Recall Lawyer: defective drug and device recall process explained

Defective products are recalled almost every day in the United States. They include medical devices such as metal hip implants, as well as tainted prescription drugs, children’s toys, and fruits and vegetables.

These recalls span a wide variety of industries and products, but they usually share one thing in common: regulatory oversight by the federal government. For food and drugs, that oversight is performed by the U.S. Food and Drug Administration, or FDA for short. This federal agency is often criticized for lax enforcement of safety rules, but it still plays a critical role in protecting American consumers from dangerous and defective products. Other non-food items such as toys, furniture, and clothing are scrutinized by the Consumer Product Safety Commission, or CPSC.

Latest recalls published by FDA

The FDA exerts pressure on companies that make thousands of consumer products, inspecting factories, evaluating proposed design changes, and crafting rules that keep us safe. You can read about some of the latest product recalls at this section of the FDA’s website. Another source of information that spans multiple agencies and types of recalled products is

But not all dangerous products are subject to a recall. Every year, thousands of consumers seek compensation for injuries caused by defective drugs, devices, and other products that fail at a dangerous rate, even though they are not recalled. Here’s a case in point: patients injured by the DePuy Pinnacle metal-on-metal hip implant will soon have their day in court as the first trial begins September 1 in Texas.

More than 6,000 lawsuits are pending in federal court against DePuy and its parent, Johnson & Johnson, maker of the Pinnacle device. Unlike its cousin, the DePuy ASR, which has been recalled, the Pinnacle is not subject to a recall. However, it was pulled from the market by DePuy after numerous reports of patient injuries due to metallosis. The lawsuits were consolidated in May 2011 before Judge Ed Kinkeade in a process known as Multi-District Litigation.
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Plaintiffs claim that the metal-on-metal parts of the Pinnacle, including the Ultamet liner, release tiny particles of cobalt and chromium into the patient’s bloodstream, in some cases leading to a dangerous condition called metallosis. For many patients, the injuries ultimately require a costly and painful revision surgery to remove the defective device.

Hip implant defects: Zimmer, Biomet, Stryker, Smith & Nephew

The attorneys at Jones Ward PLC represent many people with injuries from the DePuy Pinnacle, as well as the DePuy ASR, the Biomet Magnum, the Zimmer Durom, the Smith & Nephew BHR and the Stryker Rejuvenate hip device. Some of these devices have been recalled, such as the ASR, the Durom, and the Rejuvenate. Others have not. In some cases, a product with a high failure rate will be quietly removed from the marketplace in a maneuver known as a silent recall.

Recalled products: free case evaluations

Even as the first DePuy Pinnacle trials are about to get underway, DePuy and Johnson & Johnson are paying hundreds of millions of dollars to patients with defective and recalled DePuy ASR hip devices. The ASR device has a similar mechanism of injury compared to the Pinnacle — metallosis caused by adverse tissue reaction, pseudotumors, osteolysis, ALVAL, and loosening.

If you have a question about a defective hip implant, medical device, or prescription drug injury, call Attorney Alex C. Davis at 502-882-6000 for a free case evaluation, or send an email to