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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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We read with great interest the Ninth Circuit’s recent opinion on CAFA “mass action” jurisdiction, Corber v. Xanodyne Pharmaceuticals, Inc., No. 13-56306, 2014 WL 6436154 (9th Cir. Nov. 18, 2014).  If you have not read it yet, you should.  We hesitate to call it a blockbuster, since we think the opinion’s reasoning is more narrow that it needed to be (more on that later).  But the result (holding that CAFA removal was proper) is clearly correct, and the opinion hopefully will become a stalwart against one of the more brazen abuses that we see in pharmaceutical litigation – the disingenuous joining of hundreds of unrelated plaintiffs in multiple complaints in a single jurisdiction, but with each complaint numbering fewer than 100 plaintiffs in order to avoid CAFA removal.

It is a form of “litigation tourism”—the mass importation of plaintiffs into jurisdictions that have no interest whatsoever in adjudicating their claims—and we have always wondered why courts tolerate it.  It has become a particular problem in California, whose underfunded courts are clogged as it is and whose taxpayers should not have to subsidize transient plaintiffs and the attorneys who represent them.

You won’t find this context in Corber, but trust us, it’s simmering there just beneath the surface.  Corber was one of multiple complaints filed in California state court alleging injuries in connection with the prescription drug propoxyphene.  The complaints together asserted the claims of hundreds of unrelated plaintiffs from all parts.  But rather than file one complaint for each plaintiff (which would have subjected the vast majority to removal under standard diversity jurisdiction) or file one consolidated complaint (which clearly would have been removable as a mass action under CAFA), the plaintiffs’ attorneys divided their clients into multiple mass complaints, with each complaint including at least one non-diverse plaintiff to defeat complete diversity and each numbering fewer than 100 plaintiffs.  To review, CAFA permits removal of “any civil action . . . in which monetary relief claims of 100 or more persons are proposed to be tried jointly on the ground that the plaintiffs’ claims involve common questions of law or fact.”  28 U.S.C. § 1332(d)(11)(B)(i).  So 100 is the somewhat-magic number that plaintiffs are careful to stay beneath, which these plaintiffs’ lawyers scrupulously did.

Continue Reading The Ninth Circuit’s Must-Read Opinion on CAFA Jurisdiction

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

I didn’t know that the SPF value for sunscreens can reach higher than 100.  But they can.  As someone of Irish descent, someone who can burst into flames at the hint of sunlight like a John Carpenter vampire, I should have known that.  For instance, Coppertone markets a product called SPORT SPF 100+. I’m going to buy a case.

Now, some plaintiffs’ attorneys will tell me that I’m wasting my money.  Or, they might tell me that I have a lawsuit.

Or maybe I don’t.  Plaintiff Danika Gisvold brought a class action claiming that she paid an extra dollar for Coppertone SPORT SPF 100+ at Walmart, but it didn’t provide any more protection than Coppertone products with only an SPF value of 50 .  Gisvold v. Merck & Co., Inc., 2014 WL 6765718 (S.D.Cal.) (S.D. Cal. Nov. 25, 2014).  She thought she was getting double the protection, but she wasn’t.  She sued to get her dollar back and an order that Merck should issue a corrected label and corrective advertising.  Id. at *1.

Continue Reading When More Is Neither Better Nor a Lawsuit

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It is a pity that the case discussed in today’s post did not come out around Halloween.  That is not to say that there is anything ghoulish about the invaluable service (keep that word “service” in mind) of making blood and body tissues available to patients in need.  We are more likely to perceive certain tactics of predatory plaintiff lawyers as ghoulish.  We are not saying that our opponents often resemble vampires or werewolves.  No.  We are not saying that.  Not out loud.

It has been a while since we have seen a case about a blood shield law – that is, a state law that immunizes providers of blood (and other body tissues) from strict liability.  In Palermo v. Lifelink Foundation, Inc., 2014 WL 6480524 (Mississippi Nov. 20, 2014), the Mississippi Supreme Court for the first time addressed the interplay between the state’s blood shield law and the strict liability provisions in the Mississippi Products Liability Act (MPLA).  The plaintiff alleged that he was injured by infected tissue surgically placed into this knee.  He argued that the strict liability and breach of warranty provisions of the MPLA trumped the blood shield law.  He lost.

The Mississippi Supreme Court’s opinion is extensive, but the reasoning is straightforward.  First, we are treated to a little history.  In May of 1966, the Mississippi Legislature passed the blood banking statute.   Here is the meat of it:

“[t]he procurement, processing, storage, distribution and or/use of whole blood, plasma, blood products, and blood derivatives for the purpose of injecting or transfusing, transplanting the same or any of them into the human body for all purposes whatsoever is  the rendering of a service by every person participating therein, … and does not constitute a sale.”

Continue Reading There Will be Blood (Shield Laws)

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We often report on cases that are dismissed at the pleadings stage but in which plaintiff is afforded an opportunity to “fix” his or her complaint.  And almost as often, we refer to this as plaintiff getting a “second bite at the apple.”  Not overly creative, but it conveys the point nicely.  In the InFuse cases, for instance, the large majority of plaintiffs’ claims have been dismissed as preempted.  Typically, the claims that survive preemption are for fraud and misrepresentation and more often than not those have been dismissed for pleading deficiencies. Less often do we see blogworthy decisions on the result of plaintiff’s second bite. So we were surprised to happen upon two such decisions in the InFuse litigation issued just days apart.  Plaintiff’s second attempt in one case was more well received by the court, but even that decision has some positive notes for defendants.

To start, we’ve posted a lot about the great success defendants have had in the InFuse litigation defeating off-label promotion claims.  So, we aren’t going to reiterate all the details.  You can check out all our posts on the InFuse cases here, including our post on Martin v. Medtronic which is one of our follow-up cases today.

In Martin, the court dismissed all of plaintiff’s claims.  The preempted claims (fraud based on the labeling, failure to warn based on off-label promotion, design defect, negligent failure to warn based on labeling, negligent design/manufacture, and negligence based on off-label promotion) were dismissed with prejudice.  Plaintiff was given leave to amend her remaining claims: fraud based on misrepresentations in off-label promotion, failure to report adverse events to the FDA, and breach of express warranty.  Martin v. Medtronic, Inc., 2014 U.S. Dist. LEXIS 164980 at *8-9 (D. Ariz. Nov. 24, 2014).  She didn’t fare much better on the second go-round.  First, plaintiff re-pleaded all of her preempted claims and the court quickly dismissed them again.  Id. at *11-12.

Continue Reading InFuse Update

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Any defendant that has litigated – and lost − remand motions has encountered plaintiffs with very flexible facts, particular in opposition to fraudulent joinder arguments.  By that we mean:  dates that change after remand, non-diverse defendants that suddenly had nothing to do with anything, damages shrinking below the jurisdictional minimum, product exposures that disappear, “yes” that becomes “no” (and vice versa) in plaintiff testimony.  That kind of thing.

But there’s nothing anybody can do about it, right?  After all, a federal statute, 28 U.S.C. §1447(d), bars federal review of remand orders, so no matter how outrageous a plaintiff’s fraud on the court during the remand process is, they skate, and the defendants are stuck in state court, right?

Wrong.  At least not now.  At least in the Fourth Circuit.  See Barlow v. Colgate Palmolive Co., ___ F.3d ___, 2014 WL 6661086 (4th Cir. Nov. 25, 2014).

In the first precedential decision to address this issue, last week the en banc Fourth Circuit held in Barlow that, when a plaintiff’s remand-related misrepresentations are bad enough, a remand order can be vacated under Fed. R. Civ. P. 60(b)(3), with the result being that the case retroactively returns to federal court.  It’s a matter of first impression (prior adverse appellate decisions were all non-precedential), so all defendants should study Barlow closely.

Continue Reading Fraud on a Federal Court Allows Vacation of Remand Orders

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OK, we made that up.  It is not true at all.  A complete lie, much like “The Dallas Cowboys are America’s Team.”  Or “Eating turkey makes you sleepy because of its high tryptophan content.”  Or “The pilgrims left England because of their desire to wear stylish hats.”  Or “Lawyer advertising for drug and device cases serves an important role in improving medical care.”  If you did your duty as an American yesterday and gorged yourself on an assortment of turkey, stuffing, tubers, cranberry compotes, pie, and football, then you may be feeling somewhat bloated today.  You have many options to address that feeling, including taking a walk outside before returning to leftovers and more football.  Reading this post about a recent express preemption decision will not help with indigestion, but it should not hurt either.

The opinion in Hesik v. Boston Scientific Corp., No. 1:12-cv-00014-JMC, 2014 U.S. Dist. LEXIS 156563 (D.S.C. Nov. 4, 2014), carved up the product liability claims asserted in connection with a Class III device, specifically a cardiac defibrillator.  As our readers know, the Medical Device Amendments of 1976 served up express preemption for Class III devices—basically, those approved though a Pre-Market Application—as to state law requirements that are “different from, or in addition to” the FDA requirements.  21 U.S.C. §360k(a).  This has been interpreted by the Supreme Court to bar product liability actions premised on claims that do not impose “parallel” duties on manufacturers.  Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); our numerous posts on the subject.    A parallel claim is a “narrow exception to the rule of preemption” into which some courts strain to stuff plaintiff’s claims.  We sometime post on how it grinds us that courts, particularly federal courts sitting in diversity, extend existing state law to allow a claim that would be predicted on non-compliance with an FDA requirement such that imposing liability would not add to the federal requirements on the manufacturer.  Like here.

We do not have that situation in Hesik, which (drum)sticks with South Carolina law as is.  We do have a few twists on the typical arguments we see in cases like this, including that plaintiff had the giblets to move for summary judgment himself.

Continue Reading Nothing Helps With Post-Thanksgiving Indigestion Quite Like A Heaping Helping Of Express Preemption

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“Our rural ancestors, with little blest,
Patient of labor when the end was rest,
Indulged the day that housed their annual grain,
With feasts, and off’rings, and a thankful strain.”

― Alexander Pope, Imitations of Horace

Today isn’t officially a holiday, but the preparations for Thanksgiving make it terribly difficult to put in a productive day at the office.  (Some uncharitable types will wonder how this day is different from any other for this particular scribe.)  Because we will spend at least as much time today picking up organic butter, a bourbon pecan pie, and Beaujolais nouveau as we will perusing babbling briefs, we are thankful.  Tomorrow we will plant ourselves at table, poised between gluttony and gratitude.

We decided to canvass our DDL blog colleagues on what was making them thankful. Not surprisingly, some mentioned the learned intermediary doctrine, preemption, and statutes of limitations.  There were also shout-outs for Netflix, cornbread sausage dressing, and Eos lip balm.  One particularly high-minded blog editor was thankful to be at a law firm that recognizes the value of thought leadership.  “It takes a lot of non-billable time to write this blog.  A lot!  But it is important to our clients and to the patients who need their medicines and devices, and it is important to us.”  Just so.

Naturally, Bexis had the most to say.  We will quote his list of thanks:

  • I’m thankful to DARPA for the internet, without which none of what we’ve done would be possible.  There are some things that the government can do right.
  • I’m thankful to the tobacco companies for carrying the laboring oar in creating preemption in product liability cases.  Cipollone was the first time the United States Supreme Court found preemption in product liability litigation.
  • I’m thankful for Alfred Caronia standing up to the FDA when nobody else would.
  • I’m thankful for Obamacare because everyone deserves access to life-saving drugs and medical devices, and while I personally would prefer a single-payer system, it was the best we could hope for under the circumstances.
  • I’m thankful for off-label use because without it my daughter might have been crippled by juvenile dermatomyocitis, for which there was no on-label treatment.

The author of today’s post also has a list:

  • Thanks to the Pennsylvania Supreme Court for the Tincher opinion.  Even if Tincher does not quite render our Commonwealth’s product liability law pellucid, it at least strains out the Azzarello murkiness and muck.
  • Thanks for the Serial podcast, which has created a whole new cultural conversation.
  • Thanks to the Drug and Device Law Daughter for winding up her semester abroad in India without incident.  (Well, almost.  She was hit by a car, but apparently it was a very small, slow car.)  From her Facebook posts, it is clear that she has had quite an adventure in that marvelous country.  It is also clear that she disobeyed our strict instruction not to play with the wild monkeys.  Never mind.  Come home.  All is forgiven.
  • Thanks to the Drug and Device Law Son for displaying the number one determinant for success in this world: a motor.  His capacity for hard work is especially stunning when we contemplate how our own college days were filled with indolence and things that cannot be discussed in a PG-rated blog.
  • Thanks to our fellow DDL bloggers for basically writing most of today’s post for us.  (Our indolence continues.)
  • Last but not least, thanks to our clients and colleagues who offer support and suggestions. We are even thankful for our critics.  If you stop by our house tomorrow, perhaps whilst the Eagles are midway through thumping the Cowboys, we will gladly cut you a slice of bourbon pecan pie.
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This post is from the non-Reed Smith side of the blog.

This is the official week in the United States for giving thanks.  Counting your blessings.  Welcoming family and friends to your home.  Christmas might get top billing, but Thanksgiving is all about feeling warm and fuzzy.  And here at the Drug and Device Law Blog, we’ll get to what we are thankful for tomorrow. Today is a different story.  Today we feel more cold and hard.  And who is the unfortunate recipient of our negativity at this otherwise festive and lighthearted time – California.

And why is that we don’t want to share our turkey and pumpkin pie with California?  Three reasons:  negligence, Good Samaritan, and subsequent remedial measures.

Plaintiff Christine Scott sued manufacturer C.R. Bard, Inc. alleging injuries resulting from implantation of that company’s pelvic mesh device.  The case went to trial and the jury found the manufacturer negligent and awarded damages (reduced based on finding that surgeon was 40% at fault).  Scott v. C.R. Bard, Inc., 2014 Cal. App. LEXIS 1049, at *1 (Cal. App. Ct. Nov. 19, 2014).  On appeal, the defendant argued, among other things, that the trial court erroneously submitted the negligence theories of liability to the jury, including negligent training and erroneously admitted evidence of post-surgery events.  Id. at *1-2.  The court denied the appeal in its entirety.  We are blogging about this case because it demonstrates the potholes created by California’s recognition of negligence claims in pharma and medical device cases.

Continue Reading Thanks for Nothing California

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We posted not too long ago about a Seventh Circuit decision by Chief Judge Posner that we thought had favorable implications for reining in the steadily metastasizing concept of “cy pres” in class action litigation.  That opinion, Redman v. RadioShack Corp., 768 F.3d 622 (7th Cir. 2014), prohibited any sum that did not “benefit the class” from being included in the calculation of attorneys’ fees in a class action settlement.  Although a cy pres award was not at issue in Redman, the implications (to us at least) seemed obvious.  Funds not paid to class members do not benefit the class.

Judge Posner made that explicit last week in Pearson v. NBTY, Inc., ___ F.3d ___, 2014 WL 6466128 (7th Cir. Nov. 19, 2014).  Indeed, he thought it was “obvious,” just like we did:

The [trial] judge excluded, however, both the cy pres award of $1.13 million in calculating the benefit to the class, for the obvious reason that the recipient of that award was not a member of the class, and the injunction, which he valued at zero, which was proper too.

Id. at *2.  So, in the Seventh Circuit at least, it’s improper to use funds paid to non-class members via cy pres to calculate the fee that class action plaintiff lawyers are allowed to receive under the “common fund” doctrine.

And there’s more.

Continue Reading Judge Posner Drops the Other Shoe on Cy Pres

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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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