A Twist on PMA Preemption

By Michelle Yeary on December 27, 2016

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.

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Fraud on the FDA Doesn’t Fly Under the FCA Either

By Bexis on December 26, 2016

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.

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Alter Ego and Agency – A Different Spin on Jurisdiction

By Steven Boranian on December 23, 2016

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.

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The Pits – The Worst Prescription Drug/Medical Device Decisions Of 2016

By Bexis on December 22, 2016

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.

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Good Things Come in Small Packages: M.D. Fla. Rejects Plaintiff’s Discovery Gotcha Gamesmanship

By Stephen McConnell on December 21, 2016

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

Guest Post – Ontario Court Decision Highlights Summary Judgment as a Potential Tool in Class Proceedings North of the Border

By Bexis on December 20, 2016

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”.

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The Multi-District Litigation Statute Needs Rewriting

By Bexis on December 19, 2016

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.

(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.

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Heeding Presumption Only Goes So Far In Post-Sale Warning Case

By Eric Alexander on December 16, 2016

Devoted as we are to the defense of manufacturers of prescription drugs and medical devices, we have often advocated for the full implication of the fundamental—to us, at least—requirements that warnings claims focus on the decision making of the learned intermediary and that proximate cause matters. One implication is that heeding presumptions typically make little sense for claims about these products. It is one thing to say that a plaintiff should be allowed to proceed with a warnings claim when a prescriber is truly unavailable to provide testimony—like by dying before the plaintiff knew he had a claim—and the alleged missing warning would have clearly contraindicated the plaintiff from receiving the prescription product. In such a case, it might make sense to presume, absent contrary evidence, that the physician would have heeded the warning and not prescribed the product to the plaintiff. In just about every other prescription drug and device case we can imagine, the heeding presumption does not make sense.

We feel the same way about a post-sale duty to warn. Not only do such duties run contrary to the typical focus in warnings cases on the notice to the manufacturer of potential risks before the product leaves its control (or is prescribed to plaintiff), but the proximate cause inquiry can quickly become an exercise in layered speculation. Cases acknowledging such a post-sale duty have typically involved situations where the seller had a continuing relationship with the purchaser, with an obvious route for relaying additional information about the product in a way that allows a jury to evaluate whether injury would have been avoided. In prescription drug and device cases, there tends not to be any direct relationship at any time and the manufacturer does not know the names or addresses of patients using its products. Over time, patients move, change their physicians, and even see physicians for reasons unrelated to the reason they were prescribed a drug or device in the past. Over time, manufacturers also stop selling specific products or product lines and may even go out of business. When it comes to drugs with alleged remote effects or devices that are implanted for many years, these real world considerations make potentially unlimited post-sale duties to warn a folly. We could go on, but we will not.

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A Gem on Alternative Design from a Pelvic Mesh MDL

By Steven Boranian on December 15, 2016

We don’t write a lot on the various pelvic mesh MDLs in West Virginia because we are so heavily involved in two of them. But the MDL court entered an order last week on design defect and alternative design that we consider to be a real gem. The case is Mullins v. Ethicon, Inc., No. 2:12-cv-02952, 2016 WL 7197441 (S.D. W. Va. Dec. 9, 2016), and we recommend it to all of you. We say that not only because the district court held that West Virginia law requires that each plaintiff must prove a feasible alternative design—which is the correct result—but also because the order is particularly well reasoned.

Not every state requires proof of a feasible alternative design, but it is nevertheless a basic product liability concept. It is a particularly good fit when dealing with products that always bear risks—such as implanted medical devices. The Restatement (Third) of Torts, Product Liability § 2 is as good a place as any to start, as it bakes alternative design right into the definition of a design defect: “A product . . . (b) is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe.” (emphasis added).

Take the obvious example of a machine with sharp spinning parts. The same machine with a protective guard may be a safer alternative design. Or it might not. The point is that the plaintiff has to prove it. Take also the example we discussed in Bexis’ aptly named post “On Alternative Design.” That case involved hernia mesh, not pelvic mesh, and the plaintiffs’ claims failed because, among other reasons, they had failed to prove that a mesh of a different design would have been any safer. Consider hormone-based contraceptives. Cholesterol drugs. We could go on and on. All these products bear known and unavoidable risks, and those risks should not be labeled “defects” and result in potential liability unless the plaintiff can prove an alternate design would feasibly mitigate them. And, no, it is not sufficient to say that the feasible alternative is to use a different product or not use any product at all. As we observed in the aforementioned post, that would convert strict liability into absolute liability. As we asked in yet another post on this topic, are motorcycles defective because full-sized automobiles are generally safer? You get the point.

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Law Review Article Argues that Contraception Mass Torts Injured Consumers

By Stephen McConnell on December 14, 2016

It is bad enough that the mass tort system in our country approximates a system of jackpot justice that, if it ever does justice among the parties, does so accidentally. But its wild inefficiencies and inconsistencies also have macro adverse effects on things like consumer choice and the overall healthcare system.

A recent law review article offers further support for our scurvy view of mass torts by explaining how the long, inglorious history of lawsuits against contraceptives has hurt consumers and society. The article is by Eric Lindenfeld, is entitled “The Unintended Pregnancy Crisis: A No-Fault Fix,” and it appears in the Spring 2016 issue of the Marquette Benefits & Social Welfare Law Review.

The article begins by outlining the unintended pregnancy crisis, which is caused at least in part by dissatisfaction with current methods of contraceptives. The article argues that the less-than-robust portfolio of available contraceptives is attributable to a stagnant research and development milieu for new contraceptives. That stagnant milieu is attributable, in turn, to the frenzy of mass torts against contraceptives. The article recites the history of litigation against the birth control pill, Dalkon Shield, Norplant, as well as more recent litigations, such Yaz/Yasmin, Mirena, and Essure. Not all of those litigations were particularly successful for plaintiffs. Not all possessed any merit. For example, the article cites evidence that Norplant turned out to be safe and efficacious – but the expense of the litigation and the enormous adverse publicity drove the product from the market. The real losers were consumers.

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Drug & Device Law