Product liability lawsuits stem from issues such as defective design of a product, defect in manufacture processes, and failure to warn of the risks associated with the product. The law of strict liability requires companies to make products at least as safe as state-of-the-art technology. Also, customers have to be warned about potential risks and hazards associated with the product so that they can take an informed decision regarding buying the product. To evaluate the technical aspects of the product, non-medical consultants/experts may be called in; and to evaluate the cause and effect relationship between the product and the injury/illness a medical consultant or expert may be needed. When a product has caused an injury or illness, it automatically entails a medical records review usually completed with the support of medical record review companies. A serious case of product liability is that associated with the hip implants manufactured by Stryker Orthopedics.
A worldwide market leader in total hip replacement products, Stryker had achieved that position through its innovative hip arthroplasty products that help restore patients to normal daily activities. However, the company faces trouble now with many patients experiencing problems with some of its products and filing product liability lawsuits. Last year, Stryker had issued a hazard alert warning doctors and patients of potential side effects that may be caused by seven models of Stryker V40 femoral heads that are used in MoM (metal-on-metal) hip replacement procedures. Many patients exhibited severe side effects and some even had to undergo revision surgery following MoM complications.
In early 2017, a hip replacement implant failure was filed against Howmedica Osteonics Corp., (Howmedica), the parent company of Stryker. This is a clear indication that ongoing litigation is increasing over allegedly defective hip implants and implant components. The hazard alert issued last year cited the following side effects.
- Loss of mobility
- Adverse tissue reaction
- Joint instability
- Broken bones
- Leg length discrepancy
- Need for revision surgery
Alerts such as this would discourage surgeons and patients from pursuing total hip replacements using the product, though this was not a recall in the technical sense. The problem with MoM hip implants is that when the metal head rubs against the metal socket, metal particles can be released into the bloodstream that could lead to cobalt chromium poisoning.
Troubles faced by Stryker include the continuing hip implant lawsuits involving the Stryker V40 hip implant system, and the 2016 hip implant recall of large-diameter femoral heads sold before 2011. The femoral heads were used along with a number of metal-on-metal hip implant products manufactured by Stryker including Accolade TMZF, Accolade 2, Meridian, and Citation. The company was forced to recall the defective products because of issues such as extensive metal wear, trunnion failure and numerous hip implant side effects. At least 42,500 metal hip implants were recalled because of the possibility of corrosion of the metal components, metallosis or metal toxicity, and failure of the taper lock that leads to the loosening and dislocation of the implant. Metallosis is a serious health hazard wherein metal ions from the cobalt and chromium alloys dislodge from the components and enter the bloodstream. Patients may have to undergo revision surgery to remove the defective hip implant.
Serious cases of Stryker’s product failures include the following.
- David Campbell received the Stryker Accolade TMZF hip stem along with a Stryker LFit Anatomic V40 Femoral Head in 2010. His implant soon failed allegedly because of the fretting and corrosion of the cobalt and chromium alloys used to manufacture the femoral head and its interaction with the Accolade artificial hip. Due to the intense pain and lack of mobility, and the risky metallosis, he had to undergo revision surgery in 2015, 5 years after receiving the implant. He filed a lawsuit in March this year in US District Court, in the Northern District of Alabama.
- Another person Gary Smith belonging to Philadelphia claims to have suffered pain and injury after receiving a Gamma 3 Nail System implant (a product of Stryker) into his left hip and leg following a fracture. He received the implant in May 2015, and a broken nail in the device prevented the fracture from healing correctly. In 2016 he had to undergo a complete hip replacement allegedly because of the injury from the Stryker nail implant. Though his initial lawsuit (he sued in Bucks County Court of Common Pleas, a lawsuit later removed to federal court) was dismissed according to Section 402A of the Restatement (Second) barring strict liability claims for “unavoidably unsafe products” to the extent that “such a product, properly prepared, and accompanied by proper directions and warnings is not defective, nor is it undeniably dangerous,” Smith appealed and a US federal judge has now determined a two-year-old overhaul of products liability law in the state of Pennsylvania by the Pennsylvania Supreme Court did not bar strict liability claims against manufacturers of medical devices. Smith can take his claims forward in a lawsuit that is about an allegedly defective device that led to him receiving the hip implant. This case is now before the US District Court for the Eastern District of Pennsylvania.
It is evident how in issues such as these legal support is indispensable. Attorneys handling product liability and injury cases involving metal poisoning, pain, inflammation, dislocations, broken bones, revision surgery and so on utilize medical record review for attorneys to determine the validity of the case. Medical review services help them with a quick and accurate summary of the various medical aspects that saves them considerable time, effort and expenses. With more quality time in their hands, the legal team can prepare the case well and obtain reasonable settlements for their clients.