Tag: Mass Torts Lawyers

40 Under 40

Amy Hargis: Top 40 Under 40

Texas mass tort and bad faith insurance litigation attorney Amy Hargis has been selected for inclusion in The National Trial Lawyers: Top 40 Under 40. Membership is by invitation only and is extended exclusively to those trial lawyers practicing civil plaintiff and/or criminal defense law.  Ms. Hargis was nominated by her peers and selected for inclusion in the category of civil plaintiff law.

After obtaining her Bachelor of Arts in International Studies at Texas A&M University in 2008. Ms. Hargis attended South Texas College of Law where she graduated magna cum laude  in 2011. While in law school, she was a Dean’s Merit Scholar and served both as the Note and Comment Editor for the South Texas Law Review and the Managing Student Editor for the Construction Law Journal. She was active in the advocacy program and earned five CALI Excellence Awards for her academic performance in the classroom.

Active with various professional associations, she serves on the Editorial Board of The Houston Lawyer, a Houston Bar Association publication, and is a member of the Young Alumni Council at South Texas College of Law. Ms. Hargis is also an active member of the American Association For Justice, the Texas Trial Lawyers Association, and the Houston Trial Lawyers Association Women’s Caucus.

The National Trial Lawyers: Top 40 under 40 includes top trial lawyers from each state who are younger than the age of 40.  Invitees have superior qualifications, trial results, and leadership. Selection is based on a multi-phase process that includes peer nominations and third-party research. The group promotes the pursuit of justice for those injured by the negligence of others and public education about the importance of access to courts and the right of trial by jury.

Ms. Hargis handles a nationwide docket of pharmaceutical and medical device cases against some of the largest drug companies in the world, as well as insurance disputes involving commercial properties such as apartment complexes, hotels, office buildings, and churches

Bard IVC Filters

Bard IVC Filters – Problems With The FDA

Inferior vena cava (IVC) filters are medical devices implanted to eliminate or catch blood clots before they travel through the bloodstream to the lungs or the heart. The Food and Drug Administration (FDA) issued a safety communication in 2010 after receiving nearly 1,000 reports of significant complications caused by implanted IVC filters.

An IVC filter should be removed after a set period of time; however, in many cases, the devices stay in the vein for too long and dangerous side effects occur.

If an IVC filter is left in place for too long, the following can happen:

  • IVC filters may move, migrate, and/or change position, causing damage to internal organs
  • IVC filters may perforate or erode into other veins, damaging them
  • Parts of IVC filters can break off, travel through the bloodstream and damage the heart or lungs
  • IVC filters can become clogged with clots that impede blood flow to the heart
  • A doctor may be unable to remove IVC filters at all

Medical Research and The FDA Find Fault With Bard IVC Filters

In one study that took place between 2004 and 2009, 80 people who had been implanted with Bard IVC filters were given a fluoroscopy check up on the status of their filters. The fracture rates for the filters were found to be 25 percent with first generation devices, and 12 percent with second-generation devices.

The FDA sent a warning letter to C.R. Bard, one of the most prolific manufacturers of IVC filters, because the company did not address or correct violations found at its facilities. The FDA had previously cited Bard for the issues. Questions arose as to the level of adherence to Quality System Regulations, notably this misclassification of serious IVC filter injuries and deaths as “device malfunctions.”

NBC News investigated Bard IVC filters, and questioned Bard’s internal process to clear its IVC filters for market. A company insider revealed that the FDA failed to approve one application for the device. After that misfire, Bard recruited a regulation specialist to help it gain the necessary clearance with the federal agency. The specialist ultimately was concerned about the safety of the IVC filters and refused to sign the application paperwork. An allegation of the forgery of her signature on the documents was later levied.

Raizner Slania, Handling Bard IVC Filter Injury and Death Claims Nationally

If you or somebody you know had an IVC filter implanted, you may have a legal claim and can potentially reach an IVC filter lawsuit settlement. Contact the experienced defective medical device lawyers of Raizner Slania for a free and confidential consultation about your concerns.

patient-using-bair-hugger

Bair Hugger Consolidation Into Multidistrict Litigation

The Judicial Panel on Multidistrict Litigation recently consolidated Bair Hugger claims into MDL No. 2666 and transferred the cases on file to the District of Minnesota under The Honorable Joan N. Ericksen. This MDL centralizes and coordinates all of the federal court litigation against 3M Company and its Arizant Healthcare subsidiary over allegations linking Bair Hugger forced air warming devices to joint infections following hip or knee replacement surgery.

Centralization helps the cases be administered more efficiently and makes the logistics more convenient for the parties. Complex cases are often centralized to avoid the duplication of efforts in discovery, prevent inconsistent evidentiary rulings, and conserve judicial resources.

There are currently several dozen hip infection lawsuits and knee infection lawsuits pending in federal courts across the country. Each defective medical device lawsuit involves allegations that a Bair Hugger warming blanket used during joint replacement surgery caused contaminants to enter the sterile surgical field and caused resulting infections. It is ultimately expected that hundreds, if not thousands, of Bair Hugger lawsuits will be brought throughout the federal court system.

Why Are Bair Hugger Devices So Dangerous?

Patients who have filed cases against 3M assert that the use of forced air warming blankets causes substantial increases in the number of particles in the air near a surgical wound and higher risks of deep joint infections following hip or knee replacement surgery. There are more than 50,000 Bair Hugger warming blankets in hospitals nationwide, and the devices have been used on millions of patients. Hospitals have used these products for decades, and more than 80% of American hospitals use these products in millions of surgeries each year.

Raizner Slania: Lawyers For Bair Hugger Defect Claims

Lawsuits involving this device are already pending in state courts across the country and now a federal MDL has also been formed. Time limitations apply to medical device injury claims, so you should contact a lawyer as soon as possible. Patients who had a total hip or knee implant replacement that developed infection in the last five years may be entitled to compensation. Call Raizner Slania at (844) 456-5065 to learn more about your legal rights.

IVC Filter

IVC Filter Lawsuit Settlements

Lawsuits involving Bard and Cook IVC filters have been underway for a few years. Recently, a few of these cases were settled, one of which during trial.

In October 2014, several federal court IVC filter lawsuits were consolidated into multidistrict litigation. Since that time, now at least 56 lawsuits are on file in the Bard MDL (In Re: Bard IVC Filters Products Liability Litigation, MDL 2641) and at least 133 lawsuits have been filed against Cook Medical in MDL 2570 (In Re: Cook Medical, Inc., IVC Filters Marketing, Sales, Practices And Products Liability Litigation).

IVC Filter Claims That Have Been Settled

A Nevada IVC filter lawsuit where a patient implanted with a Bard Recovery Filter System had his organs perforated, requiring open heart surgery was recently resolved during trial.

IVC Filter
IVC Filter

While some courts have found in favor of the medical device manufacturers, several claims have been resolved positively for the injured plaintiffs. In Nevada, a Bard plaintiff filed suit after his implant migrated to his heart, requiring emergency open-heart surgery. Ten days into this year’s February trial, C.R. Bard settled with the plaintiff for a confidential amount.

Another confidential settlement was reached after 11 days of a Bard trial in January of this year. According to court documents in that case, the Recovery Filter fractured at a rate 28.3 times higher than all similar devices combined.

So far, no IVC filter lawsuits have gone to a verdict, but the first bellwether trials in the Cook Medical MDL have been requested for August 2016.

What’s So Bad About IVC Filters?

IVC filters are placed to prevent blood clots in certain patients. There is a growing body of clinical evidence regarding the association between inferior vena cava (IVC) filters and life-threatening health complications, even going so far as to question whether trauma patients really benefit from having these implants placed at all.

A June 2015 study in the Journal of Vascular Interventional Radiology found that Cook Celect IVC filters have a statistically significant risk of puncturing a major blood vessel and a 43% rate of perforation when compared to other types of filters.

The latest study on IVC filters was published in the October 2015 edition of the Annals of Surgery, where researchers analyzed 803 cases in which trauma patients were implanted with IVC filters. The research found that if these patients had their filters removed, they had an 83% increased risk of developing deep vein thrombosis (DVT), a type of blood clot. They also found that there was no increase in life expectancy with the implant versus without, indicating these devices may be largely prophylactic and without purpose.

Raizner Slania Handles Defective Medical Device Claims Nationally

Our experienced IVC filter lawyers are currently reviewing potential claims across the country. Plaintiffs may be entitled to compensation for medical expenses, lost income, lost future earning capacity, pain and suffering, and more.

Invokana Bone Fracture

FDA Strengthens Invokana Risk Warnings

Earlier this month, the Food and Drug Administration (FDA) announced that it will now require Johnson & Johnson to add new warnings regarding the potential risk of side effects for users related to Type 2 diabetes drugs Invokana and Invokamet (canagliflozin) after newer, updated data demonstrated a far greater risk than previously thought.

Invokana Bone Fracture Lawsuits

In the FDA statement announcing the increased warnings, the agency noted that they had concerns that side effects of the two drugs may include a risk of bone density loss even before they approved the drug and it was introduced in March 2013, but there were no warnings about bone fracture in either the “Highlights of Prescribing Information” or in the “Warnings and Precautions” sections; there was simply a small mention in the “adverse reactions” section of the drug label, saying that bone fractures were possible. Since then, however, updated clinical trial data demonstrates a far more certain link between Invokana and bone fractures, which is why they’re requiring Johnson & Johnson to strengthen the warnings.

Data from several recent studies suggest that fractures occur more frequently with canagliflozin than a placebo, and that the increased risk of fracture can occur as little as 12 weeks after starting treatment with the drug. The clinical trials demonstrated that even minor trauma can cause a fracture, including simply falling from a standing height. In addition to the clinical trials, the FDA also received additional information about the nature of the bone density loss related to Invokana and Invokamet, when a study of 714 elderly patients demonstrated that those taking Invokana and Invokamet saw loss of bone density in the hip and lower spine that was not present in those patients who were given a placebo.

The FDA will now require that the label for Invokana contain much stronger bone fracture warnings and that those warnings be placed prominently in the “warnings and precautions” section of the label. They are continuing research, but they have not yet named any other drugs that will be required to carry these warnings, because they have not yet determined whether the risk of bone fracture and bone density loss is also present in other Type 2 diabetes medications in the same class of sodium-glucose co-transporter 2 (SGLT2) inhibitors, a group which includes drugs like Farxiga, Xigduo XR, Jardiance and Glyxambi.

A number of lawsuits are being considered with regard to Invokana, because there seems to be evidence that the drug manufacturer, Johnson & Johnson, appears to have been aware of the potential bone fracture side effects of the drug even before they asked the FDA for approval. It’s entirely possible that, instead of providing accurate information for the medical community and consumers, the drug maker may have placed their quest for profits ahead of patient safety by minimizing the risk and providing everyone with warnings that were potentially misleading.

Invokana Side Effects Lawyers

The drug defect lawyers at Raizner Slania are evaluating potential claims for those users of Invokana and Invokamet who perhaps suffered a bone fracture, which could include spinal fractures, as a side effect of their treatment using this medication. If you have taken one of these drugs, please contact the firm so that we can take a look at the circumstances and see if there is a potential claim to be made.

patient-using-bair-hugger

Accepting 3M Bair Hugger Claims

The Bair Hugger warm air blanket, which was introduced by its manufacturer, 3M, in 1988, was once considered a great idea. It is a medical device that is ostensibly designed to help maintain the body temperature of a patient while they are under anesthesia during a surgical procedure. The blanket is draped over the patient and warm air is moved over it, in order to prevent hypothermia and keep the patient’s body temperature up and as close to the ideal 98.6 degrees Fahrenheit as possible.

According to numerous studies, by regulating a patient’s body temperature they can recover much more quickly. The Bair Hugger has also proven itself effective at treating hypothermia in patients who suffer from exposure. The concept is so popular that the Bair Hugger can be found in four out of every five hospitals in the United States.

Bair Hugger Warming Blankets Circulate Bacteria

Unfortunately, patients who have filed cases against 3M assert that the use of forced air warming blankets causes substantial increases in the number of particles in the air near a surgical wound and higher risks of deep joint infections following hip or knee replacement surgery.

So far, the most serious side effects, problems and risks associated with the use of a Bair Hugger have been deep joint infections, especially in the hip and knee, that have been contracted during replacement surgeries. These infections can lead to patients needing further procedures to replace the device that was implanted or to clean the joint tissues and to require antibiotic therapy in order to treat the infection. In some severe cases, patients had to have limbs amputated.

This problem has been known for some time. In fact, the inventor of the Bair Hugger, Dr. Scott Augustine, has been attempting to warn hospitals about the possibility of infection for years. Dr. Augustine, a Minnesota-based anesthesiologist, realized some years ago that his invention was serving to spread infectious bacteria throughout operating rooms during surgery and he even came up with a new device called a “Hot Dog” that takes warm air out of the equation and works more like an electric blanket. Though many have accused Dr. Augustine of exaggerating the negative health effects of the Bair Hugger to sell more of his latest invention, it’s difficult to ignore the large number of infections that have been reported to date associated with the use of the Bair Hugger.

According to research that was published in the Journal of Bone and Joint Surgery in 2013, researchers found that air that was circulated by the Bair Hugger system contained more than 1500 times the contaminants compared to air circulated by similar devices. Despite this, to date, 3M has not issued a recall of Bair Hugger warming blankets for any reason related to deep joint infections.

Raizner Slania Now Accepting Bair Hugger Claims

Due to a significant rise in the number of joint replacement patients who have come forward recently and alleged that their infections and other postsurgical complications were caused by their surgeons’ use of the Bair Hugger, the Defective Medical Products Attorneys at Raizner Slania LLP are now accepting potential claims against 3M and the other manufacturers of these devices. We will review your case, in order to determine whether or not the 3M Bair Hugger was the cause of your infection or injuries, and determine whether you may be able to receive compensation for your pain and suffering, and we’ll do it all at no cost to you.