Wednesday, March 11, 2015

Zofran Breaking News - New Study shows that Zofran can cause birth defects including cleft lip, cleft palate, and congenital heart defects.

Zofran was approved by the U.S. Food and Drug Administration (FDA) to treat nausea and vomiting caused by chemotherapy and radiation. The drug was also prescribed to treat morning sickness in pregnant women, but it was not approved by the FDA for this use.

The Center for Birth Defects Research and Prevention recently published a study isuggesting that women who used Zofranduring the first trimester of pregnancy had a twofold increase risk of having a child with birth defects.

Possible Zofran defects may include cleft lip, cleft palate, and congenital heart defects. Although Zofran was not approved by the FDA for morning sickness, GlaxoSmithKline (GSK) promoted off-label use of the drug. GSK agreed to pay $3 billion in 2012 to settle numerous allegations including illegally marketing Zofran® for non-approved use. 

Mothers who took Zofran during pregnancy and had a child with cleft lip, cleft palate, or heart defects may be entitled to compensation.  Contact a Nelson Bryan and Jones (205-387-7777) to find out if you and your child are eligible for compensation.

Saturday, March 7, 2015

Black Lung Benefits



The Black Lung Benefits Act is a federal law that creates a compensation system for a disabled miner and, after his death, for his surviving dependents.  In general, miners are considered disabled under the law if they can prove that their lung function is impaired enough to render them incapable of further work, and that the lung impairment is caused by pneumoconiosis (Black Lung), a medical diagnosis of pulmonary impairment from exposure to mine conditions. 

In some instances, however, a miner who has been employed in the mines for over 15 years can take advantage of a legal “presumption” that any lung disease or impairment is the result of exposure to mine conditions, whether or not the miner has a diagnosis of “pneumoconiosis.”  Miners, who benefit from the “presumption,” in other words, do not necessarily have to prove that their lung conditions were caused specifically by exposure in the mines.

Survivor benefits are a little different in what proof is required – and the law on the subject has a confusing history.  The original Black Lung law from 1970 required that a surviving spouse prove that the miner died from pneumoconiosis.  In 1972, Congress expanded it to cover spouses who could show that their miners either died or at death were disabled by pneumoconiosis.   Then in 1978, Congress expanded it again in two ways: (1) to include children, parents, and siblings of the deceased as being potentially eligible to receive benefits, and (2) to eliminate the need for the survivor to file a new benefits claim, if the miner had been receiving benefits before the miner’s death.  Then in the 1980s, Congress tightened back up many of the 1970s amendments, and in particular restored the requirement that death benefits to survivors required a showing that the miner died due to pneumoconiosis. 

Then came 2010 and the Patient Protection and Affordable Care Act, a/k/a “Obamacare.”  That law restored the 1978 law by eliminating the need for the survivor to re-file a claim for benefits after the miner died, if the miner had been receiving benefits before death.  The net effect was that if the miner had been receiving Black Lung benefits before death, the eligible survivor was entitled to benefits after death, regardless of any specific diagnosis.  The law also was written to be “retroactive,” or to apply backward, to claims filed after January 1, 2005 that were still pending in 2010. 

In a recent federal appeals court decision, U.S. Steel Mining Company challenged this provision in the Obamacare law.  The case involved a widow, Mrs. Starks, whose husband had worked in the mines and had been receiving Black Lung benefits before his death.  After his death, she filed a claim for survivor benefits under the Obamacare amendment, but U.S. Steel opposed that request, claiming that even after the Obamacare law, Mrs. Starks still had to prove that her miner died of pneumoconiosis in order to receive benefits.  Mrs. Starks won her case in late June of 2013 in a decision from the Eleventh Circuit Court of Appeals, which is the federal appellate court with jurisdiction over Alabama residents.  The Court rejected U.S. Steel’s arguments, finding that Mrs. Starks did not have to prove a cause of death in order to receive survivor benefits, and that the Obamacare provisions concerning Black Lung were constitutional.

The decision in the Starks case is a significant win for families of miners. The significant “takeaway” from the Starks decision is this: it is better to have your miner apply for Black Lung benefits while he is still alive, even if he is totally disabled, because there may be a higher burden of proof on survivor benefits claims after he dies.

Whatever you may think of the Obamacare law generally, the provision that expands Black Lung benefits for families of miners is a major win for many folks in this area. 

If your family has a miner who you think may be disabled, we encourage you to talk to an attorney.   We have handled Black Lung Cases for over 30 years.  Give us a call at 205-387-7777. 

Wednesday, March 4, 2015

FDA Orders Warning Labels on Testosterone Drugs

The Food and Drug Administration said Tuesday that it is requiring drugmakers to warn patients that testosterone products may increase the risk for heart attacks and strokes.

From WebMD:

March 4, 2015 -- Testosterone-boosting drugs taken by millions of American men have never been proven to be safe or effective for treating aging-related problems, the U.S. Food and Drug Administration says.

On Tuesday, the agency also said the drugs can increase the risk of heart attack and told manufacturers they must add that caution to the warning labels on the products, the Associated Press reported.

A similar warning about testosterone drugs was issued last summer by Canadian health officials.

The agency also told drug companies must clarify that the drugs are only approved to treat low testosterone levels caused by injury or disease.

For years, testosterone pills, patches, gels and injections have been marketed as treatments for low testosterone levels, and sales of the drugs have risen to more than $2 billion.
"There's been a very successful advertising campaign to make men feel that whatever their problem is, the answer is to buy more testosterone," Dr. Sidney Wolfe, of the consumer advocacy group Public Citizen, told the AP.

Last February, the group petitioned the FDA to have testosterone drugs carry a boxed warning -- the most serious type -- about heart risks, but the FDA said there was "insufficient evidence" for such a warning and rejected the petition.

The FDA launched a safety review of testosterone drugs in January 2014 after two federal studies linked them with higher rates of serious problems such as heart attack and stroke. However, other studies have suggested an association between testosterone replacement and longevity, the AP reported.

Men's testosterone levels naturally decrease after age 40, but there is disagreement on whether this actually causes problems such as lower bone density and less energy.