Have Stryker Hip Devices Been Officially Recalled?
Actually, several Stryker artificial hip components have been recalled by the manufacturer over the past few years. Stryker first announced its most recent hip device recall – regarding more than 4000 lot numbers of its LFIT V40 Cobalt-Chromium Femoral Heads – on August 29 2016.
This initial notice, distributed to all relevant healthcare providers, reported “higher-than-expected” failure rates for the affected lots and included an order to “quarantine” any devices manufactured before 2011 from the following catalog numbers:
- 6260-9-236 – Head Diameter: 36 mm – Offset: +5
- 6260-9-240 – Head Diameter: 40 mm – Offset: +4
- 6260-9-244 – Head Diameter: 44 mm – Offset: +4
- 6260-9-340 – Head Diameter: 40 mm – Offset: +8
- 6260-9-440 – Head Diameter: 40 mm – Offset: +12
- 6260-9-344 – Head Diameter: 44 mm – Offset: +8
- 6260-9-444 – Head Diameter: 44 mm – Offset: +12
Shortly after hearing about Stryker’s “voluntary recall,” a number of federal agencies, including the Food and Drug Administration (FDA), Australia’s Department of Health Therapeutic Goods Administration, and Health Canada issued urgent alerts to medical professionals, hip replacement patients, and the general public.
Did Stryker Warn Us Early Enough?
In past years, Stryker recalled its Accolade hip stems and other key components of its popular Rejuvenate and ABG II hip systems, a pair of replacement devices that ultimately led to a wave of product liability lawsuits and settlement agreements ranging into the millions of dollars.
Though the more recent Stryker recall was meant to help prevent more patients from being harmed, critics say the company didn’t disclose enough information to government agencies and the public about the possible reasons for the reported unexpected failure rates.
According to recent lawsuits, Stryker should have known that several key design choices were found to put patients at risk for severe complications.
When Should I File A Hip Failure Lawsuit?
It’s crucial to learn more about your legal options as soon as possible. If you had serious complications from a recalled artificial hip component and need to / needed to have revision surgery much earlier than expected, you may be entitled to receive considerable compensation for any pain, suffering, and loss you endured as a result of a “defective” implant.
Statute Of Limitations
But your potential claim may be time-restrained by your state’s “statute of limitations,” a period of time in which you’re permitted to take legal action regarding a particular event. If you wait too long to file a lawsuit, your case could be dismissed outright for exceeding the statute of limitations before it even gets a chance at trial. You can look up your state’s law for product liability claims at Nolo’s legal encyclopedia.
However, even if it’s been several years since you were injured by your hip replacement device, you should still check with an experienced attorney to see if you have a potential case, because you may be able to invoke the “discovery rule.” This allows plaintiffs to file lawsuits after the statute of limitations is over if they can demonstrate that they couldn’t have known their injury was connected to a particular product within the statute period. For example, many victims of “defective” Stryker hip components successfully used the discovery rule, explaining that the company hadn’t warned the public of the possible risks of its products, and so the earliest time that patients could plausibly have discovered their hip injuries were caused by Stryker was after the recalls were issued.
Indeed, many patients may be suffering from design-related hip replacement failure without knowing it. Anyone who was implanted with a recalled hip component and is suffering from unexpected complications or adverse symptoms should check with a doctor as soon as possible to find out if these could be related to the hip replacement.
Do I Need A Lawyer To Take Legal Action?
Yes, if you want to ensure your case has a good chance of being resolved favorably.
Product liability litigation against medical device manufacturers is extremely complex and difficult, and attempting to represent yourself most likely will put your hip replacement failure case at a considerable disadvantage.
Large corporations like Stryker have vast resources at their disposal, and often hire teams of aggressive defense attorneys to fight consumer lawsuits. But a seasoned personal injury lawyer will have the experience and know-how to help you draw up a strong case, fight for you in trial, and negotiate settlement offers that may arise.
Has Stryker Issued Settlements To Victims?
Stryker hasn’t yet settled lawsuits involving the recent LFIT V40 Co-Cr Femoral Head recall, but the manufacturer has given considerable settlements to victims of earlier recalled Stryker hip devices.
In 2014, Stryker established a global settlement fund for patients who underwent early revision surgery due to failed hip components from Stryker’s Rejuvenate and AG II hip replacement systems. The terms of this settlement agreement were developed through a process called mediation, where one or more neutral parties are assigned to help the plaintiffs and defendants hash out their differences and peaceably compromise on a resolution that benefits both sides.
$1 Billion Settlement Fund
According to reports on the official Stryker settlement websites, the mediation process conducted in the Experimental Bellwether Mediation Program ordered by District Judge Brian Martinotti was intense and included Stryker representatives hearing out heartbreaking, emotional testimony from victims who had their lives and families torn apart by complications from failed hip implants. The resulting settlement agreement offered a base settlement amount of $300,000 per failed hip.
This settlement could be increased for individual patients who, in addition to requiring revision surgery, suffered additional complications or hardships from their failed implant, such as heart attack, stroke, or infection. These “enhancements” to the base settlement could be reduced depending on factors such as the age and previous health status of the patient in question–for example, smokers received a reduction. Additional lawsuits have continued to arise, however, and in 2016 Stryker decided to extend the settlement claim period and to add more money to the global settlement fund for these earlier hip devices.
Were Stryker Femoral Heads FDA-Approved?
No. Technically, the Stryker hip implants weren’t approved by the FDA.
In order to obtain FDA approval, drugs and medical devices must go through a rigorous process that includes clinical trials and other studies, safety testing, and an extensive review of current research by a panel of experts that concludes with voting to decide approval status.
The FDA groups medical devices into 3 classes characterized by the relative risk they pose to consumers, from low-risk Class I Devices (e.g. dental floss) to high-risk Class III Devices that are designed to sustain life or can otherwise pose lethal hazards (e.g. artificial hearts). The full FDA approval process, though, is only required for Class III devices.
Despite Concerns, Stryker Hip Approval Fast-Tracked
Many researchers and medical professionals believe that hip implants should be considered Class III devices, but the FDA currently classifies them as Class II, so they don’t have to be FDA-approved for manufacturers to distribute them. Actually, Stryker hip implants didn’t even go through a typical Class II application to the FDA. Instead, Stryker had them rushed to market with a special process called 510(k) Clearance. This means that instead of having to submit the usual safety testing and research data to the FDA for review, the devices were “cleared” based simply on their supposed similarity to a device already on the market.
Stryker was able to sidestep the usual review process in bringing the LFIT V40 Co-Cr Femoral Heads to market, partly because hip replacement implants are considered only “moderate risk” Class II devices, though some medical professionals are skeptical of this classification.
The Stryker hip system employed in the cases described in many hip replacement lawsuits are metal-on-polyethylene, not metal-on-metal, the type about which the FDA issued serious warnings to the healthcare community. However, many recent research studies have demonstrated MOP hip implants to have many of the same problems as MoM. MoP implants still produce a considerable amount of metal debris, causing deleterious adverse local tissue reactions.
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