Defective Medical Devices and Product Liability Claims for Compensation

You have the right to seek compensation for harm caused by a defective medical device. Learn more about liability lawsuits for medical device injuries.

Thanks to rapid advances in medical science, thousands of patients each day are helped by medical devices to overcome the effects of illness or injury.

Unfortunately, there are risks to these devices, especially those that are implanted in the body. Faulty medical devices have killed as many as 80,000 patients in the last decade. ¹

During that same period, more than 1.7 million patients were injured by faulty medical devices. ²

Experts have found that the use of implantable medical devices is inadequately regulated, with many risks not recognized until patients are seriously injured. ³

If a failed or faulty medical device has harmed you or a loved one, you have the right to pursue compensation for your injuries and pain and suffering.

Medical Devices and Risk of Harm

A medical device is any product developed to assist medical professionals in treating patients. They are used to diagnose, prevent, and treat numerous illnesses and injuries.

Medical devices can range from external products like bandages or crutches, to devices that are surgically implanted into the body. Each type of device carries a certain level of risk, even when everything works the way it’s supposed to.

Medical Device Regulations Act

The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act created three regulatory classes for medical devices. The three classes are based on the amount of government oversight needed to assure the devices are safe and effective.

Class I – These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category, and 95% of these are exempt from the regulatory process.

Class II – Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 43% of medical devices fall under this category.

Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.

Many medical devices are exempt, meaning they don’t have to get approval from the FDA before marketing, although the manufacturer does have to list the device with the FDA. Exempt devices are usually Class I items like bedpans and bandages.

The most common medical devices include:

  • Pacemakers
  • Defibrillators
  • Heart Stents
  • Breast Implants
  • Spinal Cord Stimulators
  • Insulin Pumps
  • Artificial Knee or Hip Joints

Before a Class III medical device can be sold to physicians, hospitals and other medical providers, the device must go through a stringent Food and Drug Administration (FDA) approval process.

While the FDA does everything possible to ensure medical devices are safe, there are times when a potentially dangerous device makes its way into the public domain.

The FDA maintains a searchable Medical Device Recall Database available to the public.

A patient harmed by a medical device has the right to file a civil action, or lawsuit, to recover “damages” caused by the faulty device. Damages can include the patient’s present and future medical bills, out-of-pocket medical expenses, lost wages, and pain and suffering.

In cases of intentional harm, or a willful disregard for a patient’s health and safety, the lawsuit may include punitive damages. Punitive damages are intended to “punish” the at-fault party for egregious conduct.

Liability for Defective Medical Devices

Most medical devices begin in the research and development department of corporations. Once the device makes its way through the design and manufacturing phase, it goes through the FDA approval process. The device is then marketed for use by physicians, hospitals, paramedics, and other health care professionals.

Medical device defects can occur during the:

  • Design phase
  • Manufacturing phase
  • Marketing phase

Design Defects

A design defect is a problem which occurs during the design process. It doesn’t necessarily mean the device is harmful to a patient.

For example, a newly designed defibrillator may have an on-off switch in an uncomfortable position for the operator, or a universal knee joint may not fit as many patients as it was designed to fit. These design defects do not make the device dangerous.

If, however, the defect causes injury, or exacerbates an existing injury or illness, the patient will likely have the basis of a product liability lawsuit.

To determine whether the medical device design defect directly caused a patient’s harm, the courts rely on two rules. They are the “consumer expectations rule” and the “risk-utility balancing rule.” Under these rules an actionable design defect exists when the medical device is:

  • Unreasonably dangerous as designed, or
  • Not safe for its intended and reasonably foreseeable uses

Case Summary: $41 Million Awarded for Medical Device Liability  

Suzanne Emmett was permanently injured by a pelvic mesh product implanted to help support a fallen organ.

The failed pelvic mesh caused Ms. Emmett to endure nine surgeries and more than 40 nerve treatments while suffering from pain and the inability to control her bladder.

Attorneys for Suzanne Emmett and her husband filed a product liability lawsuit against Johnson & Johnson, alleging negligence for the promotion and sale of a defective medical device.

The jury determined the pelvic mesh was negligently designed, and awarded $41 million to the Emmett, including $15 million in compensatory damages, $25 million in punitive damages and $1 million for a loss of consortium claim.

Manufacturing Defects

Most medical products are manufactured in large plants owned and managed by medical corporations. Most of the time, the manufacturing process goes smoothly.

There are occasions, however, when the manufacturing process becomes flawed due to machinery aging or breakdown, human error, or faulty components. Any of these failures can result in defective and dangerous products. Some manufacturing flaws may be visible to the naked eye, while others may be hidden within the device itself.

Once again, a manufacturing defect doesn’t necessarily mean a medical device is dangerous. The defect must have resulted in undue harm for a patient to have the basis of a medical device product liability claim.

Case Summary: $3 Million Verdict for Defective Blood Filter

Tonya Brand trusted the IVC filter device implanted in her body to help protect her from a heart attack or other life-threatening conditions. An IVC filter is placed in the inferior vena cava, a vein leading to the heart, to catch blood clots and stop them from traveling to the heart or lungs.

However, Brand suffered medical complications when the IVC filter began to deteriorate and fall apart. Brand asserts she pulled a piece of the defective filter out of her thigh and has multiple pieces lodged in her body that cannot be removed.

Brand’s attorneys filed a lawsuit against the manufacturer of the defective medical device. At trial, the jury was convinced the medical device was defective and dangerous.

Brand was awarded $3 million in compensatory damages.

Marketing Defects / Failure to Warn

Once a medical device is designed and manufactured, it is distributed for sale. While the design and manufacturing processes can be flawless, the device may still have the potential to cause harm, including the wrongful death of patients.

Medical devices are sold by marketing representatives trained in the device’s intended use, and its potential for misuse and injury. These representatives must be able to explain the device’s intended uses to medical professionals clearly.

Failure to provide a complete and accurate description of the device to medical providers can result in misuse, a misunderstanding about its medical contraindications, or both. Any lack of understanding can result in harm to patients.

Case Summary: $2.1 Million Award for Defective Hip Implant

Robyn Christiansen was an athletic retired ski instructor when her hip was replaced with a metal-on-metal implant manufactured by Wright Medical Technology.

Although the manufacturer marketed the hip implant as a durable medical device, and a good choice for physically active patients, Christiansen began to suffer severe pain.

Christiansen was suffering from severe metal poisoning and tissue death caused by the device. She required another hip replacement surgery.

Her attorneys argued that the manufacturer misled Christiansen’s doctors into using their metal device rather than a hip implant made with safer materials.

The jury originally awarded $11 million to Christiansen. However, the federal judge ruled the punitive part of the award was excessive, reducing her award to $2.1 million.

The manufacturer appealed, but the $2.1 million verdict was affirmed. The manufacturer had to pay.

Winning a Medical Product Liability Case

Proving a medical device product liability case against the company responsible for the design, manufacture, and sale of the device requires several legal elements.

You must be able to prove:

  1. The company had a duty of care not to harm you.
  2. The company breached its duty, through negligent actions.
  3. The negligence was the direct and proximate cause of your injuries.
  4. As a result of your injuries, you suffered compensable damages.

Product liability lawsuits are complicated and expensive. You’ll need a seasoned attorney with experience in product liability litigation to get the compensation you and your family deserve. Your attorney will track down every party that might share liability for your injuries.

Besides the manufacturer, your lawsuit may seek compensation from:

  • The laboratory that tested the device and provided test results that failed to reveal defects
  • The marketing firm that convinced your doctor to use the device that harmed you
  • The doctor who failed to warn you of the possible risks associated with the device, especially if the doctor accepted kickbacks from the manufacturer

Look for an attorney who can advance the funds needed to pay for expert witnesses, independent testing, extensive discovery, and more.

Successful product liability attorneys usually won’t charge for their initial consultation, and represent injured victims like you on a contingency fee basis. That means the attorney won’t get any fees unless your case settles before trial or your attorney wins a verdict in court.

You are entitled to seek fair compensation for your injuries and suffering. Find out what a skilled attorney can do for you.

Medical Device Liability Questions & Answers

Charles R. Gueli, Esq. is a personal injury attorney with over 20 years of legal experience. He’s admitted to the NY State Bar, and been named a Super Lawyer for the NY Metro area, an exclusive honor awarded to the top five percent of attorneys. Charles has worked extensively in the areas of auto accidents,... Read More >>