October 2013

Photo of Steven Boranian

Data privacy is a hot topic. We regularly speak on data privacy at Reed Smith’s annual California continuing legal education day, and it takes hours to prepare because the landscape changes so rapidly. The law changes day-by-day, both legislatively and in our courts, and entire emerging industries (e.g., the “apps” industry) are organized around the collection and monetization of personal information disclosing what we do, when we do it, for how long, and where we are located. The very definition of “privacy” is now robustly debated, which is a significant change from the days when everyone knew that “private” information meant name, date of birth, social security number, account numbers, or some combination thereof. Today if you asked 25 privacy professionals to define “private” information, you might get 25 answers, and some would say “everything.”

When we expanded our drug and medical device practice into the data privacy realm a few years ago (along with the co-author of this post, Reed Smith’s Joshua Marker, an outstanding privacy lawyer and active blogger in his own right), we found that the healthcare industry was, for the most part, ahead of the game because the rules were relatively clear. Everyone agreed that personal health information was private, and there was HIPAA, the ubiquitous federal law that has regulated the security and privacy of personal health information since enacted in 1996. Drug and medical device companies typically are not HIPAA-covered entities, but they often have possession of personal health information in connection with patients who use their products, and our experience is that our clients and the lawyers who represent them take patient privacy very seriously.

One thing that has not changed is that there is no private right of action under HIPAA. That does not mean, of course, that plaintiffs have not tried to sue over breaches of security involving their private information. A handful of cases have permitted state law claims supported in part by alleged HIPAA violations, pleaded as claims like “negligence per se.” And there are numerous state laws regulating medical information that have garnered more attention as data privacy has become front-page news.Continue Reading Privacy of Medical Information: No Harm, No Foul, No Private Right of Action

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For some reason, we recently found ourselves comparing our favorite defenses to our favorite rock bands.  Preemption, of course, would be The Beatles, and Daubert/Frye the Rolling Stones.  The learned intermediary rule could be Bob Dylan (I know, we’re showing our age, here).  Comment k could correspond to Led Zeppelin, and state of the art might be The Who.

And it seems that, for each of these bands, there’s a song we really like that gets slighted (in our opinion) when it comes to air time on classic rock stations.  For The Beatles that would be It’s All Too Much.  For the Rolling Stones, when you discount those songs generally considered too raunchy for mainstream radio (one from Beggars Banquet, one from Let It Bleed and one from Goats Head Soup, you can guess which ones), we’d say the disrespected Stones song we like most is Child of the Moon.  For Bob Dylan, we almost never hear Desolation Row on the radio (and thanks to Zimmerman’s late-in-life conversion to copyright trolldom, you won’t find a decent studio version on YouTube, either).  For Zep, we’d award the buried treasure award to Immigrant Song.  And finally, for The Who, we’ve always been peculiarly partial to the Punk and the Godfather.

Somewhat similarly disrespected as a defense to warning causation has been the prescriber’s failure to read the relevant warnings.  One of the benefits of the learned intermediary rule is that it replaces self-interested plaintiffs with highly trained medical professionals when it comes to warnings, and in particular with respect to warning causation.  While a plaintiff with dollar signs in his/her eyes will typically testify to whatever is necessary to establish warning causation (“Oh, yes, if I had only known about that risk, I would have rejected my oncologist’s recommendation and never taken the drug.”), medical doctors are most interested in the effective treatment of their patients, and thus typically tell it like it is.  The truth often is that, for one reason or another, the prescribing physician did not rely on the particular warning in question, and thus a different one wouldn’t have made any difference.

There are a number of fact patterns that lead to physician non-reliance, the golden boy of the bunch being when a doctor (a trained professional, after all) already knew about the risk in question and thus did not need to be warned about it.  Another commonly seen warning causation defense is when the doctor testifies that none of the plaintiff’s warning sophistry matters, s/he would still treat the plaintiff the same way today.Continue Reading Don’t Forget About A Prescribing Physician’s Failure To Read Warnings

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Most of the time we do not linger on cases that turn on the statute of limitations.  They are often fact-specific to the point of dreariness.  In addition, from a doctrinal perspective, there isn’t much new under the Sun when it comes to a SOL analysis.  But the SOL discussion in Hendrix v. Novartis Pharmaceutical Corp., 2013 U.S. Dist. LEXIS 14936 (C.D. Cal. Oct. 2, 2013), is so comprehensive and cogent that it merits a look, a post, and a new entry on our cross-jurisdictional tolling scorecard.

Hendrix is yet another Aredia-Zometa case.  As we said last week, we are becoming a scrivener for the ongoing A-Z saga.  As with all A-Z cases, the plaintiff ingested Aredia or Zometa as part of cancer treatment and claimed to have suffered osteonecrosis of the jaw (ONJ) as a result.  Also, because there is an A-Z MDL, the filing/forum  history of the case is something of an adventure.  The plaintiff filed his Complaint in the Eastern District of New York on January 17, 2006.  The case was consolidated in 2007 into the MDL in the Middle District of Tennessee.  The defendant filed its SOL motion, but before it could be heard by the MDL court, the case was remanded back to EDNY.  Then the parties moved to transfer the case to C.D. Cal.  If the case could acquire frequent flyer miles, it would have earned enough to … ah, who are we kidding?  With all the restrictions on frequent flyer awards, the case wouldn’t be able to get a free flight anywhere.  It wouldn’t even get free WiFi or a do-it-yourself Bloody Mary.

It makes sense for Hendrix to end up in C.D. Cal., because the treatment and alleged injury took place in California and California law applies.  Under California law, personal injury actions are subject to a two year limitation.  Thus, the issue is whether the cause of action accrued before January 17, 2004.  If it did, the SOL means that the plaintiff is SOL.  To avoid that result, the plaintiff assembled the usual suspects when it comes to SOL:  (1) the defendant waited too long to raise the issue (almost as if there is an SOL to SOL defenses); (2) the “discovery” rules saves the day for the plaintiff; (3) cross-jurisdictional tolling saves the day, because somebody somewhere filed a baseless class action that somehow made everybody else freeze up; and (4) equitable tolling is necessary, because … because it would be “equitable.” Let’s face it, the word “equitable” too often is the last refuge for litigants with shoddy arguments.  We are happy to report that none of those arguments worked.
Continue Reading Discovery Rule, Cross-Jurisdictional Tolling, and “Equitable” Tolling Cannot Save Aredia-Zometa Case

Photo of Michelle Yeary

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

A few weeks ago we brought you up to speed on the goings on around the country in the Infuse litigation.    We’ve decided not to let the cases pile up again and so, today’s post is on the latest Infuse decision – Eidson v. Medtronic, Inc., 2013 U.S. Dist. LEXIS 144179 (N.D. Cal. Oct. 3, 2013).  Like most of the decisions this summer, this one is strong on preemption and ultimately, it dismisses most of plaintiffs’ claims.

Eidson actually involves two related cases – claims by Mr. Eidson and claims by Mr. and Mrs. Bell.  The allegations are more or less the same.  The Infuse bone graft system is a Class III medical device approved by the FDA through the Premarket Approval (“PMA”) process.  The system was approved as a medical device consisting of three parts (a spinal fusion cage, a bone graft substitute, and a spongy carrier) for use in anterior (through the abdomen) lumbar surgery.  Both plaintiffs allege that the device was used off-label in their surgeries because it was implanted posteriorly (through the back) and without the spinal fusion cage.  Eidson, 2013 U.S. Dist. LEXIS 144179, at *6-7.  At the outset, both plaintiffs also abandoned their strict liability design defect claims as barred by California law.  Id. at *57-58.

Continue Reading An Infuse Update

Photo of John Sullivan

There’s been a lot of movement amongst the bloggers on this site over the last two years.  And now there’s more.  Sullivan – that’s me – has moved to Cozen O’Connor.  I’ll miss my old firm, Dechert.  But I’m excited about my move to Cozen, and I look forward to continuing to give you my thoughts on drug and device law, and sometimes pop culture, from within Cozen’s walls.  And, for me, those walls will be in two Cozen offices, one in downtown Manhattan  (where I practiced for years when I started my career) and the other in Cherry Hill, New Jersey.  Now, Cherry Hill is a great town.  I was in that office Friday when I began drafting this post.  But today I’m in Manhattan. That’s different.  If for no other reason than the views.  It’s hard to beat the Freedom Tower as it’s being completed or ships sailing their way down the Hudson River into New York Harbor.

Frankly, if you’re in an office in just about any town other than New York City, “you lose that battle, you lose that battle nine times out of ten.”  But that’s not the real advantage of spending much of my time in Cozen’s New York office.  The most important benefit is that I now have the ultimate “bona fides” to counter what has been a distinctly Philadelphia voice on this blog.  The New York-Philadelphia rivalry has now hit the legal blogosphere.  If all else fails, I can just say, “fuhgeddaboudit.”Anyway, here’s my first Cozen post.

So where were we?  Oh yes, the learned intermediary doctrine.  On Friday, we reported on Calisi v. Abbott Labs., 2013 U.S. Dis. LEXIS 139257 (D. Mass. Sept. 27, 2013), a decision in which the court excluded plaintiff’s warnings expert thereby ending plaintiff’s failure to warn claim.  Underlying that decision was the court’s refusal to adopt plaintiff’s argument that Abbott had “assumed a duty” to warn the plaintiff directly rather than warn her doctor because Abbott had earlier communicated directly with plaintiff via a patient video and direct-to-consumer (DTC) advertising.Continue Reading Moving on to a New Law Firm; Still Discussing the Learned Intermediary Doctrine

Photo of Eric Alexander

We sometimes take an impish delight in the comments we get from readers who are surprised that we tout defense wins, question the logic of decisions that allow plaintiffs to get past summary judgment with questionable evidence, or—gasp—use sarcasm in how we discuss cases.  The approach of this blog is not a mystery—the contributors spend most of their working days defending drug and device manufacturers from lawsuits that we often think are bogus, over reaching, and/or an affront to the regulatory scheme that governs the products at issue.  We describe cases or discuss recurring issues with the hopes that lawyers who do what we do or those in-house who hire them will be able to repeat successful strategies and avoid pitfalls in their own cases.  We also get the opportunity to blather on about things we think are important, legal or otherwise.

Sometimes, we run across a case that does not require much of our renowned wit.  We can just set out what happened and crow.

In Calisi v. Abbott Labs., No. 11-10671-DJC, 2013 U.S. Dist. LEXIS 139257 (D. Mass. Sept. 27, 2013), the court struck questionable expert testimony on the adequacy of a prescription rheumatoid arthritis drug’s warnings for lymphoma.  Without admissible expert testimony—and, as a Calisi instead of Khaleesi, she was unable to rely on bloodriders, dragons, or Unsullied for her cause—plaintiff had no way to carry her burden and lost.  Along the way, the court made a number of sensible decisions on issues that recur in prescription drug cases.
Continue Reading Getting 702ed on The Impact of Warnings to Prescribing Physicians

Photo of Stephen McConnell

Over the years, more than a few colleagues have told us that the Godfather movies contain every bit of wisdom needed to conduct business or practice law.  Whenever we are involved in tough negotiations (with our clients, with our adversaries, with our teen-aged children), we cannot help but think of that moment in Godfather 2 when a U.S. Senator is trying to shake down Michael Corleone.  The Senator agrees to pull a few strings to get a Nevada casino gaming license for the Family, but his price is way, way above the standard $20,000 license fee. Why is the Senator asking for so much more?  Because he can.  And because he makes no bones about how much he despises Corleone for his criminality and, perhaps even more, for his ethnicity.  The Senator wants a response to his extortionate offer by noon the next day.  Before the Senator can walk out the door, Michael Corleone (Pacino at his most chilling – so much better than the hoo-haa-ing bellower he later became),  calmly tells the Senator that he can have the answer right now:  “My offer is this: nothing.  Not even the fee for the gaming license, which I would appreciate if you would put up personally.”  The Senator ends up complying. But only after Corleone sets him up in a scenario reminiscent of that boast by Edwin Edwards that the only way he wouldn’t be re-elected as Governor of Louisiana was if he was found in bed with a “dead girl or a live boy.”

We do not usually have that sort of leverage available in our negotiations.  But when we prosecuted cases we often had decent ammo.  Fingerprints, recordings, and FBI agents knocking on doors at 6 am can all be very persuasive.  Sometimes our hand was strengthened in more unusual ways.  Once we secured a guilty plea by threatening to dismiss the case.  The defense lawyer knew that if we dismissed the case, the matter would go stateside, where California’s three-strikes rule would likely produce a much longer sentence.  Plus, state prisons are nastier than the federal ones.

We wonder how much fun the feds had in their negotiations with the whistleblowers in the qui tam case of U.S. ex. rel. Piacentile v. Amgen Inc., et al., 2013 U.S. Dist. LEXIS  141073 (E.D.N.Y. Sept. 30, 2013).  That case involved ten qui tam actions alleging claims under the False Claims Act against a pharmaceutical company.  Two of the relators were Piacentile and Kilcoyne.  They claimed to be whistleblowers and they wanted a big part of the settlement of the matter.  What’s that phrase about pigs getting fat and hogs getting slaughtered?  Piacentile and Kilcoyne wanted to get very, very fat off the qui tam settlement, but they ended up getting … er, disappointed.  The Piacentile case offers a little window into the ugly side of the qui tam business.
Continue Reading Strictly Business: The Ugly Side of Qui Tam Actions

Photo of Michelle Yeary

We think most litigators would agree that doing legal research is sometimes like following Hansel and Gretel’s trail of bread crumbs.  You sort of wander around in the darkness for a little while reading cases that Westlaw or Lexis thought you might be looking for – but they turn out to be dead ends.  Then you pick up a faint scent of warm bread and you start to follow it.  And in that first crumb of a case you find a cite to another case that sounds even more like what you were looking for.  Then from there you pick up a headnote that looks promising.  And so on, and so on.  If you aren’t keen on the fairy tale analogy, there’s always that 1980s hit by the The Fixx – “One Thing Leads to Another.”  Not sure they were talking about the same thing, but the title sums up the concept nicely.

And that’s just what happened when we picked up today’s case of McPhee v. DePuy Orthopedics, Inc., 2013 U.S. Dist. LEXIS 140276 (W.D. Pa. Sep. 30, 2013) (McPhee II) and it led us to an early decision in the same case – McPhee I, No. 3:11-cv-287, slip op. (W.D. Pa. Sep. 28, 2012).  The two decisions, rendered almost exactly one year apart, dismiss plaintiff’s original and amended complaints.  More often than not when we are reporting on a motion to dismiss where leave is granted to amend the complaint – we never hear about the case again.  So, we found it interesting to look at these two rulings together to see what plaintiff was told to fix and how she apparently didn’t do so.

The case involves a Pre-Market Approved (PMA) hip implant that was implanted in plaintiff in 1999 and broke in 2008.  McPhee II at *2-3.  In her original
complaint, plaintiff alleged causes of action for strict liability, negligence, and breach of express and implied warranties. McPhee I, slip op. at 3.  Let’s get rid of the strict liability claim right from the beginning.  This is Pennsylvania law.  No strict liability for prescription medical devices.  Id. at 11-13.  Plaintiff’s breach of implied warranty claims suffered the same fate – not viable under Pennsylvania law.  Id. at 18-19.  (The court also agreed with defendant that the implied warranty claims were time-barred.  Id.  at 15-17).Continue Reading Pleasing Pennsylvania PMA Preemption Pronouncement

Photo of Bexis

A couple of quick hits today, on once “novel” causes of action whose time – at least in the novel legal spaces to which plaintiffs attempted to export them – appears to have passed.

The first of these is the shopworn effort, popular back in the late 1990s but more or less petered out by now, to use the ill-defined concept of public nuisance as a club to attack the products of an entire industry, and not incidentally, to try an end run around product specific causation.  We’ve blogged on it before, criticizing public nuisance claims against products on various grounds.

Us?  The Drug And Device Law Blog?  Who listens to us?

Not too many people, unfortunately.

But a lot of people – most importantly, judges – listen to the American Law Institute.  Bexis has joined the Members’ Consultative Group for the ALI’s Third Restatement of Torts: Liability for Economic Harm, and that group met recently.  Preliminary Draft #2, circulated last month, has this to say about attempts to use “public nuisance” to encroach upon the law of product liability:

g.         Products.

Tort suits seeking to recover for public nuisance have occasionally been brought against the makers of products that have caused harm, such as tobacco, firearms, and lead paint.  These cases vary in the theory of damages on which they seek recovery, but often involve claims for economic losses the plaintiffs have suffered on account of the defendant’s activities: the costs of removing lead paint, for example, or of providing health care to those injured by smoking cigarettes.  Liability on such theories has been rejected by most courts, and is excluded by this Section, because the common law of public nuisance is an inapt vehicle for addressing the conduct at issue. . . . If those [existing] bodies of law provide do not supply adequate remedies or deterrence, the best response is to address the problems at issue through legislation that can account for all the affected interests.

As noted in Comment g [sic, we think this should be “b”], problems caused by dangerous products might have seemed to be matters for the law of public nuisance only because the term “public nuisance” has sometimes been defined in broad language that appears to encompass anything injurious to public health.  The traditional office of the tort, however, has been narrower than those formulations suggest, and contemporary case law has made clear that its reach remains more modest.  The rules of this Section reflect that modesty.Continue Reading Bad Ideas Whose Time Has Passed

Photo of Steven Boranian

Reading the recent order in Morritt v. Stryker Corp., 1:07-cv-02319, 2013 U.S. Dist. LEXIS 136843 (E.D.N.Y. Aug 12, 2013) (Report and Recommendation adopted Sept. 23, 2013), reminds us of walking down a long corridor with numerous open doors, each leading to a jury trial on the merits of the plaintiffs’ medical device product liability

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Drug & Device Resources

Bexis’ Book

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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