Dietary products containing the stimulant ephedra, such as Fen-Phen and Metabolite, made news over ten years ago when the substance was linked to deadly heart and lung conditions. As a result, the sale of these substances was heavily restricted in 2006. However, a court recently ruled that those who’ve been diagnosed with the lung condition PPH can still file lawsuits.
Anyone who took Fen-Phen, Adipex, Redux or Pondimin, or ephedra supplements, and has been diagnosed with Primary Pulmonary Hypertension (PPH) may be entitled to significant compensation, and should learn more about their rights.
Ephedra, also known as ephedrine, is a natural stimulant medicine derived from the plant ephedra sinica. It is found in more than 35 different species throughout the dry areas of central Asia.
Ephedra has been used in Chinese culture for nearly 2,000 years. There, it is referred to as Ma Huang and often served as a tea. Native Americans and early Mormon settlers also drank versions of ephedra tea.
Ephedra works much like adrenaline by increasing the levels of certain hormones in the body. Its chemical makeup is also similar to amphetamines.
PPH stands for Primary Pulmonary Hypertension, a serious lung condition that develops over time and causes a spike in the blood pressure of the heart’s pulmonary artery. It is also sometimes called Pulmonary Arterial Hypertension, or PAH.
In its natural state, PPH is a rare condition that affects fewer than 1,000 people each year in the U.S. However, reports have linked ephedra products with a higher risk of PPH.
With PPH, the rise in blood pressure in the pulmonary artery causes an elevation in the pressure within the capillaries, which are tiny blood vessels in the lungs. This, in turn, causes the capillary endothelial cell linings to expand or shrink, allowing blood to leak into the lungs and restricting the flow of new blood and oxygen to them.
PPH often progresses very slowly, and early symptoms are hard to diagnose as they mimic other common diseases. However, once it fully develops, the condition can be deadly.
In some cases, patients that took ephedra products like Fen-Phen more than 10 years before have developed signs of PPH.
Although ephedra was originally brewed as a stimulant tea, it was marketed in recent decades as a dietary supplement for weight loss, appetite suppression, muscle enhancement, or to increase athletic performance.
Some of the products sold in the 1990s and 2000s that contained ephedra include:
The makers of these ephedra products told consumers that they were safe when taken as directed. However, reports to the FDA and later studies uncovered numerous health risks such as heart attack, stroke, lung disease and death.
As early as 1994, the FDA began investigating the side effects associated with ephedra products, after receiving more than 800 adverse event reports. One of these claimed that over 150 people died from heart attack, stroke or hypertension while using the most popular ephedra drug, Fen-Phen. Some of the more common side effects linked to Fen-Phen and ephedra products include:
In addition, Fen-Phen, Adipex, Redux and Pondimin and ephedra supplements have been associated with more serious conditions like:
These conditions can often result in hospitalization, permanent injury, or even death.
The FDA first suggested a restriction on the sale of ephedra products in 1997 due to mounting evidence of health risks. However, they were pushed back by the strong lobbying efforts of the billion-dollar supplement industry.
Then, in 2000, a study revealed in the New England Journal of Medicine found that ephedra supplements were related in 62% of cases of serious patient side effects. Of these, hypertension like PPH, and heart issues, were the most common. A quarter of all cases also resulted in permanent disability or death.
Due to media pressure, the Justice Department then ordered the maker of Metabolife to uncover reports of patient side effects in 2002. When they did so, it appeared they had been concealing 15,000 side effect reports from the FDA.
A year later, the Journal of the American Medical Association published a study of ephedra safety, showing that products like Fen-Phen were linked to 2 to 3 times the risk of heart problems, nervous system problems and psychiatric issues.
Also in 2003, the Annals of Internal Medicine published a study from the University of California at San Francisco and the Veterans Affairs Medical Center finding that ephedra was up to 720 times more likely to cause serious side effects than other common supplements. While ephedra products accounted for less than 1% of supplement sales, they were linked to 64% of reported side effects.
One study noted the disparity in ephedra dosage in these products, due to a lack of federal regulation. In some cases, different batches of the same product could have dosages that varied 10-fold.
As the popularity of ephedra supplements for weight loss increased with the general population, its use was also growing within the professional athlete community. Two cases in the early 2000s made national headlines, highlighting the risks of these products.
In 2001, offensive lineman Korey Stringer of the Minnesota Vikings died after an apparent heatstroke at training camp practice. His death was later tied to his use of Use of ephedra in the supplement Ripped Fuel according to court filings.
In February of 2003, Steve Bechler, a pitcher for the Baltimore Orioles, was only 23 years old when he died of issues related to heatstroke during conditioning drills at spring training. According to teammates and his wife, he had been taking the ephedra supplement Xenadrine in order to get in shape for the season. A doctor ruled this a significant factor in his death.
The mounting evidence of ephedra risks and high-profile deaths of two professional athletes gave the FDA new backing in its bid to restrict ephedrine use.
On December 30, 2003, the agency released a warning to consumers indicating the health risks of products containing ephedra, and advised of their intention to ban the sale of the drugs the next year.
On February 6, 2004, the FDA gave 60-day notice of a ban on the sale dietary supplements that contained ephedra, and the rule went into full effect on April 12, 2004.
At the time, the Director of the United States Health and Human Services, Tommy Thompson, advised consumers: “...These products pose unacceptable health risks, and any consumers who are still using them should stop immediately.”
The FDA ephedra ban was later challenged in federal court by a group of weight loss and dietary supplement manufacturers, but was confirmed in 2006.
Today, dietary, weight loss and performance supplements containing ephedra are still banned from sale in the U.S. However, ephedra is available in herbal and tea forms in many states.
The original Fen-Phen was taken off the market in 1997, however, more than 6 million prescriptions were written for the drug before that time. In the years following, thousands of patients with aortic heart valve problems filed lawsuits, which were eventually settled in 1999 for an estimated $3.75 billion.
However, experts believe there are thousands more patients who suffered the more-serious PPH after using ephedra drugs that have not received compensation.
Although Fen-Phen and other ephedra drugs have been off the market for nearly two decades, many of those who suffered PPH may have just recently been diagnosed.
Recently, U.S. District Judge Harvey Bartle ruled that patients afflicted with PPH even 10 years or more after taking ephedra drugs may still file claims. This also includes family members of those who have died.
So far, juries have awarded those who suffered from PPH, or their families, more than $1 billion in damages. And, Pfizer, Inc., who in 2009 bought the company that made Fen-Phen, is now responsible and has set aside billions for new claims.
Even if you believe the statute of limitations has expired on your PPH claim, you may still have legal rights to compensation. It is important for you to speak with a lawyer. Contact us today for more information.
Injured by Ephedra? Speak with a lawyer who specializes in the Ephedra litigation.
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