A key to many drug or device law cases is the learned intermediary doctrine. It can powerful, and so we generally approach it with great care and from multiple angles.  We meticulously develop labeling histories to establish when the label first mentioned the alleged side effect and how and where it was discussed over time.  We do scientific research so that we can show the contemporaneous state of the science, when there was a signal to warn and, just as important, when there wasn’t, and we then match that to the contents of the label.  We lay out the company’s internal and regulatory history to show that it understood and advanced the science and included it, when appropriate, in the label.  And we take testimony of prescribers and treaters to show that they knew the potential side effects, were warned, and/or would’ve made the same decision even today.  When we do this well in discovery, we often feel that we should win summary judgment.

But despite a good discovery record on the learned intermediary doctrine courts sometimes seem unwilling to end a case before trial.  They gloss over which party has the burden of proof.  They can misconstrue the doctrine as an affirmative defense.  They can punt the decision on a seemingly adequate warning to the jury, or ask the jury to consider whether it should have been disseminated differently or better.  We’re sure that many of you have had similar experiences on summary judgment.

With that background, we want to discuss D’Agnese v. Novartis Pharmaceuticals Corp., 2013 U.S. Dist. LEXIS 92757 (D. Az. July 2,
2013).  It involves a plaintiff (and his wife suing for loss of consortium) who claimed to have suffered bisphosphonate-related osteonecrosis of the jaw as a result of using Aredia/Zometa.  While he brought a number of claims, they were all, at bottom, based on failure to warn. And the learned intermediary doctrine played a vital role. The defendant, Novartis, established its labeling history during discovery.  It had placed osteonecrosis in the Adverse Reactions section in September 2003 and revised the language in February 2004 to say that causality could not be determined but it was prudent to avoid dental surgery while on the drug.  In September 2004, Novartis added a three-paragraph discussion of osteonecrosis to the Precautions section.  It sent a Dear Doctor Letter to doctors attaching the revised label.  Id. at *15-18.As for plaintiff, his original prescriber prescribed him Aredia in 1996.  In March 2005 – after all these label changes were put into effect – a second prescriber informed plaintiff of the risk of osteonecrosis, plaintiff signed an informed consent form and, later that year, plaintiff made it clear that he wanted to continue on the drug. Plaintiff’s story was different in litigation.  He claimed no memory of the risk discussion or of signing the informed consent.  In 2005, Plaintiff was tentatively diagnosed with osteonecrosis of the jaw.  Finally, plaintiff’s second prescriber testified that he still prescribes Zometa today and even suggested that plaintiff restart it in 2010.  Id. at *18-19.These facts make this is one of those cases that we feel should be a defense win on summary judgment. But, as we mentioned, we’ve seen courts find the smallest of holes through which to push a trial.  Maybe the plaintiff’s different recollection about being told of the risk is enough for a jury to consider. . . . Or maybe a court could send it to a jury because there was no testimony from the original prescriber, like there was from the second prescriber, that he still prescribes Zometa and suggested that plaintiff restart it . . . . Or maybe there were some adverse events or animal studies that the doctor didn’t know about … Let a jury decide.
Continue Reading An Aredia/Zometa Win Thanks to the Learned Intermediary Doctrine

We stand at the midpoint of our journey around the Sun.  182 days precede us this year, and 182 remain before 2013 concludes.  July 2 is a big day historically, and not just because it is the day when Larry David and Lindsay Lohan entered this world and Vladimir Nabokov left it.  Exactly 237 years ago in Philly our Founders approved the Declaration of Independence. There is a good argument that we should celebrate the Second of July rather than the Fourth, when the Declaration was publicized. Zounds, why not celebrate both? Who can get enough barbecues and fireworks?

150 years ago on this date Joshua Chamberlain and his Maine boys held Little Roundtop and prevented day 2 of the Battle of Gettysburg from turning into a very bad day for the Union.  (Bexis is vacationing Down East and reports that the weather is miserable there and that it is no wonder the Maine contingent took their chances at Gettysburg.)  As we sweat in this soupy weather, barely able to rouse ourselves from terminal torpor, it seems a good time to reassess where we are, to count our blessings, to acknowledge the bravery and sacrifice of our predecessors, to laugh at the faults of others and grieve at our own … and to talk once again about the Aredia-Zometa litigation.

Last week was eventful in the Aredia-Zometa litigation.  After a two-week trial, a jury in the Eastern District of California returned a defense verdict in Hill v. Novartis Pharmaceuticals Corp., No. 1:06-cv-00939-JSR-SAB (E.D. Cal. June 26, 2013). Any drug and device trial is likely to catch our attention, but this one was especially interesting because it was presided over by Judge Rakoff, who hails from the Southern District of New York and was sitting by special designation.  For those of you who follow securities and other financial litigation, you know that Judge Rakoff is brilliant, opinionated, and strong-willed.  If he does not like a proposed settlement, he will not approve it.   We remember going to a RICO conference over 20 years ago where Rakoff was one of the two MCs. He was then at the Mudge Rose firm, where Richard Nixon practiced law once upon a time.  It was clear that Rakoff was lightning smart.  After one session, we went up and chatted with him about some of the intricacies of the much-overused RICO statute.  Rakoff was helpful.  He was nice.


Continue Reading Mid-Summer Aredia-Zometa Doings

You have almost certainly heard the phrase, “Waiting with bated breath.”  As in: we awaited the Red Wedding scene in Game of Thrones with bated breath.  Or:  we greeted the Drug and Device Law Son’s diploma  ceremony with bated breath.  (The former was impressive and awful. As one friend wrote on his Facebook wall, if you had a favorite character in GoT, maybe now you don’t. The latter was the occasion for unalloyed joy, and we expect to be levitating for a while – at least until the first college tuition payment comes due.)   Maybe you thought it was “baited breath,” as if referring to some sort of seafood-borne halitosis.  But, no, it’s “bated,” meaning restrained, lessened, diminished, or stopped.  The word and the phrase in which it typically resides have been around since at least Shakespeare.  This is from The Merchant of Venice, Act I, scene iii:  “With bated breath, and whispering humbleness.”

“Bated” is a variant of “abate,” a word that almost any lawyer has bumped up against more than a few times.  Different jurisdictions can have slightly different meanings for the concept of abatement, but it usually refers to some external reason for putting off or dismissing a case.  Like jurisdiction or, say, preemption, it offers a way of kicking a case on grounds pretty well divorced from the underlying merits.  For that reason lawyers find it enthralling and non-lawyers find it maddening.  In our days working on diet drug cases, it was amazing how many of the plaintiffs had filed for bankruptcy yet had not listed their tort claims as an asset of the estate. That omission, whether intentional or not, could lead to abatement of the tort action until things were set right in bankruptcy court, perhaps even reopening the bankruptcy proceedings.  Or maybe the failure to list the claim could form the basis of an estoppel with respect to the tort claim.  You denied having any such claim, so now you cannot pursue it.  We have posted before on bankrupt plaintiffs.

Here in our charming little commonwealth of Pennsylvania, one common species of abatement arises when the plaintiff dies and the substitution of the estate is not accomplished properly.  That abatement recently resulted in out-and-out dismissal of one of the cases in the Aredia-Zometa MDL —  In re Aredia and Zometa Products Liability Litigation,  2013 WL 2317743 (M.D. Tenn. May 28, 2013).  The Aredia-Zometa MDL is based in M.D. Tenn., but the particular case at issue was governed by Pennsylvania law.  The facts are as convoluted as these things usually are, and the court seems to have been displeased with the way things were handled by the plaintiff’s side.  It was actually the Magistrate Judge who seemed especially displeased and who initially recommended dismissal of the case.  The plaintiff did not file timely objections, and the district court did not appear to wait with bated breath in adopting the recommendations.


Continue Reading We Greet a New Aredia-Zometa Dismissal with Abated Breath

The Aredia/Zometa case of Guenther v. Novartis Pharmaceuticals Inc., 2013 U.S. Dist. LEXIS 50945 (M.D. Fl. Apr. 9, 2013), produced another interesting decision last week.  Not necessarily good, but interesting.  The defense moved for summary judgment on plaintiffs’ failure-to-warn-based claims for failure to satisfy the proximate causation element of the learned intermediary doctrine.  Id

The geezers in our family have been busy recently ululating over the rule of three celebrity deaths. We are not sure we have ever before witnessed a trilogy quite like Roger Ebert, Margaret Thatcher, and Annette Funicello.  An aunt insists that it is actually a trilogy of three celebrity women, with fashion designer Lily Pulitzer

We’ve blogged several times in opposition to consolidation of individual plaintiffs’ lawsuits in product liability actions.  The only thing that plaintiffs seeking consolidation for trial have in common is that:  (1) they were allegedly injured by the same product, and (2) they are trying to salvage weak cases by attempting to prejudice the defendants’ defense.  Strong plaintiffs’ cases stand on their own, so why bother with consolidation?

One thing we know about mass torts, through years of experience, is that for lots of reasons most individual cases in any given mass tort are poor, as in weak.  So consolidation requests show up frequently in mass torts.  One of the busiest mass torts currently is Aredia/Zometa, so it’s no surprise to find consolidation attempts there.  The only question is whether the courts will throw these plaintiffs the lifeline they’re seeking.  Happily, that doesn’t seem to be happening.

The first consolidation attempt, in Guenther v. Novartis Pharmaceutical Corp., 2012 WL 5398219 (Mag. M.D. Fla. Oct. 12, 2012), adopted 2012 WL 5305995 (M.D. Fla. Oct. 29, 2012), failed because the two plaintiffs involved “filed their claims separately years apart, did not use the same [defendant’s] products, allegedly used [those] products at different times, have different medical and dental histories, were treated by different physicians, have identified different expert witnesses . . ., are pursuing different legal theories under different laws, and seek different damages.”  Id. at *1.  That’s pretty typical of attempted consolidations.


Continue Reading Consolidation Fails In Aredia/Zometa

…You know somebody’s getting hammered. You just hope it’s the other side.

In Wilson v. Novartis Pharmaceuticals Corp., 2013 WL 593895 (N.D. Tex. Feb. 15, 2013), thankfully it was. The first line was a quote from Marmion: “Oh, what a tangled web we weave when first we practice to deceive!” We first heard that line in middle school, from a teacher who caught a miscreant classmate lying about failure to turn in a homework assignment.

It’s much worse when uttered by a federal judge.

Wilson was an Aredia/Zometa case – and, yes, it was pitched to us by defense counsel (Hollingsworth).   But the opinion is such a stark cautionary tale that we would have blogged about it anyway (assuming we otherwise found out).

Here’s what happened.

The plaintiff died.

That’s of course tragic for all immediately concerned, but it is hardly something to dismiss a case over.   Death is a fact of life, and the court system has evolved standard procedures for dealing with the mid-stream death of a party to litigation.


Continue Reading When An Opinion Starts Out This Way….

Here’s another quasi-guest post from our quasi-regular blogger – Reed Smith’s Melissa Wojtylak.  It’s her post, I’m just the piano player.

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Novartis scored a double victory in the Northern District of California last week, when the court granted a Daubert motion to preclude Plaintiff’s experts’ specific causation testimony, then granted summary judgment on the