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May 4, 2009
Table of Contents
1. Will there be legal trouble for lab that botched polo horse supplement? (Gainesville Sun)
2. Ocala pharmacy violated FDA rules, got warning letter in 2005 (Palm Beach Post)
1. SOURCE: Gainesville Sun
DATE: 5/3/2009
HEADLINE: Will there be legal trouble for lab that botched polo horse supplement?
AUTHOR: Naseem Sowti Miller
When Franck's Pharmacy Compounding Lab admitted that it botched a vitamin supplement that killed 21 polo
horses, most questions about how the horses died and who is responsible were laid to rest.
Yet to be determined is whether the Ocala pharmacy will run into legal or regulatory trouble.
The investigating agencies, including the Florida Department of Health and the state Department of
Agriculture, remain silent about possible repercussions against Franck's.
But legal experts say the pharmacy could face lawsuits from the Venezuelan polo team that owned the horses;
could be sanctioned by the state Department of Health, which regulates Florida pharmacies; and could face
criminal prosecution if the Department of Health or the Food and Drug Administration finds that federal drug
laws were violated.
Past problems
The worst-case scenario for the pharmacy: Investigators find it formulated a prescription that is illegal or
banned, said Don Dufresne, a West Palm Beach attorney who specializes in equine law.
"The best case," he said, "is that they simply made a mistake."
The pharmacy has had no violations in its 25-year history of operation, according to the Florida Department of
Health.
But the Palm Beach Post reported Friday that in 2005, the Food and Drug Administration issued a warning letter
to the pharmacy's owner, Paul Franck, for making "unapproved veterinary drugs" in the lab.
The warning didn't result in any action from the FDA or the state's Department of Health, the Post said.
A Sun reporter's call to the pharmacy on Saturday was not returned.
A member of the Lechuza Polo Team has said the mixture of vitamins and minerals that Franck's made for the
polo horses was a generic version of the supplement Biodyl, which is not approved by the FDA.
Legal issues
At the state level, if the Department of Health's Board of Pharmacy finds a violation of the state's pharmacy
act, it could file a complaint against the pharmacy or the pharmacist who mixed the supplement.
In response, the pharmacy would be able to appeal and likely would negotiate a penalty, explained Sandra
Greenblatt, a board-certified expert in health law.
"It's a good thing to come forward and admit the mistake, but it does not let them off the hook if there has
been a violation," she said.
The penalties could range from "a fine to suspension to continuing education," said Greenblatt. In the most
severe cases, the pharmacy's license could be revoked, but that is unlikely.
To be determined
It is yet to be determined if the pharmacy violated any federal drug laws, but the possibility of criminal
charges for the horses' deaths is almost nonexistent at this point.
The Palm Beach County Sheriff's Office is no longer involved with the case, spokeswoman Teri Barbera said
Wednesday.
But a civil lawsuit is a strong possibility.
"When a person unintentionally compounds a medication or fills a prescription incorrectly, that's not a
criminal action. It's negligence. It's a mistake," said Brian Kahan, a Boca Raton pharmacist and attorney who
specializes in pharmacy and health care law.
"Once the determination is made as to the responsibility, what typically results is that the party who
believes they've been harmed will make a determination if they'd like to seek reparation," he said.
A lawsuit, according to attorneys, would most likely seek damages for economic loss, not pain and suffering.
The horses have been valued at about $100,000 apiece.
It is not clear whether Franck's Pharmacy has liability insurance, and if it does, whether the insurer would
cover the costs in this case. Legal experts said that, depending on the outcome of the investigation, the
insurance company could decide not to provide any coverage.
2. SOURCE: Pam Beach Post
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May 1, 2009
DATE: 5/1/2009
HEADLINE: Ocala pharmacy violated FDA rules, got warning letter in 2005
AUTHOR: Jane Musgrave
The Ocala-based pharmacy that admitted it mixed a bad batch of medication that killed 21 Wellington polo
horses has been criticized before for "significant violations" of federal drug laws.
In 2005, the U.S. Food and Drug Administration issued a warning letter to Paul Franck, owner of Franck's
Pharmacy, after inspectors found his lab was making unapproved veterinary drugs.
The pharmacy admitted last week that a medication it prepared for the elite Lechuza Caracas polo team
contained too much selenium. State veterinarian Thomas Holt said the horses died from a selenium overdose.
Officials have indicated that the element was in a generic version of Biodyl, a supplement used to help the
horses recover after matches. Biodyl, made in France, is not approved for use in the U.S.
In the strongly-worded 2005 letter, FDA investigators said drugs the pharmacy was making were "unsafe" and
produced "in a manner that is clearly outside the bounds of traditional pharmacy practice."
In a statement, the chief operations officer for Franck's, said it satisfied the FDA's concerns.
"Franck's Pharmacy received a letter from the FDA in 2005 and, in a timely fashion, informed the agency of our
enhanced practices," Jennifer Beckett said. "FDA did not request any further action or raise follow-up issues,
which we believe indicates they were satisfied with our response."
Dr. Loyd Allen, a pharmacist and editor of the International Journal of Pharmaceutical Compounding, agreed.
The Florida Department of Health, which regulates pharmacists, took no action.
The FDA declined comment, citing its involvement in the ongoing investigation into the role Franck's played in
the Wellington horses' deaths.
The letter, Allen said, illustrates the continuing battle between compounding pharmacists and the FDA. Such
pharmacists produce drugs from raw ingredients.
The FDA takes the position that everything produced in a compounding lab must be approved by the agency, he
said. Technically, a pharmacist would need FDA approval before adding cherry flavoring to a medication to make
it more palatable to a child.
Thousands of compounded medications are used daily - from intravenous drugs administered at hospitals to drugs
given sick or injured animals.
It's even more critical for veterinary care because animals come in all sizes, from parrots to elephants, said
L.D. King, executive director of the International Academy of Compounding Pharmacists. It's not economically
feasible for drug companies to produce drugs for every animal. That's where compounding labs come in.
Allen said the practice is safe. The FDA reports less than three deaths annually from compounded drugs
compared to tens of thousands from drugs with FDA approval, he said.
Veterinarians have described Franck's, which has been in business for 25 years, as "highly reputable."
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4/30/2009
Link to NY Times Article April 30th
http://www.nytimes.com/2009/05/01/sports/othersports/01polo.html?_r=1&emc=eta1
FOR IMMEDIATE RELEASE
April 30, 2009
ESPN’s E:60 Examines The Darkest Day in Polo
ESPN's award-winning primetime newsmagazine E:60 will examine the recent deaths of 21 polo horses at an event
in Florida in the episode airing Tuesday, May 5, at 7 p.m. ET. The program, which launched in October 2007,
combines investigative reporting, in-depth profiles of intriguing sports personalities and features on
emerging star athletes. These stories are presented in a fresh and innovative format that incorporates
producer/correspondent meetings.
A few weeks ago, the genteel world of polo was rocked when 21 prized horses died during the U.S. Open Polo
Championship in Wellington, Fla., the Super Bowl of the sport. Lechuza Caracas, one of eight teams in
competition, was one win away from the semifinals and favored to win until the team's horses became ill and
started falling to the ground one by one. Spectators watched in horror as veterinarians, players, grooms and
total strangers worked together in vain to try to save the horses. E:60's Rachel Nichols talks with witnesses
and participants, including an exclusive on-camera interview with the team manager of Lechuza Caracas, who
explains what really happened leading up to Polo's most tragic day.
A preview clip of the feature can be viewed here.
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April 28, 2009
Florida Department of Agriculture Press Release
Polo Horses Likely Died From Selenium Overdose,
Florida State Veterinarian Reports
TALLAHASSEE - Florida State Veterinarian Thomas J. Holt reported today that an overdose of selenium was the
probable cause of death of the 21 polo horses that collapsed prior to a competition in Wellington on April 19.
In a memorandum to Florida Agriculture and Consumer Services Commissioner Charles H. Bronson’s office, Dr.
Holt stated that the animals had “significantly increased selenium levels” in samples tested. He reported
that the findings obtained at the department’s Animal Disease Diagnostic Laboratory in Kissimmee were
confirmed by independent testing conducted at the University of Florida’s College of Veterinary Medicine in
Gainesville, the University of California, Davis’ Animal Health and Food Safety lab and at testing facilities
at Cornell University in Ithaca, New York. The three universities assisted in the laboratory testing.
“Signs exhibited by the horses and their rapid deaths were consistent with toxic doses of selenium,” Dr. Holt
said.
Selenium is a trace mineral which is essential for normal cell function and health in animals, and is often
included in small quantities in supplements and feed for horses. Large doses, however, can be fatal to
animals.
Commissioner Bronson expressed gratitude for the work done at the University of Florida, which conducted
necropsies on 15 of the horses and performed extensive toxicology testing. He also thanked the University of
California, Davis and Cornell University for testing conducted in their labs.
Meanwhile, Commissioner Bronson noted that the deaths of the horses have triggered an investigation by a
number of state agencies, including the Department of Agriculture and Consumer Services, and he emphasized
that the inquiry is ongoing.
He said that no further information on the investigation can be disclosed at this time to prevent the
investigation from being compromised.
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April 28, 2009
For Immediate Release
Statement from Peter Rizzo, Executive Director, U.S. Polo Association on Florida Department of Agriculture
Findings on Cause of Death of 21 Polo Horses on April 19
April 28, 2009 – Wellington, FL – Peter Rizzo, Executive Director of the U.S. Polo Association (USPA) released
the following statement following the release of the Florida Department of Agriculture findings that indicate
an overdose of selenium is the probable cause of death for 21 polo ponies on April 19:
“The Florida Department of Agriculture report confirms that what happened to the Lechuza Polo Team was a
tragic accident. USPA is forming a special committee to examine additional safety measures and regulations
to further protect our horses. We will examine these reports and develop a stronger prohibited substance
policy that will ensure the safety and well-being of polo horses in the future. The USPA is 100% committed to
preventing a tragedy of this nature from happening in the future.”
The United States Polo Association has been organized and exists for the purposes of promoting the game of
polo, coordinating the activities of its Member Clubs (Clubs) and Registered Players, arranging and
supervising polo tournaments, competitions, and games and providing rules, handicaps, and conditions for those
tournaments, competitions, and games including the safety and welfare of participants and mounts.
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April 27, 2009
Issue 263
--- A MESSAGE FROM THE American Association of Equine Practioners
The possible role of a compounded product in the deaths of 21 polo ponies on April 19 has brought intense
scrutiny to the safe and proper use of compounded medications. As equine practitioners, we understand the
importance of drug compounding when trying to address the health needs of a specific patient. The use of
compounded products must always adhere to FDA guidelines, and it is critical that veterinarians become
knowledgeable about drug compounding in order to make the right decision for the horse.
The AAEP has focused considerable effort on the legalities of drug compounding the last several years and has
prepared numerous resources to help our members understand this complex subject. All of these materials are
available on ourWeb site, and I encourage you to use them. While the equine world awaits the final
determination on the cause of the tragic deaths of the horses in Florida, we as veterinarians must use this
event as a catalyst for ensuring that we completely understand the potential impact of using a compounded
product. The health of our patients depends on it.
Sincerely,
Harry W. Werner, VMD
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For Immediate Release
April 25, 2009
USPA Establishes Committee to Examine Additional Safeguards for Polo Horses
Wellington, FL - During its semi-annual Board of Governors meeting today, the United States Polo Association
(USPA) voted to establish a committee to examine existing and additional safeguards for polo horses including
developing a prohibited substance policy.
The USPA’s Board of Governors approved the following motion:
“In light of the tragedy that occurred this past week, the USPA Equine Welfare Committee requests that the
USPA Chairman establish a research committee to (i) review the forthcoming results from the civil authorities
conducting the formal investigation and (ii) develop appropriate policies that will ensure the safety and
well-being of polo horses.”
“The USPA has a tradition of promoting equine safety. The Board of Governors today approved the establishment
of a review committee to examine equine safety issues in polo, including veterinarians, players, owners and
polo leaders. The committee will examine the practices and policies of other equestrian organizations, as well
as examine existing protections for horses and possible improvements including the establishment of a
prohibited substance policy,” said Peter Rizzo, executive director of the USPA.
"We need to look after the best interests of the horses. Ultimately, what we do best for the horses will be
best for polo and the United States Polo Association," said Adam Snow, a world-class U.S. polo player and
former 10-goaler who will be participating in the finals of the U.S. Open Championship on Sunday.
For over sixteen years, the USPA has maintained an Equine Welfare Committee whose major goal is to ensure the
welfare, safety and protection of horses. The committee focuses on the rules of polo in an effort to make the
game as safe as possible for the horses. The USPA is 100% committed to preventing a tragedy of this nature
from happening in the future.
The USPA has been organized and exists for the purposes of promoting the game of polo, coordinating the
activities of its Member Clubs and Registered Players, arranging and supervising polo tournaments,
competitions, and games and providing rules, handicaps, and conditions for those tournaments, competitions,
and games including the safety and welfare of participants and mounts.
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April 24, 2009
For Immediate Release
Polo Assn. Pledges Continued Cooperation with Investigations,
And is Pleased with Vargas’ Organization’s Commitment to Work with Authorities
Lexington, KY - On Friday, Peter Rizzo, Executive Director of the United States Polo Association, USPA,
(www.uspolo.org), issued the following statement about the ongoing investigation into the tragic death of 21
polo ponies earlier this week:
“The United States Polo Association pledges continued full cooperation with federal, state and local
authorities in the ongoing investigations into Sunday’s tragic accident. We remain in contact with the Palm
Beach County Sheriff’s office.”
“We are pleased that Victor Vargas’ polo organization continues their commitment to fully cooperate with the
ongoing investigations. We will be in the strongest position to help prevent future tragedies only after all
the facts come forward.”
“As we await the full report, we are pleased with the hard work of the local and state authorities, working
together to determine exactly what happened that caused this tragedy.”
Following the conclusion of its semi-annual Board of Governors meeting on Saturday, the USPA expects to
announce its plans to provide additional protections for polo horses.
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For Immediate Release
April 23, 2009
Statement from USPA Exec. Dir. on News Reports of Florida Pharmacy Admission of Error in the Medicine
Dispensed to the Horses who died on Sunday.
April 23, 2009 – Lexington, KY. Peter Rizzo, Executive Director of the United States Polo Association
(USPA), issued the following statement about the news reports about the Ocala Franck’s pharmacy internal
report findings:
“The news reports of the pharmacy admitting to wrongly preparing the medicine before last Sunday’s match is
very disheartening. We have all suffered a terrible loss.”
“Today we come together to celebrate our sport with our championship matches and tonight we will come together
again to mourn our fallen ponies in a memorial service.”
“We will continue to work with all the authorities to get to the bottom of this tragedy and determine
definitively what happened to the horses in this isolated and unprecedented event.”
UNITED STATES POLO ASSOCIATION www.uspolo.org
The United States Polo Association has been organized and exists for the purposes of promoting the game of
polo, coordinating the activities of its Member Clubs (Clubs) and Registered Players, arranging and
supervising polo tournaments, competitions, and games and providing rules, handicaps, and conditions for those
tournaments, competitions, and games including the safety and welfare of participants and mounts.
Peter Rizzo, Executive Director of the United States Polo Association
Peter Rizzo is the executive director of the United States Polo Association (USPA). He has played polo for
over forty-five years as an amateur and professional both nationally and internationally. As the USPA Equine
Welfare Representative Rizzo’s responsibilities include being the primary contact for reporting to the
appropriate civil authorities who have jurisdiction to review and remedy cases of alleged horse abuse and
neglect.
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DATE: April 22, 2009
I am sure by now all of you are aware of the tragedy that occurred on April 7th in Wellington, FL and some of
you may have besieged with requests for information about the event or about polo in general. The media
attention is national as well as internationally and focus on this event has increased considerably over the
past few days.
As a result, the USPA has retained the BGR Group to assist the USPA with processing the numerous requests for
information. When and if you are asked to provide insight or information about this event you can refer the
requests to me for processing. If it is media related request, that will be passed along to the BGR Group.
The USPA's goal is to provide a concerted and professional response to the sad, unfortunate event and to
determine the ways and means to prevent this from happening in the future.
At this time, we are waiting for the official report from the Florida Department of Agriculture as to the
cause of the deaths of these horses and there is an ongoing investigation by civil authorities that have
jurisdiction on this matter. The USPA will be issuing a another formal statement later today.
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April 22, 2009
Statement from Peter Rizzo, Executive Director of the United States Polo Association (USPA)
The United States Polo Association sends our condolences and shares everyone’s grief in the tragedy and mourns
the loss of these horses. There are no words to describe the sadness shared by everyone - particularly the
devastated owners of those magnificent horses.
We are actively working with the management of the International Polo Club-Palm Beach, state and local
veterinarians and state and county regulatory agencies including the State Department of Agriculture, the Palm
Beach County Department of Animal Care and Control and the Palm Beach County Sheriff’s office to determine
what caused this terrible tragedy. While there is much speculation as to the cause of death, we will withhold
an assessment until the Department of Agriculture completes its tests and releases its findings.
Victor Vargas, owner of the Lechuza Caracas team, has withdrawn his team from the U.S. Open Polo
Championships.
The United States Polo Association wants to get to the bottom of this tragedy and determine what happened to
the horses in this isolated and unprecedented event. We await the findings of the toxicology report and will
provide additional comment when those results are announced.
UNITED STATES POLO ASSOCIATION www.uspolo.org
The United States Polo Association has been organized and exists for the purposes of promoting the game of
polo, coordinating the activities of its Member Clubs (Clubs) and Registered Players, arranging and
supervising polo tournaments, competitions, and games and providing rules, handicaps, and conditions for those
tournaments, competitions, and games including the safety and welfare of participants and mounts.
Bio of Peter Rizzo, Executive Director of the United States Polo Association
Peter Rizzo is the executive director of the United States Polo Association (USPA). He has played polo for
over forty-five years as an amateur and professional both nationally and internationally. As the USPA Equine
Welfare Representative Rizzo’s responsibilities include being the primary contact for reporting to the
appropriate civil authorities who have jurisdiction to review and remedy cases of alleged horse abuse and
neglect.
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PRESS RELEASE
DATE: April 20, 2009
CONTACT: Peter Rizzo (859) 219-1000
RE: Equine medical incident in Wellington, Florida
The United States Polo Association is participating in an investigation to determine the cause of death of
over 20 polo ponies that died prior to a polo match on Sunday, April 19 at the International Polo Club-Palm
Beach, located in Wellington Florida.
The cause of death for these horses will not be determined until after the Florida State Department of
Agriculture completes necropsies and toxicology testing on the affected animals. There has been much
speculation and rumor concerning the cause of death however, according to Dr. Paul Wollenman, who was on the
scene and led a valiant rescue effort with many local veterinarians and polo players to save the stricken
horses: "Based on initial, overwhelming clinical evidence this medical event was isolated to the Lechuza barn
and horses and the initial evidence shows no infectious element."
Peter Rizzo, Executive Director of the United States Polo Association (USPA) stated:
"The USPA is participating in a formal investigation of the unprecedented equine medical event that occurred
this past Sunday, April 19. We are actively working with the management of the International Polo Club-Palm
Beach, state and local veterinarians and state and county regulatory agencies including the State Department
of Agriculture and Palm Beach County Department of Animal Care and Control to determine what caused these
horses to die. While there is much speculation as to the cause of death, we will have to wait until the
Department of Agriculture completes its tests and releases its findings to the owners of the horses. In the
meantime, we all mourn the loss of these horses. There are no words to describe the grief and sadness shared
by everyone- particularly the devastated owners of those magnificent horses."
