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JMJ Racing Stables, LLC v WICKLIFFE PHARMACEUTICAL, INC., a Kentucky Corporation, d/b/a Wickliffe Veterinary Pharmacy, et al.

No. 5:14-CV-323-OC22

 

US District Court of Florida

COMPLAINT FOR DAMAGES AND DEMAND FOR JURY TRIAL

Plaintiff JMJ Racing Stables, LLC, hereby sues Wickliffe
Pharmaceutical, Inc., Jacqueline Kemezy Bernard, Kelly Zaccarelli, and
William V. Bernard and alleges:

 

Jurisdiction and Venue

1. This action seeks money damages and other relief for veterinary
pharmaceutical product liability against Defendants Wickliffe Pharmaceutical,
Inc., which does business under the assumed name Wickliffe Veterinary

Pharmacy (hereinafter called Wickliffe), its President, Jacqueline Kemezy
Bernard, its chief pharmacist, Kelly Zaccarelli and its principal veterinarian,
William V. Bernard.
2. Plaintiff JMJ Racing Stables, LLC is, and at all times material to
this action, has been a limited liability company formed and organized under
the laws of the state of California, whose offices are located at 34 700 Coast
Hwy Ste 301 Capistrano Beach, CA 92624.
3. The principal place of business of JMJ Racing Stables, LLC is
located in Capistrano Beach, CA.
4. Plaintiff JMJ Racing Stables, LLC owns and breeds thoroughbred
race horses and is the owner of the four previously valuable race horses which
are the subject of this action. One of Plaintiffs horses which was killed and the
others have been injured as the result of the conduct of Defendants.
5. Defendant Wickliffe Pharmaceutical, Inc., (hereinafter

is and at all times material to this action has been a corporation
formed and organized under the laws of the state of Kentucky, whose address
is 4340 Georgetown Road, Lexington KY 40511. The principal place of
Wickliffe’s business is located in Lexington, Kentucky.

6. In or about August 2009 Wickliffe obtained a certificate from the
Kentucky Secretary of State to do business under the assumed name “Wickliffe
Veterinary Pharmacy,” an assumed name under which it continues to do
business at this time.
7. In addition, Wickliffe obtained U.S. Trademark Registration
Number 77861152 for the mark “Wickliffe Veterinary Pharmacy” and design
on October 30, 2009 in international class 35 for retail veterinary pharmacy
services.
8. Since at least 2009 Wickliffe has promoted itself as a
compounding pharmacy and particularly as a source for very high quality
prescriptions for veterinarians, pet owners and other pharmacists through
various publications and advertisements, including its website, as more
particularly noted hereinafter.
9. This action arises out of one of Wickliffe’s compounded drug
preparations supplied to a veterinarian for use in Ocala, Marion County,
Florida and administered to eight horses, including four thoroughbred horses
owned by Plaintiff MJ Racing Stables, LLC.

10. The compounded drug preparation m question was toxic and
caused substantial injury to Plaintiff’s horses, as more particularly noted
hereinafter.
11. At all times relevant to this action, the Defendant Wickliffe was
engaged m the business of designing, formulating, compounding,
manufacturing, selling, and distributing veterinary pharmaceuticals and
nutritional supplements, at 4340 Georgetown Rd., Lexington, KY 40511.
12. Defendant Jacqueline Kemezy Bernard is the president of
Wickliffe as well as the principal owner, director, and chief executive officer of
Wickliffe.
13. Defendant Jacqueline Kemezy Bernard has ultimate responsibility
for FDA compliance at Wickliffe and for ensuring that proper measures are in
place for the appropriate compounding, labeling and dispensing of drugs and
drug preparations provided to veterinarians for the treatment of horses. This
includes proper supervision of the company pharmacist Kelly Zaccarelli. On
information and belief, Defendant was involved in oversight of the pharmacy
operations at Wickliffe and thus a senior manager of the compounding
operations that negligently produced drug preparations containing toxic
amounts of pyrimethamine.

14. Defendant Jacqueline Kemezy Bernard is and at all times material
to this action has been a citizen of Kentucky, residing in the Lexington,
Kentucky area.
15. Defendant Kelly Zaccarelli is and at all times material to this
action has been a citizen of Kentucky, residing in the Lexington, Kentucky
area.
16. Defendant Kelly Zaccarelli is and was at all times material to this
action the head pharmacist for Wickliffe.
1 7. Defendant William V. Bernard is and at all times material to this
action has been a citizen of Kentucky, residing in the Lexington, Kentucky
area.
18. Defendant William V. Bernard is also a licensed veterinarian and,
on information and belief, was and is the chief veterinarian at Wickliffe and at
all times material to this action has been integrally involved in the management
of Wickliffe and the design and sale of its products for racehorses. On
information and belief, Defendant William V. Bernard was involved in oversight of

the pharmacy operations at Wickliffe and thus a senior manager of
the compounding operations that negligently produced drug preparations
having containing toxic amounts of pyrimethamine.

19. The amount in controversy as a result of the impairment of
Plaintiffs valuable racehorses is substantially in excess of $75,000, exclusive
of interests and costs.
20. This Court has jurisdiction over the subject matter pursuant to 28
U.S.C. § 1332(a) in that this action is between citizens of different states and
the matter in controversy exceeds the jurisdictional threshold.
21. The events leading to the subject matter of this complaint occurred
in Marion County, Florida, where the drug was administered and where
Plaintiff’s horses suffered either immediate injury or death as a result.
Accordingly venue is proper in this district and division pursuant to 28 U.S.C.
§ 139l(a)(2).

Facts Common to All Claims

22. Defendant Wickliffe has long promoted itself to veterinarians as a
source for high quality drugs for treating racehorses for various afflictions,
including Equine Protozoal Myeloencephalitis or EPM. EPM is a protozoal
infection which affects the central nervous system in horses. EPM is generally
treated by administering to horses one or more drugs known to kill or retard the
reproduction of the protozoa S. neurona. Such drugs typically reduce the
protozoa population to a level where the horse’s immune system kills the rest.

23. The FDA has approved various drugs for the treatment of EPM.
The FDA-approved drugs may have side effects and success rates that are less
than optimal. Accordingly, researchers and veterinarians have regularly sought
alternative methods of treating or preventing this disease. Compounding
pharmacies such as Wickliffe can, consistent with FDA regulations and
guidelines, provide non-FDA approved preparations of existing FDA approved
drugs where reason exists not to use the FDA approved drugs.
24. Well prior to the incidents that are the subject of this action,
Wickliffe made available to veterinarians a compounded drug formulation
consisting of toltrazuril and pyrimethamine. Wickliffe routinely compounded
toltrazuril and pyrimethamine in the following combination (in oral
suspension): toltrazuril 416 mglml and Pyrimethamine 17 mg/ml. This
combination of ingredients was also produced by Wickliffe for administration
via paste.
25. This combination of animal drugs in the above ratio has been
perceived to be efficacious in treating or preventing suspected EPM for at least
two years (and possibly longer) prior to the incidents that gave rise to this
action.
26. The combination has for at least this time been considered safe
and efficacious in the treatment or prevention of EPM in horses.
27. One of the veterinarians who contacted Wickliffe and was advised
to use the above mentioned compound was Dr. Jonathan McLellan, a well
respected veterinarian practicing in Marion County, Florida.
28. Dr. McLellan’s staff contacted the Wickliffe rep who had been
handling his account about using toltrazuril to treat horses suffering from EPM.
The representative, who is well known to Dr. McLellan, informed Dr.
McLellan in substance that Wickliffe had already compounded a preparation
consisting of toltrazuril and pyrimethamine, which other veterinarians were
successfully using. Pyrimethamine is also a drug used for treating protozoal
infections.
29. Relying upon the representations of Wickliffe, Dr. McLellan used
the Wickliffe compounded preparation in treating thoroughbred horses
suspected of being infected or believed to be at risk for EPM for about two
years prior to the incident which is the subject of this action. Dr. McLellan was
satisfied with the product and believed that it was efficacious for treating or
preventing suspected EPM in horses.
30. On or about March 26, 2014 Dr. McLellan ordered the same
Wickliffe preparation (in oral suspension) which he had been using
successfully so that he would have sufficient product on hand to treat several
horses, all of whom were then being trained by a highly respected horse trainer
at the horse trainer’s racing stable in Marion County, Florida. These horses
were either suspected of early EPM infection or were considered at risk of
EPM infection. Consistent with the recommended standard of care, these
horses required the prompt administration of an anti-protozoal drug believed to
treat or prevent EPM.
31. On April 2, 2014, Dr. McLellan ordered another three bottles of
the same preparation, to be sure that he had sufficient quantities in stock.
32. Shortly thereafter, not before April 3, 2014, Dr. McClellan
received a total of nine bottles all bearing the same lot number, that is, lot
number “28-03-20 14@44” but having different fill dates: six having a fill date
of 3-28-14 and three having a fill date of 4-2-14.
33. All of the bottles supplied by Wickliffe had the same label and lot
number although not the same fill date. An authentic sample of the label is
attached hereto as Exhibit A.
34. As Exhibit A shows, each label claimed to contain
toltrazuril/pyrimethamine in the quantify of 416/17mglml in suspension, which
was the precise amount in suspension that Dr. McLellan had regularly been
administering to race horses suspected of having EPM or sufficiently at risk to
warrant prevention against EPM.
35. Dr. McLellan kept the Wickliffe bottles in his possession and
control unaltered until he visited the trainer near Ocala, Florida, who by then
had eight horses in his care that were at risk for EPM infection.
36. On May 3, 2014 Dr. McLellan visited the aforementioned trainer
and discussed procedures and medications for the trainer’s horses for that
week. He prepared and dispensed a 30 ml dose of the Wickliffe drug product
for each horse to be treated, believing that the drugs were in the combination
claimed on the label: that is, that the oral suspension consisted of 17
milligrams/milliliter of pyrimethamine and 416 mg/ml of toltrazuril.
37. Dr. McLellan had every reason to believe that the drugs in the
suspension he was administering were in fact in the quantities claimed on the
Wickliffe label.
38. Dr. McLellan had every reason to believe that the Wickliffe oral
suspension was safe and efficacious in the proportions claimed on Wickliffe’s
drug label.
39. Dr. McLellan placed each dose of the Wickliffe product in a
catheter tipped syringe, each labeled TOL T, and placed them in a lockable
medicine cabinet for the trainer’s use the following Monday.
40. On May 5, 2014 at about 10:30 am one syringe was orally
administered to each of the eight horses after they were extracted from the
medicine cabinet precisely as prescribed by Dr. McLellan.
41. All eight of the horses were then in good health and settled in their
stalls. At about 12 pm there was a loud disturbance in one of the horse’s stalls
and the trainer’s personnel found the horse in extreme distress, unable to stand
and demonstrating extreme neurological symptoms. He also had a large lesion
on the top of his head and was bleeding. An immediate call for veterinarian
help was placed, and the first vet on the scene was present within 15 minutes.
42. While the first horse was being treated, another of the eight horses
began having violent seizures and thrashing uncontrollably within his stall to
the point that he kicked the metal door off the track and thrashed into the shed
row. This happened about 1: 10 pm.
43. As the above events took place two other horses began to
experience seizures also. The trainer’s stable suddenly became a place of triage
for the emergency care of the horses. Grooms began to break down the board
on the trainer’s shed row in order to get the horses into the lawn to protect them
from further contact with hard surfaces while seizing. Dr. McLellan began to
administer large quantities of ice and intravenous medications in order to
control extremely high body temperatures, approaching in some of the eight
horses 107 degrees Fahrenheit.
44. While the surviving horses exhibited their symptoms at different
times, the horses exhibited common problems including seizures, elevated
temperatures and convulsions. Subsequently nearly all of the surviving horses
experienced a radical decrease in white blood cells and required large doses of
folic acid to combat the drug’s adverse effects.
45. By 2:15 p.m. one of the eight horses treated with the Wickliffe
product perished, in spite of all efforts of many personnel to save him. This
was Plaintiffs colt, Free Association.
46. Soon thereafter, another of the eight horses lost all ability to stand
and was rushed to the University of Florida for emergency treatment at the
University’s Large Animal Hospital, where he was euthanized after remaining
unresponsive to aggressive management for 2 days.
47. The remaining horses were thereafter transported to the University
of Florida for care and treatment. Five of the horses had generalized severe
repeated seizures, two had complex partial seizures, and one was ataxic and
weak in all four limbs after arrival at the University of Florida.
48. These horses are still alive after intensive management but many
of them have severe injury including low blood counts and ulcers on the gums
and tongue.
49. Samples of the remaining syringes of Wickliffe product were
delivered to the University of Florida and the FDA for testing.
50. The latest report from the University of Florida shows that the true
concentration of pyrimethamine in the suspension Wickliffe supplied to Dr.
McLellan was 229 mg/ml, rather than the 17 mg/ml claimed on Wickliffe’s
label. This is many times the claimed concentration of pyrimethamine. The
true concentration of toltrazuril is 22 mg/ml was opposed to 416 mg/ml as
claimed on the label. An authentic copy of this report is attached hereto as
Exhibit B.
51. The amount of pyrimethamine is believed to be toxic at the level
actually present in the solution Wickliffe provided.
52. Pyrimethamine is known to be a potent protozoal medication but
can cause severe injury or death in overdose amounts.
53. The symptoms exhibited by all eight horses is consistent with an
overdose of pyrimethamine.
54. The FDA investigation of the product provided by Wickliffe for
the eight horses in Marion County also shows that the pyrimethamine was very
significantly overdosed.
55. The FDA investigation also shows that Wickliffe provided an
earlier lot of the same drugs (in paste) containing excessive amounts of
pyrimethamine in March 20 14.
56. On information and belief, the lot delivered by Wickliffe in March
2014 killed at least two horses in Lexington, Kentucky.
57. On information and belief, Defendants had actual knowledge that
the lot it provided for the horses in Kentucky contained a poisonous amount of
pyrimethamine no later than March 31, 2014, before it shipped lot number “28-
03-2014@44” to Dr. McLellan on or near April 2, 2014. It had this knowledge
because the veterinarian for the horses in Kentucky contacted Wickliffe, on
information and belief, on March 31, 2014 or April 1, 20 14, after the first of
the two horses in Kentucky suffered a seizure and died as the result of the toxic
dose of pyrimethamine which Wickliffe provided. 1
58. On information and belief, an agent of the owner of the Kentucky
horses also contacted Wickliffe on March 31, 2014 about the overdose of the
Kentucky horses.
59. In addition, on information and belief, no later than April 1, 2014,
a representative of the University of Kentucky Veterinary Diagnostic
Laboratory also contacted Wickliffe to advise Wickliffe that its test report
concerning one of the two horses that died in Kentucky had received a lethal
overdose of pyrimethamine as the result of Wickliffe lot number “25-03-2014
@25” which contained no less than 340 mg/mL of pyrimethamine.
60. Defendants knew or should have known that lot number “25-03-
2014@25” (the lot in Kentucky) contained a toxic amount of this potent drug.
61. In spite of its actual knowledge that it has just dispensed
poisonous overdoses of pyrimethamine, Wickliffe took no additional measures
to correct its compounding practices or to test lot number “28-03-21 04@44”
before shipping that lot to Dr. McLellan, in order to determine if it had been
misformulated or otherwise contained excessive amounts of pyrimethamine.
Nor did Defendants notify veterinarians or horse owners of the risks associated
with using its drug in light of the overdose sustained by the two horses in
Kentucky.
62. Wickliffe was aware of the importance of having safe and sound
compounding practices at all times material to this action. Indeed, it took
special efforts to hold itself out on its website as a provider of safe
compounding drugs, specifically representing on its website, as late as
May 25, 2014, as is shown by Exhibit C, the following:
a. “We stand for excellence and offer qualify products-safety
is out foremost concern.”
b. “We strictly abide by the highest standards m the
compounding industry, including all local and federal guidelines.”
c. “Our ingredients-purchased only from FDA-approved
pharmaceutical companies-are validated and certified, meeting the latest
requirements of the United States Pharmacopeia and the FDA by sending
samples of our compounds off-site for independent testing. This extra step
ensures that the sterility, purity and concentration of the compound are precise.
Meticulous validation and documentation provide an optimal product that
remains consistent with each batch.” (Emphasis added).
d. “Quality is our guarantee.” (Emphasis in original).
An authentic copy of a press report on the FDA findings is set forth in Exhibit
D to this Complaint.
63. The painful experience, possibly career-ending to those horses
which survived, and the death of those horses which did not, was caused by the
improper compounding and mislabeling of the Wickliffe product. The product
was administered in an appropriate dose, and had the product actually been
constituted as it was represented to be on the label, no harm would have
resulted.
64. The cause in fact of the injury to Plaintiffs horses is overdose of
pyrimethamine, which is toxic in the concentrations that actually existed in the
oral suspension which Defendants provided to Dr. McLellan.
65. All eight of the horses were healthy prior to the administration of
the Wickliffe drug and would have remained so had the drug contained the
medication in the proportions claimed on the Wickliffe label.
Plaintiff’s Specific Horses
66. JMJ Racing Stables, LLC owned four of the eight horses that were
administered the Wickliffe drug. These horses were: ( 1.) Free Association, who
died, (2.) Unknown Road, (3.) a two year old colt that was not yet named, and
(4.) Imposing Figure. The last three have thus far survived but are impaired to
one degree or another, as more particularly noted hereinafter.
67. Free Association was an unraced colt widely reported as
competitive and breezing well in preparation for his first race just prior to his
untimely death.
68. Plaintiff JMJ Racing Stables, LLC paid $100,000 to purchase Free
Association at the Fasig Tipton Sale in Saratoga and invested heavily in his
training and preparation for a racing career. But for the toxic medication that
killed him, Free Association would have been a competitive racehorse.
69. The next of the four horses, Unknown Road, was before this
incident a competitive race horse with press reports such as “Future Star
Watch-Unknown-Road” at http://www·.horscracim.?.nation.com/blous/zatt/
Future Star Watch Unknown Road 123. See also “Unknown Road Might
Tackle Lecomte” at http://www.horseracingnation.com/news/Unknown Road
Might Tackle Lecomte 123; “New York’s 2014 Kentucky Derby Contenders
III” at http://www.horseracingnation.com/blogs/NYState/Nev York s-
2014 Kentucky Derbv C. ”
70. Unknown Road’s career statistics include earnmgs of $40,460
over a very short career prematurely interrupted by this incident. Although he
had earlier received a knee injury, he was in good shape just prior to this
incident.
71. Unknown Road suffered significant impairment as the direct and
proximate result of the toxic concentration of pyrimethamine contained in the
Wickliffe product.
72. Unknown Road suffered severe seizures even while in the Large
Animal Hospital in intensive care. He had numerous wounds and injuries
related to his prolonged recumbency and repeated convulsions including
periorbital swellings and abrasions, scrapes, hair loss over much of his torso,
skin loss, and a large corneal ulcer on his right eye. By May II his white blood
count was dropping rapidly as a result of folate deficiency induced by the
overdose of pyrimethamine. This required folic acid and other measures to
bring his white blood count within normal ranges. He also suffered acute
laminitis and factures secondary to the toxic overdose. As late as June 5, 2014,
Dr. Robert MacKay observed in his discharge summary that this horse has
“been through several extremely serious clinical crises, each of which should
have been fatal, and even now his long-term survival is very much in the
balance.”
73. Unknown Road’s racing career has been impaired if not ruined as
the result of the overdose and the prognosis for his survival is grave.
74. The third horse was a two year old colt not yet named or raced but
out of the mare Sunday Geisha, a stakes winner. This horse had significant
potential as a racehorse.
75. Imposing Figure, the fourth of the horses to suffer injury from the
overdose, is a New York bred two year old colt. He was accepted for the Fasig
Tipton Preferred sale as a yearling. At the time of this incident, he had not yet
been raced but was about to be sent north for racing at the time this incident
occurred. His prospects as a race horse were excellent.
76. As the result of the overdose, Imposing Figure suffered an eye
ulcer and additional maladies. He has returned to the racing stable but his
prospects for entering upon a racing career are guarded at present.
77. As the direct result of the toxic nature of the Wickliffe drug,
Plaintiff has sustained substantial monetary loss from the death of one of its
horses and the substantial impairment of the other three.
78. Even if all of the remaining horses survive, their race potential and
therefore their economic value has been substantially reduced, or eliminated, as
a direct result of the toxicity of the Wickliffe product. Even in the best of
circumstances, Plaintiffs three surviving horses have lost the better part of a
year of their racing career.
79. All four horses were valuable and were injured at a time when
they were preparing to race.
80. The replacement value of such race horses IS very high m a
market that has steadily appreciated.
81. All conditions precedent to the filing of this action have been
performed or occurred or have been waived.
COUNT I- NEGLIGENCE AND GROSS NEGLIGENCE
82. This is an action for the recovery of damages and other relief
under the common law of Florida for negligence and gross negligence.
83. Plaintiff reasserts the allegations in paragraphs 1 through 81 as if
fully incorporated herein.
84. The death of Plaintiffs horse Free Association and the injury of
Plaintiffs other horses was caused by the negligent, careless and even reckless
acts and omissions of Defendants and their agents, representatives and
employees acting within the course and scope of their employment, as more
particularly set forth herein.
85. Defendants had a duty of care to all individuals, including the
Plaintiff in this action, to supply veterinarians of the Plaintiff (and others) with
a product which was of the nature and substance of that described by the
Defendant in its label and in its quality claims and to exercise due care in
dispensing its toltrazuril and pyrimethamine preparation.
86. This product Defendants either knew, or reasonably should have
known, would be used by Plaintiff for its intended use in a reasonable manner,
and with every reason to believe that such use would not pose an unreasonable
risk of harm.
87. Defendants breached their duty of care when the product was
dispensed and shipped by Defendants and then administered by a veterinarian,
Jonathan McLellan, licensed in the State of Florida, and who routinely
performed the veterinary work for a racing stable near Ocala, with the approval
and consent of the Plaintiff.
88. Within a short time following the first and only administration of
Defendants’ medication with lot number “28-03-2014 @44” one of Plaintiffs
horses died (Free Association) and the remaining three suffered severe injury
from the toxic concentration of pyrimethamine.
89. There was no other reason for the display of the severe neurologic
signs exhibited by all of Plaintiffs horses and indeed all of the treated horses.
All eight of the horses suffered to one degree or another a spectrum of
symptoms of overdose including but not limited to convulsions, seizures,
ataxia, and other physical manifestations of severe injury including, but not
limited to severe ulceration of the gastrointestinal tract, head and eye injuries,
laminitis and abnormal blood counts with severe leukopenia. After initial
treatment on site, Plaintiffs horses were transferred to the University of
Florida Large Animal Hospital. Those that survived have been temporarily
retired from training, with a view to possibly returning many months in the
future, although their performance is unlikely to be of the same promising
nature as before the incident.
90. Plaintiffs remaining horses continue, at the time of filing this
complaint, to be in receipt of therapy.
91. Defendants were negligent in the dispensing and/or compounding
of the drug, and their conduct in dispensing the drug with excessive doses of
pyrimethamine fell below the acceptable standard of care for a veterinary
pharmacy.
92. Defendants knew or should have known that the product it
supplied to Dr. McLellan for the treatment of Plaintiffs horses did not contain
the appropriate concentrations of pyrimethamine claimed on its label.
93. Defendants did not test a sample even though they claimed on
Wickliffe’s website that it always performed such testing, nor did Defendants
apparently retain a sample of that lot for future testing. This is a departure from
the standard of care and of the claimed practices of Wickliffe itself.
94. Defendants were also negligent in failing to exercise the standard
of care of a compounding pharmacy for veterinary products by, among other
things, failing to use acceptable practices for compounding and dispensing the
drug and failing to use appropriate quality control procedures to ensure that the
proper dose of pyrimethamine was present in the solution and failing to
supervise its personnel involved in dispensing the drug.
95. Defendants were also negligent in failing to supervtse the
pharmacy staff and in failing to implement proper procedures for qualify
control of the pharmacy personnel or for responding to adverse incident reports
such as the information Defendants received regarding the Kentucky horses
before shipping the product to Dr. McLellan in Florida.
96. Defendant William V. Bernard was, on information and belief,
additionally negligent as a director and chief veterinarian of Wickliffe because
he attempted to conceal his knowledge of the Kentucky overdose and failed to
either warn the veterinarian community of the risks of additional harm
associated with the drug and with Wickliffe’s compounding practices or to
correct the company’s compounding practices or even to test lot “28-03-
20 14@44” before it was shipped to Dr. McLellan, as Wickliffe represented that
it always did.
97. Defendants were additionally negligent m one or more of the
following respects: (a) compounding or manufacturing a dangerously defective
drug compound; (b) distributing a dangerously defective drug having a toxic
dose of pyrimethamine; (c) failing to properly compound or manufacture the
drug before dispensing it and sending it to Dr. McLellan; (d) failing to properly
inspect or test the drug before sending it to Dr McLellan; (e) failing to provide
warnings that the drug was toxic in the concentrations the drug in fact had; (f)
failing to correct the unreasonably dangerous compounding practices that
caused the horses in Kentucky to be poisoned, even with full knowledge that
the drug has killed at least one horse before the lot send to Dr. McLellan was
dispensed; (g) failing to correct the procedures which caused the overdose in
the lot that poisoned the horse in Kentucky before the lot sent to Dr. McLellan
was dispensed; (h) failing to ensure that the proper and safe formulating and
compounding practices were implemented even after knowing of the poisoning
of the horses in Kentucky; and (i) failing to use due care in the circumstances.
98. But for the negligence of Defendants in providing an improper
dosage of pyrimethamine Plaintiffs horses would not have suffered injury.
99. Defendants knew that Dr. McLellan would be administering the
drug to horses under his care and thus knew that Plaintiff as the owner of the
horses would be injured in the event of an improper dosage of pyrimethamine.
100. Plaintiff is a foreseeable victim of Defendants’ negligence.
101. Defendants owed Plaintiff a duty of care and breached that duty to
Plaintiffs injury.
102. On information and belief, Defendants are liable also for gross
negligence in that they had actual knowledge of the harmful nature of the lot in
Kentucky and of the injury to the horses there and took no additional
precautions to ensure that the lot supplied for Plaintiffs horses was adequate or
to test that lot in a way that would detect the overdose of pyrimethamine or to
warn Dr. McLellan (and others) about the risks of misformulation associated
with its drug in light of what had just happened to the horses in Kentucky.
1 03. Plaintiff accordingly alleges on information and belief that
Defendants are each individually guilty of gross negligence which was a
substantial cause of the injury to Plaintiff in that Defendants were each so
reckless or lacking in due care that their respective actions and omissions
constituted a conscious disregard or indifference to the safety of the horses that
would be administered the drug. Defendants well knew by March 31, 20 14,
before the lot to Dr. McLellan was shipped that there was a serious defect in
their compounding and quality control practices but did nothing to correct the
defect or test the concentration of pyrimethamine before the drug was
forwarded for the treatment of Plaintiffs horses.
104. As a direct result of the harm described, the Plaintiff has suffered
damage in terms of a) the cost of the horse, b) the cost of training and regular
vet fees up to the time of injury, c) the cost of veterinary treatment for the
harm, both by the attending and referral veterinarians which is continuing,
d) vanning costs, e) extreme loss of value in the future, f) loss of earning
potential in the interim, both racing and potential sales, g) replacement costs
and h) damages in other respects that discovery shall show after more is known
of the extent of the recovery of the remaining horses. Plaintiff alleges based on
present information that the damages directly caused by the conduct of
Defendants substantially exceeds the jurisdictional amount.
Wherefore Plaintiff hereby demand a judgment against each of the
Defendants, jointly and severally, for (a) compensatory damages in an amount
greater than $75,000, (b) costs of this action and (c) punitive damages should
the jury determine that the Defendants, or either of them, committed gross
negligence and (d) such other relief as the Court may deem warranted in the
circumstances.
COUNT II- BREACH OF IMPLIED WARRANTY
105. This is a claim for damages for breach of implied warranty under
the law of the state of Florida against Defendant Wickliffe.
106. Plaintiff reasserts the allegations in paragraphs 1 through 81 as if
fully incorporated herein.
107. Wickliffe impliedly warranted that the drug preparation it
provided to Dr. McLellan for the care of horses under his control was
reasonably fit for its intended use as a veterinary medication to the horses
being treated, including those of Plaintiff.
108. Wickliffe had reason to know of the particular purpose for which
the drug it supplied was required and that Dr. McLellan was relying on
Wickliffe’s skill in selecting ingredients that conformed to that purpose and to
the label on the bottle. Specifically, Wickliffe recommended its compound as
an already existing and successful alternative to existing FDA approved drugs
for the treatment or in order to prevent EPM.
109. The drug was defective in that it contained a substantial overdose
of pyrimethamine, many times the dosage claimed on Wickliffe’s label.
110. On May 5, 2014, the Plaintiff caused this product to be
administered by Dr. McLellan to Plaintiffs horses at the racing stable near
Ocala, Florida.
111. While being used for the intended purpose, injury was caused to
the Plaintiff, who was the user of the product.
112. One of the Plaintiffs horses died and the remaining three were
substantially injured and may be permanently impaired as the result of the drug
overdose.
113. As a result, Plaintiff has suffered substantial financial loss and
Injury.
114. The value of one of the horses was totally lost and value of the
remaining horses, all of which were race horses of substantial value, has been
substantially impaired as the direct, natural and foreseeable result of the breach
of warranty.
115. As a direct result of the harm described, the Plaintiff has suffered
damage in terms of a) the cost of the horse, b) the cost of training and regular
vet fees up to the time of injury, c) the cost of veterinary treatment for the
harm, both by the attending and referral veterinarians which is continuing,
d) vanning costs, e) extreme loss of value in the future, f) loss of earning
potential in the interim, both racing and potential sales, g) replacement costs
and h) damages in other respects that discovery shall show after more is known
of the extent of the recovery of the remaining horses. Plaintiff alleges based on
present information that the damages directly caused by the conduct of
Defendants exceeds $1,000,000.
Wherefore, Plaintiff hereby demands a judgment against Defendant
Wickliffe for (a) compensatory damages in an amount greater than $75,000, (b)
costs of this action and (c) such other relief as the Court may deem warranted
in the circumstances.
COUNT III– BREACH OF EXPRESS WARRANTY
116. This is a claim by Plaintiff against Defendant Wickliffe for breach
of express warranty under the law ofthe state of Florida.
117. Plaintiff reasserts the allegations of Paragraphs I through 81 as if
fully set forth herein.
118. Defendant Wickliffe made express warranties to Plaintiffs
veterinarian, Dr. McLellan, well knowing that Dr. McLellan would reply upon,
and intending to induce Dr. McLellan to rely upon, these express warranties.
119. The express warranties included the warranty on the label which is
an express affirmation that the prescription drug contained in the product
packaging had, in suspension, the proportions of toltrazuril and pyrimethamine
claimed on the label.
120. The express warranties also included Wickliffe’s advertising and
claims on its website, including those enumerated in Exhibit C, wherein
Wickliffe represented expressly that safety was its foremost concern, that it had
the highest standards in the compounding industry, that it met or exceeded
federal guidelines, and that it sent samples of all compounds offsite for
independent testing to ensure sterility, purity and concentration of the
compounds, and wherein it represented that quality is its “guarantee.”
121. The above representations were made by Wickliffe to induce
veterinarians for horse owners, such as Plaintiff, to purchase Wickliffe’s
compound drug preparation.
122. Dr. McLellan as Plaintiffs veterinarian did in fact rely upon the
label and the express representations made by Wickliffe on the label and its
various advertising claims in ordering the drug for the horses.
123. The label contained a false representation in that the actual
solution delivered to Dr. McLellan did not contain 17 mg per ml of
pyrimethamine in suspension, but in fact exceeded that amount by many times,
such that it was poisonous.
124. Dr. McLellan would not have administered the drug to Plaintiffs
horses, or to any horses, had he known that the label was false, nor would he
have ordered it.
125. Wickliffe’s advertising claims about its compounding practices
were also false.
126. Wickliffe knew or should have known that the label and its other
advertising representations made in reference to the drug were false.
127. Because the representations were false, the drug preparation was
nonconforming and in fact poisonous.
128. Each of the Plaintiffs two horses were substantially injured or
permanently impaired as the result of the drug overdose.
129. As a result, Plaintiff has suffered substantial financial loss and
injury as a direct and proximate result of the breach of warranty.
130. But for the breach of warranty, Plaintiffs horses would not have
been impaired or injured.
131. Injury to horses was foreseeable in that an overdose of
pyrimethamine is toxic to horses and would have produced precisely the type
of injury Plaintiffs horses sustained.
132. Plaintiff was the ultimate consumer to whom the product was
provided and was entitled to believe the representations made to Plaintiffs
veterinarian.
133. The product provided to Plaintiffs veterinarian was not suitable
and was not conforming to the warranties made by Wickliffe.
134. The legal cause of Plaintiffs injury is the dangerous drug
overdose which directly and in natural and continuous sequence produced or
substantially contributed to the injury to Plaintiffs horses, in that but for the
defective condition of the drug the injury to the horses and Plaintiffs financial
loss would not have occurred.
135. The value of one of the horses has been totally lost and the value
of the remaining horses has substantially been impaired as the direct, natural
and foreseeable result of the breach of warranty.
136. As a direct result of the harm described, the Plaintiff has suffered
damage in terms of a) the cost of the horse, b) the cost of training and regular
vet fees up to the time of injury, c) the cost of veterinary treatment for the
harm, both by the attending and referral veterinarians which is continuing,
d) vanning costs, e) extreme loss of value in the future, f) loss of earning
potential in the interim, both racing and potential sales, g) replacement costs
and h) damages in other respects that discovery shall show after more is known
of the extent of the recovery of the remaining horses. Plaintiff alleges based on
present information that the damages directly caused by the conduct of
Defendants exceeds $75,000.
Wherefore, Plaintiff hereby demands a judgment against Defendant
Wickliffe for (a) compensatory damages in an amount greater than $75,000, (b)
costs of this action and (c) such other relief as the Court may deem warranted
in the circumstances.
COUNT IV- STRICT LIABILITY
137. This is a claim for the recovery of damages for strict liability
against Defendant Wickliffe under the common law of the state of Florida for
the sale of a defective and unreasonably dangerous product that caused injury
to Plaintiffs horses.
138. Plaintiff reasserts the allegations in paragraphs 1 through 81 as if
fully incorporated herein
139. At all times relevant to this action the product that the Defendant
designed, formulated, compounded, labeled, manufactured, sold, and
distributed into the stream of commerce, namely its compounded drug, was not
modified, changed, or abused by Plaintiff or other users of the product prior to
its administration to Plaintiffs horses.
140. The Defendant designed, formulated, compounded, manufactured,
sold, and distributed into the stream of commerce the product in an
unreasonably defective condition in that it contained a dangerous overdose of
pyrimethamine many times greater than the ingredients claimed on the label.
141. Wickliffe supplied the defective product to Plaintiffs veterinarian
knowing that he would rely upon the label as being an accurate description of
the product ingredients.
142. On May 5, 2014, Plaintiff caused this product to be administered
to Plaintiffs horses at the racing stable near Ocala, Florida, believing the label
to be accurate.
143. One of Plaintiffs horses died and the remammg horses were
substantially injured and impaired as the result of an overdose pyrimethamine,
which made the product defective and unreasonably dangerous.
144. As a result Plaintiff has suffered substantial financial loss and
InJUry.
145. The injury to the Plaintiffs horses was caused by the
administration of the product which was delivered to the Plaintiff in an
unreasonably dangerous condition by the Defendant, for which the Defendant
is strictly liable.
146. Furthermore, Wickliffe either knew, or should have known, that
the product which it shipped to Dr. McLellan on or about April 2, 20 14 was
defective and unreasonably dangerous. Defendant well knew that similar
injuries had occurred under similar circumstances to Defendant’s actual
knowledge, and failed to warn of any possible adverse effects or use reasonable
diligence.
147. The legal cause of Plaintiffs injury is the dangerous drug
overdose which directly and in natural and continuous sequence produced or
substantially contributed to the injury to Plaintiffs horses, in that but for the
defective condition of the drug the injury to the horses and Plaintiffs financial
loss would not have occurred.
148. As a direct result of the harm described, the Plaintiff has suffered
damage in terms of a) the cost of the horse, b) the cost of training and regular
vet fees up to the time of injury, c) the cost of veterinary treatment for the
harm, both by the attending and referral veterinarians which is continuing,
d) vanning costs, e) extreme loss of value in the future, t) loss of earning
potential in the interim, both racing and potential sales, g) replacement costs
and h) damages in other respects that discovery shall show after more is known
of the extent of the recovery of the remaining horses. Plaintiff alleges based on
present information that the damages directly caused by the conduct of
Defendants exceeds $75,000.
Wherefore, Plaintiff hereby demands a judgment against Defendant
Wickliffe for (a) compensatory damages in an amount greater than $75,000.
(b) costs of this action, and (c) such other relief as the Court may deem
warranted in the circumstances.
JURY TRIAL DEMAND
Plaintiff demands trial by jury on all issues so triable.
DATED this 9th day of June 2014.
Stephen D Milbrath

 

January 2015

Case dismissed after parties settled

   

FDA: 4 Horses Dead from Compounded EPM Drug

 


 

 

View Robert Harvey and Al Wortzman v Wickliffe Pharmaceutical, et al 
January 26, 2015

Case dismissed after parties settled

 


 

View Galen Ho’o LLC v Wickliffe Pharmaceutical, et al

January 26, 2015

Case dismissed after parties settled