Faulty Medical Devices and Lawsuits

This post highlights injuries from faulty medical devices, such as joint replacements, but our law firm’s practice areas aren’t limited to these cases. We assist clients with claims for various other devices, from defective catheters to prosthetics, understanding that each person’s experience may differ. If you’ve been harmed by any faulty medical device or a negligent procedure, please tell us your story.

Medical device lawsuits expose manufacturing shortcuts and improve awareness of production practices that prioritize profits over patient safety. Millions of joint replacement surgeries are performed in the U.S. annually, making this a lucrative market for medical product companies. Unfortunately, companies’ desire to compete in the medical market results in countless recalled devices, harmed patients, and lawsuits.

Manufacturers’ low-quality production, improper packaging, and flawed designs result in knee and hip replacement problems that cause patients joint instability, fractures, chronic pain, infections, and immobility. While people may not realize why medical devices malfunction, there’s one thing they can do: seek legal help. A defective medical device attorney understands the factors leading to the growing number of joint replacement failures and how to begin a product liability lawsuit on your behalf.

Controversial Medical Device Policies

Manufacturers take advantage of lax policies regarding medical devices to produce and sell devices that later fail. A premarket submission policy called 510(k) allows a producer to compare a new item to an existing ‘substantially equivalent’ medical device and fast-track clearances. This divisive FDA process faces criticism because it allows knee replacements and other ‘low-risk’ replacement devices to forego rigorous testing that could identify safety issues before surgeons implant faulty parts into their patients.

Delayed Medical Device Recalls

Recalls remove or correct products that violate regulations and threaten public health, like problematic knee replacements. The issue with the recall process is that it relies on manufacturers’ transparency with regulators like the FDA. Many medical brands underreport issues, and company stakeholders prefer to evaluate the cost of the problem before pulling a product from operating rooms.

Gambling with a wait-and-see strategy allows faulty medical devices to continue hurting patients. Thankfully, medical device attorneys trained to take on these negligent companies can help those harmed file lawsuits to demand accountability.

Poor Post-Market Surveillance

Companies that produce certain classes of medical devices, including joint replacements, must surveil the products to ensure they meet long-term needs and expectations. The National Science Foundation, an independent testing agency, reported that 60% of FDA citations in recent years were related to post-market surveillance (PMS) issues.¹ These manufacturers ignore user issues, adverse events, and performance failures to continue churning out ineffective products.

Manufacturers should consider protecting patients from harm with the same level of concern as protecting their public image. Yet many companies reserve urgency for public relations issues. It’s up to patients to file medical device lawsuits and expose companies’ profit-first mentalities. When defects are brought to light, regulatory agencies gain insights on ‘substantially equivalent’ products that fail, and faulty devices are pulled from the market, improving patient safety.

Contact Bell Legal if you’ve been harmed by a faulty medical device. We want to hear your story.

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¹ Download the full NSF White Paper on PMS for more information.