Do you feel that your
companion was harmed or died due to a drug?
Does your vet agree or disagree with you? Not
that it matters. This will be an attempt to put in
simple language what avenues (to our knowledge) are
available to you.
#1 (the easiest)
If your dog dies and you have a necropsy done that comes
back with the conclusion that it was drug induced, that
should be all you need. The drug manufacturer should
pay for the necropsy and they are under obligation to
the FDA to get good lab data. Probably a major pathology
lab or a teaching hospital if nearby.
If your dog dies and you have necropsy done and it
does NOT come back conclusive it was the drugs fault,
or you don't have a necropsy done, don't give up yet!
#2
(a little time consuming) Get a case number from the
manufacturer. They may not be very 'polite' but they
HAVE to give you a case number. Yes, your vet 'may'
have already filed a report with them. If that is the
case they will give you the same case number given to
him. Each companion can only have one case number. Then
file a report with the FDA.
Please remember: The FDA regulates
drugs and drug manufacturers (NOT vets and/or clinics).
It is necessary to file ADE report with
FDA for several reasons.
One, it will help them understand the entire drug safety
and efficacy profile of the product which is used to
support or revise critical label information on the
product.
Two, the more suspected reactions reported, the sooner
they will see a possible problem with a drug.
Three, the FDA will review all records pertaining to
your case and make a determination regarding your dog
and the use of the drug. It takes time and you then
must request the information by an FOIA request, but
they can give you their determination if it was 'definitely'
- 'probably' - 'possibly' - or 'remotely' related to
the drug. If you do NOT have a necropsy done, the highest
score you can get is 'probable'.
Remember that to make an adverse reaction report you
must only 'suspect' that it was related to a drug. You
do NOT have to prove it. It doesn't matter what your
vet says, what the manufacturer says, or even what you
think (after all most of us are not vets, doctors, scientists
etc). Once the report is made, the FDA will draw their
own conclusion taking into account: previous medical
problems, age, any tests and/or treatments. Unfortunately,
the FDA may not give it to you. It is imperative that
the request is worded properly. "Murphy's
scoring"
#3 Was it caused only by fault of your vet? If it is
a vets fault, then you have recourse of filing a complaint
with your State Vet Board. Each state varies, but the
general theory is that this is where you can verify
a license, you can make a complaint regarding a vet,
and possibly find out if a vet has had complaints in
the past.
PA State is detailed to say: "The
State Board of Veterinary Medicine regulates the licensure
and practice of veterinary medicine in the Commonwealth
of Pennsylvania. Among its other functions, the Board
licenses veterinarians; certifies veterinary technicians
and approves schools and colleges of veterinary medicine
and veterinary technology programs. The Board protects
the public from being misled by incompetent, unscrupulous
and unauthorized persons and from unprofessional or
illegal practices by persons licensed to practice veterinary
medicine."
All state boards are different though.
They supposedly go by "Standards of Care"
which may vary.
One way or the other, if you get your evaluation from
the FDA and it comes in your favor (or at least not
a 'remotely') THEN you should have recourse against
the manufacturer, vet, vet board etc.
In my opinion the FDA is a Federal government
agency, where vet boards are only by state.
You can read the FDA handbook on FOIA
requests http://www.fda.gov/opacom/backgrounders/foiahand.html
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