2022

Photo of Steven Boranian

We wrote recently that California’s courts have never met a case they did not like.  We were speaking somewhat tongue in cheek of course, but still California remains a destination for litigation tourists trying to take advantage of laws and procedures that many view as plaintiff friendly.  One bulwark against blatant forum shopping is personal jurisdiction under the U.S. Supreme Court’s Bauman and Bristol-Myers Squibb cases, the latter reversing the California Supreme Court, which restored some measure of discipline to jurisdiction over out-of-state defendants.

Another potential bulwark is choice of law.  That is to say, even when a plaintiff sues in California, the applicable choice-of-law rules might compel the application of another state’s law, which could doom the plaintiff’s claims.

That is what happened this week in Nelson v. F. Hoffmann-La Roche, Inc., No. 21-cv-10074, 2022 WL 17259056 (N.D. Cal. Nov. 28, 2022) (to be published in F. Supp. 3d), where a Florida resident and Army veteran used a generic prescription drug while stationed in Kentucky and overseas and allegedly suffered complications.  But he chose to sue in California.  Why?  Because the manufacturer of the branded version of the drug (not the generic version that the plaintiff actually used) was based in California at the time he filed (having relocated from New Jersey), and California is one of a very few states that allows innovator liability—i.e., holding an innovator/branded manufacturer potentially liable for a generic product that it did not make, did not sell, and from which it did not make any profit. Continue Reading Federal Judge In California Cabins Innovator Liability

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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

Photo of Stephen McConnell

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

Photo of Michelle Yeary

We have had occasion over the years to opine on cases involving allegations against sales representatives who are present in the operating room—a not uncommon practice when medical devices are being used.  While the practice is not uncommon, what is rare are instances where a sales representative participates in the surgery.  Rare, but not non-existent.  Where the line is drawn between presence and participation, and possibility liability or not, is extremely fact sensitive.  And as the court in Owens v. Boston SCI Corp. concluded, in the absence of facts, conclusory allegations of participation are not enough. 2022 U.S. DIST. Lexis 212427, *7 (E.D. Mo. Nov. 23, 2022).

 Plaintiff underwent surgery involving implantation of a pelvic mesh medical device.  Plaintiff alleged complications following surgery and filed a lawsuit against the manufacturer alleging design defects and against one of the manufacturer’s sales representatives for failure to warn both plaintiff’s surgeon and plaintiff.  The manufacturer removed the case to federal court alleging the sales representative, who was not diverse to plaintiff, was fraudulently joined.  Plaintiff moved to remand.Continue Reading Sales Representative’s Presence in Operating Room Not Enough to Beat Fraudulent Joinder

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Three years ago we published a lengthy post, “Stupid Expert Tricks,” detailing several of the other side’s egregious attempts at passing off junk science “experts” as the real thing, along with our side’s trials and tribulations during the course of unmasking these phonies.  Our rogues’ gallery contained:  In In re Zofran (Ondansetron) Products Liability Litigation, 392 F. Supp.3d 179, 181-87 (D. Mass. 2019) (Zambelli-Weiner); In re 3M Bair Hugger Litigation, 924 N.W.2d 16, 19 (Minn. App. 2019) (Augustine); In re Mirena IUD Levonorgestrel-Related Products Liability Litigation (No. II), 341 F. Supp.3d 213, 222-23, 229-32 (S.D.N.Y. 2018) (Etminan); Gerke v. Travelers Casualty Insurance Co., 289 F.R.D. 316, 328-29 (D. Or. 2013) (Painter); McClellan v. I-Flow Corp., 710 F. Supp.2d 1092, 1119-25 (D. Or. 2010) (Matsen); Nelson v. Tennessee Gas Pipeline Co., 1998 WL 1297690, at *4, 7-8 (W.D. Tenn. Aug. 31, 1998), aff’d, 243 F.3d 244 (6th Cir. 2001) (Kilburn); and Wade-Greaux v. Whitehall Laboratories, Inc., 874 F. Supp. 1441, 1559-62 (D.V.I. 1994), aff’d mem., 46 F.3d 1120 (3d Cir. 1994) (Gilbert).

We’ve found another one – this time from talc litigation.Continue Reading Stupid Expert Tricks Redux

Photo of Rachel B. Weil

We write on the heels of a long weekend layered with dogs and fun.  The National Dog Show, which you may have watched on TV yesterday, is held about ten minutes from our house, and a fabulous corded Standard Poodle named Joel, who just happens to be “family” (he is the sire of our gorgeous puppy, Luca) won Best of Opposite Sex two days running (and stayed overnight with us).  And two out-of-town handlers we know unexpectedly needed a place to exercise their charges, so we twice got to stand in our back yard while no fewer than seven show dogs, from ten pounds to 150 pounds, swirled around us.  We can’t imagine being much happier.

Layers of good mark today’s case, as well.  Arevalo v. Mentor Worldwide LLC, et al., 2022 WL 16753646 (11th Cir. Nov. 8, 2022), is a decision on the appeal of a Northern District of Florida decision we liked very much.  Arevalo is a pelvic mesh case.  The plaintiff alleged that mesh devices implanted to treat her stress urinary incontinence and pelvic organ prolapse caused her to undergo mesh removal surgery and to suffer a familiar litany of injuries.  The plaintiff’s general and specific causation expert was the ubiquitous Dr. Bruce Rosenzweig.  Among numerous other motions, the defendant moved to exclude Dr. Rosenzweig’s specific causation opinion as unreliable because Dr. Rosenzweig did not perform an adequate differential diagnosis.  The court granted the motion and excluded the specific causation opinions, holding that Dr. Rosenzweig “did not explain how he systematically and scientifically ruled out the other potential causes for the plaintiff’s symptoms.  Arevalo, 2022 WL 1673646 at *4.  The court then granted summary judgment for the defendant because the plaintiff could not reach the jury without expert specific causation testimony.  The plaintiff appealed to the Eleventh Circuit, and today’s decision is the result. Continue Reading Eleventh Circuit Affirms Exclusion of Flawed “Differential Diagnosis” in Pelvic Mesh Case

Photo of Stephen McConnell

At ACI’s December session in New York we will be part of a panel discussion on product liability actions against over the counter (OTC) medicines.  Such lawsuits are certainly not new, but some aspects of them are.  For example, so called “independent” laboratories have played an outsized, perhaps inappropriate, role in driving such lawsuits.  In addition, proof of use problems abound with OTC products.  Without prescription records, can the mere say-so of a plaintiff carry the day on usage, or should there be corroboration in the form of bottles, photographs, receipts, loyalty program records, etc.?  Scientific issues of medical causation can be very different with OTC drugs as compared with rX versions. There are usually different doses and durations. Warning causation can also take a very different shape in OTC world.  The absence of a learned intermediary (though, to be sure, sometimes there is a learned intermediary advising the patient to take an OTC medicine – what to do about that?) makes it easier for patients to engage in misuse.  At the same time, alleged injuries from OTC medicines can be every bit as profound as from prescription drugs.  Think of all those terrible SJS/TEN cases.  

And then there is the defense of preemption.  As we’ve written about several times before (here, for example), there is pretty broad express preemption of non-product liability actions against OTC medicines.  Now after all that wind-up, we come to today’s case, Truss v. Bayer Healthcare Pharmaceuticals Inc., et al., 2022 WL 16951538 (S.D.N.Y. Nov. 15, 2022), which is a defense favorable OTC drug preemption case involving a purported economic loss class action against a sunscreen manufacturer. The plaintiffs filed a putative class action claiming that the sunscreen manufacturers falsely marketed the sunscreen as being hypoallergenic and gentle for skin even though the sunscreen actually contained benzophenone, which they allege to be hazardous degradation product.  (Yes, this is yet another case in which the plaintiff alleges harm from chemical breakdown/degradation substances in a product.  Perhaps a new chapter in the plaintiff drug and device playbook is being written.) The plaintiffs asserted claims under California and New York consumer protection laws, as well as common law theories of unjust enrichment and breach of warranty.  The defendant filed a motion to dismiss.  Continue Reading SDNY Dismisses Sunscreen Case Based on Preemption

Photo of Bexis

The Supreme Court’s latest foray into the constitutional thicket of personal jurisdiction, Mallory v. Norfolk Southern Railway, No. 21-1168 – to decide whether states can force corporations to “consent” to general personal jurisdiction via foreign corporation registration statutes − was orally argued on November 8, 2022.  The transcript is available here.  Since Bexis has been involved (as amicus curiae) in Mallory since the trial court’s favorable decision (which he made sure was on Westlaw and Lexis) was first appealed in Pennsylvania, we thought we’d review the highlights of the oral argument.Continue Reading Mallory Oral Argument – Litigation Tourists’ Last Stand?

Photo of Bexis

We’ve written a number of posts on whether, in various jurisdictions across the United States, software and other forms of electronic/magnetic code can be considered to be “products” for purposes of product liability – usually strict liability.  As befits the decentralized product liability litigation landscape in the United States, there is considerable uncertainty, but most decisions, as well as both the Second and Third Restatements of Torts, have determined that incorporeal items composed of electronic bytes are not “products.”Continue Reading Software as a Product – The European Union Goes There

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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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