We don’t usually report on litigation. Although legal cases often involve a LOT of scientific evidence, the outcomes are not always trustworthy. Just because a jury finds a product deficient or dangerous does not mean it deserves condemnation. And if a company is let off the hook, it does not necessarily mean a product is safe. That said, there were two BIG settlements this week that deserve attention. The Purdue Pharma company agreed to pay $270 million to the state of Oklahoma for damages attributed to OxyContin. An even larger settlement was reached by Bayer and Johnson & Johnson involving the anticoagulant Xarelto. The companies will pay $775 million to settle over 25,000 lawsuits.
What Happened in Oklahoma?
The drug company behind OxyContin (oxycodone) is Purdue Pharma. It has been accused of deceptive marketing practices. In particular, the company was charged with downplaying the risk of addiction associated with OxyContin.
60 Minutes has done an investigative piece titled “The Opioid Epidemic: Who is to Blame?” Here is a link. You can watch a segment labeled: “Did the FDA ignite the opioid epidemic.” Here is a tiny part of the report:
“60 Minutes obtained a court order to get the minutes to secret meetings in 2001 between the FDA and Purdue Pharma, the maker of OxyContin. The documents reveal that the FDA bowed to Purdue Pharma’s demands to ignore the lack of science supporting long-term use and changed the OxyContin label to “around the clock … for an extended period of time.” This gave big pharma the green light to push opioids to tens of millions of new pain patients nationwide.”
Back to Oklahoma. A big trial was scheduled for May, but this week Purdue Pharma decided to settle to the tune of $270 million. The company did not admit to any misdeeds. This was a no-fault settlement.
The money will be directed to a center that will do research and provide education about addiction. Okalohoma State University will receive funds directed to addiction treatment medicine.
The Tip of the Litigation Iceberg:
Many other states are pursuing litigation against Purdue Pharma. The New York Attorney General just filed a lawsuit against Purdue, the family that owns the company and several other opioid manufacturers and drug distributors. As one person described the litigation stew, the blood is in the water and the sharks are circling.
We have no doubt that a great many people have suffered because of opioid misuse. There is another side to this disaster, though. Many people in severe, chronic pain have been cut off from the medications that allowed them to function. Should you be interested in this aspect of the story, here are two links:
Xarelto (Rivaroxaban) and the $775 Million Settlement
This week Johnson & Johnson (J&J) and Bayer agreed to settle roughly 25,000 lawsuits to the tune of $775,000,000. The companies work together to sell this anticoagulant.
Xarelto is indicated for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE) and to prevent blood clots that might cause strokes for people with atrial fibrillation (AFib). It is also prescribed to prevent blood clots in patients who have had hip or knee replacements. Patients with heart disease or peripheral artery disease (PAD) may also get a prescription for Xarelto to reduce their risk of heart attacks or strokes.
Patients or their surviving family members claimed that they were not adequately warned that the drug could cause potentially fatal bleeding. Neither Bayer nor J&J accepted liability.
The thousands of lawsuits were all about the opposite of blood clots: hemorrhage. Patients and/or their families sued the two companies on the grounds that they failed to warn about the possibility of potentially fatal bleeding events.
Although J&J and Bayer have not admitted any culpability, they did agree to settle thousands of lawsuits. $775 million will pass hands from the drug companies to the lawyers and their clients. J&J says that it still stands behind Xarelto. And Bayer is quoted as saying that the company remains committed to Xarelto.
We’re not surprised that the companies will continue to support Xarelto. According to the New York Times (March 25, 2019), Xarelto brought in “nearly $2.5 billion in revenues” in 2018.
Want to Learn More About Xarelto?
Here are some articles we have written about this anticoagulant:
Aspirin Or Xarelto?
This is a fascinating question. Here is some research you may find interesting:
And there there is this extraordinary study:
A Word of Caution:
No one should EVER stop taking Xarelto suddenly! Doing so could increase the risk of a blood clot. The black box warning that comes with the official prescribing information states:
“Premature discontinuation of XARELTO increases the risk of thrombotic events
“Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. If anticoagulation with XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.”
If a switch to another anticoagulant is called for, it will require very careful supervision by a physician who is knowledgeable about such issues!
What Do You Think?
Share your own Xarelto story below in the comment section. What do you think about the OxyContin Settlement with Purdue Pharma?