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"This is an update to a blog we wrote in November 2014 on 'Does the FDA adequately review medical devices?'. This issue is still in the news with updates from reporters who are researching the matter. We feel this is important information for everyone," says Southwest Florida Defective Medical Device Attorney, Randall Spivey of Spivey Law Firm, Personal Injury Attorneys, P.A.

The Wall Street Journal (December 16, 2014) quoted Dr. Rita Redberg, a University of California, San Francisco, cardiologist who studies device regulation as saying, "There are too many approved moderate and high-risk devices that get on the market lacking high-quality evidence that they are safe and effective."  When addressing this issue, the FDA (Food and Drug Administration) medical device center's chief scientist, William Maisel, said that the approval process is a good way to "balance innovation and safety" and that the agency is strengthening its surveillance of devices on the market. When speaking specifically about the issue of fibroids and the morcellator's risks, Dr. Maisel said that the question of whether early clues "should have raised a caution about fibroids that only an extremely large clinical study could have turned up early evidence of the morcellator's risks. The FDA did not act because "the agency and the clinical community didn't have an appreciation of the risks of cutting presumably benign fibroids."

The majority of moderate- to high-risk medical devices approved by the U.S. Food and Drug Administration lack publicly available scientific evidence to verify their safety and effectiveness despite requirements in the law, according to a study released in late September . Forty-two of fifty selected medical devices cleared by the FDA over the past five years contain no data to justify their FDA clearance.

FDA Approval Process

The Center for Devices and Radiological Health (CDRH) is the branch of the FDA that approves all medical devices sold in the United States. In addition it oversees the manufacture and the safety of the devices. There are three categories indicating the level of risk medical devices pose to patients. Devices such as tongue depressors, arm slings and bandages represent minimal risk and are Class I devices. Class II devices pose a higher risk.  Class II devices include hearing aids, surgical instruments and syringes. The devices with the greatest potential of injuring patients are Class III devices. Class III devices include heart valves, pacemakers and metal-on-metal hip implants. 

There is a commonly used alternate route to FDA approval for devices which is known as the 510(k). This route is for medical devices that do not need to undergo a full pre-market approval review. With a 510(k) application, device manufacturers can secure market approval on a fast track simply by showing that the device is "substantially equivalent" to an existing device (known as a "predicate" device). When a device is cleared as a 510(k), it may serve as a predicate device for subsequent 510(k) submissions. When comparing the 510(k) approval method to the standard pre-market approval process, it is less stringent, less expensive, and faster. A significant difference when comparing the two methods is that, unlike the prior-to-market-approval applications, direct evidence of effectiveness is usually not required.

Flaws in the process

There are medical devices industry representatives, who have proposed accelerating the clearance and approval processes, who say it is necessary because the medical device industry is substantially composed of small business start-ups, suffering economic harm while awaiting FDA approval to sell their devices and/or products.

The Wall Street Journal reported that the FDA does not disclose the connection between medical-device makers and the doctors and other experts who review devices for it. In panels evaluating devices involved in cardiology, orthopedics and gynecology from 2012 through 2014, a third of 122 members had received compensation, such as money, research grants or travel and food, from medical-device companies. Further, a black-box warning, the strongest cautionary warning the FDA uses, is unusual. The FDA has issued them for drugs including Chantix, a smoking-cessation treatment, out of concern for psychiatric side effects; Lariam, a malaria drug, also for psychiatric side effects, and Yaz, a birth control pill, for women over 35 who smoke, out of concern for blood clots. Such warnings are rarer with medical devices, but now may become more common. On Monday, November 24, 2014, the FDA, based on further data analysis, issued a "black box warning" for the laparoscopic power morcellators.

Although the FDA is responsible for making sure that medical devices are adequately tested before they go to market, drug and device recalls have become increasingly common in recent years. U.S. medical device recalls grew from 604 in 2003 to 1,190 in 2012. Numbers of recalls for Class I and II devices increased more or less steadily during that timeframe, according to FDA research. Class III device recall numbers showed more variance from year to year.

Consumer Reports recommends taking the following steps to guard against the risks posed by dangerous medical devices:

• Consider alternatives. Ask your doctor what will happen if you do not proceed.
• Research the device. The FDA's , FDA.gov, has a wealth of information about device safety warnings, complaints, and recalls, easily accessible by typing the name of the device into the site’s search box. It is also worth searching Google.
• Write down what you got. If your doctor does not give you information about the brand name, model, and serial number (if it exists) of your device, ask for it. If you learn of a warning or safety recall, from the FDA or elsewhere, you will know whether yours is one of the problem models.
• Stay alert—but do not panic. If you learn that there are problems with your device, contact your doctor and ask what warning signs to watch for. Also, go to the FDA website to read up on official warnings and find out whether it is safe to keep the device in your body.

"This is a complex issue. If you, or a family member, has had a hysterectomy which used a laparoscopic power morcellator or other surgery using, or implanting, medical devices, please contact me for a no-cost evaluation. Our firm has the experience of handling cases involving defective medical devices and other medical product liability issues," says Florida Medical Device Attorney, Randall Spivey of Spivey Law Firm, Personal Injury Attorneys, P.A.

Florida Medical Devices Attorney,Randall L. Spivey is a Board Certified Trial Attorney – the highest recognition for competence bestowed by the Florida Bar and a distinction earned by just one (1%) percent of Florida attorneys.  He has handled over 2,000 personal injury and wrongful death cases throughout Florida.  For a free and confidential consultation to discuss your legal rights, contact the Spivey Law Firm, Personal Injury Attorneys, P.A., in Lee County at 239.337.7483 or toll free at 1.888.477.4839,or by email to Randall@SpiveyLaw.com.  Visit SpiveyLaw.com for more information.  You can contact Spivey Law Firm, Personal Injury Attorneys, P.A.in Charlotte County at 941.764.7748 and in Collier County 239.793.7748.