Ryan P. Ehlis v. Shire Richwood, Inc.

United States Court of Appeals
FOR THE EIGHTH CIRCUIT
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Nos. 02-3933/03-1057
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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. *
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Submitted: October 22, 2003
Filed: May 18, 2004
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Before RILEY, BEAM, and SMITH, Circuit Judges.
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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
1
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.
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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 “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
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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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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
4
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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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
5
“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.”
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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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