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We are pleased to have left the bullpen and joined the starting rotation of contributors to this blog. We will strive for the relevance and style our colleagues’ posts consistently display.

We adopted a Drug and Device Rescue Cat this week.  Her housemates, two Drug and Device Rescue Dogs, are poodle mixes, so we haven’t dealt with the issue of shedding since we last had cats, years ago.   We have discovered a nifty tool that claims to dramatically reduce the hair deposited on furniture and clothing, reminding us of our fondness for anything that strips away the clutter of useless underbrush and leaves only what is neat and firmly rooted.   And that is the (admittedly tenuous) segue to today’s case, in which the United States District Court for the Northern District of West Virginia bushwhacks through plaintiff’s detritus to arrive at a solid holding and a (mostly) tidy opinion.

In Muzichuck v. Forest Laboratories, Inc., No. 1:07-CV-16, 2015 U.S. Dist. LEXIS 5440 (N.D.W.Va. Jan. 16, 2015), the Court considered defendant’s Motion for Summary Judgment in a Lexapro suicide case.   Plaintiff, who opted out of the global Lexapro settlement, alleged that defendants, Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. (“Forest”) failed to warn her decedent-husband and his prescribing physicians of the risk of suicide associated with the antidepressant Lexapro.

Continue Reading Opt-out Out of Court: Northern District of West Virginia Dispatches Lexapro Warnings Case

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We’ve made no secret of our distaste for the so called “heeding presumption” – that juries may presume that any alternative “adequate” warning would have been heeded by the plaintiff (or, in prescription medical product cases, the prescriber).  We have a topic header on this subject with multiple posts decrying such presumptions, both generally and in the particular context of prescription medical products.

The biggest conceptual problem is that there are two fundamentally different kinds of warnings.  Most warnings concern a product’s use – that if you use (or don’t use) the product in a certain way, you are likely to get hurt; and if you follow the warning, you won’t.  Examples are not driving a riding lawnmower parallel to a slope (because you’ll tip over) or only handling asbestos while using a respirator (because breathing asbestos can do nasty things to you).  Most step-by-step directions also fall in this category.

While so-called “use” warnings occasionally arise as to prescription medical products – overdose instructions come to mind – that type of warning is not what most litigation involving these products is about.  Rather, with prescription-only products, most of the relevant risks arise whenever the product is used.  A warning about an inherent risk – a so-called “risk warning” – serves an entirely different purpose.

With inherent risks, people are warned so they can decide whether that risk outweighs the benefits that might be gained from using the product.  The only way to avoid the risk is not to use the product at all.  All prescription medical products have inherent risks – which is why the FDA requires a physician’s prescription in the first place.  For a case discussing the distinctions between these two types of warnings in detail, read Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 814 (5th Cir. 1992) (applying Mississippi law), which you can find later in this post.

Continue Reading Who Heeds The Heeding Presumption?

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In the index to this blog, we list 39 posts about the Aredia-Zometa litigation.  After today it will be 40.  And counting.  That might actually be understating our coverage.  (We’re not always so punctilious at affixing topical labels to our posts.) Sometimes it seems as if one could understand all of recent drug and device

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We like juries. Jurors give us their time and attention, sometimes for weeks or months at a time, and they receive little or nothing in terms of tangible benefit in return. The vast majority take the task seriously and give us their best on topics that are at once human and very complex. We sometimes embrace their results, and sometimes we appeal from them or move to set them aside, but either way we respect the process without reservation.

Not every issue, however, is best left to juror discretion, and juries require guidance, mainly in the form of instructions on the law and rulings on the evidence. The former provides a proper legal referent against which to render a verdict. The latter regulates the information they receive so they consider material that is relevant and helpful, and not information that is misleading, improper, or tends to show nothing of consequence to the issues in the case. And the court should provide a necessary check against jury discretion with its power to decide issues as a matter of law and grant new trials.

Juries operating outside these parameters might not come to fair results, through no fault of their own, and we think that is what went wrong in Cox v. KLS Martin, L.P., 2013 U.S. Dist. LEXIS 114708 (W.D. Mo. Aug. 14, 2013). As with many bloggable cases, the facts provoke sympathy. Cox involved an implanted medical device known as a mechanical intraoral distracter, which was used as intended to treat Pierre Robins Sequence, a rare disorder in which an infant’s lower jaw is underdeveloped. As the court described it, mandibular distraction involves cutting through bones on both sides of the patient’s mandible behind the molars and securing a mechanical intraoral distraction device to both sides of each cut. By then turning an activation mechanism, each distractor slowly separates the bone sections, allowing the formation of new bone. Id. at *1-*2.

Continue Reading Shared Too Much: Missouri Court Gives Jury Too Much Leeway

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Another remanded Aredia/Zometa case has apparently bitten the dust.  See Ingram v. Novartis Pharmaceuticals Corp., No Civ-05-913-L, slip op. (W.D. Okla. July 18, 2012).  Ingram threw out all of the plaintiff’s on warning causation grounds, a strong defense in this litigation, which involves a drug used to treat cancer.  A basic problem that plaintiffs

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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 previously discussed the Montana Supreme Court case of Riley v. American Honda Motor Co., 856 P.2d 196 (Mont. 1993) and touted it as one of the best rejections of the heeding presumption we’ve seen – rejecting all of the most often advanced arguments in favor of the heeding presumption.  So we were a bit surprised when we learned about that same court’s decision in Patch v. Hillerich & Bradsby Co., No. 2011 MT 175, slip op. (Mont. July 21, 2011) (unpublished) – applying the heeding presumption.
While not a drug or medical device case, Patch is definitely a step backward by the Montana Supreme Court and one that may well have implications for our clients.  Patch involves the tragic death of an 18 year-old boy who, while pitching a baseball game, was struck in the head by a ball hit using an aluminum bat manufactured by the defendant.  Patch, slip op. at 2.  A jury returned a verdict for the plaintiff finding that the defendant failed to adequately warn about the enhanced risks associated with its bat which allegedly increased the velocity speed of a batted ball.  Id. at 3.
On appeal, the defendant sought review, among other things, of the lower’s court’s denial of defendant’s motion for judgment as a matter of law on the failure to warn claim.  Id. at 2 (other aspects of the appeal raised issues related to decedent’s status as a bystander, the “workability” of providing a warning, and assumption of the risk, see id. at 5-8, 12-13).  The main issue – causation.  It is here that the Montana Supreme Court seems to do an about face.
The question in Patch was whether the trial court’s adoption of the heeding presumption violated the holding of RileyId. at 9.  Clearly, it does.  In Riley, the court specifically rejected the argument that the heeding presumption – i.e. shifting the burden of causation to the defendant – is necessitated by the policy underlying strict products liability.  Riley, 856 P.2d at 200 (“[w]e are unwilling to shift the respective parties’ burdens in such a fashion. . . . A defendant certainly is in no better position to rebut a presumption which totally excuses a plaintiff from meeting the causation element than a plaintiff is in establishing the causation element as part of the prima facie case.”).

Continue Reading Montana Takes a Flexible Approach to the Heeding Presumption

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We have recently highlighted a few decisions coming out of Hogan v. Novartis Pharmaceuticals Corp., No. 06-Civ-260 (BMC) (EDNY), and we’ve got some good news to report. After a week and a half long liability-only trial in the EDNY Brooklyn division, a six-member jury returned a defense verdict after about five hours of deliberation

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Last week we settled a case. It was a good settlement. But we groused about it a bit, because we thought the judge should have granted us summary judgment on preemption grounds. The denial of summary judgment was truly “summary.” There was no written opinion at all, and the judge’s few statements at the hearing

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Litigated a prescription drug product liability case in Ohio lately? Say in, oh … the last quarter century or so?
If you have, then you’ve run into our old friend the heeding presumption. In the very first prescription drug product liability case that the Ohio Supreme Court ever encountered, it adopted a “presumption” that a