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.

Richard E. Vollertsen, of The Alaska Personal Injury Law Group, has been selected as Alaska counsel for the New York law firm, Weitz & Luxenberg, to assist in defective product claims concerning hip implant devices manufactured by Stryker Orthopedics. Weitz & Luxenberg has been designated as one of the lead counsel of the litigation filed in New Jersey, and are nationally-recognized counsel with extensive expertise in such claims.

In July, 2012, Stryker recalled its Rejuvenate and ABG II modular-neck hip stems because of fretting and corrosion at the modular-neck junction. When this corrosion occurs, local tissue damage and systemic toxic metal exposure can occur. Adverse effects of the implant’s failure include pain, fluid buildup in the joint, pseudotumor, localized tissue necrosis, and loss of blood supply to the bone causing bone cell death. These problems often require that the implant be removed and replaced in a revision surgery. Before revision is undertaken, physicians will complete blood testing to determine the level of toxic metal exposure from the cobalt and chromium in the implant, and will take MRI images to determine the health of the tissue and bone surrounding the implant.

Multiple claims for Alaska residents have now been asserted in this litigation.

Christmas is the time for toys. Parents expect that toys have been designed and manufactured with safety in mind. That is not a safe assumption. Ninety five percent (95%) of the toys sold in the United States are now manufactured overseas, mainly in China. In the last 10 years, the number of toy-related injures has increased 54%. In 2008, more than 235,000 children were treated at U.S. emergency rooms for toy-related injuries, and at least 19 children died. The causes of these injuries and deaths have included choking hazards from small detachable or easily broken parts; lead and cadmium contamination, particularly in children’s jewelry; toxic chemicals in candy; and a variety of additional dangers such as igniting batteries, broken straps, and exploding parts. Small, powerful magnets swallowed by young children present a particularly insidious danger. If multiple magnets are swallowed, they can attract each other through the intestinal walls pinching, blocking or eroding the intestinal wall resulting in infections, blood poisoning, and even death. The undermanned Consumer Products Safety Commission is only able to check a tiny fraction of the toys imported into this country every year. Many of the dangers in modern toys are either latent or intentionally concealed. Even careful parents need to know that profits, and not necessarily safety, are the first priority for a number of toy manufacturers.


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.

The Alaska Personal Injury Law Group recently posted an article about how the FDA and other federal agencies have systematically attempted to use preemption to make manufacturers immune from suit for injuries caused by their defective products. One point of discussion was how the FDA has weakened regulatory protection of consumers from dangerous, defective drugs. Now, just a few days later, an independent group of objective scientists has issued a new report chastising the FDA for its approval of bisphenol A, commonly referred to as BPA.

The new report was issued by the Science Board, a group of independent scientists that provides advice to the Commissioner of the FDA. The Science Board provided peer review of the FDA’s draft assessment of use of BPA in food contact applications. The Science Board concluded that the FDA position was seriously flawed.

BPA is an industrial chemical used to make polycarbonate plastic and an epoxy resin used in many consumer products. The FDA approved it for use in baby bottles and as a liner in food containers like baby formula cans. It is also used extensively in other food containers, in sport bottles such as Nalgene bottles, and as a liner in soda cans. In mid-2008, the National Toxicology Center issued an extensive report addressing the health risks resulting from exposure to BPA, including effects on brain and behavioral development in infants and small children, and the potential to cause cancer. In response, the FDA steadfastly maintained its position that BPA was safe.

The Science Board has now found multiple flaws in the FDA assessment. First and foremost, the FDA assessment failed to provide “reasonable and appropriate scientific support” for its finding that the public wasn’t at risk from BPA. Second, the FDA ignored many peer reviewed studies that found BPA presents serious health hazards. Instead, the FDA relied upon two studies funded by the chemical manufacturers’ association, only one of which was peer reviewed. The studies ignored by FDA show multiple risks, including impaired neural development, developmental changes in children, impaired reproductive tract development and diabetes. Third, the FDA assessment improperly analyzed the margin of safety (MOS) provided by the FDA standard for BPA exposure. The Science Board found extensive evidence that the FDA standard for allowable exposure levels was at least an order of magnitude too high, particularly for children.
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For the past several years, the Bush administration has pursued a covert campaign to steal the rights of victims of dangerous drugs and other defective products. Contrary to the conservative Republican mantra of “personal responsibility,” federal agencies have been giving “Get Out of Jail Free” cards to irresponsible corporate wrongdoers. The goal is to deprive the injured victims of defective products of their rights to fair compensation under state law.

An in depth study just released by the American Association for Justice has documented how federal agencies have used “preemption” to try to allow corporate wrongdoers to escape justice. What is preemption? Rightly used, preemption means a federal law preempts all contrary state laws where Congress has expressed its intent to totally occupy a specific area of law.

What is the result of such language? If it is effective, consumers can be prevented from filing lawsuits in state court when the product that injured them complied with federal standards, no matter how inadequate those regulations may be. No suit may be maintained even though the product might be considered defective under state law. By this means, the federal law trumps the state law, and the corporate wrongdoer is immune from liability for the injuries its product caused.

Political appointees of the Bush administration have gutted many of the regulations that are supposed to protect us all. Compounding the wrong, they then inserted into those ineffective regulations language that purports to preempt lawsuits by victims of dangerously defective drugs, defective automobiles, and other harmful products. Since 2005, seven agencies of the United States government have issued more than 60 rules with preemption language in the preamble to the rule. These preemption provisions generally were inserted at the last minute, without notice to interested state governments, consumers or other affected groups. Often, the proposed rule stated that no preemption was intended, but the Bush bureaucrats inserted a preemption provision into the final rule after public comment had ended.

“Why,” you may ask, “would the government want to keep people injured by dangerous drugs or other defective products from asserting their legal rights?” Why, indeed. Protection of the public is the mission of many of the agencies that have tried to cheat these victims and help the corporations that harmed them. Contrary to their true mission, under the Bush administration the agencies have taken up the cause of protecting corporations at the expense of public safety. A bigger perversion of the role of federal regulators would be hard to find.
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Once a medical device is on the market, doctors can use them for other, unapproved purposes. Given this running room, Medtronic allegedly touted to doctors the use of its Infuse Bone Graft for use in cervical spine surgeries. Three whistleblower suits have been filed by former Medronic employees asserting that the company paid inducements to doctors to use Infuse and other Medtronic spine products. Medtronic has paid $40 million to settle two of the suits, and the third remains pending. It alleges that the doctors working with Medtronic received inflated royalty payments and inappropriate consulting fees. (We have previously reported on other odious industry practices, here and here.)

In July, the FDA sent out a warning letter to doctors warning of life-threatening complications when the device is used in the cervical spine. The complications arose from use of recombinant morphogenic proteins, which caused swelling of the neck and throat tissue and led to compression of the airway and the neurological structures of the neck. Patients suffered difficulties swallowing, breathing, or speaking, and required emergency medical care including intubation and tracheotomies.

If a surgeon were going to operate on your neck, would you want to know if a medical device manufacturer was paying him to use the product on you, money paid in addition to the surgical fees you are already paying?

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