In previous posts,1 I noted that, due to the monopoly granted by patent, people suffering from the genetic illness Fabry disease are unable to obtain the drug Fabrazyme, which is in short supply because of patents and the FDA. People are literally dying because Fabrazyme is in short supply and the sole, monopolistic manufacturer, Genzyme, can’t make enough quickly enough–and no one else is permitted to make it due to the patent.
Pro bono lawyer Allen Black, representing the victims, just notified me of the press release below, and said: We just filed a civil rights suit against the government for its role in two drug shortages–including Fabrazyme. I have attached the press release and the link to the complaint itself is here: http://freepdfhosting.com/
Drug Shortage Patients File Lawsuit against DHHS, FDA and NIH Over Two Life-Saving, Injectable Medicines
Pittsburgh, PA – February 21, 2012, — Today, 25 drug shortage patients announced that they have filed a lawsuit against the Department of Health and Human Services (“DHHS”), the Food and Drug Administration (“FDA”), and the National Institutes of Health (“NIH”) over their handling of two ongoing drug shortages. The first drug, Fabrazyme, is used to treat Fabry disease, but has been severely rationed since June 2009 (manufactured by Genzyme, a Sanofi Company). The second drug is Aquasol A used to treat vitamin A deficiency but has not been manufactured since November 2010 (manufactured by Hospira Corporation).
Patients are arguing that their constitutional rights were violated by FDA licensees saying “no” to state-authorized prescriptions and that the FDA has failed to take adequate enforcement actions against their licensees. The complaint is available here: http://freepdfhosting.com/3e9cb8c1ad.pdf
Patients argue that in failing to address the drug shortage issues, the DHHS, FDA and NIH have interfered with the treatment decisions of state-licensed physicians and endangered patients’ health and the public health. Patients argue that the government’s actions violate (1) patients’ the 5th Amendment right to due process (2) the states’ 10th amendment right to protect the public health and (3) patients’ individual right to medical privacy and their right to control their own bodies.
Patients’ requests include asking the court to supervise the allocation of the currently limited supplies of drugs based on constitutional principles and medical oversight. Patients request that drug companies be enjoined from creating secret waiting lists naming and ranking individual Americans for access to shortage drugs based on their private medical information or otherwise retaliating against patients by withdrawing or re-ranking access to medication.
Plaintiffs also are requesting that the FDA licenses issued to drug companies causing drug shortages be invalidated and their patents declared unenforceable so that the Government can escrow shortage drug as well as contract manufacture life-saving medicines just as the HHS currently provides for pandemic flu vaccines.
Fabrazyme is an injectable drug used to treat the lethal genetic illness Fabry disease, affecting over 1,500 Americans. American taxpayers funded the invention of Fabrazyme with an NIH grant. Genzyme has not manufactured enough Fabrazyme for over two and one-half years due to manufacturing errors. Genzyme rationed full FDA approved doses to Europeans but only provided diluted doses for Americans, despite Europeans having an alternative medication that is not available in America. The European Medicines Agency observed that Fabry patients receiving diluted dosing had a return of symptoms including stroke, renal disease, and heart damage, so it banned the practice. The FDA has not.
In March 2010, Fabrazyme patients sued Genzyme and Mt. Sinai for compensation for their injuries. Patients had previously petitioned the FDA and NIH to end the preferential allocation favoring European patients who have access to a medical alternative over the U.S. patient who do not have access to the alternative. The FDA and NIH have not responded more than one year later.
Aquasol A is an injectable drug manufactured by Hospira Corporation and is used to treat vitamin A deficiency for patients that cannot absorb the vitamin their diet. Left untreated, vitamin A deficiency causes irreversible blindness and the susceptibility to lethal infections. Hospira has not manufactured the drug for over one year because of manufacturing errors. Hospira currently leads the FDA list for causing the most drug shortages (over thirty concurrent shortages as of this release).
The petitioners are being represented pro bono by C. Allen Black, Ph.D. Dr. Black is a licensed patent attorney and has assisted patients in petitioning the NIH and the FDA for access to Fabrazyme. He is currently representing fourteen patients in a lawsuit against Genzyme and Mt. Sinai for their injuries caused by the Fabrazyme shortage. Dr. Black holds a Ph.D. in Immunology.
Dr. Black offered the following comments on the lawsuit:
“Currently, if there is a full blown shortage, a patient’s request for treatment will be met with a “no” and the patient will be placed on a secret corporate waiting list. The FDA just goes along with it. The HHS forgets that Americans are forced to rely on FDA licensees for access to drugs by federal law. Patients can’t just order the drug from overseas or contract a company to manufacture it on their own behalf. There is simply no room for failure under the Food, Drug and Cosmetics Act.”
“Civil rights violations stem from patients being forced to rely on FDA licensees for access to a drug but cannot get it when they need it. Thus, a denial of access to medication by FDA licensees violates Americans’ civil rights just like denying access to wheel chair ramps violates the rights of handicapped Americans.”
“The FDA has clearly failed in its mandate to protect American lives. There is no point in ensuring that a drug is safe or effective if patients cannot get access in the first place and suffer or die anyway. However, the FDA seems to be asking Americans to choose between a safe drug supply and a reliable drug supply. Obviously if the FDA wants to save lives, then it must ensure both.”
“The FDA should not allow Americans to be held hostage by drug companies creating or threatening shortages. It is irrelevant whether a private corporation finds a drug profitable. If Americans need a drug to survive, they have a fundamental Constitutional right to access. The Government can make all of the drug that is needed, if corporations cannot. HHS has already spent nearly one billion dollars manufacturing pandemic flu vaccines, so why not make drugs that are actually needed now?”
“Corporations that cause drug shortages through their own negligence should be immediately excluded from interstate commerce for breaching the public trust. Such corporations are injuring the most vulnerable Americans but being rewarded with future profits garnered from the remaining survivors. Even worse, the FDA lets these companies, not public health authorities, decide how to allocate the drug among the victims with no right of to a hearing or appeal. It is unconscionable that the Government gives FDA licensees the power to choose who will live or die during a shortage.
“Right now there are millions of Americans being injured or even killed by drug shortages. While we support legislation that will help victims of future drug shortages, we believe that action must be taken immediately to save the innocent lives that are currently in jeopardy. The courts must step in to protect citizens that are suffering right now.”
Contact information:
C. Allen Black, Ph.D. Esq.: TEL +1.412.908.3268; email: allen@patentlawyersite.com; www.patentlawyersite.com.
An outline of the facts of the Drug Shortage Lawsuit follows
DRUG SHORTAGE LAWSUIT FACT SHEET
FABRAZYME SHORTAGE
1) Fabrazyme is protein enzyme injected I.V. into patients that do not have the ability to break down certain fats. The buildup of fats in the brain, heart and kidneys usually kills male patients by their early 50s without treatment.
2) U.S. taxpayers funded the invention and patenting of Fabrazyme through an NIH grant. The Bayh-Dole act which regulates U.S. funded inventions does not allow non-use or misuse of taxpayer inventions. 35 USC 200 et seq.
3) Genzyme licensed Fabrazyme from Mt. Sinai Hospital. Current cost for treatment is over $250,000 per year for the life of the patient. Genzyme was able to manufacture enough enzyme until June 2009, when it contaminated injectable vials of the drug with virus, glass, rubber and steel particles.
4) The FDA issued a consent decree in March 2010 against Genzyme Corporation. Fabrazyme has been manufactured sporadically and rationed by diluting the dosage to 30-50% of the FDA recommended dosage in only the U.S.
5) According to Genzyme’s rationing plan, if a patient was diagnosed with Fabry before June 2009, they received diluted medication—sometimes less than 1/3 of the FDA dose. If a patient was diagnosed after June 2009, they were banned from access.
6) There is an alternative medication available overseas (Replagal™) manufactured by Shire corporation. It is not currently approved in the US, but Shire is waiting for approval in the US.
7) The European Medicines agency (FDA equivalent in Europe) studied the effects of diluted dosing in Fabry patients and determined it was ineffective and dangerous leading to increased risk of progression of disease. The EMA banned use of diluted dosing.
8) Genzyme ships full dose treatment to Europeans despite Europeans having an alternative medication, but bans use of FDA approved doses for Americans or bans them from access completely. Physicians in the US have protested against the use of diluted medication, but Genzyme has overruled them.
9) Twenty four of the Plaintiffs have Fabry disease and have been forced to take diluted medication or have been banned from access. Many US patient, including those treated at Mt. Sinai Hospital, are individually named on a secret waiting list for access that has been created and maintained by Genzyme.
10) Mt. Sinai is currently suing Shire for patent infringement for making Replagal even though Genzyme cannot make enough to treat patients. It is suing in Germany, Sweden and the United Kingdom, but not seeking an injunction. However, Mr. Sinai is still demanding money damages from Shire even as it attempts to mitigate the global Fabrazyme shortage by making an alternative.
AQUASOL A SHORTAGE
1) Aquasol A, manufactured by Hospira Corporation, is an injectable form of vitamin A.
2) Injectable vitamin A is used to treat patients that cannot absorb vitamin A in their diet. It is a generic drug and treatment cost is low.
3) One of the plaintiffs, Jennifer Lacognata has vitamin A deficiency but cannot obtain access because Hospira changed manufacturing sites but failed to secure the supply during the transition.
4) The Aquasol A shortage began in November 2010 when Hospira Corporation switched manufacturing sites.
5) No injectable vitamin A is available anywhere in the world, although veterinary treatment for cattle is available, but dangerous for human use.
6) Due to the progression of her vitamin A deficiency, Mrs. Lacognata has become blind in one eye and is rapidly losing sight in the other eye. United Airlines, her employer, placed her on unpaid medical leave and withdrew her insurance coverage due to her blindness.
7) Mrs. Lacognata has two children, and has said that she is trying to memorize the faces of her children before she becomes completely blind due the shortage.
8) Her physician said Mrs. Lacognata should not waste her money visiting him until the shortage is over since he has no way to treat her disease without the drug.
LEGAL ISSUES
Constitutional Violations Alleged:
1) Violation of Separation of Powers- Legislative: The FDA has placed the authority to control interstate and foreign commerce over shortage medications in the hands of its licensees. The FDA may not delegate the authority to regulate interstate and foreign commerce to private citizens under the U.S. Constitution.
2) Violation of separation of Powers-Judiciary: The FDA has delegated the power to discriminate among equally deserving citizens to private licensees and adjudicate drug shortage victim’s claims for access without being subject to judicial oversight. The FDA may not bar the judicial branch of government from reviewing the decisions of FDA licensees affecting the health and life of citizens under the U.S. Constitution.
3) Violation of the 10th Amendment reservation of Police Powers to the States: The states regulate public health and safety for their citizens. The FDA has given its licensees the power to veto state authorized prescriptions necessary to protect the health and safety of their citizens. The States’ police power to regulate health and safety is not delegable to private individuals under the Constitution. State police power may not be vetoed by the Executive agencies or their licensees under an FDA license.
4) Violation of the Patent Clause of the Constitution. A patent may only be granted to the extent it “promotes the sciences” under the Patent Clause. Withholding access to a medically necessary drug or suing companies for patent infringement that wish to mitigate a shortage merely injures more innocent Americans and prolongs drug shortages. Causing otherwise preventable death and injury to innocent Americans does not promote the sciences and defeats the purpose of granting patents. The patent to Fabrazyme is therefore invalid or unenforceable, or in the alternative, the Bayh-Dole act prohibiting non-use of taxpayer-funded inventions but allowing drug shortages to occur should be declared Unconstitutional.
5) Violation of the 5th Amendment right of Due Process: The FDA has delegated the authority to veto and interfere with medical treatment decisions. Decisions regarding medical treatment and the ability to control your own body are fundamental Constitutional rights. FDA licensees discriminate among equally deserving Americans by creating secret waiting lists based on Americans private medical records. The FDA does not provide a hearing for patients being deprived of these constitutional rights by licensees. The licensees’ decisions and their waiting lists regarding drug access are made in secret, unilateral, and unreviewable by courts or public health officials.
To the extent that FDA licensees have asserted hat they are using an “equitable and fair” allocation system for life-saving drugs, the Plaintiffs have discovered that these systems are not based on medical principles but profit retention strategies primarily benefiting the FDA licensees.
6) Violation of the Food, Drug and Cosmetics act: While the FDCA explicitly states that the FDA may regulate the safety and efficacy of a drug, it does not state that the FDA can “force” manufacturers to make the drug. While true, the FDA can and should withdraw all current and pending licenses to companies that negligently manufacture a drug so that a responsible manufacturer can take their place in interstate commerce. If a drug is determined to be safe and effective, but patients die anyway because the drug access is not provided, there is no reason for the FDA to grant the license in the first place.
7) The Plaintiffs note in the complaint that manufacturers can use innocent Americans as hostages by arguing that it would kill and injure more Americans if the license is withdrawn. However, the Plaintiffs are requesting that the Government step in to contract manufacture drugs in order to prevent hostage taking by threatening to withdraw further access to drug if the FDA invalidates licenses or stays review of new licenses.
Remedies requested:
1) To the extent that the court rules that the FDA or NIH is powerless to protect Americans from manufacturers causing drug shortages, declare the FDCA unconstitutional so as to return drug regulation authority to the exclusive jurisdiction of the individual states under their constitutionally reserved state police powers. The FDCA serves no purpose if the FDA deems a drug safe and efficacious, but patients are injured or die anyway due to FDA licensees creating drug shortages.
2) Enjoin FDA licensees retaliating against the plaintiffs, HHS employees or the court officers by withdrawing their access to drugs or blacklisting patients on secret waiting list by placing them at the end of the line.
3) Enjoin FDA licensees making allocation decisions based on individuals’ private information by shipping all shortage drugs to a court appointed third party for subsequent allocation in accordance with medical and legal principles during the shortage.
4) Enjoin FDA licensees from communicating to investors, doctors or patients regarding the end dates of a shortage, until the FDA has been able to ascertain the truth of such promises for future sales.
5) Enjoin FDA licensees from exporting drug overseas outside of the jurisdiction of the courts and interstate commerce during a domestic drug shortage.
6) Enjoin FDA licensees from making any further rationing decisions affecting the life and health of innocent Americans and place such decision under the authority of the courts or Congressional authority or the authority of the States.
7) Declare invalid current FDA licenses and any pending licenses to drug companies causing injuries by causing drug shortage due to violating FDA regulations.
8) Disgorge all fines collected from FDA licenses from profiting during an ongoing drug shortage and reallocate such a disgorgement in a manner that will help restore the drug supply.
9) Enjoin any corporation or individual from receiving any federal monies or subsidies while at the same time profiting directly (billing) or indirectly (collecting royalties) from patients that are being or have been injured by a drug shortage caused by violation of FDA regulations.
10) Declare invalid and unenforceable the Fabrazyme patent as being exercised against the US Patent Clause because drug shortages to not “promote the progress… of the sciences.” In the alternative declare the Bayh-Dole act unconstitutional because it artificially prolongs drug shortages by allowing patentees to threaten money judgment or other damages which deter competitors from entering the market to mitigate the shortage.
- Update: Patents Kill: Compulsory Licenses and Genzyme’s Life Saving Drug and Patents Kill: Compulsory Licenses and Genzyme’s Life Saving Drug, FDA and USPTO: Joint Killers [↩]
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