Although pharmaceutical drugs save millions of lives each year, the pharmaceutical industry continues to grapple with a persistently negative reputation. In some cases, pharmaceutical companies miss out on providing the necessary warning to users, which leads to health concerns.
When the consumer suffers a personal injury due to drug consumption, he can take legal action against drug manufacturers. However, pursuing legal action against drug makers for health issues requires a thorough understanding of the legal process and the complexities of pharmaceutical litigation.
In this article, we will provide a comprehensive overview of the steps involved in pursuing legal actions.

Understanding Pharmaceutical Liability
According to Statista, the pharmaceutical industry is huge, with a total global revenue of $1.48 trillion in 2022. This industry manufactures drugs and researches and develops new medications. The substantial turnover and profound responsibility inherent in the pharmaceutical industry make pharmaceutical liability increasingly significant.
Pharmaceutical liability denotes the legal obligation of drug manufacturers to ensure the safety and efficacy of their products. This responsibility encompasses all stages of a drug’s lifecycle, including research, development, manufacturing, marketing, and distribution.
The Current Good Manufacturing Practice (CGMP) serves as the primary regulatory framework governing human pharmaceutical manufacturing processes. If the pharmaceutical company does not comply with CGMP, FDA can take regulatory actions against them.
In cases where drugs cause personal injury to the users or fail to comply with their promises, the manufacturer is held responsible. In such cases, the users can take legal action against the company under product liability lawsuits.
Steps to Pursuing Legal Action
Firstly, it is crucial to consult a qualified attorney specializing in pharmaceutical litigation to assess the validity of your case. Your legal representative will undertake a comprehensive inquiry to collect evidence, which may include medical records, expert testimonies, and documentation of damages. Subsequently, they will prepare and submit a formal complaint against the drug manufacturer, delineating the accusations and seeking appropriate damages.
The drug maker will then respond, and the legal process will proceed to discovery, where both sides exchange relevant information. The outcome may involve either a trial or resolution through negotiations for a settlement, contingent on the specific circumstances of the case.
However, it is important to consider the trial rate when initiating a lawsuit. According to Forbes, most personal injury cases end in settlements, and only 4%- 5% of these cases go to trial.
It should be noted that not all personal injury cases are product liability lawsuits related to pharmaceutical companies. However, product liability lawsuits are also a part of personal injury cases, so the rate of cases going to trial is even lower.
However, throughout the process, it is important to adhere to legal deadlines and procedures to ensure the best possible outcome in your case.
Potential Challenges and Considerations
One of the key challenges while accusing a pharmaceutical company is establishing a causal link between the drug and the health issue. It requires expert medical testimony and thorough documentation of the harm caused.
Additionally, pharmaceutical companies typically have substantial resources and legal teams, making litigation against them a daunting task. It is also important to consider the potential costs involved in pursuing legal action, including attorney fees and court expenses.
The legal process can be lengthy and time-consuming, requiring patience and perseverance.
Case Study: Suboxone Lawsuit and Tooth Issues
In recent years, several lawsuits have been filed against the makers of Suboxone, a medication used to treat opioid addiction. The lawsuits allege that the drug caused serious dental issues.
These lawsuits claim that Suboxone, which contains the active ingredients buprenorphine and naloxone, can cause severe tooth decay and dental problems, including tooth loss.
Lawyers all over the country are accepting these types of cases in which Suboxone has caused dental problems to the users. The Suboxone lawsuit is a product liability lawsuit for the plaintiffs to get compensation for their loss of teeth or other dental problems. They can seek compensation for medical expenses, pain and suffering, lost wages, or other damages caused by Suboxone.
As per DrugWatch, in January 2022, the FDA publicly disclosed receiving reports linking medications containing buprenorphine, including Suboxone, to dental issues. Consequently, updating the drug’s prescribing information and patient medication guide with a new warning became mandatory.
The latest update in February 2024 states 51 pending lawsuits related to Suboxone tooth decay. They are consolidated under multidistrict litigation within the Northern District of Ohio.
The lawsuits allege that the manufacturers of Suboxone knew about the potential side effects of the drug but failed to provide proper warning.
Patients who experience extreme side effects from medications should consult their healthcare providers and consider seeking legal advice to understand their rights and options.
Seeking Compensation and Justice
It typically involves working with an experienced attorney who can help navigate the legal process and advocate for the individual’s rights. Through a lawsuit, individuals can seek to hold the drug manufacturer accountable for their actions, potentially leading to changes in drug marketing strategies.
TorHoerman Law advises individuals to seek justice by raising awareness about their experiences and advocating for changes in the healthcare system. Individuals can share their stories and educate about the potential risks of certain medications and work towards preventing similar harm in the future.
Seeking Legal Representation
Individuals should look for attorneys who specialize in pharmaceutical litigation and have experience handling cases similar to theirs. A good attorney will offer a free initial consultation to assess the case and provide guidance on the best course of action.
When selecting an attorney, individuals should consider their track record of success and their familiarity with the legal issues involved. It’s crucial to ascertain their readiness to proceed to trial if required. Additionally, discussing fees and expenses upfront is essential to prevent any unforeseen surprises down the line.
Considering Alternative Legal Avenues

One alternative is joining or initiating a class-action lawsuit, where multiple individuals with similar claims are represented collectively.
According to a survey done by Innoplexus, only 5.2% of respondents have a positive attitude towards pharmaceutical companies. This indicates that the remaining respondents have expressed various grievances or issues with the pharmaceutical companies. If you know such people who had a personal injury due to a certain medication as yours, you can connect to take class action.
Class action lawsuits often offer a more streamlined and economical approach compared to individual legal actions, particularly when addressing widespread harm resulting from a drug.
Individuals may also opt for arbitration or mediation, which tend to be less confrontational and time-intensive than traditional litigation. These avenues involve the intervention of a neutral third party who aids in facilitating resolution between the involved parties.
Additionally, individuals can consider lodging complaints with regulatory agencies like the Food and Drug Administration (FDA). Engaging in advocacy initiatives to increase awareness about their experiences is another avenue available to affected individuals.
These avenues can help hold drug makers accountable and bring attention to the need for improved drug safety and regulation.
In conclusion, pursuing legal action against drug makers for health issues is a complex process that requires careful consideration and planning. Individuals who believe they have been harmed by a pharmaceutical product should seek legal representation from attorneys experienced in pharmaceutical litigation.
By following the above steps, individuals can seek compensation and justice for the harm they have suffered. Holding drug makers accountable not only for benefits but also helps promote consumer safety and accountability in the pharmaceutical industry.