Imagine a conspiracy so vast that it includes not only your usual plaintiff-side fantasy of the FDA conspiring with a drug company, but also high FDA officials, President Obama, Robert Mercer (noted Trump supporter and reputed Breitbart financier), a number of other investors, and just for good measure President and Hillary Clinton.

Larry Klaman could, and thus brought the lawsuit that recently resulted in Aston v. Johnson & Johnson, ___ F. Supp.3d ___, 2017 WL 1214399 (D.D.C. March 31, 2017).

Nobody else did, though.

In particular, and fortunately for everyone on the defense side, the judge in Aston could not.  Reading the Aston opinion, it is evident that the court is beyond skeptical of the vast, or even half-vast, conspiracy claims.  In a nutshell, five plaintiffs who claimed a great many personal injuries (the opinion lists 74 separate alleged injuries, 2017 WL 1214399, at *1) from their use of the drug Levaquin, brought suit alleging that the drug’s manufacturer and the FDA were in cahoots to cover up the drug’s risks, in order to increase the value of the manufacturer’s stock, to the advantage of various investors.  As for the political officials, according to the opinion:

Amazingly, former presidents Barack Obama and Bill Clinton also make cameo appearances in plaintiffs’ alleged scheme, together with former Secretary of State Hillary Clinton, and the Clinton Foundation; these actors are alleged to have solicited, or received, “gratuities” from defendants in exchange for securing [another alleged conspirator’s] appointment as FDA Commissioner.

Id. at *2.  We admit, this is an extreme oversimplification – the opinion took two Westlaw pages just to sort through the Aston plaintiffs’ labyrinthine conspiracy allegations.

Plaintiffs’ legal theories were almost as numerous as their injury allegations – twenty-two counts, including RICO, state-law (Arizona (?)) RICO, strict product liability, negligence, fraud, express and implied warranty, unjust enrichment, Lanham Act, and a bunch of state consumer fraud claims (D.C., New York, Maryland, Pennsylvania, Illinois, Arizona, and California). Id. at *3.

Aston threw everything out on the many defendants’ motions to dismiss. The half-vast conspiracy, and all its subsidiary theories of liability went down in a hail of defense-friendly rulings, and that’s why – aside from its humor value – the Aston opinion is well worth reading.  We’ll list the rulings so our readers will have an idea of what this goodie basket contains.

RICO – The deficiency in the RICO counts was rather basic. RICO does not allow recovery for personal injuries.  “The overwhelming weight of authority discussing the RICO standing issue holds that the ‘business or property’ language of Section 1964(c) does not encompass personal injuries.” Aston, 2017 WL 1214399, at *4 (citation and quotation marks omitted).  For a compilation of that authority, see Bexis’ Book, §2.15, footnote 3.  Further, “as plaintiffs’ counsel is well aware, courts in this District and elsewhere have consistently rejected the argument that pecuniary losses derivative of personal injuries are injuries to ‘business or property’ cognizable under RICO.”  Aston, 2017 WL 1214399, at *4 (citing, inter alia, Klayman v. Obama, 125 F. Supp.3d 67, 88 (D.D.C. 2015)).  Aston also distinguishes “tobacco litigation [RICO] precedents” because those cases arose from a federal prosecution that was not limited by the “business or property” requirements of RICO’s private cause of action.  2017 WL 1214399, at *5.

Nor did the Aston plaintiffs satisfy RICO’s causation requirements – for another very basic reason.  Even the most recent of the five plaintiffs’ injuries arose before the conspirators allegedly acted:

Barring some sort of temporal paradox, there is no way that suppression of an FDA report in 2013 could have caused plaintiffs to be injured in 2012 or earlier.  Because plaintiffs’ allegations, taken as true, are insufficient to establish proximate causation, their federal RICO counts must be dismissed.

Id. (citing H.G. Wells, The Time Machine, 22–23 (1895)) (other citation omitted).  On this basis alone, we’re rooting for the defendants to obtain recovery of their counsel fees, since the underlying premise of the entire litigation was physically impossible.

Arizona RICO – Same basis:  “[P]laintiffs have failed to plead facts that make possible − let alone plausible − the conclusion that the alleged cover up by defendants was the proximate cause of plaintiffs’ injuries.”  Id. at *6.  Unfortunately, the relatively terse dismissal of does not answer the burning question − Why Arizona?

Lanham Act – Another fundamental basis for dismissal.  “[T]o come within the zone of interests in a suit for false advertising under [the Lanham Act], a plaintiff must allege an injury to a commercial interest in reputation or sales.”  Id. (quoting Lexmark International, Inc. v. Static Control Components, Inc., 134 S. Ct. 1377, 1390 (2014) (emphasis original in Aston).

Now comes the most useful stuff – dismissal of the common-law claims.  For the record, Aston applies the law of the District of Columbia rather than the law of the plaintiffs’ (Maryland, Pennsylvania, Arizona, Illinois, California) or defendants’ (New Jersey) domiciles.  Aston, 2017 WL 1214399, at *6.

Product Liability (both strict liability and negligence) – Manufacturing defect is TwIqballed.  For all its factual prolixity, the Aston complaint was utterly devoid of any allegations that the drug wasn’t made precisely as intended.  Id. at *7 (“for all these recitals of the term ‘manufacture’ and its derivatives, plaintiffs plead no facts that would appear to relate to manufacturing defects”) (citation and quotation marks omitted).

Warning related claims were also dismissed, in a usefully rigorous application of TwIqbal.  Dismissal in Aston occurred because plaintiffs failed to plead:  (1) “the contents of the warning label” when the drug was taken (2) “how the contents of the label were inadequate,” (3) “the timing of each plaintiffs use of” the drug, including “when each individual plaintiff was prescribed,” (4) “the onset of [plaintiffs’] injuries,” (5) “how the alleged distinctions in the warnings would have had a causal effect,” (6) “what injuries each individual plaintiff experienced,” (7) “why [plaintiffs] think [the drug] was the cause of the[ir] injuries,” and (8) “why [plaintiffs] think inadequate warnings contributed to their injuries.”  Id. (various quotations omitted).  That’s a spicy TwIqbal – without even having to get into the learned intermediary rule.

As to warnings, we also note that the court held that all warnings publicly available on the FDA’s website are subject to judicial notice.  Id. at *2 n.1.

Design defect claims were preempted under Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), and Aston rejected the well-worn plaintiff argument that, for some reason, implied preemption is different in generic, as opposed to branded (as in Aston) drugs:

Plaintiffs are mistaken.  [Bartlett] expressly found that “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to [its formulation]” by federal law.  133 S. Ct. at 2471.  Thus, even though [Bartlett] arose from a state-law design-defect claim against a manufacturer of a generic drug, its holding applies to both types of drugs, and plaintiffs’ design-defect claim must be dismissed.

Aston, 2017 WL 1214399, at *8. Preemption is “fully consistent with the well-established tort law principle, ‘especially common in the field of drugs,’ that an unavoidably unsafe product is ‘not defective, nor is it unreasonably dangerous’ where it is ‘properly prepared, and accompanied by proper directions and warning.’”  Id. at *8 n.7 (quoting Restatement (Second) of Torts §402A, comment k (1965)).

Fraud/Misrepresentation – Perhaps predictably, plaintiffs’ fraud-based claims failed under Fed. R. Civ. P. 9(b).  Id.  Allegations broadly “span[ning] the more than twenty-year period” alleged could not possibly allow defendants to file a response.  Id.  Plaintiffs “do not even specify which corporate entity they believe was responsible.”  Id.  Nor did any of the five plaintiffs allege their own circumstances with the required specificity.  Id.  “In sum, plaintiffs fall woefully short of pleading any specific allegations that would support a claim of fraud or misrepresentation.”  Id.

Warranty – Again, perhaps predictably, plaintiffs’ express warranty claims failed for not “plead[ing] any express promises.”  Id. at *9.  Here, Aston made another good TwIqbal ruling:

[T]o state a claim for breach of express warranty in cases involving prescription drugs, Plaintiffs must allege facts demonstrating that Defendants’ affirmations formed the basis of the bargain, i.e., facts regarding how the warranties were made to Plaintiff’s physician, and that Plaintiff’s specific physician relied on them.

Id. (citations and quotation marks omitted).  Implied warranty claims “cannot be independently maintained in a case involving prescription drugs.”  Id.

Unjust Enrichment – As against the investor defendants, merely “earn[ing] profits” from allegedly more valuable stock was “far too remote and speculative to support an unjust enrichment claim.”  Id. at *9.  As against the drug manufacturer defendants, the plaintiffs did not allege “that they conferred a benefit” on those defendants.  Id. at *10 (emphasis original).

[Plaintiffs] do[] not allege that [they] paid any money for [the drug], rather than relying on an insurer, as most patients do.  This omission is significant because there is no authority demonstrating that benefits received from third-parties can be the proper subject of an unjust enrichment claim.

Id. “Because plaintiffs have not pleaded any facts showing that they paid for [the drug], I must dismiss their unjust enrichment claim.”  Id.

Obamacare to the rescue.

Readers should remember this point; we don’t remember ever seeing an individual (as opposed to TPP) unjust enrichment claim that contains the allegations – personal, as opposed to third party payer – required by Aston and the precedent it follows.

Consumer Fraud Claims

Seven states’ laws were implicated − D.C., New York, Maryland, Pennsylvania, Illinois, Arizona, and California. “Each count fails to state a claim.” Id.

Six of the states (all but Arizona) did not recognize consumer fraud claims involving prescription drugs.  Some states’ statutes did not allow personal injury damages (Pennsylvania, California, D.C.).  Others did not consider prescription drugs to be “consumer” goods (Maryland, New York).  Still other statutes simply had been held inapplicable to prescription drugs (California, Pennsylvania, Illinois).  Id.  Beyond that, all of the consumer fraud claims were dismissed as inadequately pleaded under Rule 9(b), which Aston applied to all consumer fraud claims.  Id. at *11.  In prescription drug cases, Rule 9(b) required specific pleading of prescriber reliance:

[T]he circumstances of those prescription decisions, and plaintiffs’ reliance on them, are particularly important − yet plaintiffs allege no information about them. The absence of detail about Plaintiffs experiences leads to the conclusion that Plaintiffs have not pleaded these claims with the requisite particularity.

Id. (citations and quotation marks omitted).

Finally, none of the plaintiffs resided in D.C. or New York.  Thus, claims under those two states’ consumer fraud statutes were also “dismissed because neither statute applies extraterritorially.”  Id. at *10 n.9.  We’ve always been interested in extraterritoriality.

So that’s Aston for you – an example of really poor facts (for the plaintiffs) making some quite excellent law for our side of the “v.”  Our only quibble with Aston is grammatical – in a couple of places, “principle” is used where “principal” is meant.  Id. at *2 (“principle role”); *6 (“principle place of business”).  But apart from a law clerk needing to repeat fifth grade English, the legal rulings in Aston are truly vast, and not half-vast at all.  In Ashton all too many defendants were made to spend all too much money to hire all too many of us lawyers.  With Aston now dismissed in its entirety, we certainly hope that all the defendants so inconvenienced seek to recover their fees as a sanction against such frivolous litigation.

We recently brought you the breaking news that the Arizona Supreme Court has adopted the learned intermediary doctrine in prescription drug cases.  The case is Watts v. Medicis Pharmaceutical Corp., No. cv-15-0065-PR, 2016 WL 237777 (Ariz. Jan. 21, 1016), and the Arizona Supreme Court’s unequivocal adoption of the doctrine allows us to check one more state off the list—the number stand at 37 states (plus D.C.) whose highest courts have adopted the LID.  (See our headcount here).

Having now had the opportunity to take a deeper dive, we can say that the Watts opinion is a solid endorsement of the learned intermediary doctrine and an artful explanation of the doctrine’s underpinnings.  But before we get there, we note that Bexis filed an amicus brief in support of adopting the doctrine.  On the other side, the lead author of an amicus brief for the trial lawyers was former Arizona Supreme Court Chief Justice Stanley G. Feldman.  Bexis versus the former Chief?  We like those odds.  We actually worked in Phoenix for a year following law school and became acquainted with Chief Justice Feldman while we clerked in the chambers next door.  This was in the mid-1990s, and while he was a polarizing figure even then because of his background as a plaintiffs’ advocate, we came to know him as a brilliant and vigorous individual.  On the learned intermediary doctrine, however, we don’t mind saying that the former Chief is wrong and that his successors (and Bexis) got it right.

Continue Reading Learned Intermediary: Arizona Supreme Court Restores Order in the Desert

We’ve been following Watts v. Medicis Pharmaceutical Corp. ever since the Arizona Court of Appeals issued its bizarre ruling that the learned intermediary doctrine (“LID”), which has been adopted in almost every state, was somehow incompatible with the Uniform Contribution Among Tortfeasors Act (“UCATA”), which has been adopted in over half of the states – although no other jurisdiction following both ever thought so.  Fortunately, the Arizona Supreme Court granted review, which we hoped would lead to the 37th state high court adoption of the LID.

We weren’t disappointed.

Continue Reading Breaking News – High Wattage Reasoning – Arizona Adopts Learned Intermediary

We’ve posted previously about the awful learned intermediary decision by the Arizona Court of Appeals in Watts v. Medicis Pharmaceutical Corp., 342 P.3d 847 (Ariz App. 2015).  Well, that’s not the last word anymore.  Today the Arizona Supreme Court granted the defendant’s petition for review in Watts.  Here’s a copy of the court’s order.  The first issue is of most importance:  “Did the court of appeals err in wholly eliminating the widely accepted, longstanding learned intermediary doctrine on the erroneous ground that it conflicts with Arizona’s comparative fault scheme?”

So the Arizona Supreme Court will decide whether or not to adopt the learned intermediary rule and what, if any, effect statutory contribution among joint tortfeasors has on the rule.  Here are the amicus briefs already filed in Watts by PLAC and PhRMA.  They should be in there again, advocating for the rule on the merits.

 

Here’s a guest blogpost, this time from Jaclyn Setili, an associate in Reed Smith’s San Francisco office.  As always with guest posts, our posters deserve all the credit, and shoulder any blame, for what follows.  Take it away, Jaclyn:

**************

Here at the DDL Blog, there are few things we enjoy more than a defense-friendly Daubert ruling – one of those things being, of course, our regular Sunday night HBO date with Game of Thrones.  The “Hardhome” episode two Sundays ago finally provided the action-packed relief the show had been somewhat lacking thus far this season, culminating in an adrenaline-charged showdown between the Wildlings (and Crows) at Hardhome and the zombie-like army led by the White Walkers (speaking of which, we would gladly take a losing Daubert ruling over facing even one of those child wights any day).

Always thinking of our DDL readers, we were naturally struck with the comparisons one might draw between Daubert practice and this particular GoT storyline.  First, the standard for expert testimony draws some parallels to the constant challenges to Jon Snow’s recent promotion as Lord Commander of the Night’s Watch.  As we know, Federal Rule of Evidence 702 governs the admissibility of expert testimony.  The test requires that (1) the expert be qualified to testify competently regarding the matters he or she intends to address, (2) the methodology the expert uses to reach his or her conclusions is sufficiently reliable under the inquiry set forth in Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), and (3) the testimony assists the trier of fact through the application of scientific, technical, or other specialized expertise.

Likewise, Jon Snow is regularly subjected to Daubert-like inquiry in his dealings at Castle Black and elsewhere.  Is he truly qualified to lead the Night’s Watch?  After all, he certainly is young, and has not had many opportunities to successfully wield his Valyrian steel to victory.  Are his decisions sufficiently reliable – for instance, journeying to Hardhome in the first place to forge an unlikely alliance with a centuries-old adversary of those living south of the Wall?  Finally, can Jon truly assist the “trier of fact” – in this case, the inhabitants of Hardhome – with his “specialized expertise”?  For poor Jon, doubts abound, and leaving that bag of Dragonglass behind when he and his cohorts made their escape by boat at the episode’s climax is not helping his case.

Second, constructing arguments for exclusion in a Daubert motion truly is a Game of Unknowns.  Parties are likely tempted to throw any argument but the kitchen sink at a potential testifying expert at the hopes of an exclusion order, and are often rewarded only with a “grant in part, deny in part” ruling.  In other words, as Jon Snow well knows, you can’t win them all (or as the dearly-missed Ygritte might observe, “You know nothing Jon Snow”).

This Game of Unknowns was on full display in a recent decision from the Middle District of Florida, Ocasio v. C.R. Bard, Inc., 2015 U.S. Dist. LEXIS 58163 (M.D. Fla. May 4, 2015), where it was plaintiffs’ experts who were on the chopping block.  Plaintiff claimed injuries from an allegedly defective inferior vena cava (“IVC”) filter.  Plaintiffs sought to disclose a number of expert opinions, including those of Drs. Hyman and Begley and Ritchie, regarding the alleged defects of the filter. Defendants challenged the various opinions of all three experts, aiming their sword strokes at any or all of the Daubert elements.  Ultimately, the battle was a toss-up, with the court granting in part and denying in part Bard’s motions.  The rulings we like, and the rulings we don’t, are summarized below.

The Good

Lack of Qualifications

First, several of the experts’ opinions were struck down due to lack of relevant qualifications.  In excluding Hyman’s opinions regarding the filter’s labeling, the court found relevant his testimony that he had never drafted the  IFU (“Instructions for Use”) for any medical device, and that he had only had input or commented on pieces of “a few” unspecified IFUs.  Further, as Hyman was not a medical doctor, he had “never personally relied upon an IFU” in making a medical decision.  Id. at *9.  With no prior expertise, on either the giving or receiving end, out those opinions went.

Similarly, the court excluded Begley’s opinions on the adequacy of the defendants’ manufacturing process and quality control for the filter.  While Begley’s doctorate degree in Mechanical Engineering might sometimes be enough, the court found that plaintiffs “set forth no evidence that Begley [had] any training or professional experience in manufacturing techniques or manufacturing control measures.”  Id. at *16.  Significantly, the court noted that Begley’s background in mechanical processes and his testimony on manufacturing processes were “not so closely related that such expertise in one would
necessarily establish expertise in the other.” Id. at *16-*17.

Opinions Not Supported by Sufficient Data or Reliable Methodology

Next, a failure of reliable methodology convinced the court to knock out a number of other opinions.  As to Hyman’s opinions regarding the design and testing of the filter, the court disagreed with Bard, and found Hyman qualified.  While Hyman “lack[ed] training specifically in regard to implantable medical devices, such as IVC filters,” the court found that his thirty-plus year career in the design, testing and regulation of other medical devices rendered him “clearly qualified” to opine on design and testing (making this part of the ruling more properly assigned to “The Bad”).  Id. at *5-*6.  However, the court still excluded these opinions on the grounds that they were not the product of reliable principles and methods.  Specifically, Hyman “failed to test or examine the [product] or any other type of IVC filter”; indeed, he had “never even seen in person or touched” any IVC filter at all.  Id. at *7.  Rather, Hyman’s only opinions on design and testing were “gleaned from documents selected by Plaintiffs’ counsel,” and completely lacked “any independent verification of the data or testing of the device.”  Id. 

Hyman’s methodology itself was also concerning:  he simply reviewed the facts of the case, the known failure modes of the device, and relevant medical literature; he then compared his impression of the defendants’ approach to “what he believed a prudent product manufacturer would have done.” Id. at *8.  According to the court,

 

[I]t appears that Hyman arrived at his opinions based solely upon a comparison of the underlying facts to his own subjective idea of what a prudent manufacturer would have done.

Hyman has failed to articulate any scientific or regulatory bases for his methodology.  He has not developed any test protocols that he believes should have been performed on the device.  There is no objective standard that could be employed to evaluate Hyman’s design and testing opinions.

Id.  Thus, these opinions were excluded.

The court also noted that Begley’s opinions on manufacturing and quality control would be excluded under this ground as well, given that his opinions appeared “to rest solely on other experts’ observations of variability between the filters and [Begley’s] observations of” the defendants’ “internal documents.”  Id. at *17.  Like Hyman, Begley did not conduct any tests of his own, and could not even recall if he had ever reviewed the manufacturing specifications for the this product.  Id.

As to Ritchie, he opined that certain factors known to result in filter fracture also caused the perforation of plaintiff’s filter.  The court held that this opinion was not the product of reliable scientific methodology.  The court concluded that “Ritchie offers nothing more than his own ipse dixit to conclude that these conditions [leading to fracture] also cause tilt, migration, and perforation. . . . As the Eleventh Circuit has cautioned, courts must be wary of leaping from an accepted scientific premise to an unsupported one.”  Id. at *15.

Opinions That Would Not Assist the Trier of Fact

The last bit of helpful rulings precluded opinions the court determined would not be helpful to the trier of fact.  These involved the all-too-common transgressions of plaintiff-side experts. For one, the court rightly excluded Hyman’s opinions summarizing the defendants’ internal documents, finding that such testimony both “invades the province of the jury,” which does not need expert aid to interpret corporate documents, and is improper, because “[a]n expert cannot be presented to the jury for the purpose of constructing a factual narrative based upon record evidence.”  Id. at *11-*12.

The court also excluded much of Begley’s chosen vocabulary in characterizing the defendants’ conduct.  The court agreed with Bard that terms such as “negligent” and “reckless” have a “specialized meaning in the law,” and precluded Begley from using these words, as it is “well-established that a testifying expert may not offer legal conclusions.”  Id. at *20.  Begley was also prevented from using the word “unethical,” finding that it was “founded only upon his own subjective ideas on how a medical device company should act.”  Id. at *22.

The Bad

And now, for the fatalities.  First, while Begley was prohibited from using certain words, the court ruled that he could be allowed to use other unflattering terms when characterizing the defendants’ conduct.  “Incompetent” passed muster, given that the word carries no distinct legal definition and would supposedly assist the trier of fact in evaluating the defendants’ “duty of care.”  Id. at *21.  Begley’s use of the word “misleading” also squeaked through for the same reasons.  Id. at *22-*23.

Other opinions were deemed helpful to the trier of fact.  Hyman’s opinions on the FDA regulatory process, for example.  As a
slight consolation, the court limited Hyman’s opinions on this topic by precluding him from opining on whether the defendants “should have done more than was required by FDA regulations.”  Id. at *10-*11.

Ritchie’s opinions regarding causes of fracture of the filter were similarly permitted.  Defendants attempted to argue that, because plaintiff’s filter did not fracture, Ritchie’s opinions did not “fit” the facts of the case.  Instead, the court found that Ritchie’s opinion that perforation (which plaintiff did experience) could “increase the risk” of fracture would be helpful to the trier of fact, and “[t]he fact that Ritchie was unable to establish the increase in likelihood of fracture due to perforation to a reasonable degree of engineering certainty does not warrant the exclusion” of such opinions.  Id. at *13.  Since when has “increase in risk” even been a product liability theory?  The court did, thankfully, leave open the possibility that such opinions could be subject to a motion in limine or objection at trial due to the risk of unfair prejudice.

Finally, the court ruled to allow Begley’s opinions regarding a stress/strain analysis and the adequacy of product testing, finding both would assist the jury.  As to the adequacy of testing specifically, defendants argued that Begley could not point to any specific defect that caused plaintiff’s filter to perforate.  The court was not persuaded, noting that there is “no requirement that Plaintiffs or their experts establish that any one specific defect caused [plaintiff’s] filter to perforate.”  Id. at *19.  The Court found that opinions on the adequacy of testing would assist the jury in determining whether the filter was defective and whether the warnings were sufficient.  Id.

Ultimately, we think the message of Ocasio is that, while you may swing your sword widely in commencing a Daubert attack, only some blows will stick.  Fortunately, this case provides enough satisfactory rulings that it may just stick around long enough (parts of it anyway) to be cited in the next Eleventh Circuit Daubert battle.

We’ve already discussed the peculiar decision in Watts v. Medicis Pharmaceutical Corp., 342 P.3d 847 (Ariz App. 2015), once, here.  This time, we don’t care much about the peculiar facts, but rather we’re directing ourselves to the court’s odd reasoning that somehow there’s a conflict between the learned intermediary rule (adopted at some level now in every American jurisdiction – see our “headcount” post here − and the Uniform Contribution Among Tortfeasors Act (“UCATA”).  Among the cases following the learned intermediary rule are four prior Arizona appellate decisions.  Davis v. Cessna Aircraft Corp., 893 P.2d 26, 38 (Ariz. App. 1994) (non-medical product), review denied (Ariz. April 25, 1995); Piper v. Bear Medical Systems, Inc., 883 P.2d 407, 415 (Ariz. App. 1993), review denied (Ariz. Nov. 1, 1994); Gaston v. Hunter, 588 P.2d 326, 340 (Ariz. App. 1978), review denied (Ariz. Nov. 21, 1978); Dyer v. Best Pharmacal, 577 P.2d 1084, 1087 (Ariz. App. 1978), review denied (Ariz. May 2, 1978).  In all four of these cases, the Arizona Supreme Court had the opportunity to evaluate the learned intermediary rule; all four times it passed and denied review.

Don’t be fooled by the 2007 date on our “headcount” post.  We’ve kept updating it.  Since we originally wrote that post in mid-2007, prompted by the terrible decision in State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007), two more state supreme courts have adopted the learned intermediary rule for the first time:  Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 154-59 (Tex. 2012); Rohde v. Smiths Medical, 165 P.3d 433, 438 (Wyo. 2007).  Two other state supreme courts have reaffirmed the learned intermediary rule since then, Wyeth, Inc. v. Weeks, ___ So.3d___, 2014 WL 4055813, at *19-20 (Ala. Aug. 15, 2014) (the only good thing about an otherwise awful opinion); Klasch v. Walgreen Co., 264 P.3d 1155, 1159 (Nev. 2011), as have two state intermediate courts of appeal.  O’Connell v. Biomet, Inc., 250 P.3d 1278, 1281-82 (Colo. App. 2010), cert. denied, 2010 WL 4851480 (Colo. Nov. 30, 2010); Silva v. SmithKlineBeecham Corp., 2013 WL 4516160, at *2-3 (N.M. App. Feb. 7, 2013).  In addition, federal courts have predicted the rule’s adoption in Rhode Island, where there used to be no law.  Greaves v. Eli Lilly & Co., 503 F. Appx. 70, 71-72 (2d Cir. 2012); Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467, at *9-10 (E.D.N.Y. April 23, 2011), and in South Dakota, reconfirming earlier predictions.  Schilf v. Eli Lilly & Co., 2010 WL 4024922 (D.S.D. Oct. 13, 2010).  Finally, as we’ve blogged about before, West Virginia federal courts have recently cut back Karl to drug DTC advertising cases.  See O’Bryan v. Synthes, Inc., 2015 WL 1220973, at *6-7 (S.D.W. Va. March 17, 2015); Wise v. C.R. Bard, Inc., 2015 WL 502010, at *4 (S.D.W. Va. Feb. 5, 2015); Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993, at *5-6 (S.D.W. Va. Oct. 23, 2014).

So even since Karl, the learned intermediary rule has been doing quite well for itself.

Continue Reading Low Wattage Reasoning

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

Last week we mentioned the decision in Watts v. Medicis Pharmaceutical Corp., 2015 Ariz. App. LEXIS 12 (Ariz. Ct. App. Jan. 29, 2015) in a breaking news post when it first hit the wires and promised more detail would follow.  Well that day has come.

We take a lot of abuse here in New Jersey:  waste dumps, wise guys, Jersey Shore; Chris Christie.  But as drug and device products liability lawyers in New Jersey, we bear another burden — Perez v. Wyeth Laboratories, Inc., 734 A.2d 1245 (N.J. 1999) – the decision that makes New Jersey the only state to adopt a direct-to-consumer (“DTC”) exception to the learned intermediary rule (putting aside West Virginia’s use of DTC as an excuse for rejecting the rule altogether).  But it is a burden we are more than happy to bear on our own.  Texans managed to dodge a bullet and avoided joining our ranks in 2012.  And the DTC issue has been rather quiet in our world in the last few years.

Unfortunately, in Watts an Arizona intermediate appellate court has decided to see whether it wants to keep New Jersey company.  Arizona is one of the relatively few states where the highest court has never passed on the learned intermediary rule.  But heretofore, its appellate courts have gotten it right – adopting and applying the doctrine.  That is, until now.

Continue Reading Arizona Recognizes DTC Exception to Learned Intermediary Rule

We’ve just learned that an Arizona appellate court has held, in effect, that the learned intermediary rule can’t apply in direct to consumer cases because it – get this – it supposedly violates the Uniform Contribution Among Joint Tortfeasors Act (UCATA).  The case is Watts v. Medicis Pharmaceutical Corp., 2015 Ariz. App. Lexis. 12 (Ariz. App. Jan. 29, 2015).  Arizona is one of the relatively few states where the highest court has never passed on the learned intermediary rule.  According to our Head Count post, the Arizona Court of Appeals has followed the learned intermediary rule three times:  Piper v. Bear Medical Systems, Inc., 883 P.2d 407, 415 (Ariz. App. 1993); Gaston v. Hunter, 588 P.2d 326, 340 (Ariz. App. 1978); Dyer v. Best Pharmacal, 577 P.2d 1084, 1087 (Ariz. App. 1978).  But not anymore, according to Watts, at least not if a plaintiff claims that s/he was personally influenced to seek a drug by false direct to consumer advertising.

The UCATA rationale is so unusual that we’ll need some time to dissect it.  However, we believe, for reasons expressed a few years ago in the second half of this post, the traditional causation regime under the learned intermediary rule easily incorporates situations where direct to consumer advertising allegedly
influenced a plaintiff to influence a prescribing physician to obtain a drug.

All we can say right now – after 5 on a Friday − is that Watts  (1) is inconsistent with three prior rulings of the same court; and (2) is based on a rationale that nobody has adopted anywhere – not even in West Virginia.