The Rule 702 Toolbox: Cherry-Picking Is a Recipe for Exclusion

Most courts (but certainly, and unfortunately, not all of them) recognize that cherry-picking is a cardinal sin under Rule 702.  Science generally requires a rigorous and conservative approach to evaluating cause-and-effect relationships.  This schema inherently clashes with litigation, an arena where parties prioritize results over neutral principles of process purity.

“Cherry-picking” involves the selective consideration of facts and data to support a desired or pre-determined result, rather than the analysis of all relevant facts and data to find a scientific truth (or determine that the truth remains elusive based on the available facts and data).  It evades the scrupulous adherence to principles of objectivity, rigor, and process validity that are the hallmark of the scientific method.  In Daubert-speak, such a methodology does not produce “scientific knowledge.”  Rather, cherry-picking represents a failure of methodology that cannot be waived off as a matter of weight rather than admissibility.

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The Rule 702 Toolbox: How Do You Solve a Problem Like the Ninth Circuit?

There has been much discussion recently about how Rule 702 is in need of a tune-up to better guide district courts’ gatekeeping.  More about that soon.

But a case now pending before the Supreme Court, Monsanto Company v. Hardeman, No. 21-241, demonstrates that it’s not always the fault of the district courts.  (Disclaimer:  This firm (and this author) filed an amicus brief supporting certiorari.)  Sometimes it’s about a lack of stewardship at the circuit level.  Absent direct and unequivocal guidance from the Supreme Court, appellate courts call the tune, and the district courts are required to follow it.  And in the interstices, district judges read the tea leaves and try to follow the circuit court’s leads and signals.  No one likes to get reversed.  Even if the district judges think the circuit has gotten it wrong, they honor the hierarchy and follow the commands of stare decisis, human nature and common sense.

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Southern District of Texas Holds Learned Intermediary Doctrine Applies to Clinical Trials

Does the learned intermediary doctrine apply in the context of a clinical trial?  According to the Southern District of Texas, it does.  The case in question is Butler et al. v. Juno Therapeutics, Inc., a tragic case involving the death of a 19-year-old woman with terminal leukemia who died within days of receiving an experimental cancer drug as a participant in a clinical trial.

In 2015, Juno Therapeutics (Juno) was developing a treatment for advanced blood cancers involving Chimeric Antigen Receptor T-cell (CAR-T) therapy.  CAR-T therapy is designed to modify a patient’s white blood cells to target cancer cells with the goal of improving the patient’s condition so a bone marrow or stem cell transplant can be tolerated.  In October 2015, Juno entered into a Clinical Study Agreement with MD Anderson (and other hospitals) as part of a Phase 2 clinical trial (the “Rocket Study”) of a drug identified as JCAR015, a CAR-T therapy.  Drs. William Wierda and Michael Rytting were the principal investigators of the Rocket Study at MD Anderson.

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Not All’s Well That Ends Well: The Seventh Circuit Misapplies Daubert, but Still Delivers a Victory

The nature of advocacy makes it hard sometimes for lawyers to focus solely on the outcome and the bottom line result.  How a court gets there may not matter much to the prevailing party in the dispute as they celebrate the win, but it may have an impact on later cases.  A recent example is the opinion in Burton et al. v. E.I. DuPont de Nemours and Co., Inc., 2021 WL 1422814 (7th Cir. Apr. 15, 2021).  The court found the winner’s circle, but it dented the car a bit along the way.

[Disclosure/disclaimer:  The author filed an amicus brief in support of defendants in the case.]

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Ninth Circuit Affirms Dismissal of Breast Implant Cases on Preemption Grounds

The Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim.  The court affirmed the dismissal of four lawsuits by plaintiffs claiming they were injured by breast implants on the grounds that their claims are barred by the 1976 Medical Device Amendment to the Food, Drug and Cosmetic Act (MDA).  Sewell v. Mentor Worldwide, LLC, et al., no. 19-56393; Vieira v. Mentor Worldwide, LLC, et al., no. 19-56394; Billetts v. Mentor Worldwide, LLC, et al., no. 19-56398; Nunn v. Mentor Worldwide, LLC, et al., no. 19-56391.

In each case, California plaintiffs alleged their breast implants were defective and caused them to experience fatigue, muscle pain, and migraines.  The district courts dismissed the complaints for failure to state a claim on grounds of preemption, and plaintiffs appealed.

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Failure to Fully Disclose Expert Opinions Results in Summary Judgment

Federal Rule of Civil Procedure 26(a)(2) requires retained expert witnesses to provide an expert report which gives “a complete statement of all opinions the witness will express and the basis and reasons for them.”  Fed. R. Civ. P. 26(a)(2)(B)(i).  If a party fails to disclose information required under Rule 26(a)(2), “the party is not allowed to use that information or witness to supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially justified or is harmless.”  Fed. R. Civ. P. 37(c)(1).  As a plaintiff in the Western District of Washington recently learned, failure to adhere to Rule 26 can be fatal to a case.

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