Learned Intermediary

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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

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

In pharmaceutical litigation, discovery is almost always massive.  Plaintiffs depose dozens of company witnesses, often over several days and sometimes in multiple jurisdictions.  Defendants have to produce millions of pages of documents of which usually only a handful are ever used at depositions and trial.  Both sides retain several experts in various areas of specialty and each expert produces a voluminous report supported by thousands of pages of back-up materials. The time and costs associated are staggering.  And when all of that is said and done and you actually get to the discovery related to one particular plaintiff, there is one particular deposition that can make all the difference – the prescriber.

There are any number of cases, too many reported on by this blog alone to count, where the prescriber’s testimony was the linchpin for the defense.  But in the overwhelming machine that is mass tort discovery, it might be easy to overlook that one particular deposition.  Like Jimmy Buffett’s One Particular Harbor – this one particular deposition can be a haven.  “Sheltered from the wind . . . where all are safe within.”  OK, prescriber testimony is that idyllic, but allow us a little poetic leeway.

The reason for our focus on the prescriber today is a recent win in the Avandia litigation, Schatz v. GSK, 2015 U.S. Dist. LEXIS 37411 (E.D. Pa. Mar. 24, 2015), where the defendant embraced that one particular deposition.  Faced with several claims that all essentially boiled down to failure to warn claims, GSK moved for summary judgment on the ground that plaintiff could not establish causation.  The crux of defendant’s argument was that plaintiff could point to no evidence that had the prescribing doctor received a different warning, he would have altered his prescribing habits.  Id. at *9.  And since that’s the standard under Pennsylvania law, plaintiff’s claims should be summarily dismissed.Continue Reading That One Particular Deposition

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We have said it before – birth defect cases are hard.

Juries and judges are sympathetic where the individual whose health is at issue had no say in the matter.  We have also said that we do not like it when judges frame the insistence of the defendant on things like proof of proximate cause as an attempt to avoid liability, as if liability were the default where the plaintiff has a tangible injury.  We may or may not have said that we do not like it when opinions refer to plaintiffs by their first names, especially when only women and children get that discourtesy.  We have said over and over that we do not like it when the decision in Levine is held up like an anti-drug preemption talisman, particularly after Mensing and Bartlett.  So, we are not terribly surprised that the large trial verdict over birth defects in the child of a woman taking her mother’s anti-seizure medication while pregnant was affirmed in Gurley v. Janssen Pharms., Inc., No. 239 EDA 2014, 2015 Pa. Super. LEXIS 112 (Pa. Super. Mar. 16, 2015), but we were still somewhat perturbed by the tone and less-than-probing analysis of the opinion.

Plaintiffs were a minor child born with a cleft lip, his mother, and his father.  The minor plaintiff was referred to by his first name, as was his mother.  The father was only ever referred to by his full name or as the “husband” of the mother (listing her first name).  The mother’s mother, who was taking the same anti-seizure drug on a prescription from another doctor and was the sole source for her daughter’s use of the drug while pregnant, was also referred to by her first name.  We have been known to parse words, but that is some paternalistic nonsense.  Maybe we would not read it like that if the opinion had been written by a judge from a different demographic, but it does seem to fit with the rest of the opinion.  Plaintiff’s mother was first prescribed the medication for “juvenile myoclonic seizures” in March 2006, and received and filled refills that should have carried her through July 2007, three months before she became pregnant.  She would not have taken the medication while pregnant if not for taking medication obtained by her own mother on her (the minor’s  grandmother’s) own prescription for a different indication (migraines).  The opinion never addresses 1) whether it was legal for the minor plaintiff’s mother to take the drug (as we addressed here), 2) whether it was foreseeable—the only claim presented to the jury was for negligent failure to warn, after all—for the minor plaintiff’s mother to take the drug while pregnant under these circumstances, or 3) the knowledge of the physician who prescribed the drug to the minor plaintiff’s grandmother about the risk of birth defects or the impact of additional information on the decision to prescribe to her.  Even though one of the issues on appeal highlighted the lack of evidence of proximate cause through either prescribing physician, the opinion’s only discussion of the grandmother’s prescription—the one that allegedly caused the injury—was  that “Sandra [grandmother] testified that her family was having financial difficulties and she filled her prescription instead of Haley’s [mother] to save money on the insurance co-pay.”  2015 Pa. Super. LEXIS 112, *2 n.4.  This would be the “financial hardship” exception to both the requirement of proximate cause or the in pari delicto defense.  But we are getting ahead of ourselves.Continue Reading Result-Driven Affirmance of Birth Defect Verdict

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Back in November, we exulted over the pelvic mesh MDL judge’s resurrection of West Virginia’s learned intermediary doctrine.   In Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993 (S.D.W. Va. Oct. 23, 2014), as we reported, the Court held that the learned intermediary doctrine governed a medical device manufacturer’s duty to…

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A tip of the hat to our friend and former colleague Ken Zucker from Pepper Hamilton, who achieved this victory and sent us the decision.  In the consolidated California Byetta litigation, 2015 WL 663211 (Cal. Super. Feb. 26, 2015), defendant Eli Lilly & Co. moved for summary judgment in a Byetta pancreatitis case, arguing that, under the “learned intermediary” doctrine, it was entitled to summary judgment on plaintiff’s claims that Byetta’s pancreatitis warnings were inadequate.

Plaintiff cross-moved for summary adjudication, arguing that manufacturer’s duty to warn ran to the plaintiff because, pursuant to 21 C.F.R. §208, a required Medication Guide was provided to the patient when the drug was dispensed.    Id. at *1.  The plaintiff claimed that “the [Medication Guide] given directly to a patient changes or eliminates the traditional ‘learned intermediary’ defense [sic] for prescription medicines where the entire focus is on the adequacy of the warnings given to the  prescribing doctor, not the quality or accuracy of communications that may have come to the patient user’s attention.”  Id.

This was an attempt to revive a moribund would-be “exception” to the doctrine – involving then-novel FDA-mandated direct-to-patient oral contraceptive warnings – that gained a couple of adherents in the early to mid 1980s (Massachusetts and Oklahoma), and then promptly died out as its contradictions became increasingly overwhelming.  See In re Norplant Contraceptive Products Litigation, 165 F.3d 374, 379 (5th Cir. 1999) (applying Texas law), which debunks this purported “exception” at some length.  Not a single jurisdiction had signed on with this exception in the last thirty or so years, and California in particular has never given it the time of day.Continue Reading An Exemplary “Learned Intermediary” Win for Lilly and Byetta

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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

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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…

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Any time you find yourself drawing an analogy to asbestos lawsuits, you know you’re in trouble.   We have too often heard plaintiff lawyers or, worse, judges advocate for borrowing procedures from asbestos litigation.  Almost always those procedures would make it easier for plaintiffs to ‘prove’ little things like product identification, and would abridge defendants’ rights…

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In searching for cases for this blog, we sometimes feel like its Groundhog Day.  Another preemption win in a PMA medical device case.  Another food labeling decision from California.  Another failure to plead fraud with particularity dismissal.  Another “Okay, campers, rise and shine, and don’t forget your booties ’cause it’s cooooold out there today.”  Well, that last one really only applies to Phil Connors, but you get the idea.

Faced with routine rulings, it can be difficult to be creative, to find the new hook or twist.  So, sometimes the answer is simply to not – be creative that is.  Sometimes, a decision is just what it looks like it is on its face.  Another good ruling in an already good body of law.  But that doesn’t mean it should be disregarded either.  We just need to pluck out the good sound bites and add them to top of the pile.

For instance, if faced with a claim for negligent failure to test in Pennsylvania, you can now add Houtz v. Encore Medical Corp., 2014 U.S. Dist. LEXIS 170481 (M.D. Pa. Dec. 10, 2014) to your motion to dismiss on the ground that “Pennsylvania courts have explicitly stated that negligent failure to test is not a viable cause of action.”  Id. at *7.Continue Reading Pennsylvania Sound Bites

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

We’ve reported on multiple sets of in limine and summary judgment rulings coming out of the Pelvic Mesh MDLs (see here, here, here and here for example).  And there is a new batch just in.  Like the other rulings coming out of this litigation, they are a mixed bag.  As is our usual procedure, we are going to primarily focus on the positive and we’ll skip over a lot of the redundant and more mundane rulings.  It should make for a short, but hopefully informative post.

All of the rulings were entered in Bellew v. Ethicon, Inc., No. 2:13-cv-22473 (S.D. W. Va.), a bellwether case in the Ethicon Pelvic Mesh MDL.  We’ll start with the in limine rulings which can be found at Bellew, 2014 U.S. Dist. LEXIS 165709.  Many of the motions were standard – by defendant to exclude evidence of other allegedly bad acts (denied without prejudice); by plaintiff to exclude evidence of other allegedly good acts (denied in part (granted only as to things defendant agreed they would not introduce at trial)); by defendant to exclude that it no longer sells the product at issue (granted); by plaintiff to exclude evidence of 510k clearance (granted).

There was one motion in limine, however, that caught our attention as one we see more commonly brought by defendants.  Although, this issue can cut both ways, so we aren’t going to offer much commentary here.  Plaintiff moved to exclude “opinion testimony from treating physicians.”  Id. at *24.  The reason this is more often a defense motion is the unlevel playing field we’ve railed against for years.  Plaintiffs have unfettered, ex parte access to the treaters.  So, they often use that time to show the doctor things like medical literature the doctor had never read, corporate documents the doctor would never have otherwise seen, or information that post-dates the doctor’s treatment of the plaintiff.   All of this is done in an attempt to secure opinion testimony on causation.  Now, if the treater is retained by plaintiff as an expert and prepares an expert report, his opinions, like those of any other properly disclosed expert, are scrutinized under Daubert.  The problem comes when plaintiff tries to proffer the causation opinion without the expert report.Continue Reading A Collection of Ethicon Mesh Rulings

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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