February 2015

Photo of Michelle Yeary

On Friday, we posted about a Florida court that allowed negligence claims against a pharmacy that did nothing more than fill prescriptions as they were written (Oleckna).  As you can imagine, we had some reservations about the ruling.  Well, those reservations were driven home when we happened upon another recent pharmacy liability case, this one in Indiana – Kadambi v. Express Scripts, 2015 U.S. Dist. LEXIS 13607 (N.D. Ind. Feb. 5, 2015).

If we call Oleckna a “damned if you don’t” case, then Kadambi is the example of “damned if you do.”  Which leaves the question – what is a pharmacy to do?

Plaintiffs in Kadambi are an endocrinologist, Dr. Kadambi, and 8 of his patients for whom he prescribed human growth hormone (HIGH).  While plaintiffs allege that the prescriptions were medically necessary, the defendant pharmacies refused to fill HIGH prescriptions from Dr. Kadambi because they believe the prescriptions might violate federal law making it a “crime to knowingly distribute HIGH” for improper purposes.  Id. at *3.  Defendants alleged that they had a good faith belief that Dr. Kadambi was prescribing HIGH for non-medically acceptable reasons and/or that he was affiliated with organizations that advocate
off-label use of HIGH.  Id. at *4.

Plaintiffs advanced essentially two causes of action against the pharmacies – violation of Indiana’s statute governing pharmacies and defamation.   While the court dismissed the statutory claim, it allowed the defamation action.  We’ll go through the court’s ruling, but our real interest lies in the fact that both Kadambi and Oleckna are moving forward.Continue Reading The Flip Side of Pharmacy Liability

Photo of Rachel B. Weil

This week, we are attending the 139th annual Westminster Kennel Club dog show. We are Standard Poodle aficionados. Before the current passel of Drug and Device Rescue Dogs – mixed breeds – we always had a Standard Poodle or two. Though Standard Poodles were developed as hunting dogs in Germany – water retrievers — the Standard Poodle class at a dog show displays these tough, athletic creatures in extreme haircuts (we won’t waste blog space on the utilitarian origins of these haircuts) as they prance – “gait” – around a ring. Our all-time favorite movie, “Best in Show,” portrays this accurately. While we adore Westminster, it is startling for the uninitiated, some of whom recoil at the spectacle of these beautiful animals out of their natural context and in unfamiliar trappings. And that sets the stage for our weak transition to today’s case. It is a case about off-label promotion, but not in its familiar context. Rather, this interesting and sensible decision out of the (not always hospitable) First Circuit rejects plaintiffs’ attempt to dress off-label promotion in the trappings of a 10(b)(5) violation.

In Fire and Police Pension Association of Colorado v. Abiomed, No. 14-1502, 2015 U.S. App. LEXIS 1944 (1st Cir., Feb. 6, 2015) the First Circuit considered the appeal of the district court’s dismissal of a complaint alleging that defendant Abiomed and two of its officers had committed securities fraud when they told investors that the company’s policy was “to avoid off-label marketing” of its Impella 2.5 micro heart pump, when they were in fact “orchestrating and engaged in widespread off-label marketing promotion.” Fire and Police Pension Association, 2015 U.S. App. LEXIS 1944 at *2 (citation omitted). The complaint further alleged that defendants told investors that the company was cooperating with the FDA’s investigation into its marketing practices and working “to resolve a few discrete issues,” while it was actually “trivializing the concerns” and “continuing to off-label market.” Id. (citation omitted). The district court held that plaintiffs had not pleaded facts “giving rise to a cogent and compelling inference of scienter,” as required under the Private Securities Litigation Reform Act of 1995 (“PSLRA”). Id. at *2-3.Continue Reading Off-label Promotion, Securities Law Style

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A pharmacy case from Florida caught our eye this week.  We still have fresh in our minds the survey that Bexis posted a few days ago of state laws limiting the liability of non-manufacturing sellers of prescription medical products.  It was an impressive collection, as Bexis-prepared surveys tend to be, and it covered the potential liability (or lack thereof) of distributors, suppliers, pharmacies, etc.  You know, anyone in the chain who did not manufacture the drug or device and who typically would have no role in developing the product or its warnings. It comes up a lot for us in the context of removal jurisdiction, where plaintiffs fraudulently join local or non-diverse defendants in an attempt to prevent removal to federal court.  The plaintiffs never—and we mean never—actually pursue claims against the local defendants, and we routinely resist their motions to remand cases to state court with arguments that there are no viable claims against mere pass-through sellers of pharmaceutical products and medical devices.

In this regard, the result in Oleckna v. Daytona Discount Pharmacy, No. 5D13-3057, 2015 WL 477841 (Fla. Dist. Ct. App. Feb. 6, 2015), is not helpful because it allows negligence claims against a pharmacy that did nothing more than fill prescriptions as they were written.  In Oleckna, the patient was being treated for stress, and his doctor prescribed Xanax and narcotic pain medication over a period of two years.  Id. at *1.  The patient, sadly, died allegedly “due to combined drug intoxication” of the prescribed medications, and his estate sued the physician who wrote the prescriptions and a pharmacy who filled many of them—allegedly more than 30 prescriptions.  Id. Continue Reading Florida Court Races to Questionable Conclusion on Pharmacy Liability

Photo of Michelle Yeary

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

Photo of Stephen McConnell

Today’s case under discussion, Robison v. Orthotic & Prosthetic Lab, Inc., 2015 Ill. App. LEXIS 68 (Ill. App. Ct. Feb. 4, 2015), makes us think of Jim Carrey, George Costanza, and Bruce Willis.  You might already have heard of the Robison case.  Only a week old, this product liability case, involving a claim that a prosthesis failed, has quickly garnered notoriety.  The Illinois appellate court threw out a settlement because the plaintiff attorney extracted that settlement without bothering to disclose that his client had died.

Why do we think of those three particular cultural icons?  To begin, let’s lay out the procedural posture of the Robison case.  The defendant appealed from an order enforcing a settlement agreement in the product liability action.  The defendant argued that the settlement agreement was invalid because the attorneys who purportedly represented the plaintiff during settlement negotiations lacked the authority to negotiate a settlement inasmuch as the plaintiff had died and a proper representative of the estate had not been substituted as the party plaintiff.  (The substitution process begins with the quaintly named “suggestion of death” that many jurisdictions, including our home jurisdiction here in the Commonwealth of Pennsylvania, require.)  The defendant also contended that the settlement agreement was invalid because the attorneys who purportedly represented the plaintiff during settlement negotiations failed to disclose the material fact that the plaintiff had died eight months prior to the commencement of the negotiations.  Got it?Continue Reading The Death of a Client is a Material Fact That Must Be Disclosed in Settlement Negotiations

Photo of Bexis

Many states have legislation on the books that insulates non- manufacturing intermediate sellers from strict liability.  Here’s a bunch that we’re aware of.  Ala. Code §§6-5-501, 6-5-521; Colo. Rev. Stat. §13-21-402(2); 18 Del. Code Ann. §7001; Ga. Code Ann. §51-1-11.1(b); Idaho Code §6-1407; Ill. Ann. Stat., Ch. 735 §5/2-621(a)-(c)(ignore the WL red unconstitutionality flag; the prior provision remains); Iowa Code §613.18; Kan. Stat. Ann. §60-3306; Ky. Rev. Stat. Ann. §411.340; La. Rev. Stat. Ann. §9:2800.52(5); Md. Code Ann. § 5-311; Minn. Stat. Ann. §544.41; Mo. Rev. Stat. §537.762; Miss. Code. Ann. § 11-1-63(h); Neb. Rev. Stat. §25-21, 181; N.C. Gen. Stat. §99B-2; N.D. Cent. Code §28-01.1-06.1; Ohio Rev. Code Ann. §2307.78; S.D. Comp. L. §20-9-9; Tenn. Code Ann. §29-28-106; Tex. Civ. Prac. & Rem. Code Ann. § 82.003; Wash. Rev. Code Ann. §7.72.040; Wis. Stat. Ann. §895.047(2).  If we missed any, let us know and we’ll add them.  Some of these are “innocent supplier” statutes, many with caveats about the manufacturer being subject to suit.  Some are “sealed container” statutes.  What they have in common is the imposition of limits on the liability of non-manufacturing distributors of products.

Have these statutes been applied to the distributors of prescription medical products?  Yes, we’re happy to report, and that’s what this post is about.Continue Reading State Statutes Concerning Distributors As Intermediate Sellers

Photo of Rachel B. Weil

We wanted to draw your attention to a draft bill recently released by House Republicans, proposing amendments and overhauls of numerous FDCA provisions. It is a monster – 400 pages long – and you can read it here.  Here is the summary that accompanied the draft.  We haven’t seen anything looking at this bill through the lens of litigation, and we thought we would.  Several potentially defense-friendly provisions caught our attention:

Definition of Prescription Medical Device

Title V of the draft is entitled “Modernizing Medical Product Regulation.”  Subtitle E under this title, “Supply Chain Security for Devices,” includes, for the first time in an FDCA provision, a definition of “Prescription Medical Device.” Section 586(7), at page 370, provides that a “prescription device” is a restricted device which “which, because of any potentiality for harmful effect, the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device” and “for which the Secretary has determined adequate directions for use cannot be prepared” and which therefore must a carry a designation that it is for physician- or dentist-use only, “or a statement that Federal law restricts the device to sale by or on the order of a licensed health care practitioner.”  How something becomes “prescription only” is one of those FDCA basics that has always struck us as needlessly complex to explain.  This definition does a good job of that.Continue Reading 400 Pages of Proposed FDCA Amendments – What Might Help Us?

Photo of Steven Boranian

Because we hail from San Francisco, we sometimes feel a certain hometown pride in the Ninth Circuit, whose San Francisco home is one of the most beautiful public buildings in the United States. Opened in 1905, the James R. Browning United States Courthouse underwent a spectacular renovation in the late 1990s and has survived two catastrophic earthquakes — the big one in 1906 and the one in 1989 that knocked down elevated highways and famously disrupted the World Series at now-decrepit Candlestick Park. We also frequently praise the Ninth Circuit here on the DDL blog for its sense of justice and learned contributions to drug and device law. But not today. The Ninth Circuit swung mightily and missed with McClellan v. I-Flow Corp., No. 11–35109, 2015 WL 294292 (9th Cir. Jan. 23, 2015), where the court allowed the plaintiff to proceed on a negligence per se theory based on alleged violations of the FDCA.  We have another name for claims like that—private enforcement of the FDCA, and the Supreme Court ruled that federal law impliedly preempts such claims more than ten years ago in Buckman.  In fact, this negligence per se scenario is where it seems most transparent that the plaintiff is purporting to enforce the FDCA and where Buckman should apply most strongly. Yet the Ninth Circuit somehow gave the plaintiff a green light.

How can this be?  The plaintiff underwent shoulder surgery and was prescribed continuous infusion of pain medicine through a pump, appropriately named the PainBuster.  Id. at *1.  After a second surgery, and further treatment with the infusion pump, the plaintiff experienced cartilage loss resulting in fusion of bones in her shoulder and severely restricted mobility.  Id.  Her lawsuit against the pump’s manufacturer went to trial on strict liability and negligent failure-to-warn claims, and the jury returned a defense verdict.  Id.

Continue Reading Ninth Circuit Swings and Misses with Buckman Preemption

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The other day we read a thoughtful Bloomberg piece on 3D printing in the medical device context by a trio of Alston & Bird litigators.  We’ve given you the link, but it might be behind a paywall.

The article indicates that 3D printing of medical devices is already a reality.  3D printing is currently being used with implants where sizing is both critical and extremely patient specific – the article mentions tracheal splints, skull plates, hip cups, spinal cages, knee trays, and dental reconstruction devices. Here’s a cool slide show that we found on the FDA’s website showing some of them and discussing relevant 3D printing techniques.  Also according to the article, the FDA doesn’t have any specific 3D printing guidance available – which we confirmed on Westlaw (no mention of “3D printing” or “additive manufacturing” in any FDA guidance).Continue Reading Some Ideas About 3D Printing

Photo of Rachel B. Weil

We saw the movie “Whiplash” last weekend.  In this Oscar contender, a drum student at a prestigious music conservatory seeks the approval of a harsh and punishing conductor, as well as a berth in the conductor’s competition jazz band.  The film is so tense and so consistently painful to watch that it would not be accurate to say that we “enjoyed” it, but we wouldn’t have missed it for the world.

Early in the movie, the conductor demands that the student play several measures over and over and over again in a relentless and seemingly futile attempt to find the correct tempo. In today’s decision out of the Denture Cream MDL pending in the Southern District of Florida (thanks to David Walz at Carlton Fields for sending it to us)  Plaintiffs are back, beating the same drum, in a repeat attempt to surmount defendant Procter & Gamble’s (“P & G’s”) Daubert challenges to their general causation experts.  In re Denture Cream Prods. Liab. Litig., No. 09-2051-MD-Altonaga, 2015 U.S. Dist. LEXIS 9653 (S.D. Fla. Jan.. 28, 2015).  In these cases, Plaintiffs allege that, with long-term use of Fixodent denture adhesive, the zinc in the product causes copper deficiency and, ultimately, a neurological condition known as copper deficiency myeloneuropathy (“CDM”).  In 2011, the court granted P & G’s Daubert motions to exclude Plaintiffs’ general causation experts. See In re Denture Cream Prods. Liab. Litig. (Chapman, et al. v. Procter & Gamble Distributing, LLC), 795 F. Supp. 2d 1345 (S.D. Fla. 2011), aff’d, 766 F.3d 1296 (11th Cir. 2014) (“Chapman’).  As we discussed at the time, the Court held, “[Plaintiffs’] theory is not ridiculous, but neither is it necessarily true; it is ripe for testing.  . . . [T]aking everything together, there is enough data in the scientific literature to hypothesize causation, but not to infer it.”  795 F. Supp. 2d at 1367 (emphasis in original).  This past September, as we reported here, the Eleventh Circuit affirmed the District Court’ Chapman decision.

Continue Reading Rule 702 Decision Bites Denture Cream Plaintiffs Again

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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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