Friday, April 18, 2014

The Ninth Circuit Taketh Away on Daubert

We reported on the Northern District of California’s order granting summary judgment in Messick v. Novartis Pharmaceutical Corp. when it came out in February 2013, and a good and proper order it was.  The plaintiff was treated with bisphosphonate therapy for approximately two years, and she alleged that she developed osteonecrosis of the jaw (“ONJ”) more than a year after she stopped the therapy.  The problem for the plaintiff was that she had no reliable scientific evidence linking her drug therapy to her alleged disease.  Sure, she had an expert, but the expert admitted that pathology results upon which he relied were not scientifically reliable.  He also admitted that his “differential diagnosis” failed to take into account numerous other risk factors, asserting that “it just doesn’t happen” that someone like the plaintiff would experience ONJ without contribution from bisphosphonates. 
“It just doesn’t happen” is what we say when discussing whether the Chicago Cubs will win the World Series or whether we will ever fully appreciate the talents of Miley Cyrus.  When it comes to giving causation opinions to a reasonable degree of medical certainty, you will forgive us for expecting more.  The district court expected more too, and it found the opinion lacking in reliable methodology and also relevancy because the expert could not say that bisphosphonate exposure caused the plaintiff’s ONJ. 
You can imagine then our disappointment with the Ninth Circuit’s recent opinion reversing the district court’s sound and well-reasoned order.  Messick v. Novartis Pharmaceuticals Corp., No. 13-15433, 2014 U.S. App. LEXIS 6257 (9th Cir. Apr. 4, 2014).  The Ninth Circuit began its analysis by stating that “[t]he relevancy bar is low,” and it faulted the district court for excluding the opinion because, even though the expert could not say that the plaintiff’s ONJ was caused by bisphosphonate therapy, he did say that the ONJ was related to bisphosphonate therapy.  Id. at **6-7. 
The Ninth Circuit was willing to brush aside the difference between association and causation, but we’re not.  A disease may be associated with a certain drug, but it does not take an epidemiologist to understand that such an association does not demonstrate that the drug caused the disease.  Perhaps the condition calling for the drug therapy is also a risk factor for the disease.  Take for example a hypothetical obesity drug.  You might see cardiovascular events in people who take that drug, but that does not mean the drug caused any patient’s heart attack because obesity is itself a major risk factor.  We have no idea how bisphosphonates are “related” to ONJ (if at all), but we do know that that an expert who cannot say that the drug caused the disease is no help to the jury, which makes the expert’s opinion irrelevant. 
The Ninth Circuit’s discussion of the opinion’s reliability is equally off the mark, mainly in its acceptance of the expert’s “differential diagnosis.”  There is no concept in drug and device litigation that has been more misused than the “differential diagnosis,” which is a process of elimination that physicians use to makes diagnoses and prescribe treatment.  As our readers already know, there is no need for a diagnostic tool when you’ve already got a diagnosis, which plaintiffs in litigation generally already have.  However, somewhere along the way, plaintiffs and their lawyers advanced “differential diagnosis” as a method to determine the cause of a disease already diagnosed, and many courts have regrettably accepted this concept.
But even accepting that state of the law, we think the expert’s “differential diagnosis” in Messick was flawed.  For one thing, it is not clear from the opinion that he reliably “ruled in” bisphosphonate therapy as a potential cause of the plaintiff’s ONJ.  We have already belabored that he could not say it was a cause, and the district court observed that the expert “never explained the scientific basis for his opinion.”  Id. at *11.  The Ninth Circuit nonetheless gave him a pass because of the “inherent uncertainty” in the medicine.  As the court explained,

[T]he [American Association of Oral and Mixillofacial Surgeons] stated in a 2009 position paper that “the current level of evidence does not fully support a cause-and-effect relationship between bisphosphonate exposure and necrosis of the jaws.”  But the paper goes on to explain that while “causality might never be proven, emerging experimental and epidemiologic studies have established a firm foundation for a strong association between monthly IV bisphosphonate therapy and the development of BRONJ [bisphosphonate-related ONJ].  []  Because of that inherent uncertainty, we do not require that an expert be able to identify the sole cause of a medical condition in order for his or her testimony to be reliable. 

Id. at *13.  This is a remarkable passage for several reasons:  First, we are not asking an expert to identify the “sole cause” of anything; we would merely have experts identify reliable scientific bases for their opinions, and so would the Supreme Court and the Ninth Circuit itself.  Second, the Ninth Circuit acknowledged that there is no scientific evidence of causation and that there may never be scientific evidence of causation.  But the plaintiff’s expert still gets to testify and the plaintiff gets to proceed with meritless claims because of an “association” based on “emerging” science, as described in a position paper which itself is not a scientific study.  We are not impressed by an association (see above), and the reliance on “emerging” science calls to mind a favorite quote:  “Law lags science; it does not lead it.”  Rosen v. Ciba-Geigy Corporation, 78 F.3d 316, 319 (7th Cir. 1996). 
Third, the plaintiff bears the burden of proving causation, and the proponent of expert opinions bears the burden of establishing their admissibility.  If there is significant uncertainty—and it appears there was not, since the expert himself admitted that he could not say that bisphosphonate therapy caused the plaintiff’s ONJ—that uncertainty should result in the opinion being excluded. 
Finally, separate and apart from the expert’s failure to reliably “rule in” bisphosphonate therapy as a cause, he also failed to “rule out” five other risk factors, which the Ninth Circuit did not even mention.  This “differential diagnosis” is flawed coming and going, which the district court readily detected.  The Ninth Circuit unfortunately did not, and it came to the wrong result. 

Sweet Home [Fill in the Blank] − A Sea Change In Personal Jurisdiction?

We’ve been reviewing the (relatively, in Internet time) recent Supreme Court decision in Daimler AG v. Bauman, 134 S.Ct. 746 (2014), and having done so we recommend it to anyone representing overseas clients worried about being swept into the maw of the overlawyered legal climate in the United States.  But more than overseas companies are affected.  All companies should give Bauman a thorough look.  It may portend a sea change – and a favorable one – in the concept of “general” personal jurisdiction.

The underlying litigation was ridiculous, involving Argentinian nationals whose relatives were injured (often “disappeared”) in Argentina’s quasi-civil war between 1976 and 1983 (Statute of limitations?  We don’t need no stinkin’ statute of limitations!).  Allegedly the Argentinian government of the time collaborated with the Argentinian subsidiary (Mercedes-Benz Argentina) of a German corporation (Daimler AG) in committing nefarious acts – on Argentinian soil.  From this brief description of the facts, it should be immediately obvious why the proper venue for this action (according to plaintiffs) was – wait for it – San Francisco.

We don’t know, and it would take too much time for us to figure out, whether Bauman was actually mooted on the merits by Kiobel v. Royal Dutch Petroleum Co., 133 S. Ct. 1659 (2013), instructing American courts to keep their noses out of disputes arising from overseas activities, but it should be.  Bauman is another example of the same type of “we can tell the rest of the world what to do” hubris that we decried in connection with Kiobel.

Sorry for the tangent.  Back to personal jurisdiction.

The trial court quite reasonably found no personal jurisdiction over a German company for actions in Argentina.  However, the schizophrenic Ninth Circuit – assuming its “Ninth Circus” persona in this matter – reversed.  In a ruling that sent shivers up the spine of many of our overseas clients, it held that general personal jurisdiction, that is, where a defendant is sufficiently ensconced in a forum to be sued for anything, no matter where the claim arose, could be established merely because the German parent controlled a subsidiary (not alleged to have anything to do with long-ago Argentinian events) that did business in the forum state.  No, this wasn’t a form of “piercing the corporate veil.”  There was no allegation that either parent or subsidiary messed up any of the details of corporate separation.  Nope, the Ninth Circuit found jurisdiction on an “agency” theory:  essentially that a subsidiary controlled by a parent (as almost all of them, by definition, are) can be considered an agent of the parent and their forum contacts aggregated for jurisdictional purposes.  Bauman v. DaimlerChrysler Corp., 644 F.3d 909, 923-24 (9th Cir. 2011), rev’d, 134 S. Ct. 746 (2014).

The Supreme Court reversed – unanimously.  That wasn’t much of a surprise, frankly, but the Court (the majority opinion; there was more than one rationale for reversal) didn’t just blow out the “agency theory.”  It went beyond that, returning to first principles.  Even if the Ninth Circuit’s cockamamie agency theory were otherwise accepted, the Court held, that was insufficient to create general personal jurisdiction over the defendant for things that happened in Argentina – not California.

The test for general (as opposed to “specific”) jurisdiction is “when [a defendant’s] affiliations with the State are so ‘continuous and systematic’ as to render them essentially at home in the forum State.”  Bauman, 134 S. Ct. at 754 (citation and quotation marks omitted).  Over the years, most lawyers (and many courts) forgot about the “essentially at home” part of this definition.  Not the Supreme Court in Bauman. The Court focused on “essentially at home,” and gave it independent weight.  “Continuous and systematic” wasn’t enough, by itself.  The defendant must be “at home” to be amenable to general personal jurisdiction.  “Specific jurisdiction has been cut loose from Pennoyer’s sway, but we have declined to stretch general jurisdiction beyond limits traditionally recognized.”  Id. at 757-58 (discussing Pennoyer v. Neff, 95 U.S. 714 (1878), restricting exercise of personal jurisdiction to “the geographic bounds of the forum”).  The Pennoyer rule, while long since abandoned in “specific” jurisdiction cases, was held in Bauman to be alive and well when “general” jurisdiction is asserted.

That’s a big deal, because “geographic bounds” is a quite limited test.

The Ninth Circuit’s “agency” theory went straight out the window.  Agency had nothing to do with being “at home” in this or that forum, so it has nothing to do with general personal jurisdiction.  The Ninth Circuit had improperly “stacked the deck”:

[T]he inquiry into importance stacks the deck, for it will always yield a pro-jurisdiction answer. . . .  The Ninth Circuit's agency theory thus appears to subject foreign corporations to general jurisdiction whenever they have an in-state subsidiary or affiliate, an outcome that would sweep beyond even the “sprawling view of general jurisdiction” we rejected in Goodyear [Dunlop Tires Operations, S.A. v. Brown, 131 S.Ct. 2846 (2011)].

Bauman, 134 S. Ct. at 759-60.  Instead, “only a limited set of affiliations with a forum” will create general or “all-purpose” jurisdiction.  Id. at 760.

So what is the general jurisdiction test, then?

Where a corporate defendant is “essentially at home”?  Creating and supervising an agent that does business somewhere else are “slim” contacts, not nearly enough.  “Daimler’s slim contacts with the State hardly render it at home there.”  Id. at 760.  More importantly, even “continuous and substantial” contacts don’t suffice by themselves – the corporate defendant must also be “at home” – this is the key point for future cases.

Goodyear did not hold that a corporation may be subject to general jurisdiction only in a forum where it is incorporated or has its principal place of business; it simply typed those places paradigm all-purpose forums. . . .  [T]he inquiry under Goodyear is not whether a foreign corporation’s in-forum contacts can be said to be in some sense “continuous and systematic,” it is whether that corporation’s “affiliations with the State are so ‘continuous and systematic’ as to render [it] essentially at home in the forum State.”

Id. at 761. This is continuous and substantial plus.   Only in an “exceptional” case (not defined) will a corporate defendant be subject to personal jurisdiction beyond the places where it is either:   (1) incorporated, or (2) has its principal place of business.   Id. at 761 n.19.   The example the court used of such a case was Perkins v. Benguet Consolidated Mining Co., 342 U.S. 437 (1952), which was pretty darn exceptional:  the company was run out of its usual principal place of business (the Philippines) by the Japanese invasion in World War II, and had set up temporary quarters in Ohio.  So, short of a corporation becoming a wartime refugee, being “at home”looks pretty well limited to incorporation/principal place of business.   Bauman thus set a standard well beyond having an agent for service of process.
So – what if an overseas corporation (like the defendant in Bauman) doesn’t have an American principal place of business? The answer appears to be,“tough”:

The Ninth Circuit, moreover, paid little heed to the risks to international comity its expansive view of general jurisdiction posed.  Other nations do not share the uninhibited approach to personal jurisdiction advanced by the Court of Appeals in this case. . . .  Considerations of international rapport thus reinforce our determination that subjecting Daimler to the general jurisdiction of courts in California would not accord with the “fair play and substantial justice” due process demands.

134 S. Ct. at 763.  “Comity” means that, in the interest of the smoother operation of international affairs generally, a court refrains from upsetting the international applecart, even if it could.  So overseas corporations may well be shielded altogether.  Comity would not, however, be an additional factor for companies incorporated in an American state.

Bauman could be a big deal.  Our shorthand from law school – general = continuous & substantial; specific = minimum contacts, is no longer so.  Continuous and substantial is not enough.  Some of our clients are large enough that they arguably had a continuous and substantial presence in every state.  But they’re still only domiciled in a couple of states.  This will make it harder, we think, for forum-shopping plaintiffs to aggregate claims by limiting (or in some cases eliminating altogether) the fora in which claims may be aggregated.  Consider:

  • Will plaintiffs be able to concoct nationwide class actions and bring them in jurisdictions with peculiarly unfavorable law or procedures, when the target defendant isn't domiciled there, and thus is not subject to jurisdiction where the plaintiff was not injured in forum state?
  • Will all these food class actions still be able to be brought in California?  Can plaintiffs claim specific jurisdiction instead?
  • Will all these False Claims Act cases (unless the FCA has special federal jurisdictional provisions, which we don’t know) still be able to be brought in Massachusetts?
  • Will all those cases about just about anything be able to be brought in Madison County Illinois – or Philadelphia, Pennsylvania, for that matter, when the plaintiff suffered no injury in the forum?
  • What about fraudulent misjoinder cases, since personal jurisdiction is a constitutional issue?

We don’t know the answers to these questions (although we can guess as to some), but we’re sure looking forward to finding out.  So should every lawyer currently engaged in the defense of mass tort litigation – and not just drug and device mass torts (plane crashes have never fit well into territorial models, and patent “hellholes” may be just as threatened).

What we do know is that the contacts in Bauman of the defendant’s claimed agent – Mercedes-Benz, USA – with California weren’t near enough to sustain general jurisdiction.  Eight justices (all but Sotomayor) signed on to Bauman, which was authored by Justice Ginsburg, not ordinarily considered a conservative ideolgue.  So the mere fact that a company sells lots of its products all over the country doesn't cut it for general jurisdictional purposes.  That's all the jurisdictional facts that plaintiffs ordinarily have against most of our clients, and against most large U.S. companies.
But the idea of “continuous and substantial” as the sole test for general jurisdiction is now dead.  Instead, “[g]eneral jurisdiction . . . calls for an appraisal of a corporation’s activities in their entirety, nationwide and worldwide.  A corporation that operates in many places can scarcely be at home on all of them.”  Bauman, 134 S. Ct. at 762 n.20.  Likewise dead is the assumption that large companies conducting “continuous and substantial” business everywhere in the country may be sued anywhere for anything.  Thus, the jurisdictional basis for this country’s litigation hellholes is, after Bauman, open to considerable question.  And what happens if a hellhole is limited to defendants actually domiciled in that state?   Those defendants may just pack up and leave, since escape is now possible.

So, where can a plaintiff sue a corporate entity?  Three places in most instances – where the plaintiff was injured/exposed (under principles of specific jurisdiction), where the defendant is incorporated, or where the defendant has a principal place of business.  After that, anything else, and the plaintiff better have something "exceptional" – like a World War II-style military invasion.  By and large, they won't.

Thursday, April 17, 2014

O Defect, Defect! Wherefore art thou Defect?

            This post is from the non-Reed Smith side of the blog.

            This is apparently the question the court was asking in deciding whether to dismiss Dilley v. C.R. Bard, Inc., 2014 U.S. Dist. LEXIS 47066 (C.D. Cal. Apr. 3, 2014).  Now Shakespeare may have been using “wherefore” to have Juliet ask the question “why.”  Why, of all the families in Verona, does Romeo have to be a Montague?  But, for our purposes, we’ll take the modern translation.  Where is the defect?  Turns out it wasn’t in the complaint.  We’ll try to keep today’s post as short as we believe the complaint in this case was.

            The case involved a surgical mesh used to repair plaintiff’s hernias.  Plaintiff developed chronic pain post surgery and three years later he had revision surgery, including removal of the mesh.  Id. at *1.  Plaintiff’s terse complaint alleged three causes of action.  First, plaintiff attempted to plead a manufacturing defect by simply alleging that the device “possessed a defect.”  You could argue, isn’t a defect, a defect?  After all, “what’s in name?  That which we call a rose by any other name would smell as sweet.”  That might work for Juliet, but in a products liability action, simply calling something a defect isn’t enough.  For a manufacturing defect, plaintiff “must identify/explain how the [product] either deviated from the [manufacturer’s] intended result/design or how the [product] deviated from other seemingly identical [products.].”  Id. at *8 (citation omitted).  The same lack of specificity was the downfall for plaintiff’s negligent design defect claim.  Id. at *9-10.  And, of course, under California law, there is no strict liability design defect for medical devices.  Id. at *9. 

            Plaintiff’s failure to warn claim similarly failed because plaintiff did “not identif[y] any warnings that were given . . . let alone how they were allegedly deficient.”  Id.  at *11.  But that wasn’t plaintiff’s only pleading mistake.  The complaint also included a medical malpractice claim against plaintiff’s surgeon.  In the malpractice allegations, plaintiff alleged the surgeon “was aware of the problems associate with the use of defendants’ [product] or reasonably should have been aware of the problems associated with the use of them.”  Id.  So, plaintiff pleaded himself right into the learned intermediary defense.  “Under California law, the learned intermediary’s prescription of the medical devices in light of the knowledge of the risks precludes a failure-to-warn claim.”  Id.

            The complaint also contained a request for punitive damages.  But, you’ve probably guessed by now based on the substantive allegations – or lack thereof – that plaintiff failed to meet “even the most lenient pleading standard” available for punitive damages.  Id. at *12-14. 

            It would certainly be an overstatement to say “for never was a story of more woe than this.”  But, the allegations in Dilley are among some of the most woeful we’ve seen.  And the dismissal, for us, is only the sweet without the sorrow.

Annual DRI Shameless Plug

Here is our annual publicity stunt for the Defense Research Institute’s Drug and Device Seminar:


Please join us at the 2014 DRI Drug & Device Seminar May 15 – 16, 2014 at the Renaissance Downtown Hotel in Washington, D.C. The program includes:

           The head of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, MD, will share her thoughts about conveying drug safety information in the Digital Age.

           A federal judge and state court judge will discuss how they work together to coordinate parallel mass tort proceedings.

           A nationally renowned settlement expert, Kenneth Feinberg – Special Master of the September 11 Victim Compensation Fund – will discuss how to resolve the most difficult personal injury cases.

           An experienced practitioner will give the inside scoop on the plaintiff bar's latest litigation tactics.

           There will be a "fireside chat" with four prominent in-house counsel attorneys who will share insights regarding questions all outside counsel want to know.

           And back by popular demand, there will be an exclusive in-house counsel breakout session that will address unique issues facing in-house counsel and provide an opportunity for sharing and networking with other in-house counsel.

For more information or to register, go to

Wednesday, April 16, 2014

Déjà Vu to You Too

            We sometimes read decisions and think we must have already read the same decision under a different caption.  Critical as we are, we might even give a moment’s thought to the possibility that somehow the same decision was reissued under an alias.  The more likely explanations for this phenomenon—setting aside glitches in the space-time continuum—are that cases come to our attention through means that lend to similarities in subject matter and results and that courts with coordinated proceedings sometimes issue similar decisions in batches.  As to the former, we cannot really reveal how we get all the cases considered by the blog cabal for our posts.  Suffice it to say that part of the process involves Bexis and a cauldron.  As to the latter, lots of drug and device cases are handled by federal MDL courts, state coordinated proceeding, or courts that otherwise preside simultaneously over many cases with the same core allegations.  For various reasons, multiple decisions addressing common issues can issue from those courts over relatively short periods of time.  (For reasons we also cannot explain, we sometimes see common issues addressed in decisions by multiple courts over relatively short periods of time.  This is our fourth post in less than two weeks on decisions involving contraceptives or discussing law based solely on cases with a fertility drug.  Bexis may have changed the ingredients in the cauldron to augur the coming of spring.)

            The decision in Yates v. Ortho-McNeil-Janssen Pharms., Inc., No. 1:09 oe 40023, 2014 U.S. Dist. LEXIS 47722 (N.D. Ohio Apr. 7, 2014), reminds us quite a bit of the Averhart and Casso decisions we posted about recently.  Maybe any decision about a summary judgment motion on a warnings claim on Ortho Evra from the judge overseeing the Ortho Evra MDL would.  In discussing the prior decisions, we offered that, because knowledge of the risks of hormonal contraceptives is widespread and “the risk-benefit decision for prescribing a particular contraceptive is very much tied up patient-specific considerations . . . . the manufacturers of these products should have a good chance of getting summary judgment on inadequate warnings claims for the risk of blood clots.”  If we change the injury at issue from “blood clots” to “stroke,” the injury in Yates, then we still agree with ourselves.  Like Averhart, Yates involved a minor getting an Ortho Evra prescription from a healthcare provider who was not a physician.  Like Averhart and Casso, we cannot figure out why the defendant’s motion for summary judgment did not address non-warnings claims, which easily survived an accompanying motion to dismiss.  Even more than the prior decisions, however, the presented facts show that the system in place for prescription drugs worked how it was supposed to work, other than plaintiff experiencing a serious warned-of event while on the drug.
            Under New York law, which applied in Yates, the physician’s assistant who prescribed to the plaintiff counted as a learned intermediary based on statutory prescribing authority.  2014 U.S. Dist. LEXIS 47722, *12.  She also qualified as a learned intermediary by any measure because she was knowledgeable about the risks of hormonal contraceptives, including the risk of stroke with Ortho Evra—from the prominent warnings in the label and otherwise—and warned all her patients about those risks in connection with recommending the particular therapy she thought would be best for the particular patient.  Id. at **3-5.  She followed her normal practice with plaintiff, who admitted was warned about the risk of stroke with Ortho Evra.  Id. at **5-6.  (It sounds like the assumption of the risk defense might be available for at least some of those remaining non-warnings claims.)  With the options laid out for her intelligently, plaintiff initially chose contraception in the form of an injection given every three months (as opposed to a weekly patch, daily pill, etc.).  Id. at *6.  Plaintiff wanted hormonal contraception because she was sexually active and had severe menstrual cramps.  Id. at *5.  When she experienced weight gain and heavy bleeding, known side effects of the shot, plaintiff returned to her physician’s assistant and asked for Ortho Evra, which she received (via free samples with included patient package insert) after again being warned of the risk of stroke and other injuries and the possibility of diminished efficacy because of her obesity.  Id. at **6-7.  Plaintiff apparently did not read the patient package insert, but admitted that she would have used the patch even if she had read the stroke warnings in the patient package insert.  Id. at *7.  We have a hard time thinking of anything about stroke warnings that plaintiff could really criticize under these facts to defeat summary judgment.

            Rather than argue about the warning actually given, the effect of a different warning on the prescriber’s actual decision to prescribe, or even her actual decision to pick the patch, plaintiff claimed no warning could be adequate for a prescription to a minor.  Id. at *14.  Before turning to how the court handled this argument, we ponder how it would be if all warnings to physicians who prescribe to minors were deemed inadequate.  Would drug companies seek to limit usage by minors for drugs that had a favorable risk-benefit and therapeutic niche for minors?  Would physicians and other healthcare providers who treat minors resist prescribing drugs to their patients even when that was the best option notwithstanding potential liability?  Would signed informed consents be required before any minor—even one, like Yates, who was 17 years old and actively sought out prescription medication twice—received a prescription?  Would medical care of minors suffer?  We will not answer these questions except to say the public policy did not support plaintiff’s argument.  Luckily for minors, the court did not need to consider public policy to reject the argument.
            The Yates court started with the fact that New York law (unlike Mississippi law in Averhart) did not have any requirement for parental consent for minors to receive prescription contraception from licensed healthcare providers.  Rather than deciding whether New York would change the operation of its learned intermediary doctrine for a minor receiving a prescription contraception—in an unspoken bit of Erie restraint, we think—the court looked at the facts of the plaintiff’s use and her mother’s consent to it.  The defendant wisely elicited testimony from the mother that, we think, reflects a fairly common pattern, at least when relayed honestly.  Plaintiff’s mother drove her to the appointments with the PA, knew she on prescription contraceptives, saw there was a patient package insert provided, and never attempted to learn the risks or benefits of the contraceptive her daughter was using.  Id.  She did, however, agree that she would have let her daughter use Ortho Evra if she had read the stroke warnings.  Id.  Thus, the court held that parental consent was given, whether or not it was required by New York law.  Id. at *15.  This mooted plaintiff’s attempted end run around standard New York warnings law and led to the court’s conclusion that the warnings provided to the learned intermediary of the risk of the condition plaintiff claimed was caused by the drug were adequate.  The court actually said “The Defendants have met their burden to warn.”  Id. at *15.  We quibble with this, because it really was that “plaintiff did not carry her burden to show Defendants inadequately warned.”  We will cut the court some slack on this, though, because the result was right.

            We also cut the court some slack for not explaining the expert opinion at issue in the plaintiff’s motion to amend her complaint.  We know—not just feel—that we have commented a few times on how Rule 15’s directive to “freely give leave [to amend] when justice so requires” should not give plaintiffs unlimited bites at the proverbial apple.  In denying the motion, the court stated plaintiff “has had years to be able to amend her complaint.  Discovery has been conducted and any motion to amend the complaint now that the summary judgment motion has been filed would be extremely prejudicial to the Defendants.”  Id. at *18.  That is the kind of statement we would not mind seeing again, particularly if it is part of putting an end to claims that never should have been pursued.

Tuesday, April 15, 2014

Mixed Reasoning and Wrongful Conception

Way back in law school our moot court topic involved allegations of “wrongful birth” or “wrongful conception.”  The plaintiffs alleged that a doctor failed to detect a catastrophic birth defect, thus depriving the parents of the option to terminate the pregnancy.  The case involved intractable moral/philosophical  and, thus, legal issues.  That “thus” feels mandatory, but perhaps will not withstand rigorous analysis.  Nevertheless, it’s a touchy subject.  Such claims suggest, at least implicitly, that it might be better never to have been yanked from the void into this maelstrom of meat.  Many people recoil from that notion.  When a recent New Yorker article quoted the father of the Newtown, Ct shooter as wishing his son had never been born, the sentiment seemed both sensible and shocking.


Law school seems like a long time ago, and the intervening years have been blissfully bereft of issues of wrongful conception.  But a case last week caught our eye and contains some of these same issues, as well as others that are more typical in our practice.  The case was Vanden Bosch v. Bayer Healthcare Pharmaceuticals, Inc., 2014 U.S. Dist. LEXIS 48055 (W.D. Ky. April 8, 2014), and it concerned an intrauterine contraceptive system.  One of the plaintiffs, Ms. Vanden Bosch, was an Indiana resident.  She claimed that the contraceptive system caused her to suffer from interstitial cystitis.  The other two plaintiffs were Kentucky residents.  They were a mother and daughter.  The mother claimed that the contraceptive caused a chromosome deletion and that, consequently, the daughter was born with severe genetic defects. 


The first issue was choice of law.  This topic can seem dry, but it can be outcome dispositive and in this case we were treated to a rather colorful statement of law that Kentucky courts “are very egocentric or protective concerning choice of law questions” and there is a “strong preference in Kentucky for applying Kentucky law”.  Vanden Bosch, 2014 U.S. Dist. LEXIS 48055 at *7.  Kentucky has a one year statute of limitations and plaintiff Vanden Bosch acknowledged that her claim was barred if that one-year rule applied.  She tried to escape the one year rule, but could not.  In responding to the defendant’s motion to dismiss, Vanden Bosch submitted an affidavit stating that the Amended Complaint “mistakenly alleges the place of the device insertion as Louisville, Kentucky” and that to the best of her recollection, her contraceptive device was actually inserted in Indiana.  Indiana had a longer SOL.  But the court refused to consider these new facts, as they were outside of the pleadings.   Id. at *9 n. 2.  It does not much matter, because Kentucky’s borrowing statute applies the statute of limitations of another state only when a cause of action arose in that state and only when the other state has a shorter statute of limitations.  The real problem for Vanden Bosch was the filing of her case in Kentucky. 


And now we get to the wrongful conception issue.  To the extent that plaintiff Hogue was trying to recover damages based on the birth of her daughter, the court was having none of it:  “A parent has no cognizable legal injury when alleged wrongdoing results in a genetically or congenitally impaired human life, even severally impaired….”  Id. at *17.  Put another way, a “child’s life cannot be considered a legally cognizable injury.”  Id. at *18.  That’s it.  There is considerably less agonizing over that issue than we recall from our law school exercise.  Real life can be cut and dry.  Law school never is.    The former pays better. 


The rest of the plaintiffs’ tort claims were relatively quotidian.   The claim for negligent design and manufacturing encountered the usual problem; the plaintiffs did not actually allege how the device was defectively designed, nor did they allege how their specific devices were defective due to manufacturing.  “It is not enough for Plaintiffs to simply rely on their basic injury allegations and argue that the product was somehow defective because it was ‘dangerous.’”  Id. at *25.  The plaintiffs asserted that the products were in an “unsafe, defective, and inherently dangerous condition,” and that they were defectively designed because they were “not  reasonably fit, suitable, or safe” for their intended purpose.  They never alleged what part of their devices failed-or that their devices broke or malfunctioned once inserted.  The plaintiffs also failed to allege specific facts to support their manufacturing defect claim.  They did not allege any specific manufacturing defect that occurred with their products and did not allege how their specific contraceptive products differed from Bayer’s specifications.  Goodbye negligence claims, right?  Well, mostly.  The court did not completely knock out the negligence cause of action, because the defendant did not challenge that cause of action insofar as it addressed “researching, marketing, supplying, promoting, packaging, sale, testing, quality assurance, quality control and/or distribution” of the device.  Id. at *25-26.  Really?  We cannot believe the motion to dismiss did not reach those issues.  Nor can we figure out how researching, packaging, testing, QA, and QC manage to linger after design and manufacturing claims go by the boards. 


Strange to say, but the plaintiffs’ fraud-based claims, which must satisfy a higher pleading standard, fared better.  Fed. R. Civ. P. 9(b) requires plaintiffs to show: (1) the time, place, and content of any allegedly false representations; (2) the fraudulent scheme; (3) the defendant’s fraudulent intent; and (4) the resulting injury.  The plaintiffs argued for “a less stringent pleading standard” on the ground that they were alleging sins of omission rather than commission.  The court did not buy it.  But the court did buy the plaintiffs’ argument that they  had satisfied Rule 9(b) when they identified the type and source of communications (i.e. pamphlets, brochures, and commercials), identified when they received such communications (i.e. “on or around” the time of the contraceptive insertions), and alleged that the communications “omitted, concealed, downplayed, underreported and underestimated the dangers” of the device.  Id. at *33-39.  Yikes.  The court seems to have performed rough dentistry on Rule 9(b), removing most of its teeth.    


Just when we are about to toss the decision into the circular file, trying to forget it as completely as we contrived to forget that moot court assignment, the court revives our faith in judicial modesty and common sense by refusing to read into Kentucky products liability law an independent failure to test claim.  Id. at *42.  The court also threw out the claims for implied warranty for want of privity.  Id. at *48.  Sadly, though, the court resorted to an exception to the privity requirement for the express warranty claim, reasoning that such a claim “can be maintained…where…express warranties were clearly intended for the product’s consumers.”  Id. at *52.  The plaintiffs alleged that certain television commercials, pamphlets, or brochures implied that the contraceptive had been tested and was found to be safe and effective for contraceptive purposes.  The court was agnostic on these allegations, content to wait for them to be “better fleshed out at the summary judgment stage.”  Id. at *47.   


The Amended Complaint included a section entitled “Federal Requirements,” alleging violations of federal law.  The allegations were as vague as such things invariably are, and the defendant filed a motion to strike.  For one thing, the “Federal Requirements” section did not bother to indicate that the plaintiffs were harmed by any violation.  We can understand how any defendant would want to excise from a complaint any allegations that are improper and potentially prejudicial.  It always makesense to clear the underbrush.  It makes for cleaner and leaner discovery and trial.  But the court considered striking a pleading to be “a drastic remedy to be resorted to only when required for the purposes of justice” and only when “the pleading to be stricken has no possible relation to the controversy.”   Id. at *56.  Because the defendant did not contend that the allegations were immaterial, impertinent, or scandalous but, instead, only that they were  vague (in fact, the allegations were all of those things), the court declined to wield the judicial red pen.

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After we were done with law school and all things law school-ish, such as moot courts, late nights in the library, sweating over the Socratic method in first year, and blithely uttering “pass” in third year, we went on the almost mandatory backpack trek through Europe before joining a law firm.  It’s like the reverse of that architectural technique of compression-and-release.  One day we were trudging through a field in Ireland.  We saw a farmer leaning against a fence.  He was reading a book.  In a preemptive strike of friendliness (always tough to pull off among the supremely chummy Irish), we asked the farmer how the book was.  “Well,” he said, “some parts I like, some parts I’m not so sure about, and some parts I haven’t gotten to yet.”   That’s how we feel about the Vanden Bosch decision.  Some parts we like.  Some parts seem lazy or weird.  And in some parts the court seems to have accorded undue leniency to the plaintiffs, though summary judgment hovers just off-stage.


Monday, April 14, 2014

Summary Judgment Decision for the Defense in the Propoxyphene Litigation References the Rejection of Market-Share Liability in the DES Litigation

A recent decision in the propoxyphene litigation – Schiller v. Eli Lilly & Co., No. 2:12-247-DCR (E.D. Ky. Apr. 7, 2014) – confirms a now basic premise of product liability law: if you claim to have been injured by a drug that you don’t identify, you will lose.  

The plaintiff in Schiller, a resident of Ohio, claimed to have been injured by generic propoxyphene, which she claimed to have taken for almost seven years.  She didn’t – or couldn’t – identify the particular drug or its manufacturer, so she instead named as defendants a number of companies that manufactured the drug.  Discovery didn't help her.  She still couldn't identify the drug or its manufacturer.  She had a serious product identification problem: 

It is well-settled that a threshold requirement of any products-liability claim is that the plaintiff assert that the defendant’s product caused the injury. . . . There is no theory of product liability under which a defendant can be held liable for an injury caused by a product that it did not sell, manufacture, or otherwise supply to the plaintiff.

Slip op. at 3.  

Unable to identify the product, the plaintiff had no claim.  And so, when one of the defendants moved for summary judgment, the court granted it.

It was of some interest to us, though, that the court relied on two decisions that rejected market-share liability in the DES litigation.  Id. at 3-4 (citing Sutowski v. Eli Lilly & Co., 696 N.E.2d 187 (Ohio 1998); Kurczi v. Eli Lilly & Co., 113 F.3d 1426, 1431-32 (6th Cir. 1997) (applying Ohio law)).  For those who don't recall, market-share liability was an attempt by DES plaintiffs who couldn't identify which DES drug allegedly injured them to hold all DES manufacturers liable to the extent of their share of the overall DES market. That’s not too different from what the Schiller plaintiff tried to do, or from what some plaintiffs have tried to do in generic drug litigation. Ohio was one of the states to reject market-share liability in the DES litigation.  As we put it a few years ago, “[m]arket share liability is so not happening in Ohio.”
Nor is it in many other states.  Let's see whether in the future we see more references to the DES market-share/product identification decisions in generic drug cases brought against multiple defendants by plaintiffs with product identification problems.