In early September, news reports surfaced regarding a $10-12 Billion settlement Purdue Pharma LP proposed to reduce its liability and to end the thousands of lawsuits filed against it.1 The primary driver of the lawsuits has been dozens of states claiming that they have been damaged by the additional cost of medical care to treat people addicted to oxycodone. They allege that the product is highly addictive, that Purdue and its ownership family the Sacklers knew about it, and that they did nothing to prevent the damage its caused, even going to the extent of deceiving the public and medical professionals about its addictive nature.
Families whose members have overdosed on the product (or other drugs like fentanyl or heroin) have also filed cases. Over 400,000 people have died in the U.S in the past 20 years from oxycodone overdose. The settlement is part of a “prepackaged” bankruptcy filing where a company that has been subjected to numerous lawsuits signs a deal with the other parties then files bankruptcy to have the court administer all of the cases and claims. Purdue filed its bankruptcy case on September 15.
Before the settlement, Purdue ran a few advertisements stating that it really cares about the safety of the product and that it has taken efforts over the years to improve its safety profile. While these statements may have some kernels of truth to them, it just seems a bit disingenuous when placed against its factual behavior.
Part I — Citizens Petitions
ParagraphFour.com and its other database FDAPetitions.com follow market activity — PIV cases and citizens petitions. These data points tend to tell a different story.
Starting back in 2004, 15 years ago, citizens petitions were submitted to FDA — from a variety of entities from the State of Connecticut to concerned health care professionals to patients2— regarding the safety of OxyContin as well as encouraging restrictive use of the product or even its removal from the market. These would include opioids as a class of drug as well. Purdue often responded to these petitions, assuring FDA and the public that the product had enough safeguards and has been safely used by millions. FDA denied many of these petitions.
Purdue went to further lengths to file its own petitions. These petitions sought to inhibit generic ANDA filers from reaching the market. Often arguing about the “uniqueness” of its formulation or legal procedure, Purdue asked FDA to deny approval of ANDA products in its effort to create another barrier of entry for a competitive product.3
The petitions establish two things: (1) the risk of oxycodone addiction and abuse was well-known by the early 2000’s and (2) Purdue used the petition process in what may be considered an aggressive manner. While their petition responses and filed petitions try to establish concern for patient safety, the risk was well-known, and yet the company made several attempts to deflect these concerns and inhibit competition. The actions seem to defy the stated intent.
Of course, responding to petitions and submitting petitions is certainly legal, as is aggressively defending one’s product. But there is a broader point when addiction and lives are at risk.
Part II of this post will cover Purdue’s behavior in the Paragraph IV Market.
1 See for example, “Purdue Tentatively Settles Claims,” The Wall Street Journal, by Sara Randazzo and Jared Hopkins, September 12, 2019. Some additional data for this blog post are taken from this article.
2 See for example, 2004P-0043, 2005P-0076, 2009P-0227, et al.
3 See for example, 2006P-0511, 2007P-0232, 2011P-0433, 2012P-0760, et al.