Guthrie v. Ball et al

Filing 238

ORDER denying 137 "Motion in Limine #23 to Exclude FDA Alert from Evidence at Trial." Signed by Magistrate Judge Susan K Lee on 10/17/2014. (BJL, )

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF TENNESSEE
AT CHATTANOOGA
KAREN GUTHRIE, individually and on
behalf of the Estate of Donald Guthrie,
Plaintiff,
v.
GREGORY BALL, M.D.,
Defendant.

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No. 1:11-cv-333-SKL

ORDER
Before the Court is Defendant’s “Motion in Limine #23 to Exclude FDA Alert from
Evidence at Trial” [Doc. 137], in which Defendant seeks to exclude a warning letter (“FDA
Alert”) sent by the Federal Drug Administration (“FDA”) to physicians regarding the dangers of
fentanyl patches from evidence at trial.

Plaintiff filed a timely response in opposition to

Defendant’s motion [Doc. 147], and Defendant filed a late reply [Doc. 203]. This motion is now
ripe.
I.

BACKGROUND
As reflected in multiple orders addressing a vast number of motions in limine filed by the

parties, this is a healthcare liability action in which Plaintiff asserts negligence claims against
Defendant for prescribing fentanyl patches for her late husband, Donald Guthrie (“Mr. Guthrie”).
It appears to be undisputed that Mr. Guthrie’s autopsy report indicates the cause of death resulted
from fentanyl toxicity, but Defendant disputes this was the actual cause of death.
II.

SUMMARY OF THE PARTIES’ ARGUMENTS
In his motion, Defendant states that the FDA issued an FDA Alert to healthcare

professionals regarding fentanyl transdermal patches, which were marketed as Duragesic and

generic brands. The FDA Alert at issue is attached to Defendant’s motion [Doc. 137-1]. During
the depositions of expert witnesses in this case, Plaintiff’s counsel referenced and questioned the
experts regarding the FDA Alert. Defendant contends that Plaintiff is relying on the FDA Alert
to define the standard of care. Defendant argues that the FDA Alert should be excluded at trial
because it (1) is irrelevant for purposes of defining the standard of care, (2) is inadmissible
hearsay, and (3) would be unfairly prejudicial to Defendant and confusing to the jury.
First, Defendant argues that the FDA Alert is irrelevant to defining the standard of care in
this case because Tenn. Code Ann. § 29-26-115(a) requires that each of the three basic elements
of a medical malpractice action—standard of care, breach of the standard, and proximate
cause—be proven by testimony of experts who were licensed and practicing in Tennessee or an
adjacent state during the year preceding the date that the alleged injury or wrongful act occurred.
Defendant therefore argues that the FDA Alert is not sufficient to prove standard of care, and
cites authority that American Medical Association rulings do not establish the medical standard
of care. See Hartsell v. Fort Sanders Reg. Med. Ctr., 905 S.W.2d 944, 950 (Tenn. Ct. App.
1995). Defendant argues that federal law is clear that the FDA cannot intrude upon decisions
statutorily committed to the discretion of healthcare professionals, and cannot prevent off-label
use of drugs because to do so would interfere with the practice of medicine. Thus, Defendant
contends that the FDA Alert does not define the standard of care and should be excluded.
Defendant also argues that the FDA Alert is inadmissible hearsay, to which no exception
applies, including the 803(8) hearsay exception, because Defendant contends that the FDA Alert
does not contain a statement identifying the office responsible for the alert or reflect the FDA’s
activities, does not indicate whether it pertains to a matter observed under a legal duty to report,

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and does not appear to reflect actual findings from a legally authorized investigation. Defendant
therefore argues that the FDA Alert should be excluded.
Finally, Defendant argues that evidence relating to the FDA Alert would be prejudicial to
Defendant and confuse or mislead the jury. Because Defendant contends that the FDA Alert
does not define the standard of care, as summarized above, Defendant argues that the
introduction of the FDA Alert will only prejudice Defendant and confuse and mislead the jury.
In response to Defendant’s motion, Plaintiff argues that the FDA Alert is admissible at
trial because it consists of excerpts from the prescribing information, which is admissible in a
Tennessee medical malpractice case. Plaintiff cites to case law for her argument that the FDA
Alert should be admissible because “‘a prescription drug’s labeling or its PDR reference, when
introduced along with other expert evidence on the standard of care, is admissible to assist the
trier-of-fact to determine whether the drug presented an unacceptable risk to the patient.’” [Doc.
147 at Page ID # 2814 (quoting Richardson v. Miller, 44 S.W.3d 1, 16-17 (Tenn. Ct. App.
2000))]. Plaintiff argues that because the FDA Alert contains the same information, largely
verbatim from the prescribing information, the FDA Alert should be admissible.
Plaintiff also argues that Defendant’s reliance upon Hartsell is misplaced, because that
case focused on whether the trial court had erred by excluding the AMA ethical opinion, and the
case turned on the fact that the plaintiff had waived the error by failing to offer proof at trial.
Plaintiff further argues that the admissibility of AMA ethical opinions has no bearing on the
admissibility of the FDA Alert. Plaintiff further states that the other case relied upon by
Defendant, French v. Stratford House, 333 S.W.3d 546, 561 (Tenn. 2011), which Defendant
cited for the proposition that “it is improper to use alleged violations of federal and state
regulations to prove a deviation in the standard of care as a component of a medical malpractice

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claim,” [Doc. 137 at Page ID # 2494], actually only holds that federal and state regulations are
inadmissible in medical malpractice claims to prove negligence per se. Plaintiff states that the
French holding did not apply to the plaintiff’s ordinary negligence claims in that case, but rather
only to the negligence per se claim. As Plaintiff’s claims in the instant case are not based on a
negligence-per-se theory, Plaintiff contends that the French case is inapplicable here.
Additionally, Plaintiff argues that the FDA Alert is admissible because it is relevant to
cause of death. The FDA Alert was sent out to prescribing physicians because deaths had
occurred when fentanyl was prescribed or used improperly. Plaintiff states that Defendant
admitted he received and read the FDA Alert before he prescribed the fentanyl to Mr. Guthrie,
but Defendant disputes that fentanyl toxicity caused Mr. Guthrie’s death. Plaintiff argues that
the FDA Alert is therefore relevant to cause of death and can be properly relied upon by
Plaintiff’s experts and used to cross-examine Defendant’s witnesses.
Plaintiff also argues that the FDA Alert is not barred from evidence as hearsay because
experts can rely on otherwise inadmissible evidence, including hearsay, under Rule 703 if it is
reasonably relied upon by experts in the field. Plaintiff argues that the FDA Alert is also not
barred as hearsay because it is not being offered for the truth of the matter asserted if the FDA
Alert is offered to impeach Defendant and his experts or as a party admission, since Defendant
has admitted he read the FDA Alert prior to prescribing the fentanyl patch to Mr. Guthrie.
Additionally, Plaintiff argues that the FDA Alert is admissible under Rule 803(8) as a public
records hearsay exception, and cites to case law where other courts have admitted FDA
warnings. See Musgrave v. Breg, Inc., No. 2:09-cv-01029, 2011 WL 4502032, at *6 (S.D. Ohio
Sept. 28, 2011); Toole v. McClintock, 778 F. Supp. 1543, n.11 (M.D. Ala. 1991) (rev’d, 999 F.2d
1430 (11th Cir. 1993)) [hereinafter Toole I]; Sabel v. Mead Johnson & Co., 737 F. Supp. 135 (D.

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Mass. 1990). Plaintiff further contends that the FDA Alert will be established as a reliable
authority through expert testimony, making it admissible under Rule 803(18)’s exception for
learned treatises, periodicals, or pamphlets. Finally, Plaintiff contends that the residual exception
under Rule 807 should result in the FDA Alert not being barred from admission as hearsay,
because Plaintiff states that it would be hard to imagine a document with greater circumstantial
evidence of trustworthiness than drug warning letters prepared by the FDA and sent to
prescribing doctors, especially considering that Defendant and his expert have admitted under
oath that they received and read the FDA Alert.
Plaintiff’s last argument is that the probative value of the FDA Alert is not substantially
outweighed by its prejudicial effect. Plaintiff cites to a Sixth Circuit case, United States v.
Gibbs, 182 F.3d 408, 430 (6th Cir. 1999), stating that “‘[u]nfair prejudice does not mean the
damage to a defendant’s case that results from the legitimate probative force of the evidence;
rather it refers to evidence which tends to suggest decision on an improper basis.’” [Doc. 147 at
Page ID # 2816]. Plaintiff also cites to Musgrave, 2011 WL 4502032, at *2, which found FDA
warnings to be admissible over Defendant’s arguments of unfair prejudice and relevance.
In Defendant’s reply, he argues that Plaintiff’s citation to Toole I should be disregarded
because it was vacated and remanded by the Eleventh Circuit. Defendant also argues that the
other cases cited by Plaintiff are distinguishable, because the FDA Alert in the instant case was
not issued following a legally authorized investigation and it does not state it was based on
reliable underlying data, such as peer-reviewed medical journals. Rather, Defendant states that
the FDA Alert here is based on reports regarding patients who have had issues from fentanyl
patches, but the FDA Alert does not specify who the reports were from or when they were made.
Defendant also argues that the Rule 807 residual exception does not apply because Defendant

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contends the FDA alert does not contain information that is more probative on the applicable
standard of care in this case than the expert testimony provided. Defendant therefore argues that
the FDA Alert is inadmissible hearsay.
III.

ANALYSIS
Defendant’s reply makes essentially two arguments: first, that the FDA Alert would not

be admissible as a public records exception under Rule 803(8) because the cases cited by
Plaintiff are either bad law, having been reversed, or are distinguishable; and second, that the
Rule 807 residual exception does not apply to the FDA Alert. The Court will first address the
parties’ arguments regarding the admissibility of the FDA Alert under the public records
exception of Rule 803(8) before turning to the parties’ other arguments.
Rule 803(8) creates an exception to the hearsay bar for “[a] record or statement of a
public office if: (A) it sets out: (i) the office’s activities; (ii) a matter observed while under a
legal duty to report . . . ; or (iii) in a civil case . . . , factual findings from a legally authorized
investigation; and (B) the opponent does not show that the source of information or other
circumstances indicate a lack of trustworthiness.” Fed. R. Evid. 803(8). A public report should
be admitted as a hearsay exception as long as it “contains factual findings and satisfies [the]
trustworthiness requirement.” Sabel, 737 F. Supp. at 142. Courts have held that FDA warnings,
like the FDA Alert here, are admissible under the public records hearsay exception in Rule
803(8). Musgrave, 2011 WL 4502032, at *6 (citing Toole I, 778 F. Supp. 1543, n.11; Sabel, 737
F. Supp. 135). In Musgrave, the court refused to grant the defendant’s motion in limine to
exclude FDA statements, finding them to be relevant (at least for impeachment purposes),
probative, and admissible hearsay as public records under Rule 803(8). Specifically, the court
found that “[t]hese portions of the FDA bulletins fall within the hearsay exception defined by

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Rule 803(8) because they are statements directly from the FDA ‘setting forth matters observed
pursuant to duty imposed by law as to which matters there was a duty to report.’” Musgrave,
2011 WL 4502032, at *6 (quoting Fed. R. Evid. 803(8)).
Regarding Defendant’s first argument in his reply that Toole I should be disregarded, the
Court notes that the Eleventh Circuit did in fact reverse and remand the case.

Toole v.

McClintock, 999 F.2d 1430 (11th Cir. 1993) [hereinafter Toole II]. However, while Defendant
attempts to use Toole II to support his motion to exclude the FDA Alert in this case, the Court
finds Toole II to be factually distinguishable from the instant case. In Toole II, the Eleventh
Circuit found that the trial court erred in admitting an FDA document containing “the agency’s
proposal to require pre-market approval for silicone-gel filled breast prostheses,” which included
the FDA’s “‘proposed findings’ on risks posed by the devices.” Id. at 1434 (citing General and
Plastic Surgery Devices; Effective Date of Requirement for Premarket Approval of Silicone Gelfilled Breast Prosthesis, Proposed Rule, 55 Fed. Reg. 20,568 (1990) (to be codified at 21 C.F.R.
§ 878) (proposed May 17, 1990)). The appellate court determined it was an abuse of discretion
by the trial court to admit the FDA document because the report was irrelevant and failed to
qualify for admission under Rule 803(8). Specifically, the court found that the document was
irrelevant because it did not contain findings specifically about the implants at issue in the case,
but rather proposed findings about implants generally. Additionally, the court noted that the
report was proposed by the FDA years after the dates of the plaintiff’s surgery. Thus, the court
found the FDA document to be irrelevant and inadmissible due to timeliness. The Court also
found that the FDA document was “not the kind of trustworthy report described in Rule 803”
because the document “contained only ‘proposed’ findings,” “invited public comment and

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forecasted the issuance of a ‘final’ document after more study,” and “Rule 803 makes no
exception for tentative or interim reports subject to revision and review.” Id. (citations omitted).
Here, the FDA Alert is relevant, as it specifically mentions the Duragesic patch (the
brand of patch used by Mr. Guthrie) by name, and it was issued in 2007, years prior to Mr.
Guthrie’s treatment by Defendant in 2010. Additionally, the FDA Alert is not a proposed
finding and does not invite public comment before final publication. Rather, the FDA Alert was
sent to healthcare providers to reiterate the importance of prescribing and using fentanyl patches
exactly as directed because the “FDA has continued to receive reports of death and lifethreatening adverse events related to fentanyl overdose that have occurred when the fentanyl
patch was used to treat pain in opioid-naïve patients . . . .” [Doc. 137-1 at Page ID # 2498].
There is nothing in the FDA Alert to indicate that it is a proposed or interim report, and thus
Defendant’s arguments that Toole II supports excluding the FDA Alert here fail.
Defendant next argues in his reply that Musgrave is distinguishable because the FDA
bulletin in that case was issued following a legally authorized investigation, while the FDA Alert
here was not, but the Court does not agree. Nothing in Musgrave indicates that the FDA was
participating in any legally authorized investigation beyond its normal agency activities. In fact,
the Court noted that the FDA’s warning stated it was based on “chondrolysis reports,” quoting
from the report the statement that the “‘FDA is reminding healthcare professionals that local
anesthetics are not approved for intra-articular infusions, or for use in infusion devices like
elastomeric pumps. Because of the chondrolysis reports, FDA is requiring the manufacturers of
local anesthetic drugs to specifically warn against this use in the products’ labeling. A similar
warning will be required for elastomeric pumps.’”

It appears that the FDA’s warning in

Musgrave and the FDA Alert here were both based upon adverse event reports submitted to the

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FDA. See 21 C.F.R. §§ 803.30, 803.50, 310.305 (manufacturers have an obligation to report to
the FDA any deaths or serious injuries reasonably believed to have been caused by a medical
device and any unexpected adverse drug experiences caused by the use of a drug).
The Court is unpersuaded by Defendant’s argument that Musgrave is distinguishable
from the instant case, because there is nothing in the Musgrave decision to support that the FDA
warning was based on anything more than “reports,” just as in this case. While Defendant argues
that the FDA Alert should be excluded because it was based only on “reports” it had received,
Defendant does not provide any authority that “reports” are an insufficient basis. Furthermore,
while some courts have found that expert testimony based upon adverse event reports is likely
inadmissible as unreliable because such opinion testimony is not based upon sufficient facts and
data, see Golod v. La Roche, 964 F. Supp. 841, 855 (S.D.N.Y. 1997); Wade-Greaux v. Whitehall
Labs., 874 F. Supp. 1441, 1481 (D.V.I. 1994), other courts have found that such adverse event
reports are reliable and an adequate scientific basis for expert testimony, given that such reports
are often the only data available, and they are widely relied upon by both the FDA and experts in
the industry. See Bartlett v. Mut. Pharm. Co., Inc., 678 F.3d 30, 39-40 (1st Cir. 2012) (rev’d on
other grounds, 133 S.Ct. 2466 (2013)); see also In re Heparin Prod. Liab. Litig., 803 F. Supp. 2d
712, 727 (citing Glaser v. Thompson Med. Co., 32 F.3d 969, 972 (6th Cir. 1994) (noting that
“[c]ourts also have expressed skepticism of causation opinions based solely on adverse event
reports, case series, case reports and case studies, but have admitted such opinions when
accompanied by other reliable scientific evidence”); In re Gadolinium-Based Contrast Agents
Prod. Liab. Litig., 956 F. Supp. 2d 809, 815 (N.D. Ohio 2013) (“It is entirely proper to use AERs
[adverse event reports] to show that a drug manufacturer had notice of adverse events of the type
suffered by plaintiffs in failure-to-warn claims) (collecting cases).

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Defendant also argues that Sabel is distinguishable because that court found the opinions
in an FDA letter to be admissible based on the reliable underlying data, including a peerreviewed medical journal, and because the letter was a final opinion. The Sabel court noted that
“[i]t makes no difference that the underlying data was collected by and received from an outside
party, as long as the information was reliable.” 737 F. Supp. at 142 (citing Robbins v. Whelan,
653 F.2d 47, 51 (1st Cir. 1981)). While the court did indeed find the FDA letter to be reliable
because it relied upon a peer-reviewed medical journal article, and because it was a final opinion
rather than a tentative conclusion, the court did not find reliance upon a peer-reviewed article to
be a necessary requirement in establishing reliability. The court noted that there is no authority
to support the limitation of Rule 803(8)’s public records exception to only epidemiological
studies or accident investigations, because “no formal proceedings are necessary to satisfy the
prerequisites of the rule.” Id. (citing In re Japanese Elec. Prod. Antitrust Litig., 723 F.2d 238,
268 (3d Cir. 1983)).

Furthermore, the form of the record is not determinative of their

admissibility, because the “indice of reliability for the governmental investigative report is the
fact that it is prepared pursuant to a duty imposed by law.” In Sabel, the FDA letter was based
on an investigation into the association between Desyrel (an anti-depressant medication) and
priapism (a health condition involving a prolonged, painful erection). Here, the FDA Alert was
based on the FDA’s investigation into adverse event reports which had been filed regarding the
association between fentanyl patches, including Duragesic branded patches, with fatal respiratory
depression from fentanyl overdose.
The Court does not find Defendant’s arguments that the case authority cited by Plaintiff
is distinguishable and/or supports excluding the FDA Alert.

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Instead, the Court finds that

Musgrave and Sabel support a finding that the FDA Alert is admissible as a public records
exception to the hearsay bar under Rule 803(8).
The Court therefore FINDS that the FDA Alert is admissible under Rule 803(8)’s public
records exception to the hearsay rule. Although it appears to the Court that there are other
grounds argued by Plaintiff that would support admission of the FDA Alert for some purposes,
because motions in limine may only be granted where the disputed evidence is inadmissible on
all potential grounds, the Court need not address in detail the parties’ arguments regarding the
other methods by which the FDA Alert may be admissible. See Bouchard v. Am. Home Prod.
Corp., 213 F. Supp. 2d 802, 810 (N.D. Ohio 2002); see also Malibu Media, LLC v. Pontello, No.
13-cv-12197, 2014 WL 3528615, at *2 (E.D. Mich. July 16, 2014); United States v. Afyare, No.
3:10-cr-00260, 2013 WL 1386610 at *2 (M.D. Tenn. Apr. 4, 2013).
IV.

CONCLUSION
Accordingly, for the reasons explained above, Defendant’s “Motion in Limine #23 to

Exclude FDA Alert from Evidence at Trial” [Doc. 137] is DENIED. The Court also notes that
during the Final Pretrial Conference there was a discussion of a video issued by the FDA.
Defendant stated the video was not produced in discovery. Plaintiff agreed that if she failed to
produce the video in discovery, she would not seek to use the video during the trial in any way.
Plaintiff will be held to this representation.
SO ORDERED.
ENTER:
s/fâátÇ ^A _xx
SUSAN K. LEE
UNITED STATES MAGISTRATE JUDGE

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