Prescription medications are meant to help us heal, manage chronic conditions, and improve our quality of life. But when a drug turns out to be defective, the consequences can be devastating. Patients may suffer serious injuries, permanent health complications, or even lose their lives due to side effects they were never warned about.
These claims aren’t simple, and they’re not something to take lightly. Drug litigation involves scientific evidence, federal regulations, and often, powerful pharmaceutical companies backed by extensive legal teams. In this blog, we’ll define defective drug injuries, notable defective drug cases, and the legal challenges involved in these cases.
Overview of Defective Drug Injuries
Defective drug injuries occur when a medication causes harm that outweighs its intended benefits. These injuries can stem from improper testing, undisclosed side effects, manufacturing errors, or misleading marketing, and the results can be life-changing for patients and families.
Pursuing legal action for a defective drug isn’t just about compensation; it’s about accountability. Drug manufacturers have a legal and ethical responsibility to ensure their products are safe when used as directed. When they fail to meet that standard, the consequences can be severe.
Definition and Scope of Defective Drugs
A drug is considered defective when it poses unreasonable risks to consumers, especially when those risks are not adequately disclosed. This can include both prescription and over-the-counter medications that:
- Were improperly tested before FDA approval
- Were marketed for uses not backed by clinical evidence
- Contained design or manufacturing flaws
- Failed to warn doctors and patients about serious side effects
Common Side Effects and Health Risks
The consequences of defective drug use can vary widely depending on the product and the individual. Some of the most serious health complications include:
- Birth defects in children exposed during pregnancy
- Organ failure or chronic internal damage
- Development of certain types of cancer
- Blood clots, strokes, or cardiovascular events
- Worsening of mental health conditions or onset of new psychiatric symptoms
- Long-term disability or even death
These aren’t mild, temporary side effects—they’re serious, life-altering outcomes that can carry physical, emotional, and financial burdens for years to come.
Notable Defective Drug Cases
Over the years, several high-profile cases have exposed serious flaws in how some drugs reach and remain on the market. The cases below have captured national attention and illustrate the importance of proper legal handling in this area of law.
Zantac and Cancer Risk
Zantac (ranitidine) was once a widely used heartburn medication. But in 2019, independent testing found that it could produce high levels of NDMA—a probable human carcinogen—under certain storage conditions. This led to a full market recall in 2020. Lawsuits soon followed, alleging that manufacturers knew or should have known about the risk and failed to warn consumers.
While initial litigation gained momentum, much of the Zantac multidistrict litigation (MDL) has shifted, with some claims dismissed and others still under review. As with many drug cases, proving liability involves overcoming significant legal hurdles, including FDA preemption and evidentiary burdens related to causation. Murphy & Prachthauser is not currently accepting Zantac cases, and we caution potential claimants against firms that may still be advertising for them despite the MDL’s changed status.
Risperdal and Physical Deformities
Risperdal, an antipsychotic prescribed for schizophrenia and other disorders, has faced scrutiny for its association with gynecomastia, the abnormal development of breast tissue in male patients. Plaintiffs alleged that the manufacturer, Johnson & Johnson, failed to adequately warn about this risk.
Some Risperdal lawsuits have resulted in high-profile verdicts, including one exceeding $8 billion (later reduced). However, many of these cases have already been resolved or dismissed, and the litigation has largely run its course.
Tasigna and Stroke Risk
Tasigna (nilotinib), a leukemia medication, has been linked to atherosclerosis-related conditions, including stroke, heart attack, and peripheral artery disease. Plaintiffs in emerging cases allege that the manufacturer failed to warn of the potential for serious vascular complications associated with long-term use.
Because FDA-approved labeling has evolved over time, and because of the regulatory protections afforded to drug manufacturers, litigation against Tasigna involves significant legal and scientific challenges. Cases like this require volume, experience, and strategic alliances with major firms who have the resources to pursue them aggressively.
Valsartan NDMA Contamination
In 2018, global recalls were issued after carcinogenic NDMA was discovered in several batches of Valsartan, a commonly prescribed blood pressure medication. The contamination was traced to overseas manufacturers, prompting widespread concern and litigation. A federal multidistrict litigation (MDL #2875) was established to consolidate thousands of claims, and bellwether trials are now underway.
This is one of the few ongoing drug cases with substantial traction and national coordination. However, it’s important to note that the viability of individual claims depends on many factors, including proof of use, injury, and timing.
Elmiron and Vision Damage
Elmiron (pentosan polysulfate), a drug used to treat bladder pain, has been linked to pigmentary maculopathy, a serious and often irreversible eye disease. After growing concern, a New Jersey-based MDL was created in 2020 to manage the growing number of lawsuits.
Early bellwether cases have progressed, and some confidential settlements have already been reached. This litigation remains active, but highly technical. It requires detailed medical records and expert analysis.
Invokana Amputation Risk
The diabetes drug Invokana (canagliflozin) received a black-box warning from the FDA in 2017 after studies showed a heightened risk of lower-limb amputations. Between 2018 and 2022, class-action lawsuits alleged that the manufacturer failed to provide adequate warnings about these risks. Some settlements were reached, but much of the litigation has now concluded, and the black box warning was removed in 2020.
Murphy & Prachthauser no longer accepts Invokana cases because most of the actionable claims have either been resolved or are no longer financially viable to pursue. This is a common scenario with defective drug cases; once the litigation has peaked and settled, reopening individual claims is rarely possible, especially without MDL leadership support.
Xeljanz Blood Clot & Mortality Warnings
In 2021, the FDA issued a boxed warning for Xeljanz (tofacitinib) after studies revealed increased risks of pulmonary embolism, heart-related events, and mortality in certain patients. This warning led to a surge of lawsuits from individuals who experienced these adverse outcomes, and label updates followed soon after.
As with many defective drug cases, timing and scientific causation are critical. Some cases are still in early stages, but others may already be closed to new filings. Murphy & Prachthauser works only with litigation teams who are leading these efforts and caution potential clients against signing up with firms who are no longer actively involved.
Proton Pump Inhibitors and Chronic Kidney Injury
Proton pump inhibitors (PPIs) like Nexium and Prilosec have come under scrutiny for alleged links to chronic kidney disease and renal failure after long-term use. MDLs were formed starting in 2022 to coordinate claims. Bellwether trials are in development, but as of now, no major settlements have been announced. This is an example of a complex, ongoing litigation where partnering with an established, well-resourced firm is critical.
Fosamax Atypical Femur Fracture Claims
Fosamax (alendronate), a treatment for osteoporosis, has faced legal challenges over its potential to cause rare femur fractures. After years of dormancy, the Third Circuit revived more than 500 state-law claims in 2024, reopening the door to litigation over failure-to-warn allegations against Merck.
While this may create new opportunities for certain plaintiffs, Murphy & Prachthauser remains selective. Any case we accept must align with active MDL leadership and demonstrate clear potential for resolution or trial.
Pradaxa Bleeding Risk Litigation
Pradaxa (dabigatran) is an anticoagulant that has been tied to severe bleeding events and, in some cases, wrongful death. Plaintiffs allege that the drug’s warnings were insufficient and failed to alert users to life-threatening risks. While MDLs and individual suits have surfaced over the years, litigation status varies by jurisdiction.
If you or a loved one has been harmed by a drug like Pradaxa, confirm that the case is still active and viable before pursuing litigation.
Tepezza Hearing Loss Claims
Tepezza (teprotumumab), prescribed for thyroid eye disease, has been linked to permanent hearing loss and tinnitus. Lawsuits have emerged since 2022, and the FDA has issued safety communications urging greater awareness of these risks. The litigation is in early development, with initial filings and case building still underway.
Like many new cases, Tepezza claims must be evaluated carefully. Until there’s clear direction and leadership from proven firms, Murphy & Prachthauser remains cautious and only engages when the groundwork for a strong case is in place.
Other Notable Cases
Other drug products have also raised concerns, including:
- Ozempic: Alleged links to gastroparesis and other gastrointestinal issues
- Suboxone: Reports of dental decay linked to long-term sublingual use
- Depo-Provera: Alleged links to brain and spinal tumors
- Zofran: Concerns over birth defects when used off-label during pregnancy
While some of these cases may be under review or in very early stages, it’s important to note that not all are actively being litigated at a national level. Murphy & Prachthauser never pursues claims based on rumors or speculation. Instead, we follow the facts, the law, and the leadership of firms we trust.
Legal Framework for Defective Drug Injuries
The legal process behind defective drug claims is complex. These cases involve a combination of product liability law, federal regulation, and scientific evidence. While every situation is unique, understanding the legal foundation can help you see what’s involved and why working with the right legal team is so important.
Product Liability in Defective Drugs
Manufacturers, distributors, and sometimes even retailers can be held liable when a drug causes harm due to a defect. In drug litigation, defects usually fall into three categories:
- Design defects: The drug is inherently dangerous, even when manufactured and used as intended.
- Manufacturing defects: Something went wrong during production that contaminated or altered the drug.
- Failure to warn: The drug was sold without adequate warnings about known or foreseeable risks.
Proving liability requires more than showing that the drug caused harm. Plaintiffs must demonstrate that the manufacturer knew or should have known about the danger and failed to take appropriate action. This is particularly difficult in the pharmaceutical industry, where regulatory protections often give companies the benefit of the doubt, unless there is evidence they withheld information from regulators.
Role of the FDA and Drug Recalls
The U.S. Food and Drug Administration (FDA) oversees the approval, labeling, and post-market surveillance of all medications. However, FDA approval is not a blanket defense for manufacturers. In fact, if a company fails to provide full and accurate information to the FDA during the approval process, that opens the door for legal action.
When the FDA learns of safety concerns, it may require label changes, issue warnings, or, when necessary, initiate a recall. Keep in mind that just because a drug is recalled doesn’t mean an individual claim will succeed. The legal system still requires a strong evidentiary foundation, medical proof, and expert support.
Mass Tort Cases vs. Class Action Lawsuits
Defective drug litigation often involves thousands of injured patients, but not all cases are handled the same way. Two common legal structures are:
- Mass torts: Each plaintiff files an individual case, which is consolidated for pretrial proceedings (often in an MDL). While evidence and strategy are shared, each case is judged on its own facts.
- Class actions: One or a few plaintiffs represent a larger group with nearly identical injuries. Any judgment or settlement applies equally to the entire class.
With most defective drug injuries, mass torts are more appropriate because injuries vary widely in severity, duration, and personal impact.
Proving a Defective Drug Injury Claim
Defective drug injury claims require legal and medical evidence showing that the defect in the drug was a substantial factor in causing your injury. Without that link, even the most tragic outcome may not meet the legal standard for compensation.
Establishing Injury and Causation
At the heart of any drug injury claim is the need to prove that the drug directly caused the harm you experienced. This includes:
- A confirmed injury: Such as organ damage, a diagnosis of cancer, or permanent physical effects
- Evidence of a drug defect: Due to contamination, a design flaw, or lack of adequate warnings
- A causal link: Between the drug and the injury, supported by scientific data and medical records
Causation is often the hardest part to prove. Patients may have pre-existing conditions, take multiple medications, or face other health risks. That’s why these cases require a careful review of the full medical picture, not assumptions or guesswork.
Legal and Medical Investigations
Once a potential claim is identified, in-depth investigations begin. These may include:
- Medical record reviews to identify timelines, dosages, and adverse reactions
- Expert analysis from doctors, pharmacologists, and regulatory specialists
- Scientific research showing how the drug behaves in the body and how it may have caused harm
- Legal research into FDA filings, label changes, internal documents, and manufacturer disclosures
These investigations take time and resources. Because of this, Murphy & Prachthauser only works with national litigation leaders who have the manpower, medical networks, and courtroom experience to see these cases through. We don’t cut corners, and we don’t chase cases without merit. If we pursue a claim, it’s because the evidence supports it.
The Impact of Defective Drugs on Patients
The effects of defective drugs go far beyond the initial injury. While litigation can offer a path toward justice, no legal outcome can undo the harm done. Below, we examine how defective drugs affect real people, their families, and the broader healthcare system.
Mental Health Consequences
Experiencing a drug injury can be traumatic. In addition to the physical toll, many patients suffer from anxiety, depression, or post-traumatic stress related to their condition. The shock of being harmed by something that was supposed to help—combined with the uncertainty of treatment, legal options, and long-term prognosis—can create lasting emotional strain.
Family members, too, may struggle with guilt, fear, or exhaustion as they support their loved one through the aftermath. These mental health impacts are often overlooked, but they are very real and they deserve attention in both medical care and the legal process.
Patient Safety vs. Pharmaceutical Profits
The pharmaceutical industry plays a vital role in public health, but there’s a hard truth we can’t ignore: sometimes, profits take priority over safety. In several major drug injury cases, documents have shown that manufacturers delayed warnings, downplayed risks, or pushed products to market without adequate testing.
This imbalance between patient safety and corporate gain erodes trust in the entire system. Unless drugmakers are held accountable through litigation, there is little incentive to change. Defective drug cases matter for everyone who relies on safe, transparent medical care, not just those who were directly harmed.
Physical Health and Long-Term Sequelae
Some defective drug injuries heal with time, while others result in chronic illness, permanent disability, or the need for ongoing care. Common long-term consequences include:
- Organ damage
- Neurological disorders
- Vision or hearing loss
- Reproductive harm or birth defects
- Increased cancer risk
According to data from the Centers for Disease Control (CDC), adverse drug events (ADEs) are responsible for more than 1.5 million emergency room visits and 5000,000 hospitalizations annually in the U.S. For patients affected by a defective medication, recovery often involves repeat surgeries, specialist care, rehabilitation, or assistive devices, all of which can drastically alter quality of life.
Economic and Financial Burden
With chronic illness often comes financial strain. Victims of drug injuries may face:
- Out-of-pocket medical expenses
- Hospitalizations and long-term care
- Lost income or job loss
- Insurance claim denials
- Disability-related costs
- Debt accumulation and, in some cases, bankruptcy
Even with insurance, the costs of treatment and recovery can overwhelm a family. Missed work, mounting bills, and ongoing uncertainty all contribute to emotional stress and a sense of helplessness that no one should have to face alone.
Trust in Healthcare and Medication Adherence
When a patient is harmed by a prescribed drug, it can shatter their confidence in doctors, pharmacists, and the healthcare system as a whole. Many become reluctant to take new medications, fill prescriptions, or participate in treatment plans. This medication hesitancy can lead to worsened health outcomes and increased healthcare disparities.
Even clinical research suffers. Some patients who’ve been harmed become unwilling to join clinical trials, which are crucial to developing better, safer treatments.
Vulnerable Populations and Health Disparities
Defective drugs don’t affect everyone equally. Vulnerable groups—including children, the elderly, pregnant people, and underserved communities—are often hit hardest. These populations may be:
- Less likely to receive early warnings
- More susceptible to side effects
- Less able to access specialized care
- More at risk for poor outcomes due to existing health conditions
Systemic inequities in healthcare access, insurance coverage, and legal support compound the problem. Because of this, any discussion of drug injury law must also address broader issues of fairness and access to justice.
Legal Recourse and Its Effects on Patients
While legal action can offer relief, it is not without challenges. Pursuing a defective drug claim often involves:
- Emotional stress from revisiting painful events
- Long wait times for compensation
- Detailed medical documentation
- Expert evaluations and depositions
- Legal expenses and case uncertainty
Compensation can’t always fully restore what was lost. The legal process, when done responsibly, offers accountability and support. When mishandled, it risks reopening wounds without delivering results.
At Murphy & Prachthauser, we’re committed to making sure clients understand what’s involved before proceeding. We don’t take every case, and we don’t promise outcomes we can’t deliver. What we do promise is honest guidance, deep experience, and a legal team that’s always in your corner.
Conclusion
Navigating a defective drug injury is never simple. The physical pain, emotional toll, and financial burden can feel overwhelming, especially when you’re up against powerful pharmaceutical companies with deep legal resources. That’s why it’s critical to work with a team that knows the terrain, understands the law, and has the experience to guide you through every step.At Murphy & Prachthauser, we don’t chase mass tort headlines or sign people up for cases that haven’t been fully vetted. We work only with trusted firms actively leading national litigation and only pursue claims that have clear legal merit. Contact us today for a free consultation with one of our experienced product liability lawyers. We’re here to listen, evaluate your case, and advocate for the justice you deserve.