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Defective Medical Devices

Medical devices have revolutionized medicine and allowed many patients to regain their quality of life after dealing with a serious injury or medical condition. However, it’s an unfortunate reality that some medical devices are defective and hinder the recovery process rather than expedite it. This means medical device companies or the physicians recommending them may be held legally responsible if the defective medical device caused an injury.

Additionally, medical devices are reviewed by the U.S. Food and Drug Administration (FDA) before they are available on the free market. They are required to go through strict regulations and extensive testing before they’re released. Despite these federal precautions, some dangerous defective medical devices still find a way to slip through the cracks and into the medical community. If you have suffered because of a defective medical device, then we highly encourage you to gain effective legal counsel immediately.

Attorney for Defective Medical Devices in Conroe, Texas

Patients who need medical devices implanted face serious risks already. If the device itself is defective, then the patient could face lethal risks and lifelong complications. That is why it’s important you gain legal representation if you’ve been injured by a defective medical device.

Our suggestion for an experienced and skilled attorney is to contact Evans & Powell, PLLC. Our personal injury lawyers have been practicing for years and understand what it takes to go up against major medical device companies or manufacturers. Call us at (713) 622 - 2000 to set up your first consultation or simply submit an online contact form.

Evans & Powell, PLLC accepts clients throughout the greater Montgomery County area including Willis, Montgomery, The Woodlands, Magnolia and Willis.

Overview of Defective Medical Devices in Texas

  • Common Examples of Defective Medical Devices in the U.S.
  • How Do Defective Medical Devices Get Past the FDA?
  • Who is At Fault in Defective Medical Device Lawsuit?
  • How Do I File a Lawsuit for Injury by Defective Medical Device?
  • Additional Resources

Common Examples of Defective Medical Devices in the U.S.

Medical devices are tools used by surgeons, physicians, and nurses to aid in a person’s recovery during surgery. These tools range from a scalpel to a vital life support system keeping someone alive. All these devices are required to undergo tests by the FDA before they’re available in hospitals or in the hands of surgeons.

Even with these firm standards, some defective medical devices have slipped through including:

  • Pacemakers which administer electrical shocks or are faulty;
  • Defective insulin pumps that ultimately cause conditions such as hypoglycemia;
  • Artificial joints that deteriorate over time and leak toxic chemicals;
  • Blood clot filters that puncture organs or blood vessels;
  • Transvaginal mesh that have eroded and perforated certain organs like the bladder;
  • Ruptured or leaking silicone breast implants;
  • Collagen that ends in an infection or an allergic reaction; or
  • Surgical instruments that aren’t functioning correctly such as retractors

How Do Defective Medical Devices Get Past the FDA?

It might seem impossible for defective medical devices to land in medical communities with the rigorous testing set up by the U.S. Food and Drug Administration (FDA). The reason for this is because the FDA has different regulations for certain types of medical devices that already exist. This type of testing was adopted by the FDA in 1976 and is known as the 510(k).

The 510(k)-approval process allows medical devices to clear testing a lot quicker if it’s similar to an already existing product. For example, if a new pacemaker is coming out and an older model of a pacemaker exists, then the newer model will undergo much less testing than the initial pacemaker model. This is so the FDA spends less money when testing products that have already entered the market. However, it increases the chances of possible defects in either the design or manufacturing of the product going undetected by the FDA.

Who is At Fault in a Lawsuit for a Defective Medical Device?

It can be complicated to determine who is at fault in a defective medical device lawsuit. This is because there can be more than one person who is liable for allowing the defective medical device to be used. Normally, the manufacturer or defective medical device company will be held responsible if their product had sustained either a design or manufacturing defect.

In addition, the physician, surgeon or other medical professional who recommended the device could also be held legally responsible. A lawsuit can be filed if the medical professional was aware of the device’s design defects but chose to not inform you of the dangers. The medical professional would be held responsible because they failed to act as a “learned intermediary,” and didn’t fulfill their duty of informing you possible dangers surrounding the medical device.

How Do I File a Suit for Injury by a Defective Medical Device?

If you’ve found yourself injured by a defective medical device, then you may be eligible to obtain a monetary award to cover all your losses. To do this, you will have to file a lawsuit against whoever was at fault for your injury. You can begin initiating the lawsuit by preparing a demand letter that would encompass evidence as to why the defendant is responsible for your injury as well as a settlement offer to cover the costs.

Once you send your demand letter, you will have to wait to see if the at-fault party responds. However, some defendants contest or ignore demand letters because they don’t want to pay a fair settlement. If this happens, then you and your attorney can file a lawsuit with the civil court. When pursuing your lawsuit, your goal is to prove the following elements to the court:

  • The medical device had a dangerous design or manufacturing defect that occurred during the product’s design, manufacturing, shipping or handling;
  • You used the medical device how the manufacturer or physician told you to;
  • The defect in that medical device is the reason for your serious injury; and
  • You suffered as a result of this injury

If you’re able to win the case, then a settlement may be granted to you by the court. This settlement will cover both your financial and emotional losses from the injury. Listed below are some possible damages your settlement may cover:

  • Medical expenses;
  • Rehabilitation costs;
  • Handicap installations;
  • Counseling;
  • Loss of wages;
  • Pain and suffering;
  • Loss of enjoyment for life; and
  • Loss of consortium

Additional Resources

2019 Medical Device Recalls – Visit the official website for the U.S. Food and Drug Administration (FDA) to access a list of 2019 medical device recalls. Access the site to learn which devices are currently being recalled, why, and resources for medical device safety.

FDA Regulations for Medical Devices – Visit the official website for the U.S. Food and Drug Administration (FDA) to learn more about their regulations for medical devices. Access the Code of Federal Regulations to see how products are examined and tested before they are put out on U.S. shelves.

Product Liability Attorney for Medical Devices in Conroe, TX

Were you injured because of a defective medical device? Are you now struggling both physically and emotionally due to your injuries? If so, then it may be a good idea for you to secure legal counsel. We suggest you go with the resourceful and experienced attorneys at Evans & Powell, PLLC for excellent legal representation.

Get in touch with us today at (713) 622 - 2000 to set up your first consultation. At the appointment, we can discuss your case in detail, if you’re eligible for compensation and what the next best step forward is. You can find us in Conroe, but we practice throughout the greater Montgomery County area including Willis, Montgomery, The Woodlands, Willis and New Caney.


Evans & Powell, PLLC