Stryker Lawsuit Center

If you have suffered debilitating pain or injury after a Stryker hip replacement, you may be entitled to compensation through legal system.

Even though Stryker claims it is strongly dedicated to providing quality orthopedic implants, a litany of negative reports have highlighted several problems involving their hip replacement device, which has resulted in a recall by the US Food and Drug Administration (FDA).

The recall has resulted in injured patients flocking back to their doctors to seek additional medical care, and to experienced medical malpractice attorneys for legal assistance.

The pair of devices that were the subject of a voluntary 2012 recall by the Stryker Orthopaedics Corporation are the Rejuvenate and ABG II modular-neck hip stems, both of which are popular components of many of Stryker’s most oft used hip implant systems.

These metal-on-metal hip replacement and hip implant devices led to significant complications for patients, including intense pain at the site of the joint replacement as well as in the groin and thigh and bone and chromosomal damage.

Stryker stated the voluntary recall of these two hip replacement products was due to potential risks associated with the modular-neck stems. This primarily involved “fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.”

This “wear and corrosion” can cause metal debris and ions to be released into the hip tissue, which can lead to inflammation, tissue death, severe pain, bone loss, and even the development of cancerous cells.

The FDA issued significant data for metal-on-metal hip implants in which it outlines the primary complications associated with the flawed components and systems.

The FDA also warns of secondary symptoms that are also related to the implanted devices. Often, they surround metallosis, a toxic reaction to the metal debris from the devices that is absorbed in the body. These symptoms include:

  • Chest pains
  • Shortness of breath
  • Numbness
  • Fatigue
  • Weight gain
  • Change in urination habits

Defective Foreign Medical Devices in US Markets

Before a surgical orthopedic device can be marketed in America, it must first receive FDA approval. Stryker obtained its initial approval for the Rejuvenate hip system in 2008 and the ABG II System was likewise sanctioned in 2009. Both Stryker devices gained FDA approval under what’s known as a 510(k) Premarket Notification clearance.

Under 510(k), a medical device manufacturer does not have to submit clinical trial information for approval. Instead, it must show the device is “substantially equivalent” to a similar device already on the market. The English manufactured Stryker products cited similarity to the DePuy and Zimmer Durom Cup replacement hip devices.

As such, the 510(k) approval process has many critics who claim some foreign devices don’t receive adequate scrutiny before mass marketing. They decry the “back door” that offshore medical product manufacturers have to American markets when these companies claim that many of their products may be “substantially equivalent.”

This term relates more to their function, not device construction, which can translate to some companies opting to use substandard materials to save on costs.

After FDA Approval, Stryker issued an Urgent Field Safety Notice of Corrective Action for the Rejuvenate Modular stems and necks in April of 2012. As a result of this notice, Stryker quickly announced that it had updated the instructions for use of the Rejuvenate Modular Hip System and the ABG II Modular Hip System, and acknowledged potential corrosion around the modular neck junction as the reason for the update.

Two months later, Stryker announced a voluntary hip implant recall of the Stryker Modular Primary Hip System due to a number of reports of fretting and corrosion at the modular neck junction.

Your Case Can be Procedurally Tied to Others

Civil injury litigation against Stryker is still in the very early stages; though a fair number of cases are already on court dockets throughout the country. Though it’s impossible to predict what specific factors may influence any potential settlement or court-ordered damages, most medical malpractice claims regarding dangerous drugs and defective medical devices will seek damages based upon the following factors:

  • The total amount of your medical bills from the day you suspected the device was defective.
  • The amount of lost income as a result of injuries from the defective implant including periods when you were rehabilitating from both the original procedure and any follow up procedures needed to replace the defective Stryker device.
  • If you suffered from metal toxicity (metallosis).
  • The date you received your first implant; Was it after Stryker knew that your device was defective?
  • Harms and losses suffered related to both replacement procedures.
  • Any additional expenses incurred as a direct result of this injury

Multi-District Litigation for Pending Stryker Cases

The overwhelming majority of claims against Stryker could settle before trial. This is not only true of litigation with orthopedic implant manufacturers, but of civil injury litigation regarding medical malpractice and personal injury claims in general. Nonetheless, all such complaints must begin with a damage claim filed in a civil court.

Due to the high volume of litigation that Stryker anticipates, many of these cases may be processed under a multi-district litigation procedure (MDL). This is due to the fact that most medical device injury cases involve similar evidence. An MDL allows the courts to save time by reviewing all the evidence at one time. At their discretion, judges can individually separate cases from the MDL that is under review in their court. A

n MDL is not the same as a class action lawsuit, in which all the cases are processed as a single civil action. Class action lawsuits work best when all plaintiffs have similar symptoms and damages. Many defective medical product and dangerous drug-related injuries and litigation vary widely.

In an MDL, different plaintiffs usually receive individual settlements or damage awards from their separate trials. The discovery phase is shared by all plaintiffs, and pre-trail rulings will remain consistent from case to case regardless of the individual court in which the trial is eventually held. The entire group of MDL trials will be supervised by one judge, even though each individual case will have its own judge and court room.

Experienced Lawyers are Key to Injury Claim Success

A seasoned defective medical device attorney will aggressively pursue damages outlined earlier on this page. The value of any case is dependent on the specific facts of each case. The factors above are only general in nature and may not necessarily apply to your case. This is why you need an experienced Stryker lawyer to ferret out those facts first. Attorneys can explain this process during a complimentary consultation.

We will review your specific situation, including your compensatory needs, then share the best way to achieve your goals. We’re available to our clients – and you – anytime because we’re a partner in your quest for legal success.