Staying Informed: 2nd Bellwether Trial Ends in Favor for Bayer, Johnson & Johnson

Gavel and Stethoscope on Reflective Wooden Table.
Just last month, in their initial courtroom appearance stemming from allegations against the anticoagulant medication, Xarelto, Bayer and Johnson & Johnson obtained a legal victory. The win was relatively short lived as the company was back in court for a second bellwether trial on May 30th in a federal courthouse for the U.S. District Court Eastern District of Louisiana.

The second Xarelto bellwether trial has since ended and Xarelto manufacturer, Bayer and Johnson & Johnson, has once again obtained a verdict in favor of their defense. The federal jury’s verdict cleared the company of any liability for a fatal injury suffered by Sharyn Orr and confirms the decision of the first trial.

Your team of experienced national litigation attorneys at Hotze Runkle understand that these developments may be a bit unexpected for plaintiffs with pending Xarelto lawsuits, but it is vital that we remain informed about these events so as to better serve our clients.

Background History of 2nd Bellwether Trial

While Bayer and Johnson & Johnson thus far remain unaccountable for their actions and negligence in selling their harmful anticoagulant Xarelto, there are still over 18,000 pending lawsuits against them.

There are over #18,000 #Xarelto #lawsuits. Click To Tweet

The lawsuits allege that neither patients nor prescribing physicians adequately received warning about the life threatening dangers associated with taking the medication. Even with all the negative publicity the medication has received in recent years, it has still snagged a substantial market share, bringing Bayer more than $3 billion dollars in revenue.

Despite the medication lacking an antidote to reverse its effects, Xarelto has still become the most commonly prescribed Novel Oral Anticoagulant, surpassing gold standard Warfarin along the way.

It was, however, this lack of an antidote that ultimately contributed to the passing of Mrs. Sharyn Orr.

Mrs. Orr suffered from brain hemorrhaging while taking Xarelto for her chronic atrial fibrillation. The patient had been on Xarelto for a little over a year when she became ill and required hospitalization.

Unfortunately, doctors were unable to remedy the situation as a result of the Xarelto in Mrs. Orr’s bloodstream. Consequently, they were forced to wait 12 hours in order to respond with medical care – but they were too late.

The woman’s husband and children filed a lawsuit suit on her behalf, asserting that Mrs. Orr’s death was a result of the side effects caused by Xarelto. The plaintiffs’ lawyers argued that the emergency physicians did not have enough information in order to make an effective decision that could have prevented her passing.

Still, the federal jury surmised that the warning labels on the Xarelto were not inadequate and thus provided the defendant with another legal win.

Going Forward

While Xarelto’s defense has obtained victory in these two initial bellwether trials, the company still faces thousands of other lawsuits including 40 more that have been scheduled for the upcoming months.

Two other trials are scheduled for this summer including one in Texas and one in Mississippi. The next case is scheduled for August of this year and will be overseen by Judge E. Fallon of the U.S. District Court, Eastern District of Louisiana.

Your legal team at the law offices of Hotze Runkle would like to remind you to remain vigilant and undeterred by these initial court rulings. Every case is subject to its own circumstances and outcome.

If you or someone you love has been greatly affected by the harmful effects of Xarelto, contact the premier national litigation team of Hotze Runkle today at (877) 919-0830.

We strive to put together the best case possible and will work relentlessly to ensure you obtain the justice you deserve.

Please note that there is a statute of limitations which bars claims not brought within an allotted time period after the injury has occurred.


Taxotere Lawsuits and Bellwether Trials

Gavel and Stethoscope on Reflective Wooden Table.
There are side effects that breast cancer patients can expect when undergoing chemotherapy, with hair loss being among the most common.

One thing that eases the strain of these treatments and their byproducts is the knowledge that the effects are temporary and that patients can expect a return to normalcy after completing them.

Unfortunately, for many breast cancer patients who were treated with the chemotherapy drug Taxotere, the hard times have continued. Many patients have completed treatment only to find that they have suffered from permanent hair loss, or also known as alopecia.

Lawsuits have begun to emerge, revealing that the manufacturer of this drug did not sufficiently warn patients or doctors about the risk of this side effect.

At Hotze Runkle, we understand that dealing with any type of cancer treatment is difficult enough and no one should have to face continued suffering after the treatment has been completed. Taxotere creator Sanofi-Aventis needs to be held accountable for their negligence.

Our team of expert attorneys at Hotze Runkle want to provide you valuable information so that you can be better informed about the current situation should you find yourself affected by the drug.

Taxotere Allegations In-Depth

There are now more than 1,000 lawsuits undergoing pretrial coordination in the Eastern District of Louisiana centered around allegations that Taxotere caused autoimmune skin disease alopecia in breast cancer patients.

Plaintiffs charge that the drug, which was approved by the FDA in 1996, comes with a higher risk of permanent alopecia when compared to other equally effective chemotherapy drugs. One main point of contention for plaintiffs is that this information was not included on labeling for Taxotere until 2015.

This becomes even more damning for the defendants, Sanofi-Aventis, because regulators and patients in Europe were made aware of this potential side effect a decade earlier, in 2005.

Furthermore, Canadian labels were changed in 2012 to inform patients and other parties there.

It was only in the U.S. that Taxotere came with a vague note that “hair usually grows back” concerning any possible permanent hair loss.

Orders Addressing Discovery and Bellwether Trials

On May 15, a pretrial order instructed both plaintiffs and defendant to propose an order for a discovery schedule as well as dates for bellwether trials by May 26th.

Bellwether trials are a common feature of situations like this where so many lawsuits are directed against a single defendant. The trials will usually involve lawsuits that are representative of the majority of the other cases.

This is done to help all parties involved see whether there is strength behind a plaintiff’s claims. The results can be a good predictor of how future, related trials might be decided by juries.

A May 18th Case Management Order set a number of important deadlines concerning Personal Jurisdiction Discovery:

  • By May 26, plaintiffs had to serve personal jurisdictional discovery in response to Sanofi’s motion to dismiss.
  • Before June 2, 2017, the two sides would meet again and discuss any discovery that had been served.
  • As of June 30, 2017, the defendants would respond and cite objections to discovery.

Another Case Management Order, on the 23rd of May, also addressed discovery. This order stated that any foreign merits discovery related to French Sanofi entities would also be served on the 26th of the month.

The deadlines currently set concerning discovery make it likely that the whole process will last until the early stages of Autumn. In this scenario, the first bellwether trials would likely begin in either November or December of this year.

It is important that everyone who has been affected by Taxotere, whether involved in a similar lawsuit or not, follow the developments around these cases.

Hotze Runkle is the support you need if you have been harmed as a result of taking Taxotere.

If you have been affected by Taxotere and are unsure about what your legal options are, contact Hotze Runkle today at (877) 919-0830. Our national litigation team can provide you with the guidance you need to sort through these difficult times.

Don’t face the shadow of Taxotere alone. Our attorneys have the expertise you can trust to get the justice and compensation you deserve.


What You Should Know About IVC Filters and Multidistrict Litigation

If you or a loved has fallen victim to severe injuries caused by dangerous drugs or medical devices like Xarelto, IVC Filters, or Taxotere then you may be aware that there are thousands of lawsuits all across the nation involving the manufacturers who have developed and marketed these products.

There are some vital differences to note, however, between a traditional lawsuit and what is known as multidistrict litigation (MDL) case.

Hotze Runkle is a national litigation law firm dedicated to providing top tier legal advice and assistance to individuals and families during the most troubling times. We believe that by best informing our clients, we are better able to develop a trusting environment and clear lines of communication.

We would like to educate the reader on how MDL may affect you.

What is multidistrict litigation?

Multidistrict litigation (MDL) is a special civil procedure that occurs when a complex legal issue begins to affect a large quantity of people. In the cases of Xarelto, IVC filters, and Taxotere, for instance, thousands of claims have been made against the creators of these individual products.

Generally, cases that fall under MDL have a common issue and common parties.

In order to better manage the multitude of cases that occur all around the country, the federal court system will transfer all of them into a single district court. One court will manage all the discovery and pretrial processes for the lawsuits.

The first lawsuits of an MDL are known as bellwether cases and their rulings can greatly affect litigation for the remaining cases. These initial cases are specifically chosen to represent the circumstances of the majority of the other cases.

What is the purpose of multidistrict litigation?

There are a couple of reasons that the MDL system was established.

The intent of merging all of these cases into a single district court is to conserve court resources, allow litigation to be more efficient and also move forward more quickly. Additionally, this also saves time, money, and effort for the plaintiff (as well as the defendants).

As previously mentioned, a single court will go through the discovery process, which is the investigation that both parties conduct prior to going to trial. The court will set guidelines and rules that must be followed during the discovery process but which will allow for the parties to carry out depositions of witnesses, gather official documents, and submit interrogatories.

Another important element of the MDL is that it helps develop a consistency in rulings. If a single plaintiff is facing individual lawsuits all throughout the nation, then there is a high likelihood that a variety of different rulings will occur, which can negatively affect plaintiffs in the long run.

What companies are facing MDL for IVC filters?

There are two major IVC filter producing companies that are currently facing MDL because of filters that were defective and caused serious – and sometimes deadly – injury to patients.

One of those companies is Cook Medical, which has nearly 1,600 claims filed against it in the Indiana federal court. The lawsuits allege that the Cook Celect IVC Filter was sold to patients even as its potential to break apart and damage internal organs and veins was known by the company. While a number of these cases have been recommended for settlement, if the settlements do not occur, the bellwether cases will begin later this year.

Another IVC filter manufacturer facing litigation is Bard for a number of its products including the G2 IVC filter, Recovery IVC filter, Denali, Eclipse, and several others. Individuals who have had these medical devices installed have dealt with heart or lung perforation, internal bleeding, hemorrhaging, punctured vena cava veins, chest pains, shortness of breath, and other serious medical issues.

The presiding judge is looking to narrow down the bellwether trials to about six cases and hopes to begin litigation in late 2017.

Let the experienced national litigation team of Hotze Runkle help you take action if you or loved one has been injured by an IVC filter.

Hotze Runkle law firm is committed to helping those have been harmed by others find the justice they deserve. Don’t hesitate to reach out to us immediately.

If you or a loved one has suffered physical, emotional, and financial complications due to the implantation or retrieval of an IVC Filter, we are here are to help. Contact us today at (877) 919-0830.

We can help you recover damages to cover medical expenses, lost earnings, earning capacity, physical and emotional pain, and more.


Taxotere Chemotherapy Medication Vs. Alternative Drugs

Chemotherapy - Medical Concept. On Background of Medicaments Composition - Red Pills, Injections and Syringe.

Breast cancer patients have enough to consider when finishing up treatment and preparing to get back to their lives. The serious side effects of Taxotere, manufactured and marketed by Sanofi-Aventis, can make that much more difficult than it has to be.

Sanofi-Aventis is facing the consequences, in the form of lawsuits, from breast cancer patients who used Taxotere and suffered alopecia – or permanent hair loss – as a result of the drug.

Plaintiffs contend that there was sufficient information for the company to provide a warning to all patients in the United States, yet failed to do so. Even more strikingly as similar warnings were issued to patients in other countries who were under treatment of the same drug.

Hotze Runkle is prepared to work for you and your family if you have suffered the debilitating side effects of Taxotere. We want to make sure that you receive the compensation you deserve for the physical and psychological damage you have gone through.

We also believe it is vital that patients be aware of Taxotere versus other options.

Taxol (Paclitaxel)

One French oncologist, Hugues Bourgeois, regularly recommends using Taxol as an alternative to Taxotere, as it is less likely to cause alopecia.

Dr. Bourgeois reported that there is a “negligible percentage” of severe alopecia cases associated with Taxol, making the frequency much lower than in patients who use Taxotere.

Like Taxotere, Taxol is a member of the taxane family of medicines. It is designed to stop cancer cells from repairing themselves and inhibit the growth of new ones. Both drugs operate the same way and there is no drop-off in quality when choosing Taxol.

In fact, there is plenty of evidence that suggests Taxol treats breast cancer more effectively and with fewer side effects.

In fact, the main difference exists in the manner in which Taxotere has been marketed.  Taxotere only requires chemotherapy sessions to occur once every three weeks while Taxol requires a weekly dosage.

The dosing schedule is a major reason why Taxotere has been more frequently prescribed by physicians, despite the fact that serious side effects continue to be associated with its use.

Abraxane

The main ingredients in Taxol are dissolved by a solvent called Cremophor EL, allowing them to enter the bloodstream more effectively. The presence of Cremophor EL can make Taxol tougher to use for some patients. The possibility of a reaction is typically offset by additional medication taken before someone uses Taxol.

Abraxane avoids this issue by not employing a solvent. Instead, the drug’s main components are wrapped in albumin, which is the main protein found in someone’s plasma.

This makes it far less likely that a patient will have trouble tolerating Abraxane whenever they are given a dose. The need for additional medicine beforehand is also eliminated, which helps to limit potential side effects.

Like Taxol, there is a body of research that suggests that Abraxane is both safer and more effective in treating breast cancer, including avoiding the permanent hair loss associated with Taxotere.

Regardless of where you find yourself in your battle against cancer, you should know that you have options and your fate is not out of your hands.

You don’t have to quietly accept your situation if you have been left with permanent loss from using Taxotere. Hotze Runkle is here to make sure that the negligence and indifference on the part of Sanofi-Aventis does not go unpunished.

Taxotere has a history of leaving breast cancer patients struggling with permanent cases of hair loss, and yet the drug still continues to be heavily recommended and used. There are other medicines, including Taxol and Abraxane, that offer effective treatment and are safer for you.

You don’t have to face the challenges of piecing your life back together alone. The experienced national litigation team of Hotze Runkle is more than capable of fighting for your rights and your justice.

Contact us today at (877) 919-0830 to find out how we can provide the legal support you need to start the healing process.


Chemotherapy Drug Taxotere Involved in Lawsuits

A woman bald from a health problem putting on makeup in the mirror. A woman bald from a health problem putting on makeup in the mirror.

Pharmaceutical companies continue to prove their indifference towards the wellbeing of patients and their preference for profits above all.

Manufacturer Sanofi-Aventis, maker of chemotherapy drug Taxotere (docetaxel) is under major scrutiny, and facing lawsuits from breast cancer patients who allege that the medication caused them to suffer from alopecia universalis – the permanent loss of hair.

Although this treatment has presented itself as a superior option to other chemotherapy drugs such as Taxol, which offers similar results without a greatly increased risk of permanent hair loss, patients are having to deal with the consequences of going through Taxotere treatment without full awareness of its side effects.

Your national litigation firm, Hotze Runkle, wants to ensure that you are protected from the immoral and illegal actions of major pharmaceutical companies, like Taxotere maker Sanofi-Aventis, who try to take advantage of innocent people.

A Brief History of Taxotere

Developed and marketed by the French pharmaceutical company Sanofi-Aventis, Taxotere was first approved by the U.S. Food and Drug Administration (FDA) in 1996. While the drug has been prescribed for a number of cancers including non-small cell lung cancer, advanced stomach cancer, head and neck cancer, and metastatic prostate cancer, it has primarily been used as a treatment plan for breast cancer.

According to BreastCancer.Org, as of 2017, there were more than 3.1 million women with a history of breast cancer in the United States. The vast majority of these women, estimated at around 75%, were prescribed Taxotere as a part of their treatment plan.

Because the treatment plan for Taxotere calls for chemotherapy sessions only once every three weeks, in comparison to other drugs that require treatment sessions weekly, the drug was marketed as more effective and less time consuming – an attractive option to patients.

Taxotere has made manufacturer Sanofi-Aventis billions of dollars in profit.

Litigation Issues Against Taxotere

Lawsuits have emerged against Sanofi-Aventis accusing the pharmaceutical company of deliberately failing to disclose the risk of permanent hair loss in order to increase sales.

Various studies, some sponsored by Sanofi itself and others conducted by third party institutions, revealed that a higher percentage of women were likely to suffer permanent hair loss (alopecia) in comparison to other chemotherapy drugs such as Taxol.

This means that the company was fully aware of the life damaging risk of its drug,  yet purposely avoided disclosing the dangers to patients.

Other claims against Sanofi include:

  • Selling the drug without proper testing.
  • Failing to warn healthcare providers.
  • Misleading patients through advertisements.
  • Falsely assuring patients of returning hair growth.
  • Failing to provide adequate warnings on packaging.

Many of these allegations are specific to patients in the United States, as the drug was marketed in other countries with warnings about the potential for permanent hair loss. It was not until 2015 that FDA finally issued a warning in the United States about the potential risks associated with the drug. Prior to the FDA warning, Sanofi suggested that patient’s hair would regrow after treatment.

Additionally, studies suggest that Taxotere is less effective than another chemotherapy drug – Taxol. Evidence found shows that over 89% of women who received Taxol had a higher survival rate than those undergoing treatment with Taxotere.

Additional Chemotherapy and Alopecia Side Effects

Because of the strength of chemotherapy drugs within the human body, many adverse side effects are known to occur in certain patients including:

  • Loss of appetite
  • Nausea and vomiting
  • Fatigue and drowsiness
  • Pain at injection site
  • Hair loss
  • Diarrhea
  • Infection
  • Anemia
  • Mouth or throat sores
  • Numbness in fingers and toes

While hair loss does commonly occur with chemotherapy treatment, there are a number of symptoms that you should be aware of that may suggest you are being affected by alopecia:

  • Loss of hair on entire body
  • Loss of eyebrow and eyelash hair
  • Baldness

Unnecessary Suffering

As if having to deal with breast cancer isn’t painful enough, Sanofi-Aventis has subjected women to an on-going, life-changing battle.

The impact of hair loss can greatly affect the quality of life, body image, social functioning, and self-esteem of women who have undergone chemotherapy. Even more so, these unfortunate women must also suffer the loss of or inability to work,  which can have dire economic effects in their lives.

If you or a loved one has suffered through the painful and serious side effects of Taxotere, do not hesitate to contact the law offices of Hotze Runkle today at (877) 919-0830.

Our reliable national litigation team at Hotze Runkle are here to guide and support the women and cancer patient survivors who have been injured by Taxotere.

Your situation may mean you are entitled to compensation for your pain and suffering.


New Studies, Same Unfavorable Results for Xarelto Vs. Competitors

The companies responsible for the manufacturing and distribution of Xarelto – Bayer and Johnson & Johnson – face a long and seemingly endless procession of lawsuits aimed at rectifying the damage done by their product to families all across the country.

With well over 18,000 cases pending against them, there has been no sign that they intend to admit to the inherent dangers of their product,  Xarelto.

The Hotze Runkle team knows that this unwillingness to properly address this issue goes against a constantly growing mountain of evidence. New studies into Xarelto and its competitors consistently show that Xarelto lags behind them in a number of categories.

Background Info

Xarelto (rivaroxaban) and its main competitors, Pradaxa (dabigatran), Eliquis (apixaban), and Savaysa (edoxaban), are part of a class of drugs called novel oral anticoagulants (NOACs). In comparison to warfarin, an older and similar drug still widely used, these new generation anticoagulants are designed to work both more quickly and thoroughly, while their short half-lives should allow for their effects to pass rapidly through the patient’s system.

However, there is a risk of bleeding associated with all NOACs, something that is important for patients to take into account. To date, Pradaxa is the only NOAC that has an antidote that has been proven effective to reverse its side effects, something Xarelto cannot claim and a constant topic of controversy for the medication as it has caused thousands of medical emergencies.

Warfarin has an antidote as well.

Medicare Studies

In a recent observational study, published in JAMA Internal Medicine, the records of 118,000 Medicare patients who used Xarelto or Pradaxa to treat atrial fibrillation (AFib) were collected and reviewed. AFib is a heart condition whose chief characteristic is rapid and irregular heartbeats, one for which NOACs are commonly prescribed.

Those in charge of the research discovered that more major bleeding events were experienced by people being treated by Xarelto than Pradaxa. These included cases of bleeding in the brain, a main point of contention in the death of the woman at the heart of the second bellwether trial against Xarelto, Sharyn Orr. The same was true for bleeding events elsewhere in the body, such as major gastrointestinal hemorrhaging.

The study also found that, in 2014, patients were two to three times more likely to have been prescribed Xarelto than Pradaxa to treat their AFib symptoms. One possible explanation offered by the authors was that this may have been because of a false belief amongst doctors that Pradaxa was the riskier choice in relation to serious bleeding events.

Potential physical damage is not all that a family has to consider when it comes to episodes of major bleeding. There is also the financial cost that is added on top of the emotional and mental.

Another study of Medicare records compared the costs from major bleeding events involving the NOACs Xarelto, Pradaxa, and Eliquis to ones involving Warfarin.

When each NOAC was compared individually to Warfarin, the researchers found that only Xarelto cost a patient more, on average, when it came to these situations. In fact, both Pradaxa and Eliquis offered significant savings, with Eliquis almost cutting the cost in half.

This study mirrored another finding that concluded Pradaxa was a safer choice than Xarelto in relation to major bleeding. Additionally, Eliquis outperformed all NOACs, as well as Warfarin, in terms of patient safety.

Studies on Xarelto continue to shine a light on its adverse side effects and the harm it causes patients. Don’t Xarelto ruin your life. Hotze and Runkle can help you fight.

There is a lot that should go into the decision you and your loved ones make when the time comes to deciding on which anticoagulant to take in order to treat a medical issue. Xarelto has a history of patients experiencing the misfortunes of serious internal bleeding and the companies behind it are in the midst of the legal consequences of these tragedies.

If you or a loved one has suffered through the painful and serious side effects of Xarelto, you don’t have to endure your burden in silence. Contact us today at (877) 919-0830 and let us be a part of your team.

Our experienced attorneys are available all across the country to help you and your family on the path to healing. Let us work to get you the justice you deserve and peace of mind for the future.


Dangerous Medical Devices, Prescription Drugs, and the FDA

Test tubes in clinic, pharmacy and medical research laboratory with male scientist using pipette

We as a nation, we have become familiar with news stories and exposés on dangerous medical devices and prescription drugs. Every years hundreds, if not thousands, of individuals suffer through life threatening situations because of products that have been marketed to consumers as safe and effective to treat their illness or health condition.

From medical devices like IVC filters, to prescription anticoagulants likeXarelto, patients are often the last to learn that their treatments may be dangerous, or sadly, even fatal. While there are certain federal departments designed to regulate the approval of medications and medical devices that make it into the market, flaws within these systems allow for pharmaceutical companies and manufacturers to sell products that are not always thoroughly studied or understood.

At the law offices of Hotze and Runkle, we believe that the safety and physical well being of patients should be of the utmost importance to these various medical devices and drug creators. However, the reality is that the primary focus of many of these pharmaceutical companies is simply profit.

To understand how these dangerous medical devices and prescription drugs make it through governmental approval processes, there is some vital information that you should know.

The Gatekeepers: The Food and Drug Administration

The Food and Drug Administration (FDA) is the federal department tasked with regulating the approval of medications and medical devices that the public is able to purchase, including prescription and over-the-counter products.

Unfortunately, the FDA does not actually test the products, but rather analyzes clinical trials and data to make a decision on whether or not a product will be approved. This system is rather flawed and allows for many drugs and devices to make it to the market without undergoing adequate studies or trials.

To begin with, medications and medical devices are generally tested by the same companies that make them. This means that the FDA must rely on the accuracy and integrity of studies done by the same individuals who are seeking to make a profit off of the devices and drugs. As pharmaceutical companies cannot make a profit from products that do not have approval, it is in their own best interest to only report information that is suited to their own needs. Essentially, pharmaceutical companies will only report the data that will them FDA approval.

To make matters worse, the Government Accountability Office (GAO) has warned that the FDA lacks reliable resources to adequately staff, study, and track drugs and devices before they reach the market. This is further exasperated by the FDA’s impaired oversight of postmarket medications and medical devices.

More Than Just an FDA Problem

To make matters worse, there is an unsettling trend amongst federal legislatures that is providing the FDA with even less oversight abilities and further enabling pharmaceutical companies to release products that are not adequately studied.

One of the most recent examples of this has come in the form legislation known as the 21st Century Cures Act.

One of the last pieces of law signed by Obama, the Cures Act outwardly appears to be a landmark bill that would fund a number of health initiatives. The downside, however, is that the bill also cuts into the powers of the FDA, further deregulating the pharmaceutical and medical device industry.

One of the means by which this will occur is by allowing the FDA to quickly approve new technologies and drugs with even lower standards of evidence than what is currently set in place. While the FDA currently relies on clinical tests and randomized samples to ensure the safety and effectiveness of new products, the Cures Act would now allow them to approve an item based on observations, safety and side-effect claims, and post market clinical studies, rather than pre-market analysis and thorough consideration.

Proponents of the bill argued that the FDA system was ineffective and did not allow for growing medical technologies and medications to emerge on the market quickly enough. Now, the companies can bypass the entire process and submit documentation after patients have been subjected to the medication or medical device. These post market clinical studies often take place years after approval and few are ever completed.

Additionally, the 21st Century Cures Act would require the FDA to utilize a third party to review the safety of a product if a manufacturer makes changes to it. This would allow manufacturers to select and pay the third party for approval. This could obviously lead to huge conflicts of interests.

Don’t let the negligent and deceitful practices of IVC filter manufacturers scare you. Your injury and pain deserve justice. Let the legal representatives of Hotze Runkle serve your needs and provide you with the commitment of a team that can get the job done.

If you or a loved one has suffered adverse effects as a result of an IVC filter implantation, contact a team that fights to earn your trust—contact Hotze Runkle.
Our team of experienced and high qualified lawyers have the ability to make IVC filter manufacturers 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.


Xarelto Bellwether Trials Continue

Gavel and Stethoscope on Reflective Wooden Table.
In early May, the first bellwether trial involving Xarelto ended with a verdict in favor of the defense. The victory for Bayer and Johnson & Johnson will be short-lived, though, as they were already back in a New Orleans federal courthouse for jury selection, which began on Tuesday, May 30th for the second bellwether trial.

Two other trials are scheduled for the summer, one in Texas and the other in Mississippi, in federal courts. To date around 19,000 lawsuits naming Bayer and Johnson & Johnson have been filed in various states across the country including Pennsylvania, Delaware, California, and Missouri. The bulk of these trials are centered in the U.S. District Court Eastern District of Louisiana, which will be the site of the first two trials.

The attorneys at Hotze Runkle understand that the every development surrounding these trials is important to all pending and future plaintiffs in Xarelto suits. It is vital that we remain informed as they unfold in order to better serve our clients.

Second Xarelto Bellwether Trial Set to Begin

This second trial centers around a lawsuit filed by Joseph Orr, whose wife, Sharyn, died from a brain hemorrhage he believes was linked to her use of Xarelto to treat her chronic atrial fibrillation.

She was first prescribed Xarelto in February 2014 and became critically sick in April of the next year. She was quickly taken to a local hospital where her condition declined and eventually resulted in her no longer responding to medical care. In the aftermath, it was revealed that she had been ailing from an acute brain hemorrhage and had suffered a hemorrhagic stroke.

The issues that arose while doctors attempted to treat Mrs. Orr stem from the fact that there is currently no approved antidote to counteract the effects of Xarelto. Consequently, they were forced to first allow the drug to pass completely through her body before they could begin working on draining the blood in her brain.

The day that passed between the time she arrived at the hospital and when the procedure was performed was too much time for it to have any positive effect. She did not show any improvement and gradually declined until passing on the fourth of May.

Mr. Orr follows in the precedent of other plaintiffs against Xarelto in accusing the manufacturers of not providing sufficient warning about the dangerous side effects and risks to both users and the doctors who prescribed it to them. Additionally, accusations have arisen against the marketing of Xarelto as the premier choice over gold-standard blood thinner Warfarin.

While Warfarin does also come with a risk of internal bleeding, it can be stopped if a patient is given vitamin K. Also, those using Warfarin have their blood checked regularly, which offers physicians more opportunities to ensure there are no serious side effects occurring within the patient’s body.

While the frequent checkups and dietary restrictions can be a bit of struggle, something Xarelto claimed separated it from Warfarin, Mr. Orr shares the sentiments of fellow plaintiffs that this kind of program would have been beneficial to patients.

Hotze Runkle knows that there is still much that remains to be seen regarding not only Mr. Orr’s trial, but the thousands that are still pending in Louisiana and all over the United States. Every case is different and no result should deter you from seeking out help.

If you or someone you love has had to battle the harmful effects of using the anticoagulant Xarelto, then contact your legal team at the law offices of Hotze Runkle today at (877) 919-0830. We will work tirelessly to get you the help you need and the justice you deserve for your troubles.

Please note that there is a statute of limitations which bars claims not brought within an allotted time period after the injury occurred. Please contact us for a free consultation to review your legal options and ensure proper legal guidance in your time of need.


The Decline of IVC Filters

hotze-runkle-ivc-filter

Inferior vena cava (IVC) filters are designed to prevent blood clots in patients who cannot use blood thinners. While they have enjoyed widespread use for some years, there is a good deal of controversy that surrounds them as well.

To date, there have been thousand of reports of issues arising from the use and removal of these devices. IVC filters are susceptible to migration within the body and the procedure to remove even the most modern versions can still be very dangerous and difficult to perform.

The attorneys at Hotze Runkle take great pride in staying current on news related to the various legal services we provide so that our clients can be well-informed as well.

Recent information shows that the use of IVC filters is a medical topic that is under considerable scrutiny, and because of this, professionals in the medical field are beginning to reexamine the use of the devices and the frequency in which they are implanted in patients.

Decreases in Use

One encouraging sign regarding the potential health and safety hazards associated with IVC filters is that there continues to be a decline in their use. This drop in the number of IVC filters in use began in 2010 shortly after the FDA issued a safety alert about devices that had been implanted for an extended period of time.

This overall decrease, however, has not been uniform across the country. The Northeastern U.S. has seen the bulk of the reduction, due in part to a medical environment that sees more disputes find their way into the courts. Western states have also seen decreases, but the legal atmosphere of their medical world does not have such a contentious streak.

Southern states have not experienced the same cutbacks in IVC use, largely due to tort reforms. These changes have made it harder for plaintiffs in these cases, not only to win settlements but the size of the settlements has been capped as well.

Regardless of what part of the country you find yourself in, there is likely to be a facility specializing in the removal of IVC filters. As the use of IVC filters began to decline, the number of places a patient could go to have one taken out rose greatly.

Instances of Pulmonary Embolism (PE)

Another factor that may contribute to the decline of IVC filters is that new studies are calling into question the effectiveness the devices have had in reducing the rate of PE. One particular study, published in JAMA Surgery, documents how the sharp decline in IVC use in trauma has not resulted in a rise in PE rates.

This relationship calls into question how useful these devices are in helping prevent blood clots. The possibility that they do not have much influence over the number of PE cases is something that has become hard to ignore for many physicians across the country.

While the authors of the study do not advocate the complete discontinuation of IVC filter use, they do acknowledge that there is still research to be done into their implementation.

Finding the safest ways and situations to employ IVC filters is still something that eludes even the most inquisitive and well-intentioned medical minds, which is probably as telling as recommending they not be used.

There continue to be many positive signs regarding the removal of IVC filters from medical use.

Future patients deserve to be treated with alternatives that do not come with as many safety questions.

If you or your family are seeking help with IVC filter litigation, the attorneys at Hotze Runkle are here to find the solutions to your problems and get you the justice you’ve been searching for.

Unfortunately, there are still many in need of legal aid because of the medical and health complications they have faced due to the use of an IVC filter.

The attorneys at Hotze Runkle are committed to helping those have been harmed by IVC filters.

If you or a loved one has suffered physical, emotional, and financial complications, or even death as a result of an IVC filter, Hotze Runkle is here to help.

Contact us today at (877) 919-0830.

Please be aware that there is a statute of limitations which bars claims not brought within an allotted time period after the injury occurred. Please contact us today for a free case evaluation to review your legal options and ensure proper legal guidance in your time of need.


What You Should Know About Xarelto vs. Warfarin

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Approved by the US Food and Drug Administration (FDA) in 2011, Xarelto has quickly become “the #1 prescribed novel oral anticoagulant in the US”.  With financial analysts calculating that Bayer and Johnson & Johnson could see $3.7 billion in sales for Xarelto by 2018, Xarelto has surely begin to overtake its predecessor Warfarin.

As one of the new generation blood thinners prescribed to patients who suffer from conditions such as deep vein thrombosis (DVT) and atrial fibrillation (AF), Xarelto has been marketed as the superior option to previous gold standard Warfarin, as it requires less medical checkups.

But it is that same lack of medical oversight that has come under heavy scrutiny because of the anticoagulant’s side effects, which have included serious uncontrollable internal bleeding, hospitalization, emergency surgery, and even death.

At Hotze Runkle, we believe that informing our clients is one of our most important responsibilities, and one of the best measures to inhibit major corporations from taking advantage and damaging the lives of innocent people.

Consider the following information about Xarelto vs. Warfarin if you have recently been prescribed the medication.

About Warfarin

Warfarin was the gold standard blood-thinning medication for many years. Initially approved by the FDA during the 1950’s, Warfarin was prescribed to patients who suffered from a host of ailments including those suffering from potential blood clots, to prevent strokes in individuals with atrial fibrillation, as well as for patients who suffered from DVT or PE.

With decades of positive use to its name, Warfarin had proven itself to be a highly reliable medication for various illnesses.

Xarelto recently emerged as an alternative to Warfarin and based much of its value on the notion that patients would not have to undergo constant medical monitoring.  Because Warfarin required patients to have monthly blood tests performed, as well as dietary restrictions, physician’s began to prescribe Xarelto consistently.

But the differences between the two are noteworthy for patients to know.

What are the difference between Warfarin and Xarelto?

There are some major variations between the medications that should be considered for patients on Xarelto including:

  • They affect the body differently. It is important to note the meaningful difference between Warfarin as a blood thinner and Xarelto as an anticoagulant medication. Warfarin makes the blood less likely to clot by inhibiting the use of vitamin K within the body, which is used to form blood clots. Xarelto, on the other hand, completely disables the body’s ability to form any clots whatsoever. Meaning that if a patient on Xarelto starts bleeding (hemorrhaging) there is very little a physician can do to stop it.
  • Warfarin has an antidote. Xarelto does NOT. While most medications carry some form of potentially hazardous side effect, Xarelto’s lack of an antidote can be deadly. In patients who have taken too much Warfarin are suffering the side effects, these can be countered by injecting the patient with a dose of vitamin K.

Xarelto, unfortunately, does not currently have any FDA-approved antidotes. This can lead to significant bleeding events that can take hours to stop, potentially leading to deadly situations.

 

  • New anticoagulant medications like Xarelto may not be safe for certain medical conditions. If you have been prescribed Warfarin for some time and have not experienced any bleeding problems or issues that required immediate medical attention, then it is probably safer to remain on the traditional medication. This is especially true if you have other medical conditions to consider such as kidney failure or mechanical heart valves. Newer anticoagulants may not be safe for you.
  • Xarelto may carry up to twice the risk of internal bleeding as warfarin. Despite Xarelto manufacturer Bayer and Johnson & Johnson constantly claiming the conveniences of their anticoagulant medication, research conducted by John Hopkins University and published in the British Medical Journal (BMJ) suggest that the new generation blood thinners may increase the risk of gastrointestinal bleeding in patients by twice as much as warfarin.

If you or a loved one has suffered through the painful and serious side effects of Xarelto, do not hesitate to contact the law offices of Hotze Runkle today at (877) 919-0830.

Utilizing Xarelto as a treatment for various health conditions can jeopardize a patient’s internal organs, life, and future wellbeing. Research has continually confirmed that the anticoagulant often produces more harm than it does benefits.

Our reliable national litigation team at Hotze Runkle are here to guide and support individuals and families who have been injured by Xarelto.

Your situation may mean you are entitled to compensation for your pain and suffering.
Contact us today to find out how we can help.


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