Cautious politicking or equivocal lawmaking: Senator Robert Casey Jr. on medical device safety

On November 15, 2011 the United States Senate's committee on Health, education, Labor and Pensions (HELP), heard a testimony from a special committee of the Institute of Medicine (IOM). The committee had been formed to review the primary legal mechanism used by the Food and Drug Administration (FDA) to clear medical devices for marketing – this process is known as 510(k).

You can view this IOM testimony to the United States senate here.

In this testimony the IOM committee chairman clearly stated that the: "510(k) process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions. Furthermore, the 510(k) process cannot be transformed into a premarket evaluation of safety and effectiveness".

You can read the entire transcript of this IOM review and warning regarding 510(k) here.

In other words, the federal legislation governing medical devices in the United States is not designed to ensure patient safety and public health. The implication of this conclusion is that 510(k) poses a serious threat to people's safety.

Who in congress heard about this and why has nothing been done?

Pennsylvania's senator, Robert Casey Jr., is a senior member of the senate HELP committee, responsible for FDA oversight. He was present for, at least, a portion of the 2011 hearing. But according to the video record, he seems to have missed the IOM chairman's presentation that day.

However, even if absent, senator Casey must have been briefed by his legislative assistants about this important IOM study and its public health implications – all senators are briefed on such key hearings.

That day, the senator politely asked a few questions unrelated to patient safety. You may view Casey's comments in this video from 50:20 to 56:58.

Despite specific examples of safety failures provided and the IOM's expert analysis, the United States senate HELP committee did nothing concrete to revise or replace this legislation – certainly senator Casey, remained silent on this very clear safety warning.

But in December of 2013, another severe example of a devastating medical device failure emerged into the public eye as a result of our family's tragedy. You can read the details of this medical device safety failure here.

We strongly believe that this tragedy was in great part the result of the 2011 senate HELP committee being more concerned about FDA streamlining and "speed of clearance" than to patient safety and public health.

Nonetheless, we also felt that given his intimate knowledge of the 2011 IOM report on medical device safety, senator Casey would understand the urgent need for correcting the medical device safety failure – especially, given the scale of the women's health disaster we had brought to him.

So in January 2015, we met with the senator's legislative staff – he, himself, was unavailable for this meeting.

After our meeting, Senator Casey and his staff wrote a letter with a series of questions about the power morcellator to then FDA commissioner, Margaret Hamburg. You can view this letter here.

He also wrote a letter to the president of the health insurance advocacy group, AHIP posing a few other questions.

We do not know if, to date, the FDA commissioner responded to the senator's letter. But in April 2015, the AHIP president responded to the Casey letter. You can read this letter to senator Casey here.

The AHIP letter to Casey states: "the experience with power morcellators also shines a spotlight on gaps in the device safety infrastructure and the critical need to strengthen the pre- and post-market review and approval process."

In other words, for a second time in the span of five years, senator Casey has heard about and pondered the severe hazard to patient safety and public health posed by inadequate federal regulation of medical devices by FDA.

But despite our vocal requests, as the senator's constituents, to directly call for a serious and immediate congressional hearing to reform the medical device safety legislation – we heard nothing more.

When asked by a reporter about the safety failure in 510(k), senator Casey stated that there were no plans to bring the legislation up again anytime soon. Worse yet, in this interview, he seemed more concerned about the efficiency of getting medical devices to market – he said nothing about patient safety or women's health.

You may view the senator's response to this query at 3:49 in this video.

Whether Casey's orientation on medical device regulation is cautious politicking or equivocal lawmaking, remains unclear to us. But what we know with certainty is that senator Casey is fully aware of a serious and deadly safety deficit in the medical device regulatory space.

Letter writing and formal queries by a lawmaker are fine expressions of concern and may even serve to catalyze some action. But, for the most part such letters appear to be gestures used to placate concerned constituents, while providing good defense against future political criticism.

But when deadly threats to the health of American families become evident, neither cautious politicking nor equivocal lawmaking can be accepted from our elected representatives in federal office.

When lives are being put in harm's way EVERY DAY because of a deficiency in federal legislation, letters sent and queries filed are not sufficient.  As an elected federal official, you can not stop at "I am not certain when this will be addressed".

Hooman Noorchashm and Amy Reed, husband-and-wife physicians, have campaigned to ban electric morcellators since December 2013, soon after Reed's unsuspected uterine cancer was spread by the device during a routine hysterectomy.

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