Legislation

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Even after having read it through twice, we find the result in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), hard to fathom, and even harder to stomach.  For several years after starting the blog, one of our aphorisms was “nothing good ever comes out of Missouri.”  Then legal developments caused us to retire that slogan.  Now we may have to bring it back – maybe.

Barron affirmed a $48 million verdict – concerning birth defects – against the maker of a drug that had a black box warning – about birth defects

[THE DRUG] CAN PRODUCE TERATOGENIC EFFECTS SUCH AS NEURAL TUBE DEFECTS (E.G., SPINA BIFIDA). ACCORDINGLY, THE USE OF [THE DRUG] IN WOMEN OF CHILDBEARING POTENTIAL REQUIRES THAT THE BENEFITS OF ITS USE BE WEIGHED AGAINST THE RISK OF INJURY TO THE FETUS.

Barron, 2016 WL 6596091, at *1.

Astonishingly, this boxed warning, which only the FDA can mandate, was a sufficiently inadequate advisory that the drug could cause birth defects that a St. Louis (City) jury awarded $23 million in punitive damages to the plaintiff, who was from Minnesota.

And those two places – St. Louis City and Minnesota – are as much the problem as the “Show-Me-The-Money State” verdict itself. Barron is a poster child for venue and joinder run amok.  First, the underlying action was filed by 24 plaintiffs from all over the country (13 different states), with nothing in common save claiming somewhat similar injuries to different persons from the same drug.  Id. at *4.  Of course, a couple of plaintiffs were from Missouri (and another presumably from the home state of a defendant), in order to defeat diversity.  Id. at *2.Continue Reading Awful Missouri Venue/Joinder Ruling Offers Way Out – Take It!

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No, we’re not here to muse about how our lack of contact with advanced extra-terrestrial civilizations might be due to an unfortunate proclivity for “intelligent” life to invent technology that destroys their home planets before developing technology that permits the colonization of other planets. We limit ourselves to the drug and medical device product liability space.

First, we reiterate our belief that under a Trump administration, the FDA’s proposed – and oft-postponed − final rule, the one that seeks to abolish generic preemption by enacting regulations that likely violate the FDCA’s “sameness” requirement for generic drugs, is kaput.  When we learned earlier this year that the FDA had postponed the finalization date until after the election, we immediately pronounced it dead.   We still believe that.  We find it difficult to believe that a Trump FDA would continue a controversial Obama FDA proposal that has always been pursued as a sop to the plaintiffs’ bar, a major supporter of the outgoing president.  If there’s one thing we know Donald Trump believes in, it is getting revenge.

Second, the odds of another pro-tort-preemption Supreme Court justice to fill the vacant seat created by Justice Scalia’s death have increased significantly. The stark fact is that tort preemption has become a distinctly partisan issue on the Supreme Court.  The two most recent drug/device Supreme Court decisions, PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 246 (2013), were both decided by five Republican appointees favoring preemption and four Democratic appointees opposing it.  Had the outcome been different, we would have considered the ultimate survival of Mensing/Bartlett unlikely.Continue Reading How Might a Trump Administration Affect Our Sandbox?

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Bexis recently attended the “Emerging Issues in Mass-Tort MDLs Conference” sponsored by Duke Law School (those of us from Philly remember Duke as part of “Black Saturday” back in 1979).  Several panels discussed various issues relating to MDLs including using early, issue-specific fact sheets, which Bexis advocated be considered amended pleadings subject to Rule 8…

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We blogged a couple of years ago about the beginnings of what has become a wave of state “Right to Try laws” – laws that purport to give terminal patients with no other medical options the right to seek investigational drugs for their conditions from manufacturers who have yet to obtain full FDA approval.  Mostly, these laws are motivated by the unwieldy nature of the FDA’s “compassionate use” regulations, which are directed at the same problems.  Given that these laws originated with a “states’ rights group” called the Goldwater Institute, we strongly suspect that a second motive of gratuitously poking the FDA in the eye was also at work.

Whatever their provenance, we were deeply skeptical of their practicality. Three large obstacles loomed.  Number one:

For one thing, there’s the FDA. States can pass all the laws they want, but unless the FDA gives its okay to programs more expansive than its compassionate use (“expanded access”) program, nothing’s going to happen.

Number two:

The reason, as is the case for so many things these days, is the threat of liability. . . . You won’t induce a manufacturer to participate in a voluntary program by painting a target on its back.

Number three:

There’s no upside. These statutes are for use by very ill people, and if (as is unfortunately likely) the statutory participant died, then there’s an adverse event that must be reported to the FDA.  Companies investigate drugs in the hope of obtaining approval.  Adverse events definitely don’t help get approval.

Indeed, despite a couple dozen Right to Try statutes enacted over the last few years, we are unaware of even a single instance in which anybody successfully obtained treatment with an investigational drug under any of these state laws.Continue Reading Developments in Compassionate Use and Right To Try Laws

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The West Virginia legislature has passed, and the governor signed today, S.B. 15, adopting the learned intermediary rule.  Here is a link to the legislative history of the bill. Here is the text of the bill:

[Passed February 17, 2016;  in effect 90 days from passage.]

AN ACT to amend the Code of West Virginia, 1931, as amended, by adding thereto a new section, designated §55-7-30, relating generally to manufacturers and sellers of prescription drugs and medical devices and liability of those entities for alleged inadequate warning or instruction; and adopting the learned intermediary doctrine as defense to civil action based upon inadequate warnings or instructions.

Be it enacted by the Legislature of West Virginia:

That the Code of West Virginia, 1931, as amended, be amended by adding thereto a new section, designated §55-7-30, to read as follows:

ARTICLE 7. ACTIONS FOR INJURIES.

§55-7-30. Adequate pharmaceutical warnings; limiting civil liability for manufacturers or sellers who provide warning to a learned intermediary.

(a) A manufacturer or seller of a prescription drug or device may not be held liable in a product liability action for a claim based upon inadequate warning or instruction unless the claimant proves, among other elements, that:

(1) The manufacturer or seller of a prescription drug or medical device acted unreasonably in failing to provide reasonable instructions or warnings regarding foreseeable risks of harm to prescribing or other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; and

(2) Failure to provide reasonable instructions or warnings was a proximate cause of harm.

(b) It is the intention of the Legislature in enacting this section to adopt and allow the development of a learned intermediary doctrine as a defense in cases based upon claims of inadequate warning or instruction for prescription drugs or devices.

NOTE: The purpose of this bill is to adopt and codify the learned intermediary doctrine as a defense to a civil action against a manufacturer or seller of a prescription drug based upon inadequate warnings or instructions.Continue Reading Breaking News – West Virginia Statute Adopts Learned Intermediary Rule

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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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An inter-agency taskforce is proposing a comprehensive overhaul of “Federal Policy for the Protection of Human Subjects” in today’s issue of the Federal Register (comments close on 12/7/2015).  See 80 Fed. Reg. 53933 (Sept. 8, 2015). The proposal is 130 pages long, but most of it won’t have much relevance to product liability, except insofar as a plaintiff might have been injured during the course of a clinical trial.  In the past we’ve been interested in clinical trial regulations primarily for three reasons: (1) if they allow plaintiffs to argue that entities other than treating physicians (usually hospitals) have informed consent obligations; (2) if they clearly distinguish between off-label and “investigational” use of prescription medical products, and (3) preemption.

With that in mind we’ve looked through the new proposal.

Informed Consent:

We don’t see much in the new rule expanding who is required actually to obtain informed consent – only that the informed consent requirement would be extended to a lot more types of research, such as that involving “biospecimens” lacking individualized identifying information.  That seems like a lot more work in situations without additional risk of physical injury to research subjects, id. at 54028, but precisely because of the low risk of harm inherent in most biospecimen situations, we doubt it will have much impact on product liability.  It could increase other kinds of litigation, however, such a privacy (won’t keeping all these informed consent forms effectively re-identify the specimens?) and intellectual property (identifiable research subjects are more likely to want a piece of the economic “pie” created through research using their specimens).Continue Reading Anything in the New Clinical Trial Rules of Interest to Product Liability? Not Really.

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That didn’t take long.  Yesterday the Alabama House of Representatives passed SB-80, which abolishes the innovator liability theory created in the execrable decision in Wyeth, Inc. v. Weeks, ___ So.3d___, 2014 WL 4055813 (Ala. Aug. 15, 2014 (discussed here and here, and named #1 worst decision of 2014 here).  Here is a copy of the enrolled bill.  The online legislative history indicates that SB-80 passed the Alabama Senate 32-0 and the House 86-14.

The relevant statutory language, imposing a product identification requirement in all cases seeking damages caused by a product, states:

Section 1. In any civil action for personal injury, death, or property damage caused by a product, regardless of the type of claims alleged or the theory of liability asserted, the plaintiff must prove, among other elements, that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based, and not a similar or equivalent product.  Designers, manufacturers, sellers, or lessors of products not identified as having been used, ingested, or encountered by an allegedly injured party may not be held liable for any alleged injury.  A person, firm, corporation, association, partnership, or other legal or business entity whose design is copied or otherwise used by a manufacturer without the designer’s express authorization is not subject to liability for personal injury, death, or property damage caused by the manufacturer’s product, even if use of the design is foreseeable.Continue Reading Alabama Legislature Abolishes Weeks Innovator Liability Theory

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We wanted to draw your attention to a draft bill recently released by House Republicans, proposing amendments and overhauls of numerous FDCA provisions. It is a monster – 400 pages long – and you can read it here.  Here is the summary that accompanied the draft.  We haven’t seen anything looking at this bill through the lens of litigation, and we thought we would.  Several potentially defense-friendly provisions caught our attention:

Definition of Prescription Medical Device

Title V of the draft is entitled “Modernizing Medical Product Regulation.”  Subtitle E under this title, “Supply Chain Security for Devices,” includes, for the first time in an FDCA provision, a definition of “Prescription Medical Device.” Section 586(7), at page 370, provides that a “prescription device” is a restricted device which “which, because of any potentiality for harmful effect, the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device” and “for which the Secretary has determined adequate directions for use cannot be prepared” and which therefore must a carry a designation that it is for physician- or dentist-use only, “or a statement that Federal law restricts the device to sale by or on the order of a licensed health care practitioner.”  How something becomes “prescription only” is one of those FDCA basics that has always struck us as needlessly complex to explain.  This definition does a good job of that.Continue Reading 400 Pages of Proposed FDCA Amendments – What Might Help Us?

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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