Nadrich Accident Injury Lawyers is representing those who have sustained serious liver injuries after taking Ocaliva (obeticholic acid). Call us today for a free consultation if you or a loved one:
- Took Ocaliva
- Suffered a serious liver injury
- Did not have cirrhosis at the time of the injury
We have been representing those injured by dangerous medications since 1990 and have recovered in excess of $750,000,000 for our clients. Our vast experience in helping those injured by dangerous medications will let us recover the most compensation possible on your behalf.
If you cannot afford to have your serious liver injury treated, we may be able to help you get to a doctor who can treat you on a lien, meaning you won’t be charged for treatment until your case is over. Doctors do this for our clients because doctors know that our law firm gets great results for our clients.
We will handle your Ocaliva case on a contingency fee basis, meaning we won’t charge any fee until and unless we recover money to compensate you for your injury. Our only fee to handle your Ocaliva claim will be a percentage of any compensation we recover for you – no upfront or out-of-pocket fee will be charged.
Call us today for a free consultation, text us from this page or fill out this page’s free case evaluation form if you or a loved one suffered a serious liver injury or died from a liver injury after taking Ocaliva. Our dangerous medication lawyers can help you recover compensation for medical bills, lost wages, loss of earning capacity, pain, suffering, wrongful death and more.
Intercept Pharmaceuticals should have tested Ocaliva more, and knew or should have known that Ocaliva could cause serious liver injuries, yet failed to adequately warn patients and doctors about this risk. Let us hold them accountable for your injury. Call us today.
Compensation Available in an Ocaliva Lawsuit
If you or a loved one has suffered a liver injury after taking Ocaliva, our law firm can help you recover financial compensation for:
Medical Bills
You are probably already facing medical bills if you or a loved one has been injured by Ocaliva. In addition, the liver injury may require future treatment which will generate yet more medical expenses. We can help you recover compensation for all past and future medical bills related to your liver injury.
Lost Wages
If you have been left too sick to work due to your liver injury, or you have had to miss time from work to have your liver injury treated, we can help you recover compensation for the wages you were unable to earn because of this.
Loss of Earning Capacity
If your liver injury has left you permanently disabled, this may represent a reduction or loss of your earning capacity which we can help you recover financial compensation for.
Pain and Suffering
Your liver injury may have caused you to suffer physical pain and mental suffering, which we can accurate calculate the value of and make sure you are financially compensated for.
Wrongful Death
If you have lost a loved one due to a liver injury caused by Ocaliva, financial compensation will unfortunately not be able to bring your loved one back. However, financial compensation can help make sure your family won’t have to endure financial hardship due to losing your loved one to a liver injury. We can help you recover financial compensation for:
- The grieving and suffering you have had to endure
- The pain and suffering your loved one endured prior to passing
- The medical bills your loved one incurred prior to passing
- Your loved one’s funeral and burial costs
- The loss of your loved one’s love, income, companionship, spousal benefits and household services
Grounds for an Ocaliva Lawsuit
Drug manufacturers are strictly liable for injuries caused by drug defects.
There are three types of drug defects which drug manufacturers can be held liable for:
- Manufacturing defects: This is when something goes wrong during the manufacturing process of a drug. For example, the drug could get contaminated during the manufacturing process.
- Design defects: This is when the drug is defective and dangerous even when made and used properly. The drug is defective by design.
- Failure to warn defects: This is when drug manufacturers fail to provide adequate warnings about risks, or fail to provide adequate instructions on how to mitigate or avoid risks.
In the case of Ocaliva, it appears that the drug contains a design defect and a failure to warn defect.
It appears that the drug is defective by design because no manufacturing defects have been reported, yet the drug still appears to cause serious liver injuries in patients, even when they do not have cirrhosis.
It appears the drug has a failure to warn defect because the drug’s labeling does not warn about the risk of serious liver injuries in those without cirrhosis, even though the drug manufacturer knew or should have known about this risk.
If you or a loved one has been injured by Ocaliva, we can file a lawsuit on your behalf seeking strict liability based on design defect and failure to warn defect. Call us today for a free consultation.
What Is Necessary to Win an Ocaliva Lawsuit?
In order to win a lawsuit over a liver injury caused by Ocaliva, you will need to be able to prove in court that:
- You took Ocaliva during a specific time frame. Pharmacy records, surgery reports and medical records can be used in order to prove this.
- You suffered a serious injury to your liver. Medical records will be used in order to prove this.
- You suffered damages because of the harm which was caused by Ocaliva. Damages may include medical bills, lost wages, disability, pain, suffering and wrongful death.
You will need to be able to prove all of the above in order to win the lawsuit, which is why it is vital to work with a skilled attorney.
Call us today so we can put our skill and vast experience to work for you.
Do I Need a Lawyer?
Yes, you’re going to need a lawyer if you want to take on a pharmaceutical company in court. Intercept Pharmaceuticals intakes hundreds of millions of dollars per year in revenue, so they can afford lawyers who you can’t hope to beat in court without a lawyer of your own.
Dangerous medication cases are more complicated than your typical personal injury case. It’s not always necessary to have expert testimony in order to prove liability in cases involving slip-and-fall accidents or car accidents.
However, in dangerous drug lawsuits, you’ll require medical professionals and specialists to demonstrate how Ocaliva hurt you. While personal injury cases always require the plaintiff to prove that they were injured by the defendant, medication cases are more difficult. As an example, in car accident cases, it’s fairly simple to demonstrate fault when you’re struck by someone running a red light. However, with dangerous drugs, you’ll require medical evidence to prove that Ocaliva harmed you. Pharmaceutical companies like Intercept Pharmaceuticals will pay experts a fortune in order to disprove your claims as well as argue that they’re not liable for injuries. You can be outmatched easily if you aren’t completely prepared to fight.
In a lot of dangerous medication cases, plaintiffs need to navigate complicated legal theories regarding failure to warn or product design. For example, you might argue that the drug has a defective design, or that Intercept Pharmaceuticals didn’t adequately warn users regarding possible risks. These claims require scientific evidence such as expert testimony, clinical trials and studies in order to prove that Intercept is at fault.
In addition to scientific hurdles, dangerous drug cases are costly and time-intensive. These lawsuits commonly involve a long discovery process, wherein plaintiffs and defendants exchange expert reports, pharmaceutical documents and medical records. Litigation may last years, and Intercept Pharmaceuticals has the resources to mount an aggressive defense. They could offer a settlement, but this might be a lot lower than you deserve should you not be prepared for trial.
This is why it is vital to have lawyers with the resources and experience to take on a large pharmaceutical company. We understand the complexities of dangerous drug litigation. We have handled countless defective drug cases. With our experience, we know how to put together strong cases, hire expert witnesses, and fight to recover the justice and compensation that you deserve. Call us today.
FDA Warns of Serious Liver Injury in Ocaliva Patients
In December 2024, the FDA warned about serious liver injuries being observed in Ocaliva patients who did not have cirrhosis.
The agency identified serious injuries in patients taking Ocaliva to treat primary biliary cholangitis (PBC), which is a rare chronic liver disease. The patients were not suffering from cirrhosis.
The cases of liver injury were identified in a postmarket clinical trial. The trial found that death and liver transplant risks were higher in those taking Ocaliva compared to those taking a placebo.
Seven out of 81 patients taking Ocaliva required a liver transplant. Only one out of 68 patients taking a placebo required a liver transplant.
Four patients taking Ocaliva died, compared to only one patient who was taking a placebo.
The agency indicated that those taking Ocaliva should undergo frequent liver testing to spot worsening liver function in patients suffering from PBC, making sure the drug is appropriately discontinued when need be. However, the agency warned that, based upon current data, it isn’t clear whether this monitoring will be enough to address the risk of liver injury such as liver failure.
The agency indicated that PBC patients taking Ocaliva should talk to healthcare professionals about the safety risk as well as any benefits of continuing to take the medication.
The warning came after, in 2017, the FDA warned that Ocaliva was causing liver injury in those being incorrectly dosed, and may share an association with liver injury in patients receiving correct doses. The warning noted that 19 Ocaliva patients died and at least 11 patients had developed liver disease.
Symptoms of Serious Liver Injury
The FDA advises that patients taking Ocaliva contact a healthcare professional immediately should they develop any of the following side effects, which might indicate a serious liver injury:
- Yellow skin or eyes
- Swollen belly
- Vomiting or coughing up blood
- Black or bloody stools
- Mental status changes like difficulty waking up, increased sleepiness, changes in personality, mood swings, slurred speech or confusion
In addition, the FDA advises that patients taking Ocaliva seek immediate medical attention if they develop any of the following side effects which are severe or fail to disappear within a few days:
- Diarrhea, vomiting or nausea
- Stomach pain
- Worsening or new tiredness
- Weight loss or loss of appetite
- Chills and fever
- Weakness
- Less frequent urination
- Lightheadedness
Once patients develop liver failure, they could experience symptoms such as:
- Liver cancer
- Fluid retention
- Bleeding disorders
- Coma
- Seizures
- Fluid building up in the brain
What Is Ocaliva?
Ocaliva is a medication used to treat primary biliary cholangitis. It was approved by federal regulators in 2015 for the use along with ursodeoxycholic acid (UDCA), by those who have shown an inadequate response to UDCA, or by adults unable to tolerate the use of UDCA, with the intent of improving liver function and slowing disease over time.
Ocaliva works by activating the farnesoid X receptor (FXR). This receptor is responsible for regulation of liver functions involved in your metabolism, like bile acid and glucose metabolism. PBC damages the liver by producing bile acid buildup. Ocaliva, by activating this receptor, reduces exposure to bile acid in the liver by:
- Increasing flow of bile acids out of your liver
- Limiting how much bile acid is in your liver
FXR also regulates three separate stages of PBC:
- Fibrosis (liver stiffness)
- Inflammation (liver cell damage)
- Cholestasis (bile buildup)
Call Us Today for a Free Consultation
Call us today for a free consultation if you or a loved one died or suffered a serious injury to the liver after taking Ocaliva. We’ve been handling dangerous drug cases for over 30 years and have recovered hundreds of millions of dollars for clients. We won’t charge you any fee until and unless we recover compensation for your liver injury, so there’s no risk behind calling us since you’ll never owe us even a penny out of your own pocket. Call us today.
