367 F.3d 1013 (8th Cir. 2004), 02-3933, Ehlis v. Shire Richwood, Inc.

Docket Nº:02-3933, 03-1057.
Citation:367 F.3d 1013
Party Name:Ryan P. EHLIS; Angie Moreno, individually, and as surviving parents of Tyra Lynn Ehlis, deceased, Appellants/Cross Appellees, v. SHIRE RICHWOOD, INC., now known as Shire US, Inc., Appellee/Cross Appellant, Shire Pharmaceuticals Group, PLC, Defendant. Product Liability Advisory Council, Incorporated; Pharmaceutical Research and Manufacturers of Amer
Case Date:May 18, 2004
Court:United States Courts of Appeals, Court of Appeals for the Eighth Circuit
 
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Page 1013

367 F.3d 1013 (8th Cir. 2004)

Ryan P. EHLIS; Angie Moreno, individually, and as surviving parents of Tyra Lynn Ehlis, deceased, Appellants/Cross Appellees,

v.

SHIRE RICHWOOD, INC., now known as Shire US, Inc., Appellee/Cross Appellant,

Shire Pharmaceuticals Group, PLC, Defendant.

Product Liability Advisory Council, Incorporated; Pharmaceutical Research and Manufacturers of America, Amici on Behalf of Appellee.

Nos. 02-3933, 03-1057.

United States Court of Appeals, Eighth Circuit

May 18, 2004

Submitted: Oct. 22, 2003.

Page 1014

Jessica R. Dart, argued, Los Angeles, California (Arnold Anderson Vickery, Houston, Texas, and Earl Landers Vickery, Austin, Texas on the brief), for appellant.

Joseph P. Thomas, argued, Cincinnati, Ohio (Linda E. Maichl, Cincinnati, Ohio on the brief), for appellee.

Before RILEY, BEAM, and SMITH, Circuit Judges.

RILEY, Circuit Judge.

Ryan Ehlis (Ehlis) and Angie Moreno (Moreno) 1 appeal the district court's 2 grant of summary judgment in favor of Shire US, Inc. (Shire). 3 Ehlis and Moreno sought damages from Shire for its failure to warn about the effects of Adderall, a

Page 1015

drug Shire manufactures. Moreno argues the district court erred (1) in applying the learned intermediary doctrine to bar the plaintiffs' claims and ruling Shire adequately warned Ehlis's treating physician about psychosis resulting from ingestion of Adderall and (2) in ruling their claims are preempted by the Food, Drug and Cosmetic Act (FDCA). Shire cross-appeals, arguing the district court erred (1) in deciding the plaintiffs presented expert testimony sufficient to meet their burden of proof and (2) in finding the plaintiffs presented sufficient evidence to rebut the presumption against defects contained in North Dakota's Product Liability Act, N.D. Cent.Code section 28-01.3-09. Concluding the district court did not err in ruling the learned intermediary doctrine barred the plaintiffs' claims, we affirm.

I. BACKGROUND

Ehlis, a student at the University of North Dakota having difficulties with a class, went to see Dr. Thomas Peterson (Dr. Peterson), a psychiatrist. Ehlis told Dr. Peterson that, as a child, Ehlis had been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and had taken Ritalin. Following a 45-minute office visit, Dr. Peterson prescribed for Ehlis a pharmaceutical called Adderall, which contains amphetamine salts and is manufactured for treating ADHD in children and narcolepsy in adults. Adderall is approved by the Food and Drug Administration (FDA).

Ehlis began taking Adderall shortly after receiving the prescription, and took the prescribed dosage for two days. Ehlis then reduced the dosage due to the "strong" effect it had on him. Ehlis took no Adderall over the next weekend and felt normal, but resumed taking the prescribed amount of the drug the following week. On Friday morning of the second week, Ehlis ingested the remaining pills of the thirty-day prescription. Moreno, who is Ehlis's girlfriend and the mother of his children, testified at a summary judgment hearing that Ehlis did not act like himself from the first day he took Adderall. Moreno testified Ehlis awoke frightened, and she would give him Adderall to calm him. Ehlis described delusions, hallucinations, and "out-of-body" experiences, including talking with God and with his dead grandfather, after he ingested the remainder of the Adderall. Claiming to be acting on God's orders, Ehlis shot his five-week-old daughter, then turned the gun on himself. Ehlis survived his shooting, but his daughter did not. Neither Ehlis nor Moreno contacted Dr. Peterson to discuss the alleged side effects Ehlis experienced when taking Adderall. Ehlis was charged with murder, but the charges were dismissed after various doctors testified about Ehlis's mental condition, reporting Ehlis suffered from an "Amphetamine-Induced Psychotic Disorder" and did not have the necessary criminal responsibility.

Ehlis and Moreno filed this lawsuit, contending Shire knew Adderall can induce psychosis and failed adequately to warn of the associated risks. Ehlis and Moreno also claimed Shire and Shire Pharmaceuticals Group illegally marketed and advertised the drug. The district court granted Shire's motion for summary judgment on the claims, ruling the learned intermediary doctrine barred the claims and the claims were preempted by the FDCA. On appeal, Moreno argues the district court erred. Shire cross-appeals a number of issues, which we do not reach because the learned intermediary doctrine bars the plaintiffs' claims against Shire.

II. DISCUSSION

A. Standard of Review

"We review the...

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