Attorneys for Uloric Lawsuits and Claims

Patients harmed by taking the drug Uloric as a treatment for gout may have grounds for a lawsuit against the manufacturer based on design defect and a failure to warn about dangerous side effects and complications. Uloric is prescribed to reduce the level of uric acid in the blood, but studies have shown dangerous side effects such as heart attack, stroke, unstable angina and even death.

People injured by Uloric may be eligible for sizeable compensatory damages for:

  • All doctor- and hospital-related bills
  • Pain and suffering
  • Lost wages
  • Loss of future earnings, and/or
  • Punitive damages (if applicable)

If the victim died, his or her family may be able to bring a wrongful death claim to recover money for

  • medical expenses,
  • loss of contributions,
  • funeral expenses, and
  • pain and suffering.

Patients bringing a lawsuit must do so within the statute of limitations for their state, which can range from one to five years from the time of the injury.

In this article, our personal injury attorneys answer frequently asked questions about potential Uloric lawsuits, including negligence claims, standards of proof, and statutes of limitations.

Uloric
Uloric is prescribed to reduce the level of uric acid in the blood, but studies have shown dangerous side effects such as heart attack, stroke, unstable angina and even death.

1. What is Gout and How is it Treated?

Gout can be a very painful condition, but you shouldn't die or be injured from the medication you take to treat it. A complex form of arthritis caused by a buildup of uric acid, gout attacks occur when uric acid crystals form and cause intense joint pain and swelling in the big toe or other joints. Uloric, also known as febuxostat, is a medication used to treat gout, especially for those who cannot take Zyloprim (allopurinol) because of an adverse reaction or ineffectiveness. Acting as a xanthine oxidase inhibitor, Uloric reduces the levels of uric acid in the blood to prevent the sudden attack of gout.1

Approximately 3 to 8 million American adults suffer from gout attacks each year, with the condition being more likely to occur in male patients. It is estimated that the drug has been taken by hundreds of thousands of patients in the United States since 2009.

2. What clinical trials were conducted after Uloric was introduced?

Uloric has been on the market for the past 10 years. It was approved for use in the United States in 2009, but the initial clinical trials did show an increased risk of strokes and heart attacks. The Federal Food and Drug Administration (FDA) required drug manufacturer Takeda Pharmaceuticals to conduct a large post-market safety clinical trial and to put a warning label on the drug's packaging to warn of the increased risk.

A seven-year clinical trial with 6,000 subjects was conducted by Takeda starting in 2010 to comply with the FDA requirement. All study participants had gout as well as established cardiovascular disease, such as a previous heart attack, stroke, hospitalization for chest pain (unstable angina), peripheral arterial disease, or both diabetes and small vessel disease.2 In the test subjects who took Uloric, researchers found an increased risk of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring intervention called unstable angina. It also confirmed that patients are more likely to die using Uloric than those using the drug Zyloprim (allopurinol) for the treatment of gout.3

“The results were consistent across many subgroups; there was no evidence of a relationship with age, gender, race or ethnicity, history of cardiovascular disease, or duration or severity of the gout,” said William B. White, MD, principal investigator of the trial and the study's lead author.4

In 2012 a Takeda safety consultant filed a whistleblower lawsuit, claiming the manufacturer did not report the true details of the severity and high risk of side effects from taking Uloric for gout. The consultant also said Takeda did not disclose the risks to patients when combining Uloric with other medications such as imuran, methadone, warfarin and digoxin.

In November 2017, the FDA ordered the drug company to further study the heart-related risks of Uloric. Concluding that there is an increased risk of death from Uloric, in February 2019 the FDA ordered a boxed warning to be put on the product's packaging, as well as a new patient medication guide. A boxed warning is the strongest warning that the FDA requires, and signifies medical studies have shown the drug carries a significant risk of serious or even life-threatening adverse effects. The FDA is also limiting the approved use of Uloric to certain patients who either have an adverse reaction to allopurinol or for whom that drug has not been an effective treatment.

hospital patient
There are legal options if you or a family member suffered certain side effects by Uloric

3. What can I do if I was injured by Uloric?

If you or a family member has already suffered any of the following side effects of Uloric taken for gout, you could have grounds to initiate a lawsuit for compensation against the manufacturer Takeda:

  • Heart attack
  • Heart-related death
  • Unstable angina
  • Stroke
  • Pulmonary embolism (PE)
  • Deep-vein thrombosis (DVT)

4. What Money Can I Get?

People injured by Uloric may be eligible for compensation for:

  1. All doctor- and hospital-related bills
  2. Pain and suffering
  3. Lost wages
  4. Loss of future earnings, and/or
  5. Punitive damages (if applicable)

If the victim died, his or her family may be able to bring a wrongful death claim to recover money for medical expenses, loss of contributions, funeral expenses, and pain and suffering.

As of this date, Uloric lawsuits are filed individually by each plaintiff and are not class actions. Please contact us at The Shouse Law Firm LLP at (855) 396-0370 if you have any concerns after taking Uloric.

5. How Would I Prove a Uloric Claim?

In order to recover damages in a personal injury case, a plaintiff generally needs to prove three things:

  1. That the defendant owed the plaintiff a duty of care;
  2. That the defendant breached such duty through negligence; and
  3. That the defendant's negligence was a substantial factor in causing the harm (“causation”).5

A person is negligent when he or she fails to act the way a reasonably careful person would in the same situation.

A negligence lawsuit against Uloric's manufacturer Takeda would allege that:

  • The manufacturer was negligent in developing the drug because it causes a disproportionately high number of injuries.
  • The manufacturer failed to warn physicians or patients about the elevated risks of the side effects of the drug, which in turn caused heart attack, stroke, unstable angina and heart-related deaths.
  • The manufacturer concealed its research and withheld information which showed that the drug had problems.

Consequently, plaintiffs would argue that these breaches in duty committed by the defendants caused their injuries.6

Plaintiffs in negligence lawsuits in California have to prove that it is more likely than not that the defendant was negligent. This standard of proof is called, "by the preponderance of the evidence." Therefore, evidence that typically figures into medical lawsuits include:

  • The plaintiff's medical history and records
  • Expert medical testimony drawing a causal connection between the drug and the victim's injuries
  • Marketing materials and labels that show the defendant omitted key information warning physicians and patients of possible hazards

6. How much will filing a lawsuit cost me?

Shouse Law Group charges clients no upfront costs or fees. We do not receive any fees unless and until you settle your claim or win at trial.

And while we will fight to get you the biggest settlement possible, we will never pressure you to settle your claim quickly just to make a quick buck. With years of courtroom experience, we are not afraid to take a good case to trial in front of a jury.

We invite you to call us at (855) 396-0370 to discuss your case at no cost with a caring California personal injury attorney.

7. Our Results

Our recent achievements include a number of multi-million dollar settlements on behalf of our clients.

But whether you have been a small case or a large one, our lawyers and experts will review all the evidence and interview witnesses to make sure you get the most from the manufacturer's opposing lawyers.

And unlike some firms, we are not afraid to take cases to trial in front of a jury.

Our practice is headed by trial lawyers Neil Shouse and Michael Scaffidi. Together they have tried over 100 cases with an impressive success rate.

Neil Shouse is a Harvard Law School graduate who has been a litigator with some of the nation's top law firms -- including global law firm Sidley Austin LLP — and a Deputy District Attorney with the Los Angeles County District Attorney's office.

Michael Scaffidi is a former police officer and Avvo 5-star rated lawyer who handles both civil and criminal matters throughout Southern California. Thanks to his background as a police sergeant and a private investigator, he is particularly skilled at handling cases involving catastrophic injuries, vehicle accidents, wrongful death and anything requiring the use of technical or medical experts.

Neil and Michael oversee a team of knowledgeable lawyers, investigators, medical professionals, paralegals, and legal assistants who will make sure that you and your case get the attention you deserve.

8. Resources

Additional informational websites and news articles include:

The New England Journal of Medicine - Cardiovascular Safety of Febuxostat or Allopurinol in Patients with GoutProPublica - FDA Repays Industry by Rushing Risky Drugs to Market

ProPublica - FDA Repays Industry by Rushing Risky Drugs to Market

Public Citizen – Public Citizen (founded by Ralph Nader) Files a Citizen Petition with the FDA Seeking the Withdrawal of Uloric from the Market

Call us for help...

uloric attorneys
Call us at (855) 396-0370

Legal References

  1. Therapeutic Effects of Xanthine Oxidase Inhibitors: Renaissance Half a Century after the Discovery of Allopurinol, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2233605/

  2. Febuxostat Increases Death Risk for Gout Patients With Heart Disease, Study Finds, https://www.ptcommunity.com/news/20180313/febuxostat-increases-death-risk-gout-patients-heart-disease-study-finds

  3. FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat), https://www.fda.gov/Drugs/DrugSafety/ucm631182.htm

  4. Febuxostat Increases Death Risk for Gout Patients With Heart Disease, Study Finds, https://www.ptcommunity.com/news/20180313/febuxostat-increases-death-risk-gout-patients-heart-disease-study-finds

  5. CACI No. 400. Negligence—Essential Factual Elements, Judicial Council of California Civil Jury Instructions (2017 edition)

  6. CACI No. 400. Negligence—Essential Factual Elements, Judicial Council of California Civil Jury Instructions (2017 edition)

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