Product Liability Attorneys Blog

A potentially dangerous drug has been yanked from the market, after testing by the government revealed potential risks involving ingredients that were unlisted on the label.

Our product liability attorneys know that companies have a responsibility to let consumers know what is in the products they are selling so that buyers can make informed choices. Failure to do so may result in product liability lawsuits.

In this case, the drug in question is X-Rock, a drug that was approved by the Food and Drug Administration for treatment of erectile dysfunction. News outlets are reporting that when the FDA tested the drug, it found two substances that weren't on the label - sildenafil and hydroxythiohomosildenafil. The problem with these substances is that when they interact with other prescription drugs, like nitroglycerin, a person's blood pressure can be reduced to a dangerous level.

This is especially concerning because men who are likely to have issues with erectile dysfunction are also more likely to have diabetes, high cholesterol, heart disease and high blood pressure. For each of these conditions, they are generally more likely to have been prescribed medication with nitrates.

In addition to the possibility of negative drug interactions, those two substances have been associated with a wide range of side effects, including flushing and headaches.

Both the FDA and the company claim they haven't received any reports of problems as a result of taking the drug, and that this was a precautionary measure. However, the problem of reporting in this case may be two-fold.

For one thing, individuals who suffer from these other conditions may have mistaken any adverse side effects as being solely related to their original condition. And secondly, even if they suspected that X-Rock was to blame, erectile dysfunction is a sensitive issue. They may fear that a complaint or product liability lawsuit may make their information public. Fearing ridicule, they may have simply kept quiet.

What's especially troubling about this recall is that, first of all, the drug was approved by the FDA before testing found these undeclared ingredients. And secondly, advertising for the product indicates that the drug, made in the U.S., is "totally organic." It claims that the active ingredients are derived from potent natural ingredients and are totally void of steroids or chemicals.

Clearly, that's not the case.

Much of the company's profit appears to be derived from Internet sales, although there were reportedly retail locations in Florida, New York, California, Nevada, South Carolina, New Jersey and other states.

Those who have been using the X-Rock product should stop immediately, and talk to your doctor if you have experienced any of these problems. The FDA is asking that anyone who suffered negative side effects as a result of taking this drug to report it to the agency's MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm.

If the complications you have experienced as a result of using this drug were severe, you should contact a knowledgeable product liability attorney, who can help you determine whether you may have grounds for product liability litigation.

Continue reading "Product Liability: X-Rock Sex Drug Recalled " »

Giant drug maker Pfizer has come under pressure of late because it has recalled birth control pill packets it believes were incorrectly packaged, which caused women to take a lower dose than needed to prevent pregnancy, The New York Times reports.

Product liability attorneys hear examples of products coming out of the manufacturing plant defective all the time, but sadly the news doesn't spread until there's a problem. Companies often under-test their products because they want to get them on the shelves as quickly as possible.

Consumer protection laws are designed to help the public when they suffer as a result of a defective drug or defective product. Drugs are important to curing illnesses and fending off diseases. But they can also have major side effects.

While government agencies are designed to screen for these problems, the oversight is weak -- typically the Food and Drug Administration relies upon the studies conducted by the company seeking to have a drug approved. But that is still no excuse. The companies themselves are to have stringent testing protocols to make sure the products they are selling are free from serious risk. Instead, they frequently conduct mandatory testing in third-world countries, far from the prying eyes of regulators.

In this situation, Pfizer, a leading pharmaceutical company, recalled about 1 million packets of birth control pills. The company believes as few as 30 may have actually been affected. While that's a low percentage, that is still 30 people, potentially, who were using birth control and may now be pregnant.

The 21-pill "blister" packs typically contain 21 hormone-containing pills and seven inactive pills for women to be protected from an unwanted pregnancy. In some packages, the inactive pills may have been put in the wrong spots, meaning women could have taken inactive pills on days when they should have been taking active pills. This could lead to an unplanned pregnancy.

The Times reports that it asked Pfizer if it was going to pay for health care costs related to a pregnancy or abortion and other issues, but the company hasn't directly answered the question. The company said in a written statement that women should use a non-hormonal contraception immediately.

Consumer protection laws may very well be useful to people who are affected by this issue. Women take birth control specifically because they are not ready or willing to have a child. In some cases, they have a serious medical condition that could impact the health and welfare of mother or child.

Obviously, users understand that the drug may not completely stop pregnancy, but it becomes a bigger problem if it is a manufacturing issue that leads to the defect. Regardless of the type of drug, consumer protection laws can help.

Even if the drug is designed to treat a certain ailment or problem, the effects - unintended or otherwise - of the drug can cause bigger problems than the initial symptoms. These are also issues that must be addressed by an experienced consumer protection lawyer. These drug companies make billions of dollars, but that's no excuse for putting people at risk. Despite testing, sometimes the process is rushed and that creates problems for the consumer that can lead to serious or fatal injury.

Continue reading "Pfizer Birth Control Recall Highlights Defective Drug Issues" »

CBS News reports that Actos has been pulled from the market in France and Germany after the popular diabetes drug was linked to bladder cancer.

Defective Medical Product Lawyers represent the many people who are prescribed drugs to help fend off an illness or disease only to find out that the company hid crucial information regarding side effects and other problems. Drug companies are constantly in a rush to find the next big cure and sometimes that harms patients because companies haven't done enough research on the products they have created. If you have been harmed by a defective drug, don't hesitate to seek justice.

CBS reports that the French Medicines Agency pulled Actos along with Competact, a drug that combines Actos and metformin, after a government-backed study found the drugs increase the risk of bladder cancer. The agency told French doctors to stop prescribing the drug and advised people already taking it to consult with their doctors.

Actos' parent company, Takeda, told news agencies that a 10-year U.S. trial, started in 2003, hasn't shown bladder cancer risk.

The U.S. Food and Drug Administration began reviewing Actos in September, putting it on its MedWatch list.

The FDA reports that it has been studying Takeda's 10-year trial and at the five-year mark there was no statistically significant association between the drug and bladder cancer risk. But patients with the longest exposure to the drug did have an increased risk of bladder cancer. The FDA performed further analysis looking at how long patients were on the drug and the total amount of the drug they received. The agency recommended that healthcare professionals continue following recommendations on the drug label and patients should consult with their doctor if they are concerned.

It's obvious from the FDA's MedWatch list that drug companies have many problems with their products. To date, there are 99 entries of defective drug products or warnings to consumers about possible problems.

Unfortunately, the drug industry is fueled by big money and drug companies are constantly trying to produce as many as possible to flood the market and get maximum exposure. It brings in shareholders and big profits. But in the rush to produce these products, sometimes they act too quickly, which can be damaging to the patient.

Doctors are required to give patients all the information about a drug possible so patients can make the best possible decision regarding their health and well-being. The elderly are especially at risk because many older Americans take multiple medications, some which can conflict with each other. It is a doctor's job to help you stay healthy.

But because of the complexities of dangerous and defective drug claims, it is imperative that you contact Defective Medical Product Lawyers immediately if you or a loved one is harmed by medication you were prescribed. Waiting only hurts your case. Our firm works on a contingency fee basis, which means we don't get paid unless we win your case. So, if you believe you have been harmed, call us today and set up a free consultation.

Continue reading "Defective Diabetes Drug Actos Banned in Europe, Watched in USA" »

The War over Lipitor perfectly illustrates the high-stakes fight often waged by pharmaceutical companies over designer drugs that reap billions of dollars in profits in the marketplace.

The Food and Drug Administration has come under increasing fire for doing a poor job of protecting American consumers from dangerous drugs or defective medical products. Whether it's the high-profile case of Avandia -- a dangerous diabetes medication it took years to sanction -- or the recent recall of the defective DePuy Hip Replacement System, patients are not being afforded enough protection in the medical marketplace.

Those are far from rare examples. Other pharmaceuticals with questionable history include Vioxx, Darvon/Darvocet and Accutane.

The FDA relies upon the testing of pharmaceutical companies to determine a drug's market worthiness -- the next billion dollar breakthrough is safe because the company says so -- and such testing is often done in third-world countries, far from the preying eyes of regulators. The agency has also been accused of playing politics with the approval process.

Now CNN reports that Lipitor -- the world's biggest blockbuster prescription medication -- is set to go on sale by the end of the year.

Pfizer is losing patent protection on its vaunted cholesterol-fighting statin. But the controversy rests with Ranbaxy, India's largest pharmaceutical company, which had been expected to launch its generic in the United States on Nov. 30. Federal rules would give the world's 12th largest generic maker a six-month window in which it would have the exclusive rights to market and sell a generic.

However, the FDA accuses Ranbaxy of fraudulent conduct over a period of years, including fabricating data in drug applications, shortcutting quality tests and violating manufacturing standards. So grave were the violations that the FDA barred the company from importing more than 30 different drugs in 2008. Federal prosecutors continue to negotiate civil and criminal penalties that could top $1 billion.

The company's leading generics in the United States include Valtrex (for herpes), Aricpet (for Alzheimer's) and Zocor (cholesterol). It has denied misconduct and contends it is cooperating with the federal government.

Meanwhile, generic makers are "feuding like greedy relatives at Lipitor's graveside," as CNN puts it. One company, Mylan, has even sued the FDA, alleging that the government's indecision has crimped the ability of competitors to plan.

At stake is that six-month window, during which a generic typically charges 70 to 80 percent of the name-brand price. After that, competitors typically join the party and the price drops to just 5 percent of the original drug's price.

Analysts estimate that could amount to $600 million in this case. In 2010, that would have been good enough to amount to about one-third of the company's entire gross revenue of $1.9 billion.

Continue reading "Generic Lipitor Saga Involves Company Accused of Peddling Potentially Dangerous or Defective Drugs" »