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Tracking Defective and Recalled Drugs and Medical Devices

Ask any pharmaceutical or medical device lawyer—one of the biggest problems in tackling these cases is product identification (sometimes referred to as PID). As an example, in the gadolinium MRI cases, it can take months (or longer) to go through and determine (1) whether the patient had gadolinium used for any particular MRI or MRA scan, and if so then (2) what brand of gadolinium was used. The brand is important because the lawsuit must identify a proper defendant.

Another example is the pain pump cases—typically, patients who had shoulder surgeries would go home with a pain pump, and after a few days the pain pump would be removed and thrown away (they are disposable, and in most cases not meant to be reused). There are numerous manufacturers of the device, and identifying the particular manufacturer (and, model) of a pump is often extremely difficult, especially when doctors take to using brand-specific names like “Pain Buster” in their surgical notes as a generic term. It’s like kleenex—it doesn’t always mean Kleenex.

The unfortunate solution is extensive third-party discovery—depositions of hospitals, doctors, sales representatives, account managers, and billing departments. In some cases, because of the manner in which records are kept at hospitals, there is just now way to know what brand of drug or what type of product was used. The inescapable conclusion for some victims of product defects is that they cannot bring lawsuits to recover for otherwise compensable injuries.

A recent Washington Post article commented on the problem—tracking medical implants, especially defective or recalled devices, both before and after they are used. “Unlike the auto industry, medical equipment makers have no centralized system for tracking products throughout their life span. That means in some instances, manufacturers do not have an easy way of knowing where problematic devices are or which patients got them.” The article goes on to give some frightening statistics and facts in light of these problems:

  • Nearly 2,500 medical devices were recalled for potential safety problems in 2008
  • The FDA only requires comprehensive tracking of 14 types of devices (including pacemakers, mechanical heart valves, breast implants)
  • Over 100 “Class I” recall notices went out from January to July 2009—these are defects that are serious enough to cause a reasonable probability of adverse health consequences or death.
  • Over 1,000 recall notices went out from January to July 2009.

There are thousands of devices routinely implanted into our bodies during surgeries—screws, plates, artificial “bones,” rods and others. Many of them can be ticking time-bombs, but there is no good system in place to identify the people who walk around with them. And, there is no good system to prevent the recalled devices on the shelves from being used during surgery.