But now a group of federal lawmakers are stepping up to take on medical device manufacturers and the Food and Drug Administration, the gatekeeper for deciding if such devices go on the market.

A report from Safety Research & Strategies Inc. details how four members of Congress are attempting to tighten the rules that were eased during the Bush Administration to allow medical devices on the market with far less strict review. Some types of devices can now make it to market with no clinical testing or proof of efficacy.

The legislation is being pushed by by Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.) and Jan Schakowsky (D-Ill.), who all sit on the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations.. A fourth sponsor, Rep. Rosa DeLauro (D-Conn.), is a member the appropriations committee’s Subcommittee on Agriculture, Rural Development, the FDA and related agencies.

Meanwhile, Consumers Union has stepped up its efforts to prod Washington to boost oversight. This week, Consumers Union’s Safe Patient Project is bringing eight patient safety activists from around the country to the Capitol to meet with lawmakers in a bid for improvements to the Medical Device User Fee Act (MDUFA).  That act has been the subject of intense scrutiny as problems with various medical devices have continued to make headlines.

“Most Americans would be surprised to learn of the lax oversight of medical implants,” Lisa McGiffert, director of Consumers Union’s Safe Patient Project, said in a press release announcing the effort.  “Too many of these devices are allowed on the market without testing to determine whether they are safe and effective. Innovation is important but patient safety should be our first priority. A medical device isn’t innovative if it doesn’t work and hurts people.”

Astonishingly, 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to being cleared by the FDA for distribution or sale, according to Consumers Union. The group is also pushing for a better system to monitor and track devices on the market so problems can be quickly identified and patients alerted.

Among the most notable problems have been among patients who received metal-on-metal replacement hips or hip resurfacing treatments. The group  US Drug Watchdog this week launched a campaign designed to  identify every US citizen, who is the recipient of any type of metal on metal  hip implant device since 2004.

A fact sheet on problems with medical device problems on Consumer Union’s web site also calls on changes so the FDA can to use its recall authority more effectively and for lawmakers to provide the agency with authority to require device makers to do long term post market studies, regardless of which process is used in the pre-market phase.

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The agreement to put Brius Healthcare in charge of operations at the facilities means a court-ordered injunction requiring compliance with the staffing levels no longer applies to those facilities. Under terms of the injunction, which was part of a settlement that reduced Skilled Healthcare’s liability to $62.8 million, the company is paying for a court-appointed monitor to ensure compliance. That injunction still applies to the other 17 Skilled Healthcare facilities covered by the verdict.

Tim Needham

Eureka attorney Tim Needham, one of the attorneys who represented residents of the Skilled Healthcare facilities in the class action suit, said he was not surprised by the maneuver to remove the Humboldt County facilities (four in Eureka and one in Fortuna) from the injunction, because the possibility was raised in the negotiations to reduce the jury’s $677 million verdict. “The deal was that if they transferred operations of the facilities to any type of entity affiliated with Skilled that the injunction would transfer as well,” Needham said. But if the new operator were unaffiliated with Skilled, then the injunction would not apply.

Needham said criticism of the part of the settlement that makes it possible for the facilities involved to be removed from the effects of the injunction doesn’t take into account the context of the negotiations. They took place while Skilled Healthcare officials were threatening to declare bankruptcy if the jury’s verdict were not modified. Not only would bankruptcy would have significantly reduced what the members of the class would have been able to collect, but Skilled would have been able to continue operating the facilities without an injunction requiring monitoring of staffing levels.

“You can say, in hindsight, was this bad [to remove the facilities from the injunction in the event of new operators], but I still don’t have any indication it was,” Needham said. “If they had come out of those negotiations saying, listen, we’re going to give those facilities to new operators, we would have been ecstatic. The fact that they are no longer operating five of them doesn’t hurt my heart. The way I felt when we were negotiating, it was good riddance if Skilled decided to get out.”

Needham said even though the new operators in Humboldt County won’t be monitored under the injunction, they’ll still face increased scrutiny as a result of last year’s verdict against Skilled Healthcare. “It’s our hope that they’ll play by the rules,” he said. “They’ve certainly been given every reason to understand that if they don’t play by the rules, we’ll go after them. I’m not going to jump in and prejudge these guys because it’s too easy to do so. I want to give them every chance to do a good job. And if they don’t, I’m going to be after them.”

Humboldt County native Brad Gibson, a health care industry veteran, is the Brius executive overseeing the facilities and is based in Eureka. “I’m in constant contact with Brad,” Needham said. “At least you know this much, the guy who’s responsible for the facilities now lives in our community, and you can pick up the phone and say, ‘Brad, what the hell are you doing?’ It makes a huge difference. [Skilled Healthcare senior management is based in Southern California.] He’s met with the [Humboldt County] district attorney, he’s met with me, he’s going around trying to improve their image in the community.

“At least from what I’ve seen so far there’s been pretty much a sea change [in the operation of the facilities]. I’m not upset by that.”

–J.G. Preston

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