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Seeger Weiss Blog: Legal News and Analysis

Stryker Medical Company Lawsuits and Recalls

January 7th, 2013

Stryker is a prominent medical device and orthopedic product manufacturer that supplies hip implants, knee implants and surgical equipment used at major medical centers. Over the past several years, some of Stryker’s products have been recalled due to defects in their design or construction which have resulted in devastating injuries. These defects can make medical products unsafe for their intended use. Under product liability law, a manufacturer is responsible for ensuring that its products meet safety standards and do not pose a threat to consumers. Manufacturers are also responsible for warning patients of the risks associated with their products.

Here are a few of the major lawsuits and recalls that have affected Stryker and unsuspecting consumers across the country.

The Stryker Neptune Waste Management System

Stryker issued an urgent Class I recall for its Neptune series of waste management systems. This recall was issued on June 8, 2012, after the company received reports of serious and fatal injuries. These systems collect fluids during surgery by using a vacuum-like apparatus. When operated at high-pressure, the device can cause serious tissue damage, organ damage and fatal complications. This recall covered all six waste management models in the Neptune series. Stryker is facing a growing number of product liability lawsuits for injuries caused by these dangerous devices. Investigations show that these systems were not approved by the FDA and were not labeled properly.

Stryker Ceramic Hip Recall

In January 2008, Stryker voluntarily recalled its ceramic Trident Acetabular PSL Cup and Trident Hemispherical Cup implants. Stryker’s Trident hip implants were recalled due to contamination at a manufacturing plant. These particular ceramic hip implants were prone to premature failure. A number of patients reported embarrassing squeaking and popping noises during normal activities. These issues are related to ceramic fragments, hip fractures and the loosening of components. Patients who were affected by faulty Trident hip implants are still coming forward, and more lawsuits are being filed.

Stryker Metal-on-Metal Hip Implants

On July 6, 2012, Stryker voluntarily recalled its ABG II and Rejuvenate modular neck stems that are used in hip replacement surgeries. The first product liability lawsuit alleging problems with the ABG II and Rejuvenate neck stems was filed on August 7, 2012. An increased risk of corrosion and metal poisoning were cited as the reasons for the recall. Stryker admitted that the systems were prone to wear and tear near the neck junction. These problems may cause pain, swelling and adverse local tissue reactions. If left untreated, these conditions can lead to aseptic loosening and sepsis.

More than 50,000 defective implants were sold before the recall, and people have begun to file suit. These plaintiffs are requesting a case consolidation that would allow patients from Arizona, Florida, Minnesota and New Jersey to move their cases to New Jersey’s Bergen County Superior Court where they will receive individual trials and settlements. This venue was requested due to the proximity to the Stryker headquarters.

Non-Compliance Warnings

Since 2007, Stryker has received several urgent warnings and complaints from the FDA and the U.S. Department of Health and Human Services. These citations were for failing to test problematic devices and for failing to fix the defects. The company also received multiple contamination warnings. Sterile medical implants were allegedly cleaned and packed in unsanitary areas where microbes exceeded allowable levels.

Between 2007 and 2008, Stryker, DePuy, Zimmer, Smith & Nephew and a host of high-profile orthopedic manufacturers were sued by the Department of Health for engaging in unfair sales strategies and offering unlawful kickbacks to surgeons who directed hospitals to purchase their orthopedic implants and other devices. The FDA has noted several serious design flaws and sterilization issues associated with Stryker’s surgical implements and orthopedic implants. Problems with Stryker’s Duracon, Scorpio and EIUS Unicompartmental Knee Implants have lead to more recalls and lawsuits.

Product liability issues are particularly dangerous when medical devices are involved. Due to the implications of defective medical devices, patients can often sue to recover medical expenses and punitive damages. Victims might also be eligible to request compensatory damages for pain, suffering and loss of consortium.

 


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