Medical Negligence*

Defective pharmaceuticals claims*

Defective pharmaceuticals refer to drugs or medical products that have flaws in their design, Manufacturing, labelling, or marketing that can lead to harmful effects on patients who use them.

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What is a defective pharmaceutical?

In Ireland, like in many other countries, modern medicine and pharmaceutical product usage is on the rise. The Irish Times reports that the demand for medicines and other pharmaceutical products has risen since before the Covid 19 pandemic. Unfortunately, injuries as a result of defective pharmaceuticals can occur, and are a serious matter that have significant medical implications. Defective pharmaceuticals refer to drugs or medical products that have flaws in their design, Manufacturing, labelling, or marketing that can lead to harmful effects on patients who use them. The injuries followed can range from mild side effects to severe health implementations or unfortunately even death.

Types of defects

Some key points to consider regarding injuries from defective pharmaceuticals are

Types of defects, defects in pharmaceutical can take several forms, including:

Design defects:

These occur when fundamental design of a drug is flawed, leading to adverse effects that could have been prevented with a different design.

Manufacturing defects (contamination):

These effects occur during the production process, resulting in contamination or improper formulated calculations.

Labelling defects:

These involve inadequate or inaccurate labelling, which can lead to improper usage or failure to warn about potential risk.

Marketing defects:

Improper marketing, promotion, or advertising of a drug can lead to its misuse and subsequent harm.


Injuries caused by pharmaceutical defects

Physical injuries:

Physical injuries can occur due to many reasons, such as: allergens, toxins and contamination in defective products, defective packaging, incorrect instructions, and device failures among Many others.

Some physical injuries include:

  • Diabetes
  • Strokes/hemorrhages
  • Increased blood pressure
  • Damage to internal organs
  • Chronic pain
  • Autoimmune reactions
  • Cancer and tumors
  • Developed sensitivities.

Emotional/psychological damage:

Defective medicines and other pharmaceutical products can unfortunately have emotional and psychological damage to patients.

Below are some common effects:

  • Depression
  • Anxiety
  • Mood changes
  • Higher risk of suicide due to mental challenges

Some effects from defective products can be temporary and clear within days or weeks of stopping the usage of such products, however this is not the case for all injuries due to defective medicines/products. Unfortunately, some injuries including the ones listed above can be long term.


What should I do if I receive a defective pharmaceutical?

If you suspect that you have received a defective pharmaceutical, it is vital to take the appropriate steps to ensure your health and safety, as well as protecting your legal rights.

Below are steps that can be considered:

Stop using the product: if you experience any unusual side effects, reactions, or abrupt symptoms after taking a pharmaceutical product, stop using it immediately.

Seek medical attention: If you’re experiencing adverse effects from a pharmaceutical product, contact a healthcare professional as soon as possible. They can provide medical advice, assess your condition, and document your symptoms.

Preserve the evidence: Keep the packaging, labels, and any remaining product in its original condition. This evidence can be crucial if you decide to pursue legal action or report the issue to any regulatory authorities.

Document your experience: Write down the details of your experience, including the date and time you took the product, the specific symptoms or reactions you experienced, and any medical treatment you sought.

Report the issue: Depending on your country, there may be a regulatory agency responsible for monitoring the safety of pharmaceutical products. In Ireland, for example, you can report adverse events to the Health Products Regulatory Authority (HPRA). Reporting adverse events helps regulatory agencies identify potential issues and take appropriate actions to protect public health.

Consult a legal professional: If you believe you’ve suffered harm due to a defective pharmaceutical, consider consulting a legal professional with experience in product liability or personal injury cases. They can assess the specifics of your situation and provide guidance on whether you have a potential legal claim.

Beware of time limits: Be aware of any deadlines for filing legal claims or reporting issues. Time limits, known as statutes of limitations, vary by jurisdiction and can affect your ability to seek compensation or take legal action. The time frame for filing a claim for a defective product in Ireland is 2 years minus one day from the point of injury.


Medical records: Keep copies of all medical records, prescriptions, and receipts related to your use of the pharmaceutical product and any subsequent medical treatment.


Reporting a defective product:

In Ireland, suspected or confirmed defective pharmaceuticals can be reported to the Health Products Regulatory Authority (HPRA). The HPRA is the regulatory body responsible for overseeing the safety and quality of medicines and healthcare products in Ireland. If you come across defective pharmaceuticals, you can report them to the Quality Defects Section of the HPRA. They can be reached through various means, including:

  • Email: (preferred method)
  • Phone: +353 1 6764971 (for potentially urgent issues)
  • Fax: +353 1 6767836
  • Mail: Quality Defects, Health Products Regulatory Authority, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, D02 XP77, Ireland

It’s important to provide as much detail as possible when reporting a defective pharmaceutical, including the product name, batch/lot number, description of the defect, potential risks or adverse effects, and your contact information. If the issue is urgent, using the phone number as the initial point of contact is recommended.

Time limits for filing a claim:

The statute of limitations for defective product claims in Ireland is generally 2 years minus one day from the date of knowledge of the injury or damage caused by the defective product. This means that you have 2 years less one day from the date you became aware of the injury or damage, or from the date you should have reasonably become aware, to initiate legal proceedings.

Who is responsible for defective pharmaceuticals?

The responsibility for defective pharmaceutical claims can be attributed to various parties involved in the manufacturing, distribution, and marketing of the pharmaceutical product. The specific parties that may be held responsible can include.


The pharmaceutical company that designs, produces, and packages the medication can be held responsible for defects in the product’s formulation, manufacturing, or labelling.


If the pharmaceutical product passes through distributors before reaching consumers, they may also bear some responsibility for ensuring the product’s safety and quality.

Retailer or Pharmacy

In some cases, retailers or pharmacies that sell the defective pharmaceutical product can be held accountable for failing to properly inspect or warn about the product’s defects.

Testing Laboratories

Laboratories responsible for testing the pharmaceutical product for safety and efficacy might be held responsible if they provided inaccurate or misleading test results.

Regulatory Authorities

In certain cases, regulatory authorities responsible for approving and monitoring pharmaceutical products’ safety might face criticism if they overlooked potential defects during the approval process.

Healthcare Professionals

While less common, healthcare professionals who prescribe or administer the defective pharmaceutical product could potentially be held liable if they negligently prescribed or administered a known defective product.

How can a solicitor help?

It is important to seek advice from a legal professional after receiving a defective product. At Tracey solicitors LLP our expert team of personal injury specialists are dedicated to ensuring excellent client care. We are here to guide you on your legal journey while you have time to heal. If you or any of your family members have been affected by a defective pharmaceutical product and would like to discuss your legal option further, please visit: Tracey Solicitors LLP | Personal Injury Solicitors, Dublin or call us on 01 649 9900 today.

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Our helpful team

Need Help? Just Ask.

For more information and a confidential discussion on your medical negligence claim, call Elaine Hickey, Head Medical Negligence Solicitor, on +353 1 649 9900 and tell her about your medical malpractice case or reach out via email to and she can call you back.

How do I make a claim?

Once you have gathered all the relevant information in relation to your injury it is then time to move forward with your claim. It is important to use a specialist medical negligence solicitor to help you with this.

  1. Speak with a solicitor

    If you feel that you were not provided with appropriate medical treatment whilst under the care of a medical professional which resulted in injury due to the actions or in-actions of a medical professional, then speaking with a medical negligence solicitor following the injury is imperative. Medical negligence is a complex topic in Irish law. Speak to a medical negligence solicitor when bringing a claim forward. This ensures that no essential steps are missed throughout the legal process. Bringing a claim forward without having spoken to a solicitor can delay your claims procedure. A solicitor can help to determine your medical negligence time limit claim.

  2. Obtain medical records

    In order to make a claim, it must be established and proven that the injury sustained was caused by the medical negligence of the doctor or medical staff tasked with your medical care. Therefore, after having spoken with you about your case, your solicitor will then request access to your medical records. At this stage, the solicitor will have your medical records assessed by an independent medical expert. This will help determine whether a surgeon or medical staff who treated you had, in fact, administered substandard medical care and if negligence was the cause of the injury and if your injuries/outcome could have been avoided if the appropriate level of medical care had been adhered to.

  3. Letter of Claim

    If the independent medical expert has concluded that medical negligence has occurred, then your solicitor will draft a Letter of Claim to the medical practitioner who treated you. A Letter of Claim will outline the nature of your case and invites the medical practitioner to settle your case. The next steps involved are heavily dependent on your case and response to your Letter of Claim and will determine whether your case will be brought to court or settled outside of court. Your solicitor will be on hand every step of the way to guide you through this process.

At Tracey Solicitors LLP, our dedicated medical negligence solicitors have years of experience in helping people deal with traumatic medical injury claims. We understand the injuries, both physically and emotionally, that you have suffered and have supported and helped many people in similar situations proceed with medical negligence claims in Ireland over the past 30 years.

For more information and a confidential discussion on your medical injury claim, phone 01 649 9900 or email to tell us about your case, where you can speak with a member of our team straight away.

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Case Settlement

If you are to proceed with a medical negligence claim you may be entitled to claim compensation for the accident and added expenses, you may have incurred. These claims are called damages.

General Damages

General damages are non-financial damages such as pain and suffering and/or physical and emotional injuries following a medical negligence injury.

Special Damages

Special damages are out of pocket expenses incurred as a result of the medical negligence injury, for example, loss of earnings (if you are out of work), medical bills, added travel costs as a result of the accident (for example, travel to and from the hospital) and future care costs. Learn more about Special Damages.

What are the Legal Time Limits?

The statute of limitations are the legal time limits on how long you have to make a claim, which can vary depending on the situation. When taking into account how long medical negligence claims take, it is important to remember that medical negligence cases require certain time frames in place within which you can bring a claim. For medical negligence claims it is two years less a day following the date of the incident or two years less a day following the date that a person made the connection that their illness or injuries were a result of medical negligence. Contacting a solicitor to discuss your case will help you in determining how long you have left to make a claim.

Medical Negligence Involving Children

In an unfortunate incident where a child is subject to medical negligence, the process of making a claim differs from that of an adult. A minor may be in a position to bring a claim forward in the first two years following their 18th birthday.

Learn more about Legal Time Limits

About Tracey Solicitors LLP

We draw on more than 35 years of experience in personal injury law to provide you with expert advice and legal services.

We’re here to help you with your claim, and will work with you to ensure you understand every step of your legal journey.

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