How Do I File a Dangerous Drug Claim?

When you take a prescription drug or over-the-counter medication, you never expect it can cause more harm than good. Still, numerous defective drugs have been approved and put on shelves, with unsuspecting victims suffering harm from the safe and approved use of such medication.

If you’re hurt by a dangerous drug, you likely have legal recourse.

Navigating the legal landscape of dangerous drug claims can be complex and daunting. When a drug causes serious harm, patients and their families may be entitled to compensation based on the circumstances.

If you or a loved one have sustained harm by a dangerous drug, understanding the process of filing a claim is crucial. Fortunately, you don’t have to take on your case alone. A skilled personal injury attorney can protect your rights and interests as they aggressively pursue justice and compensation on your behalf.

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What is Considered a “Dangerous Drug?”

Drugs, whether prescription or over-the-counter, can be deemed dangerous for many reasons. Some of the main reasons why a drug can be considered dangerous are drug defects, often originating from manufacturing and packaging, and the development of severe injury or illness that a drug’s label or directions fails to warn about.

It is important to recognize, though, that almost any drug that is otherwise safe can become particularly dangerous if used incorrectly. Therefore, for legal purposes, a “dangerous drug” is one that, when used as directed, causes harm.

Injuries and Conditions Due to Dangerous Drug Use

Dangerous drugs, especially with continued use, can put users at risk of developing serious injuries and conditions. Potential health issues associated with dangerous drug use include:

• Heart attack and failure
• Stroke
• Bleeding
• Blood clots
• Deep vein thrombosis (DVT)
• Pulmonary embolism
• Hemorrhage
• Organ damage, including kidneys and liver
• Gastrointestinal problems
• Cancer
• Amputation

Additionally, dangerous drug users aren’t the only ones at risk. Many medications can be hazardous for expectant mothers, and with regular use, can cause birth defects for babies, including heart defects, brain damage, and deformations.

All Drugs Require FDA Approval

It is not easy for drugs to be introduced into the market. Both prescription drugs and over-the-counter medications must obtain approval from the U. S. Food and Drug Administration (FDA) before they are available to the public. The approval process for drugs is stringent. Among the many steps involved in getting approval, key stages include:

• Preclinical testing: Before being tested on humans, a new drug undergoes preclinical testing in laboratories and on animals to evaluate its safety and efficacy.
• Investigational New Drug (IND) application: When preclinical results are promising, the drug’s developer submits an IND application to the FDA, including data from studies and plans for clinical trials.
• Clinical trials: The drug then progresses through three crucial phases of clinical trials.
• New Drug Application (NDA): Following successful clinical trials, the drug’s developer submits an NDA to the FDA, including all data from the trials, proposed labeling, and manufacturing details.
• FDA review: The FDA reviews the application and evaluates the drug’s safety, efficacy, and manufacturing processes. Review teams including doctors, statisticians, and other experts. In some cases, the FDA convenes an advisory committee of experts to provide recommendations based on the data.
• FDA decision: The FDA renders their decision based on their review and expert input. The drug may be approved, rejected, or require additional studies.
• Post-market surveillance: If approved, the drug is monitored for long-term effects and rare side effects through surveillance and additional studies.

Drugs can have a significant impact on a person’s life and health. For this reason, the FDA is so strict on its processes and requirements for new drugs.

The FDA Isn’t Always Aware of Dangers

Unfortunately, many things can fall through the cracks in big pharma. Testing and trials may not be sufficient to introduce new drugs, and known risks and side effects may not be fully understood or warned against. Additionally, some drugs move too quickly through the process and fail to undergo thorough testing to better understand the product and its effects on different individuals.

While the FDA seal of approval should signify a drug’s safety, this is not always the case. Because a drug is FDA-approved, it does not mean the medication is entirely free of risks. Additionally, drugs may be safe for their intended use, but defective or not closely monitored manufacturing processes may cause drugs to become flawed and dangerous to users.

What is a Dangerous Drug Claim?

A dangerous drug claim is a legal action by individuals who suffered harm due to a prescription or over-the-counter medication. These claims typically fall under product liability law and involve allegations that the drug was defectively designed, manufactured, or inadequately labeled, leading to injury or harm.

If you suffer harm after taking a dangerous drug, you may have a valid claim for compensation. Discuss your situation with a skilled personal injury attorney as soon as possible.

Types of Dangerous Drug Claims

Dangerous drug claims, like other types of product liability claims, fall under three categories. Depending on the issue with the defective drug, you can file your claim under any of the following categories.

Design Defects

Under a design defect claim, you’re claiming the drug was inherently dangerous due to its design, even if it was manufactured correctly.

Pharmaceutical drugs, whether or not they are prescription, should be created meticulously. However, the way a medication is created can pose a threat to consumers and their long-term health. Design defects concerning drugs are inherent flaws that existed with the drug even before it ever hit shelves.

Manufacturing Defects

In a claim for manufacturing defect, the drug was improperly manufactured or mixed, leading to contamination or incorrect dosage.

As the name suggests, manufacturing defects arise during the manufacturing process, which includes producing and delivering the medication. While the drug may have a correct design, defects can easily arise during production, making the medication hazardous for consumers.

Failure to Warn

In a failure to warn claim, the manufacturer fails to provide adequate warnings or instructions about the drug and potential side effects or risks associated with consuming the medication.

Pharmaceutical companies have a duty to inform consumers about all pertinent details concerning a drug, specifically the risks of taking it. When these companies fail to provide warnings, either through improper labeling, inadequate instructions, or insufficient side-effect information, consumers often take these drugs without thorough knowledge about the drug and its potential to cause life-altering health changes.

Seek Medical Attention

Before pursuing a legal claim for a dangerous drug, prioritize your health. Failing to get proper medical care can cause your condition to worsen or complications to arise.

Consult with a healthcare provider to address any adverse effects caused by the drug. Obtain medical records and documentation that detail the nature and extent of your injuries, as these will be essential in your legal case.

Document Your Experience

Gather all relevant information about your use of the drug, including:

• Prescription records: Details about the drug, dosage, and duration of use.
• Medical records: Documentation of your injuries, treatments, and any related healthcare visits.
• Pharmacy records: Information about where and when you obtained the drug.
• Adverse event reports: Any communications with healthcare providers or the drug manufacturer about the drug’s effects.

Along with records and documentation, it’s helpful to jot down details about your experience with the dangerous drug. Write down symptoms you experienced, treatment you sought, and other relevant details, which can help with your claim.

Research the Drug

Investigate the drug in question to determine if there have been previous complaints, lawsuits, or regulatory actions. This information can often be available through:

• FDA alerts: The Food and Drug Administration may issue warnings or recalls.
• Drug manufacturer websites: Look for information on known side effects and safety warnings.
• Legal databases: Review any ongoing or past litigation involving the drug.

So often patients take drugs without knowing of the past and present issues. Researching the dangerous drug in question can provide some clarity on the problems with the medication, and perhaps details concerning your medical conditions and side effects.

Who’s Liable for a Dangerous Drug?

Depending on the circumstances, various parties can be liable in a dangerous drug case. Some of the parties most often found responsible for harm involving defective drugs include:

• Pharmaceutical companies: The large companies responsible for developing, manufacturing, distributing, and marketing drugs.
• Drug manufacturers: The entity responsible for producing the drug. While pharmaceutical companies oversee the development and distribution of the drug, they do not actually manufacture the drugs and instead leave it in the hands of third-party manufacturers.
• Laboratories: Labs involved in tests and trials conducted in the process of trying to get a drug approved by the FDA. Errors in trials or inadequate testing can result in liability.
• Healthcare providers: Sometimes, the physician who prescribed the drug can be partially at fault. While physicians are often viewed as innocent in dangerous drug cases, they can be liable if they prescribe a medication known to cause harm or inadequately monitor patients.
• Pharmacies and pharmacists: Errors by pharmacists in dispensing prescription drugs, mislabeling, failing to warn about potentially dangerous drug interactions, and wrong dosage can also cause harm to patients.
• Sales representatives: While not directly involved in creating and producing drugs, sales reps promote and sell drugs to medical providers. When sales representatives present inaccurate information concerning a drug’s efficacy or safety, they may be liable.

Determining who is liable for your harm is key when pursuing justice and financial recovery. Multiple parties may sometimes be responsible for your injuries and losses. A personal injury attorney can thoroughly investigate your case to determine who can be liable in your dangerous drug case.

Recoverable Damages in Dangerous Drug Cases

When you file a claim for a dangerous drug, along with seeking justice, you’re trying to obtain monetary damages for your physical harm and financial losses. Recoverable damages can vary based on the specifics of your situation, but may include:

• Medical expenses: Compensation for current and future medical costs related to the injury caused by the drug. This can include hospital bills, medications, and ongoing treatment.
• Lost earnings: Reimbursement for income lost due to the inability to work due to the drug’s adverse effects. This may include future earning potential if your condition leads to long-term or permanent disability.
• Pain and suffering: Compensation for the physical discomfort and emotional distress experienced due to the drug’s effects. This is often calculated based on the severity and duration of the suffering.
• Loss of quality of life: Damages for how the injury has affected your ability to enjoy daily activities, hobbies, and a normal lifestyle.

Calculating your damages is key to ensuring you get full and fair compensation for the harm caused by the dangerous drug. Your personal injury attorney can evaluate your circumstances to determine how much your case is worth and pursue beneficial financial recovery.

Time Limits for Filing Dangerous Drug Claims

Like most other civil cases, dangerous drug claims have a statute of limitations. Under this law, you have a short window of time to file your lawsuit.

Statutes of limitations are state-specific. Based on your state’s laws, you may only have a few years to file your claim. While this may seem like sufficient time, dangerous drug cases are unique. You may not know of the harm a drug has done to you right away. For this reason, some states have a “discovery rule,” allowing for more time.

A personal injury attorney can ensure to file your defective drug claim promptly to avoid any potential issues.

If You’ve Suffered Harm Due to a Dangerous Drug, A Lawyer Can File Your Claim on Your Behalf

Filing a dangerous drug claim is a significant undertaking in most cases, requiring careful preparation, documentation, and skillful legal representation. When you’ve suffered harm after using a dangerous drug, hire a personal injury lawyer right away. Your attorney can provide direction for your case and fiercely represent your best interests to get the most favorable outcome.

Schedule a Free Initial Consultation Today!