Medical devices are important and save lives. However, in the case of a defective medical product, severe injuries may result. Regulating medical devices requires a careful balance. Overregulation can result in people being injured while data is being collected to prove safety. Under regulation can result in products getting to market that are dangerous and cause harm or death.
It can take a significant amount of detective work to establish all the facts needed to prove a medical products liability case. The injured party can help greatly if they retain as much relevant evidence as possible. The exact nature of the defect must be determined. While it is possible that a design defect caused an injury, it is more likely that a manufacture defect is responsible.
It is important to retain the device and find out the exact make, model, and lot number of the version that was used. If a device needs to be surgically removed, then prior arrangements must be made with the surgeon and hospital to allow transfer of the property to the patient. Otherwise, devices removed are generally treated as medical waste and disposed of and destroyed shortly after surgery.
Examining the device can reveal if there are structural or other features that render it unsafe. Knowing the lot number can enable a search of the FDA monitoring database to see if the device has been subject to a recall or other regulatory action. It is also important to obtain the instructions provided for how to use the device. Reviewing the warning labels and instructions is necessary to evaluate and prove a failure to warn claim.
The Food and Drug Administration (FDA) is the U.S. agency that regulates medical devices. It requires submission of requests for permission to market and sell medical devices in the U.S., and it sets standards for how to evaluate products as well. The level of control and review FDA exercises over a medical product depends on how likely it is to cause injury. Relatively simple devices, such as tongue depressors or ankle braces, are subjected to a less stringent review than more complex devices, such as hip implants and knee replacements or stents.
There are two main paths to receiving FDA approval to market a medical device. The more stringent premarket approval (PMA) involves the FDA reviewing scientific evidence provided by the manufacturer to determine if it appears the product will be safe and effective for its intended use. A 510(k) is a streamlined process where the FDA establishes that the product is substantially equivalent to a currently legally marketed product.
In addition to evaluating safety of medical devices, the FDA also requires medical products to be properly labeled with adequate warnings and instructions for use. Instructions are very important as improper use of a medical device can also cause harm.
The safety of a product depends on all steps in design, manufacture, distribution, and use. If a product does not work well for its intended use, then it suffers from a design defect. All products made in that design will likely fail and cause problems for users. The FDA’s premarket focus is on trying to detect a flawed design and keep it from being marketed.
A product can suffer defects in the manufacture stage. Examples include use of a substandard material when making the product, or a mistake happening on a production line. The FDA’s post-market focus is on detecting and addressing manufacture defects. The agency requires manufacturers to report known defects and encourages others to report defects and concerns about a product’s safety.
Sometimes, a recall is initiated by a manufacturer. For example, if a manufacturer discovers a flaw happened in the manufacture of a particular lot, it can initiate a recall and inform the FDA, downstream users, and the public not to use the affected products. The FDA can also issue its own recall if sufficient evidence exists and the manufacturer declines to recall on its own.
Medical devices can also be inadequately labeled with warnings of contraindications or other concerns. These defects are called failure to warn and can arise if instructions for use are inadequate.
The legal approach to recovering from injuries caused by medical products is different from standard negligence cases or other products liability cases. Some jurisdictions tend to evaluate medical device defect cases using a theory of strict liability. These cases must establish that the product caused the injury. In most jurisdictions, the cases are reviewed under a legal theory of negligence. These cases must establish that the manufacturer failed in their responsibility to exercise due care to protect users from harm, and that failure caused the injury.
Defective medical device claims must establish the following:
It is vital to obtain advice from an experienced lawyer. These cases are complex, requiring extensive research on the product. States are inconsistent in how they approach medical device defect cases. In order to develop a successful case, it is important that the lawyer knows FDA regulations, how to research product defects, and the specific case law that applies in the relevant jurisdiction.
Pennsylvania has decided cases of medical device defects using both strict liability and negligence approaches and has recently sent a case to the highest court for more clarity on the law. New Jersey has also had a mixed record of how it reviews and decides defective medical device cases.
If a manufacturer violated FDA requirements by either falsifying or exaggerating findings, it could help bolster the plaintiff’s case. However, even if a manufacturer did satisfy FDA requirements, it is still possible to prevail in a defective medical device case. The details of the product’s performance and use and the approach of the court in the relevant jurisdiction will determine the success.
If you have experienced an injury from a faulty medical device, one of our dedicated Philadelphia medical device lawyers at Brookman, Rosenberg, Brown & Sandler can thoroughly investigate your case. We can build a strong case while protecting your rights. Call us at 215-569-4000 or contact us online for a free consultation. Located in Philadelphia, we serve clients throughout New Jersey and Pennsylvania, including Delaware County, Chester County, and Philadelphia County.