Drug Recalls

Each year about two-thirds of Canadians take at least one prescribed medication. While some of these courses of medication are limited to short-term use, others may be taking these prescription medications regularly. Add to this tally additional over-the-counter medicine usage, and it’s not surprising that research, development and sales of patented and generic drugs is a multi-billion dollar industry.

Bringing new drugs to market and generating maximum profits from drug patents gives drug companies incentives to develop and seek approvals for these medications as quickly as possible. These companies must demonstrate the relative safety of these medications through clinical trials that are reviewed by Health Canada’s Health Products and Food Branch (HPFB). If Health Canada concludes that a drug’s benefits outweigh its risks and/or the risks can be mitigated, it will issue a Notice of Compliance (NOC) and a Drug Identification Number (DIN) that permits its distribution and sale in the country.

Once it gains regulatory approval, a drug’s manufacturers must monitor and report serious side effects or adverse medical outcomes noted by its users or medical professionals, inform the HPFB of any new studies that may alter safety protocols, and update regulatory bodies on changes to dosing or the manufacturing process. Moreover, the HPFB continues to conduct market surveillance, monitor adverse reaction reports, and investigate complaints and problem reports. Should the need arise, manufacturers and/or the HPFB would manage a drug recall.

Learning that you or a loved one has taken or is currently taking a recalled drug can be a frightening experience. Depending on the reason for the recall, you may worry that you or they have suffered serious harm or may be at increased risk for a damaging condition. And, if you have been harmed or are likely to experience harm based on your use of the drug, you may wonder if you are entitled to any compensation for your losses.

Gluckstein Personal Injury Lawyers product liability claim team is ready to help if you or your loved one may have suffered serious harm from a recalled drug. Our knowledgeable, skilled and experienced drug recall lawyers can help determine if you qualify to make an individual claim for damages or are eligible to join a class action or mass tort proceeding against a person or entity responsible for the reason behind the recall.

Why and how are drugs recalled?

A recall is any corrective action taken with respect to a product on the market. A manufacturer or regulator may issue a recall as a preventive measure out of an abundance of caution or when they discover actual defects that make a product unreasonably dangerous.

Defects can occur at the design stage (insufficient testing for harmful side effects or curative properties or falsified test results), during the manufacturing process (impurities, incorrect ingredients, or improper dosing), or during distribution (improper handling/storage guidelines, labelling or marketing).

When a drug defect is identified, an assessment process is used to determine the risk to consumers and the public. There are three types of health risk classifications and corresponding recall requirements for each:

• Type I: There is a reasonable probability that the use of (or exposure to) a recalled product will cause serious adverse health consequences or death.
  
• Type II: The use of, or exposure to, a recalled product may cause temporary adverse health consequences. Or, the probability of serious adverse health consequences is remote.
  
• Type III: The use of (or exposure to) a recalled product is not likely to cause any adverse health consequences.

Unless Health Canada determines there is a serious or imminent risk to the public, the drug manufacturer and/or distributor generally oversees the recall process. Depending on the assessed health risk of the medication, the recall process would involve establishing timelines, issuing notices of recall and communicating the risk to the general public or specified groups, establishing effectiveness checks and informing Health Canada of the progress of the recall effort. Recalls may be limited to notifying users of potential problems and supplying different labelling for the product or as expansive as complete removal of the drug from the marketplace.

Examples of major drug recalls.

Drug recalls may affect all or only certain batches of the medication. Although most drug recalls are undertaken out of an abundance of caution and the risk of harm is generally low, there have been some incidents where a recalled drug has caused a significant number of personal injuries or fatalities. Some well known examples of major drug recalls in Canada include:

• Thalidomide - a wave of severe birth deformities linked to thalidomide (Kevadon, Talimol) in the early 1960s resulted in one of the most notorious drug recalls in Canadian history. Lax regulations allowed the drug to enter the market even as other countries, such as the United States, withheld approvals over inadequate independent testing. Canada also permitted the drug to remain in the market for months after European countries recalled it when they became aware of birth defect links.
  
• Sartan - Health Canada issued recalls for blood pressure medications that include sartan due to the presence of an impurity called N-nitroso-quinapril that has the potential to cause cancer.
  
• Vioxx, Bextra - used to treat arthritis, research linked these drugs to fatal heart attacks, strokes and/or serious skin reactions and were withdrawn from the market by their manufacturers.

What should you do if you are taking a recalled drug?

If you learn that a prescription medication you are currently taking has been recalled, do not stop taking it before speaking with your doctor, the medication’s prescriber and/or your pharmacist, and receiving their direction. Some prescription medications may produce serious withdrawal symptoms if stopped suddenly. Moreover, if the medication is treating a serious health condition, your doctor may want to transition you onto another medication to provide uninterrupted management of your condition.

If you are taking over-the-counter (non-prescription) medications, you should stop consuming them as soon as you become aware of the recall. Unused over-the-counter medication should be returned to the point of purchase for disposal and a refund. The pharmacist may be able to suggest a safer alternative. Save the receipt or documentation showing you returned the recalled medication in case a future issue arises where these records are needed.

If the recall is prompted by the discovery of dangerous side effects or problems with the drug’s efficacy to treat a serious medical condition, you may have suffered significant damages and losses by taking medication you believed to be safe. In these cases, it is advisable to contact a personal injury lawyer to learn about your rights and to determine if you may have an actionable individual claim or may be eligible to participate in a class action lawsuit or mass tort proceeding.

Have you been hurt?

In some cases you or a loved one may have experienced an adverse medical event or a deteriorating condition clearly linked to the recalled drug. Your medical records may provide evidence of this harm; however, in other cases you may not have sought treatment. For example, certain recalled drugs linked to major depression or increased risk of suicide may have caused significant problems for you that did not (yet) result in trips to your doctor. Other recalled drugs may have increased your risk of suffering harm in the future (for example, an increased risk of cancer), or caused other damage to your body not yet identified by medical examinations or testing.

By contacting a personal injury lawyer with experience handling drug recall cases, you can learn about what you will need to do to protect your right to make a claim for compensation or damages.

In some instances, a class action or mass tort proceeding may be launched against a drug manufacturer, distributor or government regulator. These types of legal actions allow the claims of many people to be dealt with at one time. A class action will use a representative case to seek damages on behalf of an entire “class” or people. If you are considered to be part of a class, you will be bound by any settlement or court judgments. If you plan to pursue a claim as an individual, or as part of a mass tort proceeding, you must provide written confirmation of your intention to “opt out” of a class action.

Mass torts, which are becoming more common in medical product liability cases, allow individuals with varying degrees of injury or damages to pursue individual claims through a collective process. A mass tort permits individuals to accept proposed settlement structures, which are apportioned in relation to the extent of the injury or damage a person suffers, or proceed to trial. There are advantages and disadvantages to all these options that should be discussed with a knowledgeable personal injury lawyer to ensure you or your loved one can make an informed decision.

The Gluckstein advantage.

Recognized as one of the country’s top personal injury law firms, Gluckstein Personal Injury Lawyers’ drug recall team can be trusted to provide effective legal representation and advocacy. As a client-focussed firm, our compassionate, caring and attentive team is available to help you and your loved ones in any way we can.

If we believe we can successfully negotiate a fair settlement for you or win an award from the court, we will offer to represent you. As our client, we treat you as we would treat our own family - with the respect, dignity and supportive care you deserve during this challenging and uncertain time in your life. As they guide you through the legal process, our renowned client liaisons are available to check in to see how you are doing, listen to your concerns, and to connect you with resources that may be helpful as you move forward with your life.

At Gluckstein Lawyers, we believe a client’s finances should never be a barrier to accessing justice. Therefore, we cover all costs during legal proceedings and will only ever accept payment for our services if we negotiate an acceptable settlement or achieve a court award for you.

Learning that someone’s negligence has put you or a loved one at risk of harm can be devastating. You should know you are not alone. Trust Gluckstein Personal Injury Lawyers to help you seek the compensation you need and deserve for what’s been done to you.