A Uloric lawsuit is a mass tort claim for the serious side effects caused by the popular prescription medication for gout, Uloric. This medication (Febuxostat) has been linked to an increased risk of cardiovascular death, leading to numerous lawsuits that seek compensation for:
- Medical expenses,
- Lost wages and reduced earning capacity,
- Pain and suffering, and
- The family's loss of companionship.
- 1. What is Uloric?
- 2. Who manufactures Uloric?
- 3. Side effects and complications associated with Uloric
- 4. FDA takes action over Uloric's increased risk for cardiovascular death
- 5. Lawsuits against Takeda over heart problems caused by Uloric
- 6. Compensation for victims of Uloric
- 7. What to do if you have been taking Uloric
1. What is Uloric?
Uloric is a prescription medication for gout, which is a type of arthritis that is caused by high levels of uric acid in someone's blood. Uric acid can crystallize in a patient's tendons and joints if there is too much of it in the bloodstream. These deposits of solidified uric acid create the sensation of stiffness, swelling, and pain, and can drastically decrease the mobility of the person suffering from it.
Uloric, which comes in the form of a pill, decreases the amounts of uric acid in a patient's bloodstream. This prevents the uric acid buildups in a patient's tendons and joints that cause gout.
2. Who manufactures Uloric?
Currently, Uloric is made and sold in the U.S. by Takeda Pharmaceutical Co. However, Uloric was first discovered and produced by a different Japanese pharmaceutical company, Teijin Pharma.
The current manufacturer of Uloric, Takeda Pharmaceutical, is a massive Japanese company that was formed in Osaka, Japan as early as 1781. It was not until 1977, though, that Takeda first began to enter the U.S. drug market through a partnership it formed with the U.S. drug company Abbott Laboratories. That partnership, called TAP Pharmaceuticals, led to the introduction of numerous drugs in the United States in addition to Uloric, including:
- The antibiotics Cefonomil and Cefmax,
- The sleeping pill Estazolam, and
- Leuprorelin, also known as Lupron, a hormone supplement that can treat certain cancers.
Takeda Pharmaceutical is the largest drug company in all of Asia, and one of the largest in the entire world. It claims revenues of approximately $16 billion every year.1 Takeda employs around 30,000 people, mainly at its global headquarters in Tokyo. Around 5,000 of Takeda's employees are based in the U.S. Most of them used to be in Takeda's main U.S. office in Deerfield, Illinois, a suburb of Chicago. However, Takeda moved most of its U.S. operations to its offices in Boston in September, 2018.2
While Takeda Pharmaceuticals is currently responsible for manufacturing Uloric, that was not always the case. Teijin Pharma first synthesized the drug that would become Uloric in 1998. Teijin had noticed that the existing drug for treating gout – a drug called allopurinol, which was sold under the brand name Zyloprim – was generically available, had been in use since 1966, and was known to occasionally cause severe and even fatal dermatological side effects like toxic epidermal necrosis and Stevens-Johnson syndrome.3 Teijin Pharma set out to distill a new drug that carried fewer risks.
After creating Uloric, Teijin Pharma joined the TAP Pharmaceuticals partnership to market the drug in the U.S. with Takeda and Abbott Labs. When the TAP partnership dissolved in 2008, Teijin continued to work with Takeda, with Takeda taking responsibility for Uloric in the U.S.
3. Side effects and complications associated with Uloric
Uloric has been associated with numerous side effects and medical complications.
Some of the most common side effects are also the least severe. They include:
- Skin rashes,
- Muscle weakness,
- Numb fingers or toes,
- Shortness of breath or difficulty breathing,
- Joint pain, and
- Stiffness and swelling in the joints.
Uloric has also been known to cause more severe side effects, as well. These include:
- Gout flare-ups,
- Liver problems, including liver enzyme abnormalities,
- Severe skin reactions, like Stevens-Johnson Syndrome,
- Heart attacks,
- A diminished flow of blood to the heart, also known as unstable angina,
- Strokes, and
- Cardiovascular death.4
3.1. Uloric and cardiovascular problems
Out of all of the side effects and medical complications that Uloric can cause, the most significant is the increased risk for potentially fatal cardiovascular problems.
The risk of these cardiovascular problems was known to the U.S. Food and Drug Administration (FDA) very early on. When the FDA was considering Takeda Pharmaceutical's request to approve Uloric for use in the U.S. in 2009, it expressed concern with the likelihood that Uloric could cause heart problems. While these concerns were not strong enough for the FDA to refuse the approval of Uloric, outright, it did lead the FDA to issue several conditions on Uloric's approval.
First, the FDA refused to approve the dose levels that the Takeda Pharmaceutical Company had requested. Takeda had wanted Uloric to be approved in 80 and 120-milligram doses. However, the FDA would only approve doses of 40 and 80 milligrams because of the possibility that the drug could cause heart problems in larger doses.5
Second, the FDA included a warning on Uloric's marketing label that mentioned the possibility for Uloric to cause cardiovascular problems.6
Finally, the FDA required Takeda to conduct a postmarket clinical trial to test whether Uloric carried a risk of cardiovascular problems for people who took it to treat their gout.
This clinical trial was supposed to begin on January 31, 2010, and be submitted to the FDA five years later.7 However, the results were not released until June 14, 2018, only a short time before Takeda's patent protection for Uloric in the U.S. was set to expire.
The clinical trial, called the CARES trial,8 was both randomized and double-blind, but contained no control group taking a placebo pill. Instead, it tracked 6,198 people in the U.S. and Canada who were either taking Uloric or Zyloprim – the older gout medication that was first sold in 1966 – for their gout. Over the course of several years, the CARES trial would monitor the participants for cardiovascular events like:
- Heart-related death,
- Heart attacks, or
- Unstable anginas.
More than half of the participants completed the trial, with almost exactly half of them taking Zyloprim and Uloric.
The results of the CARES trial were mixed, with similar totals for nonfatal heart conditions like heart attacks and strokes:
Uloric (3,098 (100%))
Zyloprim (3,092 (100%))
Nonfatal Heart Attack
Nonfatal Unstable Angina
However, the CARES trial revealed that people who took Uloric tended to die from cardiovascular events or other conditions at a significantly higher rate than those who took the older drug, Zyloprim.9
4. FDA takes action over Uloric's increased risk for cardiovascular death
After the release of the results from the CARES trial, the FDA found it necessary to take further action over Uloric's risk of causing cardiovascular problems and fatalities.
First, the FDA issued a safety announcement, which stressed to doctors and patients that Uloric carried a higher risk of heart problems than the other gout treatment, Zyloprim.10 This safety announcement also narrowed the FDA's list of approved uses of Uloric to only include patients who had already tried Zyloprim but who had experienced adverse reactions or did not respond well to the drug.
The safety announcement also told patients taking Uloric to be on the lookout for symptoms of heart attacks or strokes, like:
- Chest pain or pressure,
- Difficulty breathing,
- Sudden difficulties talking,
- A strong and sudden headache,
- Irregular heartbeat, or
- A feeling of numbness or weakness that was limited to one side of the body.
In addition to the FDA's safety announcement, the FDA also updated Uloric's warning label. The new warning label for Uloric included a box warning that prominently warned doctors and patients about the risks of developing a potentially fatal heart condition from taking Uloric.11 The addition of a box warning to Uloric's warning label is significant because box warnings are reserved for life-threatening health risks that the FDA considers to be significantly heightened by a drug.
5. Lawsuits against Takeda over heart problems caused by Uloric
Since the FDA took action over the increased cardiovascular risks posed by Uloric, hundreds of lawsuits have been filed against the Takeda Pharmaceutical Company. These lawsuits claim that Takeda failed to warn doctors and patients of the risks of taking Uloric.
Doctors rely on drug companies to list the ways that the drug can hurt patients. Only with that information can doctors tell their patients about the potential for harm that can come with the drug or make prescriptions that are in the patient's best interests. Patients also rely on a drug company's disclosures so they can gauge for themselves whether it is worth taking a drug for their medical condition, or whether the side effects are too common or severe.
However, drug companies have a financial incentive to limit the disclosures they make about the potential risks that come with taking their products. If they disclose too many risks or admit to too many side effects, it can deter doctors from prescribing their drugs, cutting into the company's profits.
To force drug companies to disclose the risks of taking their products, the law recognizes a legal duty for drug companies to warn the public of reasonable risks to patient health.
The lawsuits against Takeda claim that the pharmaceutical company failed to uphold these legal duties when they did not adequately disclose the risks for potentially fatal heart problems from taking Uloric.
As of May 2019, these Uloric lawsuits are in the early stages of the litigation process. While there are no class actions, yet, and none of the individual claims have been consolidated into multidistrict litigation (MDL), Uloric lawsuits are mass tort claims that are ripe for one of these legal maneuvers that would streamline the process for victims to recover compensation.
Mass torts are injuries suffered by numerous people and that were caused by the same course of conduct by the same person or company.
Because mass torts result in hundreds or even thousands of lawsuits filed by victims across the country for the same incident, courts have come up with ways to consolidate them. This makes the legal process more efficient, saves everyone time and money, and prevents the awkward outcome where nearly identical cases end with drastically different results.
Increasingly, courts have seemed to favor the multidistrict litigation process over class actions. MDLs consolidate mass tort lawsuits into one federal district court for the pretrial procedures that would be identical in nearly all of the cases, like:
- Depositions of experts and defendants,
- Gathering of evidence,
- Motions to dismiss the case, and
- Summary judgment motions.
MDLs frequently culminate in bellwether trials, which take representative cases from the MDL through a jury trial. By giving each side's lawyers an idea of how a jury will respond to each claim, the result of a bellwether trial can drastically alter the outcomes of the other cases in the MDL.
6. Compensation for victims of Uloric
The lawsuits filed by victims against Takeda for their side effects caused by Uloric all seek compensatory damages. These damages are financial compensation for all of the ways that victims have suffered as a result of the cardiovascular problems caused by Uloric, and include:
- Medical bills paid for treatment,
- Anticipated medical expenses in the future,
- Lost wages from the recovery process,
- Reduced ability to earn a living because of the lasting repercussions of the cardiovascular problems caused by Uloric,
- Costs of home modifications made necessary by mobility problems caused by Uloric,
- Physical pain and mental suffering, and
- Loss of companionship felt by the victim's family.
Unfortunately, because the cardiovascular events that Uloric can cause are frequently fatal, many of the lawsuits filed against Takeda are wrongful death claims filed on behalf of a victim by the victim's loved ones. The nature of the compensatory damages that successful wrongful death claims can recover is different than what is available in a lawsuit filed directly by the victim. Rather than aiming to compensate the victim, wrongful death claims aim to compensate the victim's families for their loss.
Regardless of whether the lawsuit is filed by a victim or their family, Uloric lawsuits also seek punitive damages against Takeda to punish the pharmaceutical company for failing to warn of the dangers of taking Uloric. These lawsuits are still very early in the process, though, so it unclear if juries will award punitive damages to victims. In other mass tort claims where evidence was unearthed that showed that drug companies covered up dangers to patients, though, punitive damages have been awarded in substantial amounts.
7. What to do if you have been taking Uloric
If you have gout and have been taking Uloric to treat it, there are several things that you can do to stay safe.
The first thing you can do is see your doctor and discuss your medical options. There are other medications that you can take for your gout, including Zyloprim, the earlier gout treatment drug. In fact, the FDA no longer approves Uloric to treat your gout if you have not tried using Zyloprim and been dissatisfied. By discussing your medication options with your doctor, you can make an informed decision about your health and possibly avoid further cardiovascular risk.
You can also closely monitor your heart health by looking for the symptoms of the cardiovascular events that Uloric is known to cause. The symptoms of a stroke include:
- Numbness or weakness on one side of your body,
- A sudden and intense headache,
- Speech problems, or
- An irregular heartbeat.
The signs of a heart attack include:
- Intense chest pain, constriction, or pressure,
- Dizziness, or
- Shortness of breath.
Call us for help...
If you or a loved one has taken Uloric and suffered a cardiovascular event, talking to a lawyer can be an important next step. The statute of limitations requires Uloric lawsuits to be filed soon after an injury was suffered – often within two years – so learning your legal rights and filing a lawsuit has to be done fairly quickly. The defective drug lawyers at the Shouse Law Office can help you understand the process and your legal options. You can call us at 855-LAWFIRM to learn your rights and how to invoke them to recover the compensation you need and deserve.
See Takeda Press Release, “Takeda reports FY2017 full-year results and issues FY2018 guidance,” (May 14, 2018).
Lisa Schencker, “Takeda's U.S. headquarters in Deerfield, where 1,000 people work, to close,” Chicago Tribune (September 11, 2018).
Chung WH, Wang CW, Dao RL, “Severe cutaneous adverse drug reactions,” Journal of Dermatology 43(7):758-66 (July 2016).
See note 5.
See Choi H, Neogi T, Stamp L, Dalbeth N, Terkeltaub R, “New Perspectives in Rheumatology: Implications of the Cardiovascular Safety of Febuxostat and Allopurinol in Patients With Gout and Cardiovascular Morbidities Trial and the Associated Food and Drug Administration Public Safety Alert,” Arthritis Rheumatology 70(11):1702-9 (November 2018).
FDA Drug Safety Communication, “FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat),” (February 21, 2019).
See note 4.