Patients Claim Genzyme Shorted Them on Drug

     BOSTON (CN) – Genzyme and Mount Sinai School of Medicine forced people with potentially fatal Fabry disease “to be injected with non FDA-approved doses of Fabrazyme” during a drug shortage, under threat of putting them “at the end of a secret waiting list … if the unapproved and untested dose was refused,” 85 people claim in court.
     “Patients with Fabry disease often die prematurely of complications from strokes, heart disease, or renal failure,” the National Institutes of Health says it its web page about the disease. People with the congenital disease are unable to metabolize lipids, which build up to harmful levels in their eyes, kidneys, and nervous and cardiovascular systems. It is treated with hormone replacement therapy, including Fabrazyme.
     Six people with Fabry disease sued the same defendants in 2011, for imposing rationing during a shortage of the drug.
     Genzyme began having trouble making the drug in 2009, “prompting a $175 million fine, a consent decree and, more recently, a $20 billion takeover by Sanofi-Aventis,” the pharmacy website Pharmalive reported in March 2011. At that time, patients received only half the recommended dose.
     Lead plaintiff Philip Adamo’s case is typical of those in the new complaint, in Federal Court: “Plaintiff was on treatment with FDA-approved doses of Fabrazyme prior to June 2009, but since this date has been forced to be injected with non FDA-approved doses of Fabrazyme under defendants’ threat to place him at the end of a secret waiting list for access to Fabrazyme during its shortage if the unapproved and untested dose was refused,” the complaint states.
     Most of the new plaintiffs have Fabry disease, though some are spouses of ill people.
     They also complain of being given diluted doses.
     The 108-page complaint seeks damages on 35 counts, including breach of contract, product liability, deceptive trade, false advertising, consumer law violations in 19 states, violations of the Bayh-Dole Act, breach of warranty, strict liability and negligence.
     They are represented by Anthony Zelle of Boston and Matthew Kurzweg of Pittsburgh.

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