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Holding Manufacturers Accountable for Defective Medical Devices

The Importance of Holding Manufacturers of Defective Medical Devices Liable

Pennsylvania has several laws that set forth that, under the strict liability concept, the person or company responsible for the manufacture or distribution of a defective product can be held liable for the resulting harm, whether they were aware of the defect or not. With strict liability, the burden of proof rests on the victim to prove that the defect is not only present but that the defect is responsible for the injury. In addition, it has to be established that the product was used in a way that was foreseeable by the manufacturer. You should seek guidance from your experienced Allentown personal injury lawyer for advice on your defective medical device case, as these types of claims can be complicated.

How Defective Devices Escape Early Detection

The FDA is tasked with supervising every step of the medical device manufacturing process, and the manufacturers do not intend to fabricate defective devices. However, many medical products do not go through proper testing or quality control, and the designs of some products may not be appropriately researched prior to their getting to the market. It is in these circumstances we see products that actually hurt the patients instead of helping them. New medical devices and products must go through many years of clinical trials and laboratory testing before they are sold on the market. Even the most stringent testing is not infallible. While it is entirely possible that some of these products hit the market early due to conflicts of interest, there are plenty of products that are legitimately tested but found to be defective later on. There are also incidents where a new product will pass the FDA's stringent approval process and still prove to be ultimately defective. Once a large number of consumers become ill or injured by these products, legal complaints will start coming in, and an after-the-fact recall will be issued. Often these recalls are too little and too late, and the damage has been done.

Medical Device Defects

If you suffer an injury due to a defective medical device, you deserve compensation from the manufacturer. In hospitals and clinics throughout the Commonwealth of Pennsylvania, doctors perform countless medical procedures and surgeries every day. It has been found that there are actually a large number of devices that are known to be defective in their manufacturing and capable of leaving the patient suffering harmful injuries or even death from them. Some examples of defective devices that have already caused significant damage to patients include components and materials that are used on a daily basis. These include:
  • Breast implants
  • Defective knee replacement components
  • Defective hernia mesh implants
  • Defective hip replacement components
  • IVC blood clot filters
  • Pacemakers
  • Stents used in cardiovascular and neurosurgery
  • Surgical equipment
  • Transvaginal or hernia mesh
Many of the deleterious effects of these defective medical devices are not seen for many years. The results can cause the patient to suffer constant pain or other symptoms. Identifying the defects can be a long and arduous prospect during which the patient might need to have subsequent surgeries or even lead to their untimely death.

Product Liability Categories

Pennsylvania law recognizes three types of strict liability lawsuits:

Defect in Design Claims

In defect in design claims, the defect occurs when the design itself is flawed. Even if a product is carefully manufactured and meets the manufacturer's design standards, it may prove to be unreasonably dangerous to the patient. When this type of claim is brought, the patient needs to present the burden of proof that there was an alternative, cost-effective device design that would have prevented the injury the patient incurred.

Defect in Manufacturing Claims

A defect in manufacturing claim may be brought if the product itself does not meet the designer's technical specifications or the manufacturer's specifications. Manufacturing defects occur during the fabrication process. They may involve shoddy workmanship, or the manufacturer may have used materials that were of poor quality. This type of claim is the easiest to prove in court. The proof lies in the manufacturer's design standards showing a defective product.

Failure to Warn Claims

These claims can be filed if a product has a danger that is not readily obvious, yet the threat could be avoided if the patient or other user had been adequately warned of the possible risks. Suppose you or a loved one has experienced injuries or fatalities from a medical device. In that case, you will want to speak to your Allentown personal injury lawyer for advice on which claim to file.

Aspects of the Product Liability Laws

There are a few aspects of the product liability laws that may apply to your claim. Pennsylvania requires that if you have been harmed by a defective product, you must file your lawsuit within two years of when you first suffered the injury. There are, of course, exceptions to these limits, as occasionally, when it comes to medical products and devices, the flaws might not be apparent in such a short period of time. One of these exceptions is known as fraudulent concealment, which keeps the defect from being discovered at the time of the actual injury. Fraudulent concealment statute of limitations begins at the time the patient first realized that the defects of a device caused the injury. When it comes to damages, there are no caps to amounts that can be awarded after a Pennsylvania trial. If the verdict from a jury finds the case in your favor, you will be fairly compensated for the pain and suffering you have endured due to the defective medical device.

Manufacturer Liability

A manufacturer is responsible for ensuring that their product is meticulously designed, carefully produced, and honestly marketed. Negligence claims occur against a seller if they knew the product was defective and they still chose to sell the product. Proving that the reason the product caused injury due to manufacturer error or proving that the seller was aware of the defect can be challenging. The principles of strict liability work in our favor because the plaintiff does not need to carry the burden of proof that the manufacturer's actions were negligent. The product needs to be shown to be defective and that it is the defect in the product that made that product dangerous and ultimately caused the injury or death. While these cases are not easy to prove, they can be made easier to pursue when you have an attorney with the right kind of personal injury experience due to defective medical products. Your Allentown personal injury lawyer can answer your questions and provide the proper guidance for your case.

Your Allentown Personal Injury Lawyer

At Metzger and Kleiner, we are ready to help guide you through your defective medical devices case. Our lawyers are standing by to answer all your questions and provide you with guidance. We have extensive experience in medical product litigation, and one of our founding partners chaired the Medical Legal Committee for the state of Pennsylvania. Contact us today at (610) 435-7400 for more information and to set up your initial consultation.

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