Aegerion Pharmaceuticals Fined $40M for Illegal Marketing of Juxtapid

Aegerion Pharmaceuticals Fined $40M for Illegal Marketing of Juxtapid

On September 22, Aegerion Pharmaceuticals Inc., a subsidiary of Novelion Therapeutics, agreed to plead guilty to two counts of violating the Federal Food, Drug, and Cosmetic (FD&C) Act related to the company’s introduction of misbranded Juxtapid (lomitapide).

aegerion juxtapid illegal marketing

Along with the guilty pleas, Aegerion agreed to pay a fine of $40.1 million to the Justice Department and the Security Exchange Commission (SEC), and will enter into a consent decree of permanent injunction with the U.S., which includes participating in a comprehensive FDA compliance program to ensure that the company follows the law.

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Juxtapid Comes With High Price Tag, Serious Side Effects

Yearly treatment with this drug costs $200,000 to $300,000, and along with the hefty price a black box warning of serious side effects related to liver toxicity.

Juxtapid can also increase liver fat, which may lead to a condition known as hepatic steatosis, a risk factor for progressive liver disease.

Due to the risk of liver toxicity, the drug is only available from certified doctors and pharmacies through a special program called the Juxtapid Risk Evaluation and Mitigation Program. 

Aegerion Engages in Illegal Marketing

Court documents indicated that the company tried to market the drug indirectly to non-HoFH patients, even though the drug’s approval included a requirement that Aegerion educates doctors about the risks associated with Juxtapid use and that the medication should only be used for patients with a clinical or laboratory diagnosis of HoFH.  

There was also evidence that the company was using a definition of HoFH that was not consistent with Aegerion’s pre-approval filings with the FDA and did not match any peer-reviewed clinical standard for diagnosing HoFH.

In addition, Aegerion failed to comply with the requirements of the Juxtapid Risk Evaluation and Mitigation Strategy (REMS) program, according to the FDA.

The U.S. Food and Drug Administration (FDA) approved the drug in December 2012 for the treatment of homozygous familial hypercholesterolemia (HoFH), a rare genetic condition in which patients cannot reduce their LDL or “bad” cholesterol levels with conventional treatment methods.

The condition appears at birth and can cause cardiac disease in patients even before they reach their teenage years.

Juxtapid New Risks

On July 28, the FDA approved labeling changes for Juxtapid to reflect new risks of myalgia and alopecia associated with the medication.

Alopecia has been reported 27 times by Juxtapid patients, and two individuals were hospitalized due to their conditions.

Seventy-three patients reported myalgia with Juxtapid use, with four resulting in hospitalization and two in disability.

Written By:
Jessie Paluch
Jessie Paluch

Attorney Jessie Paluch has over 25 years of legal experience in personal injury lawsuits, mass tort litigations, and also spent the first decade of her career working as an international tax attorney at Deloitte. As the founder of TruLaw, Jessie collaborates with attorneys and legal experts across the United States on a daily basis — further expanding her legal expertise and enabling her to share reliable, up-to-date legal information with our readers!

This article has been written and reviewed for legal accuracy and clarity by the team of writers and attorneys at TorHoerman Law and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced injury lawyer, Tor Hoerman, you can do so here.

TorHoerman Law does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us. This article should not be taken as advice from an attorney.

Written By:
Jessie Paluch
Jessie Paluch

Experienced Attorney & Legal SaaS CEO

With over 25 years of legal experience, Jessie is an Illinois lawyer, a CPA, and a mother of three.  She spent the first decade of her career working as an international tax attorney at Deloitte.

In 2009, Jessie co-founded her own law firm with her husband – which has scaled to over 30 employees since its conception.

In 2016, Jessie founded TruLaw, which allows her to collaborate with attorneys and legal experts across the United States on a daily basis. This hypervaluable network of experts is what enables her to share reliable legal information with her readers!

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