Medical Device Injury

Every year millions of people use a variety of defective medical devices believing they are safe and that there is little chance of serious health risk. Yet defective medical devices can leave users at risk for a variety of debilitating injuries. The risk from defective medical devices is especially high for people who require their long-term use.

Most US citizens believe the FDA is carefully reviewing and testing every medical device before it is sold to doctors and hospitals. However, in the US, the 510(k) process is being used by manufacturers to push medical devices to market with little to no testing. Under the 510(k) process, the medical device manufacturers write a letter to the FDA. They just have to explain how their device is similar to another device that is already on the market.

Medical devices that are implanted in patients and left there, like meshes used to repair hernias or clips used to close off the Fallopian tubes, were placed in a lot of patients before doctors realized they were causing health problems and even deaths.

Unlike most personal injury lawsuits, cases involving defectively designed or manufactured medical devices are product liability cases. This means the physician who used the device is not at fault. Instead, the manufacturer of the device is at fault for negligently producing and selling a defective device. There are three possible ways to approach these cases:

  • 1. The manufacturer knew about the flaw and failed to recall the device.
  • 2. The manufacturer knew about the flaw and failed to warn users of the device about the harm it might cause.
  • 3. The product can be proven to have a serious design flaw that any reasonable, careful manufacturer would have noticed during its design phase, its pre-production testing, and/or during routine quality control processes.

Legal cases against medical device manufacturers tend to be complicated and require a lot of research. They can also be lengthy and expensive legal battles since medical device manufacturers have a lot to lose if one of their devices is proven in court to be defective and to be causing substantial harm to patients.

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Frequently Asked Questions

Were you hurt because of a defectively designed or manufactured medical device? We know that you expected this device to address a serious health issue, not to make your condition worse. If you believe that you might have a defective medical device claim, our attorneys will be ready to help you understand your rights and what compensation you might be owed. Call us or reach out to us online to schedule a free consultation, and read the following answers to some frequently asked questions below:

A: Medical device injury lawsuits are filed directly against the manufacturer of the device because the manufacturer was negligent by designing, producing, and selling a defective device. If you suffered an injury or became ill due to a defective medical device, you could be owed significant compensation for the harm you’ve suffered and losses you’ve incurred.

A: Generally, compensations cover medical costs, pain and suffering, mental and emotional anguish, and lost wages during the recovery period. If the injury caused permanent damage that prevents the victim from returning to their job, the compensation would also cover future lost wages. If the victim died, the compensation would also include funeral costs, the pain and suffering of the victim’s family, and the future lost wages.

A: Your attorney will do all of the necessary research into the medical device. All you need to provide are your medical records showing that the device was used on you and that you suffered harm after it was used. In many of these cases, the harm occurred months after the device was implanted, so just because you were “fine” for six months after your hernia repair operation does not “prove” the device didn’t cause your injury.

A: Since defective medical devices often harm a significant number of people, law firms will usually file two or three initial cases, sometimes called “bellwether trials”. These trials are held in front of juries and are used to establish whether reasonable, ordinary people believe that the facts support the claims about the defective devices. They are also used to establish the amount of compensation that ordinary people think should be paid to victims of these devices. Once a few bellwether trials have been won, the device manufacturer often agrees to settle all future claims out of court. Alternatively, a class-action lawsuit could be filed to seek compensation for a large number of victims in one trial.

Contact Heninger Garrison Davis Today

Even if you feel you are not ready to file a suit, consult one of our qualified lawyers as soon as possible so that you will know your options. We do not charge any fees upfront. In fact, we will only charge attorney’s fees if we obtain a financial settlement for you. If you don’t win, we won’t get paid a legal fee. Call us today for your free case evaluation 1.800.241.9779.

For more information on some of the devices that we are currently investigating and/or litigating, please follow the links below.

Current list of medical device injury claims

Essure is a birth control device usually implanted for permanent sterilization. There have been an increased number of incidences where the device migrates and results in the woman having an unplanned hysterectomy or other serious surgery. We are looking at claims where women have had a serious injury.

There are several makes/models of mesh, including Physiomesh, C Qur mesh, Parietex, Bard 3 D, and other products that have been associated with a high rate of failure resulting in recurrence of the hernia and other issues. We are looking at cases where the person had an abdominal hernia repair, and then had a revision or explant surgery. The person will usually have no idea what type of mesh was used. We are looking at cases where the initial mesh was implanted in or after 2006.

Essure is a birth control device usually implanted for permanent sterilization. There have been an increased number of incidences where the device migrates and results in the woman having an unplanned hysterectomy or other serious surgery. We are looking at claims where women have had a serious injury.

Transvaginal Mesh (TVM)

Transvaginal Mesh (TVM)

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Since 2005, the FDA has received over 1,000 reports from nine surgical transvaginal mesh manufacturers of serious, life-threatening complications associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). 

Call us today for your free case evaluation at 1-866-970-0568.

We will fight relentlessly to get you the compensation you deserve for your prescription drug injuries.

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