Res Ipsa Loquitur

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San Francisco has become a sea of orange and black.  As we post this missive, hundreds of thousands of Giants fans are flooding into the city for the third World Series parade in five years.  The 2010 parade was unlike anything we have ever seen in terms of size and ebullience.  Truth be told, we are Oakland Athletics fans, so while we are delighted at the triumph of the men in orange and black, our delight pales by comparison to the euphoria that would accompany another World Series title for the green and gold.  We attended the 2010 Giants parade therefore not because we are avid fans, but because the parade route runs one block north of our office and because we were firm in our belief that the Giants would never win another World Series for as long as we live.  Boy, were we wrong on that one!

Of course, it is also Halloween, the other reason why orange and black is San Francisco’s color scheme du jour.  We are unsure of the origins of Halloween and its signature colors, although we are very sure that the Giants’ victory had nothing to do with All Hallows’ Eve, Celtic harvest festivals, or superstition.  Indeed, we are confident that the confluence of orange and black celebration on this one day is a coincidence, albeit one accompanied by ghouls, goblins, costumes of all sorts, children begging for candy, and skeletons displayed in front of our homes.

Which brings us to the topic of bones, the subject of an interesting case from the Western District of Louisiana holding that a medical device is not defectively constructed just because it broke.  In Lirette v. DePuy Mitek, LLC, No. 2:13-cv-2892, 2014 U.S. Dist. LEXIS 149725 (W.D. La. Oct. 20, 2014), the plaintiff injured her knee while jumping rope and underwent ACL reconstruction with a prosthetic graft in her shin bone.  The graft product, however, allegedly “split open” in the plaintiff’s knee, resulting in multiple additional surgeries to relieve her pain and to remove “pieces of loose matter” that appeared to be pieces of the “split” device.  Id. at **2-3.

The plaintiff sued the product manufacturer under the Louisiana Products Liability Act (“LPLA”), a law that we like, mainly because of its strong exclusivity (and alternative design) provisions.  If you want to file a products liability claim in Louisiana, you get a claim for defect in design, defect in construction, inadequate warnings, or breach of express warranty – and that’s all.  Id. at *7.  The plaintiffs initially pleaded all four theories, but on the third round of pleading (much more common after TwIqbal), they were left with just one products liability claim for allegedly defective construction.  Id. at **8-9.Continue Reading Halloween and Broken Devices Don’t Make a Defect

We haven’t written much about res ipsa loquitur on the blog, and today’s case doesn’t really qualify as a drug or device case per se, but it’s an interesting opinion and we thought it was worth sharing.  The case is Hubbard v. Mellion, No. 108461, 2013 Kan. App. LEXIS 45 (May 17, 2013), and it’s an appellate decision reversing summary judgment in favor of a physician in a medical negligence case, on the basis of the appellate court’s finding that the lower court should have applied the doctrine of res ipsa loquitur.  The case arose when plaintiff Hubbard underwent spinal surgery (involving various –otomies and –ectomies) to repair a herniated lumbar disc.  During the procedure, the surgeon used a device known as a pituitary rongeur, which is a forceps-type instrument that’s used to remove part of the disc. Unfortunately, during Ms. Hubbard’s surgery, the tip broke off of one arm of the rongeur, and became lodged in her disc space.  Hubbard, 2013 Kan. App. LEXIS at * 6.  The surgeon tried to retrieve the tip but was unable to. Id.  Ms. Hubbard claimed that she experienced continual pain as a result of having the fragment in her spine, and eventually underwent another surgery to remove it.  Id. She later filed a negligence action in which she named the surgeon and the hospital, as well as the manufacturer of the rongeur, alleging that the latter was negligent for supplying a device that was in a dangerous and defective condition.  However, as we’ve seen plaintiffs do in other medical device cases, plaintiff later decided to pursue the surgeon alone, and backed away from her defect theory.  Really far away.  Did a 180, in fact.  Not only did plaintiff dismiss the manufacturer, her expert metallurgist authored a report in which he “ruled out the possibility that the rongeur failed due to a manufacturer’s defect, ruled out the possibility that the rongeur failed because it had been improperly maintained, and ruled out the possibility that the rongeur had failed due to normal wear and tear.” Id. at *11.  The plaintiff’s expert’s sole causation opinion was that the rongeur tip had broken off due to user error – specifically, because the surgeon had applied too much force when using the instrument.  Id. at *12.

The surgeon moved for summary judgment on the basis that plaintiff’s experts – a metallurgist, a neurosurgeon, and a quality management team leader from the rongeur manufacturer (id. at *11-12) – were not qualified to opine on the standard of care for a surgeon performing this type of procedure.  Id. at * 14-15.  The trial court agreed, and held that although these experts established that operator error had caused the rongeur to break, plaintiff had not shown that this error was outside the established standard of care.  Id. at *15.  On appeal, plaintiff argued that she was not required to present expert testimony on the standard of care because there were two exceptions to the requirement that applied in this case:  the “common knowledge” exception and/or the doctrine of res ipsa loquitur.  Id. at *20.Continue Reading Res Ipsa Loquitur, or Maybe Not

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We’ve been on the verge of triskaidekaphobia.  So far 2013 hasn’t been a very good year for us, with Weeks, Stengel, Arters, and Wells.  At this rate, we could fill up our Worst Decisions of 2013 by mid-March.  And yes, we’re not Dr. Pangloss here on DDLaw – we do cover our side’s losses, if rather grudgingly.

But finally this week turned out better, judging by the cases we’ve learned about so far.  First and foremost is a case we on the Reed Smith side just can’t talk about very much, since it’s our case.  That’s Caplinger v. Medtronic, Inc., No. CIV-12-630-M, slip op. (W.D. Okla. Feb. 6, 2013).  All we can say is that it involves PMA device preemption (Riegel), and off-label use issues, and it’s favorable.  We’re hoping that our Dechert contingent can give readers an update on just how it’s favorable.  Until then, we’ve given you a link – and put it on the medical device preemption scorecard.

We also learned about a good class action decision, In re Celexa & Lexapro Marketing & Sales Practices Litigation, MDL No. 09-02067-NMG, slip op. (D. Mass. Feb. 5, 2013).  As readers can tell from our federal and state class action cheat sheets, successful class actions in drug/device product liability litigation don’t happen much anymore, if at all.  Indeed, we’ve been following this topic more generally, and we believe that, since the groundbreaking Supreme Court decisions of the late-1990s (Amchem Prods. Inc. v. Windsor, 521 U.S. 591 (1997), and Ortiz v. Fibreboard Corp., 527 U.S. 815 (1999)), not a single contested personal injury merits class action (as opposed to settlement, where the fix is in) has survived appeal in the federal court system – that’s not just drug/device but any form of personal injury.

Is it any wonder that the purveyors of class actions have turned away from personal injury to economic loss?  We don’t think so.  But as our cheat sheets indicate, they haven’t done very well there either, at least where drugs/medical devices are concerned.  We’re pleased to report that Celexa/Lexapro
continues that trend – even though the forum-shopping plaintiffs ensconced themselves in a relatively defense-unfriendly forum (District of Massachusetts)
and eventually retreated to invoking extremely defense-unfriendly law (the infamous California UCL, and the less infamous, but we’d say now about equally bad, Missouri consumer fraud statute).Continue Reading Finally, A Decent Week

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            It was the best of times . . . . No, our story isn’t nearly as significant as that classic.  Rather, it is a tale of two medical device cases that we thought offered an interesting comparison for their numerous similarities and one key difference – the result.  This brings to mind vague memories

…

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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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When we (well, one of us) were little kids, we watched a TV show called the “Popeye Club.”  The host, Officer Don, would put four paper bags on a flat turntable – three of which were “goody bags” and one contained the infamous “ooey gooey” (mixed live on set, we recall).  Officer Don would turn the turntable so blindfolded kids from the live audience who played the game almost always got the goody bags, but when Officer Don was blindfolded, well….
We may not remember much about our early elementary school days, but we still remember the exaggerated expression on Officer Don’s face when he stuck his hand into the ooey gooey (made from stuff like coffee grounds, fresh broken eggs (shells included), Bosco, ketchup, and cottage cheese).  Nobody could look more grossed out than Officer Don.
Reading the recent opinion in DiCosolo v. Janssen Pharmaceuticals, Inc., 2011 WL 2640801, slip op. (Ill. App. June 30, 2011), was a lot like getting the ooey gooey.  Our expressions would have done Officer Don proud.
The decedent in DiCosolo died from some sort of drug overdose.  She “had access to 11 central nervous system (CNS) depressants immediately prior to her death,” including multiple sedatives (Clonazepam, Bextra, Topomax, Gabapentin), antidepressants (Venlafaxine), opiates (Avinza), narcotics (Duragesic), and barbiturates (Butalbital).  2011 WL 2640801, at *1.  The coroner tested her blood for some – not all, a bone of contention – of these drugs.  Finding several present, he initially ruled the death a suicide.  Id.
Then the plaintiff (the decedent’s husband) received a recall letter for Duragesic – a transdermal (skin) patch with the narcotic fentanyl as its active ingredient.  According to the recall, “a small percentage” of a certain batch “leaked medication” into the adhesive gel that could possibly cause an overdose.  2011 WL 2640801, at *2.  The decedent’s patches came from the batch.  Id.  The coroner’s blood work also indicated a fentanyl overdose.  Id. at *1.
Plaintiff got a lawyer.  The lawyer prevailed on the malleable coroner to “change[] his conclusions . . . from ‘suicide’ to ‘accident’.”  2011 WL 2640801, at *2.
Then the real fun and games began.  Plaintiff’s complaint alleged “that the patch that [decedent] was wearing at the time of her death caused her respiratory arrest and death.”  Id.
However, plaintiff soon had a big problem.Continue Reading Ooee Gooey

Photo of Stephen McConnell

It’s Valentine’s Day, so we blow a kiss towards our true love, preemption. But while we love preemption, we must confess ill will toward the “parallel claim” end-run around preemption. We have had our flings with some other doctrines, such as res ipsa loquitur. See, e.g., No Trout in the Milk. Like a…

Photo of Stephen McConnell

Yet once more, O ye laurels, and once more. Another splendid Viagra opinion sprang forth recently. This time we aim to avoid any silly double-entendres, even accidentally. (What’s that? We already failed?!).
The case of Ridgeway v Pfizer, Inc., No. 09-2794 (E.D. La. April 27, 2010), involves the application of that old law…

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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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