Medical Device Defect and Recall

Holding companies accountable for defective medical devices and recalls

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From artificial joints to hip replacements, prosthetics, IVC filters, and mesh products, the medical device industry in the U.S. continues to boom. There are thousands of MedTech companies making medical devices and reporting billions in combined annual sales.

Though many medical devices improve the quality of people’s lives, and in many cases, save them, there is a dark side to this fast-paced growth and innovation. Not all medical devices are safe. As more medical devices are brought to market, the number of defects and recalls also continues to rise at an alarming rate. The truth is that many devices have caused dangerous side effects, long-term impairment, or life-altering injuries to the patients they were supposed to help. In other situations, unexpected deaths have occurred.

Dangerous Medical Device Mass Tort: an act or omission that harms a large number of people

Mass tort cases arise from a defective or recalled medical device on the market that harms many people. Some of these cases are well-publicized, while many others never make headlines, but cause just as much pain to the people whose lives are affected. In a mass tort case, plaintiffs file individual lawsuits, which are grouped together only for pretrial proceedings, and then they may be tried later in their original state jurisdiction.

These personal injury cases fall under the category of product liability: the responsibility of corporations, distributors, and manufacturers of medical devices to foresee and test for potential risks and deliver safe products to the market.

Medical device manufacturers are legally responsible for ensuring that their products are safe and must do the following:

  • Conduct adequate clinical trials and other testing required by the U.S. Food and Drug Administration(FDA)
  • Clearly explain the risks and benefits of their products to healthcare providers and consumers
  • Continue to test their products for safety

When MedTech companies put profits before consumer safety, they can be liable for personal injury. Medical device defect attorneys are prepared to hold them accountable and recover full compensation for the harm done.

 

What makes a medical device dangerous?

Although products are closely monitored by the FDA, there are several reasons why a medical device may become dangerous or deadly, including:  

    • Design flaws, poor construction or the use of toxic or degradable materials
    • Inadequate testing before a product is brought to market
    • Failure to properly warn the medical community and consumers about product risks
    • Product labeling defect without warnings for safe use
    • Marketing of a product for uses not approved by the FDA

All of these failures come back to the basic principle of accountability. Manufacturers of defective medical devices can and should be held accountable if they put consumers at risk. 

How do I find out if you have a valid dangerous drug claim?

The FDA tracks thousands of implantable, life-saving, and life-sustaining medical devices and maintains a database of hundreds of medical device recalls. Among these defective medical devices, some are the source of ongoing lawsuits in courts around the country. If you have been harmed by a defective medical device, you may have a liability claim.

The first step to see if you have a valid claim is to consult with an attorney who will determine what defective or recalled medical device claims are being handled and if your potential case qualifies for further investigation. There are strict statutes of limitations in medical device and recall cases, so it’s important to get in touch with an experienced personal injury attorney as soon as possible.

Attorneys Jodi and Susan talking in conference room

What compensation can I receive from a defective medical device lawsuit?

Under state and federal law, consumers seriously harmed because of defective products have the right to recover financial damages for various categories of loss, including:

  • Pain, suffering, and emotional distress
  • Interference with enjoyment of life
  • Medical bills and healthcare expenses
  • Time lost from work
  • Any loss wages and lost future income
  • Loss of consortium in a wrongful death case

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Protecting consumers against dangerous medical devices

Dangerous medical device lawsuits involve complicated medical and legal issues and are expensive to pursue. It takes an understanding and mastery of complex theories of liability and damages, as well as the time necessary to review and process thousands of case documents, and work with many witnesses and experts.

If you’ve been injured by a defective or recalled medical device, contact Berman & Simmons to determine what devices are being considered for legal action and if your case qualifies for further investigation. By partnering with a national referral network of experienced mass tort attorneys, our goal is to protect consumers against potentially harmful medical devices and hold corporations liable to the people they harm.

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FAQs

  • What is a mass tort lawsuit?

    Mass tort cases stem from a defective drug or device on the market that harms a large number of people. Some of these cases are well-publicized, while many others never make headlines, but cause just as much pain to the people whose lives are affected.

    Mass tort claims can include different complaints against the same defendant(s), and often involve injuries from dangerous drugs and medical products.  For instance, patients can sue the maker of a defective medical implant for different types of injuries. In a mass tort case, they would file individual lawsuits, which are grouped together only for pretrial proceedings, and then they may be tried later in their original state jurisdiction.

    Prescription drug and medical device makers are legally responsible for ensuring that their products are safe
    and must:

    • Conduct adequate clinical trials and other testing as the FDA requires
    • Clearly explain the risks and benefits of their products to healthcare providers and consumers
    • Continue to test their products for safety

    When corporations fail to satisfy any of these or other requirements, they can be held liable to the people they harm. Dangerous drug and medical device lawsuits involve complex medical and legal issues and are expensive to pursue.

  • What types of mass tort claims are most common?

    Mass tort categories typically fall into three types:

    • Prescription drugs
    • Product liability, which includes medical devices: Claims typically fall into three categories: 1) defective manufacture, 2) defective design, 3) failure to provide adequate warnings or instructions concerning the proper use of a product.
    • Toxic contamination: Also known as “toxic torts,” these cases involve hazardous pollutants or chemicals that have poisoned people.
  • What are the skills needed to handle mass tort cases?

    Mass tort cases require extraordinary resources and highly sophisticated knowledge. It takes an understanding and mastery of varied and complex subject matter and theories of liability and damages, the time necessary to review and process thousands of case documents, and the ability to work with many witnesses and experts. Our lawyers have the skills and tenacity to prepare a mass tort case no matter how complex.

  • What if I was harmed by or experience abnormal side effects from a medical device?

    Companies have an obligation to ensure that the product they sell is a safe, effective solution to any medical issue you might experience. When a company doesn’t fulfill this obligation, it can leave you with injuries that degrade your quality of life.  If you believe you might have a claim, contact our lawyers at Berman & Simmons. We will fairly and accurately assess your case.

  • What is the process for a mass tort claim?

    These are the basic steps:

    • Review records – We examine statements from claimants and their medical records to identify the device or drug and injuries.
    • Injury consistency – We check for similarity of injuries among those harmed by drugs or devices as evidence for the claim and categorize the cases to understand any shared characteristics.
    • Federal court filing – Individual cases are consolidated to speed up processing and information gathering.
    • Bellwether trials – A small group of lawsuits, chosen from a larger group of similar cases, are tried first. The results can determine the potential outcomes of future cases. As an example, C.R. Bard, the maker of the inferior vena cava (IVC) filter G2, will pay plaintiff Sherr-Una Booker $3.6 million for injuries she suffered from the device and for failure to warn about its dangers in the first IVC “bellwether” case to go to trial.
    • Settlement – This occurs when both parties enter negotiations to settle the claims, and any proposed agreements are presented to claimants to decide whether they will accept them or proceed to a trial.
  • How long does a mass tort claim take?

    Because mass tort claims can involve multiple plaintiffs, they can take longer than  typical personal injury cases. Generally, these cases take years before resolution.

    There are statutes of limitations in medical device and dangerous drug cases, so it’s important to contact a lawyer as soon as possible if you believe you have a claim.

  • What type of damages can I claim in a mass tort case?

    Under state and federal law, victims of dangerous drugs have the right to recover financial damages for various categories of loss, including:

    • Current and future medical bills
    • Lost work time related to your injury
    • Disability and disfigurement
    • Pain and suffering
    • Mental and emotional damages

    If you have been harmed by a dangerous drug or a defective medical device, we are prepared to stand up for you and your family. Our team of experienced lawyers will hold companies accountable and make sure you receive full compensation for the harm done to you.