Karin J. Stiens v. Bausch & Lomb Incorporated

RENDERED: DECEMBER 11, 2020; 10:00 A.M.
TO BE PUBLISHED
Commonwealth of Kentucky
Court of Appeals
NO. 2018-CA-1762-MR
KARIN J. STIENS APPELLANT
APPEAL FROM FAYETTE CIRCUIT COURT
v. HONORABLE PAMELA R. GOODWINE, JUDGE
ACTION NO. 14-CI-02829
BAUSCH & LOMB INCORPORATED APPELLEE
OPINION
AFFIRMING
** ** ** ** **
BEFORE: DIXON, JONES, AND MAZE, JUDGES.
JONES, JUDGE: Appellant, Karin Stiens (“Stiens”), initiated the underlying
action in Fayette Circuit Court against Bausch & Lomb Incorporated (“B & L”),
Insite Vision, Inc., and Commonwealth Eye Surgery on a variety of products
liability claims. After extensive motion practice and a multitude of discovery
issues, on July 30, 2018, the Fayette Circuit Court entered an order granting
summary judgment to B & L on Stiens’s last remaining claim, which was based in
negligence.
On appeal, Stiens argues the circuit court erroneously concluded that
she could not present prima facie evidence of foreseeability. According to Stiens,
B & L should have foreseen that an injury could result from the “off-label” and
untested use of a pharmaceutical product, and so B & L should have warned of
unknown risks and tested the product for its marketed purpose. B & L counters
that it had no duty to prevent unforeseen risks caused by its product under
negligence law and that Stiens failed to present evidence suggesting that B & L
knew or should have known there were risks associated with that particular use of
its product. Following review of the record and applicable law, we AFFIRM the
Fayette Circuit Court’s order in favor of B & L for reasons more fully explained
below.
I. FACTUAL AND PROCEDURAL BACKGROUND
In 2011, B & L began marketing a new drug, Besivance, for
ophthalmological use. Besivance is a topical antibiotic comprised of besifloxacin,
a fluoroquinolone antibiotic, and DuraSite, a viscous adhesive compound designed
to increase the effectiveness of the antibacterial properties by prolonging eye
surface contact. Besivance is proven to prevent a wide range of bacterial
infections of the eye, including methicillin-resistant Staphylococcus aureus
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(“MRSA”). Besivance was approved to treat bacterial conjunctivitis (“pink eye”)
and has not been approved for surgical purposes.
On January 19, 2012, Dr. Lance S. Ferguson of Commonwealth Eye
Surgery in Lexington, Kentucky, used Besivance as Stiens’s prophylactic and post-
operative antibiotic following her photorefractive keratectomy procedure (“PRK”)
for nearsightedness. Following her surgery, Stiens suffered irreparable damage to
her left eye, impairing her vision.
PRK is a type of refractive eye surgery performed to permanently
improve eyesight without the use of glasses or contact lenses. An alternative to the
more common LASIK surgery, PRK is available for patients with thinner corneas
than is safe for LASIK surgery. The procedure requires an ophthalmologist to
remove the outer layer of the cornea and reshape the stroma layer of the cornea
beneath with a laser. In a successful PRK, the subsequent epithelial regeneration
results in permanent correction of the patient’s vision. Ophthalmologists often use
a bandage contact lens to protect the eye during the healing process.
Ophthalmologists like Dr. Ferguson use various antibiotics as post-
procedural prophylactics to prevent ensuing infections following PRK and other
refractive surgeries. However, no fluoroquinolone, including Besivance, is
approved for use as a prophylactic by the Federal Food, Drug, and Cosmetic Act
(“FDCA”). Food and Drug Administration (“FDA”) approval is use specific, and
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the labeling that accompanies the product must accurately reflect its approved use.
Use for any purpose other than what is approved by the FDCA is “off-label.”
Under the FDCA, drug manufacturers are only permitted to market their products
for on-label usage. It is unlawful for a manufacturer to introduce a drug into
interstate commerce with the intent that it be used for an off-label purpose. 21
United States Code (“U.S.C.”) § 331(a) & § 352.
While federal regulations bar drug manufacturers from marketing
their products for off-label uses, the off-label use of a drug is not similarly
restricted. In fact, doctors are permitted and even encouraged to use medications
off-label in patient care. The evidence is in agreement that in refractive eye
surgeries, off-label use of antibiotics for infection prevention is the standard of
care.
The FDA approved Besivance for use in pink eye prevention in 2009.
However, it was not until the summer of 2011 that B & L, through its
representative Julie Lawrence (“Lawrence”), began calling on ophthalmologists
throughout Kentucky and the greater Cincinnati area to promote Besivance,
targeting those ophthalmological practices reported to use fluoroquinolones
regularly. Commonwealth Eye Surgery was one such practice. Lawrence first
contacted the practice in July of 2011. While Commonwealth Eye Surgery used
fluoroquinolones, its practice was limited to surgeries. It did not provide routine
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eye care, such as the treatment of pink eye, to its patients, a fact that was made
known to Lawrence through her discussions with the practice. In short, Lawrence
knew or should have known that any need Commonwealth Eye Surgery would
have for Besivance would be in using it off-label for infection prevention
following surgery. At the time Lawrence first sought out Commonwealth Eye
Surgery, its physicians were fairly satisfied with their current fluoroquinolone; they
were not actively investigating any potential new drugs.
On July 20, 2011, Lawrence met with two of Commonwealth’s
surgeons, Dr. R. Marty Smith and Dr. Howell M. Findley, regarding Besivance.
She provided them with information about Besivance and its benefits, including its
superior coverage for patients and its higher rates of infection prevention.
Lawrence noted that Besivance had better coverage against MRSA than any other
fluoroquinolone. During this meeting, Drs. Smith and Findley informed Lawrence
that they were considering using Besivance in their surgical practice and discussed
with her whether it could be used in LASIK, PRK, and cataract surgery. Lawrence
also gave the doctors samples of Besivance and coupons for patients’ use. At this
time, there were no published clinical trials or articles regarding the use of
Besivance in any kind of refractive surgery.1
1
In 2010, Dr. Nick Mamalis, Stiens’s expert witness, published a study concerning the toxicity
of Besivance in the eye, which referenced a prior Canadian study concluding that topical
ointment applied after cataract surgery could enter the anterior chamber of the eye and cause
-5-
According to office staff, the entire practice switched from using
another fluoroquinolone to Besivance that fall. Dr. Ferguson testified he, Dr.
Smith, and Dr. Findley jointly decided to use Besivance. The decision was
motivated by the increased coverage against MRSA and the decreased cost to
patients. Even without discounts or coupons, Besivance would cost 25% less than
any other fluoroquinolone. On September 26, 2011, a Commonwealth office
manager emailed Lawrence to inform her that they had decided to prescribe
Besivance for LASIK surgeries and requested information regarding dosages. By
that time, the office had already begun using Besivance for cataract surgeries.
Patient records show that the practice prescribed Besivance in connection with
PRK surgeries as early as October 13, 2011.
Dr. Findley encouraged his partner, Dr. Ferguson, who specializes in
cataract and refractive eye surgeries, including PRK, to consider using Besivance
as he believed it to be the “latest, greatest” drug on the market. Dr. Ferguson
interacted with Lawrence on his own on two separate occasions. The first was a
brief greeting while Lawrence was dropping off coupons for patient use. The
second was an extended visit. Dr. Ferguson and B & L dispute who approached
toxic anterior segment syndrome. Another 2009 article quoted Dr. Randall Olson, Dr. Mamalis’s
mentor, who warned against the potential toxicity of Besivance in clear corneal surgery if
allowed to leak into the anterior chamber of the eye. Dr. Mamalis later testified that his articles
were “not germane” to PRK. The circuit court ruled these articles inadmissible.
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whom about arranging the second visit. At one point in his testimony, Dr.
Ferguson stated that Lawrence first approached him in the fall of 2011 about using
Besivance in his surgeries. However, in an earlier deposition,2 Dr. Ferguson
testified that Commonwealth’s office manager reached out to Lawrence about
Besivance. In any event, it was eventually agreed that Lawrence would meet with
Dr. Ferguson, and as part of the meeting would observe one of Dr. Ferguson’s
surgeries.
On November 1, 2011, Lawrence watched Dr. Ferguson perform both
cataract and PRK surgeries. During the PRK surgery, Dr. Ferguson used
Besivance. The two then had lunch together during which time they discussed
Ferguson using Besivance in refractive surgeries, although they dispute who
initiated this particular part of the conversation. When asked by Dr. Ferguson
about the efficacy of Besivance in refractive surgeries, Lawrence told him that
Besivance could be used in an equivalent fashion as other antibiotics in refractive
surgeries, including PRK. Lawrence compared Besivance to other
fluoroquinolones, saying that it was more resistant against MRSA and that it was
used by other practitioners in the area. Lawrence additionally talked about the
2
Dr. Ferguson gave an earlier deposition in a different case regarding the same subject matter,
which he has adopted for the present case.
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benefits of using Besivance in PRK surgeries with Dr. Ferguson, promoting it as a
cheaper and safer antibiotic than the other antibiotics ophthalmologists used.
Dr. Ferguson also asked whether other practitioners used Besivance in
refractive surgeries, and Lawrence responded, “They say yes.” Dr. Ferguson
testified that Lawrence added that not only do other doctors use it, but that B & L
had a paper coming out on Besivance demonstrating its safety and efficacy in
refractive surgery. Lawrence denies making any statement about an upcoming
study.
Under B & L company policy as well as the FDCA, Lawrence was
permitted only to promote Besivance for its on-label purpose and truthfully answer
questions regarding off-label use. Lawrence testified that she did not directly
promote Besivance for use in eye surgery, although she was aware when she
promoted the drug that it would likely be used by the surgeons at Commonwealth
Eye Surgery for off-label uses. Dr. Ferguson was also aware that Besivance was
only approved for use in treating pink eye and that his use would be off-label. In
earlier testimony, Dr. Ferguson admits to asking Lawrence about Besivance as a
prophylactic in refractive surgeries, although his later testimony was that Lawrence
initiated this particular portion of their conversation about Besivance.
Ultimately, Dr. Ferguson decided to begin using Besivance in all his
refractive surgeries. He testified that in making this decision, he relied upon his
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training, education, and experience as an ophthalmologist as well as Lawrence’s
assurances about the safety and efficacy of Besivance in refractive surgeries. Dr.
Ferguson formed his decision upon the literature and informational pamphlets
provided by B & L, coverage comparisons with other fluoroquinolones, and
discussions with his practice associates. He also reached out to other
ophthalmologists in the surrounding area about their experience using Besivance in
their own practices. Dr. Ferguson then conducted his own research on Besivance
and read “extensively,” reviewing the available medical literature.
Regarding Lawrence’s role in his decision, Dr. Ferguson testified that
her assurances about Besivance’s safety and efficacy were a factor in his decision
and that he relied upon them “very much.” However, Dr. Ferguson additionally
stated that no pharmaceutical representative, no matter how knowledgeable, could
persuade him to use a drug against his better judgment.
Neither Lawrence nor the available medical literature warned that
Besivance had not been tested for use in refractive surgeries or suggested that there
may be risks associated with such use. During his research, Dr. Ferguson failed to
find the article to which Lawrence referred on her November 1, 2011 visit.3 In
3
Discovery did not conclusively establish which paper Lawrence referenced in her conversation
with Dr. Ferguson. B & L did publish an animal study in April of 2012 regarding the safety and
efficacy of Besivance in refractive surgeries such as LASIK and PRK, although the drug was not
applied directly to the stroma bed or covered with a bandage contact lens. At one point, Stiens
contended that Lawrence actually referred to a paper published in 2010 concerning the toxicity
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fact, Dr. Ferguson found no medical literature that either supported or warned
against his intended use for Besivance.
On January 19, 2012, Dr. Ferguson used Besivance in a PRK on
Stiens’s left eye. Following her January PRK surgery, Stiens experienced delayed
healing. Stiens’s vision never improved and, in fact, greatly declined. She
eventually underwent a subsequent corneal transplant in December of 2014. The
second surgery was also unsuccessful, leaving Stiens with extremely blurred vision
in her left eye.
Dr. Ferguson was the first medical professional to openly express any
concerns about the negative effects of Besivance if used for infection control post-
surgery. After a number of his PRK patients experienced delayed healing,
including Stiens, Dr. Ferguson deduced that Besivance was the cause of the delay
and Stiens’s damaged vision. Dr. Ferguson then discussed his suspicions with
colleagues at a medical conference. He later wrote a letter expressing his concerns
to several ophthalmology journals, which was ultimately published in Review of
Ophthalmology.
B & L ophthalmologists responded to the letter with surprise, stating
that “no cases of delayed re-epithelialization after PRK have been reported to the
of Besivance during cataract surgery. Regardless, neither party was able to demonstrate to which
paper, if either, Lawrence allegedly referred.
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company” even though Besivance had been applied to “thousands of eyes with
large epithelial defects and bandage contact lenses.” They suggested that there was
a “yet unidentified cause” for the healing delays but admitted that Dr. Ferguson’s
report required further investigation. However, Dr. Ferguson and Stiens’s expert
witness have since testified that the DuraSite component of Besivance was the
most likely cause of Stiens’s delayed healing and injury. For the purposes of
summary judgment, B & L has not contested that Besivance caused Stiens’s eye
injury.
It was not until February 2013 that the American Society of Cataract
and Refractive Surgery issued an alert jointly with a peer-reviewed study that
certain topical medications, Besivance in particular, should not be used
intraoperatively during LASIK and PRK due to the adverse effects of its adhesive
component.
On July 24, 2014, Stiens filed her complaint against B & L, Insite
Vision, the manufacturer of DuraSite, and Commonwealth Eye Surgery in Fayette
Circuit Court. She asserted claims of negligent testing, marketing, and
distribution, strict liability, and express and implied warranty claims against B &
L. Insite and B & L filed a joint motion for summary judgment on April 2, 2018.
Stiens opposed the motion. The circuit court granted the motion for Insite on the
grounds of personal jurisdiction. On May 7, 2018, the circuit court also dismissed
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Stiens’s claims of strict liability and breach of warranty but denied summary
judgment for B & L on the negligence claim.
The circuit court denied summary judgment on the negligence claim
based on two factual disputes regarding the issue of foreseeability. First, the
circuit court stated that several scientific articles published in 2010 warning against
the injection of Besivance into the eye during refractive surgery could suggest that
B & L knew or should have known of the risks associated with using Besivance in
PRK at the time of Stiens’s surgery. Second, the court held that Lawrence’s
November 1st statements could be seen by a jury to be a substantial factor in Dr.
Ferguson’s decision to use Besivance in Stiens’s PRK.
On May 31, 2018, B & L moved in limine to exclude evidence
concerning any alleged “off-label promotion” under the FDCA. The circuit court
found that because Stiens chose to forego pursuing a claim under the FDCA, she
could not be permitted to allege that B & L engaged in off-label promotion in
violation of the FDCA. Therefore, all testimony regarding off-label promotion was
excluded.4
B & L also moved to exclude three articles about the use of Besivance
in PRK and related testimony. The circuit court excluded the articles and all
4
While the FDCA prohibits off-label promotion and imposes fines and civil liability for doing
so, there is no corresponding state-law prohibition against off-label marketing.
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related testimony as irrelevant and unduly prejudicial. Stiens’s expert witness and
co-author of two of the articles admitted in deposition that his research on the use
of Besivance injected into the anterior of the eye and his subsequent warnings of
toxicity were “not germane” to the use of Besivance as a topical antibiotic in PRK.
The third article concerned the same use of Besivance.
Following these evidentiary rulings, B & L moved to renew its motion
for summary judgment. The circuit court granted the motion in a July 30, 2018
order, holding that Stiens lacked the evidence to support a prima facie negligence
claim. The court held that even in the light most favorable to Stiens, she had failed
to present sufficient evidence of foreseeability and causation.
Stiens filed a Motion to Vacate and Reconsider Summary Judgment
under Kentucky Rules of Civil Procedure (“CR”) 59.05, arguing that foreseeability
was an issue for the jury. The circuit court denied the motion as improper under
CR 59 for failure to present new evidence or arguments. A motion that “[does]
nothing more than reassert the same arguments . . . made in challenging [the]
motion for summary judgment” is properly denied under CR 59.05. Rogers v.
Integrity Healthcare Servs., Inc., 358 S.W.3d 507, 513 (Ky. App. 2012).
The circuit court further stated that summary judgment was proper
because Stiens failed to assert prima facie evidence of her negligence claim that
“the defendant owed a duty to the plaintiff, breached that duty, and consequent
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injury followed.” Shelton v. Ky. Easter Seals Soc’y, Inc., 413 S.W.3d 901, 906
(Ky. 2013) (footnote omitted). In a products liability context, a consequent injury
is defined by whether a defendant’s conduct was a “substantial factor” in bringing
about the injury. CertainTeed Corp. v. Dexter, 330 S.W.3d 64, 77 (Ky. 2010).
The circuit court concluded that Stiens could not present any evidence of
foreseeability beyond sheer speculation, stating, “Stiens has not identified any
specific identifiable injury causally connected to Besivance® that [B & L] knew
was possible or should have known was possible.”5
The circuit court also rejected Stiens’s repeated assertion that B & L is
“presumed to know the quality and characteristics of its product when it
markets/sells it” as a presumption only applicable in strict liability, not negligence.
(Citing Isaacs v. Smith, 5 S.W.3d 500, 502 (Ky. 1999).) Finally, the circuit court
again denied Stiens’s contention that B & L violated a duty to refrain from off-
label promotion. Stiens brought state claims, and Kentucky law does not provide
for a state law claim for off-label promotion. The circuit court explained that
because Stiens had chosen to exclusively pursue state law claims, she could not
rely upon any federal law prohibiting certain kinds of off-label promotion to
establish B & L’s duty of care.
This appeal followed.
5
This conclusion of law is incorrect for reasons to be discussed.
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II. STANDARD OF REVIEW
“[S]ummary judgment is to be cautiously applied and should not be
used as a substitute for trial.” Steelvest, Inc. v. Scansteel Serv. Ctr., Inc., 807
S.W.2d 476, 483 (Ky. 1991). A motion for summary judgment should only be
granted “when it appears impossible for the nonmoving party to produce evidence
at trial warranting a judgment in his favor” even when the evidence is viewed in
the light most favorable to him. Id. at 482; Shelton, 413 S.W.3d at 905. To
survive a properly supported summary judgment motion, the opposing party must
present at least some affirmative evidence showing that there is a genuine issue of
material fact for trial. Steelvest, 807 S.W.2d at 482.
The standard of review on appeal from summary judgment is
“whether the trial court correctly found that there were no genuine issues as to any
material fact and that the moving party was entitled to judgment as a matter of
law.” Scifres v. Kraft, 916 S.W.2d 779, 781 (Ky. App. 1996) (citing CR 56.03).
“A trial court’s decision to grant summary judgment for insufficient evidence is to
be reviewed de novo on appeal.” Ashland Hosp. Corp. v. Lewis, 581 S.W.3d 572,
577 (Ky. 2019). On appeal, the record must be viewed in a light most favorable to
the party who opposed the motion for summary judgment, and all doubts are to be
resolved in his favor. Malone v. Kentucky Farm Bureau Mut. Ins. Co., 287 S.W.3d
656, 658 (Ky. 2009).
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III. ANALYSIS
Stiens raises numerous assignments of error as part of this appeal.
The primary issue put forth by Stiens, and the one we conclude is ultimately
dispositive, is whether the circuit court erred as a matter of law when it granted
summary judgment to B & L on Stiens’s negligence claim.6 Stiens argues that the
circuit court erred in concluding that she could not present prima facie evidence of
foreseeability. Because we find the issue of foreseeability to be determinative in
affirming the circuit court’s decision, Stiens’s other issues raised on appeal are
moot and will not be addressed.
To recover under a claim of negligence, a plaintiff must present
evidence that “(1) the defendant owed a duty of care to the plaintiff, (2) the
defendant breached its duty, and (3) the breach proximately caused the plaintiff’s
damages.” Lee v. Farmer’s Rural Elec. Co-op. Corp., 245 S.W.3d 209, 211-12
(Ky. App. 2007) (citation omitted). “The absence of any one of the three elements
is fatal to the claim.” M & T Chems., Inc. v. Westrick, 525 S.W.2d 740, 741 (Ky.
1974) (quoting Illinois Cent. R.R. v. Vincent, 412 S.W.2d 874 (Ky. 1967)).
The court’s “first inquiry must always involve the legal question of
the existence of a duty.” Pearson v. Pearson, 552 S.W.3d 511, 514 (Ky. App.
6
At different points in this litigation, Stiens has styled her claim as negligent marketing, failure
to warn, and failure to test. For the purposes of this Opinion, we will predominantly address her
claim under the broad category of negligence.
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2018). Kentucky law imposes the “universal duty” of care. Under the universal
duty, “[e]very person owes a duty to every other person to exercise ordinary care in
his activities to prevent foreseeable injury.” Isaacs, 5 S.W.3d at 502 (quoting
Grayson Fraternal Order of Eagles, Aerie No. 3738, Inc. v. Claywell, 736 S.W.2d
328, 332 (Ky. 1987)). Therefore, it is clear that B & L has a duty to every person,
including Stiens, to prevent foreseeable injury.
The Kentucky Supreme Court has held “that so far as foreseeability
enters into the question of liability for negligence, it is not required that the
particular, precise form of injury be foreseeable—it is sufficient if the probability
of injury of some kind to persons within the natural range of effect of the alleged
negligent act could be foreseen.” Id. (quoting Miller v. Mills, 257 S.W.2d 520, 522
(Ky. 1953)). Such risk must be foreseeable based on what the tortfeasor knew or
should have known at the time of the accident rather than what might be deemed
foreseeable in hindsight. Bruck v. Thompson, 131 S.W.3d 764, 767 (Ky. App.
2004). This is in contrast with the circuit court’s mistaken emphasis on the
importance of identifying a specific, identifiable injury that can be causally
connected to B & L’s alleged breach of duty. Record (“R.”) at 1045. To
demonstrate foreseeability, a plaintiff must only demonstrate the probability of
some general risk of injury resulting from the defendant’s negligent act – not that
of the exact injury actually manifested.
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Each of Stiens’s claims under the Kentucky Product Liability Act
(“KPLA”) – negligent marketing, failure to warn, and failure to test – is founded in
negligence and requires evidence of foreseeability. CertainTeed, 330 S.W.3d at 79
(explaining that under the failure to warn theory, liability for a manufacturer
follows only if injury was foreseeable based on the inherent dangerousness of the
product and the manufacturer still failed to provide warning); Vanden Bosch v.
Bayer Healthcare Pharm., Inc., 13 F. Supp. 3d 730, 747 (W.D. Ky. 2014)
(explaining that testing can be relevant to the duty of care, which is premised on
preventing foreseeable injury). “There is no language in the [KPLA] which
suggests that products liability actions mean only those actions based on strict
liability in tort . . . .” Monsanto Co. v. Reed, 950 S.W.2d 811, 814 (Ky. 1997). If a
claim is brought against a manufacturer “of a product which is alleged to have
caused injury, then the [KPLA] applies . . . .” Id. This is true regardless of
whether a claim is founded in strict liability, negligence, or breach of warranty,
even though “each of these theories of recovery in products liability cases requires
proof of different elements and has different implications . . . .” Id. All of this
goes to say that the classification of an action as a products liability claim does not
change its essential elements from what they would be under common law.
Despite this well-settled law, Stiens repeatedly attempts to shoehorn
her failure to warn/failure to test/negligent marketing claim into a claim imposing
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the presumption of knowledge standard. This is incorrect. Kentucky follows the
Restatement (Second) of Torts, which imposes the strict liability presumption only
when a product manufacturer or seller “sells any product in a defective condition
unreasonably dangerous to the user.” Dealers Transp. Co. v. Battery Distrib. Co.,
402 S.W.2d 441, 446 (Ky. 1965) (quoting RESTATEMENT (SECOND) OF TORTS
402A(1)). Stiens has admitted that B & L did not sell Besivance in a defective
condition, preventing her from maintaining a viable strict liability claim against B
& L. Without a strict liability claim, Stiens cannot rely upon any presumption that
B & L knew that off-label use of Besivance could cause injury.
Our Supreme Court has previously provided clarification as to the
difference between negligence and strict liability under the KPLA.
[N]egligence depends on what a prudent manufacturer
. . . by the exercise of ordinary care actually should have
discovered and foreseen, whereas strict liability depends
on what he would have anticipated had he been (but
regardless of whether he actually was or should have
been) aware of the condition of and potentialities
inhering in the product when he put it on the market.
Where the one is actual, the other is postulated.
Ulrich v. Kasco Abrasives Co., 532 S.W.2d 197, 200 (Ky. 1976); see also
Worldwide Equip., Inc. v. Mullins, 11 S.W.3d 50, 55 (Ky. App. 1999). Even under
Kentucky products liability law, the elements of negligence remain the same,
including foreseeability.
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The KPLA imposes upon manufacturers a duty to test their products
for risks that they or the medical community “had a reasonable basis to suspect”
might exist. Prather v. Abbott Labs., 960 F. Supp. 2d 700, 713 (W.D. Ky. 2013)
(citation omitted) (applying Kentucky law). Kentucky courts do not require
manufacturers to lead scientific research into the forays of cutting-edge medical
advances. “The law does not require a company to test for hidden risks that neither
it nor the medical community had a reasonable basis to suspect.” Id. (citation
omitted). Manufacturers “d[o] not have an obligation to spearhead medical
research by testing for every conceivable risk[] posed by use of” their products. Id.
at 714. Conversely, it follows that manufacturers like B & L do have an obligation
to test and warn regarding products known or suspected to be dangerous.
A manufacturer may similarly be held liable under a failure to warn
claim. CertainTeed, 330 S.W.3d at 79. A manufacturer’s liability for failure to
warn follows only if it knew or should have known of the inherent dangerousness
of the product and failed to accompany it with the quantum of warning adequate to
guard against the inherent danger. Id.; Hyman & Armstrong, P.S.C. v. Gunderson,
279 S.W.3d 93, 109-10 (Ky. 2008), as modified on reh’g (Nov. 26, 2008). In
Proctor v. Davis, the Appellate Court of Illinois held that a pharmaceutical
company defendant has a duty to warn when there is “unequal knowledge and the
defendant, possessed of such knowledge, knows or should know that harm might
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occur if no warning is given.” 682 N.E.2d 1203, 1211 (Ill. App. Ct. 1997) (quoting
Kokoyachuk v. Aeroquip Corp., 526 N.E.2d 607 (Ill. App. Ct. 1988)). In that case,
Upjohn, the drug manufacturer, failed to warn of risks associated with off-label
periocular injection of Depo-Medrol, a corticosteroid, and in fact published
research validating the safety and efficacy of the drug application in question to
increase sales. Id. at 1212. At the time of the plaintiff’s disastrous injection
procedure, Upjohn had two decades’ worth of knowledge of the drug’s dangerous
propensities when injected intraocularly. Id. at 1213.
Further, a manufacturer’s calculated marketing tactics may undermine
warnings given if marketing was pervasive enough to essentially “undo” the
warnings of known danger. Id. at 1214-15. In Hyman & Armstrong, P.S.C. v.
Gunderson, a new mother was found dead following a seizure after taking Parlodel
to prevent lactation. 279 S.W.3d at 99. Her estate successfully brought a products
liability claim against Sandoz Pharmaceutical Corporation after evidence
demonstrated that Sandoz “repeatedly attempted to downplay or conceal the risks
of Parlodel and intentionally undermined any existing warnings.” Id. at 112
(emphasis added). Despite knowledge of at least ninety-eight reported cases of
hypertension, eighty-six cases of seizure, and thirty-three cases of stroke, Sandoz
had been instructing its sales representatives not to mention any risks unless
directly asked. Id. at 111-12. The Court stated that any warnings contained in the
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product packaging were rendered inadequate due to Sandoz’s “efforts to minimize
or conceal” the associated risks of the drug. Id. at 112. Again, actual knowledge
of risk was requisite to this theory of the duty to warn.
Stiens claims that these cases demonstrate that B & L had a duty to
warn of potential risks that could arise when using Besivance. However, this
argument is not supported by any of the cases Stiens cites, which are readily
distinguishable from the present set of facts. Each case Stiens cites turns on the
presence of evidence that the drug manufacturers had actual knowledge of reported
risks or dangers associated with the use of their pharmaceutical products. See, e.g.,
Hyman, 279 S.W.3d 93; Proctor, 682 N.E.2d 1203; Smith v. Pfizer Inc., 714 F.
Supp. 2d 845 (M.D. Tenn. 2010) (holding that the drug manufacturer promoted its
product, Neurontin, for use as a pain reliever without adequate warnings of its
known side effects of depression and suicidal ideation). Additionally, more recent
case law reaffirms that warnings must be given for off-label use only where there
is empirical evidence of harm that is known by the manufacturer. See T.M. v.
Janssen Pharms. Inc., 214 A.3d 709, 728 (Pa. Super. Ct. 2019).
Unlike those decisions, there is simply no evidence suggesting that B
& L knew or should have known that the use of Besivance in PRK was associated
with any adverse effects. Following the circuit court’s evidentiary holdings, Stiens
was left with no evidence suggesting that B & L knew or should have known that
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there could be risks associated with Besivance use at all. In fact, Dr. Ferguson
testified that his use of Besivance in PRK was on the “bleeding edge,” meaning
that he was one of the first ophthalmologists to do so. Like B & L, he also
expressed surprise when he realized that Besivance was the culprit behind Stiens’s
injury. Stiens states that B & L had a duty to notify physicians of any additional
side effects discovered from its use; while this is an accurate statement of law,
there had not yet been evidence to suggest that using Besivance in PRK could be
dangerous. Without even a scintilla of evidence to support this element of Stiens’s
claim, we cannot hold that summary judgment was improvidently granted.7 While
Stiens’s injury is undoubtably lamentable, we cannot hold that B & L had a duty to
warn of or test for risks without any reason to suspect that there may be risks
associated with this particular use of Besivance.
Given the lack of specific evidence that B & L had prior knowledge
that its product posed a risk to patients when used for infection control following
surgery, Stiens makes the argument that we should infer that B & L’s promotion of
its product for an off-label use without prior testing is a sufficient basis upon which
7
Stiens did not raise any evidentiary issues on appeal despite referencing evidence the circuit
court clearly excluded. Following the exclusion of Dr. Mamalis’s research and article, the circuit
court stated, “Same with respect to . . . Last Generation article.” Video Record (“V.R.”) 6/15/18
at 10:47 a.m. Although Stiens contends that the circuit court did not exclude the article quoting
Dr. Olson, the video record makes clear otherwise. Regardless, this article does not address the
use of Besivance as a topical medication in any kind of refractive surgery but rather as an
injection during clear corneal surgery.
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to predicate foreseeability of harm. Given that Kentucky does not prohibit the off-
label promotion and marketing of drugs, we do not believe that it is appropriate to
extend the law of negligence in this regard. This is an issue for the General
Assembly to take up, not the courts.
Off-label use is not unlawful under state or federal law. United States
v. Caronia, 703 F.3d 149, 166-67 (2d Cir. 2012). Doctors are permitted and even
encouraged to prescribe drugs for both FDCA-approved and -unapproved uses for
the benefit of their patients. Id. at 153. Courts have repeatedly noted that off-label
promotion is not a private right of action that exists under state law.8 See Aaron v.
Medtronic, Inc., 209 F. Supp. 3d 994, 1010-11 (S.D. Ohio 2016) (citation omitted)
(“Off-label promotion” is “not a part of [state] law.”); Thorn v. Medtronic Sofamor
Danek, USA, Inc., 81 F. Supp. 3d 619, 628 (W.D. Mich. 2015) (“[T]here is no state
law duty to abstain from off-label promotion.”); Caplinger v. Medtronic, Inc., 921
F. Supp. 2d 1206, 1219-20 (W.D. Okla. 2013) (“‘[O]ff-label use’ . . . is not a part
of [state] substantive law.”). Stiens has not established an industry or company
standard for off-label promotion outside of the FDCA against which B & L’s
promotion of Besivance could be weighed. If Stiens wanted to rely upon FDCA
8
The FDCA preempts private actions for “off-label” marketing, as such claims would “not exist
in the absence of the FDCA[.]” McDaniel v. Upsher-Smith Pharm., Inc., 229 F. Supp. 3d 707,
713 (W.D. Tenn. 2017); see also Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353,
121 S. Ct. 1012, 1020, 148 L. Ed. 2d 854 (2001). Under Buckman, such claims are “impliedly
preempted.” McDaniel, 229 F. Supp. 3d at 710 (citation omitted).
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regulation of off-label promotions, Stiens should have brought a claim under the
FDCA.
While we agree with Stiens that the issue of foreseeability is a
question for the jury, Stiens failed to provide any affirmative evidence on that issue
in favor of her case. “The question whether the appellees will be able to present
proof of circumstances sufficient to infer that the defendant knew, or should have
known, of the likely results of his conduct, or whether the results were beyond the
foreseeable risk” is an issue for the jury after the presentation of the evidence.
Grayson, 736 S.W.2d at 334 (citation omitted) (“Except in such cases where
reasonable minds could not differ, where the court would conclude as a matter of
law that it was clearly unreasonable to foresee the potential harm from the
misconduct involved, the question of foreseeable risk is covered by the usual
instruction relating to proximate cause, which is an issue framed for the jury in
terms of whether the misconduct was a ‘substantial factor.’”).
After the circuit court excluded much of Dr. Mamalis’s testimony and
publications, Stiens was unable to identify any admissible evidence tending to
show that B & L knew or should have known that Dr. Ferguson’s decision to use
Besivance in PRK might lead to medical complications. Therefore, we hold that
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Stiens failed to meet her prima facie burden of proof, making summary judgment
the appropriate result.9
IV. CONCLUSION
In light of the foregoing, we affirm the judgment of the Fayette
Circuit Court.
ALL CONCUR.
BRIEFS AND ORAL ARGUMENT BRIEF AND ORAL ARGUMENT
FOR APPELLANT: FOR APPELLEE:
Thomas K. Herren John L. Tate
Lexington, Kentucky Louisville, Kentucky
Robin E. McGuffin
Lexington, Kentucky
9
Stiens also contests the circuit court’s holding that B & L’s alleged breach of duty was a
“substantial factor” in causing Stiens’s injury. R. at 1043. The substantial factor test is a factual
inquiry applied to the event which causes the injury rather than the injury itself. Deutsch v.
Shein, 597 S.W.2d 141, 145 (Ky. 1980), abrogated on other grounds by Osborne v. Keeney, 399
S.W.3d 1 (Ky. 2012). Thus, under this test, a jury would be asked to determine whether B & L’s
marketing of Besivance was a substantial factor that led to Dr. Ferguson’s use of Besivance, the
event that caused Stiens’s injury. We disagree with the circuit court’s ruling that no jury could
reasonably have found that B & L’s promotion of Besivance and assurances of its safety and
efficacy were a substantial factor in Dr. Ferguson’s decision to use Besivance. The circuit court
went so far as to call this connection “sheer speculation.” R. at 1043. We believe that this is too
strong of a description and that a reasonable jury could possibly have found for Stiens based
upon the facts. However, because the outcome of this appeal has already been determined by the
issue of foreseeability, the issue of causation is not dispositive and is ultimately moot.
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