FDA rebukes heart device maker, even as agency’s oversight raises questions

The serious, slowly disclosed problems of a manufacturer and its implanted heart defibrillators may offer more needed cautions to Food and Drug Administration critics who want regulators to rush the oversight of drug and medical device makers and make the agency more welcoming to big business.

St. Jude Medical, the New York Times has reported, has received a written rebuke that the FDA has hit the wall with the company and wants it to deal with its product problems. The agency says it is fed up because the company has dawdled for years in letting patients, as well as its senior management and medical advisory board know that it long has experienced major woes with its heart devices batteries.

St. Jude has been forced to issue recall notices on hundreds of thousands of its defibrillators. Hundreds of cases have been reported in which their batteries died unexpectedly. Dozens of patients have suffered “adverse effects,” and at least two deaths have been attributed to device failures.

The units, used to treat more serious cardiac dysfunction than can be handled by pacemakers, monitor the heart and deliver electrical shocks to it to normalize its beating. It isn’t easy to remedy St. Jude’s defibrillator problems because the surgery to remove the devices and replace their batteries can be riskier than leaving the units in.

Doctors began reporting problems with the devices in 2014 and 2015, leading the company to make changes in units from that point on. St. Jude did not inform doctors or patients about problems with older devices, nor did it recall any of them. Doctors continued to implant older models. The Minneapolis Star-Tribune, which estimated that defibrillators accounted for a third of St. Jude’s 2015 sales or about $1.5 billion, reported about woes with the product last fall.

St. Jude issued its recall notices in October—far too late and too slow for FDA critics. The agency said it had relied on risk information from the company, which downplayed the severity of problems and failed to disclose to the agency, as well as the company’s senior management and medical advisory board, a fatality it knew about. St. Jude has been acquired by Abbott, which says it is reviewing the FDA letter.

I’ve written how the FDA gets too cozy with companies it is supposed to regulate, relying on drug and medical device makers to fess up to problems that can cause grave injury and deaths, as occurred with an international scandal involving infection-spreading scopes used in gastrointestinal procedures.

President Trump and his political strategists have insisted that the FDA needs radical revamping because the agency is too slow, bureaucratic, tied up in red tape, and an obstacle to what many in the GOP see as “white hats”—big business people and big corporations that want to make big money with drugs and medical devices. The president’s FDA nominee has deep ties to Big Pharma and a long list of potential oversight conflicts.

In my practice, I see the terrible harms that patients can suffer when seeking medical services, especially injuries they can suffer due to dangerous drugs and defective products. I’ve seen Big Pharma and medical device makers at work, up close, for years, and make no mistake about it: They’re obsessed about profit-seeking, not necessarily patient safety and quality of care. The FDA, without argument, needs reforms. But history has shown time and again why careful, evidence-based drug and medical device reviews matter. The FDA also needs to pursue rigorous regulatory oversight of products that have reached the market.  And when it comes to enforcement of laws and standards, let’s be clear: Regulators can’t wait for drug and medical device makers to do the right thing.