Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca8-03-01057/USCOURTS-ca8-03-01057-0/pdf.json

Parties Involved:
Ryan P. Ehlis
Appellee
Angie Moreno
Appellee
Shire Pharmaceuticals Group
Not Party
Shire Richwood
Appellant

Document Text:

United States Court of Appeals

FOR THE EIGHTH CIRCUIT

___________

Nos. 02-3933/03-1057

___________

Ryan P. Ehlis; Angie Moreno, *

individually, and as surviving parents *

of Tyra Lynn Ehlis, deceased, *

*

Appellants/Cross Appellees, *

* Appeals from the United States

v. * District Court for the

* District of North Dakota.

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. *

___________

Submitted: October 22, 2003

Filed: May 18, 2004

___________

Before RILEY, BEAM, and SMITH, Circuit Judges.

___________

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The appellants state that, because Ehlis assigned his claims to Moreno to hold

in trust for Tyra Lynn Ehlis’s siblings, only Moreno is pursuing this appeal. 

2

The Honorable Karen K. Klein, United States Magistrate Judge for the District

of North Dakota, to whom this case was referred for final disposition by consent of

the parties pursuant to 28 U.S.C. § 636(c) (2000).

3

According to the appellee, Shire Richwood Inc., the defendant in the district

court, is now known as Shire US, Inc.

-2-

RILEY, Circuit Judge.

Ryan Ehlis (Ehlis) and Angie Moreno (Moreno)1

 appeal the district court’s2

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 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

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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 “outof-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

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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 district court’s grant of summary judgment de novo.” Gray v.

AT&T Corp., 357 F.3d 763, 765 (8th Cir. 2004). “We will affirm a district court’s

grant of summary judgment ‘if the pleadings, depositions, answers to interrogatories,

and admissions on file, together with affidavits . . .’ demonstrate that no genuine issue

of material fact exists and the moving party is entitled to judgment as a matter of

law.” Id. (quoting Fed. R. Civ. P. 56(c)). “As we exercise our power under diversity

jurisdiction, we must interpret the forum state’s law.” Id. (citation omitted). North

Dakota law applies to this diversity case, and we review de novo the district court’s

interpretation of North Dakota law. Triton Corp. v. Hardrives, Inc., 85 F.3d 343, 345

(8th Cir. 1996). We attempt to predict how the highest court in North Dakota would

resolve the issues before us. Nordyne, Inc. v. Int’l Controls & Measurements Corp.,

262 F.3d 843, 846 (8th Cir. 2001).

B. Learned Intermediary Doctrine

The learned intermediary doctrine provides that a pharmaceutical manufacturer

has a duty to warn a physician of the risks involved with a pharmaceutical, and the

physician then acts as a “learned intermediary” between the manufacturer and the

physician’s patient. Kirsch v. Picker Int’l, Inc., 753 F.2d 670, 671 (8th Cir. 1985).

“Thus, a warning to the [physician] is deemed a warning to the patient; the

manufacturer need not communicate directly with all ultimate users of prescription

drugs.” Id.

This [learned intermediary] doctrine states that adequate warnings to

prescribing physicians obviate the need for manufacturers of

prescription products to warn ultimate consumers directly. The doctrine

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is based on the principle that prescribing physicians act as “learned

intermediaries” between a manufacturer and consumer and, therefore,

stand in the best position to evaluate a patient’s needs and assess risks

and benefits of a particular course of treatment. The learned

intermediary doctrine has been adopted in most jurisdictions . . . .

Desmaris v. Dow Corning Corp., 712 F. Supp. 13, 17 (D. Conn. 1989) (citing Basko

v. Sterling Drug, Inc., 416 F.2d 417, 426 (2d Cir. 1969)). The Ohio Supreme Court

has explained that, as a learned intermediary, “[t]he physician has the duty to know

the patient’s condition as well as the qualities and characteristics of the drugs or

products to be prescribed for the patient’s use.” Tracy v. Merrell Dow Pharm, Inc.,

569 N.E.2d 875, 878 (Ohio 1991). Thus, the physician stands in the best position “to

balance the needs of patients against the risks and benefits of a particular drug or

therapy, and then to supervise its use.” Id.

Under the learned intermediary doctrine, the manufacturer’s failure to provide

the physician with adequate warnings of the risks associated with a particular

prescription product “is not the proximate cause of a patient’s injury if the prescribing

physician had independent knowledge of the risk that the adequate warning should

have communicated.” Christopher v. Cutter Labs., 53 F.3d 1184, 1192 (11th Cir.

1995). “Thus, the causal link between a patient’s injury and the alleged failure to

warn is broken when the prescribing physician had ‘substantially the same’

knowledge as an adequate warning from the manufacturer should have communicated

to him.” Id. We have previously recognized the rationale supporting this doctrine in

the context of pharmaceuticals:

There are several arguments supporting the application of this [learned

intermediary rule] exception to prescription drug products. First,

medical ethics and practice dictate that the doctor must be an intervening

and independent party between patient and drug manufacturer. Second,

the information regarding risks is often too technical for a patient to

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make a reasonable choice. Third, it is virtually impossible in many

cases for a manufacturer to directly warn each patient.

Hill v. Searle Labs., 884 F.2d 1064, 1070 (8th Cir. 1989).

Moreno admits “it is likely that North Dakota will adopt some version of the

‘learned intermediary’ doctrine.” Moreno contends that, regardless of whether North

Dakota would adopt the learned intermediary doctrine, Dr. Peterson was not

adequately warned of the dangers of prescribing Adderall under either a subjective

or objective standard. Shire argues North Dakota would adopt the doctrine and apply

that doctrine to bar Moreno’s claims, because Dr. Peterson knew the risks associated

with Adderall when he prescribed Adderall for Ehlis.

We believe the district court correctly determined North Dakota would adopt

the learned intermediary doctrine for two reasons. First, the district court observed

that North Dakota had adopted section 402A of the Restatement (Second) of Torts,

from which the learned intermediary doctrine evolves. The district court reasoned

that, because North Dakota has adopted other comments from section 402A “North

Dakota would recognize the learned intermediary doctrine as the rule of law in cases

where the adequacy of the warning as to a prescription drug is at issue.” In Hill, we

recognized the existence of the learned intermediary doctrine in Arkansas after

finding “the Arkansas Supreme Court has often referred to the comments of section

402A, implicitly adopting them.” Hill, 884 F.2d at 1067. Similarly, the North Dakota

Supreme Court has discussed and adopted comments to section 402A on several

occasions. See, e.g., Clarys v. Ford Motor Co., 592 N.W.2d 573, 574 n.1 (N.D. 1999)

(“This Court adopted the rule of strict liability in tort under Section 402A,

Restatement (Second) of Torts”); Bachmeier v. Wallwork Truck Ctrs., 507 N.W.2d

527, 534 n.3 (N.D. 1993) (citing section 402A for elements of prima facie products

liability case); Butz v. Werner, 438 N.W.2d 509, 517 (N.D. 1989) (adopting

Restatement (Second) of Torts § 402A, Comment j (1965), and noting “[o]ur strict

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products liability caselaw has relied heavily upon Section 402A”); Morrison v. Grand

Forks Hous. Auth., 436 N.W.2d 221, 223-24 & n.3-n.6 (N.D. 1989) (citing various

subsections of section 402A); Johnson v. Am. Motors Corp., 225 N.W.2d 57, 66

(N.D. 1974) (recognizing cause of action for strict liability in tort as encompassed in

section 402A).

Second, the district court noted an overwhelming majority of jurisdictions have

adopted the learned intermediary doctrine. One district court, collecting cases

addressing the doctrine, observed “the doctrine either applies or is recognized . . . in

48 states, the District of Columbia, and Puerto Rico.” In re Norplant Contraceptive

Prods. Liab. Litig., 215 F. Supp. 2d 795, 806 (E.D. Tex. 2002). Because the

precedent is truly overwhelming and the policy enunciated by the learned

intermediary doctrine is sound, we conclude the district court correctly ruled the

North Dakota Supreme Court would adopt the learned intermediary doctrine.

C. Learned Intermediary Doctrine Bars Moreno’s Claims

We next ask whether the learned intermediary doctrine bars Moreno’s claims.

Moreno argues a genuine issue of material fact exists as to Dr. Peterson’s knowledge

about Adderall’s side effects. Moreno contends Dr. Peterson was not adequately

warned of the dangers of prescribing Adderall to Ehlis under a subjective standard.

Moreno also contends the warnings for Adderall were insufficient under an objective

standard.

Viewing the evidence under a subjective standard leads to the inescapable

conclusion Dr. Peterson knew the risks of prescribing Adderall for Ehlis. Dr.

Peterson clearly stated the warnings were adequate, and he knew the risks of

prescribing Adderall for Ehlis. Dr. Peterson explained that, before prescribing a

stimulant to a patient, he would analyze a patient’s symptoms and other

characteristics, as well as evaluate risks and side effects of a particular stimulant. Dr.

Peterson kept current with medical knowledge and information about medications and

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This argument was soundly rejected in Woulfe v. Eli Lilly & Co., 965 F. Supp.

1478, 1484 (E.D. Okla. 1997), where the court found entirely proper the

consideration of the treating physician’s affidavit or testimony in evaluating the

presumption that a different warning would have been heeded.

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treatments, and appears conscientious about remaining current with the state of

medicine in psychiatry. Dr. Peterson stated he would review the Physicians Desk

Reference (PDR) before prescribing stimulant medications, including Adderall. With

new drugs, Dr. Peterson would read the PDR, talk to pharmacy representatives, try

to read a “double-blind study” about a medication, and roughly half the time talk to

colleagues about their experiences with the medication.

Dr. Peterson was aware that abuse of stimulants can result in psychotic or

manic experiences, acknowledging he recognized stimulants can cause psychosis as

a side effect. Referring to the Diagnostic and Statistical Manual of Mental Disorders

(4th ed. 1994), Dr. Peterson stated he (1) knew substance-induced psychosis was

“within the DSM-IV,” meaning diagnostic criteria exist for this condition, regardless

of whether the psychosis is caused by a stimulant or other medication; (2) was aware

some people can become psychotic without overdosing on a certain medication,

including Adderall; (3) knew the risk of psychosis was listed and identified in the

package insert as a side effect for Adderall when he prescribed Adderall for Ehlis; (4)

believed the statement in the insert was accurate; (5) continues to prescribe stimulant

medication for adults since the incident involving Ehlis; and (6) continues to

prescribe Adderall, because Adderall is a good medication.

Moreno argues the court should put less weight on the subjective testimony of

the prescribing physician and should apply an objective standard to determine what

a reasonable prescribing physician would have done under the circumstances.4

 We

need not directly decide whether an objective standard should supplant a subjective

standard, because the record here would not support a violation of an objective

standard in any event. Moreno provided no evidence from physicians or other experts

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“Special problems, particularly those that may lead to death or serious injury,

may be required by the [FDA] to be placed in a prominently displayed box.” 21

C.F.R. § 201.57(e) (2003). This prominently displayed box is commonly referred to

as a “black box.”

-9-

indicating the warnings on the Adderall label were inadequate. In the “Adverse

Reactions” section of Adderall’s warning label, the label warned of “[p]sychotic

episodes at recommended doses.” The “Warnings” section indicated Adderall may

exacerbate “behavior disturbance and thought disorder” in psychotic children. The

“Drug Abuse” section warned that the “most severe manifestation of chronic

intoxication is psychosis,” which is often indistinguishable from schizophrenia. The

warning that Adderall can cause psychosis at recommended doses clearly applies

equally to adults and children.

Dr. Donald Marks, Moreno’s expert witness, testified during his deposition that

the FDA standard “is also the standard for the pharmaceutical industry.” When asked

about the FDA’s refusal to permit pharmaceutical manufacturers to implement a

“black box”5

 warning, Dr. Marks stated the “FDA has, of course, final authority over

what happens on a package insert.” Finally, Dr. Marks asserted that “[i]f a standard

textbook of pharmacology says that this drug class is capable of causing these

neurologic symptoms, then that’s common knowledge to everybody.” Dr. Marks’s

testimony confirms, even if an objective standard were appropriate, the warnings in

this case were adequate.

We conclude the district court did not err in ruling Dr. Peterson knew of and

appreciated the risks associated with prescribing Adderall. Shire was responsible for

informing Dr. Peterson of these risks. Shire did exactly that. As the district court

observed, “Dr. Peterson understood the risks associated with prescribing Adderall and

voluntarily proceeded with an educated course of conduct.” Because Shire

adequately warned Dr. Peterson of the risks associated with Adderall, and because

Ehlis is unable to establish Adderall’s allegedly insufficient warnings proximately

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caused his symptoms, the learned intermediary doctrine bars legal responsibility for

the effect Adderall had on Ehlis. See Christopher, 53 F.3d at 1192.

D. Other Claims

Because we conclude the learned intermediary doctrine bars all recovery, we

do not address Moreno’s preemption argument or Shire’s cross-appeal arguments.

See Jean v. Nelson, 472 U.S. 846, 854 (1985) (a fundamental rule of judicial restraint

is courts must consider nonconstitutional grounds for decisions before reaching

constitutional questions); Doe v. Hartz, 134 F.3d 1339, 1341 (8th Cir. 1998) (citing

Jean). Shire’s motion to dismiss the appeal is otherwise denied. See 8th Cir. R. 47B.

III. CONCLUSION 

For the reasons stated herein, we affirm the district court’s grant of summary

judgment to Shire.

______________________________

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