lung – Citizens Report https://citizensreport.org a digital channel commited to health & medical rights. Wed, 17 Jan 2024 09:06:12 +0000 en-US hourly 1 https://wordpress.org/?v=4.9.24 https://citizensreport.org/wp-content/uploads/2016/12/cropped-cr-icon-1-32x32.png lung – Citizens Report https://citizensreport.org 32 32 Mother Seeks Justice For Son’s Heart And Lung Problems Caused By Zofran https://citizensreport.org/2016/01/07/mother-launches-prayers-for-finn-and-takes-on-zofran/ https://citizensreport.org/2016/01/07/mother-launches-prayers-for-finn-and-takes-on-zofran/#respond Thu, 07 Jan 2016 20:01:21 +0000 http://www.citizensreport.org/?p=10149 Health professionals estimate 90 percent of pregnant women experience symptoms of nausea or vomiting. Kelly Blumenthal was no different. During the early stages of her pregnancy, Blumenthal began using a generic version of the off-label morning sickness drug Zofran in 2014. On January 2, 2015, her son was born with multiple heart defects, a lung defect and […]

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Family Sues Zofran Manufacturer in Birth Defects Lawsuit

A Virginia woman named Kelly Blumenthal has filed a lawsuit against Zofran, the morning sickness drug that allegedly caused her son’s severe heart defects.

Health professionals estimate 90 percent of pregnant women experience symptoms of nausea or vomiting. Kelly Blumenthal was no different.

During the early stages of her pregnancy, Blumenthal began using a generic version of the off-label morning sickness drug Zofran in 2014.

On January 2, 2015, her son was born with multiple heart defects, a lung defect and an intestinal issue. In addition to developing a program to support others dealing with similar circumstances, Blumenthal has filed a suit to fight against the drug that changed her family forever.

A Son’s Birth Defects, A Mother’s Broken Heart

Blumenthal’s son suffers from atrioventricular canal defect, which caused holes to develop in the center of his heart.
Image: Hx Benefit

Although doctors believed he wouldn’t make it through the pregnancy, Blumenthal’s son pushed through. However, she knew his life wouldn’t be easy. Originally planning to name him Landon, Blumenthal decided to change his name to Finley, meaning “warrior.”

Blumenthal’s son came into the world with a list of congenital problems, but the most severe is called atrioventricular canal defect. The diagnosis means that Finn has a hole in the center of his heart.

The condition affects the natural regulation blood flow and requires costly open heart surgeries. If untreated, the condition can cause serious complications including enlargement of the heart, heart failure, pulmonary hypertension, and pneumonia. Finn had open heart surgery before his first birthday.

Additionally, Finn has a double outlet right ventricle defect. The condition involves a difference in the structure of the heart, causing the two main arteries to connect to only the right chamber rather than both pumping chambers.

Blumenthal’s 1-year-old boy also suffers from  heterotaxy of the lungs, which is a misalignment of these essential organs in the chest. Finn’s lung has been deteriorating, and his mother needs to constantly monitor his blood oxygen levels. The heterotaxy is likely also linked to Finn’s malrotation of the intestines, in which his small bowel is found on the right side of the abdomen.

Supporting Others And Fighting The Industry

In addition to pursuing legal assistance to get compensation for Finn’s medical expenses, Blumenthal created a support group for families with sick children.
Image: Fredericksburg

There is no doubt that Blumenthal’s heart was broken when she discovered her son suffered from so many medical problems.  Finn’s short life has been filled with expensive surgeries, endless tubes, heavy oxygen tanks and long nights in the hospital.

Through a Facebook page called Prayers for Finn, Blumenthal has created a community of over 26,000 members that offers mutual support and comforting donations to families with sick children. It has been instrumental in helping her get through the surgeries.

On September 28, 2015, Blumenthal took another action. She decided to fight against the drug that allegedly caused her son’s medical issues. She named Glenmark Generics Inc., USA and GlaxoSmithKline LLC in her complaint, taking on both companies that may have had a hand in causing her son’s condition.

But Blumenthal is not alone. Hundreds of lawsuits have been filed against the manufacturer of Zofran, with about 200 cases consolidated in a multi-district litigation in Boston.

If you took Zofran while pregnant and if your child was born with birth defects, then you might be entitled to compensation. Complete a free, no obligation case evaluation now to see if you qualify.

 

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FDA Is Currently Evaluating The Safety Of IVC Filters https://citizensreport.org/2015/12/21/fda-questions-ivc-filter-safety/ https://citizensreport.org/2015/12/21/fda-questions-ivc-filter-safety/#respond Mon, 21 Dec 2015 17:43:39 +0000 http://www.citizensreport.org/?p=9909 An inferior vena cava filter, also known as an IVC filter, is a medical device implanted into an essential vein that carries blood to the heart.  The devices are used to prevent life-threatening blood clots from traveling through the body and blocking the lungs from functioning properly. The growing popularity of IVC filters has come with […]

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Food and Drug Administration Analyzes The Removal Of Inferior Vena Cava Filters

The FDA began receiving injury reports related to IVC filters in 2005, which prompted the regulatory agency to evaluate the overall safety of the devices.

An inferior vena cava filter, also known as an IVC filter, is a medical device implanted into an essential vein that carries blood to the heart.  The devices are used to prevent life-threatening blood clots from traveling through the body and blocking the lungs from functioning properly.

The growing popularity of IVC filters has come with a variety of complications, including device migration, filter fracture, movement of the filter or its pieces to the heart or lungs, perforation of the vessel, and a challenging removal.

After receiving hundreds of reports of these complications, the FDA has issued a safety announcement about the device and continues to assess the adverse effects it may cause.

All About IVC Filters

The inferior vena cava is a large vein that brings blood from the lower portion of the body to the right chamber of the heart.
Image: My School Lights

The inferior vena cava is a vein that transports blood from the lower body to the heart. The small cage-like device is implanted into the major blood vessel to stop blood clots from traveling to the lungs.

The device is often recommended for patients with an increased risk of a blood clot moving toward the lungs, a condition known as pulmonary embolism (PE).

In many cases, these patients are unable to utilize pharmaceutical anticoagulant medications. While the some of the “retrievable” devices may be removed, some IVC filters are marketed as a permanent way to prevent blood clots from migrating to major organs.

The FDA Raises Concerns Once Again

In some cases, it may be very difficult to retrieve IVC filters from the body.
Image: Phase One Medical

In 2010, the FDA released an initial communication informing the public about the potential dangers of IVC filters. The regulatory body cited the growing popularity of these devices, which increased from 2,000 IVC filters used in 1979 to almost 167,000 filters in 2007.

The FDA refers to a number of difficulties that may arise from IVC filter implantation. The organization is working to analyze these occurrences in order to distinguish the frequency of the complications.

“Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforations of the IVC, and 56 involved filter fracture,” according to the FDA’s report.

In 2014, the FDA released an updated communication on the subject of IVC filters. However, the organization will continue to collect additional data on both retrievable and permanent IVC filters.

What’s The Takeaway?

The FDA urges physicians to closely supervise treatment with IVC filters and measure the risk/benefit profile of each patient.
Image: Health Tap

While an IVC filter can be very beneficial, it can also be dangerous. Doctors must closely monitor all patients using the device by following up to check the status of each individual.

The FDA recommends that physicians weigh the benefits and the risks of IVC filters. If a patient’s risk of pulmonary embolism has diminished, doctors should consider removing the device in order to prevent problems in the future.

The FDA urges doctors and patients to be aware of issues with “device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device” and long-term risks such as “lower limb deep vein thrombosis and IVC occlusion.”

However, there are many patients who have already experienced complications from IVC filters. Complete a free, no-obligation case evaluation now to see if you qualify for compensation.

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