2015

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Warning:  You have heard all this before.

Still reading?  Okay.  But please don’t tell us later that our warning was inadequate and that you would have clicked over to Scotus or Grantland or TMZ if we had been more forthcoming.  As we have mentioned/kvetched what seems like 2814 times before (according to Blogger, that is how many posts we have put up — you’re welcome), most of the drug and device cases we encounter center around an allegation of failure to warn.  And most of those cases are weak and/or incoherent.  Yet most of those cases cost our clients a lot of money, if only because of the dysfunctional, asymmetrical meat-grinder called “discovery”.

Instead of ushering nuisance cases to the exit, too many courts are too inclined to find a purported issue of fact as to whether a warning is inadequate or whether a better warning would have made a difference.  Again, we’ve said it before and will doubtless say it again in the face of judicial obstinacy or lassitude, but courts should insist that plaintiffs state exactly what the warning should have been and show that such a warning would have prompted the doctor to make a different prescribing decision.Continue Reading Lack of Warning Causation Dooms Aredia-Zometa Case

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Two weeks ago we told you that an interesting decision was rendered in Sparks v. Oxy-Health, LLC, et al, Case No. 5:13-cv-649-FL, slip op. (E.D.N.C. Sept. 15, 2015), but we could not talk about it because the opinion had been sealed.  The parties have informed the court that no redactions were necessary and now the order has been unsealed and we are free to blog about it.

We want to start our post by acknowledging that the underlying circumstances of this case are tragic.  It is simply a sad story for the individuals involved.  For that reason, we are going to deal with the legal issues in a very straight forward manner.  From a legal perspective, plaintiffs did not have the evidence required to sustain a products liability or a consumer fraud case under North Carolina law.  It is the import of the judge’s reasoning and the precedential value of the case that we center on and bring to your attention.

The lawsuit was brought by parents on behalf of their deceased son.  Their son was 19 years old and autistic.  The medical device at issue is a portable mild hyperbaric chamber.  Hyperbaric chambers are designed to increase atmospheric pressure.  Sparks, slip op. at 6.  The one at issue in this case was §510k cleared by the FDA for the treatment of “acute mountain sickness” (condition that affects climbers who climb in excess of 8,000 feet).  Id. at 7-8.  In certain medical communities, a recognized off-label use for hyperbaric chambers is the treatment of autism.  Id. at 8.  A prescription is required for this treatment.  Id.  For several years, plaintiffs took their son to clinics where he would receive hyperbaric chamber treatments.  During clinic treatments, plaintiffs’ son was not left alone. Either a family member or a technician monitored and stayed with him throughout the treatment.  Id. at 9.   In 2011, plaintiffs decide to purchase a hyperbaric chamber from the clinic for in-home use.  Id.  The chamber had been in use in plaintiffs’ home for four months before their son’s death.  On the night of his death, decedent was placed in the chamber by his brother who left the room and went to bed.  Id. at 11-12.  Decedent’s father was not home that night and his mother fell asleep downstairs.  Id. at 12.  When she woke, she checked on her son and found the chamber had deflated and that her son had asphyxiated.  It was later discovered that the hose that pumps air into the chamber had become disconnected when a book shelf had depressed the disconnect button on the hose valve.  Id. at 12-13.Continue Reading Summary Judgment Win Unsealed

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

To those of us who were unable to find a slide in anything that Chase Utley did Saturday night, it made a whole lot of sense to suspend him for two games.  The wisdom of the suspension does not only lie in the fact that, at least as we’ve seen it done and done it ourselves, sliding involves an actual slide across the ground in front of the base, not airborne hurtling above the base toward a fielder’s exposed leg.  It lies at least as much in the practical decision not to allow Utley to trot to the foul line, walk to the plate, jog to his position, or do anything at Citi Field tonight.  Because that might be dangerous.  It shouldn’t be.  But it might be.  Whether you think his play was bush league or clean [the correct answer: “bush league”], there’s no denying that New York now has a palpable dislike for him, one based as much on his getting away with it as his doing it.  And, by telling Utley, “no Citi Field for you,” MLB can defuse the situation.  It was a sensible and practical decision, whether the suspension is supported by the language of the rulebook or not [the correct answer: “it is”].

So too was the Court’s decision in Carlton v. Boston Scientific Corp., 2015 U.S. Dist. LEXIS 132675 (W.D.N.C. Sep. 30, 2015).  [That’s what we call a segue.]  North Carolina has codified the learned intermediary doctrine, but its codification mentions only prescription drugs, not medical devices:

[N]o manufacturer or seller of a prescription drug shall be liable in a products liability action for failing to provide a warning or instruction directly to a consumer if an adequate warning or instruction has been provided to the physician or other legally authorized person who prescribes or dispenses that prescription drug for the claimant unless the United States Food and Drug Administration requires such direct consumer warning or instruction to ac-company the product.

N.C. Gen. Stat. § 99B-5(c).  The learned intermediary doctrine is based on a real-world construct, however, in which patients gain access to certain medical products only through doctors, educated professionals who can understand and interpret the risks and benefits of medical products and describe them to patients.  And that construct applies equally to medical devices and prescription drugs.Continue Reading Court Interprets North Carolina Law to Apply the Learned Intermediary Doctrine to Medical Device Cases

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Over the weekend, we watched one of our favorite “chick flicks,” a holiday-themed montage entitled “Love, Actually.”  One of our favorite characters, played by the ever-brilliant Bill Nighy, is an over-the-hill former pop star who resorts to superimposing cheesy holiday lyrics on a familiar melody in an (ultimately successful) attempt to manufacture one last comeback.  A disc jockey, hearing this effort for the first time, exclaims, “How the mighty have fallen!”  This crossed our mind as we read today’s case, a decision on Daubert motions in a leftover breast implant case.

Twenty-some years ago, we cut our Drug and Device teeth on breast implant litigation, arguing motions in the infant Mass Tort Program in Philadelphia  Back then, the high-profile litigation, involving claims that breast implants caused serious auto-immune diseases in recipients, commanded high levels of attention and resources and produced some landmark verdicts.  Now, with the vast bulk of the litigation long settled, key defendants in bankruptcy, and many of plaintiff’s claims resoundingly debunked, all that remains are isolated opt-outs, like In re Dow Corning, Corp., Ezra v. DCC Litigation Facility, Inc., 2015 WL 5737997 ( E.D. Mich. Sept. 30, 2015), a primer on Daubert’s raison d’etre.

Plaintiff in Ezra claimed that her silicone gel implants caused

muscle aches and pains all over her body; metallic taste in the mouth; chronic problems with diarrhea; dizziness/vertigo problems; chronic low-grade fevers; frequent yeast infections; chronic fatigue; severe headaches; loss of taste and smell; memory loss and loss of concentration; frequent gastrointestinal problems; sinus problems with ear aches; difficulty swallowing; problems with choking; easily bruised with slow healing of bruises and cuts; spider veins on legs and feet; coldness of hands, fingers, feet, toes and face; muscle spasms; problems with rashes; tingling and numbness in extremities; difficulty breathing; unexplained dental problems; excessive hair loss; as well as emotional, physical and financial losses.

Ezra, 2015 WL 5737997, at *1.   She proffered the testimony of three causation experts, and defendant moved to exclude all three.Continue Reading Three Strikes and Out of Court for Breast Implant Opt-Out

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Ever since this blog started, we’ve made plain that we have no use for the so-called “heeding presumption.”  This presumption posits that, because under Restatement §402A, comment j, a defendant providing an adequate warning can presume it will be heeded, a plaintiff should also be able to presume that an adequate warning, had it been granted, would have been heeded.  That’s false equivalence if we’ve ever seen it.  A defendant to such a warning claim needs no heeding presumption, since it wins on adequacy without ever getting to causation.  The comment j discussion really involves design defects (about which more below).  Plaintiffs, on the other hand, are getting a burden of proof shift on warning causation that simply has no basis in reality.  People disregard adequate warnings all the time.

So we fight the heeding presumption whenever it comes up.  Some states have good law on the issue.  N.C. G.S.A. §99B-5(a); Wis. Stat. §895.047(1)(e); Ford Motor Co. v. Boomer, 736 S.E.2d 724, 733 (Va. 2013); Rivera v. Philip Morris, Inc., 209 P.3d 271, 274 (Nev. 2009); Leaf v. Goodyear Tire & Rubber Co., 590 N.W.2d 525, 528-29 (Iowa 1999); Riley v. American Honda Motor Co., 856 P.2d 196, 199-200 (Mont. 1993); Deere & Co. v. Grose, 586 So. 2d 196, 198 (Ala. 1991); Huitt v. Southern California Gas Co., 116 Cal. Rptr.3d 453, 467-68 (Cal. App. 2010); Harris v. International Truck & Engine Corp., 912 So. 2d 1101, 1109 (Miss. App. 2005); McPike v. Enciso’s Cocina Mejicana, Inc., 762 P.2d 315, 319 (Or. App. 1988); DeJesus v. Craftsman Machinery Co., 548 A.2d 736 (Conn. App. 1988); Muilenberg v. Upjohn Co., 320 N.W.2d 358, 366 (Mich. App. 1982); Potthoff v. Alms, 583 P.2d 309, 311 (Colo. App. 1978); Payne v. Novartis Pharmaceuticals Corp., 767 F.3d 526 (6th Cir. 2014) (applying Tennessee law); Tuttle v. Lorillard Tobacco Co., 377 F.3d 917, 925 (8th Cir. 2004) (applying Minnesota law); Wilson v. Bradlees of New England, Inc., 250 F.3d 10 (1st Cir. 2001) (applying New Hampshire law); Christopher v. Cutter Laboratories, 53 F.3d 1184, 1192-93 (11th Cir. 1995) (applying Florida law); Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992) (applying South Carolina law); Muzichuck v. Forest Laboratories, Inc., 2015 WL 235226, at *13 (N.D.W. Va. Jan. 16, 2015); Luttrell v. Novartis Pharmaceuticals Corp., 894 F. Supp.2d 1324, 1345 n.16 (E.D. Wash. 2012).

Almost as many states are adverse.  House v. Armour, Inc., 929 P.2d 340, 347 (Utah 1996); Coffman v. Keene Corp., 628 A.2d 710, 717-19 (N.J. 1993); Eagle-Picher Industries, Inc. v. Balbos, 604 A.2d 445, 468-69 (Md. 1992); Bushong v. Garman Co., 843 S.W.2d 807, 811 (Ark. 1992); Arnold v. Ingersoll-Rand Co., 834 S.W.2d 192, 194 (Mo. 1992); Butz v. Werner, 438 N.W.2d 509, 517 (N.D. 1989); Harlow v. Chin, 545 N.E.2d 602, 606 (Mass. 1989); Bloxom v. Bloxom, 512 So.2d 839, 850 (La. 1987); Payne v. Soft Sheen Products, Inc., 486 A.2d 712, 725 (D.C. 1985); Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038, 1057-58 (Kan. 1984); Seley v. G.D. Searle Co., 423 N.E.2d 831, 838 (Ohio 1981); Menard v. Newhall, 373 A.2d 505, 506 (Vt. 1977); Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1382 (Okla. 1974); Dole Food Co. v. North Carolina Foam Industries, Inc., 935 P.2d 876, 883 (Ariz. App. 1996); Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 555 (Ind. App. 1979).Continue Reading Heedless Heeding Presumptions – How New York Law Became a Morass

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As drug and device lawyers we live in a comment k dominated world.  When we say comment k on this blog, everyone knows what we mean.  We aren’t talking about a scientific discovery regarding potassium.  We aren’t reviewing a new flavor of k-cup for the Keurig.  We aren’t posting about breakfast cereals.  And we definitely are not passing comment on the Kardashians, Kobe, Keanu, or K-Fed.

But just in case you need a refresher, here is the comment k that concerns us:

Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . . Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. . . .  The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Restatement (Second) of Torts §402A, comment k (1965)  (emphasis added).  As you can see from the highlighted language, comment k recognizes that some products – drugs and medical devices in particular – are “unavoidably unsafe” and therefore not defective if properly prepared and accompanied by an adequate warning.  Most courts to have considered the issue have interpreted comment k to mean that manufacturers do not face strict liability for properly manufactured prescription drugs that are accompanied by adequate warnings.  That is true in Washington.  Young v. Key Pharmaceuticals, Inc., 922 P.2d 59, 63 (Wash. 1996) (under comment k, a prescription drug manufacturer is liable “only if it failed to warn of a defect of which it either knew or should have known . . . it is liable in negligence and not in strict liability”).Continue Reading No Error With Comment k Jury Instruction

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Ninety-nine years ago tomorrow Georgia Tech administered the most lop-sided beat-down in college football history, edging Cumberland University 222-0.  (By the way, who was the head coach of Georgia Tech who presided over that delightful display of sportsmanship?  Find the answer below.)  Today we blog about a legal beat-down, though in this case it is the plaintiff-losers – actually, the plaintiff lawyers – who were the bad sports.  The case involves a firm client, though we were not involved.  There is still an open issue remaining regarding transfer, so we will do our best to resist spiking the ball.  Instead, we will simply gather in the victory formation as we report the court’s holding as if we were writing a box-score, sans razzle and dazzle.

The case is Hill v. Eli Lilly & Co., 2015 U.S. Dist. LEXIS 130934 (S.D. Indiana Sept. 29, 2015), and is another step in the saga of Cymbalta plaintiff lawyers who keep pushing the litigation up a hill in an effort to create a class action, mass action, MDL, or whatever will allow them to park as many meritless cases in one place, only to have that litigation roll back down the hill, resulting in crushed toes, directed verdicts, and jury findings of no liability.  The judge in the Hill case saw through the plaintiff shenanigans and granted a motion to sever plaintiffs who had been joined in a transparent and meritless effort to create a mini-MDL.

Before granting the motion to sever, the judge supplied a bit of background, so we will, too.  Plaintiffs’ counsel, often the very same lawyers, have been filing Cymbalta cases around the country.  There are various claims, but the central allegation is that the warnings regarding withdrawal symptoms were inadequate.  Plaintiffs tried to certify a class in C.D. Cal.  They failed.  Plaintiffs petitioned for creation of a Multi-district Litigation.  They failed.  Plaintiffs’ counsel then filed six Cymbalta lawsuit in S.D. Indiana, all but one involving multiple plaintiffs from different states.  Other plaintiffs’ counsel pursued the same strategy.  Some plaintiffs who had filed their cases in other federal districts moved to transfer those cases to S.D. Indiana, mostly, though not always, without success.  Then plaintiffs’ counsel showed their hand by again seeking creation of an MDL, this time in S.D. Indiana.  If at first you don’t succeed, file, file again.Continue Reading Cymbalta Judge Severs Claims and Smacks Down Plaintiff Lawyers’ Self-Created “Quagmire”

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Just last month we collected all the favorable precedent applying impossibility preemption under Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), to innovator drugs – although the precise subject of that post was preemption of design defect claims involving §510(k) medical devices.  We were aware of four such rulings, all in the last year or so:  Yates v. Ortho-McNeil Pharmaceutical, Inc., 76 F. Supp.3d 680, 686-88 (N.D. Ohio 2015); Shah v. Forest Laboratories, Inc., 2015 WL 3396813, at *5 (N.D. Ill. May 26, 2015); Booker v. Johnson & Johnson, 54 F. Supp.3d 868, 874-75 (N.D. Ohio 2014); Amos v. Biogen Idec, Inc., 28 F. Supp.3d 164, 168-69 (W.D.N.Y. 2014).

We think the argument that Bartlett intended for implied impossibility preemption extend to all drugs – generic and innovator – is painfully obvious.  The Court in Bartlett went out of its way to state, “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications.’”  133 S. Ct. at 2471 (quoting 21 C.F.R. §314.70(b)(2)(i)) (emphasis added).  After all, why else would the Court have specifically mentioned “brand name” drugs if not to indicate that the same preemptive logic included them?Continue Reading Another Decision Applying Bartlett Preemption to All Drugs

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Here are a couple of non-litigation related matters that we thought our readers need to know about.

First, the FDA.  We’ve pointed out before that the FDA’s “intended use” regulations for drugs (21 C.F.R. §201.128) and devices 21 C.F.R. §801.4) both contain the following potentially disturbing language:

[I]f a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.

This language has the potential, if the FDA wanted to, to allow the prosecution of a drug or device manufacturer for an “adulterated”/”misbranded” product (for not having “adequate labeling”), merely because that manufacturer KNEW ABOUT off-label use of its products – forget promotion (truthful or otherwise). Fortunately, the FDA generally has not read this language literally.  Instead it requires prior agency approval of warnings about risks peculiar to off-label uses (we discussed that here).Continue Reading The FDA Tiptoes – and Congress Splashes Into – the 21st Century

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We have not posted for a while—that day job can really get in the way sometimes—so we agreed to tackle the ridiculously long decision in Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist. LEXIS 115601 (N.D. Ga. Aug. 31, 2015), as a bit of penance.  This act may be appropriate given the recent Day of Atonement and, much like long Yom Kippur services during a fast, the decision drags on, repeats itself, has some highs and lows, and maybe induces some confusion and a touch of a headache.  While we are not looking for a scapegoat, some of the reasoning for why the issues were presented how they were presented and why they were decided is lost on the reader, at least this reader.  (Much like the original meaning of Azazel, to where/whom the original scapegoat was to be sent by Aaron.  Or maybe not at all like that.)  As a combination Daubert and summary judgment order on a bellwether case from an MDL for a product, a metal-on-metal hip implant, for which there is considerable litigation on similar products made by other manufacturers, there will likely to attempts to extend various parts of this decision to other cases.  So, we will resort to the dreaded use of subheadings in discussing it.

Background

Plaintiff had a left hip replacement in 1995 with a device that used a ceramic femoral ball, a polyethylene liner, and a metal acetabular shell.  In 2006, plaintiff had her right hip replaced with the defendant’s product, which utilized a ball and cup each made of cobalt-chromium with no liner.  In 2012, plaintiff started experiencing pain in her right hip and, within a week, had a revision surgery where the defendant’s product was explanted (and presumably something else was implanted).  All three surgeries were done by Dr. Lynn Rasmussen, who happened to have been consulting with defendant on designing hip implants in between the second and third surgeries.  In doing the third surgery, Dr. Rasmussen observed what he called “metallosis” (sometimes “metalosis” in the records and briefs), but did not send any explanted tissue or material for pathological evaluation.  Plaintiff sued under a range of product liability theories based on the risk of “metallosis.”  Thereafter, plaintiff named at least ten experts to weigh in on causation and defect in some form or other, most of whom relied to some degree on Dr. Rasmussen’s characterization of what he saw—and defendant filed a bunch of Daubert motions.  Plaintiff filed a “motion for partial summary judgment” that preemption and the learned intermediary doctrine did not apply to her claims and, at the court’s request, the defendant filed a motion for summary judgment on all the claims that plaintiff did not drop.  An affiliated defendant also filed for summary judgment on different grounds.  There were some other motions we are ignoring, but everything was addressed in one big decision.Continue Reading Making Sense of the Rule 702 and Summary Judgment Orders in A Metal-on-Metal Hip Implant Bellwether Case

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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