Being seriously harmed by a medical device that was intended to improve health and quality of life is both unjust and traumatizing. From knee and hip replacements to birth control implants and hernia mesh, many of these innovative products promise great hope to people suffering from disease, injury or disability. Medical devices have the potential to restore mobility, diminish pain and even prolong life. But when design flaws and manufacturing defects occur, these devices can result in debilitating injury and death.
The number of FDA medical device recalls has more than doubled in the past decade, with over 9,000 recalls issued in 2017 alone. Ventilators, surgical mesh, artificial joints and other devices are routinely pulled off the market following reports of patient injury, grave complications and loss of life.
Medical device defects, failures cause injury
A knowledgeable medical device failure attorney at Showard Law Firm can help explore your rights to compensation in the wake of such an injury. Our legal team handles a wide range of claims stemming from medical devices that malfunction or have been recalled due to defects. We believe that patient safety is paramount, and consumers have a right to be cautioned about possible risks of devices cleared by the FDA.
Showard Law Firm is currently investigating defective medical device claims relating to:
- Bone Cement Failure
- Hernia Mesh
- Hip Replacements
- Knee Replacements
- IVC Filters
- Surgical Staplers
- Talcum Powder
Reach out to our medical device attorneys for a confidential case review, free of charge.
FDA medical device recalls
Medical device recalls are intended to address a defect in the product, a health risk or a violation of FDA laws. When the FDA learns that a device manufacturer intends to remove a device or make a correction, it assesses the dangers and classifies the recall according to relative degree of risk.
- Class I: There is a reasonable probability that a medical device will cause serious health problems or death
- Class II: A device may cause temporary health problem or there is a slight possibility it will cause serious health problems or death
- Class III: A product is not likely to cause any injury or health problem
Of the hundreds of recalled devices, an estimated 70 percent reach the marketplace through the FDA’s 510 (k) process, which does not require clinical testing and regulatory inspections. This process is much less stringent than the premarket approval (PMA) method that mandates extensive trials and scientific evidence of a product’s safety and efficacy. This suggests significant shortcomings in the regulatory process for medical devices in our country – a factor that seriously compromises patient safety.
Shortcomings of the FDA 510 (k) process
In an analysis of medical device recalls from 2010-2012, 36 percent were attributed to design flaws and defects. Another 18 percent were due to problems in the manufacturing process. The FDA’s 510 (k) process has received considerable criticism in that new devices can enter the stream of commerce without pre-market inspections or testing so long as they are substantially equivalent to a predicate device already being sold.
In the last decade, nearly 100 different knee and hip replacement systems or components have been temporarily withdrawn or recalled due to safety lapses. Because artificial joints are considered Class II medical devices, they are cleared through the much faster and less rigorous 510(k) pathway.
Until federal regulators strengthen pre and post-market surveillance and safety standards of all new medical devices, litigation will continue to mount as victims seek recourse for their injuries, medical bills, pain and suffering.
Can I file a defective medical device lawsuit?
A medical device malfunction lawsuit is analogous to other product liability claims, with the purpose of holding manufacturers liable for design defects, manufacturing defects, or marketing defects (failure to warn).
Showard Law Firm will review the circumstances of your injury and determine if you have a viable claim for damages. Legal action may be warranted if it can be proven that:
- The medical device was improperly designed
- The device contained hazardous materials or was negligently manufactured
- The device manufacturer or distributor failed to warn about possible risks and hazards
- The promotion and marketing of the device was deceptive, fraudulent or misleading
- The device had known defects and safety concerns but was not recalled
Compensation for defective medical device injuries
Defective medical devices can destroy your health, your happiness and your livelihood. Some patients have had to endure multiple revision surgeries to repair perforated organs, others have lost their mobility and are permanently unable to work due to chronic pain and ongoing complications.
If a manufacturer is found liable for designing, promoting and selling a device with flaws or failing to warn about potential hazards, the injured person or surviving family member is eligible for monetary damages. Defective medical device settlements are designed to reimburse plaintiffs for their economic losses and intangible harms.
A settlement or jury verdict will account for:
- Past and future medical expenses
- Lost wages
- Mental anguish
- Pain and suffering
- Loss of enjoyment of life
- Diminished earning capacity
When a defective medical device causes fatal harm, surviving relatives may bring a wrongful death claim to recover compensation for benefits and wages the deceased would have earned.
Speak to medical device failure attorneys
At Showard Law Firm, we have decades of experience demonstrating product defects and holding device manufacturers accountable in state and federal courts. We do not back down from multi-billion dollar corporations that have produced and distributed harmful medical devices.
Our defective medical products lawyers provide experienced legal counsel on a contingency basis and welcome the opportunity to handle complex cases.
- FDA, 510(k) Clearances https://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/510kclearances/
- FDA, What is a Medical Device Recall? https://www.fda.gov/medicaldevices/safety/listofrecalls/ucm329946.htm
- Medical Plastic News, Five big medical device recalls https://www.medicalplasticsnews.com/news/medical-devices/five-big-medical-device-recalls/
- ResearchGate, Medical Device Recalls and the FDA Approval Process https://www.researchgate.net/publication/49836276_Medical_Device_Recalls_and_the_FDA_Approval_Process