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Allen v. Am. Capital Ltd.
287 F. Supp. 3d 763
D. Ariz.
2017
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Background

  • Plaintiffs are the wife and children of Dr. Robert Allen, who received multiple heparin doses at Mayo Clinic in Dec. 2007, developed complications (including HIT), underwent surgeries, and died in March 2008; plaintiffs allege contaminated heparin (OSCS) produced or supplied by SPL and Baxter caused the injuries and death.
  • SPL produced heparin API (sourcing porcine intestines from suppliers in North America and China); Baxter produced finished heparin using SPL API and distributed it to wholesalers (Cardinal) and Mayo.
  • Public-health investigations concluded a third party adulterated crude heparin with oversulfated chondroitin sulfate (OSCS); MDL litigation in N.D. Ohio consolidated many suits and made prior rulings on product-identification issues for certain doses.
  • Plaintiffs offered expert witnesses on product identification (Ronald Moore), causation (several cardiology/hematology/pharmacology experts), and standard of care; defendants moved to exclude several experts and moved for summary judgment on warranty and punitive-damages/veil-piercing theories (ACAS).
  • The district court applied Arizona substantive law, Federal Rules of Evidence gatekeeping (Daubert/Kumho), and considered MDL court rulings as persuasive but not strictly binding when new evidence appears.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Admissibility of product-identification expert (Moore) Moore’s database review creates a genuine dispute about whether certain early doses (6:00 a.m., 10:15 a.m.) were Baxter product; he can trace lots and industry practices to identify product Moore’s turnaround-time calculations are speculative, cherry-picked, untested, and derive from incomplete data; his conclusions are unreliable under Daubert Court excludes Moore’s product-identification opinions that specific turnaround analysis supports contamination findings; permits Moore to testify about industry practices, NDC meaning, lot numbers received, and MedAltID interpretation (limited testimony)
Admissibility of defense causation expert (Dr. Fintel) (Plaintiffs) Fintel’s differential diagnosis is unreliable, failing to properly consider contaminated heparin and timing; also seek to limit general causation testimony (Defendants) Fintel is a qualified cardiologist whose differential diagnosis fits the record and rules out contaminated heparin as the proximate cause Court admits Fintel’s specific-causation opinions as reliable; excludes his undisclosed general-causation opinions to the same extent plaintiffs limited Dr. Gorton (i.e., general OSCS mechanism testimony is limited)
Admissibility of plaintiffs’ causation experts (Magalski, Gorton, Kiss, Jeske) Their experience, literature review, and differential-diagnosis methods support both general and specific causation linking OSCS -> hypotension/HIT -> MI and cardiogenic shock Defendants argue methodology produces false positives (conflicts with MDL rulings), relies on speculation, conflicts with records/treating physicians, or lacks qualifications for some opinions Court denies Daubert challenge to plaintiffs’ causation experts; finds them qualified and their methodologies sufficiently reliable for trial (weight to be tested at trial)
Summary judgment: ACAS direct/indirect liability, punitive damages, warranty claims Plaintiffs contend ACAS participated in and aided SPL, warranting direct liability or veil piercing; seek punitive damages against defendants; plaintiffs abandon warranty claims at trial ACAS argues no direct role in manufacture/distribution, separate corporate formalities and capitalization preclude veil piercing; defendants argue lack of evidence of conscious disregard for punitive damages; warranty claims merit judgment Court denies summary judgment on ACAS direct-participation and in-concert theories (fact issues exist); grants summary judgment for ACAS on veil-piercing and assumption-of-duty claims (no indirect liability). Court grants summary judgment in favor of defendants on punitive damages and on Plaintiffs’ warranty claims; remaining negligence/strict-liability/wrongful-death/survival claims proceed to trial

Key Cases Cited

  • Erie R. Co. v. Tompkins, 304 U.S. 64 (establishes that federal courts sitting in diversity apply state substantive law)
  • Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (courts act as gatekeepers under Rule 702; reliability, qualifications, fit)
  • Kumho Tire Co. v. Carmichael, 526 U.S. 137 (Daubert gatekeeping applies to all expert testimony, not only hard science)
  • Klaxon Co. v. Stentor Elec. Mfg. Co., Inc., 313 U.S. 487 (choice-of-law in diversity must follow forum state rules)
  • Thomas v. Bible, 983 F.2d 152 (9th Cir.) (law-of-the-case doctrine and standards for reconsideration of prior rulings)
  • Joiner v. General Elec. Co., 522 U.S. 136 (courts may exclude expert opinion where there is too great an analytical gap between data and opinion)
  • Celotex Corp. v. Catrett, 477 U.S. 317 (summary judgment burden shifting standard)
  • Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (standards for genuine dispute of material fact at summary judgment)
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Case Details

Case Name: Allen v. Am. Capital Ltd.
Court Name: District Court, D. Arizona
Date Published: Dec 22, 2017
Citation: 287 F. Supp. 3d 763
Docket Number: No. CV–16–02876–PHX–JAT
Court Abbreviation: D. Ariz.