Blackburn v. Shire US Inc et al

Filing 244

MEMORANDUM OPINION - By separate order, for the reasons discussed above, the Court will enter judgment for the Shire defendants on Mr. Blackburn's AEMLD failure to warn claim as a matter of law. Because that is the only remaining claim in this c ase, the Court will dismiss this case with prejudice. The Court thanks the parties for their excellent briefs and oral argument. The issues in this case were fully explored and presented carefully for consideration. This decision renders moot the pending motions in limine. Signed by Judge Madeline Hughes Haikala on 6/1/2020. (KEK)

FILED
2020 Jun-01 PM 12:18
U.S. DISTRICT COURT
N.D. OF ALABAMA

UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ALABAMA
SOUTHERN DIVISION

MARK BLACKBURN,
Plaintiff,
v.
SHIRE U.S., INC., et al.,
Defendants.

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Case No.: 2:16-cv-00963-MHH

MEMORADUM OPINION1
In this prescription drug products liability case, plaintiff Mark Blackburn
contends that defendants Shire U.S., Inc. and Shire, LLC, the makers of the
prescription drug LIALDA, breached their obligation to provide adequate
instructions for the safe use of the drug, and the breach proximately caused his
chronic, irreversible kidney injury. According to Mr. Blackburn, if Shire had
included in its written warning information that instructed prescribing physicians to
perform renal assessments at specific intervals, his prescribing physician would have
detected his kidney injury and altered the treatment he prescribed for Mr.

The Court is issuing this opinion during a declared national emergency concerning COVID-19.
To enable parties to pursue their rights during this emergency, the Court is continuing its work.
For information about the timing of appeals, please review the information provided in the
conclusion of this opinion. The Court is including this procedural information in each opinion that
it issues during the national emergency.
11

Blackburn’s Crohn’s disease. The Shire defendants have asked the Court to enter
judgment in their favor. (Doc. 194). For the reasons stated below, the Court will
grant the defendants’ motion for summary judgment.
STANDARD OF REVIEW
“The court shall grant summary judgment if the movant shows that there is no
genuine dispute as to any material fact and the movant is entitled to judgment as a
matter of law.” FED. R. CIV. P. 56(a). To demonstrate that there is a genuine dispute
as to a material fact that precludes summary judgment, a party opposing a motion
for summary judgment must cite “to particular parts of materials in the record,
including depositions, documents, electronically stored information, affidavits or
declarations, stipulations (including those made for purposes of the motion only),
admissions, interrogatory answers, or other materials.” FED. R. CIV. P. 56(c)(1)(A).
“The court need consider only the cited materials, but it may consider other materials
in the record.” FED. R. CIV. P. 56(c)(3).
FACTS
Mr. Blackburn is an accomplished golf instructor. He coaches amateur and
professional players on the PGA tour. He also speaks at conferences for Titleist, a
company that produces golf apparel and equipment. Mr. Blackburn must travel
nationally and internationally for his work. Mr. Blackburn suffers from Crohn’s
disease, and the disease sometimes interferes with his work.
2

In November of 2013, Mr. Blackburn began taking LIALDA to treat Crohn’s
disease. (Doc. 188-6, p. 18). On May 14, 2015, at age 39, Mr. Blackburn’s physician
diagnosed Mr. Blackburn with chronic interstitial nephritis and stage four chronic
kidney disease. (Doc. 188-8, p. 3). Mr. Blackburn contends that his use of LIALDA
caused these conditions.
Shire has always warned that use of LIALDA could lead to kidney damage.
In January of 2007, when the FDA initially approved LIALDA, the drug’s label
included the following information:
Renal: Reports of renal impairment, including minimal change
nephropathy, and acute or chronic interstitial nephritis have been
associated with mesalamine medications and prodrugs of mesalamine.
For any patient with known renal dysfunction, caution should be
exercised and LIALDA should be used only if the benefits outweigh
the risks. It is recommended that all patients have an evaluation of renal
function prior to initiation of therapy and periodically while on
treatment.
(Doc. 41-1, p. 5). In November of 2013, when Mr. Blackburn began taking
LIALDA, the label stated:
5.1 Renal Impairment
Renal impairment, including minimal change nephropathy, acute and
chronic interstitial nephritis, and, rarely, renal failure, has been reported
in patients given products such as LlALDA that contain mesalamine or
are converted to mesalamine.
It is recommended that patients have an evaluation of renal function
prior to initiation of LIALDA therapy and periodically while on
therapy. Exercise caution when using LIALDA in patients with known
renal dysfunction or a history of renal disease.
3

(Doc. 41-2, p. 3).
Mr. Blackburn does not contend that Shire failed to warn of possible kidney
injury when using LIALDA. Instead, Mr. Blackburn alleges that the recommended
“periodic” evaluation “constitutes a defective and unsafe instruction for safe use of
LIALDA.” (Doc. 41, p. 4, ¶ 22). He contends that the term “periodic” as generally
used in drug labels refers to either semi-annual or annual testing and that Shire’s
warning should have “provide[d] for blood testing of renal function at intervals
necessary to reasonably protect patients from LIALDA’s potential renal toxicity.”
(Doc. 41, p. 5, ¶¶ 22, 23, 25).
Mr. Blackburn contends that the language regarding testing for renal function
in Shire’s warning should resemble language used by other manufacturers of
mesalamine-based drugs. PENTASA, like LIALDA, is a 5-aminosalicylic acid
(“5-ASA”) or mesalamine-based drug. In the United Kingdom, PENTASA is
marketed with the warning that patients “should have renal function monitored, with
serum creatinine levels measured prior to treatment start, every 3 months for the first
year, then [every 6 months] for the next 4 years and annually thereafter.” (Doc.
175-8, p. 2). Similarly, OCTASA, another 5-ASA drug, is marketed in the United
Kingdom with the following instruction:
It is recommended that all patients have an evaluation of their renal
function prior to initiation of Octasa therapy and repeatedly whilst on
therapy. As a guideline, follow-up tests are recommended 14 days after
4

commencement of treatment and then every 4 weeks for the following
12 weeks. Short monitoring intervals early after the start of Octasa
therapy will discover rare acute renal reactions. In the absence of an
acute renal reaction monitoring intervals can be extended to every 3
months and then annually after 5 years.
(Doc. 175-6, p. 2).
Mr. Blackburn asserts that an appropriate label for LIALDA, a
mesalamine-based drug, should include instructions recommending “evaluation of
renal function by a simple serum (blood) test of creatinine levels on a monthly basis
for the first three months after initiation of therapy and then on a quarterly basis for
at least one year.” (Doc. 41, p. 5, ¶¶ 23, 25). Mr. Blackburn contends that Shire’s
failure to include this testing regimen in the LIALDA package warning in the fall of
2013 proximately caused his kidney injury. (Doc. 41, p. 5, ¶ 26). Embedded within
this causation contention are the suppositions that the physician who prescribed
LIALDA for Mr. Blackburn, Dr. Dino Ferrante, would have ordered specific interval
testing per the instructions that Mr. Blackburn proposes and that Mr. Blackburn
would have complied with those orders.

Mr. Blackburn’s medical history

undermines those suppositions.
Mr. Blackburn first saw Dr. Ferrante at the Center for Colon & Digestive
Disease on September 6, 2013 based on a referral from Dr. Craig Young. (Doc.
162-1, p. 5, tr. 17; Doc. 188-6, pp. 12–13). In his deposition, Dr. Ferrante testified:
[Dr. Young] called me personally first before I saw [Mr. Blackburn],
said I’m sending you this guy, Mark Blackburn. He’s having some
5

loose bowels, diarrhea. We talked about him a little bit. [Dr. Young]
said he had done some basic workup . . . , some blood work, I think
some stool tests, possibly, and everything checked out okay and he
wanted me to do some further gastrointestinal evaluation in regards to
his symptoms, which the main one being he was having, basically,
diarrhea or loose bowel movements.
(Doc. 162-1, p. 5, tr. 18).
At his initial visit with Dr. Ferrante, Mr. Blackburn complained of “diarrhea
or alteration of his stools” and “urgency,” without abdominal pain, bleeding, or
fever. (Doc. 162-1, p. 5, tr. 20). Dr. Ferrante stated:
So based on his symptoms, we decided to do what’s called a C-reactive
protein, which is an inflammatory marker, looking for -- we use it as a
marker for inflammatory bowel disease. The tissue transglutaminase
level is a marker of celiac disease. So, again, these are – we’re checking
for what causes loose bowels, and so these are two markers of things
that are fairly common. And then, of course, we set him up for a
colonoscopy to assess for his symptoms.
(Doc. 162-1, p. 6, tr. 22). Mr. Blackburn’s lab work was normal. (Doc. 162-1, p. 7,
tr. 26).

The colonoscopy revealed “chronic colitis,” otherwise known as

“inflammation of the colon,” and “non-caseating granulomas,” which are
“diagnostic for Crohn’s disease.” (Doc. 162-1, p. 9, tr. 34). Dr. Ferrante was not
sure whether Mr. Blackburn had Crohn’s disease or ulcerative colitis, so he
scheduled Mr. Blackburn for a sigmoidoscopy. (Doc. 162-1, p. 9, tr. 36). That
procedure revealed “caseating granulomas.” (Doc. 162-1, p. 11, tr. 41-42). Dr.
Ferrante also ordered blood tests to rule out ulcerative colitis. (Doc. 162-1, p. 10, tr.

6

37). Based on the results of these tests, Dr. Ferrante diagnosed Mr. Blackburn with
Crohn’s disease. (Doc. 162-1, pp. 11, 14, tr. 42, 55).
On November 5, 2013, Dr. Ferrante prescribed LIALDA and gave Mr.
Blackburn an initial prescription for a six-month course of treatment. (Doc. 162-1,
pp. 14, 30, tr. 55, 117; Doc. 188-6, p. 18).

Dr. Ferrante acknowledged that

prescribing LIALDA for Crohn’s disease was an off-label use of the product. (Doc.
162-1, p. 27, tr. 108). Dr. Ferrante stated, “you want to tailor your therapy based on
the individual.” (Doc. 162-1, p. 19, tr. 73). In Dr. Ferrante’s opinion, “a mesalamine
product” such as LIALDA was the “drug of choice” for Mr. Blackburn “because it’s
the least invasive . . . and probably easiest to administer in someone who would be
traveling,” like Mr. Blackburn. (Doc. 162-1, p. 19, tr. 73). The alternative would
have been “either oral medications that do require some monitoring or IV infusion
therapies which require even more intensive type monitoring.” (Doc. 162-1, p. 19,
tr. 73; see also Doc. 162-1, p. 19, tr. 74).
Dr. Ferrante was aware when he prescribed LIALDA to Mr. Blackburn that
mesalamine products contain warnings that “renal impairment may occur” and
directions to “assess renal function at the beginning of treatment and periodically
during treatment.” (Doc. 162-1, pp. 15–16, tr. 60–61).2 But Dr. Ferrante did not

2

Quoting the exact language from the LIALDA warning, counsel asked Dr. Ferrante if he knew
that:
7

look at the LIALDA label before he prescribed the drug to Mr. Blackburn. (Doc.
162-1, p. 24, tr. 93).
Dr. Ferrante testified that before prescribing any medication “if there’s
anything that needs to be checked prior, we will typically do that.” (Doc. 162-1, p.
15, tr. 59). Then, “during the follow-up process, I will ask [patients], you know,
how they’re doing on the medication.” (Doc. 162-1, p. 15, tr. 59). Dr. Ferrante
testified that he would have relied on discussions with Mr. Blackburn. (Doc. 162-1,
p. 17, tr. 67). Dr. Ferrante stated: “I usually ask have you had blood work done by
your primary care doctor before you came here or any other doctor, and if the answer
is no, then I’ll take it upon myself to go ahead and check that.” (Doc. 162-1, p. 17,
tr. 67). But Dr. Ferrante did not evaluate Mr. Blackburn’s renal function before he
prescribed LIALDA for him, and when he selected LIALDA for Mr. Blackburn, Dr.
Ferrante did not know whether Dr. Young had performed renal testing on Mr.
Blackburn. (Doc. 162-1, p. 23, tr. 91).

renal impairment, including minimal change nephropathy, acute and chronic
interstitial nephritis, and rarely, renal failure, has been reported in patients given
products such as LlALDA that contain mesalamine or are converted to mesalamine.
(Doc. 162-1, p. 23, tr. 92). Dr. Ferrante stated that he was aware of these problems and stated that
he had been aware “for some time prior to prescribing LIALDA for Mr. Blackburn” because “that
language had been in labeling for mesalamine products in the United States for a long period of
time.” (Doc. 162-1, pp. 23–24, tr. 92–93).
8

Dr. Ferrante testified that he ordinarily checked renal function “at least once
a year” when prescribing LIALDA. (Doc. 162-1, pp. 15-16, tr. 60-61). When asked
in his deposition what “periodically” means to him, to Dr. Ferrante responded:
Currently, I’m doing one year. This condition, like Crohn’s disease,
ulcerative colitis, is typically a condition in younger patients, so most
of the time, they don’t have a lot of other medical conditions. So I think
once a year is probably adequate in those patients. If it’s a patient who
has other medical conditions, I might be more aggressive with that.
Most of the time, these patients also come from their primary care
doctor or some other doctor being referred, and they may have already
had or are getting yearly testing or biyearly testing for other reasons.
(Doc. 162-1, p. 16, tr. 61-62). Later in his deposition Dr. Ferrante acknowledged
that “periodically” can mean other time periods as well and that there is no specific
definition of “periodically” in the medical profession. (Doc. 162-1, p. 23, tr. 90).
Dr. Ferrante explained that in his 17 years of practice he had “never seen kidney
problems from these [mesalamine] medications.” (Doc. 162-1, p. 28, tr. 109–110).
To understand a medication’s side effects, Dr. Ferrante relies on mailers from
drug companies, conferences, and drug company representatives. (Doc. 162-1, p.
16, tr. 62–63). When asked in his deposition what he relied on “for information,
data, and guidance on instructions for safe use of medications such as Lialda,” Dr.
Ferrante responded:
typically, like the package insert, if you will, of the medicines. I mean,
we’re pretty well trained on what’s the most common side effects,
adverse reactions. If anything new comes out, many times, again, that
comes out as a mailer, actually. We have seen that in other medications
before.
9

(Doc. 162-1 pp. 16-17, tr. 64–65). In his deposition, Dr. Ferrante reviewed the
LIALDA warning in place when he prescribed the medication to Mr. Blackburn.
(Doc. 162-1, p. 17, tr. 65). The following exchange then took place:
Q. . . . [I]s this information the type of information you rely on in
determining whether a medication is appropriate for your patient?
***
A. Yes. We would look at -- before we start a medicine, we’d want to
make sure that they would be a good candidate for that medication,
sure.
Q. Is this information also the type of data you rely on in determining
what safe use protocol or testing recommendations you give your
patients?
***
A. Correct.
Q. And did you rely on this information when determining [if] you
want[ed] to prescribe Lialda for Mark Blackburn?
***
A. Yes.
(Doc. 162-1, p. 17, tr. 65–66). During his deposition, Dr. Ferrante also reviewed the
PENTASA and OCTASA monitoring language set out above. (Doc. 162-1, p. 18,
tr. 69–72). Dr. Ferrante averred that if the LIALDA label had had similar language,
and he had known about it, he “would have followed those protocols.” (Doc. 162-1,
p. 18, tr. 71-72; see also Doc. 162-1, p. 20, tr. 77 (“Again, if I would have known
10

about that, I would have followed those protocols.”); Doc. 162-1, p. 24, tr. 95 (“If I
would have known about that protocol, then yes.”)).
After prescribing LIALDA, Dr. Ferrante did not tell Mr. Blackburn to come
back for renal testing. (Doc. 162-1, pp. 17–18, tr. 68–69). Dr. Ferrante believes that
his office scheduled Mr. Blackburn to return on January 14, 2014. (Doc. 162-1, pp.
12, 14, 29, tr. 45, 47, 53, 113). That visit would have been a follow-up to gauge the
effectiveness of the LIALDA therapy and the side effects of the medication. (Doc.
162-1, p. 12, tr. 47–48). Mr. Blackburn did not keep that appointment, and Dr.
Ferrante never saw Mr. Blackburn again. (Doc. 162-1, p. 29, 114).
Despite Mr. Blackburn having missed his only follow-up appointment and
despite having not seen Mr. Blackburn for almost 18 months, on March 6, 2015, Dr.
Ferrante’s office approved a new four-month prescription of LIALDA for Mr.
Blackburn. (Doc. 188-6, p. 19). Dr. Ferrante did not know that his office had given
Mr. Blackburn this new prescription. (Doc. 162-1, p. 30, tr. 117) (“I’m not aware of
that. I don’t know if he got that through our office. Maybe he called or -- you know,
I’m not aware of that. I don't remember seeing anything about that.”).
ANALYSIS
Mr. Blackburn’s remaining claim against Shire is for “strict liability for failure
to warn” under the Alabama Extended Manufacturer’s Liability Doctrine – the
AEMLD. (Doc. 41, pp. 25–28). Under the AEMLD, “‘a manufacturer, or supplier,
11

or seller, who markets a product not reasonably safe when applied to its intended use
in the usual and customary manner, [is] negligen[t] as a matter of law.’” DISA
Indus., Inc. v. Bell, 272 So. 3d 142, 149 (Ala. 2018), reh’g denied (Sept. 14, 2018)
(quoting Casrell v. Altec Indus., Inc., 335 So. 2d 128, 132 (Ala. 1976)) (emphasis in
DISA). Alabama law deems prescription drugs “unavoidably unsafe.” Stone v.
Smith, Kline & French Labs., 447 So. 2d 1301, 1304 (Ala. 1984). Accordingly,
“‘the adequacy of the accompanying warning determines whether the drug, as
marketed, is defective, or unreasonably dangerous.’” Bodie v. Purdue Pharma Co.,
236 Fed. Appx. 511, 518 (11th Cir. 2007) (quoting Stone, 447 So. 2d at 1304).
In Alabama, “[a] prescription-drug manufacturer fulfills its duty to warn the
ultimate users of the risks of its product by providing adequate warnings to the
learned intermediaries who prescribe the drug.” Wyeth, Inc. v. Weeks, 159 So. 3d
649, 673 (Ala. 2014). The Alabama Supreme Court has explained:
The principle behind the learned-intermediary doctrine is that
prescribing physicians act as learned intermediaries between a
manufacturer of a drug and the consumer/patient and that, therefore, the
physician stands in the best position to evaluate a patient’s needs and
to assess the risks and benefits of a particular course of treatment for
the patient. A consumer can obtain a prescription drug only through a
physician or other qualified health-care provider. Physicians are trained
to understand the highly technical warnings required by the FDA in
drug labeling.

12

Weeks, 159 So. 3d at 672–73 (citations omitted). The doctrine “recognizes the role
of the physician as a learned intermediary between a drug manufacturer and a
patient.” Weeks, 159 So. 3d at 673.
“‘[T]he adequacy of [a drug manufacturer’s] warning is measured by its effect
on the physician, to whom it owe[s] a duty to warn, and not by its effect on the
consumer.” Weeks, 159 So. 3d at 673 (quoting Toole v. Baxter Healthcare Corp.,
235 F.3d 1307, 1313-14 (11th Cir. 2000)) (citations, quotations and changes
omitted).
Once the manufacturer has met its duty to warn, the manufacturer holds
no further duty to warn the patient directly. See Weeks, 159 So. 3d at
673. If, however, the warning to the learned intermediary is insufficient
or is a misrepresentation of risks, “the manufacturer remains liable for
the injuries sustained by the patient.” Id. In such a situation, the patient
must show that:
the manufacturer failed to warn the physician of a risk not
otherwise known to the physician and that the failure to
warn was the actual and proximate cause of the patient’s
injury. In short, the patient must show that, but for the false
representation made [or the insufficient information
provided] in the warning, the prescribing physician would
not have prescribed the medication to his patient.
Id. at 673–74.
Tutwiler v. Sandoz, Inc., 726 Fed. Appx. 753, 756 (11th Cir. 2018). “[P]roof of
proximate cause could [also] take the form of evidence that, although the physician
still would have prescribed the drug, the physician would have changed her behavior
or treatment in some way that would have resulted in a different outcome for the
13

plaintiff.” Blackburn v. Shire U.S., Inc., No. 2:16-CV-963-RDP, 2017 WL 1833524
at *8 (May 8, 2017) (citing Barnhill v. Teva Pharm, USA, Inc., 819 F. Supp. 2d 1254,
1261 (S.D. Ala. 2011); and Fields v. Eli Lilly & Co., 116 F. Supp. 3d 1295, 1307
(M.D. Ala. 2015)).
If an alternative warning would not have impacted a prescribing physician’s
conduct in the use and monitoring of a drug, then a plaintiff cannot establish the
causation element for a products liability claim against the drug’s manufacturer.
Under Alabama law, in warnings cases concerning a prescription drug, plaintiffs:
must demonstrate a causal link between the allegedly inadequate
warning and the injury. In cases such as these, that means that the
plaintiffs must demonstrate that, had the [drug manufacturer] given an
adequate warning, it would have been read and heeded by the
prescribing physicians.
Brasher v. Sandoz Pharm. Corp., No. CV 98-TMP-2648-S, 2001 WL 36403362, at
*13 (N.D. Ala. Sept. 21, 2001) (citing Gurley v. American Honda Mtr. Co., 505 So.
2d 358, 361 (Ala. 1987)); see also, Wyeth, 159 So. 3d at 677 n.11 (“[W]e are not
deciding the merits of the underlying case. It may be that a jury finds that . . . [the]
physician did not rely on the warnings on the label[.]”); see also Wyeth, 159 So. 3d
at 681 (Moore, dissenting) (“For example, if [the] prescribing physician did not rely
on the . . . labeling when prescribing the drug, then the [plaintiffs] will have failed
to prove causation and their claims will fail.”).

14

A drug manufacturer is entitled to judgment as a matter of law on a warnings
claim when the record demonstrates that the prescribing physician would not have
read or followed an alternative warning. Bodie v. Purdue Pharma Co., 236 Fed.
Appx. 511, 521 (11th Cir. 2007) (“Because the evidence suggests that the learned
intermediary, Dr. Mangieri, prescribed OxyContin based on his independent
knowledge of the drug and its high potential for addiction, we cannot conclude that
the allegedly inadequate warning (that is, the claimed defect) proximately caused
Bodie’s injury of addiction.”); Emody v. Medtronic, Inc., 238 F. Supp. 2d 1291, 1296
(N.D. Ala. 2003) (failure to warn claim failed in light of doctor’s testimony that he
did not rely on warnings); In re Wright Med. Tech. Inc., Conserve Hip Implant Prod.
Liab. Litig., 127 F. Supp. 3d 1306, 1359 (N.D. Ga. 2015) (“[W]here a warning is
provided, but a physician does not read it or rely on it, a person cannot assert a failure
to warn claim, even if the warning is defective.”); Salyards ex rel. Salyards v. Metso
Minerals Tamper OY, No. 1:04 CV 05798 OWW LJ, 2005 WL 3021959, at *9 (E.D.
Cal. Nov. 10, 2005) (“If the doctor fails to read or heed the warning, the
manufacturer is absolved of liability.”). There is no presumption in Alabama that
an adequate warning would have been read and heeded by the prescribing physician.
“[A]s concerns proximate cause, a

Barnhill 819 F. Supp. 2d at 1262.

negligent-failure-to-warn-adequately case should not be submitted to the jury unless
there is substantial evidence that an adequate warning would have been read and
15

heeded and would have prevented the [injury].” Deere & Co. v. Grose, 586 So. 2d
196, 198 (Ala. 1991) (citing Gurley, 505 So. 2d at 361).
Here, the evidence demonstrates that Dr. Ferrante did not follow the
instructions that Shire provided in November 2013 for renal evaluation when
prescribing LIALDA, so Mr. Blackburn cannot prove that Dr. Ferrante would have
read and heeded an alternative instruction. It is undisputed that Shire warned that
LIALDA could cause interstitial nephritis and kidney disease, the conditions Mr.
Blackburn claims he developed after taking the drug. Dr. Ferrante testified that he
had been aware for some time that 5-ASA drugs such as LIALDA could cause these
conditions. He prescribed the drug to Mr. Blackburn anyway because LIALDA was
the “drug of choice . . . because it’s the least invasive . . . and probably easiest to
administer in someone [like Mr. Blackburn] who would be traveling.” (Doc. 162-1,
p. 19, tr. 73). Dr. Ferrante prescribed LIALDA for Mr. Blackburn because the drug
required less monitoring and had fewer serious side effects than alternative
treatments for Crohn’s disease. (Doc. 162-1, p. 19, tr. 73–74).
In November 2013, Shire “recommended” to prescribing physicians “that
patients have an evaluation of renal function prior to initiation of LIALDA therapy
and periodically while on therapy.” (Doc. 41-2, p. 3). But Dr. Ferrante did not read
this information before he prescribed LIALDA to treat Mr. Blackburn’s Crohn’s
disease, an off-label use of the drug. And Dr. Ferrante neither ordered tests to
16

evaluate Mr. Blackburn’s renal function before he prescribed LIALDA nor checked
with Mr. Blackburn’s referring physician, Dr. Young, to determine whether Dr.
Young had evaluated Mr. Blackburn’s renal function. (Doc. 162-1, p. 23, tr. 91).
And though Dr. Ferrante testified that it was his practice to test renal function
annually when prescribing LIALDA (Doc. 162-1, p. 16, tr. 61–62), his office
authorized CVS to refill Mr. Blackburn’s November 2013 prescription in March
2015 without conducting a renal evaluation of Mr. Blackburn. (Doc. 188-6, p. 19).
Dr. Ferrante’s inattention to Shire’s November 2013 renal evaluation protocol may
stem from the fact that in 17 years of practice as a gastroenterologist, Dr. Ferrante
had “never seen kidney problems” from mesalamine products. (Doc. 162-1, p. 28,
tr. 109–110).
Even if Dr. Ferrante had ordered a renal evaluation of Mr. Blackburn after
prescribing LIALDA, there is no evidence that Mr. Blackburn would have complied
with the instruction. Dr. Ferrante scheduled an appointment with Mr. Blackburn in
January 2014 to monitor Mr. Blackburn’s treatment, but Mr. Blackburn did not keep
the appointment. After Dr. Ferrante prescribed LIALDA for Mr. Blackburn in
November 2013, Mr. Blackburn did not return to Dr. Ferrante.
Mr. Blackburn correctly points out that Dr. Ferrante testified that he would
have followed an alternative recommended testing schedule if he “had known about
it.” (Doc. 162-1, p. 18, tr. 71–72; see also Doc. 162-1, p. 20, tr. 77; Doc. 162-1, p.
17

24, tr. 95). But that testimony amounts to unsubstantiated speculation, given Dr.
Ferrante’s conduct, and a jury verdict may not rest on speculation. See Pennsylvania
R. Co. v. Chamberlin, 288 U.S. 333, 340–44 (1933) (“And the desired inference is
precluded for the further reason that respondent’s right of recovery depends upon
the existence of a particular fact which must be inferred from proven facts, and this
is not permissible in the face of the positive and otherwise uncontradicted testimony
of unimpeached witnesses consistent with the facts actually proved, from which
testimony it affirmatively appears that the fact sought to be inferred did not exist . . .
Leaving out of consideration, then, the inference relied upon, the case for respondent
is left without any substantial support in the evidence, and a verdict in her favor
would have rested upon mere speculation and conjecture. This, of course, is
inadmissible.”) (internal marks and citations omitted).
Because Dr. Ferrante did not consult Shire’s November 2013 warning before
prescribing the drug, the Court does not have to accept his self-interested statement
that he would read an alternative warning or that a different warning would have
altered his decision to prescribe LIALDA without evaluating Mr. Blackburn’s renal
function. In a decision that is binding precedent in the Eleventh Circuit Court of
Appeals, the Fifth Circuit Court of Appeals explained:
[S]elf-serving statements alone do not create a jury question:

18

In our opinion, the isolated self-serving statements of the
Cal-Florida officers were not enough to constitute
substantial evidence for the jury on the causation issue
under Boeing Co. v. Shipman.
Yoder Bros., Inc. v. California-Florida Plant Corp., 537 F.2d 1347,
1371 (5th Cir. 1976). A trier of facts need not ignore powerful
self-interest, and where there is no relevant support for self-interested
testimony a jury must not be allowed to speculate as to causation. A
directed verdict, or judgment notwithstanding the verdict, is the proper
safeguard against such speculation by the jury . . .
Ralston Purina Co. v. Hobson, 554 F.2d 225, 729 (5th Cir. 1977) (footnotes
omitted).3 A summary judgment likewise safeguards against a jury verdict based on
a non-party witness’s self-interested, speculative testimony regarding causation that
is wholly contradicted by historical fact. This is not the type of evidence that creates
a question of disputed fact for a jury to resolve.4

Bonner v. City of Prichard, 661 F.2d 1206, 1209 (11th Cir. 1981) (adopting as binding precedent
in the Eleventh Circuit Court of Appeals decisions that the Fifth Circuit Court of Appeals rendered
before October 1, 1981).
3

When considering a summary judgment motion, a district court must view the evidence in the
record and draw reasonable inferences from the evidence in the light most favorable to the
non-moving party. Asalde v. First Class Parking Sys. LLC, 898 F.3d 1136, 1138 (11th Cir. 2018).
“A litigant’s self-serving statements based on personal knowledge or observation can defeat
summary judgment.” United States v. Stein, 881 F.3d 853, 857 (11th Cir. 2018); see also Feliciano
v. City of Miami Beach, 707 F.3d 1244, 1253 (11th Cir. 2013) (“To be sure, Feliciano’s sworn
statements are self-serving, but that alone does not permit us to disregard them at the summary
judgment stage.”). The self-serving statements of a non-party witness do not have the same power
when that witness’s conduct directly contradicts his self-interested projections of future conduct,
rendering those projections unsubstantiated speculation. A district court does not have to draw
favorable inferences from speculation. Daniels v. Twin Oaks Nursing Home, 692 F.2d 1321, 1324
(11th Cir. 1982) (“[A]n inference is not reasonable if it is ‘only a guess or a possibility,’ for such
an inference is not based on the evidence but is pure conjecture and speculation.”) (internal citation
omitted).
4

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And even if a jury could consider Dr. Ferrante’s testimony, Mr. Blackburn’s
failure to keep his January 2014 appointment and follow up with Dr. Ferrante severs
the causal chain. In the absence of admissible evidence of a causal link between
Shire’s instructions for renal evaluations when prescribing LIALDA and Mr.
Blackburn’s injury, Mr. Blackburn’s AEMLD warnings claim against Shire must
fail.
CONCLUSION
By separate order, for the reasons discussed above, the Court will enter
judgment for the Shire defendants on Mr. Blackburn’s AEMLD failure to warn claim
as a matter of law. Because that is the only remaining claim in this case, the Court
will dismiss this case with prejudice. The Court thanks the parties for their excellent
briefs and oral argument. The issues in this case were fully explored and presented
carefully for consideration. This decision renders moot the pending motions in
limine.
In light of the public health emergency caused by the COVID-19 virus, the
parties are reminded that under Rule 4(a)(5) of the Federal Rules of Appellate
Procedure, a party may request an extension of time for a notice of appeal. In
addition, pursuant to Rule 4(a)(6), a party may ask a district court to reopen the time
to file a notice of appeal for 14 days. Parties are advised to study these rules carefully
20

if exigent circumstances created by the COVID-19 public health emergency require
motions under FRAP 4(a)(5) or 4(a)(6).
DONE and ORDERED this June 01, 2020.

_________________________________
MADELINE HUGHES HAIKALA
UNITED STATES DISTRICT JUDGE

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