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Medical Device Defect and Recall


Holding companies accountable for dangerous medical devices


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Maine Medical Device Defect and Recall Lawyers

From artificial joints to implantable pacemakers, the medical device industry in the U.S. continues to boom. There are literally thousands of companies making medical devices, with combined annual sales of more than $100 billion.

But there is a dark side to this fast-paced growth and innovation. Not all medical devices are safe. The number of defects and recalls continue to rise. The truth is that many devices have caused permanent injuries and even death to the patients they were supposed to help.

When medical device manufacturers put profits before consumer safety, our attorneys are prepared to hold them accountable and recover full compensation for the harm done to you.

Mass tort cases stem from a dangerous medical device on the market that harms a large number of people.

To learn more about these cases, see our articles discussing some of the most common mass tort FAQs we receive and the differences between mass tort, class action, and multidistrict litigation (MDL) lawsuits.

How to find out if you have a valid medical device claim

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The United State Food and Drug Administration (FDA) keeps track of more than 1,700 types of medical devices. There are known problems and defects with many medical devices, and some are the source of ongoing lawsuits in courts around the country. If you have been harmed by one of these or other medical devices, you may have a claim.

  • 3M Combat Earplugs. Service members in the military between 2003 to 2015, were likely supplied with Dual-Ended Combat Arms™ Earplugs (CAEv2) manufactured by 3M. However, design and manufacturing defects rendered the earplugs largely ineffective for hearing protection.
  • Hernia Mesh. Composite meshes that use polypropylene or polyester material are often used in patients to repair hernias. Certain brands of composite meshes, such as Atrium, Johnson & Johnson, Bard, and Covidien, have caused serious complications.
  • Metal-on-metal Hip Replacement. An $800 million recall of hip replacement devices by Depuy Orthopaedics in 2010 brought public attention to a wide range of injuries caused by certain hip implants, particularly newer all-metal devices.

The first step in determining whether or not you have a valid claim is a free consultation with one of our attorneys. We will conduct a thorough review of your medical records and answer any questions you might have. There are strict statutes of limitations in medical device and recall cases, so it’s important to get in touch with us as soon as possible if you believe you have a claim.

Why are some medical devices dangerous?

There are a number of reasons why medical devices can be dangerous, including:

  • Design flaws or inadequate testing before a company brings a product to the marketplace.
  • Failure by a medical device manufacturer to properly warn the medical community and consumers about risks.
  • 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 medical devices can and should be held accountable if they put consumers at risk.

These cases fall under the category of product liability: the responsibility of manufacturers, distributors, and others involved in the supply chain to foresee and test for potential risks and deliver safe products to the market.

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.

A Law Firm That Listens

Berman & Simmons is widely recognized as the best personal injury lawyers in Maine and among the best in the U.S., having won many of the largest jury verdicts and settlements ever obtained for injured people in Maine.

Our trial lawyers have won thousands of claims on behalf of those injured in a car accident, and each year we build on that successful track record.

Our attorneys and staff members will take the time to listen to you, work to understand your concerns, and come up with solutions that can make your life better, including obtaining payment for or deferral of your debts until your case is resolved. We help you recover and make sure you receive full compensation for your injuries and loss.

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Protecting Consumers Against Dangerous Drugs and Medical Devices

What compensation can I receive if I was harmed by defective medical device?

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

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    Pain, suffering, and emotional distress, past and future

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    Interference with your enjoyment of life

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    Medical expenses, past and future

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    Time lost from work

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    Loss of future earnings

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    Wrongful death damages (for the estate)

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