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Stryker Corp.

Stryker was formed in 1941 by Dr. Homer Stryker. He invented the first mobile hospital bed, known as Circ-O-Lectric. After his retirement, Stryker left his son in charge as general manager of Stryker Corporation. In 1979, this company entered the orthopaedic implant industry and eventually split into three segments; surgical, medical, and osteonics.

Stryker Corporation bought an orthopaedic division of Pfizer and became well known for its Stryker Knee 1.0. Another popular product, the CentPillar hip stem, was released to the Japanese market in 2003. By 2010, this business held approximately 25 percent of the artificial hip and knee markets in the United States.

Medical Devices Recalled Against Stryker Corp.

Numerous Stryker medical devices have been recalled. Its Neptune Rover Waste Management System was recalled in 2012. This product was used to collect and dispose of surgical fluid waste from operating rooms. The Neptune 2 Ultra removed smoke generated by laser operating devices as well. Both items used mobile rover units that could be relocated to specified waste designated areas. The reason for these recalls stemmed from two reports of serious tissue damage that occurred from use.

Another massive class II recall came from its EIUS knee replacement device. It was reported this product had a much higher than normal failure rate as compared to other kinds of knee implants. This resulted in painful revision surgeries for affected patients. One year later, there was a similar recall of Stryker’s ShapeMatch System, a different knee replacement option.

The main reason behind many of these knee replacement recalls is the FDA’s “fast-track” approval process. This allows new medical devices to be pre-marketed if they are “substantially equivalent” to existing approved devices. This allows a product to circumvent premarket testing and various safety measures. Unfortunately, there is an additional loophole in this process. When an older approved device is recalled, the new device may still remain available.

Alongside its many knee implants, Stryker offers a variety of hip implants as well. Its Trident hip systems, which were made from ceramic-on-ceramic parts, were the first to come under fire. In 2007, the FDA began investigating the company’s New Jersey manufacturing facility and uncovered a number of deficiencies that led to the production of defective devices. In 2008, Stryker issued a voluntary recall of parts in its Trident line.

On July 6, 2012, Stryker voluntarily issued another recall on its Rejuvenate and ABG II Modular and Neck Stems. Potential risks that led to this recall included fretting and metal corrosion. Patients who suffered from hip replacement failure experienced symptoms similar to the flu, blurry vision, and tumorous growths in the hip region. Stryker recommended patients who received either of these devices to contact their surgeons and schedule follow-up appointments.

Lawsuits Facing Stryker Corp.

Various patients who received Stryker knee implants reported pain and other problems following surgery. Knee implant manufacturers are legally responsible for marketing products correctly and providing adequate warnings regarding risks. They are also supposed to monitor the safety of all products after they have been FDA approved. Many people have started filing lawsuits against Stryker and feel this company must be held responsible for its negligent behavior.

Besides knee implants, Stryker is facing problems from patients who received its hip implants. By 2012, it became clear that the Rejuvenate and ABD II modular-neck hip stem implants reacted poorly when placed in the body. These products were found to deposit shards of metal into surrounding bone, tissue, and the bloodstream. Although Stryker was allowed to market these items without premarket testing, the company still had an ethical obligation to the public. Instead of ensuring a safe product, it exploited patients and received financial gain. Many innocent victims are coming forward to file claims against Stryker and its products.

If you or a loved one has suffered problems associated with a Stryker hip replacement device, it is imperative to consult with an attorney as soon as possible. Each state has a different statute of limitations regarding the Stryker lawsuits. It is important to receive fair compensation for your suffering at the hands of a negligent company.

Verdicts Against Stryker Corp.

In May 2012, Stryker was faced with scrutiny over its knee devices. The United States Department of Justice subpoenaed the company for sales and marketing practices associated to its OtisKnee. After negotiations, Stryker agreed to pay a $33 million settlement.

In November 2014, Stryker agreed to settle thousands of claims related to its hip implant products. It is estimated that the verdict ordered Stryker to pay $1.43 billion. Since this amount is not capped, experts believe the final payout will exceed this total. The settlement includes claimants who had surgery prior to November 3, 2014. The initial payouts should begin in the summer of 2015.

Besides lawsuits over faulty products, Stryker faced other legal woes. In the fall of 2013, the U.S. Securities and Exchange Commission fined the corporation $13.2 million amidst allegations the manufacturer wrote off $2 million in bribes, charitable donations, and travel expenses. For instance, internal information surfaced that proved a hospital director was given a six-night stay in New York City with Broadway tickets to “strengthen the physician’s beliefs” that Stryker products should be used in her facility. Transactions of this nature were logged as legitimate expenses in the company’s record books.

FDA Sanctions Against Stryker Corp.

In 2005, the FDA became aware of problems with Stryker’s products, especially its implant devices. An unusually high number of knee implant patients reported serious complications after surgery, including squealing joints, implants that chipped, extreme pain, and difficulty walking. Some patients suffered bone fractures as well. In 2007, the FDA warned Stryker to correct procedural failings and better document risks. After the voluntary recall was issued, concerns were raised about the company’s quality control.

Once again, Stryker received a warning letter and inspection from the FDA in 2013. This letter questioned quality issues at its Portage, Michigan plant. The federal organization noted Stryker did not notify the regulator of any recall and was marketing its Neptune device without required approval. Despite these warnings, Stryker plans to continue developing new implant innovations.

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