffs’ challenge for two critical reasons: first, a majority of the proposed class in fact switched not to the generic comparator, but to another branded medication in the same class. Plaintiffs’ would-be generic comparator was false not just as to some class members, but as to most. To prevent this sort of farce from recurring, the Court required all future plaintiffs to present evidence as to the legitimacy of their proposed comparator. Slip op. at 19. Second, the Court wouldn’t let the plaintiffs kick the can down the road. It wasn’t just measure of damages but a question of whether damages could ever be established and measured on a class-wide basis, and thus the issue could not be put off until the merits stage. Where each class member’s comparator is an individual choice, plaintiffs failed to proffer a viable method whereby damages could be assessed at all on a class-wide basis. Slip op. at 26-27.

Vioxx Class Cases is also important because it’s one of the first big appellate post-In re Tobacco II Cases, 46 Cal.4th 298 (2009), decisions. The Court of Appeal rejected plaintiff’s argument that Tobacco II required reversal/compels certification. Instead the court held that In re Tobacco II addressed only issues about the named plaintiff; it does not alter the underlying elements of the statutory causes of action. Slip op. at 13, n.11.

Stay tuned. We might learn more about the Court of Appeal’s views on this from Pfizer v. Galfano, which was argued to the same Court as Vioxx just last week.

Tip of the cyberhat – and congratulations – to Rich Goetz and Charlie Lifland at O'Melveny & Myers for letting us know about this win.

Monday, December 21, 2009

Pleading Catch 22 in Nuvaring MDL

What is going on in Nuvaring? Defendant first moved against Plaintiffs' "master" complaint. Plaintiffs withdrew it. Then it moved against Plaintiffs' individual complaints (all 200+ of them). Now the court won't hear those either. No wonder our eyebrows go up a little more with each ruling. (Here, here, and here). At this point, we're afraid we might freeze into a permanently supercilious (literally, Latin for "raised eyebrows") skepticism of anything coming out of that MDL.



To review:


  • In November 2008, shortly after the the first MDL conference, Defendant asks for a Master Complaint so that, inter alia, Rule 12 challenges could be streamlined. The court agrees. So far, so good.  
  • Plaintiffs then file a Master Complaint that falls far short of Rule 8, Rule 9, Iqbal, and Twombly. So far, so predictable.
  •  Defendant then files Rule 12 motions. One motion seeks to strike class allegations. That one wins. But the motion challenging the pleadings under Rules 9(b) and 12(b)(6) is denied. Check that - it's sidestepped. The merits remain elusive because the Master Complaint was "simply meant to place in one document all of the claims at issue in this litigation."  In re Nuvaring Products Liability Litigation,  2009 WL 2425391, at *2 (E.D. Mo. Aug. 6, 2009).
And bad, bad, Defendant. Shame on you for not seeking a Master Complaint for a year (forget that there wasn't even an MDL for a lot of that time), and why did Defendant stop answering the complaints and start moving against them?
 

Well, duh. Twombly/Iqbal. You can't be estopped from filing a Rule 12 motion.


And, as we pointed out before that sort of reasoning will make defendants leery of doing anything other than file motions. Be careful what you ask for, you just might get it.

  • Next, Defendant seeks certification of the first order for interlocutory appeal, so that the Eight Circuit could address whether MDL master complaints are somehow immune from the pleading requirements of Rule 9, Iqbal, and Twombly.
  • That gets some action. In October 2009, the court denies the request to certify – and strikes the Master Complaint.  In re Nuvaring Products Liability Litigation, 2009 WL 3427974 (E.D. Mo. Oct. 23, 2009).  Interesting.
Our response was to express relief that the MDL judge "came around." It looked like a retreat from the untenable position that defendants can't move against master complaints (otherwise, why have them?). Master complaints can be an efficient tool for separating the pleading-wheat from the pleading-chaff (and we're betting that most of the Nuvaring cases – like most MDL cases everywhere – ain't wheat), but if a court would rather plow under the individual complaints one at a time, that's OK.

In sum, that looked like a viable procedural choice of to how to undertake motion practice.


How wrong could we be?



 Well ... not as much as it appears; at least not at the beginning. We did correctly predict what Defendant would do (we are defense lawyers, after all). We said Defendant “will now predictably file motions to dismiss each of the hundreds of individual cases pending in the Nuvaring MDL." (Did you see that word "predictably"? See, we read the rules and cases and occasionally confront reality.)  But the court was shocked, shocked that Defendant actually moved against the usual suspects – the individual complaints. Here's the kicker. Resolving Rule 8/9/12 motions against individual complaints "necessarily sidetracks the parties and the Court from the main goal of this MDL proceeding which is the expeditious and efficient discovery over the claims which are properly pleaded."  In re Nuvaring Products Liability Litigation, 2009 WL 4825170, at *2 n.3 (E.D. Mo. Dec. 11, 2009).



 Defendant is damned if it does and damned if it doesn't. Can anyone spell "m-a-n-d-a-m-u-s"?



 Never mind that most of Plaintiffs' claims are probably not properly pleaded. Never mind that Plaintiffs undoubtedly have the usual inventory of vague, schlocky claims, and it's that inflated inventory – not adherence to pleading rules – that's the real burden on the administration of the MDL. What happened to the comment in the order striking the Master Complaint? That's the order that stated it "will allow the parties and the Court to focus on the dismissal motions filed in the individual cases."  Nuvaring, 2009 WL 3427974, at *1 (Oct. 23, 2009).



That's the backstory. When actually faced with defending their pleadings, we guess that Plaintiffs started bleating. They took the usual snippets from the Manual for Complex Litigation and some stray cases (we'll bet about summary judgment - not pleadings) to argue that an MDL should be only about common issues. Translation – Plaintiffs get to take millions of dollars of "common" discovery from Defendant (at Defendant’s expense) and Defendant isn't allowed to do anything at all. By contrast, Plaintiffs, in terms of both testing their pleadings and discovering their facts, want a free ride straight through to remand. Thus, the bloated inventory of specious cases doesn't get thinned out, nor does each case's bloated inventory of specious allegations. Thus, the incentive is created to park crummy cases where they won't get tested. As we said before "build it and they will come" applies to MDLs - especially if they're managed like Nuvaring is being managed.



 Sorry, but tying both of an MDL defendant's hands behind its back doesn't make sense. And it is not the law. An MDL judge's "most important function in the early stages of litigation management" is "to press the parties to identify, define, and narrow the issues." Manual for Complex Litigation (Fourth) section 11.13.

That means MDL courts are supposed to cut down the pleadings to what's actually in dispute. Rule 9, Iqbal, and Twombly shouldn't vanish in an MDL. No way – the need to police the pleadings is ever more crucial the huger any given piece of litigation gets, and there's nothing huger (is that a word?) than multi-district litigation. While an MDL "seeks to promote judicial economy and litigant efficiency by allowing the transferee court to preside over matters common among all cases" and MDL courts "typically do[] not rule on cumbersome, case-specific legal issues," Nuvaring, 2009 WL 4825170, at *2 (quoting In re PPA Product Liability Litigation, 2004 WL 2034587 at 2 (W.D. Wash Sept. 3, 2004)), that's not what's going on here.

The PPA order involved side-show motions by minor defendants. It most certainly did not involve the core of the MDL litigation itself – whether the plaintiffs' claims against the target defendant were properly pleaded at all. Early decision of core pleading issues is the essence of MDL management – as the Manual explicitly states. Look at PPA, for instance. There are many orders in that litigation that did resolve case-specific issues, when the primary manufacturer defendants moved to dismiss or moved for judgment on the pleadings against particular claims in particular plaintiff's cases. See, e.g., In re PPA, 2006 WL 1442168 at 4 (W.D. Wash. 2006) (one of many). PPA doesn't justify the sort of abdication of judicial responsibility that the latest Nuvaring order seems to be contemplating.



 It doesn't have to be that way. Common pleading deficiencies could have been addressed via the Master Complaint. Even without a master complaint, it's not like each case is sui generis (that's lawyerspeak for "completely different"). No, we're sure that, since the same lawyers are filing complaints about the same product (that's why there's an MDL to begin with), there are patterns to the allegations and thus patterns to the pleading deficiencies in Plaintiffs' complaints. Thus the pleading motions could be grouped, and addressed in a group fashion. That's what bellwether trials do, and the same sorts of creative procedural approaches are available at earlier stages of litigation.



 It might take some work – but it's not looking at more than 200 complaints seriatim (that's lawyerspeak for "one by one"). And it's work that has to be done by someone at some time. It's hard to see the sense of kicking that can down the road to hundreds of remand courts. What do you think remand judges across the country will think if they get back bunches of cases that, after years in an MDL, still have pending Rule 12 motions?



 How about another prediction? We're willing to bet that, if Plaintiffs get a free pass to discovery no matter what their pleadings look like, the Nuvaring MDL caseload will increase dramatically. Plaintiffs' lawyers aren't stupid. If the MDL becomes an open kennel, they'll herd all their woofers to St. Louis.



 It's no wonder Nuvaring made our Worst Ten Decisions of 2009 list.


Early Christmas Present in Illinois

The Illinois Supreme Court reversed the unusual class Baycol class certification in the De Bouse case late last week.  Here's a link to the opinion (also at 2009 WL 4843362).  It's yet another of those class actions that we call "strike suits" because (1) there's no personal injury at all - only a risk that didn't befall the particular class, and (2) the drug apparently worked just fine.  She claimed "economic damages" from the drug being recalled.  Almost all courts have rejected them - with the notable exception of the intermediate appellate court in De Bouse.

That's why we were quite pleased early this year when the Illinois Supreme Court agreed to review that decision.  We're even more pleased now.

Here are the three certified questions that the court agreed to hear:  First, does the Illinois Consumer Fraud Act ("ICFA"), permit a clain even where defendant "did not engage in direct communication" with the plaintiff consumer?  Second, is the mere "offer for sale of a product . . . a representation" of "reasonable safety" so that any allegation of failure to disclose safety risks an automatic violation of the ICFA?  Third, fraudulent statements/omissions to third persons (here prescribing physicians) are actionable under the ICFA when it is intended that reach and be relied upon by the plaintiff.  Slip op. at 2-3.

The Illinois Supreme Court recognized that questions 1 and 3 could be read as being the same thing, but chose to treat them separately.  As to the third question, the court held that the ICFA does not require privity.  In some circumstances fraud can "pass through" a third party to the plaintiff.  Slip op. at 9.

But the really important point was that the court once again reaffirmed a "basic principle" of fraud/consumer fraud - you aren't defrauded by something you never knew about:
The basic principle in each of the foregoing cases is that to maintain an action under the Act, the plaintiff must actually be deceived by a statement or omission that is made by the defendant. If a consumer has neither seen nor heard any such statement, then she cannot have relied on the statement and, consequently, cannot prove proximate cause.

Slip op. at 7-8.  In short there's no "market theory" of causation under the ICFA.  Id. at 8.

As we all know, reliance kills class actions - that's why we care so much about it.  If we can keep class actions out of our sandbox, then the litigation that's left is rarely "bet your company" (with the possible exception of a multiple punitive damages situation).

On to question 2.  Initially, the court limited it - rather than discuss all products, the court restricted its discussion to prescription drugs.  Slip op. at 10 ("we limit our consideration of the question to whether offering prescription drugs for sale in Illinois is a representation that the drug is safe for its intended use").

Fine with us.  Heck, here at the Druganddevicelaw Blog we usually do the same thing.

The minute we thought of that question, we thought of the old adage "prescription drugs are unavoidably unsafe, that's why they require a prescription."  Well, so did the Illinois Supreme Court - it looked to our old friend, comment k to Restatement (second) of Torts §402A.

The risks associated with pharmaceuticals are a large part of the reason why a doctor’s prescription is required for these medications.  A drug often can affect different patients differently, causing adverse side effects in one but not another. The Restatement approach reflects the reality that even in their intended and ordinary use, prescription drugs may nonetheless cause harmful side effects in some patients. A drug manufacturer cannot say with complete certainty that its product, when used as intended, will be reasonably safe for all patients.  As a result, the mere sale of a prescription medication cannot be a representation which serves as the basis for a consumer fraud claim.  Consequently, we answer the second certified question in the negative.
Slip op. at 10-11 (emphasis added).  Defense counsel should save that quote, frame it, stick it on the wall somewhere - Bexis plans to put it in the next edition of his book.  It's as good a statement as you're likely to find of the essential nature of a prescription product and why what we do is different from litigation involving office chairs or power tools, which any person off the street can buy with no questions asked.
 
Because of its answers to questions 1 and 3, the court held that summary judgment should have been granted against the class representative's claim.  Slip op. at 12.
 
There was a new number one here in Philly over the weekend - more snow than any December storm in history.  Might there also be a new number one on our "Best Decisions" list for 2009?
 
Stay tuned.

Friday, December 18, 2009

An Ohio Idea

Litigated a prescription drug product liability case in Ohio lately? Say in, oh … the last quarter century or so?


If you have, then you’ve run into our old friend the heeding presumption. In the very first prescription drug product liability case that the Ohio Supreme Court ever encountered, it adopted a "presumption" that a plaintiff in a strict liability case would have read and heeded an “adequate” warning, had one been given:

In satisfying the first branch of the proximate cause burden stated above, the plaintiff is aided by a rebuttable presumption that the failure to adequately warn was a proximate cause of the plaintiff's ingestion of the drug.
Seley v. G.D. Searle & Co., 423 N.E.2d 831, 834 (Ohio 1981) (syllabus, para. 4). That was a long time ago – back when that court still wrote syllabuses (syllabi?) for its opinions. Heck, it was back when Dinsmore & Shohl did plaintiffs’ work (check out who represented the plaintiff in Seley; we're assuming Westlaw is accurate on this).

Relying on a couple of cases out of Indiana and Oklahoma (two hotbeds of jurisprudential innovation), Seley held that Restatement (Second) of Torts §402A, comment j (1965) – stating that a manufacturer could presume that an existing adequate warning would be read and heeded – could be stood on its head to presume, as well, that a non-existent adequate warning would hypothetically have been read and heeded had it been given:

Comment j to Section 402 A (Restatement of Torts 2d) establishes a presumption that an adequate warning, if given, will be read and heeded. In such a situation, the presumption established works to the benefit of the manufacturer. However, where no warning is given, or where an inadequate warning is given, a rebuttable presumption arises, beneficial to the plaintiff, that the failure to adequately warn was a proximate cause of the plaintiff's ingestion of the drug. This presumption, absent the production of rebutting evidence by the defendant, is sufficient to satisfy the first branch of the plaintiff's proximate cause burden.
Seley, 423 N.E.2d at 838 (citations omitted).  Since almost every prescription drug product liability case is an inadequate warning claim, that means the ostensible burden of proof (or at least production) gets shifted in every case.

A lot has happened since then. The ALI took a second look at comment j and decided that the language Seley relied upon was “unfortunate” and shouldn’t be followed. See Restatement (Third) of Torts, Products Liability §2, reporters notes to comment l (1997). Other courts recognized that the simplistic rulings in these early cases ignored reality (most plaintiffs don't read available warnings - that's why they're plaintiffs), as well as the nature of warnings where an unavoidably unsafe product was involved. That’s been discussed on this blog before, here.

But in Ohio, Seley is still the law….

Or is it?

That’s today’s bright (or maybe crazy, you decide) idea.

While the Ohio courts have pretty much stood still since Seley, the Ohio legislature has not.

It’s passed something called the Ohio Product Liability Act (“OPLA”).

And it’s had to pass OPLA more than once because for quite a few years the Ohio Supreme Court was hostile to legislative tort reform. See Ohio Academy of Trial Lawyers v. Sheward, 715 N.E.2d 1062 (Ohio 1999) (declaring large chunks of earlier version of OPLA unconstitutional); Carrel v. Allied Products Corp., 677 N.E.2d 795, 796 (Ohio 1997) (declaring that, “all common-law products liability causes of action survive [OPLA] unless specifically covered by the Act”).

The Ohio legislature didn’t like these judicial end runs around OPLA, and they tried again and again until they got things right. In particular, the legislature didn’t like Carrel, which added all sorts of loopholes to the prior version of OPLA by holding: (1) “the General Assembly will not be presumed to have intended to abrogate a common-law rule unless the language used in the statute clearly shows that intent”; and (2) “there is no explicit statement [in OPLA] that this definition [of “product liability action”] was meant to abolish common-law actions.” 677 N.E.2d at 798-99.

Since Carrel, the Ohio legislature has assiduously gone about providing the “explicit” legislative intent that the court had found lacking.

In a 2004 amendment to OPLA (effective in 2005), the legislature added Ohio R.C. §2307.71(B), which states that OPLA is “intended to abrogate all common law product liability claims or causes of action.” An uncodified part of the same law was even more explicit:

The General Assembly declares its intent that the amendment made by this act to section 2307.71 of the Revised Code is intended to supersede the holding of the Ohio Supreme Court in Carrel v. Allied Products Corp. (1997), 78 Ohio St.3d 284, that the common law product liability cause of action of negligent design survives the enactment of the Ohio Product Liability Act, sections 2307.71 to 2307.80 of the Revised Code, and to abrogate all common law product liability causes of action.
2004 Stat. 80, §3(D) (uncodified).

In 2006 the Ohio legislature amended OPLA again, and it sharpened its explicit legislate intent even further:

The General Assembly declares its intent that the amendments made by this act to sections 2307.71 and 2307.73 of the Revised Code are not intended to be substantive but are intended to clarify the General Assembly's original intent in enacting the Ohio Product Liability Act, sections 2307.71 to 2307.80 of the Revised Code, as initially expressed in Section 3 of Am. Sub. S.B. 80 of the 125th General Assembly, to abrogate all common law product liability causes of action including common law public nuisance causes of action, regardless of how the claim is described, styled, captioned, characterized, or designated. . . .
2006 S 117, § 3 (effective date August 1, 2007) (uncodified).

FYI: all this uncodified stuff is in the annotated version of OPLA, between the codified text and the annotations.

Thus, under OPLA as it currently stands, the duty to warn is now a purely statutory claim. See Ohio R.C. §2307.76. All common law claims ("regardless of how". . .etc.) concerning warnings have been quite explicitly abrogated.

There’s no heeding presumption written into OPLA – and “[i]t must be presumed that the General Assembly, in [enacting] statutes, was mindful of the common law.” In re Petition for Annexation of 368.08 Acres, More or Less, 706 N.E.2d 1, 8 (Ohio App. 1997).

Moreover, the Seley heeding presumption is clearly “common law” – based on two out-of-state cases and a now-repudiated section of the Restatement of Torts.

So we think that it’s a reasonable reading of OPLA, especially in light of the vehement and repeated expressions of legislative intent to displace the common law, to argue that with the enactment of OPLA, the Seley heeding presumption no longer exists.  It's been "abrogated" along with the rest of the common law in this field of law.

Has any defendant ever taken this position? We don’t know of it being done, and there’s certainly no case on Westlaw addressing this argument pro or con.

There’s gotta be a first time.