Generic Drugs

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Last week, the Eighth Circuit put the final seal on Pliva’s victory in Brinkley v. Pfizer, Inc., 2014 U.S. App. LEXIS 22742 (8th Cir. Dec. 2., 2014), upholding the district court’s dismissal with prejudice under Mensing and Bartlett.  The case involved a doctor who prescribed Reglan and a pharmacist who, when filling the prescription, switched it out for Pliva’s generic metoclopramide.  Id. at *2.  While the Reglan label had been changed in 2004 to add a warning on long-term use, Pliva, plaintiff claimed, failed to make the corresponding update to its label.  So she pursued a failure to update claim.

In some sense, that’s a good starting point.  By styling her failure to warn claim as a “failure to update,” Plaintiff was conceding that she could not bring a standard failure to warn claim.”  Generic manufacturers can only change their label to match a corresponding change in the branded label, and plaintiff hoped that her “failure to update” claim would avoid Mensing preemption.

But this claim had problems too, and they centered on the learned intermediary doctrine.  Pliva’s duty to warn, if any, ran to plaintiff’s prescribing doctor.  But, as plaintiff alleged, her doctor prescribed Reglan, not Pliva’s generic metoclopramide.  Consistent with that, the doctor consulted the Reglan label, not the Pliva label.  Id. at 2-3.  In short, the doctor never read Pliva’s label.  So no matter what Pliva put there, it could not have affected the doctor’s decision to prescribe the drug to plaintiff.  We lawyers call that a failure of proximate causation.Continue Reading Learned Intermediary Doctrine Gets an Assist in Preempting a Failure to Update Claim

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Bexis is pretty pleased this morning.  Almost eighteen years ago, to the day, he filed his first brief with the Pennsylvania Supreme Court challenging the negligence/strict liability dichotomy adopted in Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978) (in a case called Spino).  Over twelve years ago, he filed his first outright “overrule Azzarello” brief (in a case called Phillips).  Well, yesterday the Pennsylvania Supreme Court did precisely that – it overruled Azzarello – unanimously in an opinion written by Chief Justice Castille.  In the end, even the most pro-plaintiff members of the Court (those remaining, anyway) could not stomach the travesty that Azzarello had become.  End of self-congratulatory gloat.

We learned of this development late yesterday afternoon and published a very brief “breaking news” post alerting our readership.  At that point we had not yet read the Court’s entire 137-page opinion, Tincher v. Omega Flex, Inc., No. 17 MAP, slip op. (Pa. Nov. 19, 2014).  Now we have.  While it’s clear that the most obnoxious aspects of the Azzarello regime − the bizarre pre-trial procedure for determining “unreasonably dangerous” as a matter of law, the absolutist negligence/strict liability dichotomy, and the “plaintiff wins” guarantor/any element jury instruction (for those of you not familiar with Pennsylvania law, this is what jurors are instructed: “The supplier of a product is the guarantor of its safety.  The product must, therefore, be provided with every element necessary to make it safe for its intended use, and without any condition that makes it unsafe for its intended use,” Azzarello, 391 A.2d at 559 n.12) – have been disapproved, what’s taken their place is less clear.

On the theory that you can’t beat something with nothing, ever since Phillips Bexis had been advocating the Third Restatement of Torts as an alternative, even though there were significant aspects of the Third Restatement that could hardly be called defense friendly.  Yes, Azzarello was that bad.  The Court, however, did not adopt the Third Restatement in Tincher.  Instead, it has adopted a more mainstream (compared to Azzarello) approach to Restatement Second §402A, that in places is also informed by Third Restatement principles.  We’ll be discussing that in more detail.Continue Reading Pennsylvania Product Liability – Azzarello Is Dead, Long Live…?

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Today’s post is really three different posts on three unrelated subjects.  None of them very long (at least by DDLaw Blog standards), but we think that each will be of interest to at least some our readers.

On Generic Plaintiffs’ Preemption “Win” in New Jersey

This piece is from the non-Dechert side of the blog.

Plaintiffs alleging failure to warn of the risks of a generic drug scored a “win” of sorts in In re Reglan Litigation, 2014 WL 5840281 (N.J. Super. App. Div. Nov. 12, 2014).  The court held, in an unpublished decision, that “failure-to-update” claims survived the otherwise comprehensive impossibility preemption that applies to generic drugs:

[T]he trial court correctly determined that plaintiffs’ claims based on the Generic Defendants’ failure to update their warnings to conform to changes made to the brand-name warnings are not preempted by federal law.  The court correctly found that allowing plaintiffs to assert these claims would not frustrate any of the purposes or objectives that Congress sought to achieve . . . .  Moreover, plaintiffs are not pursuing state-law claims based on an alleged violation of federal law.

Id. at *4. As the Appellate Division points out, non-preemption of “duty to update” is the majority view.

We may not like it, but we’re not losing much sleep about it.

Why?Continue Reading Short Subjects

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What follows is another of our occasional guest posts, this time by fellow Reed Smith attorney Danielle Devens.  As always with our guest posts, the author gets all the credit, and any blame, for the contents of his/her work.

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This week, a panel of the Missouri Court of Appeals issued an opinion allowing a plaintiff to maintain a small subset of warning-related claims against a generic drug manufacturer.  It also dismissed the claims against the brand name manufacturers, albeit reluctantly, pointing out the “inherent unfairness” of the supposedly “unjust result.” Finally, same opinion reversed the trial court decision dismissing plaintiff’s claims against a publisher of information disseminated by pharmacies, but only on statute of limitations grounds.  The case is Franzman v. Wyeth Inc., No. ED100312, slip op. (Mo. App. Aug. 26, 2014) [ed note: Now at 2014 WL 4210207, as of this morning].

The plaintiff allegedly took generic version of the drug Reglan from March 2002 through October 2005, at which point she allegedly developed tardive dyskinesia, a known risk of this drug.  She brought claims against the brand-name manufacturers, generic manufacturers, and a publisher.  In a prime example of litigation tourism, plaintiff is a Kentucky resident pursuing claims under Kentucky law who filed her suit in the notoriously plaintiff-friendly St. Louis, Missouri.  [Slip Op. at 2]

But even St. Louis was not that friendly to this plaintiff.  The trial court knocked out plaintiff with a one-two-three combination, dismissing all claims against:  (1) the generic manufacturers based on Mensing preemption; (2) the brand name defendants based on lack of legal causation because they did not make the product the plaintiff took; and (3) the publisher based on the Kentucky one-year statute of limitations.  Plaintiff appealed each ruling.Continue Reading Guest Post – Not Quite a One-Two-Three Punch

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The Sixth Circuit has just affirmed 99.9% of the defendants’ wins in the Darvocet litigation.  The result is the biggest one-two punch (generic preemption/no non-manufacturer liability for the innovator drug) decision to date.  The opinion involves 68 plaintiffs and the law in 22 states.

Here’s a link to the opinion, which is encaptioned In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, Nos. 12-5368, et al. (6th Cir. June 27, 2014).

Here’s a quick summary:Continue Reading Breaking News: Big Darvocet Appellate Win – Multistate One-Two Punch

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Happy birthday, Justice Sotamayor.  Her autobiography, My Beloved World, is now in paperback and the Justice has been all over the airwaves for the inevitable promotional push.  Every time we see Justice Sotamayor interviewed, we like her more.  We learned that she shops at Costco, where she recently ran into Secretary Clinton, who was signing copies of her own book.  That makes us think that Justice Sotomayor is a real, down-to-earth person.  She is also smart and direct.  She reminds us of the old adage that the most effective politicians are tough liberals and cuddly conservatives.  Sotamayor was a prosecutor for a while, so we confess to harboring an undeniable bias in her favor.  She also makes a point of admitting her fallibility up front.  She points to retired Justice Stevens and his acknowledgment that he regrets some of his opinions and would now write them differently.  She says she fully expects to feel the same way about her judicial oeuvre in 20 years.

We do not have to wait so long to regret Justice Sotamayor’s opinions in an area close to our heart, FDA preemption.  Those opinions make for unpleasant reading. Luckily, they are dissents.  Justice Sotamayor wrote lengthy dissents in the Mensing and Bartlett cases.  Those dissents seem to turn on two fundamental notions: (1) hostility to conflict preemption, with a conviction that there is a conflict only when compliance with both federal and state law is impossible not only in a practical sense, but in a complete, almost metaphysical sense.  One gets the distinct impression that in Justice Sotamayor’s world view, it would be pretty much impossible for a manufacturer to show impossibility preemption. (2) Justice Sotamayor is irked that purchasers of generic products might be ousted from court while purchasers of branded products could still buy a ticket to the litigation lottery.  Big surprise: we think she is wrong about that, too.  Such distinct treatment of consumers of distinct products is not inherently unfair or illogical.  One could come up with a rational system where consumers could trade lower prices for reduced litigation options. Maybe that is what we have.  We certainly have it with respect to limited tort auto insurance policies.Continue Reading Ninth Circuit Applies One-Two Punch to Prevent Claims against Brandeds, and Preempt Claims against Generics

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We were surprised by the article in the New York Times this weekend about how the Supreme Court revises some of its opinions years later.  Those changes are picked up in some reporters, but not others.  Some of those changes are relatively minor (e.g., Justice Scalia correcting his statement of what the EPA’s position was on a particular issue) but others are not. The article sent us into a reverie of wishful thinking about ‘correcting’ the Wyeth v. Levine opinion to take into account the non-automatic nature of Changes Being Effected, or to excise Riegel’s frolic and detour on parallel claim exceptions, or to foreclose the Solicitor General’s new, crabbed interpretation of FDA preemption applying only to device-specific actions.  But why stop at Supreme Court opinions?  Looking back over the years, we can think of many things we said and wrote that we’d now like to edit.  That wedding toast where the ex-girlfriend, rather than the bride, was saluted would be fixed.  And now in our dotage we finally realized the correct answer to the question of whether “this makes me look fat.”  It reminds us of the classic definition of a gaffe: telling the truth at the wrong place and time.

Many of the cases we post about here could use a bit of editing.  When the blogging team goes over the cases on offer for any given week, the phrase “mixed bag” comes up more often than any other.  That shouldn’t be surprising.  For every wonderful one-two punch Mensing/anti-Conte case, or every Bausch/Perez train wreck, we get ten cases that are more like what we see regularly in real-life – cases that have a little good and a little bad.  We cannot exactly edit those cases, but we can accentuate the positive in our humble reviews.  That’s what we will do with Kruszka v. Novartis Pharms. Corp., 2014 U.S. Dist. LEXIS 68439 (D. Minn. May 19, 2014).  Kruszka is yet another Aredia-Zometa case where a cancer survivor alleges that the drugs that helped her survive cancer caused osteonecrosis of the jaw (ONJ).  Some of the rulings we like better than others.  While we cannot edit the opinion, we can certainly highlight the good stuff while mumbling sotto voce about the bad. With the glow of the long holiday weekend not yet worn off, we are reluctant to be the deliverer of evil.

The plaintiff in Kruszka was diagnosed with blood cancer in the form of multiple myeloma in 2000.  That cancer resulted in hypercalcemia, a compression fracture in her spine, and lytic lesions in her skull, spine, and bones.  Multiple myeloma patients’ survival rate is approximately six months where no treatment is received.  Doctors told the plaintiff she could expect to live six weeks without treatment.  But she did receive treatment.  Her doctor prescribed Aredia to protect against bone damage and treated the plaintiff with chemotherapy.  She received both branded and generic bisphosphonates.  The good news is that she lived.  The bad news is that a couple of years later she was diagnosed with chronic osteomyelitis (infection in the bone).  The plaintiff was prescribed a prolonged course of four different antibiotics after her prior treatments were determined to be ”suboptimal.”  Dead bone was removed from the jaw area in 2003.  A year later, the plaintiff complained of numbness in her jaw, chin, and lip resulting in difficulty swallowing and chewing, a “deformed face” and other issues.  The plaintiff alleged that the damage to her face and jaw changed her life dramatically, including her speech, eating, social interactions.  She had to give up her church choir.  There is no doubt that the plaintiff earned sympathy.  She was also, as of November 2013, still alive.Continue Reading Rule 702 and Summary Judgment Rulings in Minnesota Aredia-Zometa Case

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(This post comes from the non-Dechert side of the blog.)

Like the court, we start at the end, with the knockout blow.  Here’s how the court set it up:

It is not mind-taxing to discern why Eckhardt [the plaintiff] shies from labeling his claims as products liability claims: A products liability claim against the Generic…

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We talk about preemption so often that we can be hesitant to post on preemption cases unless we can see that they offer something new or different.  (Except for Bexis.  Preemption is like his morning, afternoon, and evening coffee.)  When we saw that there was a generic preemption decision in the Yaz litigation, we were…

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