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Defects in Medical Devices and Drugs
Every year, the market is flooded with thousands of complaints about defects in drugs and medical devices.
Depending on the circumstances, individuals who have experienced harm due to these flawed products may pursue various legal remedies, such as filing a lawsuit against the manufacturer or pursuing claims under product liability laws.
Our skilled Buchanan, Williams & O’Brien team in Springfield can fight for your rights. With extensive experience as personal injury attorneys, we’ve successfully represented numerous clients against pharmaceutical companies and hospitals. Let us be your trusted advocates on the path to seeking the compensation you deserve.
What Is the Difference Between a Medical Device and a Drug?
When it comes to medical interventions, it’s crucial to differentiate between medications and medical devices. Here are the key distinctions:
- Function: Medications exert their effects through chemical or biological means, primarily for the treatment, diagnosis, or prevention of diseases. In contrast, medical devices serve a physical or mechanical purpose.
- Regulatory Oversight: In the United States, organizations such as the FDA oversee the regulation of both medical devices and medications. However, they employ distinct regulatory approaches for each.
- Approval Process: Medications typically undergo more rigorous preclinical and clinical trials than medical devices before receiving approval for use.
- Post-Approval Surveillance: After approval, both pharmaceuticals and medical devices are closely monitored for their effectiveness and safety.
- Classification: Medical devices and medications are further categorized into various classes based on factors such as risk and mode of action. Regulatory authorities select the appropriate classification and regulatory pathway based on the primary mode of action and intended use of these products. Some products may straddle the line between medical devices and pharmaceuticals, posing unique challenges for classification and regulation.
Understanding Types of Defects
Defects in Drugs
Three types of defects are the basis for claims for a defective drug:
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Manufacturing flaws: The pharmaceutical drug is produced incorrectly or contaminated during production, harming the final consumer.
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Design flaws (Dangerous side effects): Although the pharmaceutical drug was correctly created, its adverse effects hurt or injure people.
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Failure to Warn (defective marketing): Not giving users of a drug enough or the correct instructions, warnings, or recommendations about dangerous prescription drugs.
Medical Device Defects
Defective medical products can result in more significant medical bills through further surgical procedures, serious injury, or worse. Much like drug defects, these issues can manifest in three forms:
- Design Issues: Flaws in the design of medical devices render them unsafe or prone to malfunction.
- Manufacturing Defects: Problems that arise during the manufacturing process, leading to the production of faulty medical devices.
- Failure to Warn: The absence of adequate warnings or information about potential risks associated with medical device use, resulting in harm to patients.
Medical devices that are commonly defective include:
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Metal hip replacements
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Drug-coated stents
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Guidant defibrillators
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DePuy hip implants
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IVC blood clot filters
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Transvaginal surgical mesh
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Signs of a Defective Medical Device
Defects may result from improper maintenance, bad device design, or distribution-related harm.
Implants, surgical instruments, electrical gadgets, and prostheses are just a few examples of specific medical devices that can contain flaws. For instance, programming problems brought on by electrical failures can cause a device to give medication at the wrong dosages or intervals. Electrical wires can shock healthcare professionals or clients.
Another illustration is when issues with diagnostic tools like CT and PET scanners result in incorrect patient diagnoses or a failure to detect problems. Serious harm or even death could come from this.
Possible indicators that a medical device is flawed include the following:
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It doesn’t operate as it ought to
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It is easily broken
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Reading the display is difficult
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Wires or other components are loose
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It makes odd noises or smells
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It either doesn’t hold a charge or doesn’t last as long as it should
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It results in bleeding, pain, damage, and limited mobility
Understanding Defective Medical Devices and Recalls
A defective medical device can give rise to a product liability claim, particularly if it leads to injury, surgery, or even loss of life. In some cases, the device may be subject to medical device recalls.
Despite the vigilant oversight of the U.S. Food and Drug Administration (FDA), flaws can emerge in a product’s design, manufacturing process, or marketing strategy, leading to recalls.
Medical device recalls can occur under two circumstances: correction or removal. Correction seeks to address the problem where the device is being used or sold, while removal is necessitated when a device breaches FDA regulations or poses a risk to human health.
Manufacturers and distributors of medical devices have the option to initiate voluntary recalls, notify the FDA, and take the necessary corrective actions. If they fail to do so, the FDA may step in and issue recalls.
Recalls are categorized by severity:
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Class I denotes products with a high risk of causing severe health issues or fatalities
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Class II covers items that may lead to treatable health problems
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Class III applies to products with a low likelihood of harming consumers
Understanding these classifications is crucial in navigating the complexities of defective medical device cases.
Determining Liability for a Defective Medical Device
When it comes to a defective medical device, several parties may be held liable for the issues it causes:
- Medical Device Manufacturers, Suppliers, and Distributors: Legal action can be pursued against those responsible for product quality issues and for placing a faulty product on the market.
- Retailers: If the medical device was directly purchased from retailers like drugstores or pharmacies, they may also bear accountability.
- Producers, Laboratories, and Sales Representatives: In the pharmaceutical sector, these entities may be held responsible if they downplay risks associated with the device or suggest improper applications.
- Healthcare Professionals: A medical malpractice hypothesis can be employed to take legal action against healthcare professionals who recommended a faulty device, especially if they failed to provide adequate warnings or information.
In cases involving defective medical devices, attempting to pursue a lawsuit against the manufacturer or any other potential defendant independently is generally not advisable.
Given the intricacies of the law, it’s crucial to have an experienced legal practitioner on your side.
Should you wish to bring a claim, be mindful of the medical malpractice statute of limitations, which your lawyer can advise you on.
How Can Buchanan, Williams & O’Brien Help With Drug and Medical Device Defects?
Contacting our wrong diagnosis lawyers can help you successfully pose a medical products liability claim. As your advocates, we can report the defective product to the FDA through MedWatch, the FDA’s adverse event reporting program.
We can also assist you in gathering as much proof as possible, including documentation of any potentially flawed materials utilized in the production process and evidence of any design or marketing flaws.
Our highly experienced personal injury lawyers have many years of advocating for clients who have suffered injuries from defective drugs and medical devices to hold them responsible. Contact us today.
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