Subject: Causation

The Zantac Rule 702 Order: TLBR (Too Long, But Read)

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On opening an opinion, lawyers habitually roll their eyes when they see a table of contents.  Even more so when they learn the opinion is over 300 pages.  The MDL order granting defense motions to exclude experts and for summary judgment in In re Zantac (Ranitidine) Products Liability Litig. (S.D. Fla. Dec. 6, 2022), however, is a worthwhile read.  The court’s analysis and prose is thorough, clearly reasoned, well-supported, … and highly readable.  It reveals a court willing to roll up its judicial sleeves, tackle and explain the fundamental science in detail, and rigorously apply Rule 702 to perform its essential gatekeeping function – to insulate the jury, and the defendants, from flawed advocacy masquerading as scientific evidence and holding retained experts to reasonable standards of intellectual rigor.

The Zantac litigation involves claims that the active ingredient in popular heartburn medication ranitidine breaks down to produce excessive levels of NDMA, a probable human carcinogen, under certain storage and biological conditions.  That sounds scary.  FDA has set a low daily intake limit of NDMA, a byproduct of, among other things, a common diet.

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Experts’ Disagreement with Medical Literature Leads to Exclusion

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Peer-reviewed literature can be a powerful tool in attacking an opposing expert’s opinions.  A solid, on-point article can do more than merely satisfy several of the so-called Daubert factors for assessing reliability – by showing a court that others in a challenged expert’s field disagree with his or her opinions, literature can remove any expert “aura” that might discourage a lay judge from discharging his or her duty as a gatekeeper.  Presenting literature that directly undermines the expert’s opinion can make the difference between winning and losing a motion to exclude, especially where the expert’s opinion is not supported by other literature accepted in the field.

A recent example is U.G. v. United States, 2022 WL 7426212 (S.D.N.Y. Oct. 13, 2022), a medical malpractice action under the Federal Tort Claims Act in which plaintiff suffered a shoulder injury during his birth and was later diagnosed with permanent Erb’s palsy, or brachial plexus injury.  He alleged that the obstetrician caused the injury by using excessive force on his head and shoulders during delivery.  In support of his claims, he offered two causation experts – an obstetrician/gynecologist and a pediatric neurologist– both of whom claimed the “totality of the circumstances” ruled out several possible alternate causes and thus showed that the defendant caused the injury.

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“Alternative Avenues” Argument in Failure-to-Warn Cases Adding an Additional Wrinkle to Medical Device Litigation

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A developing line of cases across the nation may have large implications for medical device manufacturers defending against failure-to-warn claims.  While a treating physician’s failure to read or rely on the manufacturer’s warnings has historically been fatal to a failure-to-warn claim in many jurisdictions (at least those without a “read and heed” presumption), plaintiffs have tried novel “alternative avenues” arguments to make summary disposition of the claim more difficult.

There are two theories under which a failure-to-warn claim may be brought in the products liability context:  a manufacturer with a duty to warn may breach its duty by either (1) failing to provide an adequate warning of the product’s potential risks (the “content theory”) or (2) failing to adequately communicate the warning to the ultimate consumer (the “communication theory”).  Plaintiffs have traditionally pursued failure-to-warn claims in prescription medical device cases under the content theory, with most courts holding that a treating physician’s failure to read or rely on the manufacturer’s warnings in the product’s instruction for use (“IFU”) is fatal to the claim.  See, e.g., Foster v. Ethicon, Inc., 2021 WL 1169473, at *7 (D.S.D. Mar. 26, 2021).

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European Commission Updates Liability Rules to the Digital Age

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The European Commission adopted two proposals that adapt liability rules to the digital age, circular economy and the impact of global value chains. These proposals are related to the Revised Product Liability Directive, fit for the green and digital transition and global value chains, and the AI Liability Directive to provide easier access to redress.

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Ipse Dixit – It’s Not Just for Analytical Gaps Anymore

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There are few legal phrases more fun to say than “ipse dixit.” The phrase is most commonly used in motions to exclude experts who base their opinions on nothing more than their own say so.  As the Court noted in General Electric Co. v. Joiner, 522 U.S. 136 (1997), an ipse dixit – Latin for “he said it himself” – leaves an impermissible “analytical gap” between the expert’s opinion and the facts on which it is based.  But ipse dixit arguments can and should stretch beyond just the “basis” part of the expert argument. Courts should also exclude experts who provide unsupported and self-serving testimony to suggest that their method is accepted generally in the community.

That is precisely what happened in Knepfle v. J-Tech Corporation, 2022 WL 4232598, — F.4th — (11th Cir. 2022).  Plaintiff was injured in a motor vehicle accident when she ran her motorcycle into the side of a vehicle that had turned in front of her, causing her to be thrown from the motorcycle.  Although the helmet she was wearing protected her head during the initial impact with the other vehicle, she alleged that it came off and failed to protect her head when it struck the pavement.  She brought product liability claims against multiple defendants in the manufacturing and distributing chain of the helmet.

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Sue Generous and the Laws of Legal Physics: Preventing Asbestos Mission Creep in California Courts

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It is virtually a law of legal physics in California that liability tends to expand until a critical mass of appellate courts rule that it has reached its limit, or the Supreme Court puts up a stop sign (a vanishingly rare occurrence).

This judicial tendency reaches its zenith in asbestos litigation.  Asbestos cases feature a combination of factors that pressure-test the boundaries of traditional tort law.  Asbestos fibers, in most cases, are relatively fungible, and the exposures are anecdotal and undifferentiated.  The injuries have extremely long latency periods, leaving exposure details fuzzy, ancient lore.  The biological mechanisms are largely mysterious.  In many cases, the plaintiff can prove an asbestos injury but cannot reliably prove causation under traditional tort standards.

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