A medical device is any product developed to assist medical professionals in treating patients. They are used to diagnose, prevent, and treat a number of illnesses and injuries. Unfortunately, sometimes medical devices fail in their intended use, causing harm to patients. These patients may be able to file medical device product liability claims for compensation.
While there are thousands of medical devices on the market, some of the most commonly known are:
- Heart stents
- Silicone implants
- Implantable contraceptives and intrauterine devices
- Artificial knee joints
- Heart valves
- Artificial hip replacements
Before a 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.
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 expenses for medications, bandages, etc., 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.
Medical device defects can occur during the:
- Design phase
- Manufacturing phase
- Marketing phase
- a combination of these phases
Most medical devices begin in the research and development department of medical 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 and put to use by physicians, hospitals, paramedics, and other health care professionals.
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 a patient’s harm was directly caused by the medical device’s design defect, 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
Example: Defective Breast Implants
Amy decided to get breast implants. She found a new implant designed to appear more natural and fit better than other implants presently on the market. A month after the implant surgery, Amy began to feel ill, and noticed one of the implants seemed to be getting smaller and smaller.
Amy eventually learned the seams in the implants were defectively designed, and as a result, they leaked. The leakage, combined with Amy’s weakened condition, caused her undue harm. The design defect made the implants unreasonably dangerous as designed, and as a result, Amy’s injury formed the basis of a medical device product liability case against the manufacturer.
Most medical products are manufactured in large plants owned and managed by medical corporations. The manufacturing process is optimized by engineers who organize, calibrate, and maintain the machines. 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. This 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.
Example: Faulty Hip Replacement
George had hip replacement surgery at the hospital. After several months of increasing pain in his hip following the surgery, George reentered the hospital. An MRI showed the artificial hip had a hairline fracture, which was the direct cause of George’s pain and discomfort. George needed to have another surgery and endure another painful recovery. This time the doctors decided to use another brand of artificial hip.
It was later determined that the device’s barely detectable fracture was caused by the bonding machine at the manufacturing plant being set to the incorrect temperature. An employee accidentally set the temperature to five degrees lower than manufacturing specifications called for.
In this case, the manufacturer’s design of the artificial hip was flawless. So was its manufacturing process. Yet, the manufacturing plant created and distributed a faulty product. As a result, the manufacturer was liable for George’s 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 who receive training in the device’s intended use, and its potential for misuse and injury. These representatives must be able to clearly explain the device’s intended uses to medical professionals.
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.
Example: Failure to Warn
Susan worked as a marketing representative for a manufacturing corporation that designed, manufactured, and sold their medical devices to physicians. She regularly visited with surgeons in her assigned sales territory. Her company recently came out with a newly designed “Magnetic Levitation Platform,” which was meant to be inserted into a patient’s abdominal cavity for diagnosis or during surgery.
The R & D team told the manufacturer there was a 1 percent chance the device might rupture an artery in children due to its size. The manufacturer chose not to make such a disclosure to the FDA, or to include it in the device’s medical literature. Susan sold the device to a doctor, who successfully used it on patients between ten and eighty years old.
One day, after using the device to diagnose a ten-year-old’s intestinal problem, the device opened. It severed the child’s artery, causing him to bleed out and die. The child’s parents filed a wrongful death lawsuit.
The court awarded five million dollars for the child’s general damages, and an additional twenty million dollars in punitive damages. In addressing the issue of punitive damages, the court stated the manufacturer’s intentional and willful disregard for the child’s health and safety was unconscionable.
In this case, the manufacturer’s failure to fully disclose the potential danger of the device was a clear misrepresentation. It didn’t matter if the possibility of injury was only 1 percent, their “failure to warn” constituted negligence.
Proving a 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:
- The company had a duty of care not to harm you.
- The company breached its duty, through negligent actions.
- The negligence was the direct and proximate cause of your injuries.
- As a result of your injuries, you suffered compensable damages.
The Role of Attorneys
Because of the complexity of medical device liability cases, you must get an experienced attorney to represent you. Without an attorney’s expertise, your allegations will likely fall on deaf ears. Large corporate manufacturers will seldom, if ever, admit to having distributed a harmful medical device. It would require massive recalls, costing millions of dollars, as well as lost business from medical institutions.
If you or a loved one has been injured by a medical device, seek out attorneys with extensive experience in medical product liability cases. Gather your evidence. If you have the medical device, bring it with you. The attorneys will review the merits of your case, and give you an honest opinion of your chances of winning.
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