The recall of 322,005 life-necessary insulin pumps by Medtronic is an example of lackluster supervision of medical manufacturers by the FDA and a failed system of after-the-fact regulation and proof that the FDA has been captured by the industry it is intended to control.
Regulatory capture or “capture theory” was first identified by Professor George Stigler, a Nobel laureate economist at the University of Chicago who first defined the term. Stigler found that regulated industries have a keen interest in influencing regulators and devote money to do so. In many cases the regulators come from a group of industry experts who return to the industry after government service ends.
In real life, here is how it plays out.
After receiving 26,421 complaints of malfunctions in its MiniMed 600 Series Insulin Pumps, 2,175 injuries and 1 death, Medtronic finally initiated a recall of 322,005 pumps on November 21, 2019. The recalled lots were sold September 2016 thru October 2019.
Over thirty-seven months Medtronic had more than 700 complaints a month before it stopped production and recalled these pumps.
The pump is used by people who have Type 1 diabetes to deliver insulin for the management of their diabetes; type 1 is usually diagnosed in young people who do not produce insulin, usually due to destruction of the insulin-producing cells of the pancreas. Type 2 diabetics can still produce some insulin but do so insufficiently and this disease typically occurs in individuals over 30 with the incidence increasing with age.
Months after Medtronic initiated its recall, the FDA classified it a Class I status, which “means that use of such products could result in serious injury or death” as a result of the pumps incorrectly dosing insulin causing hypoglycemia or hyperglycemia, both of which can cause life-threatening complications in people with Type1 diabetes.
The Medtronic recall of these pumps is a common tale and raises an important question for consumers. Why did it take so long and so many complaints before Medtronic recalled its defective pumps?
The answer is that the FDA is relies on a regulatory model in which manufacturers are self-regulated and regulation largely occurs after the fact.
For example, manufacturers are in charge of self-approving their products. One common avenue is to “grandfather” a new product by explaining it is derived from a previously approved device. The procedure formally known as a 510(k) is a pre-market submission made to FDA to show that a new device is the substantial equivalent of a legally marketed device and for that reason safe and effective. In a 510(k) application a manufacturer must compare their device to one or more similar previously legally marketed devices and support their substantial equivalence claims.
This system allows new products to be sold to doctors and hospitals without any independent evaluation by the FDA. The new product remains on the market for use by 330 million Americans until a series of adverse events are reported and eventually the manufacturer cannot avoid the inevitable fact that it produced a defective product.
In this case Medtronic received more than 700 complaints a month which does not deter Medtronic from continuing to sell this product for more than three years and that only came to an end when it was clear that the injuries were continuing to mount.
There are multiple fallacies inherent in the U.S. regulatory model.
The leading defect is that end user reports of failures and malfunctions are voluntary. When a device fails, commonly it is thrown out and another is tried. Reporting a defect is additional work, documentation and cost that professionals disdain. There is no compensation or incentive to report and in fact not reporting is the rule, across the board. Statistically only 1-2% of defective devices are reported to manufacturers.
Secondly, when those reports are received by the manufacturer, the sales department commonly has its sales representative follow up with the doctor for clarification which can be the basis for the manufacturer to conclude that the event was due to “user error” thereby wiping the record clean in favor of continued manufacturing. Equally important is “use error” which fundamentally raises the question whether the design presents with inherent flaws that precipitate an adverse result. Absent a detailed analysis “use error” can readily be whitewashed as “user error” to support continued manufacture and sale.
Third, enter the world of statistical analysis.
A “partial” defect rate of 1% when producing a widget may be acceptable, but in the medical device arena any defect that results in catastrophic harm is unacceptable. The incident of risk and the extent of potential damage must be analyzed as a whole.
In our $79.8 million jury verdict against Johnson & Johnson, we proved that its Ethicon-Endo anal circular stapler was defective by unearthing 253 adverse reports of malfunctions over ten years. Two hundred and fifty-three confirmed adverse reports against 1.2 million staplers is a low percentage but there were no minor injuries. Every adverse event revealed serious, life-threatening and life-altering catastrophic losses: deaths, exploratory laparotomies, colostomies and permanent damage to the chief rectal muscle necessary for continence. The jury readily understood the impact of living with a colostomy bag or a heavy diaper which played a significant role in awarding $70 million in punitive damages. But that was just one injured person after six years of litigation and appeal, but it provides a yardstick for measuring the magnitude of the total losses collectively suffered by 253 people severely injured by this product.
All in all, the European pro-active regulatory approach is superior to the American “after-the-fact” program of self-regulation and is one that is far better for consumers.
The European Union medical device regulatory system for its 445 million residents takes a much different approach. Medical devices cannot be marketed in the EU unless specific authorization is issued by an accepted authority showing the product conforms to the strict safety requirements of the European Union, evidenced by affixing the CE conformity mark. Only if a product meets standards, can it bear a CE marking and be sold in the EU. CE stands for Conformité Européenne, which is French for “European Conformity.” A medical device product cannot legally be sold in the EU unless it has passed tests in order to receive the CE marking.
In the absence of pre-market testing and approval by independent testing authorities, mandatory reporting of adverse events to the FDA would more readily identify the risks of medical devices and more quickly save innocent end-user of avoidable harm.
One additional note. The European approach to medical devices mirrors the EU’s approach to the sale of chemicals. The EU’s positive control requires proof of safe use before a chemical is cleared for the marketplace as sale to consumers. In the U.S. all chemicals are considered innocent until proven guilty of causing harm, often years later. Further proof of Stigler’s identification of regulatory capture, in this case of the EPA, which since its inception in the 1970s has only banned 9 chemicals of 80,000 on the market. Want to see what is really dangerous? Check California’s Proposition 65 list of carcinogens and teratogens, causing malformed embryos.
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