Articles Posted in Product Liability & Design Defect Claims

The FDA and the CDC have recently warned the public about the risk of contracting nontuberculous mycobacterium (NTM) infections associated with the use of the Sorin surgical blankets during cardiac and thoracic surgery. These surgical blankets help maintain a patient’s body temperature during surgery. NTM are bacteria commonly found in water and in the environment. Water is used in the temperature control process and, although it does not come in contact with the patient, it is suspected that it may enter the surgical theater during venting. Typically not harmful, NTM can create significant infections for patients when exposed to NTM during this type of surgery, or when a patient is suffering from a compromised immune system.

The FDA first noted this problem in a safety recall involving the Sorin 3T system, and then issued a safety communication on October, 2015, following it with a second safety communication in June, 2016. The CDC similarly issued a warning in October, 2015.

A significant concern for patients is that the latency period can be as long as 5 years as NTM infections are slow growing. Also, NTM infections have many manifestations that are often nonspecific and make it difficult for a patient or a physician to readily identify that an infection is at work, or even that an infection was associated with this type of exposure. Without knowing to look for the particular bacterium, it is often missed in a typical patient workup, but can be identified if specific testing is done. This type of infection is also new enough that medical literature does not yet exist to provide clear recommendations for treatment.

Settlement was reached today in the Stryker Rejuvenate/ABG II hip implant litigation. Claimants eligible to participate in the settlement are those who have had surgery to replace their Stryker hip implant device, in a procedure called a revision, prior to November 3, 2014. Claimants who have not yet had revision surgery to remove their device because they were deemed to be too medically infirm for the surgery are also eligible.

Those wishing to participate in the settlement are required to register by December 14, 2014. No extensions of this deadline are provided for in the settlement agreement. Thus, it is imperative that claimants seeking compensation for their injuries register by this deadline.

The attorneys at the Alaska Personal Injury Law Group are participating in the litigation, and are familiar with the elements of the settlement. Claimants needing assistance in the registration process may obtain the necessary advice by calling 907.276-1700 or 800.478.1900.

Stryker Orthopedics has recalled its Rejuvenate and ABG II hip implant components because they are shedding metal particles that cause two different types of medical concerns. First, the particles contain toxic levels of cobalt and chromium that cause local tissue reactions. These reactions include pain at the implant site, which can limit the function of the implant. These tissue changes can cause fluid collections that resemble tumor tissue (pseudotumor), and local tissue death (necrosis). Another type of tissue change is referred to as aseptic, lymphocyte-dominated vasculitis-associated lesions (ALVAL). These tissue changes can also lead to painful and expensive hip dislocations. Osteolysis can sometimes be triggered, which is a type of bone loss. Such bone loss can occur as early as 12 months after implantation, and it is usually progressive. Osteolysis often does not cause symptoms. However, it can lead to implant loosening and bone fractures that create serious medical problems.

The second concern is that these toxic metal particles infiltrate the blood stream and cerebrospinal fluid, thereby traveling throughout the body to seed into distant tissues and organs. Cobalt exposure is known to cause neurologic (central and peripheral), endocrine, and cardiac manifestations. Combinations of tinnitus, vertigo, deafness, visual impairment, electroencephalographic changes, weakness, muscle atrophy, paresthesias, hypothyroidism, and heart failure have been noted. Patients also frequently describe mood changes, depression, memory changes, inability to concentrate, weight loss, headaches, irritability, fatigue and muscle atrophy.

Because of these medical concerns, revision surgery to remove these implant components is usually recommended.

The public is often clueless about the true malice some corporations demonstrate in their willingness to put people’s lives in jeopardy for the sake of profit. The anti-plaintiff rhetoric of recent years has reached a fevered pitch with little understanding that to give into it undermines one’s constitutional right to a jury trial and the ability of a single person to use the courts to stop corporate wrongdoing when the government has failed to act. And the news tells us each day how ineffective government can be in this regard–because it is slothful, because it has been bought off with lobbyists, or because it is unwilling to challenge the prevailing political prediliections of the party in power at the moment.

We see corporate deceit in many of the cases we handle, so we get hardened to it. Sometimes we see a story, however, that amazes even us. This is one of them. A St. Petersburg, Florida company, Youth Research, had been hired to perform child safety tests on cigarette lighters. It has now been found to have falsified the tests and to have submitted fraudulent reports to federal regulators. The discovery of the fraud has prompted the Consumer Product Safety Commission to order 12 lighters off the market until they have been retested.

The CPSC implemented lighter safety standards after research showed that children under the age of 5 had inadvertently started 5,900 residential fires resulting in 170 deaths and 1,150 injuries in a two-year period. The standards require that panels of 100 children be given dummy lighters to see if they can activate the lighters. A lighter would pass only if 85% of the children could not activate it. In creating the fraudulent test results, the company altered birth dates and identity records and eliminated data that showed that a child could ignite the lighters.

Neil O’Donnell of the Alaska Personal Injury Law Group has been selected for inclusion in the 2010 edition of The Best Lawyers in America. Mr. O’Donnell was selected for inclusion in Best Lawyers in the area of product liability litigation. Selection to Best Lawyers is based on rigorous peer-review surveys. Mr. O’Donnell has now been listed in Best Lawyers for several years. Mr. O’Donnell practices in the area of product liability and personal injury litigation, business tort litigation, and professional liability litigation.