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Combies Hanson, P.C. Aug. 2, 2018

Recently, Netflix viewers got a glimpse of the medical device FDA approval process through the new documentary The Bleeding Edge. The one hour and forty-minute video showcases a number of different medical devices and the impact each has on individual victims following product failure. Additionally, The Bleeding Edge goes into some detail, explaining how medical devices are approved by the FDA for public sale, whether it be through Premarket Approval or a less rigid process known as 501K clearance.

Viewers are shocked to learn of the manipulation taking place during the different levels of approval, including the voluntary process where manufacturers are urged to report their own “adverse events.” The documentary suggests that the more harmful the “adverse event” the less likely a manufacturer is to report it.

Class III Medical Devices

Product liability lawyers are keenly aware of the manipulation taking place during the FDA approval process, as well as the poor design and testing that accompanies many of these devices. Litigation plays an important role in ferreting out instances of negligent design, testing deficiencies and inadequate warnings. Victims of these failures commonly file lawsuits against responsible manufacturers seeking compensation for corrective surgeries, medical expenses, pain and suffering and permanent injuries. The Bleeding Edge, however, leaves out an important part of product liability law: the classification of medical devices and its significance.

Medical devices are broken up into three different classes, defined on the FDA website as follows:

Class I – These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.

Class II – Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 43% of medical devices fall under this category.

Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.

Class III medical devices have the greatest propensity for risk of harm due to the sensitive nature of the device and the complex placement of it in the human body. And yet, US Courts have ruled that manufacturers of Class III devices have immunity against lawsuits for negligence, poor design and product failure. Court’s reason that because the product has gone through the FDA’s Premarket Approval Process, a sufficiently rigid vetting process has taken place and a manufacturer should not be held to a higher standard. In other words, if the government proclaims the device safe, then a manufacturer should not have to prove the same in court. Of course, in the wake of Netflix’s The Bleeding Edge, it’s easy to see merit in re-evaluating this point of view, especially where the FDA’s approval process is riddled with flaws.

Where the FDA serves as a barrier to holding class III medical device manufacturers responsible for harmful products, The Bleeding Edge shows us why this immunity is flawed, namely because the FDA approval process is shown to be fragile, susceptible to misinformation and in some cases, devoid of adequate testing data.

There is an exception to this rule. A claimant may bring suit against a Class III manufacturer for failing to update and/or accurately report information to the FDA. Traditionally, a negligence or design defect theory is considered a far easier claim to make in court, at least in part, because much of the case hinges on expert testimony. The second more restrictive type of claim relies upon finding instances of inadequate reporting usually by digging through Premarket Approval applications, adverse event records and corporate archives. And manufactures may not willingly turn this information over during the discovery phase of a lawsuit. Still, given the propensity for flaws in the Premarket Approval process, and the honor-system based voluntary reporting obligation, this thread-the-needle type of claim is ripe for aggressive pursuit by lawyers.

The Netflix documentary gives us a glimpse into the world of FDA Premarket Approval. Perhaps it will break down the vigorously fought for immunity Class III device manufacturers enjoy….one case at a time.

In March, 2018, Combies Hanson, P.C. prevailed in defeating a Class III medical device manufacturer’s Motion to Dismiss on immunity grounds. The case is presently pending in US District Court in Boston.

Combies Hanson, P.C. is a Boston-based personal injury firm. Its lawyers handle a variety of injury matters, including medical device and product liability cases. Founding partners Matthew Hanson and Adam Combies are rated by Super Lawyers magazine. In 2017, both were reported in the Massachusetts Lawyers Weekly Largest Settlements and Verdicts annual edition for their recovery of $2 Million Dollars for the family of a young woman killed due to inadequate security at her apartment. To learn more about Combies Hanson, P.C. visit our website at www.combieshanson.comor call our office for a free consultation.