2015

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This post comes only from the Cozen O’Connor side of the blog.

For years, many courts have treated RICO as a sprawling monster, awkwardly extending its civil reach into areas and transactions for which RICO was seemingly never intended, including healthcare litigation.  For over fifteen years, the Third Circuit resisted this trend.  Until now.  With its decision in In re Avandia Marketing, Sales Practices & Prod. Liab. Litig., 2015 U.S. App. LEXIS 18633 (3d Cir. Oct. 26, 2015), the Third Circuit scuttled its previous good work and stretched RICO’s arms all the way out to reach consumer disputes with pharmaceutical manufacturers.

Fifteen years ago, the Third Circuit looked at things very differently.  In Maio v. Aetna, Inc., 221 F.3d 472 (3d Cir. 2000), it upheld the dismissal of a class action complaint in which HMO members tried to turn allegations that Aetna’s HMO didn’t provide the promised quality of healthcare into RICO claims seeking financial damages.  Plaintiffs claimed that Aetna restricted doctors’ ability to provide quality care, in fact offering them financial incentives to withhold quality service, even though Aetna had represented to plaintiff that it would provide high quality care from HMO doctors incentivized to do so.  Id. at 475.  Plaintiffs made clear, however, that they were not claiming injuries suffered through a denial of benefits or subpar treatment.  Id.  They were alleging only financial losses—that is, the difference in worth between the plan that they got and the one they were promised.  But this created a disconnect.  By failing to allege denial of or substandard care, plaintiffs had alleged no concrete financial injury.  They got what they paid for.  Id. at 483, 490.  RICO’s requirement of a concrete financial injury is intended to prevent plaintiffs from converting every ordinary tort claim into a RICO claim for the purpose of trying to win treble damages.  The Third Circuit focused on that requirement and upheld dismissal of plaintiffs’ RICO claim.Continue Reading The Third Circuit Does an About-Face on RICO Claims

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We just read on 360 this morning that the FDA has again postponed its schedule for finalizing the generic drug labeling changes (the so-called “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” rule) it proposed two years ago in order to overturn Supreme Court precedent recognizing preemption in generic drug product liability…

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Albert Einstein famously defined insanity as “doing the same thing over and over again and expecting different results.”  We thought of that definition when we read Shepherd v. Vintage Pharmaceuticals, LLC, ___ F. Supp.3d ___, 2015 WL 6956767 (N.D. Ga. Nov. 4, 2015).  Shepherd is – was – a personal injury class action.  No personal injury class action has survived a contested appeal anywhere in the federal court system since the Supreme Court put the kibosh on such things with its decisions in Amchem Products, Inc. v. Windsor, 521 U.S. 591 (1997), and Ortiz v. Fibreboard Corp., 527 U.S. 815 (1999).  That includes several dozen decisions involving prescription medical products, which are listed in our federal class action denial cheat sheet.

Shepherd was decided a month ago – an eternity in blog time – but whatever reason, the decision fell through the cracks and was not picked up by the services. In fact, we first learned about it from a story in the Legal Intelligencer (local Philly legal newspaper; behind a paywall) about a bunch of these plaintiffs abandoning ship following denial of class certification and becoming litigation tourists in Philadelphia. We have a PACER account and know how to use it, so before the day was out we had located the opinion and sent it to Westlaw.

As a class action, the pleaded facts were rather (or perhaps typically) overreaching.  The manufacturer defendant, exercising extreme caution, recalled “eight different oral contraceptive products” all packaged by the same entity, after one improperly packaged blister pack was returned by a pharmacist in Iowa.  2015 WL 6956767, at *1.  “Of the 507,966 blister packs that were returned in the recall, only 53 were improperly packaged in the reverse order.”  Id. at *2.  Plaintiffs claimed that 113 women became pregnant because of the error, but never proved a single case.  Id. at *2.  As the court pointedly observed, “[t]he Iowa package is the only known defective package received by a consumer.”  Id. at *1.Continue Reading Definition of Insanity – Expecting Certification of a Personal Injury Class Action

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This week sees the annual ACI Drug and Medical Device Litigation get-together in New York.  Here’s a shameless plug: we will take part in a panel discussion on civility, diversity, and ethics.  We were assigned the dreaded end-of-conference Friday afternoon slot, so we are prepared to bellow over the din of retreating rollaboards.  Always a good time.  Rumor has it that some plaintiff lawyers are showing up.  The panel will devote a few minutes to discussing how nice it is to be nice. We might also devote a few minutes to challenging that assumption.

Not that we have anything against conviviality, especially this time of year.

Conviviality is good in itself, but it can also serve a purpose.  Recently we attended an MDL hearing. Part of the festivities included a cocktail party, complete with defense hacks, plaintiff lawyer pursuers of justice (in the form of wire transfers), and court staff. Talk about civility!  Several times we were treated to an odd bit of theater where a lawyer would snicker about how something weird and wonderful happened, but how it dare not yet be revealed.  Then, two or three sips later, that same lawyer would whisper out of a mouth corner something like, “Okay, here’s how it went down.”  Most of what we learned was silly or possibly wrong.  But we gathered at least one useful tidbit.
Continue Reading A Civil Discussion

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Based on that title, we’re guessing you don’t know if we are talking about a defense win or a defense loss.  “Funk” is a contronym – a word that has contradictory meanings.  Some examples:  continue can be used to mean keep doing an action or to suspend an action; you can use overlook to mean supervise or to mean neglect; and transparent can mean both invisible and obvious.  The word funk originally – and still does – refer to a strong odor.  A half-eaten, week old ham & cheese sandwich that has been rotting in a ten-year old’s backpack is funky (trust me!).  But somewhere along the way, funk moved from just meaning stink, to also meaning stank – a term used by jazz musicians in the early twentieth century that is still used by musicians today to mean a dirty or gritty sound – but in a good way.

What most people think of as funk music dates back to the 1960s and a blending of soul, R&B and jazz.  James Brown, Sly & the Family Stone, The Isley Brothers.  Now we’re talking the good kind of funky.  The kind you groove to.   And we couldn’t be discussing funk without mentioning George Clinton and Parliament-Funkadelic – one of the most heavily sampled funk groups of all time.  While we’re skipping over too many to name, we can’t not mention Bruno Mars.  Backed up by his band (The Hooligans) that mixes rock guitar and bass with an amazing horn section, his live shows are a mix of 11 year-old girls who’ve never heard such funky beats and 65 year-old women re-living James Brown concerts.  Either way, we’re glad funk is still going strong.

So, is today’s case sweaty gym socks funky or “Papa’s Got a Brand New Bag” funky?  Well, first of all, it’s the name of the case – Funke v. Sorin Group USA, Inc., No. SACV-15-01182-CJC(ASx), slip op. (C.D. Cal. Nov. 24, 2015).  Not to be confused with another preemption decision, Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011).  Second, the decision is “Give up the Funk” funky.  Or in legal speak – a preemption win.Continue Reading A Funky Preemption Decision from California

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Occasionally we see plaintiff-side experts attempt to opine, to a reasonable degree of medical certainty (or sometimes probability), that one of our clients’ products was a substantial factor – not in “causing” the purported injury, but in “increasing the risk” of that injury occurring.  Such an opinion should be a red flag to any of our defense-side colleagues.  It means that the plaintiff’s medical causation evidence is downright lousy.

It also means that a summary judgment motion on causation is probably appropriate.  Causation allegations based only on “increased risk” are hallmarks of medical malpractice “lost chance” cases, not product liability.  “Lost chance” is a medical malpractice concept derived from certain sections of the Second Restatement (§§321 and 323) applicable only where a pre-existing condition, not diagnosed in a timely fashion, gets significantly worse in the interim, and thereby arguably deprives the plaintiff of a “chance” for a cure.  A number of courts have considered that “lost chance” to be a cognizable injury and have relaxed causation standards to permit recovery, because “but for” causation is virtually impossible to prove where the pre-existing condition was progressive to start
with.

We have always maintained that, regardless of the validity of “lost chance” causation in medical malpractice, it’s simply not a product liability theory – since in product liability the product must actually have caused whatever injury that the plaintiff claims occurred.  We’re thinking about one of our 50-state surveys on this issue, and we invite our readers to chime in on whether they think it would be helpful.Continue Reading Lost Chance Loses In Product Liability

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In case you haven’t noticed, we like preemption.  We’ve even called ourselves “obsessed” with it.  And with good reason.  Preemption, where it’s available, is the most powerful defense around – capable of wiping out an entire MDL with a single motion to dismiss.  Preemption is not dependent on the strength of a plaintiff’s underlying case.  It doesn’t matter how solid medical causation might be, or how much the prescribing physician has (or has not) been suborned during ex parte chats with the other side.  If preemption applies, than it’s bye-bye claim, and often bye-bye plaintiff.  No discovery necessary.

Thus, it’s not surprising that plaintiffs’ lawyers fight preemption tooth and nail.  That’s their job.  They are just as ethically bound to represent their clients zealously within the boundaries of the law as we are.  Thus they pick every preemption nit they can find.

That’s what we’re on about today.  We’re discussing some recent decisions that address some lesser-known – but equally deadly − preemption arguments.Continue Reading Preemption 201 – Recent Cases Raising Specialized Issues

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We have been riding the Philly subway for years, but only recently realized how much the ads on the car walls have changed. Not so long ago there were lots of ads for vocational schools, inducing today’s un- or underemployed to become tomorrow’s truck drivers and beauticians.  But nowadays at least three quarters of the ads are from plaintiff lawyers hawking their ability to wring cash out of slip-and-falls or the latest mass tort.  Mass transit advertising space that formerly advised riders to get skills is now dedicated to pleas to get paid.  The same is true for daytime television advertising.  Perhaps we are not alone in seeing this evolution as further proof, along with Keeping up with the Kardashians and the ascendancy of kale salad, that our culture is headed to Hell in a handbasket.

You won’t be surprised to hear defendants and their lawyers bemoan plaintiff lawyer advertising.  But we are not alone.  Recently, we heard a MDL judge express frustration about how plaintiff lawyer advertising was a blatant attempt to extend the tail of an over-mature mass tort.  Some plaintiff lawyer advertising is naked poaching of other plaintiff lawyer inventories – e.g., why pay a 40% contingency fee if you can pay only 20%?  But the most obvious aim and effect of such advertising is stirring up litigation.  What might not be so obvious is the extent to which plaintiff lawyer adverting causes adverse health outcomes.  A recent law review article looks into this issue and it is well worth reading. The article is by Elizabeth Tippett, a professor at the University of Oregon School of Law. The title is “Medical Advice from Lawyers: A Content Analysis of Advertising for Drug Injury Lawsuits,” 41 Am. J. L. & Med. 7 (2015).Continue Reading The Risks of Plaintiff Lawyer DTC Advertising

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This being the week of Thanksgiving, we would be remiss to fail to weave in something about the great American (or ‘merican) holiday of giving thanks, eating turkey, watching football, and pondering the influence of the Pilgrims on our culture (beyond the obvious lasting fashion impact).  In the past, we offered our readers a “fun” word search for food and drink terms in a post on express preemption.  (Yes, the terms “fun” and “express preemption” are rarely linked in a single sentence, although “Today was no fun because I had to write a brief on express preemption” has probably been uttered.) We have offered other posts at this time of year that featured food to different degrees, like this and this.  We have talked about reasons for being thankful, how football analogizes to law, and even how shopping has become a big part of this particular holiday.  Surely, we have given our readers many reasons to ponder deeply on important issues in their lives.  Why is stuffing called dressing in the South?  Why did some combination of the Civil War, Restoration, and carpetbaggers not force a gastro-linguistic solidarity?  Do elementary school depictions of Native Americans (f/k/a Indians; a/k/a indigenous peoples of North America, pre-Colombians, Amerinds, descendants of those who migrated across Beringia) send the right message?  Should second graders learn about smallpox blankets?  Was the choking risk with that third plate of food, after more than a few adult beverages, an acceptable one?  We would like to think that we have contributed to such meaningful introspection with our purportedly clever posts during this week every year since the blog started being purportedly clever.

This year, we highlight a truly American tradition:  trying to make as much money as possible by suing a deep pocket defendant with as little proof as possible.  Recently, this has often involved combining three things.  First, use remedial federal or state statutes that are really for another purpose entirely, but allow for big damages and even fines (e.g., the False Claims Act was enacted against war profiteering, RICO was enacted to combat organized crime).  Second, seek to proceed on behalf of a class and/or some subset of the “public” to maximize the claims at issue.  Third, use only generalized proof of injury, causation, and damages, which is required for a class but does not require a class.  We could add in piggybacking on an issue with a product that has gotten attention because of other litigation or regulatory actions and outsource the work to contingency lawyers.  Such cases have been the subject of many posts, often addressing how generalized proof of causation makes no sense in the context of drugs prescribed to specific patients by specific doctors based on, hopefully, individualized clinical judgment.  High on the list of opinions that got it wrong are Kaiser Foundation Health Plan, Inc. v. Pfizer, Inc., 712 F.3d 21 (1st Cir. 2013), and the rest of the First Circuit’s Neurontin trilogy, which took the top spot in our list of worst decisions of 2013. High on the list of opinions that got it right is the Second Circuit’s Zyprexa decision, UFCW Local 1776 & Participating Health & Welfare Fund v. Eli Lilly & Co., 620 F.3d 121 (2d Cir. 2010), which took home best decision in 2010 by reversing the second worst decision of 2008.  The Second Circuit’s in Sergeants Benevolent Assoc. Health & Welfare Fund v. Sanofi-Aventis U.S. LLP, No. 14-2319-cv, 2015 U.S. App. LEXIS 19797 (2d Cir. Nov. 13, 2015), adds to the weight of the good cases rejecting the misuse of generalized proof of causation by affirming class certification denial and summary judgment in a RICO (and state consumer protection) case over the antibiotic Ketek.Continue Reading Largely Thankful For The Second Circuit Striking A Blow Against Generalized Proof of Causation

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With claims related to warnings, design, and recall all preempted, plaintiffs seeking to sue makers of generic drugs don’t have many options.  After all, as we’ve discussed before, if state common law can’t require changing a defendant’s warnings, changing the design, or making the defendant stopping selling the product altogether, there’s not much left for a plaintiff to allege.

So, who ya gonna call?

One straw that generic drug plaintiffs have grasped at is the footnote in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), “not address[ing]” the issue of “parallel claims” – facially dictum about something not raised in Bartlett:

We do not address state design-defect claims that parallel the federal misbranding statute.  The misbranding statute requires a manufacturer to pull even an FDA-approved drug from the market when it is “dangerous to health” even if “used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.” 21 U.S.C. § 352(j).  The parties and the Government appear to agree that a drug is misbranded under federal law only when liability is based on new and scientifically significant information that was not before the FDA.

Because the jury was not asked to find whether new evidence concerning [the drug] that had not been made available to the FDA rendered [it] so dangerous as to be misbranded under the federal misbranding statute, the misbranding provision is not applicable here.

Id. at 2477 n.4 (other citations omitted).Continue Reading Ghostbusters – Phantom “Parallel Claim” Exorcized by Generic Drug Preemption

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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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