Acthar Lawsuit Lawyers
Acthar has been linked to potentially fatal injuries which include renal failure, dangerous blood sugar spikes and abdominal problems in nearly 14% of people given the drug. Acthar is prescribed for the treatment of infantile spasms; multiple sclerosis (MS); rheumatic diseases and disorders; dermatologic, ophthalmic and respiratory system problems.
Acthar Side Effects Life Threatening
The New York Times noted in a financial filing from Questcor – Acthar’s maker – that from Jan. 1, 2011 to Dec. 31, 2013, 1,022 patients reported 3,100 adverse side effects while taking Acthar, known widely as a multiple sclerosis drug. “The filing said that many users of the drug were seriously ill and faced life-threatening health risks.” Acthar gives Questcor some 95 percent of its revenues. The report also attributed twenty (20) deaths and six (6) severe disabilities to the drug from 2012 to now. Some 13 deaths were attributed to Acthar from January 2000 through 2011.
Acthar Financial Disclosures reveal Problems
Acthar’s life threatening side effects seem to have surfaced publicly only after the company received a $5.6 billion takeover bid from Mallinckrodt Pharmaceuticals last year. Questcor had not previously disclosed to investors any problems experienced by Acthar patients. Such information of Questcor’s potential liability is of obvious interest to investors, not to mention those who are candidates for taking the drug. Questcor’s disclosure followed a June 2014 report in The New York Times which analyzed the FDA’s Acthar adverse events data. Questcor has, as required by law, reported some of Acthar’s adverse events to FDA, the drug maker has not revealed Acthar’s adverse outcomes to investors such as Mallinckrodt.
Marketing the Orphan Drug
Questcor paid $100,000 in 2001 for the rights to Acthar. In 2010, FDA designated Acthar an orphan drug, which is a pharmaceutical that remains commercially undeveloped owing to limited potential for profitability. Questcor then proved that Acthar would not be unprofitable for long. Acthar was approved for the treatment of infantile spasms, a rare syndrome that can delay development in children under two.
Questcor has since aggressively marketed Acthar to doctors for treating other serious illnesses, including lupus, nephrotic syndrome and multiple sclerosis. The company has done that marketing without conducting extensive clinical trials to prove that Acthar is more effective for those diseases than much cheaper drugs, like steroids. The reason Questcor has gotten so far is that Acthar was approved back in 1952, before FDA required such trials; so Acthar was grandfathered in. The cost of the drug is enormous. A five-milliliter vial costs $28,000. In 2007, a single vial cost $1,650.
Acthar Class Action Lawsuit
The New York Times also reports that Questcor is under investigation for its marketing practices by the Securities and Exchange Commission (SEC) and by U.S. attorneys in both the Southern District of New York and the Eastern District of Pennsylvania. In 2012, Acthar maker Questcor was hit with a securities class action lawsuit in Calif. directly related to Acthar. The lawsuit alleges that Questcor – based in Anaheim, Calif. – as well as some of its directors and officers, violated the Securities Exchange Act of 1934.
Acthar Prescribers’ Conflicts of Interest
Though the company highlights a couple patient studies that show good results for people using Acthar for lupus and other illnesses, these are studies of small patient populations, and they were studies conducted by doctors paid by Questcor. Company filings show that Questcor paid doctors $3.2 million in financial grants in 2013 to support these small population studies initiated by paid investigators.
Acthar has 19 indications, which include:
- Rheumatic disorders: as adjunctive therapy for short-term administration
- Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus
- Dermatologic diseases: severe erythema multiforme, Stevens-Johnson syndrome
- Allergic states: serum sickness
- Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation
- Respiratory diseases: symptomatic sarcoidosis
If you or someone you love was injured by Acthar, contact an experienced Acthar Lawyer at Matthews & Associates for a free legal consultation. Please see our Testimonials for information about how we have helped others.
We will keep you up to date regarding any Acthar class action lawsuits, additional FDA Acthar warnings, and Acthar FDA recall announcements.