2016

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Ponder the following:  A man attends an exercise class at a facility run by a local religious institution.  Assume that he belonged to this facility, wanted to attend an exercise class because his fitness was less than optimal, and was informed of the need to get medical advice before starting a new and potentially demanding exercise program.  He had a heart attack and collapsed right after leaving the class.  Assume that the heart attack was not a total surprise given his health, but that he had not had a heart attack before and had not informed the people running the class of any particular risk.  The class instructor rushed to the man’s aid while others called 911.  The instructor was certified in cardiopulmonary resuscitation (“CPR”) and did her best to help the man.  When paramedics arrived, they assumed care of the man, but he died despite their best efforts.

Based on these facts and assumptions, answer this question:

Who should the man’s estate sue over his death?

A) Nobody.  B) The class instructor.  C) The religious institution.  D) The entities that operate the 911/EMT system.

If you answered other than “A,” then you might need to examine your propensity to blame others.

Add in the following to the scenario presented above:  The class instructor tending to the man did not utilize an automated external defibrillator (“AED”) that she knew was present and was certified in using.  She brought the AED to the man’s side, but elected not to use it because, in her judgment, he was having a seizure and not a heart attack.

Based on these additional facts, answer these questions:

1.  Who should the man’s estate sue over his death?

A) Nobody.  B) The class instructor.  C) The religious institution.  D) The entities that operate the 911/EMT system.  E) The company that sold the AED and offered training to purchasers.

2.  If the man’s estate already sued the religious institution over his death, who should the defendant bring in via third-party complaint?

A)  Nobody.  B)  The class instructor.  C) The entities that operate the 911/EMT system.  D) The company that sold the AED and offered training to purchasers.

In Wallis v. Brainerd Baptist Church, No. E2015-01827-SC-R11-CV, 2016 Tenn. LEXIS 920 (Tenn. Dec. 22, 2016), the estate sued the church that ran the gym and then both turned their attention to the seller of the medical device that was not used.  It is often said that bad cases make bad law, but sometimes egregiously over-reaching cases can make good law.  Ultimately, Wallis fits into the latter category.  A contrary result, which would have allowed a negligence or contract claim against the seller of a device that was not used with the decedent, would have been bad, maybe bad enough to have been mentioned in our bottom ten post last week.Continue Reading Decision Limiting Duties regarding Automated External Defibrillators Does Not Shock The Conscience

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Happy birthday to Stan Lee, the main man behind Marvel Comics. He wrote the stories for The Amazing Spider Man which, when we were 10 years old, we read with a good deal more enthusiasm than we presently feel when encountering the deathless prose in (a) a plaintiff motion to compel, or (b) pretty much any opinion out of the Missouri state courts. When we were at Comic Con in San Diego last Summer, the only autograph we wanted was Stan Lee’s. But the line was indecently long. Hundreds of Thors, Daredevils, and X-men stood between us and the object of our adoration. We knew any hope of meeting our hero was pure fantasy. Anyway, if our friends at the Abnormal Use blog do not have a picture of a Marvel comic at the top of today’s post, we will be very much disappointed.

Happy birthday, also, to Denzel Washington. Most of you probably know him from his movies, such as Glory, Malcolm X, Training Day, and, currently, Fences. But we first laid eyes on Washington when he appeared in the very fine television show, St. Elsewhere. That program was set in a Boston hospital. It ran from 1982 to 1988. Denzel Washington was in the cast all six years. The entire cast was superb, and the writing was inventive. It is possible that the ending of St. Elsewhere (cleverly titled “The Last One”) was a little too inventive. It turned out that everything that happened in the series was the fantasy of an autistic child. To our eyes, it seemed a bit of a cheat. But maybe it was a commentary on art. Art is artifice. It is a lie in service of some bigger truth. It is a fine falsehood.

So fantasy and falsehood seem to be our themes for the day. Massachusetts has an interesting history of falsehoods in legal history. The Salem Witch trials had their origin in a silly girl’s lies. It is easy to read the trial transcripts of the Sacco and Vanzetti trial, or the trial of Lizzy Borden, and conclude that great injustices were done. More recently, and more to the point for the sort of law we practice, the history of False Claim Act cases against drug and device companies in the Bay State has been inglorious. Cases have marched forward and cost companies many millions of dollars in the absence of any actual falsehoods. We are even more dismayed when we consider the overly aggressive and incoherent positions sometimes adopted by our former employer, the Department of Justice. But maybe, just maybe, courts in the Bay State are starting to exercise some control over, and impose reasonable limits on, False Claims Act cases.Continue Reading First Circuit Affirms Dismissal of False Claims Act Case

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One doesn’t see many new PMA preemption issues raised, but we found a case that does just that – Vincent v. Medtronic, Inc., 2016 WL 7374271 (N.D. Ill. Dec. 20, 2016). We are used to seeing plaintiffs try to use off-label use to circumvent PMA preemption. Just check out any of our Infuse posts to see how badly that has worked out for plaintiffs. They largely unsuccessfully have argued that if a product is used off-label, it is used for a purpose for which its PMA approval does not apply and therefore, the PMA requirements likewise don’t apply which plaintiffs contend means preemption should not apply. The courts have disagreed.

In Vincent, plaintiffs tried a similar end run around preemption. Plaintiff underwent surgical implantation of a pacemaker on February 12, 2004. The pacemaker lead used in the surgery was a Class III, PMA medical device. Shortly before plaintiff’s surgery, Medtronic had submitted the lead for supplemental pre-market approval. The approval was granted on March 10, 2004. Id. at *1. Ten years later, plaintiff had to undergo explant surgery due to a fractured lead and then filed a products liability suit. Id. at *2. In addition to standard claims based on failure to warn and design defect, plaintiff alleged that the lead had not received FDA approval at the time of the initial procedure, which was not disclosed to plaintiff or his surgeon. Id.Continue Reading A Twist on PMA Preemption

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Ever since Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), held that state-law claims alleging fraud on the FDA are preempted, plaintiffs have been attempting to find some other way of bringing claims that attribute FDA actions to a defendant’s false pretenses.  Since preemption is based on the Supremacy Clause, and the constitutional relationship between the federal and state legal systems, the doctrine doesn’t apply where recovery is sought under a federal statute.  Since the False Claims Act (“FCA”) is a federal statute, sporadic attempts have been made to bring private fraud-on-the FDA-claims under that statute.  Bexis, who invented what became the Buckman fraud-on-the-FDA/implied-preemption defense in the Bone Screw litigation, even worked on an amicus brief in one such case, United States ex rel. Gilligan v. Medtronic, Inc., 403 F.3d 386 (6th Cir. 2005), that was ultimately decided (favorably to the defense) on other grounds.

A little less than a year ago we reported on an excellent FCA result in United States ex rel. D’Agostino v. EV3, Inc., 153 F. Supp.3d 519 (D. Mass. 2015).  Ever since we’ve been holding our breath, because the First Circuit has been known for pro-plaintiff rulings in cases against our drug and medical device clients.  Indeed, the First Circuit once led our list the worst drug/medical device cases of the year for two years running – in 2012 and 2013.  Whether something’s changed since then in the First Circuit, we can’t say.  But we can report that the district court’s dismissal of fraud-on-the-FDA-based FCA claims in D’Agostino has just been affirmed with an excellently reasoned decision.  See D’Agostino v. EV3, Inc., ___ F.3d ___, 2016 WL 7422943 (1st Cir. Dec. 23, 2016).

The facts in D’Agostino were thoroughly explained in our prior post.  Briefly, the relator (a fired sales rep) alleged that the defendants pulled fast ones on the FDA with respect to the approvals/supplemental approvals of two medical devices, one called “Onyx” and the other “Axium” (these defendants evidently like “x” as much as did the former Standard Oil of New Jersey).  The relator-plaintiff claimed that the defendants:  (1) sought approval of Onyx for a narrow indication, but intended to promote it more broadly off-label (exactly the claim in Buckman); (2) failed to live up to promises made to the FDA concerning extensive surgeon training in using Onyx (also a form of fraud on the FDA); (3) concealed the failure of Onyx’s active ingredient in a different device (ditto); and (4) failed to recall earlier versions of Axium after obtaining FDA approval (not fraud on the FDA, but a theory that could dangerously penalize innovation).  See D’Agostino, 2016 WL 7422943, at ??? (for some reason WL has omitted star paging, so we’ll also cite to the slip opinion), slip op. at 4-8.  Critically, although the FDA was informed of all of these claims, the Agency never instituted any enforcement action, nor did the government elect to join the D’Agostino FCA action.  Id. at 9, 15.  As discussed in the prior post, the district court dismissed all of these claims with prejudice as futile.Continue Reading Fraud on the FDA Doesn’t Fly Under the FCA Either

Photo of Steven Boranian

This is the second time in two years that we have written the Drug and Device Law Christmas blogpost. Last year, your dedicated blogger posted on Christmas Day a nice little piece on innovator liability that we are sure you all read while listening to Andy Williams, drinking egg nog, and roasting chestnuts on an open fire (note: If you would rather not light an open fire, a gas grill is a very capable substitute for roasting chestnuts, if that is your thing.) If you did not read our post last year, we forgive you.  And whether you read us regularly or just pop in from time to time to read about preemption, please accept our holiday greetings and our undying gratitude.  To all our readers, Happy Holidays from the DDLB!

Our gift to you on this Friday, December 23, 2016, is a blogpost discussing a topic on which we have not written a lot—alter ego personal jurisdiction.  That is when a court takes jurisdiction over a corporation based on the forum contacts of a corporate subsidiary.  We wrote about a district court rejecting alter ego jurisdiction here, but there is not much else discussing the subject in detail in the archive. That could be because successful examples of alter ego jurisdiction are exceedingly rare.  The most common scenario is where plaintiffs sue an alleged corporate wrongdoer and try to hale into court not only the alleged wrongdoer, but also its out-of-state corporate parent.  Their motivation is not a mystery:  Plaintiffs want more defendants, larger balance sheets, and deeper pockets to reach into.  And if the corporate parent has a recognizable “big” name, that’s all the better.

Unfortunately for plaintiffs and fortunately for the defense, this transparent ploy rarely works, and it did not work in a recent hip replacement case, Goldthrip v. Johnson & Johnson, No. 15-00651-KD-B, 2016 U.S. Dist. LEXIS 170801 (S.D. Ala. Dec. 8, 2016).  In Goldthrip, the plaintiffs sued not only the company that made and sold the hip implant, but also its corporate parent.  There were, however, two problems:  First, the plaintiffs sued in Alabama, but the parent corporation was a New Jersey company.  Second, the parent corporation neither made nor sold products; it was a holding company, as parent companies often tend to be. Id. at **2-4.Continue Reading Alter Ego and Agency – A Different Spin on Jurisdiction

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The “pits of hell,” “black as a pit,” a “bad feeling in the pit of my stomach” – that’s how we feel about 2016’s bottom ten decisions of the year arising from prescription medical product liability litigation. This year’s collection of coal in our collective stockings is as justifiable a cause for seasonal affective disorder as almost anything we can think of, since we do not discuss politics on the blog.

So here we go. Don’t shoot us, we’re only digital piano players.  If any of these cases is yours, we sympathize.  We’ve been there (see 2013 -2), and we know how it feels.  We can’t wait for next week we get to toast in the New Years with the best, instead of drowning our sorrows with the worst.Continue Reading The Pits – The Worst Prescription Drug/Medical Device Decisions Of 2016

Photo of Stephen McConnell

This is the time of year for Best and Worst lists.  Our own lists of the best and worst drug and device law decisions of 2016 will be coming out soon.  Meanwhile, we have no doubt that the worst moments in our own day-to-day practice consist in litigating about litigation.  That is, whether on offense or defense, it is mind-numbing to fight over, not the merits of the case, but whether some party is complying with the rules of civil procedure.

We said “offense or defense,” but who are we kidding?  Discovery in our cases is wildly asymmetrical.  Plaintiffs grudgingly sign health record authorizations, while our clients are forced to disgorge millions of documents, at an expense many times over what most defendants in other civil litigations who have already been found liable (of course, our clients have thus far not been found liable for anything) end up paying in total. Producing electronically stored information (ESI) is virtually impossible to get fully right, but plaintiffs ask for, and all too frequently get, a requirement that corporate defendants furnish certificates of completion.  Such certificates are not required by any rules.  Somehow, overreaching plaintiffs have managed to persuade some courts to take something as silly and unrealistic as the discovery rules and make them even worse.   Pretty soon, court hearings devolve into plaintiff lawyers ruefully marching to the lectern to complain about alleged gaps in discovery and demand sanctions.  Forget about the fact that this litany of carping is on behalf of an inventory of plaintiffs whose mostly meritless claims go gleefully untested until the defendant waves a white flag and submits to a fairy tale otherwise known as a settlement grid.  Apropos of the season, we say humbug.

It is a pleasant surprise when a court calls an end to the discovery gotcha game.  That happened last week in Small v. Amgen, Inc., No. 2:12-cv-476-FtM-PAM-MRM (Dec. 14,  2016).  We have written on the Small case before.  See here, for example.  The issue teed up most recently in the Small case was the plaintiffs’ motion for sanctions under Federal Rule of Civil Procedure 37 for an alleged failure to comply with the court’s omnibus discovery order.  The Small court held that “[f]or all its sound and fury … Plaintiffs’ Motion fails – utterly – to identify any actual violation” of the court’s prior orders.   That magisterial “utterly” conveys a sense of weariness and frustration.  Yes, we know the feeling.Continue Reading Good Things Come in Small Packages: M.D. Fla. Rejects Plaintiff’s Discovery Gotcha Gamesmanship

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What follows is a guest post about a recent favorable decision in Canadian drug/device litigation.  Unlike in the USA, product liability class actions cases are often certified in Canada.  Thus, any pro-defense decision is good news indeed.  Robin Linley and Jessica Lam of Blake, Cassels & Graydon LLP in Toronto have been good enough to provide us what they call a “brief and selective summary” of Wise v. Abbott Laboratories Limited, No. CV-16-550747CP, 2016 ONSC 7275 slip op. (Ont. Super. Nov. 23, 2016), which in typical Canadian fashion, takes 85 pages to reach a result that our clients will like.  As always, our guest posters are 100% responsible for their content, and thus entitled to 100% of the credit or blame, as it may be, for what appears below.

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In a recent product liability class action decision, Wise v. Abbott Laboratories Limited, No. CV-16-550747CP, 2016 ONSC 7275 slip op. (Ont. Super. Nov. 23, 2016) (“Wise“), the Ontario Superior Court of Justice (“Court”) granted the defendants’ motion for summary judgment in advance of the certification motion, concluding that there was no genuine issue requiring a trial because there was insufficient evidence of general causation.  The decision highlights the potential for defendants to use summary judgment to resolve a class action before certification in appropriate cases.

The representative plaintiff brought a proposed class action against Abbott alleging that its testosterone replacement product, for the treatment of hypogonadism (testosterone deficiency) in men, caused serious cardiovascular (CV) events.  The plaintiff further alleged that the drug had no therapeutic benefit and that class members should be compensated for their economic losses incurred in purchasing the product. The plaintiffs also sought recovery from the defendant based on allegations of failure to warn and the novel claim of “waiver of tort”.

Abbott submitted that the plaintiff’s claims should be dismissed on the grounds that they could not prove general causation, which was a constituent element in all of the plaintiff’s product liability claims, and that ultimately, there was insufficient evidence of a “genuine issue requiring a trial”.Continue Reading Guest Post – Ontario Court Decision Highlights Summary Judgment as a Potential Tool in Class Proceedings North of the Border

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It’s hard to believe that, with over half of all cases pending in the federal courts now docketed in multi-district litigations (“MDLs”), the statutory basis for all this litigation is but one section of the United States Code:

(a) When civil actions involving one or more common questions of fact are pending in different districts, such actions may be transferred to any district for coordinated or consolidated pretrial proceedings. Such transfers shall be made by the judicial panel on multidistrict litigation authorized by this section upon its determination that transfers for such proceedings will be for the convenience of parties and witnesses and will promote the just and efficient conduct of such actions.  Each action so transferred shall be remanded by the panel at or before the conclusion of such pretrial proceedings to the district from which it was transferred unless it shall have been previously terminated:  Provided, however, That the panel may separate any claim, cross-claim, counter-claim, or third-party claim and remand any of such claims before the remainder of the action is remanded.

(b) Such coordinated or consolidated pretrial proceedings shall be conducted by a judge or judges to whom such actions are assigned by the judicial panel on multidistrict litigation. For this purpose, upon request of the panel, a circuit judge or a district judge may be designated and assigned temporarily for service in the transferee district  . . .  The judge or judges to whom such actions are assigned, the members of the judicial panel on multidistrict litigation, and other circuit and district judges designated when needed by the panel may exercise the powers of a district judge in any district for the purpose of conducting pretrial depositions in such coordinated or consolidated pretrial proceedings.

(c) Proceedings for the transfer of an action under this section may be initiated by −

(i) the judicial panel on multidistrict litigation upon its own initiative, or

(ii) motion filed with the panel by a party in any action in which transfer for coordinated or consolidated pretrial proceedings under this section may be appropriate. A copy of such motion shall be filed in the district court in which the moving party’s action is pending.

[Procedures for the JPML deliberations on creating MDLs, notice, and filing of transfer orders]

(d) [Composition of JPML]

(e) [Restrictions on appealability of JPML orders]

(f) The panel may prescribe rules for the conduct of its business not inconsistent with Acts of Congress and the Federal Rules of Civil Procedure.

(g) [Peculiar to antitrust]

(h) [Peculiar to antitrust]

28 U.S.C.A. §1407.

That’s it. There are as many subsections of the MDL statute (2) peculiar to antitrust as there are governing the substance of what MDLs are intended to accomplish.Continue Reading The Multi-District Litigation Statute Needs Rewriting

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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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