ASHLEY KNAPP v. ZOETIS INC.

Henrico County

No. 3:20 CV 00191

FIRST AMENDED COMPLAINT

COMES NOW, Plaintiff Ashley Knapp (herein “Knapp” or “Plaintiff”) and makes
the following allegations against Defendant Zoetis Inc. (herein “Zoetis”):
INTRODUCTION AND PARTIES
1. Knapp brings this lawsuit seeking recovery against Zoetis relating to its
equine medical product Excede, for failure to warn, defective design and/or manufacture,
breach of express warranty, breach of implied warranty.
2. Knapp is a citizen and resident of the City of Richmond in the
Commonwealth of Virginia.
3. Zoetis is the largest global animal health company. It is incorporated in the
State of Delaware and its principal place of business and global headquarters located at 10
Sylvan Way in Parsippany, New Jersey. Zoetis is authorized to transact business in the
Commonwealth of Virginia pursuant to a certificate of authority issued by the Virginia
State Corporation Commission. Zoetis, with Virginia corporate ID F194381, maintains a

registered agent in Glen Allen, Virginia, regularly transacts business in the Commonwealth
of Virginia, and has subjected itself to the jurisdiction of Virginia courts. On information

and belief, Zoetis is additionally authorized to, and does, operate throughout the United
States.
4. Zoetis manufactures and distributes an injectable, extended-release
antibiotic for equines with the brand name Excede.
5. Plaintiff is an owner of a horse in the United States who suffered a life-threatening reaction to Excede within the last ten (10) years.

JURISDICTION AND VENUE

6. Jurisdiction is proper in this Court pursuant to 28 U.S.C. § 1332(a) because
there is complete diversity of citizenship between the parties and the amount in controversy
exceeds $75,000, exclusive of interest and costs.
7. Venue is proper in this District under 28 U.S.C. § 1391 because a substantial
part of the events or omissions giving rise to Plaintiff’s claim occurred in this District.
Plaintiff resides in this District and, as shown above and below, Zoetis transacts business
in this District and her horse was administered Excede within this District.

FACTUAL ALLEGATIONS

8. Knapp owns a now eleven-year-old Hanoverian gelding horse known as
“Boom Balou” (herein “Boomer”). Boomer was at all relevant times stabled at a boarding
facility known as Linmoorland Farm located in Gloucester, Virginia.
9. On or about the morning of August 13, 2016, Boomer was brought into the
barn by the stable staff at Linmorland after overnight turnout.
10. The staff noticed that all four of Boomer’s legs were swollen; however, no
cuts, abrasions, or scratches were noticed. Boomer was eating, drinking, defecating, and
urinating normally.

11. An equine veterinarian was called immediately to examine, diagnose, and
treat Boomer. It was determined that Boomer’s swollen legs were likely the result of an
infection or some other malady typically treatable through the use of antibiotics.
12. As a part of the treatment, the veterinarian administered an injection of
Excede to Boomer.
13. Within an hour, Boomer began to show signs of extreme pain, including
abnormal vocalization (screaming whinny), abnormal sweating, spinning in his stall,
striking out, buckling of the hind end and inability to walk normally, stretching and turning
his neck repeatedly, and biting at the air with his teeth bared.
14. The veterinarian was called back to the barn immediately.
15. When she returned, Boomer was becoming increasingly lethargic and was
unable to raise his head normally. The veterinarian observed that Boomer’s gums had
turned white, and a toxic line had appeared. She also observed that no gut sounds were
present and that his respiratory rate had increased.
16. The veterinarian referred Boomer to Blue Ridge Equine in Charlottesville,
Virginia for emergency treatment, and he was shipped immediately to Blue Ridge.
17. The treating veterinarian at Blue Ridge diagnosed Boomer with a reaction
to the Excede injection, and he ruled out colic as a source of Boomer’s symptoms.
18. Boomer was treated for his symptoms at Blue Ridge for two days, and
during the course of that treatment, an ultrasound detected a pocket of fluid on the neck at
the injection site.
19. After being shipped home on August 15, 2016, Boomer was observed
standing abnormally with his hind legs underneath him, which is an indication of pain and

discomfort. Boomer also exhibited signs of neck soreness. Over the ensuing days, a large
of patch of swelling and leathery skin spread over most of the left side of Boomer’s neck.
The swelling began to harden, and firm lumps were felt under the skin.
20. On August 18, 2016, Ms. Knapp notified Zoetis of Boomer’s severe
reaction to the Excede injection.
21. Dr. Maureen Dower of Zoetis disclosed that a similar reaction had occurred
on or about October 29, 2014, to a horse located in Vermont.
22. In addition, numerous other similar reactions, including ones with fatal
outcomes, have occurred throughout the country and have been reported to Zoetis since at
least 2012 and continuing through 2020, including several recent severe or fatal reactions
in the Charlottesville and Middleburg areas of Virginia and in Pennsylvania.
23. Despite the knowledge of these severely debilitating and/or fatal reactions,
Zoetis did not disclose or adequately warn of Excede’s danger to horses prior to Boomer’s
reaction. In or about January 2020, Zoetis changed its warning label to include the type of
reaction that Boomer suffered.
24. Since Boomer’s treatment for the Excede reaction in 2016, he has
experienced persistent lameness, and the musculature in his neck has been permanently
damaged.
25. Consistent veterinary treatment, with a variety of modalities, has been
unable to return Boomer to the soundness necessary for a performance horse.
26. Prior to the Excede injection and reaction, Boomer was a successful, young
show hunter.

27. As a result of the permanent lameness and physical damage caused by the
Excede injection, Boomer can no longer be ridden or used as a show horse.
28. From 2010 through December 2018, nearly 600 adverse reaction reports
were made by Zoetis to the FDA for Excede reactions experienced by horses in the United
States. Upon information and belief, additional significant adverse reactions also occurred
during 2019 and 2020.
29. Reactions have included fatalities, internal hemorrhaging, anaphylaxis,
other systemic-type reactions, and site reactions ranging from debilitating to minor with
complications that have included, but are not limited to, swelling, muscle damage, pain,
and scarring at the injection site. Ms. Knapp’s horse, Boomer, experienced both a severe
anaphylactic response and a severe site reaction. At the time, Boomer was given Excede,
the product carried no warnings, let alone adequate ones, concerning the above possible
reactions and the hazardous properties causing same.
30. In many of these instances, whether the end result was a fatality or not, the
affected horses were provided with extensive and expensive veterinary care and the owners
of the animals have had to absorb those costs as well as the diminished value associated
with those horses who have not, and will not, fully recover. In the case of Boomer,
veterinary bills totaled approximately $6,500.00.
31. Zoetis was made aware of these adverse reactions, and the resulting
veterinary costs and diminished value of the afflicted horses.
32. The fair market value of horses that compete within the hunter/jumper
discipline is driven by the physical and athletic ability to perform and, in the case of

hunters, is also driven by the horse’s physical appearance and lack of blemishes or scarring.
Ms. Knapp’s horse, Boomer, had a pre-injury fair market value of $90,000.00.
33. The fair market value of a horse that experiences a significant medical issue
or complication, like a severe drug reaction, muscle damage, or scarring, is significantly
diminished. In certain instances, the residual value of a damaged performance horse is
essentially zero.
34. Despite knowledge of the numerous adverse reactions suffered by horses
who were administered Excede, Zoetis refused to revise Excede’s warning label and
prescribing information to reflect the significant negative post-approval experience.
Consequently, the majority of would-be consumers and prescribing veterinarians were left
with no way of knowing the considerable risk associated with the administration of Excede.
35. Excede is an antibiotic expressly marketed as treating equine respiratory
infections with a “two dose, one solution” treatment for sick horses. Zoetis further markets
Excede as doing in two doses what would otherwise take ten.1

36. Excede is also prescribed by veterinarians for off-label uses as well, a fact
known by Zoetis. Most antibiotics prescribed by equine veterinarians are for off-label or
extra-label use, which is permissible under federal law. Zoetis was aware that equine
veterinarians used Excede off-label for treating conditions including the type of condition
Boomer had on August 13, 2016, and that some horses experience the same type of adverse
reaction that Boomer suffered as a result of the off-label use of Excede for those types of
conditions.
1 See https://www.zoetisus.com/products/horses/excede.aspx (last visited 11.18.19)

37. Excede works through an “extended release formulation” which upon
winning FDA approval in 2010, Zoetis touted as a “true innovation.” Because of Excede’s
extended release formulation, Zoetis claimed it made treatment of horses easier and more
effective because it would allow owners and veterinarians to administer treatment more
easily and with less stress to the animal.

38. The formulation, design, method of manufacture, and sources of the
ingredients contained in Excede are proprietary and known only to Zoetis.
39. Excede, and other extended release veterinary medications, are of particular
use when it comes to free roaming animals, like livestock who are not stabled and thus may
be difficult to locate at any given time. For multiple categories of horses, be they
performance horses like Boomer, racehorses, and/or other riding horses, location is rarely
an issue because they are usually stabled, or have ready access to stabling, and can be
provided medication more simply and consistently than roaming livestock. For such
horses, administration of a ten-day course of non-extended release antibiotics remains a
relatively easy task that has been accomplished in the horse industry for many decades.
40. Zoetis manufactures a non-extended release injectable ceftiofur antibiotic
for equines called Naxcel, which has been safely used in horses for decades. Upon
information and belief, the use of Naxcel has not resulted in the type of severe reactions
caused by Excede.
41. The only significant difference between Naxcel and Excede is the extended
release delivery system found in Excede, which was designed by Zoetis utilizing a caprylic
acid and cottonseed oil based suspension.
2 See https://www.zoetisus.com/news-and-media/fda-approves-pfizer-animal-healths-excede-ceftiofur-crystalline-free-acid-sterile-suspension-for-horses.aspx (last visited 11.18.19)

42. Cottonseed oil is not used as a suspension in other regularly used, approved
equine medications. Cottonseed oil that is not refined or is improperly refined contains
substances that are toxic to horses.
43. Nevertheless, despite viable alternatives and the known concerns regarding
the negative post-approval experiences suffered by hundreds of horses, Zoetis refused to
make any alterations to Excede’s label prior to January 2020 and continues to market the
product as being superior to traditional courses of antibiotic treatment for stabled horses.

COUNT I
Negligence
(Failure to Warn)

44. The foregoing allegations are hereby incorporated by reference as if fully
set forth herein.
45. At all relevant times herein, Zoetis was engaged in the business of
designing, licensing, manufacturing, distributing, selling, marketing, and/or introducing
into interstate commerce, either directly or indirectly through third parties or related
entities, the injectable animal antibiotic with brand name Excede, including the Excede that
was used on Boomer and other horses across the country.
46. Zoetis had a duty to exercise reasonable care in the design, manufacture,
sale, and/or distribution of Excede into the stream of commerce, including a duty to ensure
that its products, specifically Excede, did not pose a significantly increased risk of harm
and adverse events to the animals on which its products were used.
47. Zoetis failed to exercise ordinary care in the design, formulation,
manufacture, sale, testing, quality assurance, quality control, labeling, marketing,
promotions and distribution of Excede into interstate commerce in that Zoetis knew or

should have known that Excede could cause severely debilitating and/or fatal reactions in
horses.
48. Zoetis had a duty to exercise ordinary care in the labeling and provision of
prescribing information for Excede, including a duty to provide adequate warnings of the
known risks of the administration of Excede, to veterinarians and consumers.
49. At all times relevant, Defendant was well aware of the dangers posed by
Excede when used in both on- and off-label manners.
50. At all times relevant, Plaintiff and her veterinarians were not aware of the
dangers and risks associated with the administration of Excede to stabled horses.
51. Defendant’s warning label and treatment indication(s) for Excede made no
mention of such aforementioned dangers and risks, and specifically failed to warn of the
danger and/or risk of the type of reactions suffered by Boomer. Even after receiving
hundreds of adverse reaction reports made over the course of many years, Zoetis
intentionally, willfully, recklessly and maliciously refused to revise its prescribing
information and refused to publish the negative post-approval experience of which it was
aware in order to adequately warn of the risks of Excede, including the specific risk of a
reaction of the type suffered by Boomer.
52. As a direct result of Zoetis’ negligent, willful, wanton, and malicious
conduct, which was in reckless disregard for the rights of Knapp, Knapp has sustained
damage to Boomer in that he has diminished monetary value as a performance horse and/or
as a recreational riding horse. She has sustained substantial veterinary expenses for
Boomer’s lifesaving and recuperative treatment; has sustained veterinary expenses to try
to reverse or mitigate the debilitating effects of the reaction, and to try to return Boomer to

his prior sound condition; and will sustain in the future expenses associated with the care
and maintenance of Boomer for the remainder of his life without being able to use Boomer
for his intended purpose.

Count II
Negligence
(Defective Design and Manufacture)

53. The foregoing allegations are hereby incorporated by reference as if fully
set forth herein.
54. At all relevant times herein, Zoetis was engaged in the business of
designing, licensing, manufacturing, distributing, selling, marketing, and/or introducing
into interstate commerce, either directly or indirectly through third parties or related
entities, the injectable animal antibiotic with brand name Excede, including the Excede that
was used on Boomer and other horses across the country.
55. Zoetis had a duty to exercise reasonable care in the design and manufacture
of Excede, which was placed by Zoetis into the stream of commerce, including a duty to
ensure that its products, specifically Excede, did not pose a significantly increased risk of
harm and adverse events to the animals on which its products were used.
56. Zoetis failed to exercise ordinary care in the design, formulation,
manufacture, sale, testing, quality assurance, quality control, labeling, marketing,
promotions and distribution of Excede into interstate commerce in that Zoetis knew or
should have known that Excede could cause severely debilitating and/or fatal reactions in
horses.
57. Despite the fact that Zoetis knew or should have known that Excede, and
specifically its extended release delivery system, poses a serious risk of harm to horses,

Zoetis continues to manufacture and market Excede for use by consumers and end-users
including Knapp and myriad other horse owners. Alternative effective antibiotics that do
not pose the same risk of harm to horses exist and are available to consumers and end-users
including Knapp and myriad other horse owners.
58. The Excede antibiotic, and specifically the design and/or manufacture of its
extended release delivery system, was unreasonably dangerous for the use in horses to
which it would ordinarily be put and for its foreseeable purposes, and the unreasonably
dangerous condition existed when the Excede antibiotic left Zoetis’ hands.
59. The Excede antibiotic extended release formulation was unreasonably
dangerous because the extended release delivery system was imprudently designed and/or
manufactured. Upon information and belief, Zoetis has not modified the formulation or
method of manufacture for Excede despite knowing of its dangerousness.
60. As a direct result of Zoetis’ negligent, willful, wanton, and malicious
conduct, in reckless disregard for the rights of Knapp, Knapp has sustained damage to
Boomer in that he has diminished monetary value as a performance horse and/or as a
recreational riding horse. She has sustained substantial veterinary expenses for Boomer’s
lifesaving and recuperative treatment; has sustained veterinary expenses to try to reverse
or mitigate the debilitating effects of the reaction, and to try to return Boomer to his prior
sound condition; and will sustain in the future expenses associated with the care and
maintenance of Boomer for the remainder of his life without being able to use Boomer for
his intended purpose.

COUNT III
Breach of Express Warranty
(Virginia Commercial Code)

61. The foregoing allegations are hereby incorporated by reference as if fully
set forth herein.
62. Zoetis expressly warranted that the Excede antibiotic was safe and
reasonably fit for its intended use in the treatment of horses through its information
containing affirmations of statements of facts, promises, and descriptions regarding the
product. Such affirmations, promises, and descriptions include, but are not limited, to:
a. “Excede provides peace of mind knowing that the antibiotic has
been demonstrated to be safe and effective in horses.”
b. “In a safety study, swelling [at the injection site] completely
resolved within 7 days in the majority of cases.”
c. “Excede makes the treatment process less stressful for you and your
horse.”
d. “Excede may cause some transient swelling and edema around
injection site.”
e. “No cases of necrosis, abscess or drainage were reported in the
clinical studies.”
63. Knapp and/or her veterinarian chose the Excede antibiotic based upon
Zoetis’ express warranties and representations regarding the safety and fitness of Excede.
64. The Excede antibiotic manufactured and sold by Zoetis did not conform to
Zoetis’ express representations because an injection of Excede caused serious harm, stress,
and permanent damage to Knapp’s horse when used as recommended and directed.

65. As a direct result of Zoetis’ breach of warranty, Knapp has sustained
damage to her horse in that it no longer has significant monetary value as a show horse;
has sustained veterinary expenses for the treatment of her horse to save its life; has
sustained veterinary expenses to try to reverse or mitigate the debilitating effects of the
reaction, and to try to return the horse to its prior sound condition, which efforts have been
unsuccessful; and will sustain in the future expenses associated with the care and
maintenance of the horse for the remainder of its life without being able to use the horse
for its intended purpose.

COUNT IV
Breach of Implied Warranty
(Virginia Commercial Code)

66. The foregoing allegations are hereby incorporated by reference as if fully
set forth herein.
67. At the time Zoetis designed, manufactured, marketed, sold, and distributed
the Excede antibiotic for use by Knapp, Zoetis knew of the use for which Excede was
intended and impliedly warranted that it was of merchantable quality and safe for such use
and reasonably safe.
68. The Excede antibiotic was, in fact, unfit and unmerchantable and
unreasonably dangerous for its foreseeable and intended uses and was defective in
manufacture, imprudently designed, not accompanied by adequate warnings concerning its
hazardous properties, and not in compliance with requirements pertaining and relating to
the creation of implied warranties of merchantability.
69. The unreasonably dangerous condition of the Excede antibiotic as alleged
herein existed when it left Zoetis’ hands.

70. Knapp is not required to give notice to Zoetis of her breach of warranty
claims under Va. Code §8.2-607(3)(a). Nevertheless, on or about January 16, 2018, prior
to the institution of this action and in addition to the notice given on or about August 18,
2016, Knapp gave written notice to Zoetis regarding Boomer’s reaction as well as the danger and unfitness of Excede.

Zoetis did not respond to the January 16, 2018 correspondence.
71. As a direct result of Zoetis’ breach of warranty, Knapp has sustained
damage to her horse in that it no longer has significant monetary value as a show horse;
has sustained veterinary expenses for the treatment of her horse to save its life; has
sustained veterinary expenses to try to reverse or mitigate the debilitating effects of the
reaction, and to try to return the horse to its prior sound condition, which efforts have been
unsuccessful; and will sustain in the future expenses associated with the care and
maintenance of the horse for the remainder of its life without being able to use the horse
for its intended purpose.
WHEREFORE, Knapp respectfully requests that, as to all Counts, she be awarded
judgment against Zoetis as follows:
a. damages in the amount of no less than $500,000;
b. punitive damages in the amount of $350,000; and
c. all other relief that this Court deems just and proper.
Jury trial demanded.

ASHLEY KNAPP,
/s/ Tamara L. Tucker

By Counsel

 

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