Why worry about gung-ho approvals for medical devices? FDA’s own record

by Patrick Malone & Associates P.C. | DC Injury Lawyers

The  Food and Drug Administration has closed out the year by issuing a new white paper reaffirming the agency’s three-year-old warning to surgeons and women to avoid in general the use of a surgical device called a morcellator in “key-hole” or laparoscopic gynecological operations.

It wasn’t a surprise that the FDA retained this caution. That’s because the Wall Street Journal, back in 2014, had published a major investigative series linking morcellators to increased cancer incidences, recurrences, and risks in women. Researchers found that the popular surgical tool, by grinding up tissues such as those found in common female fibroid tumors, purportedly to permit their easier, faster removal, spread cancerous tissues throughout the body. The FDA has taken major, deserved criticism for failing for two decades to better protect thousands of women from harms caused by this medical device.

But what else did the agency do in its busy December? Scott Gottlieb, the FDA commissioner, also has reaffirmed that the FDA is motoring ahead with a stepped program to speed up an already loose approval and oversight process for medical devices like the morcellator.

Racing devices to the market will let patients benefit from the latest medical innovations that may improve their health, Gottlieb told the Wall Street Journal, echoing an argument made by the industry itself, President Trump, and Republicans in Washington.

But some doctors are skeptical, especially about heart and other devices installed in patients. Rita F. Redberg, editor of JAMA Internal Medicine and a cardiologist and researcher at the University of California San Francisco, told the newspaper that the FDA regulatory “change would put more patients at risk for having permanently implanted dangerous devices.”

That’s no small issue, considering, for example, the FDA’s running battle with St. Jude Medical, the maker of a defibrillator, for which the company already has issued hundreds of thousands of recall notices.

Patient safety advocates long have fought efforts to speed up the FDA’s approval processes for medical devices. They already aren’t as tough as critics would like, and the agency has a poor record in following up on devices’ performance after they hit the market, as the Wall Street Journal has reported:

Medical devices are already regarded as involving more lenient approvals than drugs, sometimes with bad effects on patients. In recent years, there have been health consequences from devices like metal-on-metal hips that degenerated … and defibrillator wires that fractured, causing deaths. A 2015 article in the medical journal JAMA from researchers at Yale University and elsewhere reported that just 13 percent of post- approval safety and effectiveness studies of high-risk medical devices were completed within three to five years.

The newspaper earlier reported on how medical device oversight can be laxer and speedier than, say, processes in place to regulate prescription drugs. Medications must be rigorously tested, including in the extensive process of clinical trials. But with congressional approval, the agency can and has approved thousands of medical devices annually if makers show they’re similar to products already OK’d and on the market.

Gottlieb has said that makers sometimes compare new devices with state-of-the-art technology to products four decades old. The agency, instead, wants them to meet “objective safety and performance criteria,” measures that he told the Wall Street Journal also would be in keeping with “international consensus standards.” (That’s a curious mention, considering one of the bigger recent scandals with medical devices involved dirty Japanese medical exam scopes that infected dozens and killed more than 20.)

More key to the agency’s changes: The FDA proposes to let devices into the market with “initial approval,” with planned, later follow-ups on their performance.

In my practice, I see not only the major harms that patients suffer while seeking medical services but also the serious damages that can be inflicted on them by defective and dangerous products, including bad medical devices. Here’s hoping that lawmakers with FDA oversight subject Commissioner Gottlieb’s planned changes on medical device to much more tough thought and questioning. Patients’ safety and well-being are too precious for the FDA to wave on complex and risky devices, pretending that a burdened agency later really will track back on their good or ill for consumers. It’s failing to do this with rigor already, for example, with prescription drugs.

As the FDA should well know, significant numbers of Americans can be harmed before sufficient alarms go off for officials to react. And bad products, like the proverbial bad penny, have the bad habit of hanging around once they somehow get to market. Just look at how consumers still suffer harms from baby strollers and carriers whose poor designs long ago were singled out and supposedly barred. Safety advocates long have warned about the major strangulation dangers posed to kids by window blind cords — but only now are officials cracking down in, fingers crossed, a more meaningful way. Auto products purportedly are subject to rigorous testing and standards these days but a new journalistic investigation has raised big questions, anew, about tire safety and manufacturing.

In a time when building products were expensive and difficult to get, carpenters developed a wisdom that says measure twice, cut once. Human lives are far more valuable than lumber. And the FDA should think hard whether it needs to slow the rush to get medical devices to market.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Patrick Malone & Associates P.C. | DC Injury Lawyers | Attorney Advertising

Written by:

Patrick Malone & Associates P.C. | DC Injury Lawyers

Patrick Malone & Associates P.C. | DC Injury Lawyers on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.