Issues of Product Safety: Facts of Medical Devices and Medications

By on May 7, 2013 - Comments off

In the first entry of our Product Safety blog series, the legal team at Robinson Calcagnie Robinson Shapiro Davis, Inc. discussed general issues related to defective products. While any product may potentially be defective, drugs and medical devices often pose the greatest danger.

Millions of medications and medical devices are used on a daily basis. Consumers and patients look to these products to protect them against health risks, but many of these products can cause serious injury, illness, or death due to defects. Because of the length of time it takes to get approval from the U.S. Food and Drug Administration (FDA), the public may incorrectly assume that these products are safe.

According to The Safety Report (Vol. 5 Ed. 1), it takes an average of 12 years and $350 million for a pharmaceutical company to obtain FDA approval to market and distribute a new drug. That is 12 years of spending money without making money, which is incentive to get through the process as quickly as possible. Inadequate preclinical testing or human clinical tests, failing to report adverse results, failing to warn of side-effects, and other incidents of negligence can result in an unsafe drug.

The Center for Devices and Radiological Health (CDRH), a division of the FDA, is responsible for the approval, clearance, and regulation of medical devices. Under the FDA regulations, Class III devices, which are those devices that carry “a potential unreasonable risk of illness or injury,” typically must undergo a rigorous pre-market approval (PMA) process before they can be marketed. In order to gain pre-market approval, the manufacturer must provide sufficient evidence, including clinical testing, to assure that the device is safe and effective for its intended use. However, FDA regulations allow certain Class III devices to forgo the strenuous pre-market approval process and permit the “clearance” of a new device if the manufacturer can establish that the device is “substantially equivalent” to another legally marketed device. This 510(k) “clearance” process is not the same as “approval.” 510(k) clearance does not require pre-market clinical testing, nor does it establish the safety or effectiveness of a device. As demonstrated by the recent health issues caused by metal-on-metal hip implants, the 510(k) process can lead to disastrous public health consequences.

The final post of our Issues of Product Safety Blog Series will discuss the issue of auto safety.

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