It has been a long year for those harmed by the blood thinner Xarelto. Over 20,000 lawsuits against Xarelto manufacturers are still pending in court with the pharmaceutical giant winning the first three cases that have gone into litigation.
However, one Indiana family has won the first case against Xarelto, shining a light at the end of a very dark and long tunnel. Aside from the ongoing Xarelto lawsuit, recent research funded by the makers of the drug found unexpected results – and was shockingly – abandoned.
At Hotze Runkle, our Texas attorneys keep up-to-date with the latest news about Xarelto proceedings to not only keep ourselves informed but, most importantly, our clients and readers informed as well. More and more people are waking up and realizing that their trust has been broken by the pharmaceutical makers of Xarelto. If you have been affected by the drug, you are not alone. Let our experienced Xarelto litigation lawyers earn your trust.The percentage of #Xarelto lawsuits has grown by 27% this past year. #HotzeRunkle Click To Tweet
The First Case Won Concerning the Drug Xarelto
Lynn Hartman had been taking Xarelto for over a year when she was hospitalized for intestinal bleeding in 2014. It took four blood transfusions to counteract the life-threatening bleed-out effect of the drug. Because of this, Lynn rightfully filed a lawsuit against the makers of Xarelto in 2015.
On December 5, 2017, Bayer AG and Johnson & Johnson, who jointly developed Xarelto, were ordered by a Philadelphia jury to pay out over $26 million in punitive and $1.8 million in compensatory damages to an Indiana couple who claimed they were not provided sufficient warnings about the risks of internal bleeding caused by the anticoagulant.
It was the first case won in Philadelphia, with over 1,400 more cases pending there. Over 18,500 more cases are still pending within the multidistrict litigation at the U.S. District Court for the Eastern District of Louisiana, and that number grows daily.
Win Sets Precedent
Before this win, juries had ruled that the pharmaceutical companies had indeed issued proper warnings and that the drug was safe. This win signifies hope that those harmed by Xarelto’s dangerous effects can receive restitution for their suffering.
Aside from the major headway being made regarding Xarelto lawsuits, studies are showing that Xarelto may not be as effective as once believed.
Makers of Xarelto Abandon a Clinical Study Concerning One of Its Main Purposes
A governmental study was recently abandoned by Bayer and Johnson & Johnson because there was “no efficacy improvement over aspirin at an interim analysis and very little chance of showing overall benefit if the study were completed.”
In other words, the study was abandoned when researchers found that using Xarelto doesn’t provide much more of a benefit over low-dose aspirin at preventing secondary strokes following strokes caused by blood clots or other unknown origins.
This is a monumental find but not the nail in the coffin for Xarelto. The makers of the drug are running another study and are hopeful that the effects will be more beneficial than aspirin.#StatuteOfLimitations in #Texas for product liability = 2 years #HotzeRunkle #Xarelto Click To Tweet
Now is the time to take a stand against Xarelto if you or someone you love has been harmed. Let Hotze Runkle represent you!
As a friendly reminder to all those that have been impacted by the harmful anticoagulant, Xarelto, contact our litigation team at (512) 476-7771 or (877) 919-0830 today as the statute of limitations for product liability in the state of Texas is two years from the date of the event.
There may still be time to make things right. Let us fight for you. Call today.
Product liability is a unique legal field in comparison to other types of personal injury cases. In defective product cases, the victim doesn’t have to prove negligence. Rather, he or she needs proof of injury and proof of the product’s defect.
With a concentration in product liability and personal injury, the legal team of Hotze Runkle has the skills and ambition to take on defective product manufacturers, distributors, and sellers that have wronged their customers. If you or a loved one has suffered serious personal injury as a result of product liability, you don’t have to fight alone.
What is product liability?
Product liability is an area of law that governs who is responsible when a defective product injures, harms, or even kills someone.
When an individual suffers injury because of a defective product, they can file a product liability claim to seek damages, also known as compensation, from the product’s manufacturer, distributor, or seller.
There are Three Types of Defects That Fall Under Product Liability
When filing a product liability claim, it is important to identify what kind of product defect caused the injury or harm to the victim. They are divided into three types:
- Design defects: When a product is defective because of its design and not as a result of issues with its manufacturing, it is a design defect. A prime example is when airbags deploy with too much force during a vehicular accident, injuring the driver.
- Manufacturing defects: A manufacturing defect occurs during the manufacturing process and can make a product more dangerous than it should be. For instance, appliances not properly built that cause physical injury to a victim could be considered a manufacturing defect.
- Failure to warn: Everything can go right in terms of the designing and manufacturing phase of a product, but the product itself can still be defective. If the manufacturer doesn’t provide the user with enough information on how to use the product safely or blatantly misstates that product’s benefits, the victim may qualify for a product liability claim. One example could be how the prescription drug Xarelto works as an anticoagulant, but because of a lack an antidote, can cause uncontrollable bleeding.
What kind of compensation can be expected from a product liability claim?
If a product liability claim is won, recovery can include a wide array of damages including:
- Medical expenses
- Pain and suffering
- Mental anguish
- Physical impairment
- Loss of wages and earning capacity
- Property damage
In some cases, punitive damages are also included in the compensation. Wrongful death resulting from a defective product may provide additional damages to surviving family members of the deceased.
What kind of settlement options are available in a product liability claim?
Settlements are considered full, final, and complete. This usually entails a compromise between the victim and the company with a waiver of rights to reopen or appeal the case later on, regardless of what information is uncovered later. Unless there is fraud involved with the settlement, courts normally do not undo them.
Don’t lose hope. If you incur an extensive injury or the full extent of the injury is still to be ascertained, you may qualify for a structured settlement, where a partial settlement is issued with a reservation of rights to return to court seeking additional damages later on if another problem presents itself.
For instance, if you were exposed to asbestos, you may already be suffering from fibrosis in your lungs. Fibrosis also increases the risk for lung cancer later on in life, and you may be offered a structured settlement to compensate for your current fibrosis condition and any additional damages if cancer develops.
What do I do with the defective product?
DO NOT dispose of the defective product. Throwing it away is pretty much akin to throwing away evidence. Without it, proving that it was defective at the time of injury is near impossible. Also, do not return it to the manufacturer. They may destroy it, along with your chances of compensation.
Do not try to fix the product. It needs to stay in the same condition as it was when it caused the injury.
Finally, keep all relevant documents that came along with the defective product. That includes any receipts, manuals, warranty documents, or packaging instructions or information. These are used in your case to prove how the defective product was originally meant to perform compared to how it became defective and caused injury.
What happens next?
Once you have documented and identified the defect of the product, you have met your burden of proof. We would recommend that you reach out to the qualified legal experts of Hotze Runkle if you feel that you have a product liability case.
Our firm is supported by a team of medical and engineer experts that help us build quality cases. We can also streamline the pre-trial discovery process for you while you recover.
After we have done our part, it is up to the manufacturer to prove the product wasn’t defective. The manufacturer must then attempt to prove any of the following:
- The design, manufacture, and marketing of the product was flawless.
- The victim misused or abused the product, causing the product to be defective and cause his or her injuries.
- The victim knew of the defect and the risk involved and used the product anyway.
- The victim ignored the warning label or instructions.
If the manufacturer can prove any of the above circumstances, the burden of proof back shifts back to the victim, who then has to disprove the manufacturer’s defenses.
At this point, the pre-trial discovery process—where testing and inspecting the product to replicate the defect occurs—would have to be completed to prove that the product was defective. Sometimes the lawyer has to acquire design documents, speak with medical professionals, and conduct independent research and testing of the product itself. If the defect cannot be replicated or identified, the case is usually dismissed.
In other instances, however, the victim doesn’t need to provide evidence of the defect or if the manufacturer was negligent. If the victim can prove that the product is clearly defective, the product liability case is exempt of the pre-trial discovery process, and the case moves into Res Ipsa Loquitur, which is Latin for “the thing speaks for itself.”
Have You or a Loved One Been Injured by a Defective Product? You May Qualify For Compensation!
For over 10 years, Hotze Runkle has taken on and defeated companies that try to take advantage of their customers with defective products. With our knowledge, skill set, and dependability, we have helped to collect more than $100,000,000 in compensation for our clients.
Product liability lawyers encompass a large scope of different practices and finding the right one can be an overwhelming task. But with a little help and guidance, choosing the right product liability lawyer can be a much simpler process.
Rest assured that when it comes to an injury received from pharmaceutical products like Xarelto or medical devices like IVC filters, Hotze Runkle is here to make sure you and your loved ones get restitution for your suffering.
When looking for the right legal team there are a number of aspects to consider. Let us start with the basics:
What is a product liability lawsuit?
Product liability is the legal liability manufacturers or sellers face if they make or sell a faulty product. There are generally three types of product liability:
- Defectively Manufactured
These devices or drugs were somehow tainted or faulty because of the manufacturing process. Reasons include an error in labeling, contamination, or unsecured components.
- Dangerous Side Effects and Complications
These mainly cover drugs that have been on the market for a long time before side effects were found. In some instances, manufacturers should have known – and in some instances did know – about the risks of taking the drug but never warned doctors and/or patients.
- Improper Marketing
This covers the warning labels, instructions, and uses manufacturers provide on a product, drug or device. In some cases, not enough information is provided on the warning label. Other times, the product is marketed in a way that isn’t approved by the Food and Drug Administration.
One thing to keep in mind when filing a product lawsuit is that if the prescribing doctor explained the side effects of the product, along with the associated dangers, and you still decide to use the medication, you may not be able to file a claim.
However, in cases like the multidistrict litigation for the drug Xarelto, if drug makers leave out information regarding dangerous side effects, you may qualify to file a lawsuit if that warning could have prevented injury.
You have to be vigilant, though. Pharmaceuticals companies will attempt to waive responsibility by taking actions after the fact, such as adding label warnings once product defectiveness has come to light.The #StatuteofLimitations in the state of #Texas is 2 years. #HotzeRunkle Click To Tweet
What to Look for in a Product Liability Lawyer
Finding the right personal injury or product liability lawyer isn’t a daunting task if you employ a little sound reasoning; get to know your potential lawyer a bit.
Look For Experience
Look To See How Busy The Law Firm Is
Look To See If He/She Settles
Look For A Fair Deal
Look At The Documents You Are Signing
Pay Attention To The Firm’s Staff
Pay Attention To The Attorney’s Body Language And Soft Skills
Most lawyers offer an initial consultation for free. Treat this initial meeting between you and your potential lawyer as if you were interviewing them for a job. What kind of questions would you ask?
Maybe talk a little bit about how long he or she has dealt with cases like yours, major experiences, case winnings, areas of expertise, and other things of this nature.
Another important piece of information to receive from the lawyer pertains to their firm’s workload. Ask the lawyer how many other active cases does he or she have.
Why? If the firm is dealing with a lot of cases, your case may not receive the time and attention it needs to be successfully litigated.
A good product liability lawyer knows when victory is near, but a good attorney will leave the final decision to settle or go to trial up to you. Make your wishes well known with the attorney early on in the process.
A potential attorney may require a retainer fee if you decide they should represent you. A great idea is to ask what the terms and conditions for the retainer fee are. It may be used to supplement the lawyer’s income for that case or used to obtain research.
Do not sign a contract until you have discussed at length, and to your satisfaction, what the terms and conditions are. Dishonesty has no place between you and your potential product liability lawyer. This type of behavior harms both lawyers, and most importantly, the law.
Ensure that the staff is trustworthy and caring. Often times, it is these other staff members who help to gather information and help develop your case. Their abilities are just as vital and play an important role in making sure your case gets the proper attention you need.
Does it appear that the attorney is truly paying attention to your needs and story or are they distracted performing other tasks as you describe to them your pain? They shouldn’t just be staring off into space, as it is your story that matters most.
Do they seem strong-willed? That’s a good thing! Being headstrong shows that they can take charge and command respect in the courtroom.
Are they modest? Remember, this person is representing you in a court of law, and arrogance won’t get the case pretty far. This is about you, not a stage for the lawyer to perform.
Does he or she understand the full situation of your suffering, story, and feelings? Is he or she adept in law? These are important factors when relaying what you have endured to the jury.#Lawyers should be #caring, #trustworthy, and strong-willed to fight your case #HotzeRunkle Click To Tweet
Let Hotze Runkle Law Firm Take On Your Personal Injury or Product Liability Case.
If you or your loved ones have suffered because of irresponsible pharmaceuticals or faulty medical devices, do not hesitate.
Xarelto, a blood thinner approved by the U.S. Food and Drug Administration, is responsible for serious health problems faced by its users and multidistrict litigation has begun.
At Hotze Runkle, we know the serious side effects the drug can cause, and our Xarelto litigation team wants to fight for you.
Why Are Users of Xarelto Suing Drug Companies?
In short, Xarelto, also known as rivaroxaban, reduces the risk of blood clotting and strokes. It is also prescribed to sufferers of atrial fibrillation and other abnormal blood-related illnesses like deep vein thrombosis.
However, the tragic difference between Xarelto and other anticoagulants, like warfarin, is Xarelto does not have an antidote.
This has proven to be deadly for patients as there is currently nothing that can reverse the blood thinning effects of Xarelto once it has been ingested.
Since Xarelto lacks an antidote, injuries that cause bleeding cannot be stopped, effectively bleeding the patient out without much else that doctors can do about it. This renders the product defective.
Since the makers of the drug did not inform users of the inherent risks of using Xarelto and practiced deceptive marketing tactics to sell it, thousands of citizens are seeking restitution for the personal injuries and wrongful deaths that resulted from the drug’s use.#Xarelto has been linked to at least 370 deaths, according to @U.S._FDA #HotzeRunkle Click To Tweet
Xarelto Proceeds Into Multidistrict Litigation
Because of the widespread damage this drug has caused, many local court districts have been flooded with Xarelto-related cases. Consequently, these districts conducted a legal procedure called multidistrict litigation.
Multidistrict litigation is a process designed to speed up and handle complex cases that involve one or more common questions of fact pending in different districts.Currently, the Eastern District of Louisiana handles cases dealing with Xarelto.
It is estimated that around 18,000 U.S. suits have aimed their sights on these pharmaceutical giants – blaming the drug for excessive bleeding.
This is a movement that is gaining steam, and if Xarelto affected your quality of life, it’s time to let the drug companies know.
Will There be a Settlement?
Sadly, Xarelto isn’t the only anticoagulant that has met the fury of citizens that have been harmed by careless pharmaceutical practices.
Individuals in another multidistrict litigation sought restitution in 2014 because of the drug Pradaxa, citing the same issues users of Xarelto face. Pradaxa did not have an antidote either and yet still claimed a “superiority” to warfarin.
These deceitful marketing practices, false labeling, and resulting injuries and death cost the makers of Pradaxa $650 million.
As for Xarelto, a settlement amount has yet to be given—and not entirely certain—but don’t lose hope. The more cases that are reported, the more leverage we gain and the louder our resounding voice will be heard.The first #Xarelto lawsuit was filed in 2014. #HotzeRunkle Click To Tweet
How Would I Or My Loved One Qualify?
You or your loved one may qualify for compensation if you used Xarelto and experienced any of the following:
- Excessive bruising or bleeding
- Bleeding gums or nosebleeds
- Prolonged bleeding from cuts
- Increased menstruation and vaginal bleeding
- Bloody stools
- Red or dark brown urine
- Vomiting or coughing up blood
- Intracranial, abdominal, and/or retinal hemorrhages
- Spinal or epidural hematoma
If you have been the victim of any of these symptoms you should see a physician immediately!
If a loved one has died because of excessive bleeding and you know they were taking Xarelto, you can file a wrongful death case.
What Factors Are Considered in a Settlement?
Xarelto has undoubtedly caused a lot of irreversible damage to families and patients who have suffered as a result of the drug. Settlements are intended to compensate for these damages and generally take into not only physical injuries but emotional pain and suffering, as well as loss of life in wrongful death situations.
There are a number of factors that are likely to be considered by a jury trying to negotiate through the settlement process including:
- The type of injury that occurred.
- The level and duration of pain caused by the injury.
- Future and past medical expenses caused by the injury.
- The physical and mental side effects caused by the injury.
- The injuries affect on the whole well-being of the patient.
- Future and past pain and suffering.
- Loss of future earnings or lost wages caused by the injury.
In a Xarelto wrongful death case, some additional factors will be considered in the settlement include:
- Funeral and burial expenses.
- Loss of financial support to dependents.
- Pain and suffering because of loss of life.
Has Xarelto Ruined Your Quality of Life? Contact Hotze Runkle Today and Let Our Xarelto Litigation Team Represent You!
If you or a loved one have suffered from the effects of Xarelto, do not hesitate to call Hotze Runkle today! Putting off this important call can forfeit your claim if it goes beyond the statute of limitations.
You no longer have to suffer in silence. Contact us today at (512) 476-7771 or (877) 919-0830!
Hurricane Harvey wasn’t the only event that affected Texas citizens this past week.
Recently, Texas legislators passed House Bill 1774, a bill that will change how insurance companies can be held accountable for late payments and underpaid or wrongfully denied claims.
At Hotze Runkle, we fight tirelessly to make sure insurance companies hear your voice.
In order to rein in greedy insurance companies from taking advantage of those affected by Hurricane Harvey, we gathered up all the information you need to know to stay informed about this particular law and how it will affect you.#HurricaneHarvey dumped 50” of rain in TX = one yr’s worth of rainfall in just a wk. #HotzeRunkle Click To Tweet
What HB1774 Is Designed To Do
House Bill 1774 is purported to provide protection to both insurers and policyholders by limiting lawsuit abuses.
When you file a claim in good faith, insurance companies are supposed to pay out claims in a timely manner. Giving back what is rightfully owed to the insured.
Sometimes it isn’t that easy and insurance companies act in bad faith. Denying, delaying, or underpaying legitimate claims.
While the new law may seem like a compromise that meets both governmental and public needs, what it really does is punish policyholders who cannot make the claim in a timely manner – like the millions of Texans who have been affected by Hurricane Harvey.
How House Bill 1774 Punishes Policyholders
Currently, the law enforces homeowner insurance companies to pay the full 18% in interest for late payment. But come September 1, that requirement is going to change.
The bill reduces interest payable to homeowners from 18% down to 10% if the homeowner took too long in filing a claim.
In the long run, it dampens the accountability held with homeowner’s insurance companies that take too long.
HB1774 also reduces the amount of attorney fees that homeowners can recover if they do not accurately estimate the amount of damages incurred to their home. The estimate must be within 80% when they file a suit against an insurer.
Not only do the new measures make it difficult for homeowners to demand timely payment from insurance companies, it will make it harder to find lawyers willing to take these cases.More than 30,000 people forced from their #homes by flooding #HurricaneHarvey #HotzeRunkle Click To Tweet
What You Can Do Now
With the storm still ravaging parts of Texas and Louisiana, we understand that filing an insurance claim is the least of your concerns.
However, if you do not act before August 31st, you won’t be able to take advantage of the law as it is today. Doing so after September 1st will subject you to the changes of the new law.
Here is what you can do to ensure you are getting what you were promised:
- Take photos of the damages your home has received.
- Keep any receipts for home repair.
- Review your insurance policy.
- File a claim in writing (preferably by e-mail as time is a factor).
- Advise the insurance company of the facts relating to the claim.
- Hire a lawyer right away.
It is imperative to file a claim in writing with the date and time visible. Keep a copy of that document for your records.
If the claim was made on or before August 31, and if the insurance company is taking too long to make good on their promises, or trying to underpay or deny your legitimate claim, hiring a lawyer would be the next appropriate action to take.
Were You Affected By Hurricane Harvey? Do You Feel Your Insurance Company Is Taking Advantage Of You? Do Not Wait To Make A Claim With Your Insurance Company. Call Hotze Runkle today at (877) 919-0830!
Our thoughts go out to all of those that were affected by Hurricane Harvey.
Call Hotze Runkle today at (877) 919-0830 for consultation and together we will hold greedy insurance companies accountable.
Xarelto may be harming more than it is healing. Growing evidence shows that side effects associated with the anticoagulant can be life-threatening.
When drug companies put their patients’ lives at risk, Hotze Runkle is here to represent you. Our Xarelto litigation team is here to fight in your defense.
If you or a family member are one of the 7 million people worldwide that have been prescribed Xarelto, this post may serve as your wake up call.The Institute Of Safe Medication Practices says #Xarelto accounted for 68% of all adverse events in 2016. Click To Tweet
What is Xarelto?
Xarelto, also known as rivaroxaban, is a prescription medication created to be a superior alternative to the older anticoagulant warfarin.
Xarelto stops the formation of blood clots in patients that suffer from atrial fibrillation or deep vein thrombosis. It is used to help reduce the risk of strokes and as a treatment to help prevent pulmonary embolism as well.
But the drug companies that make the drug were not able to create an antidote for it. Xarelto takes around 9 hours to be removed from your body, so if injuries like an external cut or an internal hemorrhage occur, patients and doctors must wait until the drug runs its course.
If the injury is dire, very little can be done medically to ease the symptoms. This has lead to fatalities and serious personal injuries.
In 2014 alone, 3,331 serious adverse event reports for Xarelto were filed to the Food and Drug Administration, including 379 deaths, over 1,600 hemorrhages, and more than 1,100 stroke-related events.In 2014 the #FDA received 3,331 reports on #Xarelto #HotzeRunkle Click To Tweet
What are some of the side effects?
Some of the most serious side effects caused by taking Xarelto include:
- Excessive bruising or bleeding
- Bleeding gums or nosebleeds
- Bloody stools
- Red or dark brown urine
- Vomiting or coughing blood
- Intracranial, abdominal, and/or retinal hemorrhages
- Spinal or epidural hematoma
Users of Xarelto have also experienced back pain, dizziness, headaches, numbness, paralysis, and bladder or bowel dysfunction.#CDC stated anticoagulants like #Xarelto accounted for 17% of all ER visits between 2013-‘14 #hotzerunkle Click To Tweet
How are we holding the drug companies that made Xarelto accountable?
Bayer, Johnson & Johnson, and Janssen Pharmaceutical have not announced any settlements, but cases against the company continue to increase.
Over 18,000 lawsuits have been filed against Xarelto, and Multi-District Litigation has commenced.
Xarelto has yet to be officially recalled.
If you or a loved one had taken Xarelto and experienced any of the side effects mentioned above, you may qualify for compensation.The #XareltoMDL has grown to 18,000 individual #personalinjury claims #HotzeRunkle Click To Tweet
Have you or anyone you love experienced been hospitalized while taking Xarelto? If so, please contact our national litigation firm Hotze Runkle today at (877) 919-0830.
We strongly advise that if you or one of your loved ones are currently using Xarelto, set up a consultation with your doctor. Early detection can determine if any damage has been done to vital organs because of this drug.
If Xarelto is responsible for the death or debilitation of you or your loved one, contact Hotze Runkle today at (877) 919-0830.
Act now! Failure to act quickly may mean the expiration of the statute of limitations, thus forfeiting any legal recourse.
Years of product complications and mounting litigation have left an unflattering brand on IVC filters. Patients continue to experience problems with the troublesome medical devices.
Part of what our national litigation team at Hotze Runkle has learned in dealing with the patients affected by IVC filters is that there is often as much trouble with removing these products as there is living with them.
The reasons to consider removal are often the same ones that make extracting an IVC filter so difficult. Whether the filter has torn or blocked a vein, or pieces of the metallic devices have traveled elsewhere, safely removing an IVC filter can be a dangerous undertaking.
Luckily, recent breakthroughs in IVC filter removal look promising for patients living with the pains and medical concerns caused by the devices.
The fact that these filters break down and inevitably require removal should not be all that surprising. Filters of all sorts need to be replaced in order to prevent potential issues.
What is alarming is that follow-ups to determine the status of IVC filters are not always done, even with the knowledge that most complications arise within three to six months.#IVC filter complications can begin in as little as 3 to 6 months #Fact Click To Tweet
This urgent need is what motivated a team of interventional radiologists at Rush University Medical Center to develop a safe and effective method of removing the filters.
The Journal of Vascular and Interventional Radiology published the latest techniques developed by the team in November of last year.
Lead author Osman Ahmed, MD, reflected the confidence of the interventional radiologists involved when he stated that they were able to remove any filter with this new method, regardless of the situation.
This innovative system for IVC filter removal centers around catching – or “snaring” – the device during a procedure to ensure that it doesn’t move. This minimizes the chance that additional damage is done to the vein.
Once this is done, the doctors cover the device so that no pieces break off and travel elsewhere in a patient’s body.
An excimer laser is one of the tools utilized by the team to make this technique possible. These lasers are commonly used in the production of microelectronics and eye surgery.
The confidence put forth by Ahmed is well-founded as the Rush staff has successfully retrieved 100 percent of IVC filters with their methods over the last five years.#RushUMC has 100% #IVCfilter removal rate with new method over last 5 yrs Click To Tweet
Making a Difference Where It Really Matters
While skeptics may be quick to wonder if these are primarily standard procedures, this is not the case.
Many of these procedures were performed on referred patients that required the team to deal with filters that other hospitals had deemed too difficult to remove.
Twilight (conscious) sedation is typically used for these minimally invasive outpatient procedures. If the Rush staff feel that a retrieval may take longer, a patient is given general anesthesia.
The incision made for removing an IVC filter is made either in the neck or the groin. The team uses X-rays to guide the tools they use, such as wires and catheters, to remove a filter.
The necessity to remove IVC filters is because of the inherent dangers associated with leaving the devices inside a patient’s body for too long. The FDA recommends that everyone who has an IVC filter should consult with an interventional radiologist about removing the filter. Regardless of whether removal is recommended, all patients should be evaluated.#FDA says the length of time left implanted may increase IVC filter complication risks #HotzeRunkle Click To Tweet
If you or someone you know has been harmed by complications with an IVC filter, contact the national litigation team of Hotze Runkle today at 877-919-0830.
Our experienced legal team can help you determine if you are entitled to compensation for the suffering you have experienced.
Don’t let your voice be taken away. We will take care of you and your family by holding those who failed to, accountable.
The majority of makers and distributors of IVC filters across the country find themselves entangled in litigation.
These widely-used devices, which are typically used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolisms, have a long-standing reputation for being dangerous and harmful to patients who have had them implanted.
Strangely, these companies have still persist in marketing and selling their products. Even in the face of countless reports of injuries, complications – and even death.
Hotze Runkle knows that these companies have to be held accountable for the suffering they have caused. Their disregard for the wellbeing of patients is both inhumane and criminal.
People should know that even though IVC filters are a common choice to combat DVT and pulmonary embolisms, there are other treatment options available to them.
Potential Alternatives to IVC Filters
This is the alternative choice that is most commonly used instead of an IVC Filter. Anticoagulants, or blood thinners, can be given to post-surgery patients to help minimize the risk of strokes and blood clots.
A typical blood thinner therapy plan begins with a patient being given heparin for several days. This will be accompanied by the start of a warfarin treatment that can last anywhere between three to six months.
The reason that these plans begin with heparin is that warfarin usually needs a number of days to reach its peak effectiveness. Heparin helps bridge that initial time gap between surgery and when warfarin reaches its full potency.
However, this alternative is not without drawbacks of its own. People who have medical issues that make them more likely to have severe bleeding incidents can’t take anticoagulants.
Patients with kidney problems and clotting disorders are among those who have to seek out additional treatment avenues as well.
Additionally, if the threat of DVT or pulmonary embolisms is a recurring issue, there is no definite timetable for how long a patient would have to use blood thinners.
Over time, these medications can cause scarring in a patient’s veins and potentially increase the risk of blood clots.
Intermittent Pneumatic Compression (IPC)
If circumstances and medical status prevent the use of blood thinners, a person might consider IPC treatment. In spite of the complex name, this is a relatively simple treatment method.
A patient will have an inflatable sleeve placed over the part of the body where there is risk of blood clots – often times the leg – but not always. That sleeve is connected to an air pump.
The air inflates the sleeve which in turn pushes the blood away from the trouble area to the patient’s heart. When the sleeve deflates, it allows for blood to return to where it started.
The continual process helps facilitate regular blood circulation, minimizing the likelihood of a clot forming.
Thrombolysis & Surgery
These two choices are not used as frequently but should be weighed if a patient is not a candidate for or comfortable with other treatment options.
Thrombolysis is a procedure that involves the use of a catheter to quickly break up a clot and return a vein’s blood flow to normal. There is a relatively high success rate (80%) associated with this type of treatment.
Occasionally, surgery can be employed as a solution to a blood clot. This is only done in very rare and unusual cases involving clots that are very large and blocking important blood vessels.
If you or someone you know has suffered from an implanted IVC filter, Hotze Runkle wants you to know what your legal options are.
As with all medical decisions, Hotze Runkle encourages you to speak with your physician when deciding on how to best face issues with DVT or pulmonary embolisms. It is vital that you consider all the alternatives to IVC filters.
Our experienced team of attorneys has the expertise you need to fight against the companies who made your well-being secondary to their bottom line. Contact our national litigation firm today at (877) 919-0830 and let us take care of you and your family.
Disclaimer: THIS SITE DOES NOT PROVIDE MEDICAL ADVICE. The information presented in this blog and on this site should not be interpreted as a substitute for qualified professional medical advice.
The Food and Drug Administration is the federal department which is responsible for regulating the approval of medications and medical devices such as Xarelto and IVC filters. The FDA has an approval process during which pharmaceutical companies must meet legal requirements and standards.
Unfortunately, the Government Accountability Office (GAO) has reported on several occasions that the FDA lacks adequate staffing and resources to effectively manage its responsibilities. This criticism focuses on a number of problems regarding the FDA’s approval process including:
- Conflicts of interest in the agency’s relationships with pharmaceutical companies.
- Failure to have mandatory adverse events reports.
- Flawed approval procedures.
- Faster approvals leading to more safety concerns.
Here at the law offices of Hotze Runkle, we understand the damages that can occur when faulty medical devices and dangerous drugs are allowed out into the public. We believe it is vital that victims and potential patients understand the risks associated with these products. Thus, we make it our duty to inform the public about vital information that can help you better understand the situation.
How does the FDA approval process work?
The FDA approval process can be a relatively long proceeding. There are a number of steps that must be completed in order for pharmaceutical companies to have their products approved, although, recent laws such as the 21st Century Cures Act are beginning to deregulate and quicken the process.
The FDA approval process includes:
- Preclinical Trials: This process begins before the FDA is involved and essentially works towards proving a given drug or medical device is safe on animals. Data is collected and provided to the FDA in the form of an Investigational New Drug application. If accepted, the company can begin testing their product on humans.
- Phase I Clinical Trials: Drugs are administered to healthy participants who do not have the disease for which the drug is aimed to treat. This phase is intended to determine the safety of the drug, side effects, and how the drug is processed out of the human body. If there are no unacceptable risks, the clinical trials continue on./li>
- Phase II Clinical Trials: Phase II focuses on drug safety and efficacy, and is provided to individuals with the disease. During this part of the process, 2 groups of volunteers (ranging from dozens to hundreds) are given either the drug or a placebo. The data is analyzed, and if successfully completed, the FDA and pharma company work together to develop a large-scale trial.
- Phase III Clinical Trials: This is the largest of the three clinical trials and continues to focus on safety and effectiveness. Demographic variables are introduced at this point and researchers look to see if the drug or medical device is working as it is intended to.
- New Drug Application: After the clinical trials have been successfully completed, the company submits a new drug application. They will provide data about the preclinical period as well as from the three-phased clinical trials. An advisory committee may be created to review the data and provide advice to the FDA regarding its efficacy and safety. The FDA then makes its decision.
Criticisms of the approval process.
As previously mentioned, the Government Accountability Office has taken note of some of the largest criticisms against the agency.
One of the most substantial criticisms against the FDA approval process is that the preclinical trials and the three clinical trials are all developed and performed by the companies themselves. Meaning there is a high potential that internal company researchers and scientists can essentially lie about results and effectively leave out any negative information that could result in an FDA denial.
While this could appear as mere speculation, a 2006 survey created by the Union of Concerned Scientists found that almost one-fifth of FDA scientists had been asked to exclude vital information or change technical data on their conclusions in reports and FDA documents.
Perhaps even more stunningly, a 2005 report by professional journal Nature found that 70% of FDA panels who were involved in creating clinical guidelines regarding medication usage included at least one panel member who had financial links to the companies whose products were being surveyed.
While the FDA did eventually set forth new guidelines that would no longer permit such behavior, the damage was conceivably done.
Have you or a loved one been severely injured as a result of taking medications such as Xarelto or because of faulty medical devices like IVC filters? Let the national litigation team of Hotze Runkle serve your needs and provide you with the commitment to get the job done.
If you or a loved one has suffered adverse effects as a result of an IVC filter implantation or as a direct result of taking the anticoagulant, Xarelto, contact a team that fights to earn your trust—contact Hotze Runkle.
Our team of experienced and high qualified lawyers has the ability to make pharmaceutical companies pay for the damaged they have caused. Reach us today at (877) 919-0830 to learn more about how we can put our years of experience to work fighting for you and your family.
While we can sympathize and empathize with the victims who have suffered adverse effects because of the use of IVC filters, the negligent companies behind them seem faceless and nameless.
The national litigation team at Hotze Runkle understands the importance of getting to know the people we are fighting for on a personal level. We also believe it is equally important for us to know about the reckless companies who have put these innocent people in harm’s way by disregarding data that showed their products were dangerous.
By the Names and Numbers
In deciding whether or not to pursue legal action for an injustice suffered, it is natural to ask if there is any precedent or history of similar cases.
For patients who have had trouble with IVC filters, there is an ever-growing body of cases to draw on. There are almost 4000 filed lawsuits currently pending in two separate federal litigations against the two largest makers of these devices.Nearly 4000 lawsuits against 2 largest IVC makers #HotzeRunkle #NationalLitigation #Fighting4You Click To Tweet
However, these two makers – Cook Medical and C.R. Bard – are not alone in facing potential legal consequences.
Cordis Corporation, a smaller company that also produces the filters, is also involved in around 200 cases of their own. Rex Medical, B. Braun, and Argon Medical are additional companies that distribute IVC filters who are facing lawsuits in federal and state court over the side effects associated with their products.
Still, none of the companies face more penalties and consequences than Cook Medical. The Gunther Tulip and Celect IVC models they market are at the heart of many of the claims levied against them.
The U.S. District Court, Southern District of Indiana, is currently handling all the pretrial steps for the multidistrict litigation on these cases.
C.R. Bard has a number of its models that have had injury claims directed against them. The hundreds of lawsuits focus on issues that have arisen with their Denali, Recovery, G2, and Meridian models.
The OptEase and TrapEase filters are the products that have brought suits against Cordis Corporation.
The Role of the FDA
Compounding the indifference from the distributors of IVC filters was the slow response from the FDA. Even after having received reports, in the thousands, for years concerning the negative and deadly effects of the filters, they didn’t issue a warning against them until 2010.
A subsequent warning from the FDA in 2014 advised the removal of IVC filters after a month or two followed their initial warning.
A year later, NBC followed up with a report of their own claiming that C.R. Bard had disregarded these warnings and continued to sell their products, in spite of the injuries and death associated with them.
The events covered in the report highlighted many of the common issues faced by patients who had, for various medical reasons, the devices implanted. These risks included the IVC filters puncturing the vena cava and breaking apart and moving out of place.
In some cases, the metal pieces that broke off traveled to other parts of the body, like the heart and lungs.
C.R. Bard failed to respond to these issues and also failed to pass the warnings along to doctors.
Hotze Runkle’s national litigation firm is here to provide you with the legal guidance you need and to fight for the justice you deserve.
Regardless of whether or not the IVC filter model that you have had implanted appears above, there is a high risk of harm that comes with any version of them.
We here at Hotze Runkle advise you to speak with your doctor or qualified physician on the potential risks you could face while using an IVC filter if you haven’t already struggled with their dangerous failures.
If you or someone you know has been injured because of their use of an IVC filter, contact Hotze Runkle today at (877) 919-0830.
Don’t suffer quietly or alone. These companies must be held responsible for the pain they have caused innocent victims.
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