Subject: Causation

Texas Supreme Court Refocuses on Causation and Affirms Summary Judgment in Herbicide Drift Case

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The question of whether a particular application of herbicide on one property caused damage on another’s property requires expert testimony.  When a plaintiff claims that herbicide drift caused reduced crop yields, it is not enough for an expert to opine merely that the drift caused damage to plants – the plaintiff must establish that the defendant’s application of the herbicide caused the reduced crop yield.  The distinction may sound nuanced but can have profound ramifications on litigation.  This is well illustrated in the Texas Supreme Court’s recent decision in Helena Chemical Company v. Cox, — S.W. 3d –, 2023 WL 2335694 (Tex. Mar. 3, 2023), an important and highly followed case focusing on the causation requirement in cases alleging yield loss to a crop from alleged exposure to pesticides.

The plaintiffs in Cox were cotton farmers who alleged that the defendant had supervised an aerial application of herbicide that drifted onto plaintiffs’ properties and damaged their crops, causing reduced yields.  A government inspector conducted a visual inspection of the damaged crops and claimed to find “markers” for the herbicide’s two active ingredients, but no lab testing was performed.  The inspector also identified no “consistent pattern” or “drift pattern” of crop damage over the large area encompassing the various plaintiffs’ noncontiguous properties.  Plaintiffs disclosed a slate of experts to support their allegations, but the trial court excluded the experts and granted summary judgment to the defendant.  The court of appeals reversed, finding the experts admissible despite their inability to trace the alleged drift of the herbicide in question from defendants’ application site to plaintiffs’ properties.

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5 Major Drug and Device Developments of 2022

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As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702 updates that took place this year, which will carry over into 2023?), but provides a brief recap and assessment of five of the most interesting and consequential developments affecting drug and device law in 2022.

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Failure to Comply with Lone Pine Order Results in Dismissal of Over 1,000 Cases in Zostavax MDL

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Earlier this year, we discussed the Eastern District of Pennsylvania’s decision to enter a Lone Pine order – that is, a case management order that requires all plaintiffs to produce evidence establishing specific elements of their claim – in the Zostavax MDL. That post can be viewed here. We lauded that Lone Pine order’s potential to save the parties considerable time and expense while advancing the purposes of the MDL by weeding out meritless cases. That potential recently came to fruition: the court in the Zostavax MDL dismissed 1,189 cases for failure to comply with the Lone Pine order. In re: Zostavax (Zoster Vaccine Live) Prods. Liab. Litig., 2022 WL 17477553 (E.D. Pa. Dec. 6, 2022).

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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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