Technological advances in medicine allow thousands of people to recover or receive relief from serious medical conditions. While medical devices have the potential to reduce suffering, save lives, and improve people’s quality of life, design or implantation errors can lead to unnecessary injury or illness. When a medical device causes harm to you or a loved one, you deserve experienced help.
At Shrader & Associates, L.L.P., our defective medical device lawyers are standing by to guide you through your legal options. Our award-winning and respected team believes in building a strong attorney-client relationship to seek the best possible outcome. We offer compassionate and knowledgeable legal representation for your case, starting with a free consultation to better understand your defective medical device case.
Defective Medical Device Lawsuits: Why Hire Shrader & Associates to Be Your Defective Medical Device Attorneys
Many medical devices, especially when implanted inside the body, can lead to secondary health problems. A defective product or mistake during surgery can result in side effects such as blood clots, inflammation, infection, and rejection. In addition to being life-threatening, these complications often leave the patient with unexpected medical bills.
Understanding who is responsible and how to proceed in a claim can be confusing, especially if you are sick or have serious injuries. Our defective device attorneys realize you are facing unexpected medical bills and need skilled legal advice. We will make every effort to identify all parties who are potentially liable, design a compelling case against them, and negotiate a settlement that addresses your needs.
We can manage the legal details while you focus on your recovery. We can establish whether you have a product liability claim against the manufacturer or a medical malpractice claim against the doctor. Regardless of the details of your case, we relentlessly pursue the truth on your behalf. If you pass away from your injuries, we can help your survivors file a wrongful death lawsuit to provide financial stability without you.
Defective Medical Device Claims and Your Legal Rights
Like medical malpractice claims, a medical device claim often has more legal restrictions around filing and seeking damages than a standard personal injury case. For example, a defective medical device claim operates under a strict liability principle. The definition of strict liability can vary among states, but at a high level, it means that your attorney must demonstrate a defect existed in your medical device and that you suffered harm as a result.
Strict liability does not require you to prove fault, so cases focus on how and why the device failed rather than determining who is at fault. Your lawyer will perform thorough research to collect the relevant evidence showing how the defect occurred, as well as your resulting expenses and other damages.
The Role of the FDA
Although the U.S. Food and Drug Administration (FDA) is designed to offer the public protection against unscrupulous medical device manufacturers, pressure to move medical devices to market quickly has led to loopholes in the FDA’s review process. The 510(k) approval process allows drugs and devices to be “fast-tracked” in certain situations, such as when a product is deemed an upgrade or new version of a previous device. This can occur even if the original device has design defects.
When a manufacturer violates FDA rules or existing law by making a malfunctioning device, the FDA will usually issue a recall recommendation. The manufacturer can choose to recall the product voluntarily with assistance from the FDA and then work to improve the design, manufacturing process, or labeling issues.
The FDA has three levels of recall action:
- Class I: Medical products are named as a cause of serious illness, injury, or death.
- Class II: Devices that cause short-term health problems or may occasionally lead to more severe injuries. Most recalls are Class II.
- Class III: Minor defects that do not typically cause harm.
There have been many Class I recalls over the past few years. For example, hernia mesh and vaginal mesh implants have been the subject of both individual and class action lawsuits against various manufacturers, with substantial success for the victims. Class I recalls in 2023 included COVID-19 antigen rapid tests, glucose monitoring devices, and intra-aortic balloon pumps (IABP).
Defective Medical Device Liability Cases Are Complicated
Recalls add a new level of complexity to defective medical device cases. Once a recall is issued, the manufacturer may deny all liability for your injuries. Even in the case of a recall, a seasoned personal injury attorney can still work to demonstrate negligence due to faulty design or production.
Showing liability requires a large amount of high-quality evidence that establishes that the defendant failed to provide the duty of care owed to you. Your legal team must demonstrate how you were harmed and how your damages were caused by the at-fault party’s negligence. Finally, your lawyer will provide records and receipts showing the total amount of damages you incurred as a result of the injury.
When your attorney successfully persuades a judge and jury that you deserve compensation from the defendant, you will receive your award to pay for the various losses you experienced. These can include economic (fixed price items) and non-economic (pain and suffering) damages. Examples include:
- Doctor and hospital bills
- Lost income and benefits during recovery
- Prescription medications
- Rehabilitation and physical therapy expenses
- Emotional distress
- Loss of limb or amputation
- Permanent disability
When a Defective Medical Device Causes a Wrongful Death
In the worst circumstances, your loved one could pass away due to a faulty medical device. If they suffered extensive injuries before they died, your family is left facing a tremendous financial burden in addition to a future without their income and companionship. Survivors can file a wrongful death lawsuit to recover many crucial expenses.
Your demands can include not only medical expenses that resulted from the defective medical device but also compensation for the following:
- Anxiety and depression
- Funeral, cremation, and burial expenses
- Grief, shock, fear, and isolation
- Loss of consortium (intimacy) for their spouse or partner
- Loss of future income for their dependents
- Loss of guidance and mentorship for their children
- Lost income the victim experienced before their death
- Loss of inheritance for their heirs
- Pain and suffering of the decedent
- Pain and suffering of the survivors
Each state has different laws that determine who can bring a claim in the event of a wrongful death. Typically, a personal representative brings the case on behalf of the loved one’s estate. Any settlement or jury award is paid to the spouse or domestic partner, the children, and then to the parents or siblings of the deceased. Your attorney can listen to your concerns and educate you about the laws that apply to your case, ensuring the legal details are managed while you focus on recovering from your loss.
Punitive Damages
In cases where many individuals were affected by the defective medical device, they may pursue mass tort litigation or a class-action lawsuit. Your attorney can inform you if your claim may qualify. These kinds of cases often end with awarding punitive damages, which are amounts that are above and beyond compensatory losses.
Punitive damages are intended to punish the defendant harshly to discourage both the defendant and any other party from engaging in the same behavior. Punitive damages are typically awarded in situations where the evidence shows the device manufacturer was grossly negligent or even malicious. While punitive damages are more common in mass tort cases, they can sometimes be part of an individual claim.
What Causes Medical Device Defects?
You have the right to seek compensation from any party that contributed to your injuries or illness, even if there are many events that caused the medical device defect to occur. While it can be easy to blame the surgeon who performed the operation, our defective device attorneys have learned that many cases involve product liability claims against the manufacturer. These situations usually involve one of three kinds of defects: design, manufacturing, and labeling.
Design Defects
When creating a new product, device manufacturers may fail to follow appropriate design principles, resulting in a product that is inherently at risk of failure. Many factors contribute to design defects, such as rushing to get the device to market, inadequate testing, and a company’s inexperience in the industry. When a defective medical product is faulty from the beginning, it can lead to thousands of serious injuries.
While the FDA issues medical device recalls when many people have been hurt, you may be one of the first who experienced problems. Your attorney will investigate whether a recall was issued and determine if your device qualified. If no recall is in place, your legal team will search for supporting evidence of liability against the medical equipment manufacturer.
Manufacturing Defect
Even when the design of a medical device is sound, errors or negligence in the manufacturing process can produce medical devices that cause harm. In some cases, the manufacturer may opt for a less expensive material that the design calls for, leading to a negative reaction when implanted in patients. Victims may experience allergic reactions, or their body tissues may become enmeshed in the device.
Testing and scanning devices that are improperly manufactured can cause a missed or incorrect diagnosis. Cancer patients could be in the early stages of their disease, but their doctor fails to catch the signs because the imaging device failed to identify the malignant cells. In these cases, manufacturers can be held liable for the damages suffered by patients as a result.
Other at-fault parties could include distributors who damage a device during transport or installation causing the device to be out of calibration. Another example could be contract workers who cause a malfunction by relocating a device without due care. Many different parties can hold responsibility for manufacturing defects, and a highly experienced defective medical device lawyer can successfully demonstrate the impacts of each party’s actions.
Warning Defects
Medical device manufacturers test their products to identify opportunities for improvement and increased safety. The testing process also determines how a medical device should be marketed and labeled for use. Some devices have inherent risks, such as minor radiation exposure from an X-ray machine. These risks must be labeled, and the product marketed accurately so healthcare practitioners and consumers are not uninformed victims.
Patients must be advised of all potential issues the device may cause, even if the use is temporary, such as X-ray scans. The manufacturer must ensure medical providers are properly educated on the correct use of the device. Doctors, nurses, and other professionals must clearly communicate the risks to their patients, or they could be held liable for a failure to warn. An accomplished defective medical device lawyer is familiar with the complications and nuances of these cases and can conduct a skilled examination of your claim.
Common Injuries Caused By Defective Medical Devices
When you are sick or injured, you rely on hospitals, doctors, and nurses to provide the care you need to help you heal. Even with the best quality care, your healthcare providers may be working with defective medical devices that undercut their efforts to treat you. A single flaw in an imaging device could cause medical practitioners to miss signs of a terminal illness, resulting in premature death. Improperly produced implantable devices can require corrective surgeries or cause severe harm. The stakes are high, and our defective medical device clients have suffered a wide range of injuries, including:
- Brain damage
- Hearing damage
- Infection
- Inflammation
- Internal organ damage
- Loss of limb
- Medically necessary amputations
- Organ failure
- Respiratory injuries
- Skin rashes, cuts, and bruises
- Vision loss
Common Injuries Associated With Defective Hernia Mesh
The defective medical device attorneys at Shrader & Associates have experience with one of the most damaging medical devices, hernia mesh. Many manufacturers failed to design their products appropriately, leading to recalls. Even if your specific brand of mesh was not recalled, you could still experience significant side effects, such as:
- Adhesions: The mesh can cause scarring in surrounding tissues, which can lead organs or other tissues to stick together. Adhesions can cause serious complications and surgery may be required to fix the issue.
- Bowel obstruction: When used for hernia repair, the product can migrate or adhere and obstruct the lower intestine, either partially or totally. This can require emergency surgery to correct.
- Contraction (mesh shrinkage): Various mesh materials may shrink inside the body over time, putting stress on the abdominal wall and causing tears that can lead to internal bleeding or organ damage.
- Fistula: A fistula can result from the body’s immune response to the mesh material. Fistulas can cause organ damage or infection.
- Hernia recurrence: After a hernia is corrected using an impact, another hernia may develop in the same location, requiring additional surgery. If you are already in poor health, additional surgeries could be life-threatening. Even in the best scenarios, additional surgeries are inconvenient and add additional expenses to your recovery.
- Mesh rejection: Patients’ immune systems may reject the mesh, leading to pain and additional illness. Additional surgery may be required to remove the mesh and repair the hernia.
- Migration: The mesh may migrate from its implantation site and relocate itself inside the abdominal cavity, damaging other organs or causing severe pain. If the bowel, bladder, or reproductive organs are injured, patients may suffer life-threatening infections or damage.
- Recurring infections: Poor operating procedures, aftercare, or defects in the medical device itself may result in post-surgical infections. Victims may not experience these infections until many years later, but still have the right to seek justice for their harm.
Hernia Mesh Lawsuits
At present, there are thousands of lawsuits underway for people who have been harmed by faulty hernia mesh. Some situations fall under class-action claims and others are being filed as mass tort. Your attorney can advise you on whether your case would qualify to be part of a larger effort to hold negligent manufacturers accountable. They will also explain the difference between joining a class-action claim or filing your individual claim.
Many manufacturers have chosen to settle the cases against them to avoid going to trial. Compensation amounts vary widely since every plaintiff’s situation is unique, and each person has experienced different degrees of injury. Performance of past cases are not a guarantee of how your case may be decided. Your Shrader & Associates defective medical device attorney will examine the details of your claim and keep you updated as the facts of the case change, allowing you to have appropriate expectations for your potential compensation.
Contact Shrader & Associates, Nationally Recognized Defective Medical Device Attorneys
Our team has spent over two decades representing clients from across the United States. We understand how to negotiate and litigate these claims, and we have seen how device manufacturers may try to avoid accountability. We are tenacious and dedicated to bringing manufacturers to justice on behalf of those they have wronged.
Defective medical device claims may be subject to statutes of limitations that vary by state. Do not lose the chance to seek compensation by waiting to consult with a lawyer. Contact us to arrange your free case review today.