Tag Archive for: mass tort

From Prescription to Plaintiff: How West Virginia Patients Can Join Pharmaceutical Mass Tort Cases

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A prescription from a trusted doctor represents a promise of relief and recovery. Patients in West Virginia and across the nation take medications believing they are safe and effective, a belief backed by the rigorous approval process of the U.S. Food and Drug Administration (FDA). But what happens when that trust is broken? What happens when a medication, instead of healing, causes unforeseen and devastating harm? For a growing number of people, the answer lies in a complex area of law designed to hold powerful pharmaceutical companies accountable.

When a single drug causes similar injuries to hundreds or even thousands of patients, the legal system provides a way for those individuals to band together and seek justice. This path is known as a mass tort.

What is a Pharmaceutical Mass Tort?

A mass tort is a legal action that allows a large group of individuals who have been harmed by the same product or action to file lawsuits against the same defendant. In the context of pharmaceuticals, this involves many patients who have suffered similar adverse side effects from a specific medication.

Think of it as a collection of individual lawsuits that are grouped together for efficiency. Unlike a class action, where everyone is treated as a single entity, a mass tort action preserves the individuality of each claim. Your specific injuries, medical history, and financial losses remain central to your case. The primary benefits of this approach are shared resources and consistent court rulings. By pooling legal expertise, expert witness testimony, and discovery efforts, plaintiffs can build a much stronger case than any single person could alone.

How Do Prescription Drugs End Up Harming Patients?

The journey of a drug from a laboratory to your local pharmacy is long and highly regulated. Despite this, dangerous drugs still reach the market. These failures can happen at several stages, leading to widespread patient harm. The legal claims in these cases typically fall into one of three categories:

  • Defective Design: This claim argues that the drug is inherently unsafe as formulated. Even if it is manufactured perfectly and prescribed correctly, its chemical makeup carries an unreasonable risk of harm that outweighs its potential benefits.
  • Manufacturing Defects: In these cases, the drug’s design is sound, but an error during the manufacturing process makes a specific batch or lot dangerous. This could involve contamination, incorrect dosage, or improper packaging that compromises the medication’s stability.
  • Failure to Warn (Inadequate Labeling): This is one of the most common grounds for pharmaceutical litigation. It alleges that the drug manufacturer knew or, through proper testing, should have known about a significant risk or side effect but failed to provide adequate warnings to doctors and patients on the drug’s label or packaging inserts.

What is the Difference Between a Mass Tort and a Class Action?

The terms “mass tort” and “class action” are often used interchangeably, but they represent two very different legal procedures. The distinction is important for any patient considering legal action.

Class Action Lawsuit

In a class action, a small number of named plaintiffs represent a much larger group, or “class,” of people. To proceed, a court must certify that the class members have claims that are so similar they are nearly identical.

  • Who is it for? Best suited for cases where many people have suffered the exact same type of harm, such as economic loss from a data breach or consumer fraud.
  • How are damages handled? Any settlement or verdict is divided among all class members, often according to a predetermined formula. The individual circumstances of each person are not the focus.
  • Example: A bank illegally charges 10,000 customers the same improper fee. One lawsuit is filed on behalf of everyone, and if successful, each customer receives the same refund.

Mass Tort Lawsuit

In a mass tort, a large group of people has been injured by the same product, but the nature and extent of their injuries differ.

  • Who is it for? Ideal for cases involving defective drugs or medical devices, where one patient may require a single corrective surgery while another may suffer a permanent disability.
  • How are damages handled? Each plaintiff has an individual lawsuit. While cases are grouped for pretrial proceedings, any settlement or award is based on the specific damages that particular plaintiff suffered.
  • Example: A prescription drug is found to cause kidney failure. Hundreds of patients file lawsuits. Each case is evaluated individually, as the severity of kidney damage, the need for dialysis or a transplant, and the impact on each person’s life and income will vary significantly.

How are Mass Tort Cases Organized?

When hundreds or thousands of lawsuits are filed across the country concerning a single drug, the federal court system has a mechanism to manage them efficiently: Multidistrict Litigation (MDL).

An MDL is created when a special judicial panel recognizes that numerous similar civil cases have been filed in different federal districts. The panel then transfers all of those cases to a single federal judge for all pretrial matters. This includes:

  • Discovery: The process of gathering evidence, such as internal company documents, scientific studies, and witness depositions. In an MDL, this is done once for all cases instead of hundreds of times.
  • Pretrial Motions: The judge makes key legal rulings that apply to all the consolidated cases.
  • Expert Witness Testimony: Both sides present testimony from medical and scientific professionals, which is then vetted by the court for all cases.

The purpose of an MDL is to promote efficiency, prevent inconsistent rulings from different judges, and encourage a global settlement. A case filed here in West Virginia will often become part of a larger MDL being managed in another state, but your local attorney remains your representative throughout the process.

What Types of Compensation Can Be Recovered in a Drug Injury Claim?

No amount of money can undo a serious medical injury. However, the civil justice system allows victims to seek financial compensation to cover the immense burdens caused by a dangerous drug. In West Virginia, these damages are typically divided into two categories.

Economic Damages

These are the calculable financial losses resulting from the injury. They include:

  • Past, current, and future medical expenses, such as hospital bills, corrective surgeries, medication costs, and physical therapy.
  • Lost wages from being unable to work.
  • Loss of future earning capacity if the injury results in a permanent disability.
  • Costs of rehabilitation and in-home care.

Non-Economic Damages

These compensate for the profound, intangible human losses that have no exact price tag. They include:

  • Physical pain and suffering.
  • Emotional and mental anguish, including depression, anxiety, and trauma.
  • Loss of enjoyment of life and the inability to participate in activities you once loved.
  • Loss of consortium, which addresses the negative impact the injury has on the spousal relationship.

What Steps Should You Take if You Believe a Medication Harmed You?

If you suspect that a prescription drug has caused you or a loved one to suffer a serious injury, it is important to act deliberately to protect your health and your legal rights.

  • Prioritize Your Health and Safety. Your first priority is your well-being. Speak with your doctor immediately about your symptoms and concerns. Do not stop taking a prescribed medication without medical guidance, but make sure your doctor is aware of the adverse effects you are experiencing.
  • Preserve All Related Evidence. Do not throw anything away. Keep the medication itself, the bottle, the box, the pharmacy receipts, and any instructional paperwork that came with it. This physical evidence can be very valuable.
  • Document Your Experience. Keep a detailed journal. Write down a timeline of when you started the medication, when your symptoms began, the specific nature of your symptoms, every doctor’s appointment, and any conversations you had with medical providers. Also, document how the injury is impacting your daily activities, work, and family life.
  • Obtain Your Medical Records. Request complete copies of your records from the doctor who prescribed the drug and from any hospital or specialist you saw for the treatment of your injuries. These records are the primary evidence in a pharmaceutical injury claim.
  • Speak with an Experienced West Virginia Mass Tort Attorney. These cases are among the most complex in personal injury law. A law firm with deep experience in this area can evaluate the merits of your claim, engage the necessary medical professionals to review your case, and navigate the strict procedural requirements of West Virginia law.

How Do You Prove a Defective Drug Claim in West Virginia?

To succeed in a pharmaceutical injury lawsuit, your legal team must establish several key elements. It is not enough to show that you took a drug and then suffered an injury; you must prove a direct link between the two.

  • You Suffered an Injury and Damages: You must demonstrate, through medical records and other evidence, that you sustained a tangible physical, emotional, and financial injury.
  • The Drug was Defective or the Manufacturer was Negligent: You must show that the drug was defectively designed, had a manufacturing flaw, or that the pharmaceutical company failed to adequately warn of known risks.
  • The Defect or Negligence Caused Your Injury: This is often the most contested element. Your attorney will work with medical professionals to establish “causation”—a direct link showing that the drug was a substantial factor in causing your specific health problem. This is a scientific and medical argument that requires strong expert support.

What is the Statute of Limitations for a Drug Injury Case in West Virginia?

A statute of limitations is a law that sets a strict deadline for filing a lawsuit. If you miss this deadline, you may lose your right to seek compensation forever. In West Virginia, the general statute of limitations for personal injury claims is two years.

However, for cases involving latent injuries from a drug, West Virginia law applies the “discovery rule.” This rule states that the two-year clock does not begin to run until the date that you knew, or reasonably should have known, that you were injured and that your injury was potentially caused by the defendant’s conduct (in this case, the drug).

Because the harmful side effects of a medication may not appear for months or even years, the discovery rule is a vital protection for patients. Determining the exact date the clock starts can be complex, making it important to speak with an attorney as soon as you suspect a link between your medical condition and a drug you have taken.

How Does Joining a Mass Tort Work?

The process of joining a pharmaceutical mass tort can seem intimidating, but an experienced law firm will guide you through every step.

  • Free Case Evaluation: It begins with a confidential consultation where you discuss your situation with an attorney. The legal team will review the facts of your case to see if you may have a valid claim.
  • Information Gathering: If the firm takes your case, they will begin collecting all your relevant medical records and other evidence needed to build your claim.
  • Filing a Lawsuit: A personal lawsuit is filed on your behalf in the proper court.
  • Transfer to an MDL: If an MDL exists for the drug that injured you, your case will likely be transferred to the MDL court for consolidated pretrial proceedings. You are still an individual plaintiff with your own case, but it is now managed alongside other similar cases.
  • Bellwether Trials: The MDL judge will select a small number of representative cases to go to trial first. These are known as “bellwether trials.” The outcomes of these trials provide valuable information to both the plaintiffs and the defendant about jury verdicts, which often paves the way for a large-scale settlement.
  • Settlement or Trial: If a global settlement is reached, your attorney will present you with the details and advise you on whether to accept it. The amount offered would be based on the severity of your specific injuries. If no settlement is reached, your case can be sent back to a West Virginia court for an individual trial.

Examples of Recent and Ongoing Pharmaceutical Mass Torts

Many widely used medications have become the subject of mass tort litigation. Some prominent examples include:

  • Opioids: Litigation against manufacturers and distributors for their role in the opioid crisis.
  • Zantac (Ranitidine): Lawsuits alleging the popular heartburn medication contained a cancer-causing impurity.
  • Elmiron: Claims that the bladder medication can cause serious and permanent vision problems.
  • Talcum Powder Products: Lawsuits linking long-term use of talc-based powders to ovarian cancer and mesothelioma.
  • Paraquat: Litigation filed by agricultural workers who developed Parkinson’s disease after exposure to the powerful herbicide.

Powell & Majestro, P.L.L.C.: Advocating for Injured West Virginians

A pharmaceutical company’s failure to ensure patient safety is a profound betrayal of trust. The legal team at Powell & Majestro, P.L.L.C. is dedicated to fighting for those who have been harmed by dangerous drugs and medical devices. We have the knowledge, dedication, and resources to take on powerful corporations and their insurance companies, building a strong, evidence-based case to pursue the full compensation you deserve.

If you believe a medication has caused serious harm to you or a family member, you do not have to face this fight alone. For a free, no-obligation consultation to learn more about your legal options, call our office today at (304) 346-2889 or reach out to us through our online contact form.

Tepezza Lawsuits: Patients Seek Justice for Permanent Hearing Loss

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In the realm of rare disease treatments, Tepezza (teprotumumab-trbw) emerged as a significant development for patients suffering from thyroid eye disease (TED). Developed by Horizon Therapeutics and approved by the FDA in January 2020, Tepezza became the first and only medication specifically designed to treat this uncommon autoimmune condition that can cause bulging eyes, double vision, and potential vision loss.

However, what began as a promising treatment for TED patients has become a source of concern for a growing number of individuals. An increasing number of patients who underwent Tepezza treatment are reporting an unexpected and troubling side effect: hearing loss. Reports of hearing impairment, tinnitus, and other auditory complications have raised serious questions about the drug’s safety profile within the medical community treating TED.

 

Tepezza: A Promising Treatment with Hidden Dangers

Tepezza (teprotumumab-trbw) was hailed as a groundbreaking therapy for thyroid eye disease (TED), offering hope to patients suffering from this rare and debilitating condition. Its approval by the FDA marked a significant step forward for individuals grappling with the symptoms of TED, such as eye-bulging, double vision, and potential vision loss. However, as more information has come to light, concerns have arisen about potential risks that may have been overlooked during its development and approval process.

 

Initial Purpose: Treatment for Thyroid Eye Disease

Tepezza was developed to address a significant unmet medical need for patients with TED. This innovative treatment offered several groundbreaking benefits:

  • It was the first and only FDA-approved treatment for TED.
  • Designed to reduce eye bulging, double vision, and other symptoms associated with TED.
  • Provided a non-surgical alternative for patients.

During clinical trials, Tepezza showed promising results, with 71% to 83% of patients demonstrating a significant reduction in eye protrusion compared to placebo groups. These outcomes generated widespread enthusiasm among healthcare providers and patients alike.

 

FDA Approval Process: Were There Overlooked Red Flags?

Tepezza’s approval by the FDA in January 2020 was based on two clinical trials involving a total of 170 patients. While the initial warnings focused on infusion reactions, inflammatory bowel disease exacerbation, and hyperglycemia, the risk of hearing impairment, including permanent hearing loss, was not prominently featured. It wasn’t until July 2023 that the FDA updated Tepezza’s label to include a specific warning about severe hearing impairment, raising questions about the thoroughness of the initial approval process.

 

Horizon Therapeutics’ Marketing vs. Reality

Horizon Therapeutics embarked on an aggressive marketing campaign to promote Tepezza. This campaign played a pivotal role in the drug’s financial success, yet it may have downplayed potential risks. Key elements of the marketing strategy included:

  • Generating $820 million in first-year sales, far exceeding analyst projections.
  • Launching a pre-approval disease awareness campaign six months before FDA approval.
  • Achieving 95% brand awareness among target physicians within three months of launch.

Despite the impressive marketing, post-market data began to reveal a starkly different reality for some patients. Studies have indicated that up to 65% of patients reported hearing problems after receiving Tepezza treatment. Additionally, lawsuits allege that Horizon Therapeutics failed to adequately warn patients and healthcare providers about the risks of permanent hearing loss, only updating the label years after its initial approval.

Uncovering the Link: The Long-Term Side Effects of Tepezza 

Tepezza (teprotumumab) has been a groundbreaking medication for treating Thyroid Eye Disease (TED), offering hope to many suffering from this debilitating autoimmune condition. However, as its use has become more widespread, a concerning pattern of hearing-related complications has begun to emerge. 

What was once considered a rare side effect is now understood to be a much more common and significant issue, impacting a substantial number of patients. Researchers and medical professionals have been actively working to uncover the precise link between Tepezza and these auditory issues, leading to a growing body of compelling scientific evidence that sheds light on the prevalence, types, and severity of these complications.

This increased awareness underscores the importance of both healthcare providers and patients being fully informed about the potential risks. Early detection and management of hearing changes are crucial for mitigating long-term impacts and ensuring the best possible quality of life for individuals undergoing Tepezza treatment. The journey to understanding this link has involved dedicated research and a re-evaluation of initial clinical trial data in light of real-world patient experiences.

Compelling Scientific Evidence

The initial clinical trials for Tepezza reported a relatively low incidence of hearing-related side effects, around 10%. However, as more patients received the drug in a real-world setting, anecdotal reports and subsequent studies have painted a different picture, revealing a significantly higher prevalence of auditory complications. Two key studies, in particular, have been instrumental in highlighting the true scope and nature of these issues:

Stanford Study Published in the American Journal of Ophthalmology (February 2022)

One pivotal study, conducted by Stanford University researchers and published in the American Journal of Ophthalmology in February 2022, raised significant concerns about the frequency of hearing-related side effects from Tepezza (teprotumumab). This study specifically evaluated 27 patients who had received at least four infusions of the medication. Strikingly, 81.5% of these patients (22 out of 27) reported experiencing new otologic symptoms following treatment—including hearing loss, tinnitus (persistent ringing or buzzing in the ears), and a sensation of ear plugging or fullness.

These findings revealed that hearing issues were far more common than initially reported in Tepezza’s clinical trials, where only about 10% of patients were documented to have hearing-related side effects. The discrepancy highlighted the need for more rigorous pre-treatment hearing assessments and ongoing monitoring during and after therapy. The critical data from this single influential study have helped reshape the understanding of Tepezza’s side effect profile, emphasizing the importance of post-marketing surveillance and appropriate patient care practices.

Types and Severity of Hearing Complications

Patients treated with Tepezza have reported a diverse range of auditory issues, which can vary considerably in their specific presentation and severity. Understanding these different manifestations is crucial for both diagnosis and management. The commonly reported symptoms include:

  • Sensorineural hearing loss (SNHL): This is a type of hearing loss that results from damage to the inner ear (cochlea) or the nerve pathways from the inner ear to the brain. It can range from mild to profound and may affect one or both ears. SNHL is often irreversible, which makes its occurrence a significant concern for Tepezza patients.
  • Tinnitus: Described as a phantom sound, tinnitus can manifest as ringing, buzzing, hissing, clicking, or roaring in the ears. Its intensity can range from a minor annoyance to a debilitating condition that significantly impacts a patient’s quality of life, interfering with concentration, sleep, and overall well-being.
  • Ear plugging or fullness sensation: Many patients describe a feeling of pressure or blockage in their ears, as if their ears are “plugged.” This sensation can be uncomfortable and may or may not be accompanied by actual hearing loss.
  • Autophony: This is an unusual and often disturbing symptom where a person perceives their own voice or other internal bodily sounds (like breathing or chewing) as unusually loud or resonant in their ears. It can be quite disorienting and can make conversations difficult.
  • Hypoacusis: Characterized by a decreased sensitivity to sound, meaning sounds are perceived as quieter than they actually are. This is essentially another term for hearing loss, but it specifically emphasizes the reduced perception of volume.
  • Hyperacusis: The opposite of hypoacusis, hyperacusis is an increased sensitivity to everyday sounds, which are perceived as uncomfortably or painfully loud. Sounds that most people tolerate easily, like running water or normal conversation, can become overwhelming.

The onset of these symptoms typically occurs after three to four infusions of Tepezza, suggesting a cumulative effect of the medication on the auditory system. This pattern allows for a window of opportunity for early detection and intervention if regular monitoring is in place.

While some patients have reported improvements in their hearing symptoms over time after discontinuing Tepezza, a significant number have experienced persistent or long-term issues. This highlights the potential for permanent damage and underscores the seriousness of these side effects.

Risk Factors and Monitoring

An important finding in the research is the identification of a history of prior hearing loss as a potential risk factor. This emphasizes the critical need for comprehensive pre-treatment evaluations for all patients being considered for Tepezza therapy. 

Such evaluations should include a detailed audiological assessment, including pure-tone audiometry and possibly other tests, to establish a baseline hearing status. Knowing a patient’s pre-existing hearing condition allows clinicians to identify individuals who might be at higher risk and to monitor them even more closely throughout their treatment course.

Furthermore, ongoing monitoring during therapy is paramount. Regular audiological assessments should be incorporated into the treatment protocol for all patients receiving Tepezza. 

This allows for the early detection of any changes in hearing function, enabling clinicians to intervene promptly. Early intervention could involve adjusting the treatment plan, managing symptoms, or referring the patient to an audiologist or ENT specialist for further evaluation and support.

The long-term implications of these hearing complications, especially sensorineural hearing loss, can significantly impact a patient’s quality of life, affecting communication, social interaction, and overall well-being. 

Therefore, a proactive and vigilant approach to monitoring and managing hearing health is an indispensable component of Tepezza treatment. The evolving understanding of this link between Tepezza and hearing loss empowers both healthcare providers to offer better care and patients to make more informed decisions about their treatment journey.

Types and Severity of Hearing Complications

Patients treated with Tepezza have reported a range of auditory issues, which can vary in severity. Commonly reported symptoms include:

  • Sensorineural hearing loss (SNHL)
  • Tinnitus (ringing in the ears)
  • Ear plugging or fullness sensation
  • Autophony (unusually loud perception of one’s own voice)
  • Hypoacusis (decreased sound sensitivity)
  • Hyperacusis (increased sound sensitivity)

The onset of symptoms typically occurs after three to four infusions. While some patients experienced improvements over time, others reported persistent or long-term issues. Importantly, a history of prior hearing loss has been identified as a potential risk factor, emphasizing the need for comprehensive pre-treatment evaluations and ongoing monitoring during therapy.

The Legal Battle: Holding Horizon Therapeutics Accountable

The growing number of lawsuits against Horizon Therapeutics has shed light on the company’s alleged negligence in addressing Tepezza’s risks. This litigation highlights key issues that patients and healthcare providers must consider when weighing the benefits and risks of this medication.

To address these claims, the formation of multidistrict litigation (MDL) was a pivotal step in consolidating and managing the increasing number of cases.

 

Formation and Growth of the Tepezza MDL

The MDL aimed to consolidate pretrial proceedings and ensure consistent rulings across similar cases. Key milestones include:

  • August 2023: MDL formed with 41 cases.
  • November 2024: MDL expanded to 180 pending cases.

 

Key Allegations Demonstrating Manufacturer Negligence

Plaintiffs have raised several allegations of negligence against Horizon Therapeutics, including:

  • Failure to warn patients and providers despite early indications of hearing loss risks.
  • Insufficient pre-market testing, with approval based on limited clinical trials.
  • Delay in updating the product label to reflect known risks of hearing impairment.

These allegations underscore the importance of transparency and rigorous testing in ensuring patient safety.

 

The Human Cost: Patients’ Struggles

The impact of hearing loss extends far beyond physical symptoms, profoundly affecting the lives of patients and their families. This human toll underscores the importance of addressing Tepezza’s risks.

 

Life-Altering Impacts of Permanent Hearing Loss

Hearing loss can have profound effects on a patient’s quality of life. Common challenges reported by Tepezza patients include:

  • Communication difficulties leading to social isolation.
  • Increased risk of cognitive decline and dementia.
  • Challenges in professional settings, affecting career prospects.
  • Loss of enjoyment in daily activities, such as listening to music or attending social gatherings.

 

Emotional and Financial Burdens

Beyond physical symptoms, hearing loss imposes significant emotional and financial burdens on patients and their families. These include:

  • Mental health struggles, including depression and anxiety.
  • Strained relationships due to communication barriers.
  • Financial costs for hearing aids, treatments, and potential loss of income.

For many patients, these challenges represent not only the physical consequences of hearing loss but also the emotional toll of adapting to an unexpected and often debilitating condition.

 

Horizon Therapeutics’ Negligence: A Closer Look

Critics have scrutinized Horizon’s actions surrounding Tepezza, suggesting lapses in addressing known risks and ensuring patient safety. These criticisms form a central theme in ongoing litigation.

Timeline of Knowledge vs. Action

The timeline of Horizon’s actions suggests a delay in addressing known risks. Early patient reports and studies indicated potential hearing issues, yet the label was not updated until July 2023. This delay is a central issue in the ongoing litigation.

Critique of Post-Market Surveillance Efforts

Critics argue that Horizon’s post-market monitoring efforts fell short. Delayed responses to safety signals and insufficient proactive monitoring have drawn scrutiny, highlighting the need for robust post-market surveillance systems.

 

The Ongoing Fight for Justice in Tepezza Litigation

The litigation surrounding Tepezza continues to evolve as more patients come forward, seeking accountability for the drug’s alleged risks.

As of December 2024, there are 191 pending cases in the Tepezza MDL. Bellwether trials are expected to begin in 2026, offering plaintiffs an opportunity to test the strength of their claims in court. These trials are likely to set the tone for future settlements and may provide valuable insights into how juries perceive the allegations against Horizon Therapeutics.

Legal experts estimate settlement amounts ranging from $75,000 to over $200,000, depending on the strength and circumstances of individual cases. These settlements could provide much-needed relief for affected patients, helping them cover medical expenses, lost wages, and other costs associated with their hearing loss.

Powell & Majestro, experienced leaders in pharmaceutical mass tort litigation, are dedicated to advocating for individuals who have suffered hearing loss or other auditory complications after Tepezza treatment. If you or a loved one has experienced hearing problems following Tepezza infusions, we encourage you to reach out to our firm. Our team of skilled attorneys is prepared to evaluate your case as part of the ongoing Tepezza multidistrict litigation (MDL).

Contact us today for a free, confidential consultation to discuss your legal options and potential inclusion in this important MDL. Let us help you seek the justice and compensation you deserve.