Mark Blackburn v. Shire US Inc

USCA11 Case: 20-12258    Date Filed: 11/29/2021   Page: 1 of 22




                                                  [PUBLISH]
                          In the
         United States Court of Appeals
                For the Eleventh Circuit

                 ____________________

                        No. 20-12258
                 ____________________

MARK BLACKBURN,
                                            Plaintiff-Appellant,
versus
SHIRE US INC,
SHIRE LLC,


                                        Defendants-Appellees,


SHIRE DEVELOPMENT LLC, et al.,


                                                   Defendants.
USCA11 Case: 20-12258       Date Filed: 11/29/2021   Page: 2 of 22




2                     Opinion of the Court                20-12258

                    ____________________

          Appeal from the United States District Court
             for the Northern District of Alabama
             D.C. Docket No. 2:16-cv-00963-MHH
                   ____________________

Before JILL PRYOR, LUCK, and BRASHER, Circuit Judges.
BRASHER, Circuit Judge:
       Under Alabama law, the manufacturer of an unreasonably
dangerous product has a duty to warn users of the risks presented
by the product. When the unreasonably dangerous product is a
drug that requires a prescription, a drug manufacturer’s duty to
warn is usually discharged by warning the prescribing physician of
the product’s risks.
       Mark Blackburn was diagnosed with advanced stage kidney
disease after taking LIALDA, a drug manufactured by Shire Phar-
maceuticals. Blackburn does not contend that Shire failed to warn
of the risk of kidney disease; he and his doctor knew that the drug
might impair his kidney function. Instead, Blackburn contends that
Shire should have more explicitly warned his doctor about how
regularly to monitor his kidney function after prescribing LIALDA.
He contends that, if LIALDA’s warning label had been better, his
physician would have monitored him differently after prescribing
LIALDA, discovered the effect on his kidneys sooner, and pre-
vented his injury.
USCA11 Case: 20-12258         Date Filed: 11/29/2021     Page: 3 of 22




20-12258                Opinion of the Court                          3

       In our view, Blackburn’s theory of liability raises two unset-
tled questions of Alabama law. First, may a pharmaceutical com-
pany’s duty to warn include a duty to provide instructions about
how to mitigate warned-of risks? Second, may a plaintiff establish
that an improper warning caused his injuries by showing that his
doctor would have adopted a different course of testing or mitiga-
tion, even though he would have prescribed the same drug?
       Because of how we resolve the federal issues in this appeal,
these state-law questions are dispositive. For our part, we believe
these questions are important enough—and the resolution uncer-
tain enough—for us to certify them to the Supreme Court of Ala-
bama.
                       I.     BACKGROUND

        Blackburn is a professional golf instructor. His training facil-
ity is located at a golf club in Birmingham, Alabama, but he fre-
quently travels throughout the world to counsel some of the
world’s best players and represent one of the game’s premium
brands. Blackburn suffers from Crohn’s disease.
       Prior to moving to Birmingham, he lived and worked at a
golf course in Guntersville, Alabama. Dr. Craig Young was one of
Blackburn’s clients and his de facto primary care physician. Young
ordered routine bloodwork for Blackburn, and his “labs looked
good.” About eighteen months later, Blackburn reported persistent
gastrointestinal issues, and Young referred him to Dr. Dino Fer-
rante, a gastroenterologist in Huntsville, Alabama. Ferrante
USCA11 Case: 20-12258        Date Filed: 11/29/2021      Page: 4 of 22




4                       Opinion of the Court                 20-12258

documented Blackburn’s primary complaint as urgent diarrhea up
to four times daily. Something Young said during his referral led
Ferrante to conclude that he did not need to order initial blood-
work before treating Blackburn. After several tests and procedures,
Ferrante diagnosed Blackburn with Crohn’s disease.
        Ferrante prescribed LIALDA, and Blackburn began taking
the medication on November 6, 2013. LIALDA is the brand name
for Shire’s mesalamine drug, which is an anti-inflammatory drug
specifically aimed at the gut. LIALDA is not approved by the FDA
to treat Crohn’s, but it is approved to treat ulcerative colitis,
Crohn’s “sister” disease. The drug is taken orally in pill form unlike
other, more invasive Crohn’s treatments, and Ferrante considered
it the best option for Blackburn due to his travel schedule.
        Mesalamine drugs like LIALDA pose a risk of kidney disease.
The LIALDA label warns that “[r]enal impairment, including min-
imal change nephropathy, acute and chronic interstitial nephritis,
and, rarely, renal failure, has been reported in patients given prod-
ucts such as LIALDA that contain mesalamine or are converted to
mesalamine.” Kidney disease is identified by a digression in kidney
function over time. LIALDA can cause inflammatory cells to de-
posit in the kidneys, scarring organ tissue and diminishing kidney
function. If a patient experiences this side effect, continuing to take
the drug can lead to irreversible damage. To identify potential dis-
ease—and thereby prevent severe impairment—the label recom-
mends “that patients have an evaluation of renal function prior to
initiation of LIALDA therapy and periodically while on therapy.”
USCA11 Case: 20-12258        Date Filed: 11/29/2021      Page: 5 of 22




20-12258                Opinion of the Court                         5

Renal function is evaluated by measuring the amount of creatinine
in a patient’s blood. Using the creatinine level, a physician can esti-
mate glomerular filtration rate, which is a marker of how well a
patient’s kidneys are functioning.
       Ferrante set a follow-up appointment for two months after
he prescribed LIALDA, but either he or Blackburn canceled it.
Even if Blackburn had kept the appointment, it is unlikely Ferrante
would have ordered blood work to evaluate kidney function. As a
matter of practice, Ferrante periodically tests renal function after
“about a year” of treatment. By the time Blackburn had been taking
LIALDA for a year, he had moved to Birmingham and requested a
referral to a different doctor. Ferrante provided the referral, but
Blackburn never followed up. Ferrante’s office continued to fill
Blackburn’s prescriptions for over a year without examining him.
Consequently, Blackburn’s renal function went unmonitored dur-
ing that time.
       In all, Blackburn took LIALDA for somewhere between 12
and 16 months. He stopped filling the prescriptions in January 2015.
Soon after that, Blackburn took himself off the drug because he felt
that it wasn’t working. He found that changing his diet partially
relieved his Crohn’s symptoms.
       Soon after he stopped taking LIALDA, Blackburn discovered
that he was suffering from advanced stage kidney disease. In April
2015, Blackburn underwent a blood test that revealed an excessive
amount of creatinine, resulting in a low estimated glomerular fil-
tration rate. His primary care physician referred him to Dr. Agata
USCA11 Case: 20-12258         Date Filed: 11/29/2021     Page: 6 of 22




6                       Opinion of the Court                  20-12258

Przekwas, a nephrologist. Przekwas diagnosed Blackburn with ad-
vanced chronic interstitial nephritis, a type of kidney disease that
manifests as irreversible scarring and diminished kidney function.
The severity of kidney disease is expressed in six stages, with stage
six requiring a patient to undergo dialysis. Blackburn’s kidney dis-
ease was initially diagnosed as stage four, reflecting the fact that his
kidneys were functioning at approximately 20 percent their normal
capacity. Blackburn is currently awaiting a kidney transplant.
       Przekwas and Dr. Jonathan Winston, a nephrology expert
retained by Blackburn, concluded that Blackburn’s injuries were
preventable. Winston estimated that Blackburn’s kidney disease
was detectable at least six months before it was diagnosed, and pos-
sibly as early as August 2014. If Blackburn had stopped taking
LIALDA at that time, Winston opined that his kidney function
“would be either normal or near normal.” And Winston attributed
Blackburn’s injury to the LIALDA label. Because of the amorphous
“periodic” instruction, Winston reasoned that a physician follow-
ing the label’s warning could fail to detect kidney disease before it
“worsen[ed] to a clinically significant level.”
       Benjamin England, a regulatory expert retained by Black-
burn, explained that Shire could have changed the label to include
a stronger monitoring instruction. He concurred in Winston’s as-
sessment of the label’s inadequacies and added that sufficient evi-
dence, including a “a growing body of medical literature,” sup-
ported a stronger monitoring instruction. England also identified
reports of renal impairment that Shire received between the label’s
USCA11 Case: 20-12258        Date Filed: 11/29/2021     Page: 7 of 22




20-12258               Opinion of the Court                         7

initial approval and Blackburn’s injury. He concluded that suffi-
cient evidence would have led to a label change, had Shire sought
one.
        Blackburn sued Shire in June 2016. Shire initially moved to
dismiss for lack of personal jurisdiction and judgment on the plead-
ings. Blackburn sought leave to amend his complaint, and the dis-
trict court ordered Shire to show cause why leave should not be
granted. Shire responded that the amendments would be futile, but
the district court granted Blackburn’s motion anyway.
        Blackburn originally asserted four claims under Alabama
law: strict liability for failure to warn under the Alabama Extended
Manufacturers Liability Doctrine, breach of express warranty, and
two fraud claims. On Shire’s second motion to dismiss, the district
court dismissed with prejudice all but the failure-to-warn claim.
Blackburn twice moved the district court to revive the dismissed
counts. First, Blackburn moved the district court to alter its dismis-
sal to reflect that the counts were dismissed without prejudice, ef-
fectively granting him a second opportunity to amend his com-
plaint. The district court denied the motion, concluding that Black-
burn had forgone “ample opportunit[ies] to state claims on which
relief could be granted.” Instead of moving to amend his complaint
while Shire’s motion to dismiss was pending, Blackburn had “sat
idly by” and waited for the district court to tell him whether his
allegations were sufficient. Blackburn then moved for reconsidera-
tion, but the district court denied that motion as well. It concluded
that the amendments would be futile because the LIALDA label
USCA11 Case: 20-12258         Date Filed: 11/29/2021     Page: 8 of 22




8                       Opinion of the Court                  20-12258

did not create an express warranty for safeness that would support
Blackburn’s breach of express warranty or fraud-based claims.
        Blackburn’s remaining failure-to-warn claim alleged that the
LIALDA label contained an inadequate warning regarding its po-
tential renal toxicity. Specifically, Blackburn argued that if the label
had provided more detailed instructions for safe use, his kidney dis-
ease would have been detected earlier. According to Blackburn, the
label should have instructed prescribers to “evaluat[e] . . . 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.” We refer gen-
erally to the label’s language as the “periodic” renal function in-
struction to differentiate it from Blackburn’s suggested “monthly”
instruction.
        Eventually, Shire moved for summary judgment. The dis-
trict court approved of Blackburn’s theory of liability but held that
it was not factually supported. Specifically, the district court
granted judgment in favor of Shire because it concluded that the
label’s alleged inadequacies did not actually or proximately cause
Blackburn’s injuries. The district court concluded that it was undis-
puted that Ferrante did not rely on or even “look at the LIALDA
label before he prescribed the drug.” And Blackburn failed to
demonstrate that Ferrante would have read and heeded an alterna-
tive instruction. Although Ferrante testified that he would have fol-
lowed a more explicit instruction, the district court dismissed this
testimony as “unsubstantiated speculation” and a “self-interested
USCA11 Case: 20-12258         Date Filed: 11/29/2021   Page: 9 of 22




20-12258               Opinion of the Court                        9

statement.” Thus, Blackburn’s claim failed on the facts, and the dis-
trict court granted summary judgment to Shire.
                II.    STANDARDS OF REVIEW

      We review both the denial of a motion for leave to amend a
pleading and a motion for reconsideration for abuse of discretion.
Diaz v. Jaguar Rest. Grp., LLC, 

 (11th Cir. 2010);
Corwin v. Walt Disney Co., 

 (11th Cir. 2007).
       A district court’s grant of summary judgment is reviewed de
novo, with all facts and reasonable inferences therefrom viewed in
the light most favorable to the nonmoving party. Carmical v. Bell
Helicopter Textron, Inc., 

 (11th Cir. 1997). Sum-
mary judgment is warranted only when there is no genuine issue
as to any material fact, and the moving party is entitled to judg-
ment as a matter of law. T.W. ex rel. Wilson v. Sch. Bd. of Semi-
nole Cnty., 

, 597–98 (11th Cir. 2010); FED. R. CIV. P.
56(a). We may affirm the district court on any basis supported by
the record. Miller v. Harget, 

 (11th Cir. 2006).
                       III.    DISCUSSION

       We divide our discussion into two main parts. First, we ad-
dress whether the district court abused its discretion in denying
Blackburn further opportunity to amend his complaint. Second, we
address whether the district erred in granting summary judgment
in favor of Shire.
USCA11 Case: 20-12258        Date Filed: 11/29/2021      Page: 10 of 22




10                      Opinion of the Court                  20-12258

          A. The District Court Did Not Abuse its Discretion
             in Denying Blackburn Further Opportunities to
             Amend.

       After Blackburn amended his complaint, the district court
dismissed his warranty and fraud claims with prejudice. Blackburn
moved the court to alter or amend its order to state that the dis-
missal was without prejudice and to allow him his “one chance” to
amend. The court denied that motion, so Blackburn filed a motion
for reconsideration, which the court again denied. Blackburn ar-
gues that the district court should have allowed him an opportunity
to amend his complaint after it dismissed his warranty and fraud
claims. Shire contends that Blackburn was not entitled to an addi-
tional opportunity to amend, and we agree.
       A plaintiff has the right to amend his complaint within 21
days of serving it or 21 days after certain responsive pleadings and
motions. FED. R. CIV. P. 15(a)(1). In all other cases, the plaintiff re-
quires leave of court or consent of the opposing party. Ordinarily,
a court should “freely give” leave to amend a pleading “when jus-
tice so requires.” FED. R. CIV. P. 15(a)(2). Whether justice so re-
quires is within the discretion of the district court to determine. See
Burger King Corp. v. Weaver, 

 (11th Cir. 1999).
       As an initial matter, we reject Blackburn’s argument that his
complaint was first amended as a matter of right, such that his sec-
ond request for leave to amend was his first such request. Before
he filed his first amended complaint, Blackburn expressly sought
USCA11 Case: 20-12258         Date Filed: 11/29/2021      Page: 11 of 22




20-12258                 Opinion of the Court                          11

leave to amend under Rule 15(a)(2)’s “freely given” standard, and
he acknowledged that Shire’s motion for judgment on the plead-
ings “cut off [his] ability to amend . . . as a matter of right.” See FED.
R. CIV. P. 15(a)(1). The district court then granted Blackburn leave
to amend after considering Shire’s opposing arguments. Thus, the
district court afforded Blackburn an opportunity to amend his com-
plaint that he was not entitled to as of right.
       Nor can we say that the district court abused its discretion
in denying the second motion to amend. When deciding whether
to grant leave to amend, a court considers five factors: (1) undue
delay, (2) bad faith or dilatory motive, (3) repeated failure to cure
deficiencies by amendment, (4) undue prejudice to the opposing
party by virtue of allowance of the amendment, and (5) futility. Fo-
man v. Davis, 

 (1962); Burger King Corp., 

. Here, the district court based its decision to deny the mo-
tion on the undue delay and futility factors. The district court noted
that Blackburn had “ample opportunity” and “sat idly by” as he
awaited determination of Shire’s second motion to dismiss. By the
time the district court considered Blackburn’s second request to
amend, the parties and the court had spent significant time prepar-
ing and reviewing the initial complaint, Shire’s motion for judg-
ment on the pleadings, Blackburn’s response to that motion, Black-
burn’s first motion to amend, Shire’s memorandum in response,
and Blackburn’s first amended complaint. The parties then again
briefed the sufficiency of Blackburn’s allegations, and the district
court held that they were insufficient.
USCA11 Case: 20-12258        Date Filed: 11/29/2021      Page: 12 of 22




12                      Opinion of the Court                   20-12258

       We find no abuse in the district court’s conclusion that per-
mitting such a late amendment “would be contrary to promoting
judicial efficiency.” A district court is not required to grant a coun-
seled plaintiff leave to amend his complaint sua sponte before rul-
ing on a dispositive motion. Wagner v. Daewoo Heavy Indus. Am.
Corp., 

 (11th Cir. 2002) (en banc). Accordingly, a
plaintiff may not “sit idly by as he await[s] the district court’s deter-
mination with respect to a Rule 12(b)(6) motion to dismiss.” 

.
       Relying on our decision in Bryant v. Dupree, 

,
1163 (11th Cir. 2001), Blackburn argues that, after the district court
dismissed his first amended complaint, he was still entitled to one
more chance to amend. But Bryant is distinguishable. The plaintiffs
in Bryant amended their complaint once as a matter of course;
then, in response to the defendant’s motion to dismiss, the plaintiffs
sought leave to amend a second time—while the motion to dismiss
was still pending. Id. at 1163–64. Here, Blackburn did not first
amend as a matter of course. And Blackburn did not seek leave to
amend (a second time) until after the district court granted Shire’s
second dispositive motion. Blackburn’s reliance on Bryant is there-
fore misplaced.
                B. Summary Judgment on Failure to Warn

      We now turn to the main issue—the district court’s sum-
mary judgment on Blackburn’s failure-to-warn claim. A prescrip-
tion drug manufacturer has a duty to provide a warning that
USCA11 Case: 20-12258       Date Filed: 11/29/2021     Page: 13 of 22




20-12258               Opinion of the Court                        13

adequately apprises of the product’s risks. Stone v. Smith, Kline &
French Lab’ys, 

 (Ala. 1984). Because a prescrip-
tion drug can be obtained only through an intermediary, such as a
doctor, Alabama law assesses the adequacy of the warning by ask-
ing whether the warning label adequately warned that intermedi-
ary. Wyeth, Inc. v. Weeks, 

 (Ala. 2014), super-
seded by statute on other grounds, ALA. CODE § 6-5-530, as recog-
nized in Forest Lab’ys, LLC v. Feheley, 

 (Ala. 2019).
To succeed on a failure-to-adequately-warn claim, a plaintiff must
show that the label’s inadequacies actually and proximately caused
his injury. Gurley v. Am. Honda Motor Co., 

(Ala. 1987). That is, the plaintiff must show that curing the label’s
inadequacies would have altered the prescribing physician’s con-
duct in a way that would have prevented the plaintiff’s injury. See
Weeks, 

; E.R. Squibb & Sons, Inc. v. Cox, 

 (Ala. 1985).
       Blackburn’s theory of liability is that Shire provided his doc-
tor inadequate instructions to mitigate the risk of impaired kidney
function. Blackburn argues that the district court erred in conclud-
ing that, as a matter of undisputed fact, his doctor would have pur-
sued the same course of treatment no matter the warning. For its
part, Shire argues that Alabama tort law does not recognize a cause
of action based on a pharmaceutical company’s failure to give mit-
igation instructions.
      We agree with Blackburn that the district court erred in the
way it viewed the record. We certify the question of whether
USCA11 Case: 20-12258            Date Filed: 11/29/2021         Page: 14 of 22




14                         Opinion of the Court                       20-12258

Alabama law recognizes this cause of action to the Supreme Court
of Alabama. 1
            1. The district court overlooked disputes of mate-
                rial fact.
        The district court considered three undisputed facts fatal to
Blackburn’s failure-to-warn claim: first, Ferrante did not read the
LIALDA label before prescribing the drug to Blackburn; second,
Ferrante never tested Blackburn’s renal function; and third, Black-
burn did not attend the follow-up appointment. From these three
facts, the district concluded that the label’s alleged inadequacies did
not cause Blackburn’s injuries as a matter of law. Blackburn argues
that, despite these facts, genuine issues of material fact exist con-
cerning causation because Ferrante testified that he would have
read the label and treated Blackburn differently if the label carried
a different warning. We agree with Blackburn.
       As to the first issue, we believe the district court misunder-
stood Ferrante’s testimony about reading the label. Although Fer-
rante testified that he did not actually look at the LIALDA label
before prescribing it to Blackburn, he also testified that he had


1 Shire also argues that federal law would preempt a state law cause of action
if it existed. The district court rejected this preemption defense. See generally
Wyeth v. Levine, 

 (2009). We will address it, if necessary,
after we know the contours of state law. See Blue Cross & Blue Shield of Ala.,
Inc. v. Nielsen, 

, 1412 (11th Cir. 1997) (certifying a question be-
cause “the state law issues must be decided before we can dispose of” the
preemption question), certified question answered, 

 (Ala. 1998).
USCA11 Case: 20-12258       Date Filed: 11/29/2021     Page: 15 of 22




20-12258               Opinion of the Court                        15

prescribed the medication before, he was familiar with its existing
label, and he knew that renal function should be monitored peri-
odically. He explained that he complied with his interpretation of
the label’s instructions. And he said he would have followed a dif-
ferent label. In other words, this is not a case where the label’s
warning did not matter to the physician. It is instead a case where
the existing label’s warning was so well known to the physician that
he did not read it before each new prescription.
        The district court dismissed Ferrante’s testimony about
whether he would have read and incorporated a different label into
his practices as “unsubstantiated speculation” and “self-interested”
testimony. We disagree. Shire argues that Blackburn cannot create
a genuine issue of material fact by speculating about whether he
and Ferrante would have complied with a monthly monitoring in-
struction. We agree that a party may not avoid summary judgment
by offering only his own speculation about a material fact. See, e.g.,
Cordoba v. Dillard’s, Inc., 

 (11th Cir. 2005). But
that is not what Blackburn has done.
       As an initial matter, Ferrante’s testimony is no more self-
serving than any other kind of evidence that must be considered at
summary judgment. We have held that “a litigant’s self-serving
statements based on personal knowledge or observation can defeat
summary judgment.” United States v. Stein, 

 (11th
Cir. 2018); see also FED. R. CIV. P. 56. Here, of course, Blackburn is
relying on Ferrante’s testimony, not his own. It may be, as Shire
argues, that Ferrante has some self interest in minimizing his role
USCA11 Case: 20-12258        Date Filed: 11/29/2021     Page: 16 of 22




16                      Opinion of the Court                 20-12258

in causing Blackburn’s adverse side effects. But this argument goes
to credibility, not the usefulness of the testimony at summary judg-
ment. See Stein, 

.
       Ferrante’s testimony is also not speculative, at least as we
have used that term in addressing the usefulness of summary judg-
ment evidence. The question under Blackburn’s causation theory
is whether a different label would have led to a different outcome
for Blackburn, which turns on the factual question of what Ferrante
would have done if the label had been different. As Blackburn’s
treating physician, Ferrante may testify on that issue. See United
States v. Henderson, 

 (11th Cir. 2005) (citing
FED. R. EVID. 701); see also FED. R. EVID. 704. And his testimony
here is no more speculative than testimony we have considered
when answering whether a change in label would have affected a
doctor’s treatment in other cases. Toole v. McClintock, 

, 1433 n.6 (11th Cir. 1993) (holding that a doctor’s similar tes-
timony supported sending a failure-to-warn claim to the jury).
       The district court reasoned that Ferrante’s “conduct” con-
tradicted his testimony, but we fail to see how it reached that con-
clusion if it viewed the facts in Blackburn’s favor, as it was required
to do. Although Ferrante did not initially or periodically test Black-
burn’s renal function, he explained why: first, he relied on Young’s
indication that Blackburn’s blood work “checked out” prior to the
referral; and second, Blackburn requested a referral to a new doctor
before Ferrante would have ordered periodic bloodwork. Given his
explanation for why he did not test Blackburn, a reasonable jury
USCA11 Case: 20-12258       Date Filed: 11/29/2021     Page: 17 of 22




20-12258               Opinion of the Court                        17

could find that Ferrante would have followed a different warning
label.
        Finally, the district court made an improper inference con-
cerning the missed follow-up appointment. Blackburn’s failure to
attend the appointment would “sever[] the causal chain,” as the dis-
trict court concluded, only if a doctor would have tested his renal
function at the appointment. But the record does not indicate that
any doctor would have. Ferrante testified that the appointment
was primarily to address any side-effects of the medication, that he
did not typically assess renal function until much later, and that ei-
ther he or Blackburn canceled the appointment. The district court
was also persuaded that Blackburn would not have attended an ap-
pointment for a blood test, even if Ferrante ordered one. However,
drawing inferences in Blackburn’s favor, his failure to attend the
follow-up appointment to assess medication side-effects was based
on matters completely unrelated to whether he would have at-
tended a testing appointment, such as not noticing any side effects
from the medication. There is no other evidence that Blackburn
would not have submitted to more frequent testing if his doctor
had recommended it based on a different warning label.
        Considering Ferrante’s testimony, and drawing all infer-
ences in Blackburn’s favor, a reasonable jury could find that Fer-
rante would have read and heeded a different LIALDA label that
warned of a need for more frequent testing. These genuine dis-
putes of material fact preclude us from affirming based on the dis-
trict court’s reasoning.
USCA11 Case: 20-12258        Date Filed: 11/29/2021     Page: 18 of 22




18                      Opinion of the Court                 20-12258

          2. We certify two state law questions to the Su-
             preme Court of Alabama.
       As an alternative basis to affirm the district court’s summary
judgment, Shire argues that the district court erred in recognizing
Blackburn’s theory of liability as a matter of Alabama law. There
are two parts to this argument, as we see it. First, citing the learned
intermediary doctrine, Shire contends that it satisfied its duty as a
matter of law by warning of the risk of renal impairment and that,
once a drug manufacturer warns of a risk, it is up to the prescribing
doctor to assess and mitigate that risk. Second, Shire argues that
Blackburn’s theory of proximate cause is “not in accord with Ala-
bama law.” Specifically, Shire argues that a failure-to-warn plaintiff
may establish that his injury was caused by a prescription drug only
by showing that the physician would not have prescribed the drug
if the warning had been adequate. Shire’s arguments present the
following state-law questions:
       1. Consistent with the learned intermediary doctrine,
       may a pharmaceutical company’s duty to warn in-
       clude a duty to provide instructions about how to
       mitigate warned-of risks?
       2. May a plaintiff establish that a failure to warn
       caused his injuries by showing that his doctor would
       have adopted a different course of testing or mitiga-
       tion, even though he would have prescribed the same
       drug?
USCA11 Case: 20-12258       Date Filed: 11/29/2021    Page: 19 of 22




20-12258               Opinion of the Court                       19

We believe these questions are dispositive, but we confront a
dearth of clear authority to resolve them.
       We have not expressly addressed Shire’s first argument.
Some federal district courts have arguably accepted the argument.
See In re Chantix (Varenicline) Prods. Liab. Litig., 

, 1342 n.12 (N.D. Ala. 2012) (dismissing the claim that a drug’s
label should have included prescribing instructions where the label
“clearly set[] forth” the experienced side effect); Dye v. Covidien
LP, 

, 1341 (S.D. Fla. 2020) (holding that a drug
manufacturer “need only warn of complications stemming from
the use of the Product—not the subsequent measures medical pro-
fessionals may employ to treat those complications”). On the other
hand, the Fifth Circuit has concluded (applying Louisiana law) that
“recommended medical monitoring schemes . . . are, in essence,
instructions for safe use of prescription drugs” that must be in-
cluded to satisfy a manufacturer’s duty to warn. Stahl v. Novartis
Pharms. Corp., 

, 269–70 (5th Cir. 2002) (citing Restate-
ment (Third) of Torts: Products Liability § 6(b) (1997) (noting that
a prescription drug or medical device is defective if it “is not rea-
sonably safe due to inadequate instructions or warnings” (emphasis
omitted))); see also PLIVA, Inc. v. Mensing, 

 (2011) (“a
manufacturer’s duty to warn includes a duty to provide adequate
instructions for safe use of a product”). No decision of the Supreme
Court of Alabama directly adopts either position. Although the
court has at times used the terms “instructions” and “warnings” in-
terchangeably, Yarbrough v. Sears, Roebuck & Co., 

,
USCA11 Case: 20-12258       Date Filed: 11/29/2021    Page: 20 of 22




20                     Opinion of the Court                20-12258

483 (Ala. 1993), it has also said that a drug manufacturer’s duty is
“limited to an obligation to advise the prescribing physician of any
potential dangers that may result from the use of its product,”
Weeks, 

 (quoting Toole v. Baxter Healthcare
Corp., 

, 1313–14 (11th Cir. 2000)).
       As to Shire’s second argument, the district court reasoned
that “proof 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
plaintiff.” We have arguably approved of this theory under Ala-
bama law. See Toole, 

. And several district court
decisions also endorse this position. See Barnhill v. Teva Pharms.
USA, Inc., 

 (S.D. Ala. 2011); Fields v. Eli
Lilly & Co., 

 (M.D. Ala. 2015). But Shire
argues with some force that this theory is in tension with the Su-
preme Court of Alabama’s latest statements on causation in the
pharmaceutical failure-to-warn context. See Weeks, 159 So.3d at
673–74 (“In short, the patient must show that, but for the false rep-
resentation made in the warning, the prescribing physician would
not have prescribed the medication to his patient.”).
       Thankfully, the Supreme Court of Alabama permits federal
courts to certify questions when faced with “determinative” issues
of state law upon which “there are no clear controlling precedents
in the decisions of the Supreme Court [of Alabama].” ALA. R. APP.
P. 18(a). The “most important” factors in deciding to certify are
USCA11 Case: 20-12258         Date Filed: 11/29/2021      Page: 21 of 22




20-12258                 Opinion of the Court                          21

“the closeness of the question and the existence of sufficient
sources of state law . . . to allow a principled rather than conjectural
conclusion.” Florida ex rel. Shevin v. Exxon Corp., 

,
274–75 (5th Cir. 1976). Thus, certification is generally appropriate
where we face “substantial doubt on a dispositive state law issue.”
WM Mobile Bay Env’t Ctr., Inc. v. City of Mobile Solid Waste
Auth., 

 (11th Cir. 2020). Unsurprisingly, we
have sought guidance from the Supreme Court of Alabama on sim-
ilar issues of tort liability before. See Farsian v. Pfizer, Inc., 

 (11th Cir. 1995), certified question answered, 

 (Ala. 1996); Campbell v. Cutler Hammer, Inc., 

 (11th Cir. 1993), certified question answered, 

(Ala. 1994). We believe it is the best course to seek the Supreme
Court of Alabama’s guidance again.
                        IV.    CONCLUSION

        Before we can decide whether to affirm or reverse the dis-
trict court, we must determine whether Blackburn’s theory of lia-
bility is consistent with Alabama law. We therefore certify to the
Supreme Court of Alabama the following questions:
       1. Consistent with the learned intermediary doctrine,
       may a pharmaceutical company’s duty to warn in-
       clude a duty to provide instructions about how to
       mitigate warned-of risks?
       2. May a plaintiff establish that a failure to warn
       caused his injuries by showing that his doctor would
USCA11 Case: 20-12258        Date Filed: 11/29/2021      Page: 22 of 22




22                      Opinion of the Court                   20-12258

       have adopted a different course of testing or mitiga-
       tion, even though he would have prescribed the same
       drug?
        We defer our decision in this case until the Supreme Court
of Alabama has considered our certified questions. We note that
our phrasing of the certified questions is not intended “to restrict
the Supreme Court’s consideration of the problems involved and
the issues as the Supreme Court perceives them to be in its analysis
of the record certified in this case.” Martinez v. Rodriquez, 

, 159 n.6 (5th Cir. 1968). To that end, “if we have overlooked or
mischaracterized any state law issues or inartfully stated [the] ques-
tions we have posed, we hope the Alabama Supreme Court will
feel free to make the necessary corrections.” Spain v. Brown & Wil-
liamson Tobacco Corp., 

, 1312 (11th Cir. 2000). The
entire record of this case, including the parties’ briefs, is transmitted
to the Supreme Court of Alabama.
       QUESTIONS CERTIFIED.