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ALTR Archives - Carey Danis & Lowe

FDA Sends Stryker Warning Letter about Negligent Business Practices

By | Defective Medical Device litigation, Hip/Knee Replacement, Uncategorized

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FDA Sends Stryker Warning Letter about Negligent Business PracticesAccording to a Reuters report published on March 12, the U.S. Food and Drug Administration (FDA) has sent Stryker a warning letter about its business practices and its marketing strategy. The letter follows a visit by the FDA to a Styrker plant in November 2012.

The FDA visited a Stryker plant in Portage, Michigan to conduct an inspection, and discovered that Stryker, the manufacturer of orthopedic implants, had been marketing implants without FDA approval. Furthermore, Stryker had also recalled one of their products without communicating this action to the FDA.

It appears that Stryker had been marketing the Neptune Waste Management System without having received approval from the FDA.

In June 2012, Stryker issued a voluntary recall of two of their hip implant devices. The recall included the Stryker Rejuvenate and the Stryker ABG II modular-neck hip stems. According to the Stryker website, the medical device manufacturer recalled the hip stems due to reports of corrosion.

The Stryker Rejuvenate and the Stryker ABG II modular-neck hip stems are metal-on-metal hip implants, which have recently come under heightened investigation by the FDA due to an increasing number of adverse event reports.

Patients who have received implants of the Stryker hip stems have experienced adverse local tissue reactions (ALTR) that can result in tissue inflammation and pain in the hip implant area. Caused by the release of metal ions from a metal-on-metal hip implant, ALTR has also been linked to metallosis, bone deterioration, and tissue and muscle death.

To lawyers at Carey Danis & Lowe, the FDA’s inspection of the Stryker Michigan plant is a significant piece of upholding consumer safety. Defective medical device lawyers at Carey Danis & Lowe strongly believe in holding medical device manufactuers accountable for their negligent business practices, especially in cases where they market products that have not been FDA approved.

For more information about recalled Stryker products, contact Carey Danis & Lowe. If you have received a defective and recalled Stryker hip implant, contact a lawyer at Carey Danis & Lowe to discuss your case. Call Carey Danis & Lowe at 800.721.2519 or submit a legal claim form.

DePuy ASR Hip Replacement Lawsuit Update: Trials Scheduled to Begin this Year in Maryland, New Jersey, and Ohio

By | Defective Medical Device litigation, Hip/Knee Replacement, Uncategorized

DePuy ASR Hip Replacement Lawsuit Update: Trials Scheduled to Begin this Year in Maryland, New Jersey, and OhioAround the country, individuals have been filing DePuy ASR Hip Replacement lawsuits, and a handful of these suits are slated to begin trial later this year. DePuy ASR Hip Replacement cases are pending in Ohio, Maryland, California, and New Jersey.

One trial being heard in Maryland was scheduled to begin on January 7, 2013, but court proceedings have since been stopped as the plaintiff considers consolidating the case into a federal court in Ohio. The case is Jackson v. DePuy Orthopaedics Inc., which up until the trial cessation was being heard in a Circuit Court in Prince George’s County in Upper Marlboro, Maryland, presided over by Judge Crystal Dixon Mittelstaedt.

Though the Jackson trial is stalled for an uncertain period of time, Johnson & Johnson is attempting to hinder an orthopedic surgeon, Dr. Robert Snowden, from presenting testimony as the plaintiff’s expert witness. According to a Bloomberg article about the Jackson case, Dr. Snowden intended to share with the jury the cancer risks tied to the DePuy ASR Hip Replacement system.

In venturing to block Dr. Snowden’s testimony, Johnson & Johnson argued that Dr. Snowden has no qualifications that would render him an authority on the cancer risks connected to the DePuy metal on metal hip.

In a New Jersey Superior Court, the first DePuy ASR Hip Replacement lawsuit will go on trial on September 9, 2013, with the second trial following soon after on October 21, 2013.

DePuy ASR Hip lawsuits are also being heard in Ohio, and have been consolidated into a Multi-District Litigation (MDL) in the U.S. District Court for the Northern District of Ohio in Toledo. The MDL is in re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation MDL no. 2197. The first trial in the Ohio federal court is scheduled to begin on May 6, 2013, with the second trial scheduled for July 8, 2013.

Plaintiffs who have filed DePuy ASR Hip Replacement lawsuits around the country have claimed that the device has resulted in seriously compromised health as well as numerous revision surgeries. Many plaintiffs allege that the metal-on-metal design of the ASR Hip Replacement system results in metallosis, or metal poisoning.

According to the U.S. Food and Drug Administration (FDA), metal-on-metal hip replacement systems, such as DePuy’s ASR Hip Replacement device, have a metal ball and a metal cup that brush against one another, and in doing so, scrape off metal particles of cobalt and chromium. These metal ions then enter into the bloodstream as well as damage the tissues and bones around the metal-on-metal hip replacement.

The FDA refers to the deterioration of tissue and bone following exposure to metal ions as adverse local tissue reaction (ALTR) or adverse reaction to metal debris (ARMD).

In addition to severe tissue and bone damage, the FDA has also identified a slew of neurological problems related to the DePuy ASR Hip Replacement system, as well as other metal-on-metal hip replacement devices. The FDA’s list of negative reactions to metal particles in the bloodstream include skin rashes, cardiomyopathy, problems with sight and hearing, depression, decline in mental faculties, renal failure, and thyroid complications.

If you or someone you love has suffered from a DePuy ASR Hip Replacement device, you may be entitled to receive compensation for your medical expenses, lost wages, pain, and suffering.

For a free legal evaluation about your DePuy ASR Hip case and to learn more about filing a DePuy ASR Hip Replacement lawsuit, contact a lawyer at Carey Danis & Lowe by calling 800.721.2519.