Stryker SEC pt. 1

Reading through Stryker’s 2013 SEC report, I was shocked to find this in the Risk Factors section on page 5,

We may be adversely affected by product liability claims, unfavorable court decisions or legal settlements. Our business exposes us to potential product liability risks that are inherent in the design, manufacture and marketing of medical devices, many of which are intended to be implanted in the human body for long periods of time or indefinitely.

What troubles me most are terms like “adversely affected” and “risks that are inherent” that attempt to downplay the catastrophic failure of their Rejuvenate and ABGII hip replacement systems, and summarily discount the pain and suffering of the 30,000 people worldwide who received the defective implants.

Patients in the U.S. account for 20,000 of these faulty implants which Stryker recalled in 2012 after they were found to be prone to corrosion, joint dislocation, and the release of metal ions which can cause metallosis, tissue inflammation, necrosis and death. Doctors who have performed hip replacements with the Stryker implants have been shocked at the failure rate, which has been predicted by some to go as high as 70 percent. This could mean that in the U.S. alone, 14,000 patients might be required to undergo painful revision surgery on top of the excruciating complications they’ve already endured.

The Stryker Rejuvenate and ABGII hip prosthesis recall are part one of the more serious medical device failures in recent history. Metal-on-metal hip joints have failed at catastrophic rates. The DePuy A.S.R. was the first to be recalled in 2010. Since then the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. Metal-on-metal joints still on the market such as the Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty and Lineage are also failing at unacceptably high rate.

The failure of Stryker’s recalled Rejuvenate and ABG II modular-neck hip implant products has since led to hundreds of lawsuits being filed and urrently they are moving forward in a consolidated litigation in New Jersey’s Bergen County Superior Court and in U.S. District Court, District of Minnesota.

These lawsuits and the horror endured by thousands of patients come as a direct result of the negligence of Stryker Corp., who upon the recall admitted that the artificial hips were subject to fret, corrode, loosen and ultimately fail.

So yes, I find it troubling when Stryker, a company whose net earnings in 2013 topped $1 billion, can diminish the pain and suffering of thousands of patients to something so simple as “inherent risk”