Drug Maker Loses Case Over Banned Substance

     (CN) – A drug company already had its day in court and lost, the 3rd Circuit ruled, dismissing Hi-Tech Pharmaceutical’s second challenge to the Food and Drug Administration’s ban of supplements containing ephedrine alkaloids.

     The FDA banned the substance in 2004, explaining that the risks outweighed the potential benefits. People took supplements containing ephedrine alkaloids to lose weight, increase athletic performance and boost energy.
     But ephedrine alkaloids also increased the risk of stroke and heart attack, according to the FDA.
     Hi-Tech, whose supplements contained the banned substance, filed a federal claim in Georgia that was later consolidated with the FDA’s action to seize the banned products. The agency filed a similar forfeiture claim in Pennsylvania.
     Hi-Tech lost both lawsuits at the district court level, and the 11th Circuit dismissed the Georgia claim.
     The government argued that the 11th Circuit’s dismissal blocked Hi-Tech from winning its Pennsylvania claim.
     The Philadelphia-based appeals court agreed.
     “The parties in the 11th Circuit ruling are identical to the parties before this court,” wrote U.S. District Judge Louis Pollak, who participated in the 3rd Circuit panel ruling. “The claims are also identical.”
     Hi-Tech argued that the claims were different, because different products had been seized in Georgia than in Pennsylvania.
     But Judge Pollak remained unconvinced. “Hi-Tech’s appeals as of right have been exhausted,” he wrote, adding that the company “has had two full opportunities to litigate its challenge.”

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