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 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 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 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 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 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 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 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.
Ever wonder what the difference is between talcum powder vs. baby powder? In many cases, the way manufacturers market baby powder and talcum powder — and the scents they add to them — are the only differences between the two types of powder. In the past, almost all baby powders contained talcum powder. Today many still include talc as a component. For example, one of the most popular brands of baby powder in the United States, Johnson & Johnson, is a combination of just two ingredients: talc and parfum.
What is talcum powder?
Talcum powder is nothing more than a finely ground mineral, talc. Manufacturers bottle the ground mineral, add some type of fragrance, and market it for a wide range of uses. Many people use the powder for cosmetic and hygienic uses.
Talc contains several elements that make it absorb moisture when used in powder form. It helps keep skin dry and prevents chafing, rashes, and other moisture- and friction-related problems. Talc is a common component in baby, body, and facial powders. You can even buy medicated talcum powders and those with special scents to help with everything from itch relief to relaxation.
When is baby powder not the same thing as talcum powder?
Manufacturers originally designed baby powder to prevent diaper rash by keeping the baby dry.
The formula varies by manufacturer, but the primary ingredient in baby powder is typically either talc or cornstarch. Some baby powder manufacturers swapped to a cornstarch base over the last few decades; some, however, continue to use a talc base.
Why is talcum powder dangerous?
Talc particles are much finer than cornstarch particles, and therefore much easier to inhale. For this reason, baby powder manufacturers have long recommended keeping the product out of the reach of children. Inhaling talcum powder can cause irritation, sinus inflammation, and even chronic lung issues.
Various studies have pointed to a link between talc-based baby powder and ovarian cancer that does not exist with cornstarch-based powders. Arguably, the most well-known research is that by Daniel Cramer, one of the first researchers to link ovarian cancer and talc use.
Talcum powder and its potential to cause cancer has become a hot topic in recent years because of the number of lawsuits filed against Johnson & Johnson, one of the most well-known producers of talcum powder products. Several court rulings awarded large settlements to women who developed cancer after using these products for feminine hygiene.
What should I do if I believe talcum powder use caused my ovarian cancer?
Gallon, Takacs & Boissoneault Co., L.P.A. is offering free case evaluations to women who regularly used a talc-based powder for feminine hygiene and later developed ovarian cancer, or the families of those who passed away from this disease.
Call our Toledo office today at 419-843-6663 to speak to one of our talcum powder attorneys. We will analyze the facts of your case, and help you better understand your legal options.
Inferior vena cava filters, known as IVC filters, prevent many cases of pulmonary embolism when patients cannot use traditional blood thinning drugs. Surgeons implant these tiny, octopus-shaped filters in a leg vein to snare blood clots before they can reach the heart or lungs. Unfortunately, though, there are several IVC filter complications that all patients should be aware of. Many of these complications can be deadly.
If you suffered serious complications because of an IVC filter in Toledo, you may be eligible to file a claim for compensation for your related losses. Gallon, Takacs & Boissoneault Co., L.P.A. works closely with other law firms representing patients with IVC filter complications. We can help you obtain your medical records and other evidence necessary to prove your claim, and file for compensation.
Call our Toledo office at 419-843-6663 to schedule a time to discuss your case with one of our IVC filter lawyers today.
What are some common IVC filter complications?
Like any medical procedure, there are some manageable complications that may occur during the implantation of an IVC filter. Complications can also occur during removal. The greatest threat for serious complications, however, occurs while the filter is in the vein.
The U.S. Food and Drug Administration (FDA) first began tracking complaints about these IVC filters in 2005. Just five years later, it issued a report outlining over 900 complications that occurred while patients had IVC filters in place. It is important to remember this safety alert only lists complications reported to the FDA between 2005 and 2010. With IVC filters still in use, hundreds more experience these complications each year.
The most common adverse events listed in the FDA report included:
Most of the complications reported to the FDA were filter migrations, comprising 35 percent of all reported adverse events. In the most benign of the 328 filter migration cases, the filters simply migrated away from their original positions. This migration made them ineffective in preventing pulmonary embolisms, but did no further damage.
Filter migration, though, is not always benign. In some cases, the filter can actually travel to the lungs or right ventricle of the heart, leading to serious complications.
The purpose of IVC filters is to prevent pulmonary embolisms (i.e., a blood clot in the lungs); while research shows IVC filters may decrease the risk of pulmonary embolism, it can actually increase deep vein thrombosis (DVT), i.e., blood clots in the legs.
A study published in the Journal of Vascular Surgery showed a 40 percent incidence of this type of blood clot in patients with IVC filters. These patients did not have a previous history of DVT blood clots.
DVT blood clots can also move to the lungs and become a pulmonary embolism. The blood clots that cause a pulmonary embolism can occur in other areas of the body, as well. Research published in the Journal of the American Medical Association tracked 300 patients who received an IVC filter after a pulmonary embolism. At least six suffered another fatal pulmonary embolism in the first 90 days after filter placement.
The FDA report listed 70 cases of vein perforation. When an IVC filter — or a part of the filter — punctures the vein, bleeding occurs. This bleeding under the skin is usually minor and results only in bruising, swelling and tenderness. Occasionally, this may lead to excessive swelling, a significant internal bleed, and/or infection.
A study published in Cardiovascular Interventional Radiology linked this type of perforation with filters that remained in place for longer periods of time. The study, which examined the medical records of 272 patients with IVC filters, found problems with all the filters within the first 71 days.
Perforation can happen even earlier, according to a 2015 study published in Vascular Interventional Radiology. This study found that some brands of IVC filters had a perforation rate as high as 43 percent after just two months.
In addition to the entire filter perforating the vein or migrating to another location, the metal legs can break off the filter and cause similar issues. The FDA’s report included 56 cases where the filter fractured in some way. Because the pieces of a broken filter are much smaller than the whole filter, the pieces can more easily travel in the bloodstream and migrate to other areas of the body.
Are these complications preventable?
The only way to prevent all complications related to IVC filters is to avoid using the implants. However, they are sometimes the best option when the patient’s condition contraindicates blood thinning medications.
When an IVC filter is necessary, the best way to reduce the risk of complications is to remove the device as early as possible. Since 2014, the FDA’s recommendation is to remove these filters between 29 and 54 days after implantation. Sometimes adverse effects occur even during this period.
Who should I call if I believe an IVC filter contributed to my decline in health?
At Gallon, Takacs & Boissoneault Co. L.P.A., we understand how stressful it can be when you face serious health issues. To learn that your treatment actually put you in additional danger or led to complications only adds to the emotional toll. If you suffered any adverse effects after an IVC filter implantation procedure, we would like to talk to you.
Call our Toledo office at 419-843-6663 to schedule a time for a free case evaluation with one of our knowledgeable IVC filter lawyers.