Products Liability
Recent news developments regarding the liver disease drug Ocaliva suggest this FDA-approved medication may pose previously unknown health hazards, including liver cancer. Although Ocaliva is a new medication that is not yet widely prescribed, it’s important to know the risks associated with this drug and what it could mean for your health.
What is Ocaliva?
Ocaliva (obeticholic acid) is a medication for the treatment of primary biliary cholangitis (PBC), a rare chronic liver disease. Ocaliva, is a bile acid analog, a chemical substance that has a structure based on a naturally occurring human bile acid, that selectively binds to and activates the farnesoid X receptor, or FXR. Ocaliva activates the receptor that regulates bile acid levels in the body.
According to manufacturer Intercept Pharmaceuticals, the drug is “indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.”
In effect, the drug prevents the buildup of bile, which can damage the liver’s ability to function over time. Ocaliva was approved by the Food and Drug Administration (FDA) in 2016. Ocaliva is used in combination with the standard PBC therapy, ursodeoxycholic acid, or alone in patients unable to tolerate first line of defense treatment.
The FDA’s New Concerns About Ocaliva
In September of 2017, the FDA issued an emergency health communication after 19 patients taking Ocaliva died and at least 11 others were discovered to have developed liver disease. The release advised consumers that excessive doses of the drug may result in serious liver injury or death. However, the FDA also reports that Ocaliva may also cause liver damage for those taking the correct dosage given other existing health factors. The release advises physicians to monitor patients taking Ocaliva and discontinue use if any liver injury is suspected.
We only know what happened in19 deaths. In seven of these tragic fatalities, the cause of death was listed as a worsening of primary biliary cholangitis. The other case identified cardiovascular issues.
We do not know quite what happened. The FDA expressed concern that perhaps the victims may have taken too much Ocaliva. The recommended starting dosage of Ocaliva is 5 mg, with a maximum weekly dosage of 20 mg.
In several cases, patients with moderate to advanced liver impairment were reportedly receiving Ocaliva daily in 5 mg doses. This amounts to 35 mg per week, well above the recommended maximum dosage. Whether there is any evidence to support this or whether this is just classic “blame the victim” is anyone’s guess at this point.
While the FDA’s next move is currently unknown, they may opt to issue a black box warning for Ocaliva. This warning informs consumers that a drug carries major health risks. In a public statement, Intercept announced that it has begun working with the FDA on updates to Ocaliva’s label to better ensure proper use.
Potential Symptoms and Side Effects of Ocaliva
If you are taking Ocaliva, be aware of the following possible indicators of liver injury:
More severe potential side effects from the drug include hepatitis, hepatic necrosis (tissue death in the liver), hepatic failure (liver failure), and death.
Relevant Verdicts and Settlements
Since Ocaliva has only been available to the public for a relatively short period, there are no recent verdicts or settlements with respect to its specific health hazards. However, it appears likely that future suits will arise given what we now know. If you are considering litigation, please note the information listed below:
- Nearly 30% of instances of acute liver failure were due to prescription drugs, over-the-counter medications, or dietary supplements.
- In the US, drug-induced liver failure (DILI) is the most common cause of acute liver failure. As new medications are tested in a pool of fewer than 5,000 people, DILI may not be found until after the drug has been approved.
- Adults are more at risk for DILI than children. Women are believed to be more susceptible than men.
- Hydroxycut, a line of weight loss supplements, were recalled in 2009 after products were linked to liver damage and at least one death. A $25.3 million class action settlement was reached in 2013.
- In February of 2017, Tylenol manufacturer Johnson & Johnson agreed to pay a confidential settlement resolving over 200 separate liver injury suits. Acetaminophen, Tylenol’s active ingredient, has been connected to hundreds of deaths and thousands of injuries requiring hospitalization.
There is currently a pending federal securities class action suit against Ocaliva manufacturer Intercept Pharmaceuticals. While not a medical malpractice matter, the suit alleges that Intercept violated securities laws by failing to disclose the serious health risks associated with Ocaliva. Basically, investors are mad that after this development the stock tanked from 118 to 52. The investors blame the failure of Intercept, to disclose to the shareholders that there was concern with Ocaliva. Why is this relevant to a tort lawsuit? The investors allege that Intercept “made false and/or misleading statements and/or failed to disclose that: (i) Ocaliva entailed undisclosed safety risks, including death, to patients suffering from PBC; and (ii) as a result of the foregoing, Intercept’s public statements were materially false and misleading at all relevant times.” This allegation will also be at the core of liver damage and wrongful death lawsuits filed against Intercept. In what may be a related story, this stock has continued to tank into 2022.
Ocaliva Litigation Update 2022
The claims in an Ocalvia lawsuit against Intercept would be that it intentionally downplayed safety concerns about Ocaliva with PBC patients and, with a focus on profits, pushed ahead with an application to approve the drug for the treatment of liver fibrosis due to nonalcoholic steatohepatitis, (NASH).
If you believe you have been harmed by Ocaliva or similar liver disease medication, call a lawyer. Our firm is not currently exploring these cases.
Why? The Ocaliva liver cancer lawsuits have not taken off as we expect they would with the FDA announcement last year. This could all change but we are on the sidelines for now. Hopefully, these concerns are not as serious as we originally feared when we wrote this page last year on Ocalvia lawsuits.