Girl to Get Heart Surgery After Insurance Denial

A California couple is celebrating today after winning a battle over insurance coverage for their toddler’s heart surgery. Briggette and Johan Schilling’s 14-month-old daughter, Aria, was born with a hole in her heart and a deformed valve. The girl was scheduled to have open-heart surgery Oct. 11 at Children’s Hospital and Research Center Oakland. But Western Health Advantage, the family’s insurance provider, denied coverage for the surgery since the hospital and cardiologist were out of network.

Read more about the Schilling’s battle for their daughter’s heart surgery.

Briggette Schilling said she was shocked by the last-minute denial since Aria’s case manager, assigned to her by Western Health Advantage, knew she was being tested at the Oakland hospital and never mentioned that it was out of network. “I said, ‘I don’t think you realize who I am or how I am, and I will fight this ’til the end,’” Briggette Schilling told ABC affiliate KXTV.

The Schillings tried to appeal the insurance company’s decision but were denied. So they took their case to California’s Department of Managed Health Care, KXTV reported, and found out Friday that an independent review panel took their side and overturned the denial. “It was surreal,” Johan Schilling told KXTV of the moment he heard the news. “I actually had to pull off on the side of the freeway, and I was crying because it was a tremendous sense of relief.”

Read about a baby born with her heart outside her chest.

A surgery date has yet to be set, KXTV reported. But Aria is expected to have several weeks of recovery after the operation, and she might even need additional procedures. For now though, her parents are glad the insurance battle is over. “It was a tough road, a long, tough road,” Briggette Schilling told KXTV. ”But it made me realize that we shouldn’t have stopped.”

Melinda Krigel, a spokeswoman for Children’s Hospital and Research Center in Oakland, confirmed that the insurance company had denied the procedure the week before the surgery was scheduled. Krigel said that Aria’s cardiologist, Dr. Alok Bose, worked with the hospital to offer an in-network price for Western Health Advantage for the surgery, but that the insurance company still wanted the family to take Aria to an in-network specialist.

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Zydus Pharmaceuticals (USA) Inc. to recall the single batch of warfarin after complaints

Zydus Pharmaceuticals USA Inc. is voluntarily recalling one lot of warfarin 2 mg tablets, lot # MM5767, June expiration date of 2014 for the retailer. Four tablets of warfarin 2 mg tablets, lot MM5767, were found to be oversized in the complaint of a product.

Eating a larger than intended to dose of warfarin, could lead to a greater pharmacological effect of warfarin. As a result, patients would be more likely to develop bleeding as an adverse reaction and in some patients the bleeding in a critical organ (primarily the central nervous system) can be fatal. The risk of bleeding is increased if the overdose is repeated continuously on a daily basis.

Zydus did not receive reports of adverse events or any additional product complaint related to this very date, but as a precaution, Zydus is recalling Lot distribution MM5767.

The product is used as a prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE), prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or heart valve replacement and reduction of the risk of thromboembolic events, such as stroke or systemic embolization after myocardial infarction, myocardial infarction (MI) recurrent and death. The product is packaged in HDPE bottles 1000 count, which may have been dispensed to patients in smaller bottles. Single lot affected warfarin 2 mg tablets being recalled is very MM5767.

The product can be identified by its 6838205310 of # NDC. The product was distributed nationwide in the United States for wholesalers/distributors, retailers and mail order providers, November 2012 to December 2012.

Zydus notified their direct account customers by sending the letter of formal notice of recall by FedEx next day air service and works with clients to arrange for product return.

Someone with an existing inventory in this particular MM5767 lot of 2 mg of warfarin tablets should discontinue use and distribution, quarantine lots recalled immediately and call 1-800 in INMAR-967-5952 between the hours of 07 the 4:0 pm CST, Monday through Friday, to arrange its return. In the case of patients have tablets this batch of product, make sure all the pills are the same size and if not sure, patients should consult their dispensing pharmacy.

If you have any question about the product safety issue, so please call Zydus pharmaceuticals drugs safety/Medical Affairs at 1-877-993-8779, option # 2. Consumers should contact their physician or health care provider if they have experienced problems may be related to taking or using this batch of warfarin 2 mg tablets.

Adverse reactions or quality problems with the use of this product may be reported to the FDA's MedWatch adverse event Reporting program either online, by post or by fax.

Online: http://www.fda.gov/medwatch/report.htm1 [1]

Regular mail: use postage-paid pre-addressed FDA form 3500, available at:

http://www.FDA.gov/medwatch/getforms.htm2 [2]. Mail to the address on the pre-addressed form.

Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the u.s. Food and Drug Administration.

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