Learned Intermediary

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What’s left of the OxyContin litigation produced a recent decision that addresses a myriad of procedural and substance issues, some of which we often see and others not so much. If you don’t recall, in 2007, Purdue Frederick Corp. and some of its executives pled guilty to criminal charges related to the marketing of OxyContin and paid approximately $600 million in fines.  That was almost 7 years ago.  The plaintiff in Luberda v. Purdue Frederick Corp., 2014 U.S. Dist. LEXIS 41951 (D.S. Car. Mar. 28, 2014), on the other hand, filed his complaint in 2013 in South Carolina – six years after those guilty pleas and ten years after he became addicted to OxyContin.  Although the court’s opinion doesn’t provide much detail on the background of the case, it appears that the plaintiff was asserting negligent and fraudulent failure to warn claims and attempting to assert a private right of action under South Carolina’s criminal statute on misbranding.  He sued nine companies within the Purdue Frederick family of companies and almost two-dozen executives.

This history created a background ripe for motion practice.

Personal Jurisdiction

Many of the individual defendants moved to be dismiss for insufficient service of process and/or lack of personal jurisdiction.  Two of them won their insufficient service of process motions.  They never signed for the certified mail that carried their summons and complaint.  Id. at *12-13.  Those two defendants and approximately 20 others also won dismissal because they did not have sufficient minimum contacts with South Carolina to be sued there.  The court laid out a useful primer on the procedure for analyzing personal jurisdiction:

The party seeking to invoke personal jurisdiction over a nonresident defendant bears the burden of proving the existence of personal jurisdiction.  ESAB Group, Inc. v. Centricut, LLC, 34 F.Supp.2d 323, 328 (D.S.C.1999).  At the pretrial stage, the burden of proving personal jurisdiction over a nonresident is met by a prima facie showing of jurisdiction either in the complaint or in affidavits. In determining whether a prima facie showing has been made, the Court may consider the uncontroverted allegations in Plaintiff’s pleading.  However, whenever the allegations in Plaintiff’s pleading are contested by sworn affidavit, Plaintiff can no longer rest on those allegations.  Instead, it then becomes Plaintiff’s burden to present an affidavit or other evidence proving that jurisdiction exists over the nonresident defendant.  See Wolf v. Richmond Cnty. Hosp. Auth., 745 F.2d 904, 908 (4th Cir. 1984); Clark v. Remark, 993 F.2d 228 (table), 1993 WL 134616, at *2 (4th Cir. 1993).

The Court summarily dismissed a multitude of defendants because plaintiff simply didn’t make a prima facie showing of personal jurisdiction.  Id. at *11-12.  For four of the defendants, however, the court determined that their affidavits and the complaint didn’t clarify whether they were involved in company’s decision-making regarding the marketing of OxyContin.  Id. at *15.  So the court denied the motions of these defendants, but without prejudice to their raising the arguments again at the summary judgment stage after the plaintiff had a chance for “jurisdictional discovery.”  Id. at *16.

Learned Intermediary Doctrine

The court also applied the learned intermediary doctrine to the plaintiff’s negligent failure to warn claim. Plaintiff’s allegations were, in essence, this: “Defendants owed Plaintiff a duty to properly warn of the potential for and/or risk of addiction associate (sic) with their product.” Id. at *17.  That’s wrong.  South Carolina recognizes the learned intermediary doctrine, and as we all know under that doctrine the manufacturer’s duty to warn runs to the prescribing doctor, not the patient.  Id. at *17-18.  The plaintiff has the burden to show – and allege – that the “undisclosed risk was sufficiently high that it would have changed the doctor’s [prescribing] decision.” Id. at *18.  The court dismissed the claim but gave the plaintiff a chance to amend his pleading to add factual allegations suggesting that his doctor would have changed his prescribing decision had there been a different warning.  Id.Continue Reading An OxyContin Decision That Addresses Everything from Negligence Per Se Claims to Personal Jurisdiction

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Don’t get too excited.  When we say a twitch, we mean it in its smallest sense.  A shudder, a tremor.  One blip followed by a long flat line.  We aren’t talking about resuscitation at this point.  But, just maybe West Virginia hasn’t signed a DNR order quite yet.

Ever since the West Virginia Supreme Court of Appeals refused to adopt the learned intermediary doctrine in State of West Virginia ex rel. Johnson & Johnson Corp. v. Hon. Mark A Karl, 220 W. Va. 463 (W. Va. 2007), we haven’t been shy about telling you all the ways that decision simply got it wrong (see here and here). But, ever the optimists, we sift and pan through West Virginia decisions like 19th century gold miners – looking for those little nuggets we can use to breathe life back into the learned intermediary doctrine.

We got one of those nuggets back in 2010 when the West Virginia Supreme Court of Appeals decided that there is no private cause of action under the West Virginia Consumer Credit and Protection Act (“CCPA”) for prescription drugs.  White v. Wyeth, 705 S.E. 2d 828 (W. Va. 2010). Nowhere in that decision will you find the words “learned intermediary.”  However, what that court did say was that when a plaintiff alleges affirmative misrepresentations, he must prove reliance and because for prescription drugs “the consumer cannot and does not decide what product to purchase”, id. at 838, plaintiffs can’t establish a causal connection.  If we were playing charades, we’d be making the “sounds like” gesture.  The court even went so far as to say that it is the physician who must “exercise[] judgment whether or not to prescribe a particular medication.”  Id.   So close.Continue Reading A Twitch of Life for Learned Intermediary Doctrine in West Virginia

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We watched some of the recently concluded Winter Olympics.  When the temperature at the Black Sea-side resort exceeded the temperature of Washington, D.C., by 20° Fahrenheit (or 11.1° Celsius), we questioned the “Winter” part of the event’s title in a way we never expected.  Of course, we watched some action from familiar sports, like the hockey showdowns with our once-archrival and our northern neighbor.  We also watched some of the biathlon, a fascinating sport that involves cross country skiing with a rifle on your back and stopping periodically to shoot at targets.  Our initial thoughts on that sport ran like this:  “This is not a sport that people do casually.  Maybe this is to echo the Winter War.  Maybe they could make it a more militaristic triathlon by adding a phase where an edged weapon is used to decapitate a snowman while skiing.  These tortilla chips are making me thirsty.”  This being a blog on drug and device law—as its title hints—and our thirst having been quenched, it occurs to us that our experience with the cases we write about is like watching the biathlon.  (We may have quenched our thirst with a nice winter ale and/or a little Russian water, but we are sober as we write.)  We do not hear much about the exhausting cross-country grind of discovery.  We do not follow all the ups and downs of trial argument and evidence.  We check in, periodically, when the litigants have paused long enough to shoot (at each other, unlike in the Olympic version of the biathlon) and the court issues some ruling explaining the targets, hits, and misses.  Even then, we typically pay attention to the results of the shooting only when the decision is published (or sent to us by a participant) and it seems interesting.  Occasionally, we notice multiple decisions from a single case as it proceeds past discovery, dispositive motions, and pretrial motions, and through trial.  These may not be the highest stakes or most groundbreaking cases, though.  This is somewhat like watching NBC focus on the battle for 15th place in the Men’s Relay, just because the U.S. team was battling.  (Bulgaria, you are the ancestral homeland of the mighty Spartacus.  Need you grab more glory by 0.7 seconds?)

The Guenther case is one of many Aredia/Zometa cases involving allegations about osteonecrosis of the jaw (ONJ) whose decisions have been discussed in our posts.  Guenther, however, has achieved special puffy coat status due to its recurring role in six prior posts.  Over the last year, we have posted on decisions on case consolidation, summary judgment, punitive damages, limiting Dr. Parisian (as part of a compilation), motions in limine, and more motions in limine.  Yet, we know that there were other decisions and developments in the case that shaped its course.  We know from Guenther v. Novartis Pharm. Corp., No. 6:08-cv-456, 2014 U.S. Dist. LEXIS 21182 (Feb. 20, 2014), that its course took the case all the way to trial, where the plaintiff won on strict liability and negligent warnings causes of action and was awarded $1.3 million in compensatory damages, leading defendant to move for judgment notwithstanding the verdict, a new trial, and/or remittitur.  All we know about the trial evidence from the plaintiff, prescribing physicians, other treating physicians, and the experts comes from the decision itself, as the court identifies and characterizes the evidence it wants as it explains its particular findings.  See, this is just like watching biathlon.  No need to analyze the parallels any further.Continue Reading Understanding the “Intermediary” Part of The Learned Intermediary Doctrine

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Any U.S. Circuit Court clerkship should add some sparkle to  a resume, but we used to take endless grief about the Ninth Circuit’s reputation for liberalism and for Supreme Court reversals.  Noted pharmaceutical expert and exponent of judicial (though not gastronomic) restraint Rush Limbaugh calls it the “Ninth Circus.”  We clerked for William Norris, a brilliant and fair-minded jurist.  He was considered a liberal and, indeed, he penned many prominent opinions that earned that label.  Way ahead of his time, Judge Norris in the 1980’s authored the Watkins decision, which upheld the right of a gay man to serve in the military.  But Judge Norris looked positively antediluvian compared to colleagues such as Judges Pregerson and Reinhardt.  Every couple of years Congressmen from Idaho or Montana beg to split up the Ninth Circuit, complaining that their jurisprudence has been polluted by the wackos in California.  The funny thing is that when conservative jurists assume leadership in the Ninth Circuit (such as Judges Wallace and Kozinski), they inevitably oppose such a split and discover the virtues of the country’s biggest circuit court.  Splitting the Ninth Circuit would do nothing of value; it would merely lead to more circuit splits. Maybe it is because of economies of scale, but the Ninth Circuit is productive in terms of caseloads and opinions.  Plus those judges and clerks in Billings and Boise should want to keep open the possibility of a calendar sitting in Hawaii.   And how can you dislike a court whose Chief manages to insert 215 movie titles into an opinion (Syufy) and who was once upon a time the winner on The Dating Game?   (Don’t believe us?  Look here.)

The Ninth Circuit still is at or near the top in the league tables when it comes to Supreme Court reversals (by some measures the Sixth Circuit is ahead), though at times that can feel like a badge of honor.  We remember Judge Pregerson (a wonderful man who welcomed other clerks to his chambers and liked to point out from a window in his chambers down at the LA post office annex where his dad worked many years ago) once mentioning at an oral argument how he had written an opinion on the same subject several years before, only to be reversed by the Supremes.  But, he said, he was subsequently vindicated by “a higher authority”: the Harvard Law Review.  In reality, the reputation ‘enjoyed’ by the Ninth Circuit is much ado about nothing.  Most decisions are unanimous, even when the panel is shared by people perceived to be ideological opposites.  We remember an oral argument we made as an AUSA seeking an upward departure in a criminal sentence because the defendant had slashed a woman’s face to ribbons.  The defendant committed this mayhem on the grounds of a VA Hospital, thus making it a federal crime.  On the panel were Judges Wallace and Reinhardt – the leading conservative and liberal on the court, respectively.  There was a third judge, of course, but he barely got a word in edgewise on this very hot panel.  The court unanimously upheld the upward departure, but Judge Reinhardt used the oral argument as an opportunity to bemoan the paucity of downward departures for deserving crooks.   Nothing in there for us.  We let Wallace and Reinhardt go at it, and collected the affirmance.Continue Reading Ninth Circuit Toes the Line on Learned Intermediary and Warning Causation

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This post is not from the Dechert side of the blog, because of that firm’s involvement in this matter.

We mentioned, in the “here’s what’s out there” portion of our 2013 Top Ten post that “The long-pending Lance case (2010 #-6) remains undecided by the Pennsylvania Supreme Court, some three years after oral argument.”  Full disclosure:  Some of us worked on the Lance case in the past, but none of us currently represents anybody in that litigation.  So, while we are quite familiar with Lance, the post here does not address anything outside of the Supreme Court’s opinions and official record.

Lance pends no longer.  And if Lance in the Pennsylvania Superior Court warranted #6 on 2010’s worst ten list, the Pennsylvania Supreme Court’s equally unpalatable effort is likely to rank significantly higher on the still-young 2014’s eventual list.  For background (since it has been a long time), here is our description of Lance in the Superior Court from back in 2010:

6. Lance v. Wyeth, 4 A.3d 160 (Pa. Super. 2010).  . . . Lance is another example of the disturbing trend in post-Levine cases for plaintiffs to push for – and, worse, for courts to allow – “design” related claims against prescription drugs that are really frontal assaults on FDA drug approval decisions.  Here, the claim was “negligent design,” which had never before been recognized in a prescription drug product liability case in Pennsylvania. 4 A.3d at 165-66.  Disturbingly, the opinion does not discuss the requirement, imposed in negligent design cases involving other products, that the plaintiff must prove the existence of a safer alternative design.  Compounding matters, Lance also included gratuitous dictum suggesting that a post-sale duty to warn may exist in prescription drug cases, id. at 167-68 – despite that theory being a form of strict liability, which Pennsylvania doesn’t recognize at all in prescription medical product litigation.  If not for other, favorable, aspects of Lance (rejecting the “unreasonably dangerous product theory allowed in Wimbush and also failure to test or to recall), Lance might rank even higher/lower.  We discussed Lance here.  An appeal to the Pennsylvania Supreme
Court is pending.

Quite frankly, nothing in Lance improved in the 2+ year wait for it to be decided.  After all this time we had frankly thought the Court to be irretrievably split 3-3, with the newly appointed interim justice, Stevens, recused due to his participation at the Superior Court level. Thus, we had been speculating that the
most likely outcome would be a to vacate and remand after the court decides Tincher v. OmegaFlex (discussed here, here, and here) and clarifies Pennsylvania product liability law generally.

No such luck, although Lance does allow for some interesting speculation about what might ultimately happen in Tincher (see below). That’s particularly true because Justice Thomas Saylor, ordinarily the court’s most conservative member on product liability matters (and thus our favorite), wrote the majority opinion in Lance, aligning himself in this instance with justices with whom he frequently disagrees with on tort issues. The vote was 4-2, with Chief Justice Castille and Justice Eakin dissenting.

So what happened?

The first half of the majority opinion describes the proceedings below and the arguments of the parties in considerable detail.  To us, the most interesting aspects of the first 24 pages of that opinion are footnotes and other asides.  Thus, we have footnote 6, reaffirming the learned intermediary rule: “Per the learned intermediary doctrine, the manufacturer’s duty to warn is directed to physicians.”  Maj. Op. at 5.  We have footnote 8 (discussed more later), chastising the lower court for equating “strict liability” with “product liability.”  Id. at 8-9.  We also have footnote 11 reaffirming the essential holding of Hahn v. Richter, 673 A.2d 888 (Pa. 1996), that Pennsylvania law has adopted, and applies, Restatement §402A, comment k across the board:  “Other [jurisdictions], including Pennsylvania, have taken a blanket approach applying comment k to preclude strict-liability design-defect claims for all prescription drugs.”  Maj. Op. at 13.Continue Reading Lance – If This Is Negligence, Who Needs Strict Liability?

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Today we feature a case that exemplifies two principles that we routinely encounter in our practices, but rarely at the same time.  First, there is no more sympathetic plaintiff than a disabled military veteran.  We come across and write on cases involving sad facts with some regularity, which is an occupational hazard of our practice in the drug and medical device arena.  The most compelling cases we see involve patients who have experienced actual injuries, a fact that we always bear in mind as we report on what the law is and what we believe the law should be.  Moreover, while everyone has a point of view on what kinds of cases provoke the greatest sympathy, we have learned in our many years on Reed Smith’s Pro Bono Committee that disabled veterans garner the broadest imaginable support.  Some people champion children’s issues; others promote immigration reform, or perhaps they favor housing rights.  But everyone gets behind programs supporting disabled veterans.  And rightfully so.  Today’s veterans are young men and women who have completed their service and have their whole lives ahead of them, often with significant challenges.

The second principle that today’s case brings to mind is that civil litigation cannot and should not provide a remedy if the law and facts are not there to support one, no matter how sympathetic the plaintiff may be.  The district court’s order granting summary judgment in Carnes v. Eli Lilly & Co., No. 0:13-591-CMC, 2013 U.S. Dist. LEXIS 176201 (D.S.C. Dec. 16, 2013), brings together these two principles by presenting a disabled Army veteran and physicians who prescribed prescription drugs with full knowledge of all the relevant risks.  In Carnes, the plaintiff injured his spinal cord while attempting to rescue fellow soldiers in Iraq, and as a result he is wheelchair bound, has significant physical limitations, and suffers from chronic pain.  Id. at *1.  One physician prescribed Lyrica, an antiepileptic drug indicated for treating pain associated with spinal cord injury, but after about three years on the drug, the plaintiff asked to stop.  Id. at *2.  The doctor therefore prescribed Cymbalta, which is a serotonin and norepinephrine reuptake inhibitor that is also indicated for treatment of chronic pain.  After a few months, the plaintiff changed doctors and asked to switch his medication again because he thought the drug was causing him to gain weight.  Id. at *2.  The new doctor therefore tapered the plaintiff off Cymbalta and restarted Lyrica. Id. at **2-3.  According to the doctor, she tapered the plaintiff’s dose “to avoid potential side effects from stopping Cymbalta suddenly.”  Id. at *3.

As the second doctor’s remarks suggest, discontinuing Cymbalta can result in withdrawal-like symptoms, which the doctor knew about and which the product’s label disclosed at all relevant times.  Id. at **4-5.  The physician who first prescribed the drug similarly was aware of the risk of withdrawal symptoms “having learned about them in medical school, during his residency, and from patients who experienced withdrawal symptoms.” Id. at *16.  Alas, the plaintiff experienced post-discontinuation symptoms that he attributed to the drug, including sharp headaches, nightmares, anger, and shaking. He therefore sued the drug’s manufacturer, who moved for summary judgment under South Carolina’s learned intermediary doctrine.Continue Reading No Causation, No Claim

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California and Mississippi have little in common, but they  both apply the learned intermediary doctrine in prescription drug cases.  Prescription drug manufacturers have a duty to provide adequate warnings in connection with their products, but only to prescribing physicians – the learned intermediaries – and not directly to patients.  We write on the learned intermediary doctrine a lot because it comes up in so many of our cases, and also because it is a sound legal rule that should apply, and should apply consistently.  Toward that end, the Northern District of Ohio recently gave us twin opinions applying the learned intermediary doctrine under the laws of California and Mississippi, and the district court found that the defendants in both cases were entitled to summary judgment.

In Miller v. Ortho-McNeil Pharmaceutical, Inc., 2013 U.S. Dist. LEXIS 158302 (N.D. Ohio Nov. 5, 2013), the plaintiff used a prescription contraceptive patch and experienced a pulmonary embolism, which she attributed to her contraceptive use.  Every physician in the world knows that hormonal contraceptives of this type increase the risk of blood clots, and so did the nurse practitioner who first prescribed the plaintiff’s contraceptive patch.  In fact, the nurse practitioner knew that the product’s warnings “included the elevated risks of blood clot[s].”  Id. at *3.  A second nurse practitioner who prescribed to the plaintiff likewise “was aware that [the contraceptive product] exposed patients to a higher concentration of hormones than typical birth control pills, increasing the risk of thrombotic disease and pulmonary embolism.”  Id. at **3-4.  Even with this knowledge, both nurse practitioners believed the benefits of prescribing the product to the plaintiff outweighed the risks.  Id.

On these facts, the court had little difficulty granting summary judgment on a familiar two-prong basis.  First, the product warnings were adequate under Mississippi law because “Defendants specifically warned of the risk of blood clots.”  Id. at **10-11.  We are sometimes surprised when courts allow failure-to-warn claims to proceed even where the package inserts warn about the exact risk that allegedly befell the plaintiff.  But this court was on the ball and, in our view, came to the right conclusion on these facts.  Second, the court ruled that the plaintiff could not prove causation because “she has not shown that a different warning would have changed the prescribing decision.”  Id. at *12.  This is another refreshingly straightforward holding, and it follows Mississippi’s learned intermediary doctrine to a tee:  The manufacturer owes a duty to warn only the prescribing physician, so if an alleged inadequacy in the warnings had no impact on the prescribing decision, then proof on the essential element of warnings causation fails.  In Miller, both prescribing nurse practitioners knew about the clotting risk, and they prescribed the product anyway.  For her part, the plaintiff had no evidence that a different warning would have made any difference.  Summary judgment granted.Continue Reading Learned Intermediary Rule Applies, with No Exception for Contraception

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For some reason, we recently found ourselves comparing our favorite defenses to our favorite rock bands.  Preemption, of course, would be The Beatles, and Daubert/Frye the Rolling Stones.  The learned intermediary rule could be Bob Dylan (I know, we’re showing our age, here).  Comment k could correspond to Led Zeppelin, and state of the art might be The Who.

And it seems that, for each of these bands, there’s a song we really like that gets slighted (in our opinion) when it comes to air time on classic rock stations.  For The Beatles that would be It’s All Too Much.  For the Rolling Stones, when you discount those songs generally considered too raunchy for mainstream radio (one from Beggars Banquet, one from Let It Bleed and one from Goats Head Soup, you can guess which ones), we’d say the disrespected Stones song we like most is Child of the Moon.  For Bob Dylan, we almost never hear Desolation Row on the radio (and thanks to Zimmerman’s late-in-life conversion to copyright trolldom, you won’t find a decent studio version on YouTube, either).  For Zep, we’d award the buried treasure award to Immigrant Song.  And finally, for The Who, we’ve always been peculiarly partial to the Punk and the Godfather.

Somewhat similarly disrespected as a defense to warning causation has been the prescriber’s failure to read the relevant warnings.  One of the benefits of the learned intermediary rule is that it replaces self-interested plaintiffs with highly trained medical professionals when it comes to warnings, and in particular with respect to warning causation.  While a plaintiff with dollar signs in his/her eyes will typically testify to whatever is necessary to establish warning causation (“Oh, yes, if I had only known about that risk, I would have rejected my oncologist’s recommendation and never taken the drug.”), medical doctors are most interested in the effective treatment of their patients, and thus typically tell it like it is.  The truth often is that, for one reason or another, the prescribing physician did not rely on the particular warning in question, and thus a different one wouldn’t have made any difference.

There are a number of fact patterns that lead to physician non-reliance, the golden boy of the bunch being when a doctor (a trained professional, after all) already knew about the risk in question and thus did not need to be warned about it.  Another commonly seen warning causation defense is when the doctor testifies that none of the plaintiff’s warning sophistry matters, s/he would still treat the plaintiff the same way today.Continue Reading Don’t Forget About A Prescribing Physician’s Failure To Read Warnings

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There’s been a lot of movement amongst the bloggers on this site over the last two years.  And now there’s more.  Sullivan – that’s me – has moved to Cozen O’Connor.  I’ll miss my old firm, Dechert.  But I’m excited about my move to Cozen, and I look forward to continuing to give you my thoughts on drug and device law, and sometimes pop culture, from within Cozen’s walls.  And, for me, those walls will be in two Cozen offices, one in downtown Manhattan  (where I practiced for years when I started my career) and the other in Cherry Hill, New Jersey.  Now, Cherry Hill is a great town.  I was in that office Friday when I began drafting this post.  But today I’m in Manhattan. That’s different.  If for no other reason than the views.  It’s hard to beat the Freedom Tower as it’s being completed or ships sailing their way down the Hudson River into New York Harbor.

Frankly, if you’re in an office in just about any town other than New York City, “you lose that battle, you lose that battle nine times out of ten.”  But that’s not the real advantage of spending much of my time in Cozen’s New York office.  The most important benefit is that I now have the ultimate “bona fides” to counter what has been a distinctly Philadelphia voice on this blog.  The New York-Philadelphia rivalry has now hit the legal blogosphere.  If all else fails, I can just say, “fuhgeddaboudit.”Anyway, here’s my first Cozen post.

So where were we?  Oh yes, the learned intermediary doctrine.  On Friday, we reported on Calisi v. Abbott Labs., 2013 U.S. Dis. LEXIS 139257 (D. Mass. Sept. 27, 2013), a decision in which the court excluded plaintiff’s warnings expert thereby ending plaintiff’s failure to warn claim.  Underlying that decision was the court’s refusal to adopt plaintiff’s argument that Abbott had “assumed a duty” to warn the plaintiff directly rather than warn her doctor because Abbott had earlier communicated directly with plaintiff via a patient video and direct-to-consumer (DTC) advertising.Continue Reading Moving on to a New Law Firm; Still Discussing the Learned Intermediary Doctrine

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