One such device is the surgical stapler, a medical device that is used to close both internal and external wounds without stitches or sutures. The surgical stapler is said to be quicker and produce a more uniform result. While problems with defective staples and stapling devices can vary in any case, the smallest mishap or confusion among surgeons can lead to catastrophic results for a patient undergoing even the most basic surgeries. In fact, the use of surgical staplers has resulted in thousands of reported complications annually in the United States, with many resulting in injuries or death, according to the U.S. Food and Drug Administration (FDA). In fact, between 1992 and mid-2001, the FDA received 2,180 reports of patient injury and 17,687 reports of device malfunctions during surgical stapler use. Moreover, in just the past five years alone, the FDA received over approximately 9,000 reports, approximately 90 of them leading to death, due to problems with stapling devices. Despite these large numbers, Harvath Law Group believes this exists as merely “the tip of the iceberg” since it is estimated that only a very small fraction of problems related to surgical staples gets reported.

Specifically, the Harvath Law Group is focused on the faulty staplers created and produced by Covidien and Medtronic ("MDC"), whose improper conduct has led to the manufacture, design, and sale of defective staplers unaccompanied by warning and/or training adequate to even alert most surgeons to its inherent design flaws. Additionally, MDC has failed to properly warn its users about these staplers’ inherent dangers.

One of the fundamental design flaws of MDC’s stapler products is that the staplers frequently, and inescapably for many patients, result in the incorrect size of staple being used for at least part of the staple lines it creates. This is because, especially in the upper bariatric area, where such staplers are designed to be used, a patient’s inner tissue varies in thickness so rapidly that any given staple line is too long or too short to account for the changing thickness.

Making the design of these staplers and the staples that accompany them even more problematic is that surgeons typically have to anticipate what staplers and/or staples to use before surgery ever begins, thereby having to merely guess the tissue size of a particular patient – an essentially futile endeavor even when a surgeon can see the tissue in front of him or her. Yet even notwithstanding the negligent design of the staplers and staples, the training regarding the proper use of these staplers and staples is so horribly deficient that surgeons fail to recognize the importance of the selection of staplers and their staples. In this regard, MDC simply failed to train its users on its manufactured devices so that even the highest quality and greatest amount of training offered simply is not enough. Furthermore, some staplers, such as Covidien's DST staplers used in gastric bypass surgeries, do not even come pre-packaged with instructional materials to assist surgeons.

The problem may not necessarily be with each and every staple gun and/or staple; instead, the entire model itself - along with its staples - is inherently dangerous even when used as reasonably expected.

At Harvath Law Group, we understand that negligence on the part of mass-produced medical device manufactures can cause severe and often large scale consequences on the unsuspecting public that is affected by their technology. In the case of faulty or unnecessary use of surgical staples, thousands of Americans each year suffer from unforeseen and debilitating or even fatal medical complications. Sometimes, complications occur years after surgery. Many of these victims never even find out that the cause of their problems stems from their surgical staples and go through life dealing with the immense pain, medical expenses, and stress that these complications cause.

It is our goal to provide these victims with the resources they need to understand the consequences of surgical staples and to inform them that they do not have to bare this burden alone. We will represent these victims as we strive to ensure that they are compensated for their undo pain, suffering, and medical expenses.