“Destroying Things Is Much Easier Than Making Them” – The Worst Prescription Drug/Medical Device Decisions of 2015

by Reed Smith

In the original Hunger Games movie, while Katniss and Rue are plotting to blow up the Careers’ food stash, Katniss remarks that “destroying things is much easier than making them.”  That’s how we feel about our bottom ten worst prescription drug and medical device decisions of 2015.  It’s so much easier to destroy life-saving and health-enhancing prescription medical products through litigation than to create them.  New prescription medical products have added much of the decade-plus increase in life expectancy since 1950 (from 68.2 to almost 79 years in 2013).  But the United States still trails dozens of countries that don’t tolerate the kind of litigation that we allow here – despite spending more than anyone on healthcare.  Is it mere coincidence?  We can’t say, but we doubt that litigation ever increases life expectancy.
It’s easier to denigrate products than to create them, as the cases that follow demonstrate.  Hold your collective noses because here we go again.  What follows is our annual list of the ten worst court decisions of the year (2015) arising from prescription medical product liability litigation – often with reasoning worthy of tracker jacker venom.  These blood-pressure-raising decisions did nothing for our life expectancy, and even less to encourage development of new products that could help others.  We can’t justify these rulings, except to say that sometimes the rats win the rat race, and the goose that laid the golden egg gets cooked.  Before we dampen holiday spirits too much, remember that next week we get to celebrate the best, instead of bemoaning the worst.
But for now, let the bemoaning begin:
  1. Reckis v. Johnson & Johnson, 28 N.E.3d 445 (Mass. 2015).  The worst thing about this case isn’t that it affirms a $63 million (over $100 million with interest) verdict, so you know it’s pretty bad.  It’s another SJS/TENS case in which the horrific nature of the injuries all too often overcomes a jury’s common sense.  For this reason, such cases should engender heightened judicial scrutiny, but in Reckis the opposite happened.  Doing the most potential damage, long term, was the court’s ruling on preemption, an issue that has now been appealed to the Supreme Court.  The court converted the Levine (2009 -1) “clear evidence” test from what the Supreme Court said – “that the FDA would have” rejected a warning change − to an unprecedented “FDA actually did reject” the change when proposed by the defendant standard.  To do so, Reckis presumed that the FDA would violate its statutory mandate, and be more likely to approve a label change submitted by a manufacturer (the defendant) than the same label change submitted via citizen’s petition, although the substantive standards are completely identical.  The court offered no support for this total speculation.  The actual Levine standard is bad enough; this one is essentially impossible to meet and only if the defendant ignores the regulatory scheme.  That’s not all.  The court allowed causation based solely on the testimony of a witness-for-hire pharmacologist who had never treated an SJS/TENS patient.   Since nobody knows what causes SJS/TENS, and plaintiffs have laid the condition at the doorstep of literally dozens of drugs in litigation, the court allowed an unqualified and inexperienced witness to offer a novel causation opinion where numerous, real physicians who had actually treated this condition were unwilling to tread.  Oh, and it appears to be the largest PI verdict ever allowed on appeal in Massachusetts history.  We lambasted Reckis here and then discussed the defense cert. petition to the Supreme Court here.
  2. Boston Scientific Medizintechnik GmbH v. AOK Sachsen-Anhalt - Die Gesundheitskasse, 613CJ0503 (CJEU 4th Ch. March 5, 2015).  This is the first time that any decision from outside the United States has ever appeared on our year-end best/worst lists.  This dangerous medical device decision by the equivalent of the supreme court of Europe fully warrants the exception.  From now on, anybody recalling a product (the case goes beyond medical devices) in Europe must be very careful in wording the recall notice or else will run the risk of large damages for every device of the type involved.  Plaintiffs (here, third-party payers) no longer have to prove that the particular device alleged to cause injury even had the defect that prompted the recall.  Throughout the European Union, under its consumer expectation standard a maker of a product having life-threatening risks essentially becomes an insurer.  “In view of the life-threatening risk presented by a defective device, the patient may, in principle, reasonably expect the implanted device to have a failure rate of close to zero.”  Got that?  Zero.  Furthermore, actual warnings don’t defeat this deemed “expectation.”  And we thought communism was dead in Europe.  We brought our readers the bad news from across the Pond here.
  3. State v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 777 S.E.2d 176 (S.C. 2015).  Just about every place else – Pennsylvania, Louisiana, Arkansas, Alabama, West Virginia − where state attorney generals (or more likely no-bid, contingent fee lawyers purporting to exercise state power on their behalf) have sought (and sometimes obtained) huge verdicts through endless multiplication of statutory penalties, state appellate courts have stepped in to restore sanity.  Not so in South Carolina.  As we lamented here, after the South Carolina Supreme Court got through with the aptly sounding acronym SCUTPA, the defendant was left holding an absurdly inflated $124 million verdict, simply because the FDA ordered a correction of a Dear Healthcare Provider (“DHCP”) letter.  Between sample packs, letters, and visits (details mostly irrelevant), the various penalties were multiplied to reach nine figures.  All this without any showing of actual deception or actual injury (because the state need not prove this, only a vague “tendency to deceive”).  On the merits, the worst mistake the court made was ignoring the statutory safe harbor for “[a]ctions or transactions” such as FDA-approved labeling and DHCP letters “permitted under laws administered by any regulatory body.”  That’s how the state legislature chose to frame its statute.  That such labeling might be a “floor” for preemption purposes, as the court stated, was totally irrelevant because preemption was not an issue.  The legislature chose not to punish FDA-regulated activity, but the court nullified that legislative decision, with practically no discussion.
  4. In re Avandia Marketing, Sales Practices & Product Liability Litigation, 804 F.3d 633 (3d Cir. 2015).  Until this decision, we thought the Third Circuit was one of the better places to litigate third-party payer economic loss cases.  Such cases invariably invoke statutes, here RICO, intended for much different purposes.  In all prior Third Circuit decisions of this type, the patient-specific decisions of independent professional physicians had precluded resort to aggregated statistical proof of injury and causation.  Not this time, and thus the sale and use of prescription drugs became subject to a “racketeering” statute.  Nobody claimed the drug didn’t work.  Nobody claimed any injury from the drug.  The “injury” is entirely made up – that the drug wasn’t intrinsically “worth” as much as it would have been had all the statements (which didn’t hurt anyone) been “true.”  For taking safety, effectiveness, and concrete injury out of the RICO equation, after years of getting this right, the Third Circuit’s Avandia decision nails down the #3 spot on our bottom ten.  We let Avandia have it here.
  5. Guvenoz v. Target Corp., 30 N.E.3d 404 (Ill. App. 2015).  The worst generic drug preemption decision of the year – and it isn’t close – is Guvenoz.  The court tortured two Supreme Court decisions that, between them, had held preempted practically all product liability claims involving generic drugs, and managed reached the opposite conclusion that no claims at all were preempted.  Negligence, strict liability, misrepresentation, fraud, and consumer fraud all survive.  The opinion is blatantly, unapologetically result oriented.  The court couldn’t accept that the very purpose of preemption is to bar state-law claims without regard to their state-law merit.  The court allowed to proceed the same stop selling argument that Bartlett held preempted.  In the guise of preventing a “safe harbor,” the court put entirely at sea the last five years of preemption involving generic drugs.  Guvenoz is overall the worst reasoned appellate decision we read in 2015.  We took on this monstrous decision, here.
  6. Watts v. Medicis Pharmaceutical Corp., 342 P.3d 847 (Ariz. App. 2015).  The learned intermediary rule (or “doctrine,” as preferred by some of us) is one of the most universally adopted tort principles there is.  Our 50-state survey of that rule reflects a margin of fully 51 jurisdictions (35 high courts) in favor to only one against.  At least that was the margin until Watts.  Ignoring literally (see the survey) a half-dozen prior decisions of the same court, the opinion ousted the rule on a ground that was, frankly, bizarre – that the rule conflicted with the uniform law governing joint tortfeasors.  That law has been around for quite a while, and been adopted by dozens of states, and no court had ever found such a conflict before.  Watts added some rhetoric about DTC advertising, even though there was no such advertising of the product at issue.  The decision is another example of the law being tortured to reach some pre-ordained, pro-plaintiff result.  Fortunately, the Arizona Supreme Court has granted an appeal (pending; Bexis filed a PLAC amicus brief supporting the learned intermediary rule), so this decision is not the final word.  We addressed Watts here, and critiqued its low-wattage reasoning in more detail here.
  7. Mullins v. Ethicon, Inc., ___ F. Supp.3d ___, 2015 WL 4635573 (S.D.W. Va. Aug. 4, 2015).  In Mullins, a jaw-dropping consolidated trial order (37 plaintiffs) required the most overreaching Erie prediction of the year to afford consolidation even fig-leaf plausibility.  We’ve followed tort-related consolidations, and putting that many plaintiffs together for trial just isn’t done anymore, and hasn’t been since the beginning of the century when courts cracked down on the practice in asbestos litigation.  Only “design defect” is consolidated, meaning different juries for different issues, sort of a poor man’s Rule 23(c)(4) issue class trial with all the drawbacks and none of the procedural safeguards.  As to design defect, to have even the illusion of commonality for consolidation required, in addition, the rejection of Restatement §402A, comment k as the law of West Virginia.  As we discussed here at length, states apply comment k either across the board – in which case there are no design defect cases at all – or on a “case by case” basis.  But the states do apply comment k.  Of all the states, only Alaska (1992), Nevada (1994), and Wisconsin (1984), among those allowing strict liability, ever rejected comment k.  No state had rejected comment k in over twenty years.  Two prior West Virginia federal cases (one affirmed memorandum by the Fourth Circuit) predicted that the state would follow the majority rule.  Comment k has been followed by precedent in 42 other states (and DC).  But under comment k, the alternatives are no design defect at all or case by case.  Consolidation plainly could not work with 37 case-by-case adjudications, so comment k, all prior West Virginia precedent, and the principle that federal courts are not supposed to predict novel expansions of state law all went out the window.  We – the non-RS side of the blog, that is − shook our heads at Mullins here.
  8. Briggs v. Merck Sharp & Dohme, 796 F.3d 1038 (9th Cir. 2015).  After CAFA imposed a 100-plaintiff cut off for “mass actions” removable as of right to federal court, plaintiffs began filing 90+ (but never 100) plaintiff grossly misjoined complaints all over the country, but particularly in California.  Last year, it appeared that the en banc Ninth Circuit had put the brakes on this plaintiff-side monkeying with the rules with the Corber (2014 +4) decision.  Not so fast.  That court has so many judges that it often exhibits schizophrenic tendencies.  Corber was less than a year old when this case was decided, distinguishing it on very weak grounds (there’s only one kind of consolidation in California – it doesn’t matter how plaintiffs couch their requests).  We groaned about the renewal of misjoinder-based gamesmanship in Briggs here.  However, as you’ll read next week, it appears that the California state courts have had enough of such tricks, as well.
  9. Drake v. Allergan, Inc., ___ F. Supp.3d ___, 2015 WL 2452947 (D. Vt. May 22, 2015).  Very little favorable drug/device law has come out of Vermont.  Vermont was Levine’s (2009 -1) state of origin, and almost everything else has been by federal courts further mangling the law.  Drake is a particularly bad example of this.  A torrent of “evidence” that most other courts reject – “totality of circumstances” expert opinion, fraud on the FDA claims, promotion never seen by the prescriber, ghostwriting − led to a $6.7 million verdict, including $4 million in punitives.  Causation was entirely speculative, since the prescriber testified he relied on his own experience, not anything said by the manufacturer.  Maybe he relied “unconsciously,” guessed the court.  That would require a jury to find that company promotion could overcome a doctor’s experience and training without the doctor ever knowing about it.  The punitive damages award was almost uniquely unsupported, since there was no evidence of any degree of increased risk (the Vermont standard for punitives is “known, substantial, and intolerable”), only that the drug, having been used off-label, was “not proven to be safe and effective” for that use.  It’s almost enough to make us give up Ben & Jerry’s.  We sifted through this dreck here, and criticized the result again here.  There’s still hope, though.  An appeal is pending.
  10. Krueger v. Wyeth, Inc., ___ F.R.D. ___, 2015 WL 5839197 (S.D. Cal. Oct. 7, 2015).  In a result worthy of a Nightmare on Elm Street, this case actually certified a class action against the manufacturer of an FDA-approved prescription drug.  That doesn’t happen often, and shouldn’t have happened here.  Perhaps predictably, it’s from California.  This hormone therapy case has been kicking around since 2002, with class certification denied in the Prempro MDL (most MDL judges get things right most of the time) − talk about the possible abuse of class action tolling should this puppy ever get the reversal it deserves.  Unfortunately, that MDL failure discouraged neither the plaintiffs nor the remand court.  Everybody who ever purchased the product gets to be in the class, despite eight years of differing representations about the product.  The judge, sua sponte, removed even the barest requirement of “exposure” to the alleged promotion.  Membership may be established by a self-serving plaintiff affidavit, not to be submitted until after the class trial.  Jeez!  Ascertainability alone should have been more than enough to shoot down this lead-balloon of a class action.  Defendants face the likelihood of a trial against a class of unknown persons.  And it’s all for naught; nobody was injured.  Amazingly, over a decade has been wasted, with much more apparently to come, on a class of plaintiffs defined as those experiencing no complications at all.  We engaged in some California screaming about this case here.
As for near misses, PLIVA, Inc. v. Dement, ___ S.E.2d ___, 2015 WL 7431346 (Ga. App. Nov. 20, 2015) (discussed here), might have made the list due to its demented rulings on failure to warn, “stop selling,” and publisher liability, but it was partially redeemed by a good result on innovator liability.  We also considered Gurley v. Janssen Pharmaceuticals, Inc., 113 A.3d 283 (Pa. Super. 2015) (discussed here), but the major (preemption) issues are a reprise of the earlier Maya case that received a dishonorable mention in 2014.  Flagg v. Stryker Corp., 801 F.3d 456 (5th Cir. 2015) (discussed here), was another possibility, except it was:  (1) Louisiana specific, and (2) vacated last month when rehearing en banc was granted.  See Flagg v. Stryker Corp., 805 F.3d 610 (5th Cir. 2015).
That’s it; time for a good, long shower.  We’re done with our annual unpleasant task of cataloguing our side’s biggest black marks of the year.  If any of them are yours, we apologize for resurrecting bad memories.  We understand. In today’s environment, not losing tough cases means not having tough cases.  Anyone good enough to be entrusted with the defense of big cases runs the risk of showing up on this list someday.
In any event, it’s over, now, and we’re ready to move on.  Next week you (and we) get the fun stuff:  when the odds are in our favor − the ten best drug/device decisions of 2015.

Written by:

Reed Smith

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