William Hyman: Bills in Congress Address Medical Device Safety

In April, Rep. Brian Fitzpatrick (R-PA) introduced HR 2163, the Medical Device Guardians Act. This act proposes to add physicians and physician offices to those that must report medical devices misadventures under the FDA’s Medical Device Reporting (MDR) requirements. The legislation excels in brevity and simplicity by amending the term “covered device user facility” in 21 USC 360i(b)(6) to now mean “a hospital, ambulatory surgical facility, nursing home, outpatient treatment facility, physician, or physician’s office” with the secretary of Health and Human Services able to further include “an outpatient diagnostic facility.” The phrase “physician or physician office” are the newly added entities. The rest of the bill is an editorial clean-up of other effected sections of the current law that largely focuses on changing “device user facility” to “device user.” Govtrack.us, quoting Skopos Labs, gives this bill a 6% chance of passage.

The idea here is straightforward. If there is value in the current MDR system of mandatory reporting by hospitals of medical device related deaths and serious injuries, then adverse events seen by physicians outside of hospitals or other now covered facilities, should also have value. This would be especially true for devices used only in physician’s offices or for which physicians see issues associated with devise used on or in patients in other facilities. Why physicians were not included in the first place is likely do to the strength of their lobby and the general philosophy (logical or not) to distance the FDA from addressing physician practices as opposed to addressing device manufacturers.

Another bill from Fitzpatrick from April is HR 2164, the Medical Device Safety Act. This bill is also delightfully brief, containing just seven lines. The intent here is to remove the current near-exemption of Class III medical devices from state court product liability actions. This exemption has existed in its current form since 2008 when the Supreme Court ruled that FDA’s “approval” of a Class III device precluded in most circumstances a state liability action. This hinged in part on specific language in the 1976 Medical Device Amendments that created the device classes and regulatory pathways. That language preempted any effort by a state to have requirements that were different from those of the FDA. The court’s logic was that a liability finding that created a requirement that a device differ from what was approved would not be allowable.

The large-scale use of PMA Supplements to change Class III devices from what was originally approved shows that, in fact, device designs can be readily changed, but this has not entered into the preemption discussion. This ruling reversed a 1996 ruling that allowed such actions. Interestingly, the 1996 case and the 2008 case involved the same manufacturer, although different products. Class I and Class II devices have not had such an exemption, in part under the principle that they receive far less scrutiny than Class III devices. However, some individuals, not surprisingly on the defense side, have argued (although not successfully) that Class II devices that go through a 510(k) should enjoy protection from liability. Such protection is part of the manufacturer dream package of minimal regulation, minimal liability, and maximum reimbursement. However, manufacturers might favor regulation that gives them exclusivity over service, proving the adage that regulation that hurts me is a wretched outrage but regulation that helps me is prudent governing.

After the 2008 Supreme Court action, various members of Congress said, both at that time and subsequently, that the law should be changed to eliminate the Class III preemption, but no such change has been forthcoming. HR 2164 proposes to put into law, at 21USC 360(k) that, “Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any state.” Skopos Labs puts the chance of this bill being enacted at 1%.

These are not the only medical device bills in the House or Senate. As always, and perhaps especially under current legislative circumstances, whether any of them will actually become law is unknown.

William Hyman, ScD, is an adjunct professor of biomedical engineering at The Cooper Union and a consultant in New York. He is also a professor emeritus of biomedical engineering at Texas A&M University.

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