On January 23, 2015, Chimicles & Tikellis LLP filed an amended complaint on behalf of the Southeastern Pennsylvania Transportation Authority (“SEPTA”), as well as Jane Doe and John Doe (who are utilizing pseudonyms to protect their identities) in federal court in Philadelphia, PA against Gilead Sciences, Inc. (“Gilead”) related to the sale and pricing of its Hepatitis-C drugs, Sovaldi® and Harvoni®.
Sovaldi is the first drug approved by the Food and Drug Administration for certain types of Hepatitis-C infections that does not need to be injected. It can reportedly cure about 90 percent of patients with the most common form of Hepatitis-C in three to six months, and can do so with relatively minor side effects compared to earlier available treatments. Gilead has been selling a twelve week regimen of Sovaldi in the United States for approximately $84,000, or $1,000 per pill. This is significantly more than the original price projection for Sovaldi, and in sharp contrast to the prices at which the drug is being made available in other countries. Gilead recently announced its intention to make Sovaldi available in 91 developing countries at deeply discounted prices, and the drug is reportedly available in Egypt for 99% below the U.S. price. This obvious pricing paradox is under investigation by the Senate Finance Committee, which has questioned if the market for Sovaldi “is working efficiently and rationally,” and whether “payors of health care….can carry such a load.”
Harvoni received FDA approval in October 2014. Unlike Sovaldi, which must be taken in conjunction with another Hepatitis C drug, Harvoni is a complete, on-a-day pill that can be taken alone. It reportedly costs in excess of $94,000 for a 12 week regimen.
While there are some orphan drugs that are similarly expensive, they are typically limited to rare conditions that affect only a very small patient population. In those instances, charging high prices may be necessary to recoup amounts invested in research and development. In the case of Sovaldi and Harvoni, however, there are between 2.7 and 5.2 million people in the United States infected with Hepatitis C, and 185 million people worldwide. The amended complaint alleges that, if left unchecked, Gilead’s exorbitant pricing scheme has the potential to bankrupt segments of the U.S. healthcare system. According to the amended complaint, Gilead’s pricing practices have also had the effect of pricing certain consumers and government programs out of the Sovaldi and Harvoni markets, thus preventing sick patients from obtaining these critical drugs. The amended complaint also cites reports that Gilead’s pricing scheme has had a disproportionately high impact on minorities and those in lower income brackets (demographics that have had historically higher incidents of Hepatitis C infections). Meanwhile, Gilead has recorded an astounding $8.5 billion in Sovaldi sales through the first three quarters of 2014 alone and Bloomberg has predicted that Harvoni sales would total $1.8 billion in the fourth quarter of 2014.
The amended complaint alleges that, under these extraordinary circumstances, Gilead’s pricing cannot be justified by any patent rights it purports to have related to Sovaldi and Harvoni. The lawsuit seeks class action status on behalf of all persons and entities that have paid some or all of the purchase price of Sovaldi and/or Harvoni, and those who have been prevented from obtaining or having access to a needed Sovaldi and/or Harvoni regimen due to its excessive price. The amended complaint asserts causes of action for unjust enrichment, for violations of the Affordable Care Act and California’s Unfair Competition Law, and based on a breach of contract theory.
If you have paid for Sovaldi or Harvoni, or have been unable to obtain needed Sovaldi or Harvoni due to its cost, please contact the attorneys listed below to discuss our investigation.
Upcoming Case-Related Events
- On March 9, 2015, Gilead filed a motion to dismiss the case.
- On March 20, 2015, we filed a brief in opposition to Gilead’s motion to dismiss. A copy of the brief can be accessed here
- Gilead’s response to our opposition brief is due on March 30, 2015.
To view other press releases and pages related to the Gilead Sovaldi class action lawsuit, please go to Gilead Sovaldi Press Releases.
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