When To File A Lawsuit Against A Drug Manufacturer

The pharmaceutical industry plays a crucial role in advancing healthcare, providing life-saving medications to millions around the world. However, there are instances where drug manufacturers may be held accountable for the harm caused by their products.

Filing a lawsuit against a pharmaceutical company is a complex and significant step. After all, according to Research and Markets, the global pharmaceuticals market had total revenues of around $1,300 billion as of 2022. However, there are often compelling reasons to seek legal recourse.

In this article, we explore a few reasons why individuals and communities might consider pursuing legal action against drug manufacturers.

Defective Drugs and Product Liability

One of the primary reasons individuals file lawsuits against drug manufacturers is the presence of defective drugs. Defects may arise during the manufacturing process, causing unforeseen side effects, inadequate warnings, or contamination issues. 

As reported by The Bureau of Investigative Journalism, new testing procedures are already in the works to catch defective cancer drugs. Similar testing procedures are likely to pop up for various other types of drugs. In the meantime, when consumers are harmed due to these defective drugs, they may have grounds to file a lawsuit based on product liability.

Product liability claims assert that the drug manufacturer is responsible for injuries or damages resulting from their product. Plaintiffs in such cases often argue that the drug was unreasonably dangerous or lacked proper warnings about potential risks. Successful lawsuits can result in compensation for medical expenses, pain and suffering, and other damages incurred due to the defective drug.

Failure to Warn and Inadequate Labeling

Pharmaceutical companies are obligated to provide accurate and comprehensive information about their products, including potential side effects and risks. However, at times, drug manufacturers fail to adequately warn consumers and healthcare professionals about the potential dangers associated with their medication. This, in turn, can lead to serious health consequences and legal action.

Inadequate labeling claims are often filed when patients experience unexpected side effects that were not properly disclosed. It needs to be demonstrated that the pharmaceutical company knew or should have known about these risks but failed to communicate them effectively. Then, a lawsuit may be pursued to hold them accountable for the resulting harm.

Fraudulent Marketing Practices

In some cases, drug manufacturers may engage in deceptive or fraudulent marketing practices to promote their products. This can include exaggerating the effectiveness of a drug, downplaying potential risks, or marketing the medication for uses not approved by regulatory agencies. According to the US FDA, such practices are often referred to as medication health fraud.

When patients are harmed because of relying on false or misleading information, they may have legal grounds to file a lawsuit for damages. Fraudulent marketing claims often involve proving that the pharmaceutical company intentionally misrepresented information about their drug. Lawsuits in this category may result in compensation for the victim’s financial losses designed to punish the company for its deceptive practices.

Unreasonable Side Effects and Adverse Reactions

While all medications carry some level of risk, pharmaceutical companies have a responsibility to thoroughly research and disclose potential side effects. If a drug causes unexpected side effects that were not adequately communicated to consumers, affected individuals may have grounds for legal action.

These lawsuits often hinge on proving that the drug manufacturer knew or should have known about the risks but failed to provide sufficient warnings. Plaintiffs may seek compensation for medical expenses, ongoing treatment, and the impact on their quality of life resulting from these unforeseen reactions.

Such an approach to seeking compensation for adverse reactions and side effects was seen in the Tepezza lawsuit. Tepezza – used for treating thyroid eye disease – was found to cause hearing problems and even permanent hearing loss. Because of these side effects, the Tepezza lawsuits were filed. 

According to TorHoerman Law, the Tepezza hearing loss lawsuit was filed by the victims to seek compensation for their hearing damage. The case is still ongoing, but it’s being estimated that the Tepezza settlement amounts, on average, may range between $75,000 and $200,000.

Contamination and Quality Control Issues

Pharmaceutical companies must adhere to strict quality control standards to ensure the safety and efficacy of their products. Contamination issues during the manufacturing process can lead to serious health risks for consumers. If individuals suffer harm due to contaminated medications, they may pursue legal action against the drug manufacturer.

Contamination lawsuits involve demonstrating that the lack of adherence to quality control standards directly resulted in the presence of harmful substances in the medication. Compensation may be sought for medical expenses, pain and suffering, and other damages resulting from the contamination.

Off-Label Use and Regulatory Violations

Pharmaceutical drugs are approved for specific uses by regulatory agencies. Marketing a drug for purposes not approved by these agencies is considered off-label use. When drug manufacturers engage in off-label promotion or violate regulatory standards, they may face legal consequences.

Lawsuits based on off-label use and regulatory violations often focus on the company’s failure to comply with safety standards. Individuals harmed by off-label use may seek compensation for damages, and successful lawsuits can lead to regulatory action against the pharmaceutical company.

Epidemic and Mass Tort Cases

In some instances, a drug may be linked to widespread harm, affecting a large number of individuals. These cases, known as mass tort or epidemic lawsuits, involve numerous plaintiffs collectively seeking justice against a common defendant, such as a drug manufacturer.

Epidemic cases often arise when a drug is found to cause severe, widespread harm that goes beyond individual claims. These cases can involve extensive investigations, expert testimony, and coordinated legal efforts. 

Successful resolution of epidemic lawsuits may result in substantial compensation for affected individuals and contribute to changes in industry practices.

In summary, while pharmaceutical companies play a crucial role in advancing healthcare, instances of harm caused by their products cannot be ignored. Filing a lawsuit against a drug manufacturer is a complex undertaking. However, when justified, it serves as a crucial mechanism for holding companies accountable for the impact of their products on individuals and communities.