Valsartan is a drug used to treat high blood pressure and heart failure. In June 2018, the FDA announced a voluntary recall of Valsartan due to the discovery of carcinogenic chemicals in the drug. Anyone who has taken Valsartan needs to know what this recall entails and what to do if they currently take this medication.
FDA Guidance on Valsartan
Valsartan’s main intended uses include the treatment of high blood pressure and heart failure conditions. However, the manufacturer issued a voluntary recall after identifying an impurity detected in this medication. The impurity is the presence of N-nitrosodimethylamine (NDMA), a substance classified as a potential human carcinogen. The manufacturer identified recent changes in the production process as the probable cause of this impurity.
The FDA recommends that despite this recall, patients currently taking Valsartan do so for very serious health conditions, and interruptions in their medication dosage schedule can be disastrous for some individuals. The FDA advises continuing to take Valsartan until replacement doses become available. The manufacturers affected by the recall are taking appropriate steps to remove this impurity from their Valsartan products.
Patients can identify recalled drug products by checking their prescription labels and manufacturer information. Patients taking Valsartan made by Major Pharmaceuticals, Solco Healthcare, or Teva Pharmaceuticals, Ltd. should note these products have been recalled. The recall also applies to Valsartan/Hydrochlorothiazide (HCTZ) produced by Solco Healthcare and Teva Pharmaceuticals, Ltd.
What to Do if You Currently Take or Have Taken Valsartan
Any person who confirms that he or she has taken or is taking any Valsartan medications affected by the recall should confirm the manufacturer of their medication and check the company’s recall information. Every company handles recalls differently, but most will encourage patients to continue taking their medications as prescribed until a safe replacement becomes available.
If you have concerns about your exposure to potentially harmful NDMA, speak with your primary care physician as soon as possible to learn more. A doctor may be able to prescribe a replacement or substitute product so the patient experiences minimal interruption in his or her medication schedule.
NDMA is a possible carcinogen, so it is unclear if there is any possibility of short-term cancer risk after taking Valsartan. The long-term health implications also remain unclear. Despite the possible risk of carcinogenic exposure, patients who take Valsartan do so for serious medical conditions that require consistent doses of these medications, and interruptions may cause serious health problems. Ultimately, patients taking recalled Valsartan medications should consult with their physicians and refer to manufacturers’ recall information in the meantime.
The first bellwether trial against the drugmaker of AndroGel was recently concluded and the jury found the company AbbVie guilty of fraudulently misrepresenting its product. The jury awarded the plaintiff $150 million in punitive damages. Get the latest details.
In October 2016, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) issued warnings concerning the risk of infection associated with Stockert 3T heater-cooler units. These specialized devices are routinely used during open heart surgeries and other procedures. Federal agencies report that some of the devices may be contaminated with a bacteria that can be dangerous or fatal for heart patients. Patients should be aware of the risk and seek a medical diagnosis if they have recently undergone open heart surgery.
If you or a loved one were recently diagnosed with a bacterial infection after surgery, speak to one of our injury attorneys about your situation. You may be entitled to compensation. Call Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A. at 419-843-6663 for a free consultation.
What is the problem with Stockert 3T Heater-Cooler units?
Heater-cooler devices are an essential part of open heart surgery. More than 250,000 people under heart bypass procedures using heater-cooler devices every year, according to the CDC. Using cool water and fans, these machines help keep the patients’ blood, heart, and body at a safe, specific temperature during the procedure.
The problem is that some of the devices have been contaminated with Nontuberculous Mycobacteria (NTM) bacteria during the manufacturing process in Germany. NTM bacteria is a common organism often found in soil and tap water. They are usually harmless for healthy people, but can cause serious, life-threatening infections in patients with compromised immune systems.
“Samples of the water drained from the 3T devices and air samples collected while the devices were in operation were tested. The results strongly suggest the 3T heater-cooler units are the source of M. chimaera [a type of NTM] contamination,” reports the FDA. In contaminated devices, the fans can potentially blow the bacteria from inside the machine into the surgery room and into the patient’s body.
How do I know if I have been infected with NTM bacteria?
Roughly 60 percent of all heart bypass procedures performed use a heater-cooler device that has been associated with NTM bacterial infections. The FDA has received dozens of reports of patient infections associated with heater-cooler devices. In hospitals where at least one infection has been identified, the CDC estimates patients’ risk of getting an infection between one in 100 and one in 1,000.
Diagnosis is challenging because it can take months for the bacteria to cause symptoms. Plus, the symptoms are non-specific so neither patients nor doctors may first realize at first that the symptoms have anything to do with an NTM infection. CDC Deputy Director Dr. Michael Bell explains, “If you are a couple of years out from your surgery, and you aren’t having any symptoms, then you don’t need to worry about this particular issue.” However, if your surgery was more recent, you should go to your clinician if you are having any of the following symptoms which could be related to an NTM infection:
- Night sweats
- Redness, heat, or pus at the surgical site
- Muscle or joint pain
- Weight loss
- Nausea or vomiting
Where can I find more information about contaminated heater-cooler units?
Inform yourself of the risks of Stockert 3T heater-cooler device-related bacterial infection, and speak to your doctor if you have any concerns. Here are a few helpfuol resources with more information:
- Sample Letter for Patients to Give their Healthcare Provider
- CDC Video: Important information for heart surgery patients
- FDA Safety Communication: Infections Associated with Stӧckert 3T Heater-Cooler System
- CDC Q&A on heater-cooler device-related infections
How are NTM bacterial infections treated?
If you test positive for a NTM bacterial infection, your doctor will probably begin your treatment by giving you a round of strong antibiotics. This particular type of bacteria can be resistant to treatment, however, and some patients need prolonged treatment lasting months or even years. Although rare, some patients who contract an NTM infection after heart surgery may require additional surgery. If left untreated, NTM infection can be potentially fatal.
What remedies do patients have if they have developed a NTM infection?
Infected patients (and family members in fatal cases) have already begun filing personal injury and class action lawsuits against the manufacturer. If you have been diagnosed with an NTM infection after surgery that utilized a heater-cooler device, you may be eligible to file a claim and pursue compensation for your losses. There is strong evidence to support the link between the devices and NTM infections, so the chances of winning your case are excellent. Not only have the CDC and FDA issued warning reports on the device, but there has even been a national recall.
You may be able to recover damages for losses such as:
- Medical bills associated with the infection, both current and future
- Miscellaneous expenses related to your injuries
- Loss of wages
- Household services
- Pain and suffering
- Loss of quality of life
- Death benefits such as funeral expenses, loss of income, and loss of support (in fatal case)
How do I pursue compensation for a post-surgery NTM infection?
If you have a serious infection related to a surgery, your first step in pursuing compensation is to speak to an injury lawyer about your case. Our attorneys at Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A would be happy to assist you. We will review your case, investigate the facts, and let you know if your case meets the criteria to file a liability claim.
Our firm cares deeply about our clients’ situations. We know how devastating a serious infection can be, not only physically, but for financially and emotionally. If your illness was caused my a defective device or medical mistake, we can help you hold the appropriate party liable and fight for maximum compensation on your behalf.
Contact our office today at 419-843-6663 for a free consultation to learn more.
Issues with retrievable inferior vena cava (IVC) filters have caused serious health concerns for thousands of Americans, leading to numerous lawsuits against manufacturers. These pending IVC filter lawsuits allege that defects in the tiny implantable metal filters allow them to fracture or simply migrate through the body. These fractures or migrations have led to complications such as:
- Perforation of veins
- Embolism in the heart or lungs
- Deep vein thrombosis (embolism in the leg)
- Blood around the heart
- Disruption in heart function due to excess fluid around the heart
- An accelerated heart rate
- Puncturing of the vena cava
- The need for emergency surgery, including open heart surgery
- Death, in the most serious cases
At Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A., we provide free case evaluations for those in the Toledo area. We can discuss your situation, and determine if you are eligible for compensation based on adverse effects due to an IVC filter implant. We have the resources and skills necessary to represent you against the IVC manufacturer who produced your defective IVC filter and caused your or your loved one’s injuries. Call us today at 419-843-6663 to speak with a knowledgeable Toledo IVC filter lawsuit attorney.
Status of Lawsuits Against Cook Medical
The U.S. Judicial Panel on Multidistrict Litigation consolidated the cases filed against Cook Medical in October of 2014. Presiding over MDL 2570 is Judge Richard L. Young and Magistrate Judge Tim A. Baker of the Southern District of Indiana.
This multidistrict litigation (MDL) contains several hundreds of pending product liability claims alleging Cook Medical’s IVC filters caused serious health complications. The MDL combined the discovery process for all these claims. In 2016, the court selected three of the claims in the MDL as bellwether cases.
Note: A bellwether case is essentially a test case. The results of the bellwether case help predict how the rest of the cases will turn out.
According to the case management order the Southern District of Indiana filed, the first two cases include Hill v. Cook Medical, Inc., et al. and Gage v. Cook Medical, Inc., et al. Both trials are on the court’s docket for October 2017. The court has scheduled a third bellwether case for Spring 2018.
Status of Lawsuits Against C.R. Bard
The U.S. Judicial Panel on Multidistrict Litigation also consolidated hundreds of lawsuits pending against filter manufacturer C.R. Bard. MDL 2641 is currently in pretrial proceedings in the U.S. District Court for the District of Arizona, with Judge David G. Campbell presiding. The discovery process is ongoing.
In the coming months, Judge Campbell will narrow down the list to select a group of six bellwether cases. While the judicial panel consolidated these cases almost a year after the panel recommended an MDL for the Cook Medical cases, both MDLs are proceeding on a similar timetable. Bellwether trials in MDL 2641 may be on the docket as soon as Fall 2017.
How can I hold a manufacturer liable for ill effects from a defective IVC filter in Toledo?
The number of claims against IVC filter manufacturers is increasing almost daily, as more people see news of the lawsuits and reach out to skilled IVC filter lawsuit attorneys. Do not let the opportunity to hold any of the manufacturers liable pass you by. If you suffered complications in Toledo due to a retrievable IVC filter, the team at Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A. wants to hear from you.
Our knowledgeable IVC filter lawyers are working closely with other attorneys involved in the IVC filter MDL. We can ensure proper protection of your rights if you suffered ill effects from one of these filters. Call us today at 419-843-6663 to schedule a time to discuss your concerns with a Toledo IVC filter lawsuit attorney at Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A. The consultation is free.
It is impossible to know exactly how much you might get in a Toledo IVC filter settlement, but if you suffered adverse effects from one of these implantable metal filters, it is certainly worth pursuing compensation for your pain and suffering and other losses.
At Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A., our Toledo IVC filter lawyers can evaluate your claim and represent you through the legal process. If you suffered complications due to a fractured IVC device or any other adverse effects after filter implantation, we can help you determine your legal options. Many people are eligible to join ongoing mass actions against filter manufacturers. Call us today at 419-843-6663 to learn more.
What do we know about the value of other IVC filter cases?
Unfortunately, because no cases have settled or seen their day in court, we do not yet know much about the range of awards or settlements that may occur in IVC filter cases. Almost all IVC filter cases are currently tied up in multidistrict litigation (MDL), a type of mass civil action that allows the claimants to combine their resources for pretrial proceedings and the discovery process. These MDLs are preparing for the first bellwether trials against IVC manufacturers. Only once federal courts in Arizona and Indiana hear these bellwether cases can we begin to guess at a range for these settlements. The first trials are on the calendar for October 2017.
What factors play into how much compensation I may receive?
Even once we know a general range for some of these payouts, it tells us very little about your specific situation. Instead, we need to collect all the evidence specific to your case, calculate your economic and noneconomic losses, and determine a range for what we believe is a fair settlement. The factors we will look into to estimate your damages include:
Your Economic Losses
Your economic losses stemming from your injuries, complications, or adverse effects from an IVC filter issue depend heavily on the severity of your injury and the medical treatment necessary. For example, if the filter punctured a vein in your leg and caused localized bruising, your settlement might be much less than if the fractured filter migrated to your heart requiring open heart surgery. In addition to the treatment costs, other economic losses may include:
- Rehabilitation costs
- Wage loss
- Ongoing care costs
- Funeral expenses, if the victim passed away from his/her injuries
Your Noneconomic Losses
Noneconomic losses are more difficult to calculate than economic losses, but often account for a larger percentage of your total settlement. The severity of your injury also plays a major role in this type of loss. A severe injury or one that requires invasive treatment naturally causes more pain and suffering than a minor complication. We can also help you determine other types of noneconomic damages that apply to your situation.
The Case for Punitive Damages
It is not yet clear if the courts will award punitive damages in IVC filter cases. These damages serve as a way to punish the manufacturer of a defective device, in an attempt to limit similar actions in the future. There is some evidence the manufacturers were aware of issues with the filters, but failed to notify doctors or patients about the risk. This is the type of situation when courts may consider punitive damages.
How can I take action?
The lawyers at Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A. are ready to analyze your medical records and evaluate your case to determine if you qualify to pursue legal action against an IVC filter manufacturer. We have the resources and skills to protect your legal right to compensation, and secure the settlement you deserve.
Call our Toledo office at 419-843-6663 to make a free appointment with one of our IVC filter lawsuit attorneys.