When you take a prescription or over-the-counter medication, you trust that it has been properly tested, manufactured, and approved for safe use. Unfortunately, dangerous or defective drugs continue to reach the market and cause serious harm to patients before being recalled by the FDA or voluntarily withdrawn by manufacturers. From contaminated medications and undisclosed cancer risks to severe side effects that weren't properly disclosed, drug recalls can leave patients dealing with life-altering health consequences.
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If you've been harmed by a recalled drug in New York, you may be wondering whether you can seek compensation for your injuries, medical expenses, and suffering. In many cases, the answer is yes. New York's legal framework provides multiple avenues for injured patients to pursue compensation when pharmaceutical companies place unsafe products on the market. Recent multimillion-dollar settlements demonstrate that courts and juries are willing to hold pharmaceutical companies accountable when their products cause harm.
Understanding Drug Recalls and Legal Rights
Drug recalls occur when the FDA or pharmaceutical companies determine that a medication poses significant health risks that were not known or disclosed at the time of approval. These recalls can happen for various reasons, including contamination during manufacturing, discovery of serious side effects not found during clinical trials, mislabeling that could lead to dangerous dosing errors, or identification of cancer-causing impurities in the medication.
While a recall doesn’t automatically entitle all users to compensation, it can serve as compelling evidence that the drug was defective. Courts often view recalls as admissions by manufacturers that their products posed unreasonable risks to consumers, which can significantly strengthen patients' legal claims.
The key to successful compensation claims lies in demonstrating that the recalled drug actually caused your specific injuries or health problems. This typically requires a thorough documentation of your medical condition, treatment history, and the connection between your drug use and resulting harm.
New York's Legal Framework for Drug Recall Compensation
New York law offers several legal pathways that patients can use to pursue compensation for injuries caused by recalled drugs. Each theory offers different advantages and may be more appropriate depending on the specific circumstances of your case.
Strict Liability: Holding Manufacturers Accountable
Strict liability is often the most effective legal theory for drug recall cases because it focuses on the product itself rather than the manufacturer's conduct. Under strict liability, patients don't need to prove that the pharmaceutical company was negligent or careless. Instead, they only need to demonstrate that the drug was defective and that this defect caused their injuries.
Drug defects can take several forms. Design defects involve issues inherent in the drug's formula or active ingredients that make it unreasonably dangerous for intended use. Manufacturing defects occur during production when contamination, incorrect dosing, or other errors create dangerous products that deviate from their intended specifications. Failure to warn defects, also known as marketing defects, involve situations where manufacturers fail to adequately disclose known risks or provide sufficient warnings about potential side effects. Even drugs that are properly designed and manufactured can be unreasonably dangerous if patients and healthcare providers aren't properly informed about their risks.
Negligence Claims Against Pharmaceutical Companies
Negligence claims focus on the conduct of the drug manufacturer during the development, testing, manufacturing, and marketing process. To succeed on a negligence claim, patients must prove that the manufacturer breached its duty of care by failing to meet industry standards or regulatory requirements.
Common examples of pharmaceutical negligence include ignoring safety signals during clinical trials, falsifying or withholding test data from regulators, failing to conduct adequate post-market safety monitoring, rushing drugs to market without sufficient testing, or continuing to sell drugs after learning about serious safety problems.
Negligence claims can be particularly powerful when internal company documents reveal that manufacturers knew about problems but failed to take appropriate action. These cases often involve extensive discovery to uncover evidence of corporate misconduct or cover-ups.
Breach of Warranty Protections
Warranty claims arise when drugs fail to meet express or implied promises made by manufacturers. Express warranties are specific representations about the drug's safety or effectiveness, while implied warranties guarantee that drugs will be suitable for their intended medical purpose and free from unreasonable dangers.
A key benefit of breach of warranty claims in New York is the extended four-year statute of limitations, compared to three years for personal injury claims. This is especially helpful for patients whose injuries develop gradually.
Major Drug Recall Settlements in New York
Recent high-profile settlements demonstrate the substantial compensation available to patients harmed by recalled or dangerous drugs, while also illustrating the types of evidence and legal theories that lead to successful outcomes.
Zantac Settlement: $2.2 Billion for Cancer Claims
In 2024, GlaxoSmithKline agreed to a $2.2 billion settlement for 80,000 claims alleging that its popular heartburn medication Zantac contained NDMA, a probable human carcinogen. The settlement compensated patients who developed various cancers, including bladder, stomach, and liver cancer, after taking Zantac for extended periods.
This case illustrates how contamination during manufacturing can lead to massive liability when it causes serious health problems. The NDMA contamination wasn't disclosed to patients or regulators until testing revealed dangerous levels of the carcinogen in the medication.
Vioxx Settlement: Landmark Cardiovascular Injury Compensation
Merck’s 2007 Vioxx settlement totaling $4.85 billion is one of the largest in pharmaceutical history, setting important precedents for drug liability cases. New York received $61 million of the national settlement, with individual payouts based on proof of cardiovascular injuries like heart attacks and strokes.
The Vioxx case showed how failure to warn about serious risks can lead to massive liability for pharmaceutical companies, even when a drug provides real benefits for many patients.
Johnson & Johnson Talcum Powder: $700 Million for Failure to Warn
While not technically a drug recall case, Johnson & Johnson's $700 million settlement over allegations that its talcum powder products caused ovarian cancer provides important insights into failure-to-warn liability. New York received $44 million of this settlement to fund public health programs, illustrating how these cases can benefit broader public health initiatives.
This case shows how manufacturers face serious consequences when they fail to disclose known cancer risks, particularly for products marketed to vulnerable populations.
Ongoing Litigation: Ozempic and Mounjaro
Current litigation involving diabetes and weight-loss drugs Ozempic and Mounjaro illustrates how drug liability cases continue to evolve. Patients are pursuing claims alleging that these medications caused severe gastrointestinal injuries, including gastroparesis (stomach paralysis) and bowel obstructions, without adequate warnings about these risks.
These cases are being pursued under both strict liability and negligence theories, with plaintiffs arguing that the manufacturers knew or should have known about these serious side effects but failed to provide adequate warnings to patients and healthcare providers.
Procedural Requirements and Building Your Case
Successfully pursuing compensation for drug recall injuries requires careful attention to procedural requirements and thorough case preparation. If you’ve been injured by a defective drug that has now been recalled, reach out to the experienced personal injury lawyers at the Porter Law Group for a free consultation. We will walk you through all your legal options, and examine every detail of your case, to see what the best course of action will be.
Critical Documentation and Evidence
Preserving evidence is crucial for drug recall cases. Keep all packaging, labels, and prescription bottles from the recalled medication, as these can provide important information about manufacturing dates, lot numbers, and dosing instructions. Obtain complete medical records documenting your condition before, during, and after taking the recalled drug.
Prescription records from your pharmacy can establish exactly when you took the medication and for how long. These records often include important details about dosage, refill dates, and prescribing physicians that can be crucial for establishing the timeline of your drug use and injury development.
Establishing Medical Causation
One of the most challenging aspects of drug recall cases is proving that the recalled medication actually caused your specific injuries rather than other factors like underlying medical conditions, other medications, or lifestyle factors. This typically requires expert medical testimony from physicians who specialize in the relevant medical conditions.
Expert witnesses will review your complete medical history, analyze the timing between your drug use and injury development, and explain how the recalled drug's defects could have caused your specific health problems. This analysis often involves reviewing scientific literature, clinical studies, and regulatory documents related to the recalled medication.
Understanding Filing Options
Depending on the scope of the recall and the number of affected patients, you may have several options for pursuing compensation. Individual lawsuits are often appropriate for severe or unique injuries that require personalized attention and strategy.
Multidistrict litigation (MDL) is commonly used for mass tort cases involving widely prescribed drugs that have harmed large numbers of patients. MDL proceedings consolidate pretrial activities like discovery while preserving individual rights to trial if settlements cannot be reached.
Class action lawsuits may be appropriate for cases involving widespread minor injuries or when the primary goal is obtaining refunds for recalled medications rather than compensation for personal injuries.
Challenges in Drug Recall Litigation
Drug recall cases present unique challenges that distinguish them from other types of product liability litigation:
Federal Preemption Defenses
Pharmaceutical companies may argue that FDA approval shields them from state law product liability claims. However, New York courts generally reject these preemption defenses when plaintiffs can prove that companies withheld safety data from regulators or misled the FDA about their products' risks.
The key is demonstrating that the manufacturer violated federal regulations or duties, which allows state law claims to proceed parallel to federal requirements rather than conflicting with them.
Comparative Negligence Issues
Defendants often argue that patients contributed to their own injuries by misusing medications, failing to follow dosing instructions, or not disclosing relevant medical history to their physicians. Under New York’s pure comparative fault rule, your compensation may be reduced—but not eliminated—if patients are found to share responsibility for their injuries.
However, these defenses are often unsuccessful when patients can show they followed their doctors' instructions and used medications as prescribed, particularly when the injuries resulted from undisclosed risks rather than misuse.
Corporate Bankruptcy Strategies
Some pharmaceutical companies attempt to use bankruptcy proceedings to limit their liability for recalled drugs. When this occurs, injury victims must file claims through specialized bankruptcy courts, which can complicate and delay the compensation process.
However, bankruptcy doesn't eliminate pharmaceutical companies' obligations to compensate injury victims. Skilled legal representation is essential to protect your rights in these proceedings.
Types of Compensation Available for Drug Recall Cases
Patients injured by recalled drugs can recover several types of damages that reflect the full scope of their injuries and losses:
Economic Damages
Economic damages include all quantifiable financial losses resulting from the recalled drug. This encompasses past and future medical expenses, including hospitalization, surgery, ongoing treatment, prescription medications, and rehabilitation costs. These damages can be substantial when recalled drugs cause serious conditions requiring extensive medical intervention.
Lost wages and diminished earning capacity are also recoverable, reflecting both time missed from work due to drug-related injuries and any permanent reduction in your ability to earn income. For severe injuries that prevent you from returning to your previous occupation, these damages can represent hundreds of thousands or millions of dollars over a lifetime.
Non-Economic Damages
Non-economic damages compensate for the physical pain, emotional suffering, and diminished quality of life caused by recalled drugs. These damages recognize that pharmaceutical injuries often involve chronic pain, disability, and psychological trauma that extends far beyond financial losses.
Pain and suffering damages can be particularly substantial in drug recall cases, especially when medications cause cancer, organ damage, or other serious conditions requiring extensive treatment. Loss of enjoyment of life damages compensate for your inability to participate in activities you previously enjoyed due to drug-related injuries.
Punitive Damages
In cases involving particularly egregious conduct, such as knowingly selling dangerous drugs or concealing serious safety risks, punitive damages may be available. These damages are designed to punish pharmaceutical companies for misconduct and deter similar behavior in the future.
Recent cases involving companies that continued marketing drugs despite knowing about serious safety problems have resulted in substantial punitive damage awards, sending a clear message that such conduct will not be tolerated.
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Why Choose the Porter Law Group
The lawyers at the Porter Law Group have decades of experience representing individuals and families whose lives have been devastated by catastrophic injuries. We have obtained some of the largest settlements and verdicts in courts throughout the State of New York. We are a state-wide firm that handles cases with a hometown feel.
Our clients come to us looking for guidance and answers. With seasoned trial lawyers, the Porter Law Group has the resources necessary to help you navigate the most complex cases, against goliath insurance companies that will stop at nothing to prevent you from receiving the compensation you deserve.
You only get one chance to hire the best lawyer for you and your family. Hire the lawyers most recommended by former clients and local attorneys, and the firm that obtains superior results.
When you or a loved one's life has been devastated by a serious personal injury in New York, don't hire a lawyer without calling the Porter Law Group to learn why so many of our clients are thankful they trusted us with their case in their time of need.
Contact a New York Drug Recall Attorney Today
If you've been harmed by a recalled drug, don't wait to protect your legal rights. The complex intersection of pharmaceutical regulation, product liability law, and medical evidence requires immediate attention from experienced legal professionals who understand the unique challenges of drug recall litigation.
At the Porter Law Group, we offer free, no-obligation consultations to evaluate your case and explain your legal options. We work on a contingency fee basis, which means there are no attorney fees unless we win your case. This allows you to pursue the compensation you deserve without worrying about upfront legal costs.
Recent settlements demonstrate that pharmaceutical companies can be held accountable for recalled drugs that cause harm, but these cases require experienced legal representation to navigate successfully. Contact the Porter Law Group today at 833-PORTER9 or email info@porterlawteam.com to schedule your free consultation. Let our experienced New York drug recall attorneys fight for the full compensation you deserve while you focus on your recovery and healing.
