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What is a Stockert 3T Heater-Cooler System? When a patient is under anesthesia during surgery, it is important to regulate body temperature to keep the patient comfortable and safe, and to improve the outcome of the surgery. Heater-cooler devices do this through the use of temperature controlled blankets which can alternately warm and cool the patient’s body. Unfortunately, these devices have recently been linked to life-threatening infections, especially during cardiothoracic surgeries.

Multiple lawsuits against LivaNova PLC, the manufacturer of Stockert 3T Heater-Cooler Systems, claim that it failed to warn physicians and hospitals of the risk of infection. Studies have revealed that the device is capable of transmitting a bacterium called Mycobacterium chimaera to patients during surgeries. This bacteria can lead to a condition called nontuberculous mycobacteria infection, which can be fatal, even after years of treatment with antibiotics. A Boston defective medical device attorney can help you determine how to proceed if you’ve been harmed by a heater-cooler system.

How Do Heater-Cooler Devices Spread Infection?

To cool and warm a patient’s body, a heater-cooler device uses a water-tank system to regulate the temperature of the attached warming blanket. Research has show that when the water in these tanks becomes contaminated, bacteria may be released into the air surrounding the patient’s body through an exhaust vent. If this happens, a patient who may have a weakened immune system and open wounds due to the surgical procedure, has a highly-increased chance of contracting an infection from the bacteria.

Look Out for these Signs and Symptoms

One of the most concerning aspects of nontuberculous mycobacteria infection is that it can take several years for the infection to occur following exposure to Mycobacterium chimaera. If you have undergone cardiac surgery with a heater-cooler device, you should look for the following signs / symptoms:

  • Chronic fever
  • Night sweats
  • Unexplained weight loss
  • Joint pain
  • General malaise
  • Infection in the surgical site
  • Abscess
  • Endocarditis (infection of the lining of the heart)
  • Hepatitis
  • Bacteremia (bacteria in the blood)
  • Kidney failure
  • Pancytopenia (loss of red and white blood cells)
  • Enlargement of the spleen
  • Osteomyelitis (bone infection)

Any of the above complications could be evidence of a nontuberculous mycobacteria infection. Even if your surgery was weeks, months or years ago, it is still possible to develop this potentially-deadly infection. If you notice any of the above symptoms, it is crucial to seek medical attention immediately. Cultures can be taken and diagnostic testing can be performed to determine if you have an infection. The earlier an infection is identified and treated, the better your chances of a positive outcome. A MA defective medical device lawyer can help you recover damages if you’ve been injured due to the negligence of a medical device manufacturer. Continue reading

Invokana is the first of a new class of diabetes drugs known as sodium-glucose co-transporter 2 inhibitors (SGLT2). Shortly after its release in March of 2013, patients began reporting adverse side effects, including nausea and vomiting. A Georgia woman named Paula Brazil recently filed a lawsuit against Invokana’s manufacturer, Johnson & Johnson, alleging that she developed ketoacidosis after taking the drug. Ketoacidosis is characterized by abnormally high levels of blood acid and can be extremely dangerous, often resulting in hospitalization. The lawsuit claims that Johnson & Johnson and its subsidiary Janssen neglected to adequately warn of Invokana’s potential for causing ketoacidosis. Contact a Boston Drug Injury Lawyer Today.

Failure to Warn

Brazil claims that after beginning treatment with Invokana, she immediately began to experience significant weight loss, nausea, and vomiting. Within two weeks, she was admitted to the hospital and was subsequently diagnosed with ketoacidosis. Invokana is specifically designed to treat type 2 diabetes, a condition that is not typically associated with ketoacidosis. In addition to vomiting and nausea, ketoacidosis also involves symptoms such as confusion, difficulty breathing, fatigue, and abdominal pain, and it typically requires emergency healthcare and/or hospitalization. Brazil’s lawsuit stated that, “Invokana is unreasonably dangerous and defective as formulated, putting consumers, including Plaintiff, at an unreasonable risk of suffering injury and death.” It went on to say that, ““As the developers, manufacturers and distributors of Invokana, Defendants knew or should have known that it was associated with serious complications, including diabetic ketoacidosis.”

FDA Received 457 Adverse Event Reports for Invokana

Brazil’s lawsuit is only the latest in a rising number of lawsuits filed against Invokana’s manufacturer’s in recent weeks. In addition to claims of developing ketoacidosis, several plaintiffs allege they developed kidney failure, kidney stones, urinary tract infections, and other forms of kidney impairment. Following the FDA’s safety warning issued in May 2015, lawsuits have begun to grow rapidly. The warning indicated that reports of high levels of blood acid among Invokana-users was being investigated. The Institute of Safe Medication Practices (ISMP) also released a report evaluating 457 adverse drug event reports, potentially linking Invokana and other SGLT2 drugs with kidney problems in patients. In fact, Invokana receives more adverse event reports than 92% of the drugs monitored by the same group. ISMP’s report addressed the questions of whether the benefits outweigh the risks, and if a recall of Invokana should be issued. Continue reading

In most cases, patients are required by their insurance companies to take cheaper, generic versions of prescription drugs if and when they are available. But an I-Team investigative report by CBS discovered there is an unsafe drawback to these medicines that both doctors and pharmacists don’t want patients to know about. One local family is speaking out in the hopes that their story will create change for a legal loophole that’s putting numerous patients at risk.

According to CBS Boston, Foxboro resident Alisa Steele gave birth to her daughter, Rowan, last November. Rowan was delivered more than two months prematurely and diagnosed with a congenial heart defect; a condition that Alisa was devastated to learn was most likely caused by her use of a generic version of the prescription morning sickness pill, Zofran, called Ondansetron. The drugs are currently approved by the FDA to treat nausea in cancer patients receiving chemotherapy and radiation treatments, as well as post-operative nausea. Never have either Zofran or its generic form, Ondansetron, been tested on or approved for use in pregnant women yet they are both readily prescribed off-label to treat severe morning sickness.

Kimberly Dougherty, a Boston attorney, says she’s seen countless injuries caused by generic drugs. The problem is, according to the current law, only patients who were injured after taking the brand name drug are allowed to sue the manufacturer.

“The current law does not allow generic manufacturers to be held liable when their drug injures someone. That means that even though several recent studies have linked Zofran to an increased risk of birth defects, including heart problems and cleft palate, them manufacturer of the identical drug cannot be touched in court,” Dougherty said. In light of the numerous reports linking generic drugs to injury, the FDA proposed a rule change that would also give patients more legal rights when they take generic drugs, though the drug industry continues to fight it. A decision is expected early next year.

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Ciprofloxacin is an antibiotic used to treat common types of bacterial infections, including urinary tract and ear infections. Approved by the U.S. Food and Drug Administration (FDA) in 1987, Ciprofloxacin (Cipro) is in a class of synthetic antibacterial drugs called fluoroquinolones, and has become one of the most commonly prescribed antibiotic treatments. However, in 2008 the FDA required Cipro’s warning labels to alert patients of potential side effects, including tendon ruptures. Five years later, in 2013, the FDA required the use of labels warning patients about a central nervous system condition called peripheral neuropathy. Subsequent pharmaceutical liability lawsuits have claimed the manufacturers of Cipro and other fluoroquinolones had previously known about the associated health risks, yet failed to warn both patients and healthcare professionals.

What is Peripheral Neuropathy?

Peripheral neuropathy is a general term for numerous kinds of nerve damage occurring between the brain, spinal cord, and body’s tissues (muscles, tendons, ligaments, ligaments and connective tissue). The two categories of peripheral neuropathy are motor nerve damage and sensory nerve damage:

  • Motor nerve damage affects coordination and use of the hands and arms, resulting in muscle spasms, difficulty walking, significantly decreased strength, and muscle cramping.
  • Sensory nerve damage affects the sense preceptors of the nerves serving the skin, causing numbness, paresthesia (tingling sensations), sharp pain, and extreme sensitivity to touch.

Cipro’s Effects on Collagen

Collagen is a protein found in connective tissues, vital for providing strength and structure to the human body. Collagen is necessary for healthy relationships between bones, cartilage, tendons, muscles, and skin. Studies have shown that Cipro and other fluoroquinolones erode existing collagen and prevent collagen synthesis. The tendon ruptures cited in the FDA’s 2008 mandatory warnings are thought to be caused by this collagen breakdown. Paired with the potential for peripheral neuropathy, collagen degeneration provides excessive risks to patients prescribed Cipro. Continue reading

Pradaxa is an anti-coagulant that doctors have prescribed to reduce the risk of stroke and blood clots in certain patients. Unfortunately, it carries an incredibly high risk for potentially deadly side effects. The Food and Drug Administration (FDA) had more than 500 complaints of death and serious injury due to internal bleeding associated with Pradaxa in the first three months of 2011. It’s typically used as a substitute for Coumadin, which has a reversal agent. The most dangerous side effects associated with Pradaxa are internal bleeding and hemorrhaging.
Pradaxa in the News A lawsuit has recently been filed against the makers of Pradaxa on behalf of the daughters of a woman who reportedly died after taking Pradaxa. Janine V. McHugh and Jennifer D. Merlino filed a lawsuit against Boehringer Ingelheim Pharmaceuticals and various subsidiaries. Their mother was said to have developed a gastrointestinal hemorrhage four months after she began taking Pradaxa for non-valvular atrial fibrillation. The Pennsylvania Record reports that the lawsuit argues that Boehringer Ingelheim knew or should have known that the original labeling of the drug did not adequately warn the plaintiff of the risks associated with Pradaxa. The lawsuit goes on to argue that the defendants knew or should have known that certain patients were at an increased risk for developing life-threatening “bleeds” as a result of taking Pradaxa.
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A settlement was recently reached between an Israeli diabetes patient and GlaxoSmithKline, the manufacturer of Avandia, in which an award of NIS 12.1 million was granted-the largest in Israeli history. The drug, which was approved for treatment in 1999, was once one of the West’s most popular in diabetes treatment but has since become associated with a number of serious risks, including, most notably, cardiac failure. The award will reportedly be used to fund a new treatment program for diabetics.

In the suit, the diabetic alleged that GSK had concealed information from the public that showed the drug was linked to an increase in the risk of dying from a heart attack. Avandia is included in the range of health services covered by Israel’s HMOs as a pre-treatment, and the Israel Diabetes Association estimates that about 30,000 Israeli diabetics have been given the drug. However, it says that the number has decreased significantly since the risks have started to become more widely-known.

At least two reports, by the New England Journal of Medicine and the U.S. Food and Drug Administration, have prompted regulators to reassess the safety of Avandia. The Israeli filed suit in July 2007 in Tel Aviv District Court, and it was later recognized as class-action. The attorneys representing the man essentially argued that GSK hid the drug’s risks despite having evidence of them as early as 2002.
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Germany’s largest drug company, Bayer AG, has resolved to pay at least $110 million in order to settle about 500 lawsuits relating to complaints that its Yasmin birth-control pills cause blood clots. The settlement, reported by people familiar with the case, is the first resolution of any suit relating to the drug. Officials from the company have agreed to pay about $220,000 per case to resolve claims regarding its Yasmin and Yaz contraceptives. The information was revealed by two people familiar with the details but seeking anonymity as they have not yet been made public.

There were more than 11,000 lawsuits filed over injuries allegedly stemming from the two drugs. A suit accusing Bayer of misleading women about the health risks of its contraceptive pills was set for trial Jan. 9 but was postponed by a federal judge in Illinois in order to allow for negotiations, which seems to have ultimately prompted the $110 million settlement. Carl Tobias, a professor of product-liability law at the University of Virginia at Richmond, speculated that Bayer, “as a German company,” is hoping to avoid the costs of litigation in U.S. courts.

On April 10, the FDA had ordered Bayer and other makers of birth-control pills to make the blood-clot warnings on their products stronger. Researchers have found that one of the active ingredients in the pills may increase the risk for clots by more than three times. A spokeswoman for Bayer, Rosemarie Yancosek, has confirmed that some of the cases pending litigation in the U.S. are being settled. Bayer has also confirmed in a previous filing with the SEC that it has already settled at least 70 cases relating to the Yasmin line of contraceptives.
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