Major Pain Pump Decision

We've just been informed of Miller v. Stryker Instruments, No. CV 09-813-PHX-SRB, slip op. (D. Ariz. March 29, 2012), which decided both Daubert and summary judgment motions in a pain pump case.  Part of it's good, part not so good, and part of the not so good part is a little hard to understand.  Probably the best part of Miller, at least from the broader perspective, is the court's exclusion of - you guessed it - Suzanne Parisian.  Slip op. at 14-19.  Dr. Parisian was excluded for the usual reasons:  She offers improper regulatory opinions on legal matters that invade the province of the court.  She offers other regulatory opinions that have no discernable basis in fact.  She offers non-expert opinions that invade the province of the jury.  She has no coherent methodology.  She offers causation opinions that are incompetent.  She offers examples of "less than admirable conduct by Defendant" that are entirely irrelevant to the case.  Most of her report "state[s] facts that could be directly presented to the jury and then make[s] legal conclusions."

Yup, that's Dr. Parisian in a nutshell.  Miller excludes it all.

Certain challenged portions of another plaintiff expert, Dr. Busman, are also excluded.  Dr. Busman seems to be offered mostly as a medical causation expert, but he tried to stray into other areas.  The court excluded his attempted regulatory opinions - after the plaintiff fell on his sword and effectively withdrew them.  Dr. Busman was also excluded as a warnings expert.  Since some courts have allowed medical experts to opine on warnings, simply because they have medical degrees, what Miller holds in this regard is also of note:

Plaintiff does not assert that Dr. Busfield is a warnings or humans factor expert, nor does Plaintiff contend that Dr. Busfield has a special methodology for interpreting warnings.  Rather, Plaintiff argues that Dr. Busfield should be able to state “what the words of the labeling communicate to him” as a licensed, qualified orthopedic surgeon.  The Court agrees with Defendant that Dr. Busfield is not an expert on the adequacy of warnings and that only Plaintiff’s surgeon, Dr. Hofstedt’s understanding of the label is relevant.

We confess to having some trouble following how the court purports to distinguish Talley v. Danek Medical, Inc., 179 F.3d 154 (4th Cir. 1999) - one of our prior Bone Screw wins.  See Slip op. at 15 n.11.  Miller admits that the plaintiff here "is arguing that Defendant was negligent or strictly liable at least in part because it marketed its pain pumps for [a] use when it knew this specific indication had not been cleared by the FDA."  Slip op. at 15.  Well, that's exactly what was going on in Talley, as off-label marketing was essentially all that the Bone Screw cases were about.  Marketing without a license is like driving without a license - an insufficient ground for arguing negligence per se.  It's not anything to do with "quality or proper labeling."  Since, according to Miller, the pain pump had not been cleared for the use in question, that use wasn't on the label.  Nor is the pump alleged to have been of poor quality.  We can see a failure-to-warn claim based on off-label promotion, if some risk was left unstated, but the discussion of Talley doesn't get into that.  Without an allegation of failure to warn, marketing without a license is just that.  Ultimately, though, it might not matter much, since the issue involved Dr. Parisian's testimony, and all that was excluded.  We do feel protective of our Bone Screw wins, however.

More turgid overanalysis is found in the discussion of the defendant's alleged testing (or lack of same).  Miller, slip op. at 26-28.  The same result could have been reached in no time flat under the usual rubric that evidence of a failure to test is admissible as part of a claim of failure to warn, which is standard stuff.  Instead, we're treated to the court's discussion of why a duty to test "is not fictitious."  Slip op. at 26.  It may not be, but duties to test, including under the Third Restatement, certainly are "subsumed."  Id.  There are only three types of defect in the Third Restatement, and the discussion of testing in comment m is explicitly entitled "reasonably foreseable uses and risks in design and warning claims."  Further, Miller's reliance on the FDA's refusal to clear the device, slip. op. at 27, bears the hallmarks of a sub rosa attempt to shift the burden of proof.  In the regulatory context, the manufacturer has the burden of affirmatively establishing safety and effectiveness.  In the tort context, by contrast, the plaintiff has the burden of affirmatively establishing lack of safety (or effectiveness, but that's not at issue here).  There's nothing in the FDA's "no evidence" finding that proves lack of safety.  So the whole "testing" issue seems to us to be a red herring, offered in an attempt to get around the plaintiff's need to establish the state of the art in warning cases.  There is no "duty to test" separate from accepted design/warning claims, and the entire structure of the Third Restatement makes that clear.  Unfortunately, the Miller opinion is less than clear.

While the defendant's summary judgment motion on design defect also failed, we don't have anywhere near the problem with Miller's reasoning on that score.  Essentially, and as indicated in Bexis' book (citing  Arizona follows the case-by-case approach to comment k.  We don't like it, but that's what the law is there.  So a defendant is unlikely to win by arguing the opposite.
Gaston v. Hunter, 588 P.2d 326 (Ariz. App. 1978)),

Finally, we would be remiss not to point out that Miller granted summary judgment against the plaintiff's punitive damages claim, finding as a matter of law that the evidence did not establish the requisite "evil mind."  Slip op. at 32-34.  It's completely fact specific, but if you're defending pain pump cases, it's something you'd want to know.Slip op. at 14 (emphasis added).  The Miller court thus seems to recognize that physician adequacy opinions amount to impermissible "reasonable physician" testimony on matters that the learned intermediary rule requires be proven through the prescribing physician.

Putting It All Together

Our first reaction upon reading Metz v. Wyeth, 2012 U.S. Dist. Lexis 42432 (M.D. Fla. March 28, 2012), is boy, this case has a little of everything!  After it was over, the plaintiffs must have felt a little like the French after they went to war against the Prussians in 1870.

First, Metz has a little Conte (for the uninitiated, that’s shorthand for the branded liability in generic cases controversy), although only a little – the court notes (at *2 n.1) that it previously dismissed the claims against the non-manufacturing branded drugmaker.  See Metz v. Wyeth, Inc., ___ F. Supp.2d ___, 2011 WL 5826005, at *1-3 (M.D. Fla. Nov. 18, 2011).  That moves Metz onto our list of one-two punch cases that combine product identification with Mensing preemption.  It’s the seventh suit to achieve this distinction that we know of.

Second, as you might have guessed, Metz has Mensing/generic drug preemption issues all over it.  The court held that most of the plaintiff’s claims against the manufacturer of the generic drugs she took were preempted.  Those were:  (1) negligence claims, except for (possibly, the court used “may” and never definitively decided the point) allegations that the defendant could have “take[n] additional steps to warn doctors and/or consumers of information already appearing in, or recently added to, the label.”  Metz, 2012 U.S. Dist. Lexis 42432, at *8; (2) the defendant’s failure to “inform itself” of alleged risks, id. at *10; (3) all strict liability claims, including design defect and failure to withdraw the drug from the market, id. at *11-13; (4) warranty claims (unless based on the “additional steps” theory), id. at *13-15; and (5) misrepresentation/fraud.  Id. at *15-17.

In addition to Mensing-based preemption, the court invoked Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), in holding that claims “that [defendant] failed to supply relevant information to the FDA” were also preempted.  2012 U.S. Dist. Lexis 42432, at *17 n.6.

Third, the court addressed another of our pet peeves, negligence per se claims based on alleged allegations of Food, Drug and Cosmetic Act (“FDCA”) violations.  As a matter of state law, Metz held that Florida did not recognize such an animal.  Only statutes that the legislature (Congress, in the case of the FDCA) intended be privately enforced could give rise to negligence per se.  Id. at *17-19. Furthermore, “failure to comply with administrative regulations rather than substantive regulations establishing a specific standard of care” also cannot be the basis of an negligence per se claim.  Id. at 19 n.8.  These are two of the grounds covered in our comprehensive negligence per se post on state-law defenses.

Fourth, the court noted the plaintiff’s improperly vague pleading at two points in the first half of the Metz opinion.  No facts concerning manufacturing defect were pleaded, leading to a dismissal under TwIqbal. 2012 U.S. Dist. Lexis 42432, at *11 n.4 . Plaintiff’s misrepresentation claims – mostly concerning post-marketing pharmacovigilance – failed the particularity requirements of Rule 9(b).  Id. at *16.

Fifth, all non-preempted claims failed on summary judgment under the learned intermediary rule because the labeling, specifically warning against long-term use, was adequate as a matter of law:

[T]he product label . . . contained the accurate, clear, and unambiguous warning that “[t]herapy should not exceed 12 weeks in duration.”  This warning, which was available both in the package insert and on the internet . . .. satisfied [defendant’s] duty to provide Plaintiff’s treating physician with adequate information about the risks associated with [the drug’s] use (including the FDA indicated prohibition on long term use).

Metz, 2012 U.S. Dist. Lexis 42432, at *23 (footnote omitted).

The warning discussion in Metz also accepted a couple other noteworthy propositions.  (1) Once an adequate warning is given, “[w]hether the physician in fact reads the warning, or passes its contents along to the recipient of the drug is irrelevant.”  Id. at *22.  “This is true even if [defendant] knew or should have known that the medical profession was not warning patients of allegedly known harmful side effects.”  Id. at *23 n.12.  Also, (2) “there is no duty to communicate an inadequate warning,” so the plaintiff cannot claim liability for not changing to a warning that they still allege is inadequate.  Id. at 23 n.11.  It would a good idea to save these quotes somewhere.  Both of these points are worth remembering for future cases.

Thus, the Metz case featured Conte, preemption, negligence per se, TwIqbal, and the learned intermediary rule – and the defendant won on all of them.  That’s what we call putting it all together.

A New York Minute

There’s something to be said for having themes. Not only do themes provide organizing principles, but if properly chosen, themes are like a well that never runs dry. Instead of being repetitive, one just returns to one of his/her overarching themes.  Here at DDLaw, practically from the beginning, we’ve harped on the principle that, under federalism as exemplified by Erie v. Tompkins, federal courts sitting in diversity jurisdiction should not usurp the function of state appellate courts and predict expansions of state tort law.  Most of the posts on our Erie Doctrine topic are variations on this theme.


But all the while, we’ve had in the back of our minds the analogous situation in state court.  It would be hard for us not to, being so close to the mass tort mills in Philadelphia, New Jersey, and New York – jam-packed with litigation tourists from all over the country.  In our collective gut, we sense that state court judges – no less than federal judges – should refrain from predicting the laws of other states in novel ways that expand liability beyond the precedents set by the courts of those other states. The same principles of comity and respect for the interest (and primacy) of other states in their own laws apply.

But we’d never blogged about it, because we never had a hook to hang our hats on.

That changed this week.  Not to step on McConnell, who will be looking at Gianvito v. Premo Pharmaceutical Laboratories Inc., ___ N.Y.S.2d ___, 2012 WL 914997 (N.Y. App. Div. March 20, 2012), more comprehensively next Monday, we were quite pleased to come across this gem from New York’s first appellate division:

[T]o the extent New Jersey law is unsettled on the issue, we decline to expand the law therein to allow plaintiffs to allege a market share theory.

Id. at *1. That’s the same general principle of Erie federalism, extended to the state vs. state context as some form of comity.

Not only that, but Gianvito actually cited something for the proposition.  So we took a look at the cited case, In re New York County DES Actions (Kush), 655 N.Y.S.2d 520 (N.Y. App. Div. 1997), and sure enough Kush stated, “it would be improper and presumptuous for the courts of this State to expand the theories of products liability recognized by foreign states.”  Id. at 173 (refusing to predict expansion of Pennsylvania law).

Amen, brother.

Kush, in turn, quoted from yet another DES/market share liability case, In re New York County DES Litigation (Godfrey), 636 N.Y.S.2d 338 (N.Y. App. Div. 1996), which examined interstate comity concerns in a bit more length:

These three actions were commenced by foreign residents whose exposures to [the drug] occurred in foreign states. . . . The substantive laws of the foreign states at issue here do not recognize non-identification theories of liability in products liability cases such as these. . . . Under the circumstances, it would be improper and presumptuous for the courts of this State to expand the theories of products liability recognized by foreign states.

Id. at 428 (Georgia, Iowa, and Missouri law) (citations omitted).  That’s as far back as we can go on that thread, because Godfrey's citation for the “presumptuous” language is a federal case, applying our familiar Erie principle – so the two definitely are related.

But in Godfrey, at last, there was also a key number (unfortunately, for present purposes, under product liability) for the proposition.  We looked, and found the “presumptuous” language cited in another New York DES case:  Armata v. Abbott Laboratories, 747 N.Y.S.2d 863, 866 (N.Y. App. Div. 2002) (Massachusetts law).  Good language, to be sure, but so far it’s all New York and all market share liability.

This is a hard principle to research, as it could (and probably does) arise in many areas of the law, and it could be phrased in many ways.  Our quick attempt at locating law elsewhere did not uncover much – although we did find a relatively recent unpublished New Jersey court decision advocating “cautionary principles . . . in approaching novel legal issues arising under another state’s law” in the corporate context.  Employer Teamsters Local Nos. 175 & 505 Pension Trust Fund v. Caspersen, 2006 WL 435289, at *11 (N.J. Super. A.D. Feb. 24, 2006) (“If [another state] is going to recognize the . . . obligation for [defendants] advocated by plaintiff, that recognition should come from a [that state’s] tribunal rather than from a foreign state’s court”).  The New Jersey court “affirm[ed], as we likewise conclude that plaintiff's legal theory has yet to be recognized in the courts of [the relevant state], and that principles of interstate comity warrant our forbearance in so expansively interpreting the corporations law of a sister state.”  Id. at *1.  It's hard to argue that another state’s tort law should be treated any less respectfully.  We offer this case because New Jersey is another state where the issue of novel, expansive liability under other state’s laws could be expected to arise with some frequency.

If anybody else out there is familiar with similar principles adopted in his/her state, let us know and we’ll give you credit.  Also, if there are any law professors out there looking for topics for law review articles, the issue of interstate comity and one state court’s prediction of novel forms of tort liability under a different state’s law appears not to have been addressed in any prior law review article that we could find.

Any Exposure ≠ Enough Exposure

It would be a remarkable business plan to win product liability lawsuits.  Locate a potential plaintiff who has the disease and who also has had some – any – exposure to the product or toxic substance.  That’s it.  You win.  No need to worry about the other side ruling out the product or substance as a cause.  They can’t.  Once there’s exposure, it’s a cause.  No need to worry about your side ruling out other potential causes of the disease.  That doesn’t matter.  The plaintiff has the disease, and the plaintiff was exposed: you win.

It’s a plaintiffs’ lawyer’s dream.  Case specific facts for the most part become irrelevant.  You don’t have to worry about alternative causes, other risk factors or evidence of low exposure.  You don’t need to sweat the science.  Specific causation expert opinions are simple and almost unassailable.  No worrying your way through tense depositions dissecting your expert’s opinions on the necessary levels of exposure or the effect of exposure at low levels.  It just doesn’t matter.  Any exposure is enough exposure.  You win.

Of course, this dream business plan would be a nightmare for defendants, and the courts.  Fortunately, all this remains in the world of dreams and nightmares.  Because it isn’t reality.

The decision in Schultz v. Glidden Co., No. 08-C-919, 2012 U.S. Dist. LEXIS 38163 (E.D. Wi. Mar. 20, 2002), is a good example of this.  In Schulz, the plaintiff claimed that her deceased husband got Acute Myeloid Leukemia (“AML”) from exposure to the defendants’ products, which contained benzene.  The plaintiff had a case-specific expert who opined that the husband had been exposed to 20 ppm-years of benzene, and the defense had an expert who opined that almost twice that exposure was necessary to cause AML.  Id. at *6-7.  Those types of opinions are fairly standard in product liability litigation.

But what makes this case interesting is that neither of those opinions really mattered because the plaintiff offered a general causation expert who said that any non-trivial exposure to benzene was enough to cause the deceased’s AML:

When no safe threshold of exposure to a carcinogen has been established, this means that each and every exposure to the chemical will increase the risk of development of the types of cancer that the carcinogen is capable of causing.  To the extent that an individual has developed a type of cancer caused by the carcinogen in question, then any non-trivial exposure to that carcinogen during a time frame consistent with the range of latency periods with the disease should be considered as a probable substantial factor that contributed to the development of the individual’s cancer.

Id. at *8-9.  In other words, it didn’t matter whether the deceased had been exposed to 24 ppm-years of benzene, or 5, or 100.  Any non-negligible, non-trivial exposure was enough. 

That’s not all.  The expert also opined that, once you find this exposure to benzene, you cannot exclude benzene as a possible cause of the deceased’s AML.  Not ever:

To the extent a known risk factor for a particular type of cancer has been identified in an individual who has developed that form of cancer, exclusion of that risk factor as one of the probable causes contributing to the cancer is not scientifically possible.

Id. at *9.  So, not only is any non-trivial exposure enough, but once you’ve got it you can’t rule it out.

There’s still more.  According to this expert, even if there were sufficient and present alternative causes of the deceased’s AML, that wouldn’t matter.  Alternative causes “in no way undermine[]”that benzene played a “substantial role in the development” of the deceased’s AML.  Id. at *13.   

Well, that’s a non-trivial amount to swallow.  Any non-negligible exposure to benzene and the case is essentially over.  Benzene becomes a cause that cannot be eliminated.  None of the other causes – even if present – can change that.  No further evidence or explanations are needed.  That’s a bad place for the defense to be.  

Fortunately – science, Daubert and common sense to the rescue.  The Schultz court found plenty of reasoning in previous benzene cases that the science just doesn’t work this way.  It doesn’t support this “no-threshold” or “one-hit” theory of causation:

The theory that any amount of exposure more than negligible should be considered substantial risk factor for AML flies in the face of the scientific literature reviewed and other expert testimony in this case that there is a threshold or dose below which you do not see a statistically significant risk of developing AML.  Even though benzene has been shown to cause AML, it is too difficult a leap to allow testimony that says any amount of exposure . . . to this toxin can cause AML and caused AML in the plaintiff.

Id. at *9-10 (quoting Henricksen v. ConocoPhillips Co., 605 F. Supp. 2d 1142, 1166 (E.D. Wash. 2009); citing Baker v. Chevron USA, Inc., 680 F. Supp. 2d 865, 878 n.9 (S.D. Ohio 2010) (“The ‘one-hit’ or ‘no threshold’ theory of causation in which exposure to one molecule of a cancer-causing agent has some finite possibility of causing a genetic mutation leading to cancer is not a reliable theory for causation under Daubert standards.”))

The court also properly found that this “no-threshold” theory of causation fails every Daubert smell test there is: 

The linear non-threshold model cannot be falsified, nor can it be validated.  To the extent that it has been subjected to peer review and publication, it has been rejected by the overwhelming majority of the scientific community. It has no known or potential rate of error.  It is merely a hypothesis.

Id. at *10-11 (quoting Whiting v. Bos. Edison Co., 891 F. Supp. 12, 25 (D. Mass. 1995); citing Sutera v. Perrier Grp. of Am., Inc., 986 F. Supp. 655, 666 (D. Mass. 1997) (“There is no scientific evidence that the linear no-safe threshold analysis is an acceptable scientific technique used by experts in determining causation in an individual instance”)).

The Schulz court was on a roll.  Not only did the non-threshold test fall in the face of science and Daubert, the expert’s opinion that he didn’t need to address or disprove other alternative causes was also a Daubert loser: “if an expert utterly fails to consider alternative causes or fails to offer an explanation for why the proffered alternative cause was not the sole cause, a district court is justified in excluding the expert’s testimony.”  Id. at *12.  This comports with our common sense: if something else caused the AML, then it wasn’t the benzene.  This isn’t reasoning that can be dispensed with simply because it makes things more complicated or more difficult for the plaintiff or the court.  It must be dealt with head on and, if not, plaintiff’s claim must fall.

Science in the courtroom isn’t, or shouldn’t be, a process that can be gamed. The idea is not to put forward expert opinions that will work for every case and that resist testing and evaluation. It is in fact the opposite. The science must be the science, not a strategy. The nature of science is testing, probing and questioning, not insulation from these things. The no-threshold, no alternative cause approach defies all of this.

So, while these types of expert opinions may seem like a dream to some plaintiff’s attorneys, in reality they’re straight-up losers. The Schulz court granted summary judgment to the defendants and dismissed the case.

Aredia/Zometa – The Punitive Dance Continues

            When last we wrote of punitive damages in the Aredia/Zometa litigation, we predicted the parties were entangled in a dance that would involve back and forth on both sides and that wasn’t likely to end anytime soon.  See prior post.   We were right on both accounts. 

Then we brought you a favorable decision by the New Jersey Superior Court that New Jersey punitive damages law applied to a case brought by a Virginia resident against a New Jersey company in New Jersey.  See Irby v. Novartis Pharmaceuticals Corp., 2011 WL 5835414 (N.J. Super. Nov. 18, 2011).  Change the plaintiff to a California resident and the forum to California and you get the exact opposite result.  Or so said the court in Hill v. Novartis Pharmaceutical Corp., 2012 U.S. Dist. LEXIS 38516 (E.D. Cal. Mar. 20, 2012).  

This is a pro-defense blog and we don’t pretend be otherwise.  Our regular readers are fully aware of our feelings on preemption, Twiqbal and personal injury class actions.  Choice of law, however, is one of those legal issues that is difficult to take a firm position on.  Primarily because as good lawyers, we naturally want whatever law is more favorable for our clients.  Plaintiffs control where a lawsuit is brought.  While defendants can’t control what law is applied, at least we can be heard.  And, where the issue is punitive damages, our clients rightfully demand we be very vocal.    The reason is as clear as comparing the punitive damages law of the two states at issue in Hill.

In prescription drug cases, New Jersey has three limits on punitive damages.  First, the New Jersey Punitive Damages Act caps punitive damages at five times compensatory damages.  N.J. Stat. Ann. §2A:15-5.14(b).  Second, the New Jersey Product Liability Act prohibits punitive damages

if a drug . . . which caused the claimant’s harm was subject to premarket approval or licensure by the [FDA] . . . and was approved or licensed. . .  [except] where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency’s regulations, which information was material and relevant to the harm in question.

N.J. Stat. Ann. §2A:58C-5.  Third, the New Jersey appellate courts have held that the fraud on the FDA exception in the statute is preempted.  See McDarby v. Merck & Co., 949 A.2d 223, 272 (N.J. Super. A.D. 2008).  So, where a product is FDA approved, application of New Jersey law is tantamount to a dismissal of the punitive damages claim.

On the west coast, things are a bit different.  Punitive damages are available in California “in any action for breach of a non-contractual obligation – including products liability actions” and “punitive damages awards in products liability actions are not statutorily limited.”  Hill, 2012 U.S. Dist. LEXIS 38516 at *7.  Pretty much a night and day situation.  But what to do about it?

California applies the governmental interest analysis to determine choice of law.  Id. at *3.    Three steps – 1.  Do the laws of the competing states differ such that there is a true conflict?  2.  If yes, does each state have an interest in having its own law applied?  3.  If yes, which state has the greater interest (or which state would be more significantly impaired if its law was not applied)?  Id. at *4-5. 

The first two are easy.  The law is different.  And, both states have an interest in the case.  Plaintiff is a California resident and alleges she was injured in California.  Id. at *14.  Defendant is headquartered in New Jersey.  So, the crux of the case comes down to which state has the greater interest.  This is where plaintiff’s choice of forum becomes difficult to overcome.  As this court said:

[W]hen the forum state undertakes its search to find the proper law to apply based upon the interests of the litigants and the involved states, it is understood that normally, even in cases involving foreign elements, the court should be expected, as a matter of course, to apply the rule of decision found in the law of the forum. The law of the forum, will be displaced only if there is a compelling reason for doing so.  It is applicable unless either the plaintiff or the defendant has been forced into a forum devoid of any such contact as would justify application of its own law. . . . Thus, California law presumptively applies unless Defendant can present a compelling reason why it should not.

Id. at *25-27 (quotation marks and citations omitted).   Unless there is no connection to the forum, a local court wants to apply its own laws.  We get that and the Hill court had some reasons why New Jersey law should cede to California law in this case.  They are what they are – all else being equal, we’ll apply our own law.  That’s not to say that the defendants didn’t have some good arguments – they did and they made them.  But asking a local court to apply foreign law to a local plaintiff is almost always going to be an uphill battle.  (Uphill, but not impossible.  See Deutsch v. Novartis Pharmaceutical Corp., 723 F. Supp.2d 521 (E.D.N.Y. 2010) (federal court in NY willing to apply NJ punitive damages law in an Aredia/Zometa case, discussed here).

Maybe that is the more significant difference between Hill and the earlier mentioned Irby v. Novartis case from New Jersey.  In Irby a Virginia resident sued a New Jersey based company in New Jersey, while in Hill, a California resident sued a New Jersey based company in California. So, in Irby, the New Jersey court placed greater emphasis on the fact that the alleged punitive conduct would have occurred in the defendant’s New Jersey corporate headquarters and “stem[med] from [defendant’s] New Jersey business activities.”  Irby, 2011 WL 5835414, slip op. at 8-10.  And with respect to conduct outside of New Jersey, the Irby court found that the drug (Zometa) “was widely distributed throughout the United States,” and “nothing in [defendant’s] sales, marketing, or distribution practices suggests that the alleged injury was more likely to occur in Virginia than in any other state.”  Id. at 7. 

In Hill, the California court was less persuaded by the location of corporate conduct argument and more focused on activity that occurred within its borders.  

Some of Defendant's misconduct undoubtedly occurred in New Jersey. Whether the misconduct occurred primarily in New Jersey, however, is not discernible from the pleadings or the competent and admissible evidence submitted by the parties. What is discernible is the misconduct extends into California. Plaintiff alleges Defendant "markets Zometa to physicians in California," "distributes and sells Zometa . . . in California," "compensates agents who pitch the drug to doctors . . . in California" and "sends instructional materials about the drug . . . to patients and physicians in California." Plaintiff further alleges Defendant failed to communicate the known risks of Zometa to doctors and patients in California. Under these circumstances, Defendant's misconduct arguably occurred as much in California as in New Jersey, if not more so.

Hill, 2012 U.S. Dist. LEXIS 38516 at *27-28.  Same drug, same general marketing activities.  Change the forum, change the result.

            Ultimately, the Hill court boiled the issue down to one of pure economics when, ignoring McDarby v. Merck, it concluded that

applying California's punitive damages  law would not impose an entirely new rule of punitive liability on Defendant. Its effect would be to raise the upper limit on any potential award of punitive damages. But this increased economic exposure . . . is nothing more than the cost of doing business.

Id. at *34-35.    And so the dance continues  . . . .

Parisian in the Spring, and the Winter of Our Discontent

With the arrival of Spring, we flipped the mattresses, moved the snowblower behind the lawnmower, and refilled the bird-feeder. We sprayed deer repellent on the tulips. It did not work, but at least now our front yard smells like coyote urine. Sadly, our poor plantings, unlike the daisies and violets in Shakespeare’s “Spring,” shall never “paint the meadows with delight.” We also made a brief pilgrimage to Clearwater, Florida to view the 2012 version of the Phillies. Hope Springs eternal. Yes, Spring brings taxes. And Spring brings mud. But Spring mostly brings good things.

Spring was only a day old when we received yet another judicial opinion curtailing the purported testimony of that World’s Foremost Authority, Suzanne Parisian. On March 21, 2012, Judge Graham Mullen ruled on Novartis’s Daubert motion in a Zometa case, excluding large portions of the opinions of Dr. Parisian. Lemons v. Novartis Pharms. Corp., No. 3:08-cv-00361 (W.D.N.C. Order March 21, 2012). We’re not stalkers or anything like that, but you probably know that we’ve been compiling a list of Dr. Parisian’s recurring performances as a plaintiff’s expert, with a view toward highlighting those courts that decided Dr. Parisian was not qualified or that her opinions flunked Daubert, Frye, Fraubert, or the judicial smell-test. The Lemons case comes out of the Aredia-Zometa MDL. Judge Mullen refused to preclude the entirety of Dr. Parisian’s opinions. It goes without saying that the authors of this blog would have granted the defense motion in a nanosecond. Heck, Bexis would probably have ordered the witness manacled and placed in an orange jumpsuit.

But the court turned Lemons into lemonade when, after conducting a Daubert hearing where Dr. Parisian was cross-examined, it disallowed any testimony from Dr. Parisian about Novartis’s conduct in interacting with the FDA because “Dr. Parisian does not possess the requisite experience or expertise, as an employee or insider of a pharmaceutical drug sponsor, to opine on the conduct of Novartis.” Slip op. at 10. For the same reason, the court barred Dr. Parisian from commenting on Novartis’s communication of the risks at issue in the litigation to health care providers. Id. The Court also found that Dr. Parisian was not qualified to testify regarding Novartis’s pharmacovigilance efforts or its internal investigation of the alleged association of its drug with the adverse event. Dr. Parisian was further barred from offering testimony “regarding NPC’s intent, NPC’s monitoring of its clinical trials, ghostwriting, legal conclusions, or causation.” Id. at 12. Dr. Parisian’s testimony was limited to a generic discussion of the role of the FDA and the responsibilities of pharmaceutical companies and to commenting on Novartis’s interactions with the FDA on the subject of labeling. We call that a win and congratulate the good folks at Hollingsworth LLP and Faegre.

We’d like to forget Winter. We don’t mean the season; this year, Winter seemed almost tropical. The only really bad snowstorm took place on Halloween. No, we mean the wretched case of Winter v. Novartis Pharms. Corp., No. 06-4049-CV (W.D. Mo. March 8, 2012). Same defendant. Same expert (plus some others). Same Daubert issue. Different result. And it is not as if the court keeps you in suspense. When the court up front emphasizes how “Daubert was not written as a barrier to the admission of expert testimony, but as the rejection of a rigid prerequisite to admissibility incompatible with Rule 702” (a half-truth, at best) and how “we can neither rule out, nor rule in, for all cases and for all time the applicability of the factors mentioned in Daubert, nor can we now do so for subsets of cases categorized by category of expert or by kind of evidence” -- well, we know we are in for some nasty weather. Slip op. at 3. Thus, with hardly a raindrop’s worth of reasoning, the court “denies NPC’s motion to preclude Dr. Parisian from quoting or summarizing documents. She may testify about industry standards for the pharmaceutical industry and whether … NPC may have violated industry standards.” Id. at 7. Thus, the court “denies NPC’s motion to exclude Dr. Parisian’s testimony about labeling and warnings.” Id. Thus, the court “denies, in part, NPC’s motion to exclude discussion by Dr. Parisian of clinical trials and other bisphonate drugs regulated by the FDA.” Id. The court “may reconsider its ruling in this area if Dr. Parisian’s testimony strays too far from the issues the jury here must decide and a timely objection is made at trial.” Id.

Here’s the thing: Dr. Parisian is guaranteed to “stray.” That is what she is really expert in doing. Still, even in the slush, a lonely crocus flower sprouts. The court granted NPC’s motion to “exclude Dr. Parisian’s opinions about NPC’s intent and personal opinions about NPC’s and its employees’ states of mind, motivations, or subjective intent.” Id. As the Classics scholars would say, mirabile dictu! Somehow Dr. Parisian failed to convince this generous judge that she was a mind-reader. Perhaps one should be grateful for small favors.

We’re certainly not mind-readers, so there’s little point in trying to figure out how the Winter court got it so wrong. In “Winter in America,” Gil Scott-Heron sang about vultures circling under dark skies. Those vultures would circle over the Winter opinion forever without finding a morsel of Daubert logic. We suspect it is significant that the court did “not believe a Daubert hearing at this late stage would be helpful or is necessary in order to rule.” Slip op. at 5. Sometimes it helps to see a witness to disbelieve her. There have been cases (like this one) where it was Dr. Parisian’s live Daubert testimony -- utterly evasive and adversarial -- that sunk her. It’s a pity that the Winter court did not even take a look and get a preview of what Dr. Parisian would try to do on the witness stand. But we should not be too surprised at anything the Winter court does. As we reported here last year, the Winter court has already produced a ghastly ruling on the significance of Dear Doctor letters. As in Game of Thrones, we are seized with dread at the thought that Winter is coming.

Updates

Here are a few updates to some of our previous posts.


First, we posted about In re Aspartame Antitrust Litigation, ___ F. Supp.2d ___, 2011 WL 4793239 (E.D. Pa. Oct. 5, 2011), as we considered the case a promising development insofar as taxation of costs of production could exercise a restraining influence on the out-of-control cost and scope of ediscovery.  Well, we’d be remiss if we didn’t point out that the Third Circuit recently reversed that opinion.  See Race Tires America Inc v. Hoosier Racing Tire Corp., No. 11-2316, slip op. (3d Cir. March 16, 2012).  All is not lost, however.  While the Third Circuit held that such relief could not be obtained under the outdated language of the costs statute, it did recognize that there was another avenue that an aggrieved party could utilize:

A responding party, however, may invoke the district court’s discretion under Rule 26(c) to grant orders protecting him from undue burden or expense in [complying with discovery requests], including orders conditioning discovery on the requesting party’s payment of the costs of discovery.  Here, neither [party] obtained a cost-shifting protective order.  We are consequently limited to shifting only those costs explicitly enumerated in §1920.

Slip op. at 28-29 (footnote omitted).  If the court seems sympathetic, this may be a useful avenue to try.

Second, we posted some time ago about Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp.2d 1264 (W.D. Okla. 2011), in which a judge, post-Levine, held that a suicide claim involving a selective seratonin reuptake inhibitor (“SSRI”) was impliedly preempted under the Supreme Court’s “clear evidence” standard.  As we discussed in some of our Colacicco posts, the SSRI/suicide cases present the best available fact pattern that we know of for preemption.  The FDA reviewed the scientific data over and over again and held that it did not support a suicide warning, given that the condition SSRIs treat – depression – is itself a far more serious risk of suicide than anything else.  To this day, the FDA has not found sufficient data for adults over 26 (the plaintiff in Dobbs was 53 years old when he killed himself) to justify any warning.  Indeed, SSRI/suicide claims were what brought the FDA into the preemption arena to start with.

The Dobbs opinion did not dispose of every claim in the litigation, so it was not appealable.  We've recently received word from defense counsel that another decision has been rendered in Dobbs, disposing of the remaining claims.  Dobbs v. Wyeth Pharmaceuticals, No. CIV-04-1762-F, slip op. (W.D. Okla. March 16, 2012).  That order, which dismisses fraud claims that the plaintiff did not assert very strongly, see slip op. at 2 n.1, is not particularly important by itself.  It rejected those claims for failure to establish reliance, misrepresentation, or damages.  Id. at 8-10.  This dismissal, however, does make the earlier preemption ruling in Dobbs appealable – and that could be extremely important.  Dobbs could tell us whether “clear evidence” really means just that, or rather is some sort of judicial code for “no preemption ever.”  While we can’t rule it out, if an SSRI adult suicide claim is not impliedly preempted on a full record of the FDA’s review, it’s hard to think of any other warning claim that would be preempted.

We’ll be rooting for the defense in Dobbs through what is likely to be a long appellate process.

Third, friend of the blog Dan Cummins passed along to us another favorable ediscovery for defendants decision.  Sourdiff v. Texas Roadhouse Holdings, LLC, 2011 WL 7560647 (Mag. N.D.N.Y. Oct. 24, 2011).  It’s not particularly detailed, but Sourdiff continues the trend of broad discoverability of information that plaintiffs voluntarily post on social media sites.  In Sourdiff, plaintiff’s counsel was directed to turn over:

any photographs, profile information, postings, messages, comments and status updates and/or other posts, including deleted content, that are in any way related to plaintiff's emotional or mental state, her physical condition, activity level, employment, this litigation, and the injuries and damages claimed by plaintiffs in their complaint in this action.

Id. at *1. Significantly, the order also encompasses “any deleted postings” made to any “to internet social networking sites maintained by plaintiff . . ., including Facebook and MySpace.”  Id.

Our posting about Sourdiff seemed to be a good time to update our research on the social media ediscovery issue.  We found one other useful decision, Davenport v. State Farm Mutual Automobile Insurance Co., 2012 WL 555759 (M.D. Fla. Feb. 21, 2012), in which the court ordered production of every photo of the plaintiff posted on any social media site, whether or not she posted them (that is, including “tags” by other people).

Pennsylvania Product Liability Law - The Muddle Continues

The Pennsylvania Supreme Court yesterday decided Beard v. Johnson & Johnson, Inc., No. 35 WAP 2010, slip op. (Pa. March 22, 2012), a decision that is good, bad, and ugly at the same time.  We say "ugly" because the entire decision - a discussion of strict "malfunction theory" liability in the context of a medical device, is based on a fundamental error (at least we'd say so) that was never brought to the court's attention.  That is, the Court in Hahn v. Richter, 543 Pa. 558, 673 A.2d 888 (1996), held that strict liability did not apply at all to any prescription drug, given the court's reading of Restatement §402A, comment k.  Subsequently, the Pennsylvania Superior Court (in accordance with the massive majority of cases nationwide) held that comment k would be applied in the same fashion to medical devices.  See Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. 2006).  Thus, Creazzo followed Hahn and held that strict liability simply does not apply to prescription medical devices.


But this foundational issue - whether a strict liability theory was even appropriate in a case involving a prescription medical product - was neither raised nor discussed, apparently at any level in Beard.  Why?  We don't know.


Next, the good parts of Beard.  The medical device in question, a really fancy stapler used for holding tissue together in complicated surgery where for one reason or another suturing is impossible or inappropriate, was designed for use in a variety of different surgical settings.  The plaintiffs (who had not preserved the device in question) claimed that risk-utility balancing concerning the design of the device should be conducted with blinders on - that the analysis should be limited to the particular use to which the device was put in the plaintiff's surgery.  The Court refused to limit the scope of risk-utility balancing in that fashion:

For better or worse, this Court’s decisions have relegated our trial courts in the unenviable position of “social philosopher” and “risk-utility economic analyst.”  This having been done -- and as the present case does not provide an appropriate opportunity for reconsideration of such assignment – we decline to require the trial courts to put on blinders. It should be enough to say that a product’s utility obviously may be enhanced by multi-functionality, so that it would be imprudent to deny trial courts the ability to assign some weight to this factor in assessing product design. . . . [Plaintiff’s] concessions of the net social utility calculus in the area of the [device’s] primary design [a different kind of surgery] are irreconcilably inconsistent with his claim of an inherent design defect. . . .


[T]here is much at stake in the condemnation of a product’s design, above and beyond any individual damages award or awards, including the impact on product costs and design innovation. On balance, we differ with [plaintiff's] position that the desire to streamline a particular facet of products litigation should be accorded priority over the wider-ranging assessment which was obviously intended from the outset, as manifested in the above characterizations of the trial court’s role, in the open-ended factors which have been accepted by Pennsylvania courts as the basis for risk-utility review, and otherwise.

Beard, slip op. at 24-24 (footnotes omitted).


After Beard, it is settled that, with respect to design defect claims in Pennsylvania, defendants will be able to defend by relying on the benefits of their designs in other uses of the product.  This should apply both to the Pennsylvania-peculiar judicial balancing of risks and benefits required under existing law (see Beard, slip op. at 25), and to the presentation of a risk/utility defense to the jury at trial.  See Phatak v. United Chair Co., 756 A.2d 690 (Pa. Super. 2000) (evidence bearing on same risk utility factors may be submitted to the jury in design defect cases).


This aspect of Beard can only help defendants by allowing them to compare their design to the plaintiff's alternative design across the entire spectrum of a product's intended uses.  Since the plaintiff's alternative design is usually tailormade to address only the accident in a given case, the alternative's adverse consequences to many other people who use the product will put before the jury the same broad perspective of product design that manufacturers necessarily employ in the real world.


The bad aspects of Beard are hinted at in the language we quoted above:  "the present case does not provide an appropriate opportunity for reconsideration of such assignment."  Yet again, the defense community has missed an opportunity to have the wide-open existential question that hovers over all Pennsylvania product liability law - the negligence-based Restatement Third theory, versus Pennslvania's idiosyncratic form of strict liability expressed by Azzarello v. Black Brothers Co., 480 Pa. 547, 391 A.2d 1020 (1978) - decided.


Justice Saylor, who wrote Beard, is (as he stated in the opinion, slip op. at 23)  one of "several justices" on record as supporting a shift away from Azzarello's extreme separation of "strict liability" from "negligence."  But as yet "a majority consensus has not yet been attained in any case."  Slip op. at 23.  The three justices who first advocated the change, "Saylor, J., joined by Castille, J. and Eakin, J.," id., aren't getting any younger.  Since Justice Saylor wrote Beard, he was careful to avoid anything that would undercut the Third Circuit's prediction (which we discussed here) that the Court would eventually move to the Third Restatement.  See slip op. at 23 (mentioning Third Circuit prediction in Covell v. Bell Sports, Inc., 651 F.3d 357 (3d Cir. 2011), and "[r]ecogniz[ing] the continuing state of disrepair in the arena of Pennsylvania strict-liability design defect law").  The Beard opinion also mentions the Third Restatement favorably in a footnote.  Id. at 26 n.18.


A three-justice concurrence (Baer, McCafferty, Todd, JJ.) dissaociates itself with footnote 18, also pointing out the unfortunate truth that, “[defendants] failed to raise this [Third Restatement] issue  in their Pa .R.A.P. 1925(b) statement of errors complained of on appeal.”  Id. at 2.  These three justices steadfastly “express no opinion on the merits of the adoption of the Restatement Third.”  Id.  Significantly, however, none of these justices comments adversely on the Third Circuit's continuing prediction in Covell of an eventual change.


However, another chance to get rid of Pennsylvania's archaic and extremely pro-plaintiff strict liability has gone by the boards.  While reading tea leaves is never easy, the fact that only three justices chose to disassociate themselves from Justice Saylor's pro-Third Restatement comments in Beard suggests that there could well be a four-justice majority on the current court to jettison Azzarello in a case where this issue is preserved.  Every defendant adversely affected by Azzarello should take care to preserve this issue from the outset.  Express preservation at the trial court level is required.  See Schmidt v. Boardman, 608 Pa. 327, 353, 11 A.3d 924, 940 (2011).

We're Not Grossed Out

From the beginning of Gross v. Stryker Corp., 2012 WL 876719 (W.D. Pa. March 14, 2012), discussing PMA medical device preemption, to the end of the opinion, pointedly referring to the Rule 11 obligation to investigate cases before bringing them, we liked what we read.  As you’ve probably already gathered, Gross is a Riegel-based preemption dismissal.  Definitely worth a read by anyone defending PMA cases.

Gross is another Trident hip case – litigation that, but for Riegel, may well have grown up to be a mature mass tort.  But after preemption, there isn’t very much there there any longer (assuming there ever was).  Indeed, our medical device preemption scorecard is rife with decisions holding that all, or virtually all, claims involving this product are preempted.  See Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011); Gelber v. Stryker Corp., 788 F. Supp.2d 145 (S.D.N.Y. 2011); Rhynes v. Stryker Corp., 2011 WL 5117168 (N.D. Cal. Oct. 27, 2011); Desabio v. Howmedica Osteonics Corp., ___ F. Supp.2d ___, 2011 WL 4074391 (W.D.N.Y. Sept. 13, 2011); Wilhite v. Howmedica Osteonics Corp., 2011 WL 2530984 (N.D. Ohio June 20, 2011); White v. Stryker Corp., ___ F. Supp.2d ___, 2011 WL 1131496 (W.D. Ky. Mar. 25, 2011); Gelber v. Stryker Corp., 752 F. Supp.2d 328 (S.D.N.Y. 2010); Lewkut v. Stryker Corp., 724 F. Supp.2d 648 (S.D. Tex. 2010); Lemelle v. Stryker Orthopaedics, 698 F. Supp.2d 668 (W.D. La. 2010); Cornwell v. Stryker Corp., 2010 WL 4641112 (D. Idaho Nov. 1, 2010); Van Dyke v. Howmedica Osteonics Corp., 2010 WL 8490858 (D. Mont. Apr. 23, 2010); Anthony v. Stryker Corp., 2010 WL 1387790 (N.D. Ohio Mar. 31, 2010); Yost v. Stryker Corp., 2010 WL 1141586 (M.D. Fla. Mar. 23, 2010); Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. 2009); Hayes v. Howmedica Osteonics Corp., 2009 WL 6841859 (D.N.J. Dec. 15, 2009); Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009) Delaney v. Stryker Orthopaedics, 2009 WL 564243 (D.N.J. Mar. 5, 2009); Parker v. Stryker Corp., 584 F. Supp.2d 1298 (D. Colo. 2008).

Thus, some parts of the Gross decision only repeat what has been decided before.  We’ll simply note those parts of the opinion and move on:  (1) a recall is not a revocation of approval for preemption purposes, 2012 WL 876719, at *2 n.13; (2) TwIqbal applies to actions removed from state court (see our prior post here), id. at *4 n.9; (3) Pennsylvania’s across-the-board application of Restatement §401A, comment k to bar strict liability applies to medical devices as well as drugs, id. at *7-9; (4) lots of different kinds of FDA documents are subject to judicial notice on a Rule 12 motion to dismiss, id. at *9 & n.26 (see our prior post here); (5) all components of a PMA-approved device are protected by Riegel preemption, including those with earlier §510k clearance, id. at *13-15; (6) just as Pennsylvania does not recognize strict liability, it does not recognize implied warranty in prescription medical product cases (see our prior post here), id. at *17 n.34; (7) to plead causation, a warning letter and/or a recall must cover the plaintiff’s particular device, id. at 23; (8) the ultra-liberal Hofts opinion is not a proper statement of TwIqbal pleading standards (see our prior post here), id. at *25; and (9) pleading an express warranty claim requires stating what the warranty is and how it became part of basis of the bargain.  Id. at *27.

Gross also comes down on the side of those courts ruling that general GMP regulations are too vague to support parallel violation claims.  2012 WL 876719, at *20-22.  The main reason given by prior courts for rejecting vague GMP claims is that they’re not “genuinely equivalent” because their vagueness allows plaintiffs to interpret them differently from the FDA and thus to impose obligations that the FDA itself does not impose.  While Gross does not disagree, and indeed embraces this vagueness argument, id. at *21, the court also offers another rationale – that reliance upon generalized GMP regulations applicable to all devices is incompatible with the preemption rationale in Riegel, which bases preemption on “device specific” requirements imposed through PMA approval:

Under the premarket approval process, the FDA imposes federal “requirements” that are “specific to individual devices.”  Allowing a plaintiff to plead nonspecific regulations as a basis for a parallel claim is inconsistent with the Supreme Court’s reasoning in Riegel, as well as the pleading requirements articulated in Twombly, Iqbal, and Fowler [a Third Circuit TwIqbal case].  This Court requires a greater level of specificity in pleading a parallel claim, rather than allowing claims premised on violations of general regulations to go forward merely because plaintiffs will supplement their pleadings at trial.

Gross, 2012 WL 876719, at *22 (all quotes to Riegel) (emphasis added).  Riegel requires device-specific PMA requirements to establish preemption, and thus also requires a violation of device-specific PMA requirements to avoid preemption through the parallel violation loophole:

[P]ursuant to the premarket approval process, medical device manufacturers must adhere to device-specific requirements.  As such, violations of same, and not merely any requirement, properly serve as the basis of a parallel claim. . . .  In the instant case, the CGMPs cited by Plaintiff . . . are not only general; they apply to all Class III PMA medical devices.  Furthermore, because these regulations do not address the manufacturing of the specific device at issue . . ., they cannot establish the requisite standard of care that a particular manufacturer must meet.  The regulations delegate the maintenance of device-specific quality control to the manufacturer.  Yet, Plaintiff does not plead that [defendant] violated its own policies regarding product safety.  Plaintiff, instead, alleges that [defendant] violated very broad CGMPs that are not device-specific to the [device at issue].  As a result, Plaintiff does not plead sufficient facts to support a claim that [defendant] did not comply with these CGMPs.

Id. at *22-23 (citation and quotation marks omitted) (emphasis original).  In short, since the device-specific PMA process is what created preemption in Riegel, only a device-specific violation claim can avoid preemption.

Because we haven’t seen a court articulate this rationale in this way before, we thought we’d point it out. Since Riegel hinges preemption on device specific requirements, which the GMPs are not, and because TwIqbal does not allow discovery based upon inadequate pleadings, Gross thus disagreed with the Fifth Circuit bootstrap approach in Bass v. Stryker Corp., ___ F.3d ___, 2012 WL 266985 (5th Cir. Jan. 31, 2012), insofar as the Fifth Circuit let plaintiff slide on pleading GMP violations because later discovery would provide the necessary specificity.  2012 WL 876719, at *22.

The court in Gross also engages in a more detailed analysis of res ipsa loquitur than we’re accustomed to seeing in preemption (or TwIqbal) opinions.  Essentially, if the FDA’s GMPs are too vague to support a parallel claim – well res ipsa loquitur is even vaguer:

[T]his Court declines to infer the existence of such negligence in accordance with the doctrine of res ipsa loquitur under Pennsylvania law.  Finding res ipsa loquitur here would require the Court to rely on even fewer facts than Plaintiff pled in support of his negligence claim.

Gross, 2012 WL 876719, at *24.  In addition, nothing in the complaint ruled out the alternative cause of physician error, particularly since infection (the plaintiff’s claimed injury) was specifically warned of as both an adverse reaction and a contraindication.  Id. at *24-25.  So remember Gross for another proposition – TwIqbal requires a plaintiff pleading res ipsa loquitur to plead it plausibly by including some factual basis for excluding alternative causes.

A third particularly interesting aspect of Gross, from our standpoint at least, comes in its discussion of the FDA’s recall of some of these devices for “impermissible, excessive manufacturing residuals.”  The plaintiff, however, admitted in the complaint that “he has not yet determined whether the residues on the hip prosthesis were” what the FDA had recalled.  Gross, 2012 WL 876719, at *2.  The court was none too pleased with this failure:

An attorney must conduct a reasonable inquiry before filing a lawsuit, and cannot pursue the action unless he or she reasonably believes that facts exist to support the allegations.  Plaintiff underwent the [surgery in question] in October 2008.  Almost two years later . . ., Plaintiff's counsel [brought suit].  During this approximately two-year time period, Plaintiff's attorney had a duty to investigate whether the residues on Plaintiff's initial hip prosthesis were foreign bodies or native material from the manufacturing process.

Id. at *2 n.11 (citing, inter alia, Rule 11).  Rule 11 “imposes on counsel a duty to look before leaping and may be seen as a litigation version of the familiar railroad crossing admonition to ‘stop, look, and listen’.”  Id. at *5 (citation and quotation marks omitted).

For similar reasons, the court in Gross rejected plaintiff’s plea for discovery prior to dismissal.  In TwIqbal, the Supreme Court had specifically stated that discovery was available only after the plaintiff pleaded a plausible claim.  In order to plead a claim, a plaintiff may engage in self-help and nothing more:

To obtain additional information from the FDA to aid in drafting his Complaint, Plaintiff could have submitted a Freedom of Information Act (“FOIA”) request. . . .  Plaintiff also had an opportunity to conduct pre-complaint discovery when he commenced this action in [state court]. . . .  Finally, the Court finds Plaintiff's request for discovery to be inapposite to Rule 8 and Rule 11(b) of the Federal Rules of Civil Procedure.  Rule 8 . . . does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions.  A plaintiff who fails to meet the pleading requirements of Rule 8 is not entitled to conduct discovery with the hope that it might permit her to state a claim.  In addition, Rule 11(b) requires a pleading to be a representation of “the best of the person’s knowledge, information, and belief, formed after an inquiry reasonable under the circumstances.”  An attorney must conduct a reasonable inquiry before filing a lawsuit, and cannot pursue the action unless he or she reasonably believes that facts exist to support the allegations.  Allowing Plaintiff to “file first and investigate later” contradicts the reasonable inquiry requirement in Rule 11(b).

Id. at 29 (citations and quotation marks, except to Rule 11, omitted).

The court’s several references to Rule 11 echo our own feelings.  It’s time for courts to crack down on knee-jerk filings in PMA preemption cases (and everywhere else, for that matter, but that’s a different gripe).  Even the barest of investigations would have revealed the preemption issues involving this product.  As our earlier list demonstrates, preemption has been on the front burner literally for years.  In this situation, it’s not enough “reasonable inquiry” to plead “I dunno but I’ll find out later.”  Preemption is a manifestation of congressional intent that certain types of actions should not be brought, and more courts, like Gross, should be willing to uphold that intent, rather than assist evasive plaintiffs.

Needless to say, Gross now enjoys a position of honor on both our device preemption scorecard and our TwIqbal cheat sheet.

Because it found that plaintiff had not come close to pleading an unpreempted claim, and indeed had not properly pleaded most of his preempted claims, the court in Gross dismissed all of the claims with prejudice and without leave to amend.  That means there is an appealable order.  We’ll keep watching Gross to see what the Third Circuit does with it.

Arbitration, Sales Reps and Personal Injury Claims

While it doesn’t involve a drug or device claim, James v. Conceptus, Inc., N. H-11-1183, 2012 U.S. Dist. LEXIS 32434 (S.D. Tex. Mar. 12, 2012), does involve a device company, sales rep, arbitration clause, and a determination that it isn’t unconscionable to send someone unwillingly to California.  That was enough to pique our interest.     

The plaintiff was a medical device sales rep.  Id. at *1.  He claimed that he was fired after he discovered certain information that he believed showed that a doctor and previous sales rep violated the False Claims Act.  Id. at *5-6.  He saw his firing as retaliation and filed a retaliation claim under False Claims Act §3730(h).  But this case really isn’t so much about what the sales rep claimed.  It’s more about where and how he could claim it. 

The sales rep filed his case in Texas federal court. The company wanted arbitration in California.  Id. at 1.  Why?  Because the sales rep’s employment agreement required that “any dispute” concerning his employment agreement be resolved by arbitration in “in San Mateo County of the State of California.”  

So the company moved to dismiss the case in favor of arbitration.  As you’d expect, the sales rep tried to get around the arbitration clause. 

But that isn’t so easy these days.  At least, not since the Supreme Court’ recent decision in AT&T Mobility LLC v. Concepcion, 131 S. Ct. 1740 (2011).  This decision gave teeth to section 2 of the Federal Arbitration Act (“FAA”), which says that agreements to arbitrate are “valid, irrevocable, and enforceable, save upon such grounds as exist at law or in equity for revocation of any contract.”  The Concepcion court read the FAA to require courts to “place arbitration agreements on an equal footing with other contracts and enforce them according to their terms.”  Id. at 1745. Moreover, the Court recently re-emphasized this the importance of this decision by upholding pre-dispute agreements to arbitrate personal injury or wrongful death claims against nursing homes.  Marmet Health Care Ctr. v. Brown, 132 S. Ct. 1201 (2012).

Facing this strong mandate, it’s not surprising that the sales rep tried to get around the FAA by arguing that a different federal statute, the more-recent Dodd-Frank Act, rendered the arbitration clause unenforceable.  Dodd-Frank amended the whistleblower provisions of the Commodity Exchange Act and the Sarbanes-Oxley Act to make unenforceable any pre-dispute clause that required arbitration of claims under their whistleblower provisions.  2012 U.S. Dist. LEXIS, at *15.  The problem, though, is that the sales rep wasn’t suing under either of those Acts.  His retaliation claim was under the False Claims Act, which Dodd-Frank didn’t amend.  “When Congress amends one statutory provision but not another, it is presumed to have acted intentionally.”  Id. at *15-16.  The court properly rejected this argument. 

The sales rep’s fall-back position was that two provisions of the arbitration clause – that he must pay half the costs of the arbitration, and that the arbitration occur in California – were unenforceable because they were unconscionable under California law, which applied under the employment agreement.  He got, at best, a split decision. 

In considering the applicability of California’s law of unconscionability, the James court applied its general understanding of Concepcion: “if the state law singles out arbitration agreements by imposing requirements that do not apply to other contracts, §2 of the FAA preempts applying that law to ‘disfavor’ arbitration.”  Id. at *8.   The court determined that the requirement that the sales rep pay half the cost of the arbitration was unconscionable because it would have required the sales rep to do something that he could not – pay half the arbitration bill.  Id. at *33-34.  The court felt that this application of California’s law on unconscionable agreements did not single out arbitration.

More important, though, the Court upheld the requirement that the sales rep, who lived in Texas, arbitrate his claim in California.  Underlying the court’s decision was the fact that California law had two separate standards for forum selection clauses, one that applied generally (a fair and reasonable standard) and one that applied only to arbitration agreements (which are considered categorically unconscionable.)  Id. at *35-39.  Under Concepcion, this stricter standard that applied to arbitration agreements is preempted because it improperly singles out arbitration.

Applying the fair and reasonable standard instead, the Court upheld the forum selection clause.  Id. at *42-43.  While the sales rep argued that he didn’t have the assets to hire local counsel or pay travel costs, the court didn't buy this argument.  The court noted that the sales rep didn’t need local counsel in an arbitration and that his Texas counsel had shown himself capable of arguing California law.  Id. at *43.  Additionally, travel costs are insufficient to invalidate an arbitration clause – particularly where, as here, plaintiff would have to take only one trip to California .  Id. at *43-44. 

So the forum selection clause was enforced.  And, like it or not, the sales rep was going to California. 

The Plaintiff and The Known Risk

            As we are sure you can tell from many of our posts – we are television junkies (well, most of us).  We watch it all – comedies, dramas, news, sports, movies, documentaries, and yes, we’ll even admit to some knowledge of reality TV.  And while we are sitting on the couch taking in all that our high definition television can throw at us, we are at fairly low risk of injury – carpal tunnel remote control syndrome?  But, once we stand up and start moving around, all of that changes.  There is a risk we’ll stub our toe on the coffee table as we head to the kitchen to refill the popcorn bowl.  There is a risk of getting into a car accident driving to the movie theater (to again sit and become lost in another visual story).  There is a risk of choking on our hamburger at dinner following the movie.   

            Sometimes, like the examples above, the risks are things we just inherently know exist.  Other times, we need some additional warning.  Like the sign on our ride to work that warns of fog ahead or caution tape around a broken sidewalk.  How about a food label that says the product contains nuts – a warning to someone with a peanut allergy to avoid that food.    Bottom line -- we are surrounded by risks.  And in our everyday lives, we make decisions about how risk averse we want to be.  Will we walk around the broken sidewalk or jump over the caution tape?  But, if we decide to walk through rather than around, maybe because going around requires us to step into the street, presenting its own risks, we have to accept the fact that we might trip and fall on the broken concrete. 

            The same is every bit as true in the context of prescription drugs.  We don’t need to belabor the point that all prescription drugs contain risks.  All prescription drugs have side effects, that’s why they require a doctor’s prescription in the first place.  Where we rely on our own knowledge and experience in deciding whether the broken sidewalk or the street present the greater risk of injury, with prescription drugs we rely on our physicians.  When the drug label warns of a risk and the doctors are aware of the risk but decide that it is in the patient’s best interest to administer the drug in light of the risk and then the patient develops the very risk warned about – it is unfortunate but it is not a basis for liability against the drug manufacturer.

            So said the Connecticut Superior Court in Zelle v. Bayer Healthcare, LLC, 2012 Conn. Super. LEXIS 481 (Feb. 16, 2012).  Plaintiff was admitted to the hospital with symptoms that caused doctors to believe she was having a stroke.  The doctors ordered two MRIs, one with and one without contrast agent.  The contrast agent contains a known and warned of risk of anaphylactoid allergic reaction.  After administration of the agent, plaintiff did exhibit signs of an allergic reaction including respiratory arrest and hypotensive shock.  Plaintiff was treated for this reaction and released from the hospital.  Id. at *2-3.  Plaintiff alleged both failure to warn and design defect under the Connecticut Product Liability Statute and both claims were dismissed on summary judgment.

            First, failure to warn fell based on the learned intermediary doctrine.  The evidence of warning in this case was abundant.  It was documented in the label under the warnings, precautions and adverse reaction sections.  Id. at *13 n.4.  It was well-known by the doctors and nurses:

     The deposition testimony of each of the physicians and the MRI technician leave no doubt that they were well aware of the possibility of adverse effects as noted in the FDA approved warnings and had for years been well aware of the specific risk of an anaphylactic reaction to the contrast agent. Each confirmed that they had considered the risks versus the necessity to diagnose and treat a possible stroke and determined that the MRI with the contrast agent should be ordered.

Id. at *15.  In other words, the doctors decided to walk through the broken concrete (use contrast agent) because the risk of stepping into a busy street (the stroke) was greater.  Indeed, precisely due to this potentially fatal risk with the contrast agent, the doctors at the facility kept a “crash cart” in the MRI room.  Id. at *22.   

          The court also found that the “plaintiff [did] not present evidence or testimony that contradicts the adequacy of the warning, the nature of the warning, the approval by the FDA or the knowledge and understanding of the warnings by the treating physicians.”  Id. at *15-16.  In fact, apparently, plaintiff’s only “proof” was an unsigned consent form which the court found not only irrelevant, but detrimental to plaintiff’s argument:

the [learned intermediary] doctrine is applicable to the warnings being provided to the physicians and health care professionals and it is not relevant for purposes of this action whether the defendants provided specific warnings directly to the plaintiff.  What the testimony and existence of the Consent Form does confirm is that the health care professionals had specific information concerning the adverse reactions as evidenced by the inclusion of these reactions within a form created by the hospital. Therefore, the plaintiff's reliance upon the unsigned form to create a genuine issue of facts is misplaced. 

Id. at *12-13. 

            The court then turned to the design defect claim.  In dismissing the claim, the court made two good points.  First, plaintiff needed an expert to establish both the alleged design defect and proximate causation: 

     In an action involving the complications of prescription medication . . . where the claims are either scientific or medical, an expert opinion is required to discuss the development, manufacture, testing, handling and marketing of the product alleged to be defective.  Id. at *19-20.

. . . .

A finding of a defect in the drug is not within the common knowledge of an ordinary person. Without an expert as to the allegations that the product was in some manner defective causing serious unexpected and unforeseen physical injuries, the plaintiff has not been able to forge a sufficient link in the causal chain that would assist a jury in reaching an educated finding that the injuries were caused by a defect in the [drug] which was administered to her.  Id. at *23.

That was enough to grant the defendants’ motion for summary judgment.  But the court also had this to say about design defect in the context of a warned about risk:

[T]he plaintiff's allegations about the adverse effect of the drug which is noted in the product labeling information approved by the FDA does not, by itself, rise to the level of a defective product. Many courts have recognized that prescription drugs can cause adverse effects but do not create liability in every instance where there is an adverse effect. This is especially relevant for an action in which the plaintiff alleges she has suffered the adverse effects noted in the product labeling. This recognition impacts the plaintiff's obligation to prove not only that there are adverse impacts but that the plaintiff suffered because the drug was defective and the defect caused other adverse impacts or heightened in some manner the adverse impacts already recognized and addressed through precautions or warnings.

Id. at *21-22 (emphasis added).  Suffering from a warned about risk isn’t enough.  Even if the allergic reaction was connected to the injection of the contrast agent, that by itself does not create a defect.  Id. at *22.  As the court noted, “the product labeling . . . recognized the possibility of this exact reaction from a non-defective drug.”  Id. at *24.  Therefore, without expert testimony of a particular defect in the product, all plaintiff has proven is that she suffered from one of the potential, known, warned about side effects of the drug.  She tripped on the broken concrete.  Unfortunate, yes. A basis for liability, no.