December 2015

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We do not have a case to blog about this week.  Things in the DDL world are slow.  Well, that is not exactly right.  In fact, maybe it is exactly wrong.  There is plenty going on, but virtually all the bloggable (that is, interesting and not yet already well-publicized) DDL cases involve our firm, Reed Smith, in some way, and blogging about such cases is like running through a gauntlet and minefield.  It is probably a good problem to have – unless you are staring at an empty computer screen and Bexis is clamoring for content.  So where does that leave us?

Usually we run into these doldrums during the Summer, when courts plunge into a blissful torpor.  The first time we completely discarded the DDL script and blogged about no case  was the Summer of 2011, when we went fully self-indulgent (or, at least, more self-indulgent than usual) and told a story about a deposition against a plaintiff lawyer who claimed to be the provocation behind Star Wars.  In truth, it is probably the single best blog post that emerged from our clumsily pecking fingers.  The folks at Abnormal Use recently linked to that post, so the number of views spiked.  Our cheap immortality grows yet again.

So now comes our Return of the Nerdy.  Put plainly, we are embarrassingly excited about the release of The Force Awakens later this week.  Our childish enthusiasm is marred only a little by the grim undercurrent mantra of “Please Please Don’t Suck”.  The prequel trilogy left psychological and aesthetic scars.  From what we hear, this new entry is set 30 years after Return of the Jedi.  And, in fact, it is about 30 years since Return of the Jedi.  JH Abrams has taken the helm from George Lucas, which is almost certainly a Very Good Thing.  Abrams did a nice job with the Star Trek reboot.  And let’s not forget that Lucas did not direct the best Star Wars film, The Empire Strikes Back, while he did oversee the excrescence called The Phantom Menace.  (The Simpsons episode where Bart watches in disbelief how that film centered on a tariff dispute is absolutely precious).  The great Lawrence Kasdan wrote The Force Awakens screenplay.  John Williams composed the score.   We are weak-kneed with anticipation.Continue Reading “You are unwise to lower your defenses!”

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

The remake is a Hollywood staple.  From Annie to Planet of the Apes.  From The Thomas Crown Affair to Willard (couldn’t come up with a “Z” remake) – everything old is new again.  Sometimes a remake turns out better than the original – True Grit, The Fly, You’ve Got Mail, and maybe Ocean’s 11 (feel free to disagree).  More often than not, remakes do not live up to our expectations.  Why, oh why, did Steve Martin even attempt to remake The Pink Panther?  Sorry Billy Bob, but your Bad News Bears is not even in the same league as Walter Matthau’s.  Russell Brand and Jennifer Garner don’t even come close to Dudley Moore and Liza Minnelli’s magic in Arthur.  And while Patrick Swayze’s Point Break and Road House may not be of the same caliber as the aforementioned originals – do they both need to be remade? (With all due respect to Rhonda Rousey who we are quite certain would make an extremely effective bouncer in real life).

Remakes are apparently inevitable and not limited to the movies.  Lawyers on both sides of the v. are often looking to “remake” the law.  But when it comes to PMA preemption, we defense counsel say leave it alone.  That’s just what the court did in today’s case – Pearsall v. Medtronics, Inc., 2015 U.S. Dist. LEXIS 164199 (E.D.N.Y. Dec. 7, 2015).  At issue was the same cardiac defibrillator and lead that was the subject of the In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation (D. Minn.) in which the Eighth Circuit affirmed dismissal of plaintiffs’ claims as preempted.  The blog is peppered with mentions of Sprint Fidelis as it was probably the first major post-Riegel PMA preemption battle and victory.  So plaintiff had a bit of an uphill fight on his hands.  His approach:  draw attention away from Sprint Fidelis by focusing on Hughes and Stengel.  The blog also is loaded with references to these cases, only they aren’t as flattering.  The court didn’t fall for the old switcheroo.Continue Reading Plaintiff Seeking to Remake Sprint Fidelis Gets Shut Down

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The preemption clause in the Nutrition Labeling and Education Act of 1990 is clear and direct.  It prohibits states from imposing nutritional labeling requirements that are not “identical to” federal requirements.  21 U.S.C §343-1(a).  If they’re not identical, they’re preempted.

This came squarely into play last week in Dougherty v. Source Natural, Inc., 2015  U.S. Dist. LEXIS 164117 (E.D. Mo. Dec. 8, 2015).  A putative class action plaintiff claimed that a multivitamin distributed by defendant Source Natural, Inc. contained actual nutrient levels for six of its vitamins and minerals that were less than the labeled amount.  Id. at *1-2.  She requested a refund for her and everyone else in the class. Id. at *2.  But she ran into a problem, a big one.  Her expert (really, the expert hired by her lawyer) calculated the nutrient levels of the multivitamin using a testing methodology that was different from the FDA’s methodology.  Uh-oh.

The FDA’s methodology is laid out in the Code of Federal Regulations.  It involves, among other things, sampling from 12 different product cases:

[T]he FDA has enacted regulations pertaining to expressed nutrient content claims.  Under 21 C.F.R. § 101.13, “[a] claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling under §101.9 or under § 101.36 (that is, nutrient content claim) may not be made on the label or in labeling of foods unless the claim is made in accordance with this regulation.”  21 C.F.R. § 101.13(b).  Whether the requirements or nutrient content claims comply with the regulations are determined by using the methodology provided in § 101.9. 21 C.F.R. § 101.13(o).  Under § 101.9(g), “[t]he sample for nutrient analysis shall consist of a composite of 12 subsamples (consumer units), taken 1 from each of 12 randomly chosen shipping cases, to be representative of a lot.”  21 C.F.R. § 101.9(g)(2).

Id. at *5-6.  Plaintiff’s test didn’t use 12 cases, or even 12 bottles.  It used one bottle.  That’s a “different” test from the FDA’s.  Allowing a plaintiff to hold a manufacturer liable for not meeting that “different” test would impose a requirement on the manufacturer that is different from the FDA’s requirement.  And, so, Plaintiff’s claim was preempted:

Because Plaintiff has failed to allege she followed FDA testing protocols, her state law claims that rely on a different methodology to demonstrate such labeling violations are inconsistent with the FDCA and are thus preempted.

Id. at *11.  That’s certainly a quick and neat preemption win.Continue Reading Court Dismisses Nutritional Labeling Class Action on the Basis of Preemption

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We’ve been advocating preemption of all product liability design defect claims against prescription drug manufacturers – “whether generic or brand name” – since we read that phrase in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2471 (2013), two years ago.  We’ve written on just about every case since Bartlett that has done so.  One of them was Yates v. Ortho-McNeil Pharmaceuticals, Inc., 76 F. Supp.3d 680 (N.D. Ohio 2015).

Today, Yates was affirmed by the Sixth Circuit, creating the first appellate authority recognizing impossibility preemption of design defect claims under the Bartlett rationale in a case not involving a generic drug.  Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., No. 15-3104, slip op. (6th Cir. Dec. 11, 2015).  The court held both “post-approval” and “pre-approval” design claims were preempted.  A “post-approval design defect claim is clearly preempted” because both “major” and “moderate” changes required FDA preapproval.  Slip op. at 18.  While “minor” changes do not, a dosage change that would affect the product’s safety could not be considered “minor.”

We think it clear that changing the dosage level of the active ingredient of [the patch] constitutes a “major change,” such that prior FDA approval is necessary.  Therefore, to the extent [plaintiff] argues that defendants should have altered the formulation of [the patch] after the FDA had approved the patch, we find this claim clearly preempted.  Quite simply, federal law prohibited defendants from decreasing the dosage of estrogen post-approval.

Id. at 18-19.Continue Reading Breaking News – Sixth Circuit Affirms Impossibility Preemption of Design Defect Claims Against Branded Manufacturers

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Everybody knows that it is three strikes and you are out in baseball.  (Bexis and Ken Burns could discuss the history of baseball’s rules on balls and strikes in the nineteenth century, but we will stick with the public consciousness at least since “Take Me Out to the Ball Game” became popular.)  In MDL product liability litigation, there is no magic number of times that proffered general causation experts must get knocked out before it is apparent that no plaintiff suing over the injury at issue will have a viable case.  In boxing, many jurisdictions have a three knockdown rule, where a knockout victory is awarded if the opponent is knocked down to the canvas three times in the same round.  In litigation, there is no such rule, nor would the parties ever agree on what constitutes the same round.

The Zoloft MDL in the Eastern District of Pennsylvania has been playing this out.  First, the MDL court excluded the generic causation opinion of the plaintiffs’—all of them, since this is common discovery—epidemiology expert.  Next, the court excluded the general causation opinions of three separate experts who focused on purported mechanisms.  It looked like plaintiffs were dead in the water.  Then, plaintiffs got a mulligan—yes, we are mixing sports metaphors like some courts mix up the standards for expert evidence on medical causation—and were allowed to put up another expert on general causation, this time a late-designated, frequent flyer biostatistician.  (Along the way, a motion to reconsider was denied and, across town, a state court excluded the causation opinions of an epidemiologist and mechanism expert in an individual case.)  Now, after every apparent opportunity for plaintiffs to do better, the court also excluded the general causation opinion of the new expert in In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., MDL No. 2342, 2015 U.S. Dist. LEXIS 161355 (E.D. Pa. Dec. 2, 2015).Continue Reading Another Zoloft Rule 702 Win: How Many Strikes Before The Plaintiffs Are Out?

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In addition to being on the warpath about cy pres class action settlements, we try to keep an eye on various other issues related to the much-abused Fed. R. Civ. P. 23.  First, we’re pleased as punch to let you know that all the really awful things that the Federal Judicial Conference’s Rule 23 Subcommittee was contemplating doing (rejecting/watering down ascertainability, recognizing issue classes, writing cy pres into Rule 23, and eliminating offers of judgment) have all been dropped.  You can read about it here.  Only comparatively minor settlement-related issues (opt-outs, notice, objectors, approval) remain on the Subcommittee’s agenda.

There are also two recent, and pending, petitions for certiorari of note raising class action-related issues.  One of them, Wal-Mart Stores, Inc. v. Phipps, No. 15-597 (U.S., filed Nov. 6, 2015), is a spin-off of the employment-related litigation that produced Wal-Mart Stores, Inc. v. Dukes, 131 S. Ct. 2541 (2011).  Having lost Dukes, plaintiffs have tried to regroup by filing separate, smaller class actions.  Given how long the Dukes litigation was pending, the statute of limitations becomes a serious problem for these newer, still quite large class actions.  Hence the issue of “stacking” the tolling effect of successive class actions under American Pipe & Construction Co. v. Utah, 414 U.S. 538 (1974), is a major issue.  We’ve been aware of stacking attempts for some time, but the courts had largely gotten it right – until now.  The Phipps petition is from the first court of appeals decision ever to allow stacking as a general rule.  Hence, the question presented is:

Whether the Sixth Circuit erred in concluding, in conflict with the decisions of seven other Circuits, that statutory limitations periods applicable to the claims of absent and unknown persons can be extended indefinitely by filing successive (or “stacked”) class actions.

More information, including links to all filed documents, is available on SCOTUSBlog, here.  Full disclosure – Bexis and his firm are filing an amicus brief for the Product Liability Advisory Council (“PLAC”)  in the Phipps matter.Continue Reading Class Action Issues at the Supreme Court (and Elsewhere)

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The rumblings began shortly after the industry First Amendment victory over the FDA in Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015).  A couple of anonymous, obviously plaintiff-side, comments to our “breaking news” Amarin post suggested that the Amarin First Amendment victory for truthful off-label promotion might have a downside.  Both comments raised the same issue:  what happens to “impossibility” preemption in the drug warning context once First Amendment protection is extended to truthful pharmaceutical promotion?

One response would be that, if such speech is fully protected, as the Supreme Court indicated in Sorrell v. IMS Health, Inc. – “[s]peech in aid of pharmaceutical marketing, however, is a form of expression protected by the Free Speech Clause of the First Amendment” − 131 S. Ct. 2653, 2660 (2011), then it’s game over.  The same First Amendment protection equally precludes private suits under New York Times Co. v. Sullivan, 376 U.S. 254 (1964).  “What a State may not constitutionally bring about by means of a criminal statute is likewise beyond the reach of its civil law.”  Id. at 277.  See also In re Asbestos School Litigation, 46 F.3d 1284, 1294-96 (3d Cir. 1994) (First Amendment precluded product liability action).  Sullivan also roundly rejected the “commercial” overtones of otherwise fully protected speech as a basis for suppressing it through tort litigation:

The publication here was not a ‘commercial’ advertisement. . . .  That the [defendant] was paid for publishing the advertisement is as immaterial in this connection as is the fact that newspapers and books are sold. . . .  To avoid placing such a handicap upon the freedoms of expression, we hold that if the allegedly [tortious] statements would otherwise be constitutionally protected from the present judgment, they do not forfeit that protection because they were published in the form of a paid advertisement.

376 U.S. at 266 (citations and quotation marks omitted).Continue Reading When They Don’t Have Anything, They’ll Try Anything

Photo of Michelle Yeary

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

We are going to begin this post by breaking the third person rule for a minute because Plaintiffs (really their counsel) in today’s case remind me of my third-grader.  Generally speaking she’s a great kid, a handful at times – but then again who isn’t?  But almost every day we go through the same evening routine.  She gets out her homework, glances at it and immediately announces:  “It’s too hard.  I don’t know what to do!”  To which I respond:  “Did you try?”  Of course she hasn’t.  But the rule in our house is, you have to try on your own first – really try.  If I see effort – real effort – and she’s still struggling, then I’m only too happy to help.  More times than not, no assistance is needed other than some quick proofing.  She just didn’t want to put in the effort.  I don’t think this is that uncommon of a scenario for a grade-schooler.  But when plaintiffs’ counsel try to pull the same nonsense, well that’s just *&#$%^@.

And that is just what happened in Marion v. Smith & Nephew, Inc., 2015 U.S. Dist. LEXIS 161681 (D. Utah Dec. 1, 2015).  Plaintiff underwent hip repair surgery during which defendant’s hip resurfacing device was implanted.  Six years later the system failed and had to be surgically removed.  Id. at *1-2.  Plaintiff filed a complaint alleging twelve state law causes of action against the device’s manufacturer.  Id. at *6.  The device, however, was pre-market approved by the FDA.  That means, for any claim to survive preemption, it would need to impose a duty on defendant that was “narrower than or equal to” the federal device-specific PMA requirements (a parallel claim) and the state law duty has to “predate the federal statutory scheme” (no private right of action for FDCA violations) Id. at *5.  That’s the “narrow gap” between Riegel and Buckman preemption.Continue Reading Befuddled Plaintiffs Get Second Chance

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