Medical Device Manufacturers should be Held Accountable if Their Devices Fail and Cause Injuries

Feb 23

There are three bones that make up the shoulder:

  • the shoulder blade or scapula;
  • the upper arm bone or the humerus; and,
  • the collarbone or the clavicle

A capsule, called the rotator cuff, which connects the upper arm bone to the shoulder blade, keeps the humeral head (also called the ball) on the glenoid (or the socket) and makes it possible for the arm to be raised and rotated. This humeral head and glenoid are what make up the shoulder joint.

Covering the ends of bones (where joints are formed) is a smooth and rubbery white tissue, called the Articular cartilage. Besides cushioning the bones of the joints, this cartilage also enables the joints to move with ease and reduces the friction when bones glide over each other. Though tough and flexible, the Articular cartilage can break down or get damaged quite easily. When this happens, the result is shoulder arthritis. The symptoms of shoulder arthritis include inflammation, shoulder stiffness and decreased motion, abnormal bone formation, and pain.

One popular corrective solution for those suffering from extreme joint pain or a limited range of shoulder motion is shoulder replacement surgery, which doctors recommend, but only if all non-surgical forms of treatment fail. This surgery involves the removal and replacement of damaged parts of the shoulder. In replacing damaged parts, an artificial device, known as prosthesis, is used. Though artificial, this implant is designed to offer relief by reducing or removing pain and restoring shoulder strength, function and motion. These are the expected results of a shoulder replacement surgery, unless something else than what should be, happens, like implanting in patients a faulty replacement device. The result of this would be increased pain, additional costly medical expenses and probably the necessity for a corrective surgery plus the removal of the implanted device.

On August 25, 2008, pharmaceutical company Zimmer Biomet manufactured a device called the Comprehensive Reverse Shoulder System Humeral Tray. This surgically implanted shoulder replacement device is intended to help restore arm movement. This device would benefit those with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy, as well as those with previously failed shoulder joint replacement.

Zimmer Biomet, according to the U.S. Food and Drug Administration (FDA), however, had to recall this Comprehensive Reverse Shoulder replacement device because these are said to be fracturing at a higher rate than is stated in its labeling. Zimmer shoulder implant fracture may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection or death.

As explained by the law firm Williams Kherkher, medical device manufacturers have a responsibility to properly test and label their devices, and if those systems fail, they should be held accountable for the injuries they cause.

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The Potential Dangers of Unnecessary Caesarean Deliveries

Aug 11

According to a recent report by the World Health Organization (WHO), the last few decades show a huge spike in the rate of Caesarean section operations. While the ideal rate for C-section deliveries is at 10 to 15 percent, the rate at which C-sections are performed in the United States in recent years doubles this range at 33 percent. As pointed out by Centers for Disease Control and Prevention (CDC) based on separate data, this translates to about 1.3 million Caesarean section deliveries for the year 2013.

The WHO report emphasizes that the increase in C-section deliveries is a cause for concern. The difference between the ideal rate and the current rate in the U.S. goes to show that many of the C-sections performed are unnecessary. While there are certain instances when C-sections are extremely crucial for the health of both mother and infant, C-section deliveries that are not medically justified are known to lead to potentially dangerous situations.

As quoted from the cited report, unnecessary C-section operations can lead to “significant and sometimes permanent complications, disability or death particularly in settings that lack the facilities and/or capacity to properly conduct safe surgery and treat surgical complications.” In other words, physicians can end up causing dangerous and unintended outcomes when they go through a C-section delivery that is not medically necessitated. In certain cases, unnecessary C-section deliveries could lead to certain birth injuries or even wrongful death.

In the same way, critical deliveries that are not aided by a C-section operation can also be harmful for both mother and infant. Chicago cerebral palsy lawyers would generally say that medically justified C-sections that are not performed immediately can also cause grave consequences. As a result, it’s extremely important that medical professionals are careful in determining whether a given situation warrants a C-section or not. West Palm Beach personal injury attorneys are typically all too aware of the consequences of poorly performed procedures, especially when they weren’t medically necessary.

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