Ocaliva Frequently Asked Questions

If you have taken Ocaliva and had negative side effects that caused you injury, you have the right to seek financial compensation. The drug is primarily designed to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults that do not adequately respond to UDCA alone. However, certain side effects can occur that can severely damage a person's liver and even death has been reported.  When a defective drug injures you, you can file a defective products lawsuit against the manufacturer of the medication or file a medical malpractice lawsuit against a doctor who failed to warn you of the possible side effects.

If you or someone you love has been harmed by Ocaliva, the highly experienced attorneys at Gilman & Bedigian are here to fight for you. Here, we answer frequently asked questions about the medication, as well as what to do once you have suffered injury.

Frequently Asked Questions

1. What is Ocaliva?

Ocaliva is a pill that is prescribed to adults who suffer from primary biliary cholangitis (PBC). It is taken in combination with a different medication called ursodeoxycholic acid (UDCA). Ocaliva is intended to be used in combination with UDCA when UDCA is not enough, or for those patients who are unable to tolerate UDCA. The drug was approved by the FDA in 2016 for use by the American public.

2. What is primary biliary cholangitis (PBC)?

Primary biliary cholangitis, formerly known as primary biliary cirrhosis, is a disease that is caused by damage to the bile ducts of the liver. The small channels are intended to carry digestive fluid, or bile, from the liver to the small intestine. When they are damaged, it allows bile to build up in the liver, causing scarring, cirrhosis, and other severe side effects.

3. What are some of the side effects of Ocaliva?

Ocaliva can have very severe side effects that primarily affect the liver, the very organ it is designed to help protect. Side effects of Ocaliva include:

  • Hepatic failure
  • Hepatic necrosis
  • Liver failure
  • Drug-induced liver injury
  • Pruritus (itching of the skin)

These are all indicators of damage to the liver, possibly due to taking Ocaliva. Certain signs and symptoms can help you know if your liver is being damaged by Ocaliva.

4. What are the signs and symptoms of liver injury?

There are certain symptoms that, if you are experiencing them, may suggest that your liver is being damaged by Ocaliva, including:

  • decreased appetite
  • swollen abdomen
  • tenderness or pain in abdomen
  • nausea and vomiting
  • pale, cold, clammy, and bluish skin
  • blood in stool
  • rapid breathing
  • rapid heartbeat
  • yellow skin and eyes
  • increasing or sudden fatigue
  • new or worsening skin itching
  • confusion
  • anxiety
  • behavioral changes

If you are taking Ocaliva and are experiencing any of these symptoms, it is critical you talk to your doctor immediately.

5. What is a "failure to warn"?

Ocaliva has known risks and side effects, as mentioned above. Because of this, your doctor is required to warn you about the possible side effects of the drug before you are prescribed it.  The FDA first issued its emergency health communication regarding Ocaliva in September of 2017, so doctors should be aware of these possible dangers. If a doctor does not warn you, and you suffer injury as a result, a medical malpractice claim for a "failure to warn" may be appropriate in your case.

Your attorney can discuss with you the strengths of your case, and how best to proceed.

6. What is a products liability lawsuit?

A products liability lawsuit stems from when a manufacturer puts into the market a defective product of some kind that injures those that use that product. In the case of medications, the pharmaceutical company that manufactures the drug is responsible for your harm. When this is the case, the defective product can be the basis for a lawsuit to compensate you for the injuries you have suffered.

The maker of Ocaliva, Intercept Pharmaceuticals, is also accused of making false and misleading statements about the drug and its safety. The accusations allege that Intercept knew about the risks of liver injury and death before marketing the drug but failed to warn doctors of the risks. Intercept has subsequently released letters warning about the dangers of Ocaliva, suggesting they may have known about these issues prior to when they filed the warnings.

7. What experience does your firm have with Ocaliva lawsuits?

Our firm is highly experienced in representing patients injured by the use of Ocaliva. Our firm is also highly experienced in the area of medical malpractice law and product liability law. We understand the complicated medical issues associated with this medication, as well as how to prove that your injuries were caused by it. Our team of experts is ready to put in the time on your individual case to make sure your rights are protected.

8. What compensation can I receive?

An injured person is entitled to receive financial compensation in the form of money damages for any injuries that result from the use of Ocaliva. This financial compensation may include, but is not limited to:

  • cost of medical bills
  • future medical costs
  • rehabilitation costs
  • pain and suffering
  • lost wages
  • loss of consortium
  • damages related to loss of ability to get pregnant
  • wrongful death damages

These money damages can help make you whole again and help pay for the costs you have incurred already, as well as any future costs as well. You also deserve compensation for any lost work, as well as money damages for the pain and suffering you were forced to go through. You should not be on the hook for the costs of your injuries—only the responsible party should be.

Ocaliva Lawyers in Philadelphia

When Ocaliva causes you harm, you are entitled to bring a medical malpractice and/or products liability claim to receive financial compensation. The experienced attorneys at Gilman & Bedigian have the knowledge and years of practice to fight for your rights.

Contact us online or call our law office at (800) 529-6162 for a free consultation.

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If someone you are close to has been seriously injured or worse, you are naturally devastated not only by what has happened, but by the effect that the injury or loss has had on you and your family. At a time when you're vulnerable, traumatized and emotionally exhausted, you need a team that will support you through the often complex process that lies ahead.

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