What to Do If You’re Injured by a Defective Medical Device

Patients have the right to expect that the medical devices their physicians recommend will improve their health or, at least, prevent their health from worsening. Often, manufacturers rush to market their devices before ensuring that their pacemakers, hip implants, stents, and other devices work properly. At Smith McBroom, we hold medical device manufacturers accountable when they place their profits before your safety.

We file medical malpractice claims if your doctors should have been aware that the medical devices they recommend or use are subject to recalls or are dangerous for other reasons.

The approval process for medical devices

Generally, the Food and Drug Administration (FDA) has the authority to approve medical devices. There are two basic ways to approve medical devices:

• Premarket approval process. This process uses rigorous scientific analysis.
• 510 (k) process. The process involves showing that a new medical device is “substantially equivalent” to an already approved medical device.

The FDA also recalls many medical devices based on its own investigations or recalls by manufacturers. The FDA uses the term “recall” when a manufacturer takes a corrective or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a health risk, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company.

Common medical device recalls and lawsuits

Some of the medical devices that have been or are currently subject to recalls or lawsuits involve the following:

• IVC (intra vena cava) filters. Doctors implant these devices in patients who have a high risk of blood clots. Device defects can cause the filters to break or shift, causing injuries or death.
• Transvaginal mesh. Physicians use transvaginal or pelvic mesh devices to treat a patient who has urinary incontinence or pelvic organ prolapse. These mesh devices are known to cause infections, pain, and bladder damage.
• Metal-on-metal hip implants. According to the Arthritis Foundation, “artificial hips generally last 10 to 15 years, but metal-on-metal (MoM) implants have a much shorter lifespan – failing after five years in some patients. They’re also linked to a growing list of other problems, including bone and tissue destruction and high levels of metal ions in the blood.”
• Other medical devices subject to recalls and/or litigation include the following:
  • Various birth control products
  • Prosthetic devices
  • Implantable defibrillators
  • Breast implants
  • Insulin pumps

What type of harm do defective medical devices cause in Seattle?

Medical devices that fail can cause a whole range of problems, such as the following:

• Failing to treat the health disorder they were supposed to treat. Examples include insulin pumps that fail to regulate a diabetic’s insulin level or metal hip-on-hip implants that cause hip pain instead of relieving the pain.
• Failing to sterilize. Doctors may be liable for medical malpractice if they fail to sterilize the devices. Manufacturers may be liable if medical devices increase the risk of infection.
• Organ damage. Surgical implants or instruments that are defective can puncture or damage lungs, kidneys, and other organs.
• Bleeding/blood clots. Some medical devices may cause large amounts of bleeding or increase the odds of a blood clot.
• Chronic pain. Defective prosthetics or implants can cause continual pain in a patient.
• Allergic reactions. Some medical devices can cause a patient to suffer allergic reactions to the materials in the devices.
• Corrective surgeries. Defective medical devices may require that physicians remove the device or replace the device.
• Damage to nerves, tissue, and bones. Hip implants can become faulty and cause complications such as nerve damage, tissue death, and even damage to bones.

Patients may lose the ability to use a body part. The emotional trauma of coping with a defective medical device that hurts or fails to work can be devastating.

Some defective medical devices may be fatal.

Who is responsible for defective medical devices

At Smith McBroom, we file claims against manufacturers who make and sell defective medical devices. The manufacturers may be liable on the following grounds.

• Strict liability. Our product liability lawyers hold manufacturers liable if their products are defective and the defect causes a patient harm. A product is defective if the design is defective, the workmanship is defective, the appropriate warnings are lacking, or the instructions on how to use the medical device are unclear.
• Breach of warranty. We hold manufacturers liable if their medical devices breach any express or implied warranties the manufacturer gives.
• Failure to follow industry standards. We hold manufacturers liable if they fail to use acceptable industry standards, fail to properly test their products, or are otherwise negligent in any other way.
• False or misleading promises. Manufacturers of medical devices may be liable if they make false or misleading promises or statements about their devices.
• Failure to abide by a recall. It helps a patient’s claim if their injuries occur when the manufacturer/doctor has (or should have) knowledge of the recall. If the manufacturer knows of the recall, then their response or lack of response can affect your claim. You can still file a claim even if there is no recall.

Our lawyers file individual personal injury and wrongful death claims against the manufacturers, doctors, and any other responsible parties. We also file class action lawsuits when medical devices affect a large number of patients.

How much can patients receive for injuries that a medical device causes?

At Smith McBroom, we will help you recover compensation for all your financial and personal damages. These damages include all your current and future:

• Medical bills, including corrective surgeries, hospitalizations, ER care, doctor visits, rehabilitative therapy, psychological counseling, medications, and other assistive technology.
• Lost income, which includes wages, salary, business income, work benefits, and long-term disability compensation.
• Physical pain and emotional suffering, including chronic pain, anxiety, depression, and post-traumatic stress disorder.
• Inability to enjoy life’s pleasures.
• Loss of bodily function.
• Loss of consortium.

We also seek wrongful death damages if a defective medical device causes the death of your loved one.

At Smith McBroom, we’re ready to fight to maximize your financial recovery so you can support your medical recovery. Our Seattle product liability lawyers have more than 20 years of experience fighting for patients and families when medical devices cause injuries or fatalities. Call our office in Tukwila or contact us to schedule your free consultation.