Informed Consent

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Our first reaction to Zeman v. Williams, 2014 U.S. Dist. LEXIS 91501 (D. Mass. July 7, 2014), wasn’t related to the fact that it involved a federal court recognizing a cause of action previously unrecognized by Massachusetts state courts.  Our first reaction was that the case shouldn’t be complicated.  The plaintiff participated in a clinical trial involving a bilateral gene transfer, which is a new procedure intended to treat Young-Onset Parkinson’s Disease.  Id. at *3.  As the “bilateral” in its name implies, a bilateral gene transfer consists of two injections of genes into the brain, one into the right side and one into the left.  Id. at *3-4.  But (plaintiff alleged) the surgeon gave both injections to the left side.  Id. at *4.

It seems fairly easy to identify the problem here.  If an engineer designs a twin-engine plane, and the mechanics put both engines on the left side, you’ve got a good idea who made the mistake.  If the Doublemint gum company told its casting director to hire blond twins for its commercial, and the casting director hired some guy named Roy, you can be pretty sure who made that mistake too.  So whom did the Zeman plaintiffs sue over the improper procedure?  The manufacturer and the Institutional Review Board (“IRB”), of course.Continue Reading Federal Court Finds a Duty With Regard to Consent Forms in Clinical Trials That the State Court Had Not Previously Recognized

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The last opinion available on Lexis or Westlaw for Seavey v. Globus Medical, Inc., is from early 2012, when the manufacturer defendant failed to get the plaintiff’s express warranty claim thrown out on the pleadings. See 2012 WL 253116 and/or 2012 U.S. Dist. Lexis 9435. Fortunately, all the defendants did better on summary judgment…

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We’ve blogged several times about the nearly unanimously accepted proposition that FDA regulatory status – that is, the bare fact that a drug or medical device is used off-label – is not a medical risk, benefit, or alternative about which physicians must tell patients under the law of informed consent.  Bexis in particular is emphatic…

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This discussion of an opinion in the Pelvic Mesh litigation once again comes only from the Dechert side of the blog. The MDL court in the pelvic mesh litigation issued rulings on motions in limine last week.  In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00195, 2:11-cv-00012, 2:10-cv-01224, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 90210 (S.D.W.V. June 27, 2013).  In previous pretrial rulings, the defense made out well, winning summary judgment on a number of plaintiffs’ claims, including a failure to warn claim in one case (see here and here), and winning a number of key Daubert motions (here).  Things didn’t go as well with the in limine motions.  It was more of a mixed bag.  Here are a few of the issues addressed by the court.

FDA 510(k) Clearance 

This was plaintiffs’ motion.  They wanted to exclude evidence related to the FDA’s clearance of the Avaulta products through its 510(k) process.  Id. at *4-6.  Seems pretty relevant, doesn’t it?  It’s the process established by the industry’s primary regulator as to what the industry must do and how it must do it in order to be able to bring its product to market.  Yet the court granted plaintiffs’ motion.Continue Reading Pelvic Mesh Litigation: In Limine Rulings

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When we saw the first one we thought, that’s odd, but it’s mostly a malpractice claim pretty far from our sweet spot.  When we saw the second one, we thought, maybe we should blog about this now….  But the result was mostly unfavorable, and other, more significant things were happening.  But now that we’ve seen…

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A lot of people think that Ronald Reagan won the presidency in 1980 in his first debate when he replied jokingly “there you go again” to then-President Carter’s attempt to portray him as some sort of rightwing nut intent upon destroying accepted government programs like Medicare.
Whether one believes that President Reagan’s election was a good thing or a bad thing, there’s no denying that his disarming line was effective in dispelling his opponent’s attempt to sow fear of his then unknown policies.
We’ve confronted similar situations ourselves as, periodically, some law review article or another decides to tilt at the windmill of FDA regulatory informed consent claims in off-label use cases.  Bexis dealt with that topic in a law review article he wrote long before he wised up and started blogging.  Beck & Azari, “FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions,” 53 Food & Drug L.J. 71 (1998) (available here).
Here on the blog, we addressed this topic back in 2007, critiquing an article that advocated informed consent suits against doctors for not discussing the non-FDA-approved status of off-label use, essentially as a means of indirectly punishing drug companies for allegedly promoting such uses too effectively.Continue Reading There They Go Again

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Every now and then there’s a piece of litigation that boldly goes where no court has gone before and opens up a host of new legal issues.  Bone Screw was like that, with plaintiffs inventing new causes of action (fraud on the FDA and regulatory informed consent) and our side having to invent new defenses.  We also felt that way while we were involved in the Fagan v. AmerisourceBergen litigation involving the then novel concept of liability of non-counterfeiters for injuries caused by counterfeit drugs.
We’ve just seen another opinion, Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701, slip op. (D. Minn. Sept. 27, 2011), that makes us feel the same way.  We can’t recall ever seeing an opinion previously that addressing liability issues in the context of a reprocessed medical device that allegedly failed due to defects introduced by the reprocessing.
Kapps involves something analogous to the aftermarket for automobile parts, only in the medical device field.  The product, a heart catheter, was originally manufactured as a single-use product – expressly stated in the product’s original labeling.  2011 WL 4470701, at *3.  Apparently the FDA has chosen not only to tolerate, but to affirmatively allow the particular type of off-label use:  the reprocessing and reuse of products whose labeling is limited to single use.  Id. at *5-6 (describing FDA regulation of reprocessing/reuse of single-use devices).  After being completely relabeled and refurbished according to relevant FDA regulations, the heart catheter was reused and broke inside the plaintiff’s heart.  Id. (refurbishing changed the device’s serial number, and replaced its labeling with its own).  Plaintiff sued both the aftermarket and original equipment manufacturers.
The 68-page Kapps opinion raises, and in some cases decides for the first time, many fascinating issues.Continue Reading Twice Nice?

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We’ve heard about a new plaintiffs’ informed consent theory that’s making the rounds.  It’s similar to, if even goofier than, the FDA regulatory status (that is, off-label use) theory that the plaintiffs tried with notable lack of success in the Bone Screw litigation (which we’ve discussed here and here).

As with all informed consent…

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Back in April we posted about the “funky” non-manufacturer claims in Timberlake v. Synthes Spine Co., 2009 U.S. Dist. Lexis 29074 (S.D. Tex. Mar. 31, 2009).  Those claims – trying to hold people who conducted clinical trials liable in a post-approval case for alleged misconduct in how the trials were conducted – were dismissed, but…

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As long-time readers know, this blog was founded by a couple of guys who first got to know each other defending co-defendant manufacturers in the Orthopedic Bone Screw Mass Tort.  That fact significantly colors what you read here.  A lot of the issues that we harp on – off-label use, medical device preemption, fraud on the FDA, cross-jurisdictional class action tolling, broken device cases, expert testimony on issues of (FDA) law (that’s just off the tops or our heads) – we spent close to a decade litigating in Bone Screw land.
It wasn’t a bad living. 360 (requires subscription) recently named one of our old Bone Screw cases (Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001)) as the top product liability case of the last decade. (It also stole a post idea we’d kicked around but never gotten off our duff to write up).  Even though we’ve moved on, our pet peeves haven’t.
But probably the most singularly “Bone Screw” issue was the theory that a surgeon could be liable under an “informed consent” rationale just because s/he didn’t tell a patient about the FDA regulatory status (that is to say, off-label use) of the drugs/medical devices used in the patient’s treatment. And we Bone Screwers killed that theory dead – maybe not as dead as we killed fraud on the FDA, but pretty darn close.Continue Reading Once More Into The Breach

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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