Have you or a loved one suffered injury or lost their life due to the recalled Integra LifeSciences CSF Drainage and ICP Monitoring System? Lawsuits Reviewed by the Defective Medical Devices Attorneys at Parker Waichman LLP. No Expenses or Fees Unless You Win Your Lawsuit!
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Integra Lifesciences CSF Drainage and ICP Monitoring System Lawsuit Lawyers
How to Recover Full Compensation for Injuries Caused by Recalled Integra Lifesciences CSF Drainage and ICP Monitoring Systems
The United States Food and Drug Administration (FDA) issues recalls when either a medical device manufacturer comes forward to communicate known defects with a medical device and/or when the FDA receives adverse event reports regarding defects associated with a medical device. The FDA classifies recalls based on the dangers medical devices pose to patients. A class I recall is considered the most severe type of recall available, and the FDA only issues a class I recall when a drug or medical device poses a serious risk of injury or death to patients.
A recent FDA public health notification communicating a class I recall of certain medical devices manufactured by Integra LifeSciences used to drain cerebral spinal fluid (CSF) and to monitor and reduce intracranial pressure (ICP) has raised concerns among medical providers and patients. The FDA has received reports of patient injuries, but so far, there are no reported deaths. According to the FDA’s class I recall notification, certain components of the cerebral and intracranial devices have broken off and failed to work as intended.
If you or a loved one has sustained injuries following a medical procedure involving the use of Integra LifeSciences’ CSF Drainage and ICF Monitoring Systems, you may be entitled to compensation. However, you first must speak with a qualified Defective Medical Device Lawyer to determine if you have grounds to seek legal action. Because time is limited to file a claim, it is essential to speak with a lawyer right away.
Choosing Parker Waichman LLP to Handle Your Potential Legal Claim
The Defective Medical Device Lawyers of Parker Waichman LLP have substantial experience handling complex legal claims involving defective drugs and medical devices. Such cases require the assistance of a law firm that has a good understanding of the science associated with many drugs and medical devices. Defective drug and medical device cases can be much more complicated than an ordinary personal injury lawsuit, such as a slip and fall case or a case involving a workplace accident.
However, at Parker Waichman LLP, our team of legal professionals handles not only defective drug and medical device cases, but also general personal injury claims including, among others, slip and fall accidents, auto accidents, workplace accidents, construction accidents, medical malpractice, nursing home abuse and neglect, and wrongful death. As such, our law firm has the necessary resources, skill, and dedication to handle a wide variety of personal injury matters.
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Parker Waichman LLP employs a team of nationally-recognized trial lawyers who have not only obtained plaintiffs’ verdicts at trial but who have also successfully negotiated settlements for their clients, helping these clients recover compensation for their injuries. Overall, Parker Waichman LLP has recovered more than $2 billion collectively in compensation for injured clients from across the United States, demonstrating our law firm’s ability to fight for every client’s legal rights to the fullest extent possible. Because Parker Waichman LLP has been successful in helping thousands of clients, the legal community has recognized such success, and Parker Waichman LLP has received the following positive peer-reviewed ratings:
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In addition to receiving positive peer-reviewed ratings, Parker Waichman LLP has a reputation for providing each client with excellent customer service, maintaining a close relationship with every client throughout the entire legal process. Lawsuits can take a very long time to resolve. Therefore, our legal team takes pride in ensuring clients are kept up-to-date on the progress of their legal claims and are always available to answer questions and address concerns clients may have.
What are Integra Lifesciences CSF Drainage and ICF Monitoring Systems?
Integra LifeSciences manufactures medical devices used to treat serious brain conditions that are often life-threatening. The LimiTorr Volume Limiting Cerebrospinal Spinal Fluid (CSF) Drainage System and the MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring Systems are used to not only monitor the pressure in a patient’s brain, but also, to drain CSF from the brain as well as reduce ICP in the brain. In other words, these medical devices are essential to ensuring a patient’s brain does not retain too much cerebral spinal fluid or maintain too much pressure, both of which can pose a risk of harm or death to patients.
Patients may experience an increase in CSF or ICP when they have infected “CSF Shunt Systems,” which are used to drain CSF from the brain to other parts of the body. Such shunt systems are often used to treat hydrocephalus, a condition that results from a build-up of CSF and ICP in the brain. Infected shunt systems can pose a risk of harm to patients. As such, patients rely on drainage and monitoring systems to ensure infections and a buildup of CSF and ICP do not cause further damage or even death.
What Integra Lifesciences CSF Drainage and ICF Monitoring Systems Have Been Recalled?
Cerebrospinal Fluid (CSF) Drainage System and MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring Systems. Because the failure of these medical devices poses a risk of serious injury or death to patients, on May 24, 2019, the FDA classified the recall as “class I,” the most serious type of recall available.
The following dates apply to the specific devices recalled by Integra LifeSciences:
- Manufacturing Dates: March 1, 2017 to March 31, 2019
- Distribution Dates: March 1, 2017 to March 31, 2019
- Total Number of Devices Recalled in the United States: 24,587
- Date Integra LifeSciences Issued the Recall: April 8, 2019
Various versions of the LimiTorr and MoniTorr medical devices (found at FDA.gov) are subject to the widespread recall, and include the following:
|Catalog Number||Catalog Description||UDI|
|10-100||CSF Drainage System w/Patient Line One Way Valve||10381780070825|
|10-102||CSF Drainage System w/Patient Line One Way Valve w||10381780070832|
|10-110||CSF Drainage System used with Pole Mount System||10381780070849|
|10-140||CSF Drainage System w/Vinyl Measuring Strip||10381780070856|
|10-150||CSF Drainage System Simple Bag and Line||10381780070887|
|10-150||CSF Drainage System w/o Manifold Stopcock||10381780070894|
|INS-1100||CSF Drainage System used with Pole Mount System||10381780071037|
|INS-9020||LIMITORR VOLUME LIMITING EVD 20 ML||10381780071105|
|INS- 9020SP1||LIMITORR VOLUME EVD 20ML||10381780071112|
|INS- 9020SP1||LIMITORR VOLUME LIMITING EVD 30 ML||10381780071129|
|INS- 9030SP1||LIMITORR VOLUME LIMITING EVD 30 ML||10381780071136|
|SP0017||Special EVD 10-110 w/o Y Site Latex Free Sites||10381780071891|
|SP0042||Special EVD 10-100 w/o Y Site||10381780071914|
|SP0090||Special EVD 10-110 w/o Y Site||10381780071945|
|SP0164||Special EVD 10-140 w/Y Site & Stopcock Reverse||10381780071945|
|SP0236||INS 1100 WITH NEEDLE AT Y-ACCESS AND NEEDLELESS SI||10381780072560|
Why Has the FDA Issued a Class I Recall of Integra Lifesciences CSF Drainage and ICF Monitoring Systems?
The specific reasons why Integra LifeSciences issued a recall of its LimiTorr and MoniTorr devices, and why the FDA has issued the recall as class I include, but may not be limited to, the following reported complaints:
- “[P]iece breaking off at connection point”
- “[B]roken manifold-stopcock”
- “[S]topcock problem”
- “[C]onnection where the external transducer is attached to the transducer holder bracket broke off”
- “[T]ransducer attachment on the LimiTorr/MoniTorr has cracked and was leaking CSF"
According to the FDA’s recall notification, breakage happens when there is “over-bending” of the stopcock, which is most often related to using the LimiTorr or MoniTorr devices in conjunction with a Fluid Filled Transducer. Such defects and device failures may result in the following:
- Infection (such as meningitis or ventriculitis)
- Over drainage leading to subdural hematoma
- Over-drainage leading to shifting of brain tissue (herniation)
- Backflow of air leading to a condition in which air or gas is trapped within the intracranial cavity
All patients undergoing procedures involving the use of the recalled LimiTorr and MoniTorr medical devices are at risk of suffering the above-listed serious health consequences.
Frequently Asked Questions About Integra Lifesciences Medical Device Lawsuits
How Do I Know if My Injuries are Related to the Integra LifeSciences CSF Drainage and ICF Monitoring Systems?
If you believe you have sustained injuries related to the use of the CSF drainage and/or ICF monitoring devices manufactured by Integra LifeSciences, you must discuss your situation with a qualified lawyer to find out whether your injuries are linked to use of the recalled medical devices. Your attorney will seek to obtain your medical records which should document what procedure(s) you underwent, and what device(s), if any, were used as part of those procedure(s).
Can I Receive Compensation for My Injuries Without Filing a Lawsuit?
It depends. With some defective drug and medical device litigations, defendants wish to resolve claims without going to court to minimize the cost of litigation and the negative consequences associated with widespread lawsuits. However, many drug and medical device companies fight allegations in court to the fullest extent. In such cases, injured plaintiffs will likely have to file lawsuits to seek compensation for their suffering. When possible, your attorney may seek to obtain a settlement award without going to court, and this option is often more favorable to plaintiffs who do not wish to take the risk of going to trial, as trials are always unpredictable.
If I Decide to File a Lawsuit, Where Will My Lawsuit be Filed?
If you proceed with filing a lawsuit, there are various courts in which your case may be filed. Depending on where a defendant is located, your case may be filed in federal court or state court. Typically, a lawsuit is filed in the jurisdiction in which a plaintiff is injured and/or where the plaintiff lives. In some cases, a lawsuit may be filed in a defendant’s home state. If the defendant and plaintiff are not located in the same state, the case will likely be filed in federal court.
Are There Limits on How Much Compensation I Can Receive for My Injuries?
It depends. Some states place “caps” or limits on damages for pain and suffering. What this means is that any award granted by a plaintiff’s verdict at trial or through settlement may be limited based on a state’s law. For example, some states have a limit of $250,000 on pain and suffering damages, while other states have no limits. While caps on damages can be harsh, a qualified law firm like Parker Waichman LLP will seek to maximize the amount of compensation an injured plaintiff is entitled to. When a defendant wants to avoid the chance of facing a large plaintiff’s verdict, settling a case for an amount that exceeds a state’s cap/limitation on damages is sometimes possible.
How Much Time Do I Have to Move Forward with Filing a Lawsuit?
Like caps on damages, states have limits on how much time an injured plaintiff has to file a product liability lawsuit. Some states only allow one or two years from the date of injury to file a lawsuit while other states provide a four or five-year time limitation. Additionally, some states allow injured plaintiffs to extend or “toll” a limitation period, allowing the period to begin when an injured plaintiff becomes aware or “discovers” that his or her injuries were caused by a defective product.
Free Case Review With an Experienced Medical Device Injury Attorney
Parker Waichman LLP is offering free claim review for potential Integra LifeSciences CSF Drainage and ICP Monitoring System clients. If our firm is able to represent you or your loved one, our defective medical device attorneys will thoroughly investigate your case at no charge and our firm will contract your case on a contingency fee basis. In other words, our recovery is contingent on yours. If you or your loved one doesn’t receive compensation, neither do we. Contact Parker Waichman LLP today for free information about your CSF Drainage and ICP Monitoring System case.