Pharmacy defends Eli Lilly off-label drug suit

Diabetes drug is known for its off-label use as a weight-loss aid | Judge censures pharma giant for using state law instead of federal law in complaint | Development follows a wave of litigation involving Mounjaro.

Eli Lilly suffered a blow in a Florida federal court when a judge dismissed its claims accusing an online pharmacy of selling an unauthorised version of its diabetes drug Mounjaro (tirzepatide), which has gained notoriety for its off-label use as a weight-loss aid.

Judge Roy Altman granted RXCompound Store’s motion to dismiss with prejudice yesterday, April 10, at the US District Court for the Southern District of Florida.

In September, the Indianapolis-based pharmaceutical giant sued the pharmacy business as part of a slew of suits accusing companies of marketing drugs to patients for weight loss under the Mounjaro label.

Litigation wave

In separate lawsuits filed in Florida and Texas federal courts, Eli Lilly also sought to prevent Better Life Pharmacy, ReviveRX and Wells Pharmacy Network from selling tirzepatide, and requested unspecified damages.

In another complaint filed at the US International Trade Commission, Lilly accused three Chinese companies, another three in Europe and five in the US of duping consumers by selling “low-grade” versions of the drug.

Eli Lilly sued the Florida-based pharmacies under the Florida Drug and Cosmetic Act (DCA) and Florida’s Deceptive and Unfair Trade Practices Act (FDUTPA)

The complaint said that: "The unapproved drug products are dangerous research chemicals that are not approved for human consumption and have no connection to Eli Lilly or Mounjaro.”

Federal and state law require approval for new drugs for good reason, added the complaint.

“Drug approval is evidence-based, and it is essential to ensure the quality, safety, and

effectiveness of new drugs. When companies circumvent the drug-approval process,

safety and efficacy are, at best, unknown,” it continued.

Preemption by federal law

“The danger is not merely theoretical, as manufacturing and distribution of unapproved new drugs of unknown quality has endangered or adversely impacted public health.”

However, Judge Altman found that Elli Lilly was wrongly using state rather than federal law as a basis for its arguments and granted the pharmacy’s motion to dismiss.

“In its primary argument for dismissal, RXCompoundStorecontends that Eli Lilly’s claim—which Eli Lilly purports to bring under Florida’s DCA and FDUTPA—is preempted by federal law.

“Specifically, the defendant argues that the FDCA includes no private right of action, and that a party may not use “state laws—ie FDUTPA and the [Florida] DCA—to enforce the terms of the FDCA…..and we agree.”

Eli Lilly was represented by Brian Miller of King & Spalding, while RXCompound was represented by Daniel Loren Leyton of Kravitz, Talamo & Leyton.

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