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One of the decisions we were looking forward to at the end of 2022 has occurred. In In re Zofran (Ondansetron) Products Liability Litigation, ___ F.4th ___, 2023 WL 128570 (1st Cir. Jan. 9, 2023), the court unanimously affirmed the MDL-wide preemption order dismissing all claims.  Since the history of the Zofran litigation is well covered in our prior posts, we’ll stick to the First Circuit’s preemption rationale here.

Continue Reading MDL-Wide Preemption Win in Zofran Affirmed

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The idea that software can be a product (as in “product liability”) is not new, but gray areas remain with regard to when that should be and how courts should handle it.  Take for example a case that we wrote on a couple of years ago, in which a district judge in Virginia granted summary judgment for the manufacturer of an electronic health records (“EHR”) system.  A patient suffered severe complications after a doctor entered post-op instructions into the hospital’s EHR computer system, but the hospital implemented the orders at the wrong time.  Whose fault was that?  We don’t know, but the district court ruled that, even though the patient’s experts identified software changes that would have made the system safer, they did not identify a standard of care that the EHR system failed to meet. 

Well, a couple of weeks ago, the Fourth Circuit reversed and held that the experts had very well identified a standard of care and further that there was evidence sufficient to support a failure-to-warn claim.  The case is Lowe v. Cerner Corp., No. 20-2270, 2022 WL 17269066 (4th Cir. Nov. 29, 2022), and the facts are worth repeating.  Following surgery, the patient’s surgeon entered orders for “continuous pulse oximetry” into the EHR software developed by the defendant and deployed by the hospital.  However, although the surgeon intended for pulse oximetry—i.e., checking blood oxygen—to be continuous, she chose “once” and “daily” from the system’s dropdown menus, which defaulted to 10:00 each day.  The system correctly displayed that time on the order confirmation screen, but several orders were entered that day, and the surgeon did not scroll down to review them all.  She clicked through some version of “accept all.”  Unfortunately, checking blood oxygen at 10:00 was too late for this poor patient, who suffered severe and permanent disability.  Id. at *2-*3. 

Continue Reading Yes Virginia, Software Can Be A Product

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We are just back from a lovely long weekend in Mexico.   We were delighted to find, on our DVR, a show we’d forgotten we set to record:  a special interviewing the cast and director of Love, Actually on the 20th anniversary of that film’s release.  This is our all-time favorite holiday film, and pretty close to our favorite film of any genre.  We love how it has crept into popular culture (the SNL parody of the flip cards scene, featuring Kate McKinnon as Hillary Clinton is nothing short of brilliant), and we find the film endlessly charming and restorative, no matter how many times we watch it.   Take a look at the special, if you missed it

Speaking of all-time favorites, today’s case deals with warnings causation, our all-time favorite doctrine.  (Along with our co-blogger, Mr. McConnell, we just presented a CLE on this topic.)  This is the doctrine:  to prevail on a failure-to-warn claim in a prescription drug or medical device case, a plaintiff must prove both that the products warnings were inadequate and that the inadequate warning proximately caused the plaintiff’s injuries. Subject to variations of local law, the general rule is that, to prove the warnings causation piece, a plaintiff must adduce evidence that a different or stronger warning would have altered her physician’s decision to prescribe the drug or device. 

In Brennan v. Johnson & Johnson, et al., 2022 WL 17219513 (C.D. Cal. Nov. 18, 2022), the plaintiff alleged that the warnings provided with her pelvic mesh devices were inadequate.  She asserted failure-to-warn claims sounding in negligence and strict liability, and the defendant moved to dismiss both, arguing that the plaintiff could not prove that any inadequacy of the warnings proximately caused her injuries because her prescribing physician had not testified that she would have acted differently in the face of a different warning. 

Continue Reading Lovely Warnings Causation (and More) Mesh Decision from the Central District of California

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Two weeks ago, we decried the pattern that some courts follow in allowing shifting slates of boilerplate allegations to cases to discovery.  The decision in Corrigan v. Covidien LP, No. 22-cv-10220, 2022 U.S. Dist. LEXIS 210296 (D. Mass. Nov. 21, 2022), reminded us of another of our post-TwIqbal pet peeves:  when courts treat sweeping legal conclusions as if they were plausible factual assertions.  The basic allegations in Corrigan were that the plaintiff’s surgeon used defendant’s surgical stapler to perform an anastomosis—reattachment of two parts of the digestive tract—in connection with removing part of his sigmoid colon (for unspecified reasons, but often diverticulitis or cancer) and the anastomosis later leaked, leading to further surgical intervention.  As we said two weeks ago, medical device manufacturers are not insurers.  That makes sense because surgery on humans, even done by the best surgeons, in the best hospitals, and with the best devices and equipment, has less than a 100% success rate.  Anastomoses leak, infections develop, hernias recur, patients report post-operative pain, and all manner of complications and less than optimal outcomes occur.  A common refrain when scientists are presented with a surgical study reporting no complications or failures is that the study was too small, too short, and/or insufficiently rigorous.  Thus, a common procedure with a very high success rate will still generate large numbers of reported failures, like anastomoses that leak.  This is part of why rates, and particularly comparative rates, provide more useful information about devices and surgeries than do gross numbers.

Even more authoritative sources than this Blog agree with us.  FDA, for instance, makes clear that data from its Manufacturer and User Facility Device Experience (“MAUDE”) database “is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.”  The reasons for this are not a secret:  “The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.”  Directly stated, “[t]he submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event.”  FDA’s description of the MAUDE database also makes clear in a number of places that the data may be outdated or incomplete for various benign reasons.

Continue Reading Criticizing FDA Reporting Systems Should Not Be Enough To Plead A Warnings Claim

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In preparation for our OTC panel next week at ACI-NY, we have kept our eyes open for any OTC cases that raise interesting issues.  Today’s case, Rooney v. Procter & Gamble Co., 2022 U.S. Dist. LEXIS 210218 (E.D. La. Nov. 21, 2022), involves a claim by the plaintiffs that a woman developed triple negative breast cancer as a result of using an antiperspirant that she asserts contained benzene.  

The assertion that benzene was in the antiperspirant rested on testing by Valisure, an analytical pharmacy.   Some of you have heard of a Valisure before, as its testing, and results allegedly showing contamination, have been relied upon by plaintiffs in other mass torts.  Valisure calls itself “the pharmacy that checks.”  Perhaps we are cynical, but we think of a different sort of checks when we see a purported independent outfit that seems to cooperate closely with plaintiff lawyers. Here, Valisure ran tests on batches of the antiperspirant and came up with concentrations of benzene significantly higher than levels recommended by OSHA.  Valisure filed a Citizen’s Petition with the FDA seeking a recall of antiperspirant batches containing too much benzene.  (Sound familiar?) The FDA had not responded to the Citizen’s Petition.  The defendant voluntarily implemented a recall of certain batches of the antiperspirant.  

Before the court was the defendant’s motion to dismiss the plaintiffs’ second amended complaint.  The plaintiffs alleged that the defendant violated the Louisiana Products Liability Act by selling antiperspirants without issuing adequate warnings.  The plaintiffs also alleged that the defendant was liable under theories of negligence, gross negligence, strict liability, and “fault,” and that the defendant violated the FDCA.  Some of those claims seem weird (some of what’s missing also seems weird, but it’s not our job to help plaintiffs author complaints – our criticisms are strictly destructive), but remember, we’re in Louisiana.  Not that we’re complaining.  The people are fun, the food is great, and did we mention that the Judge in this case dismissed the second amended complaint?  

Continue Reading E.D. Louisiana Dismisses Antiperspirant/Benzene Claims

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Drug manufacturers are not insurers against injury from or while taking medications.  Neither are distributors or pharmacies.  Just because a patient experiences a complication while taking a medication, including the very condition the medication is supposed to help prevent, does not mean that some person or entity should be liable to the patient for her injuries.  Sometimes, there is no fault or liability to be found.  We do not think these are controversial principles, but we find that they apply to more than a few of the cases giving rise to the decisions about which we expound.

We also find that missing facts from complaints can speak volumes.  Similarly, when a plaintiff waits until the third complaint to add case-specific factual allegations that should have been there from the start or when factual allegations pop in and out of serial amendments you have to question the basis for those allegations.  At least we do.  As inveterate curmudgeons, we tend to think bare-bones, boilerplate allegations are unlikely to be supported if the case gets to the merits.  Of course, part of the game for some plaintiffs is to get past pleadings and hope the defendants opt for settlement instead of paying the costs of defense.  The Twombly and Iqbal decisions tightened pleading standards, and thus improved the chance of success on motions to dismiss in federal court and some states have followed along.  The hole, and source of our periodic grumbling, is how often dismissals are without prejudice and accompanied by leave to amend.  Too often, it seems that the provision in Fed. R. Civ. P. 15 that courts “should freely give leave when justice so requires” leads to leave even when it should be obvious that amendment will be futile, not to mention a waste of judicial resources.

Continue Reading Five Strikes Needed To Dismiss A Questionable Case