Feds Investigate Maker of Cholesterol Drug, Juxtapid, over False Marketing

Feds Investigate Maker of Cholesterol Drug, Juxtapid, over False Marketing | Pintas & Mullins Law Firm

The CEO of Aegerion Pharmaceuticals, which manufactures popular cholesterol drug Jextapid, recently went on CNBC’s Fast Money to talk about the drug. During his interview, the CEO stated that Juxtapid could prevent heart attacks and lengthen life, though neither claim has been studied or approved. Dangerous drug lawyers at Pintas & Mullins Law Firm see this type of fraudulent marketing all too often by Big Pharma, and remind Juxtapid patients that the drug should only be used for treatment of HoFH.

Familial homozygous hypercholesterolemia, or HoFH, is a rare genetic disorder causing dangerously high cholesterol. The disease renders patients unable to remove LDL, or “bad” cholesterol from the blood, significantly increasing the risk of cardiac arrest and heart disease. Symptoms of this disorder include cholesterol deposits in the eyelids, fatty skin deposits on the ankles, hands, elbows, or knees, and chest pain.

False Claims, Subpoenas, and Federal Investigations

When Aegerion’s CEO, Marc Beer, appeared on Fast Money, he illegally touted Juxtapid (lomitapide) for the prevention of heart attacks and extending life in general practice. The FDA notes that clinical trials used for market approval show no such data, as the pill was only effective in lowering LDL cholesterol in HoFH patients. After his illegal promotion, the FDA sent Beer a warning letter, reminding him that Juxtapid is not approved or labelled as a treatment to prevent heart attacks and lengthening life expectancy.

Juxtapid costs HoFH patients over $250,000 per year, and Aegerion is clearly hoping to get the drug prescribed in higher numbers in 2014. Confirming this, the company increased its sales predictions for 2013 from $15-25 million to $30-35 million, though the actual sales numbers are much, much higher. The company is projecting sales of $210 million for 2014.

A few months after the warning letter, the U.S. Department of Justice sent Aegerion a subpoena requesting documents related to the marketing and sales of Juxtapid. The federal investigation will undoubtedly lead to a hefty fine for Aegerion for its misbranding.

Fast Money interviewed Beer on June 5 and October 31, 2013. Among his misleading claims, he is quoted as saying that the drug can significantly lower the risk of death in younger patients, and that HoFH patients will suffer fatal cardiac events if not prescribed to Juxtapid therapy. Federal agencies could not let these statements slide, as they were both misleading and failed to address the true risks of such therapy.

Aegerion was swiftly asked to stop misbranding and recommending Juxtapid for unapproved uses. The company was also required to submit a plan of action to the FDA by November 22, 2013, correcting any misimpressions the public may have gleaned from the interview (a copy of the FDA warning letter can be read here).

Potential Lawsuits

If a drug is prescribed to you for uses not intended on its labels and you suffer a serious adverse event, you have every right to file a lawsuit, particularly if the drug’s manufacturer knowingly marketed it for unapproved uses. Similarly, if a prescription or over-the-counter drug causes a serious side effect that was not listed on its labels, patients may file a lawsuit for the manufacturer’s failure to warn. 

The rate of prescription drug use in the U.S. is extraordinarily high and only continues to rise. Too often, patients are unaware or misinformed of a drug’s actual risks because of fraudulent promotions such as Beer’s. The federal government is doing its part to warn manufacturers that this type of misrepresentation will not be tolerated. Injured patients need to have their voices heard too.

This is where we come in. Lawsuits are often the most efficient and effective way to change pharmaceutical company’s behavior. Anyone seriously injured or sickened by a prescription or over-the-counter drug should consider filing a claim against the manufacturer. If you have any questions related to filing such a claim, our team of drug injury lawyers is here to help. Our legal consultations are always free, and available to patients nationwide.