Generic Drug Maker Pleads Guilty, Agrees to Pay $500 Million in Fines

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Ranbaxy, an India-based generic drug manufacturer, has pleaded guilty to federal drug safety violations and has agreed to pay $500 million in fines to resolve claims that it sold substandard drugs, The New York Times reports.

The article states that the company also made false statements to the U.S. Food and Drug Administration (FDA) regarding its manufacturing practices at two factories in India. This is the largest settlement in U.S. history, which involves safety violations by a generic drug manufacturer.

Several Safety Violations

Since last year, Ranbaxy has been operating under a “consent decree” with the FDA, after the agency identified a number of manufacturing lapses at plants in India and one in the United States. As part of the settlement, Ranbaxy pleaded guilty to three felony counts of violating the federal drug safety law and four of making false statements to the FDA. Company officials also admitted that they failed to conduct proper safety and quality tests of several drugs manufactured in their plants including gabapentin, which treats epilepsy and nerve pain and the antibiotic ciprofloxacin.

In the case of gabapentin, although the company knew between June and August of 2007 that certain batches were contaminated, it waited until October 2007 to issue a recall, which eventually included more than 73 million pills. In addition, prosecutors said the company’s workers did not properly ensure that certain batches of the drugs remained effective throughout their estimated shelf life.

Liability Issues

It is appalling that the manufacturers of these generic medications were so brazen in terms of giving false information or lying to the FDA. It is reassuring that the government went after this manufacturer and held them accountable. It is unclear how many patients may have been affected by these defective drugs. At question is the epilepsy drug, which may have been contaminated. In addition, there were also other drugs that lost their effectiveness before their estimated shelf life.

Anyone who has suffered adverse effects as the result of taking these or other defective drugs would be well advised to contact an experienced California product liability attorney who will hold the negligent corporations accountable. Drug companies have formidable legal defense teams on their side looking out for their best interests. Victims and their families need a committed lawyer on their side who will fight hard for their rights and ensure that they receive fair and full compensation for their significant losses.

Proposed Legislation to Give FDA Control of Compounding Pharmacies

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Under a proposed legislation announced recently, the U.S. Food and Drug Administration (FDA) would gain greater authority over compounding pharmacies. According to a Reuters news report, the proposal came from a bipartisan group of U.S. senators in the aftermath of a deadly fungal meningitis outbreak that killed 53 people across several states and made more than 700 sick. This outbreak was linked to vials of tainted steroid injections produced at the New England Compounding Center in Massachusetts.

New Rules for Compounding Pharmacies

Traditionally, compounding pharmacies that make very specific types of medications come under the purview of state health agencies and not the FDA like other large pharmaceutical companies that mass-produce drugs. However, under this legislation, a new class of drug manufacturer will be created that would then be regulated by the FDA. This category will be exempt from regulations that apply to large pharmaceutical companies.

For example, the drugs produced at the compounding pharmacies for individual patients will not need approval from the FDA and are not subject to labeling standards. But, there will be changes. These companies will no longer be registered as “pharmacies.” They would be required to register with the agency and must report any problems reported by patients or physicians with regard to their products. In addition, they must pay an annual fee to the FDA to cover inspection costs. There are about 2,800 compounding pharmacies nationwide.

Product Liability Issues

All facilities that manufacture medications have an obligation to maintain a safe and clean environment. A recent FDA sweep of a number of compounding pharmacies found dangerously unhygienic conditions at a number of these facilities, according to recent media reports. While these pharmacies do come under the purview of the states, the state departments apparently do little to regulate these facilities.

Anyone who has been seriously injured or has lost a loved one as the result of a defective drug would be well advised to contact a product liability attorney who will fight for their rights and ensure that they receive just compensation for their significant losses.

Contraceptive NuvaRing is Under Fire after More Than 1,000 Lawsuits Allege that it Causes Blood Clots

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More than 1,000 women are suing the manufacturers of the contraceptive device NuvaRing alleging that it causes blood clots. Women are claiming that the vaginal ring, which sends out hormones directly into the bloodstream, has caused them to suffer potentially lethal blood clots.

The lawsuits also claim that the manufacturers of the device, Merck, did not properly test or label it to warn consumers about its risks and potential dangers before NuvaRing made it to the market in 2002. The NuvaRing is a small, flexible ring made of transparent plastic, which when inserted into the vagina, releases the hormones estrogen and progestin into the blood stream, preventing ovulation and pregnancy.

Why Are NuvaRing Devices Dangerous?

Women who have used NuvaRing and have suffered dangerous side effects say that the manner in which these devices deliver hormones to the body plays a significant role in their risk factor. Unlike other contraceptives, the NuvaRing emits hormones directly into the woman’s bloodstream. Experts say that these “hormone spikes” experienced by the women may make them vulnerable to blood clots.

While all hormone-based contraceptives are likely to increase a woman’s chance of developing blood clots and strokes, the riskiest ones are those that have hormones such as desogestrel, also known as “third-generation” hormones. NuvaRing uses a compound related to desogestrel. Since 1995, we have seen research that these newer hormones double blood clot risks.

NuvaRing in fact contains a lower dose of hormones than oral contraceptives. However, while birth control pills, lose up to half their hormones in the digestive tract, the ring’s dose is directly absorbed into the blood.

Lawyers for NuvaRing victims say pharmaceutical companies never studied whether this aspect of the ring makes it riskier than taking pills. The U.S. Food and Drug Administration (FDA) did not demand such a study either. Its approval of NuvaRing in 2002 was based largely on studies involving pills containing similar hormones.

Studies Linking NuvaRing to Blood Clots

Based on numerous complaints filed, even young women who never smoked in their lives, reported suffering from serious blood clots. Even fatalities were reported. A recent study funded by the FDA found that women taking contraceptives such as NuvaRing are 1.4 to four times more likely to develop blood clots than those taking birth control pills with hormones containing second-generation progestin.

Does how the hormone is delivered matter? In a case involving a different product, drug maker Johnson & Johnson discovered that changing the manner of delivery can significantly modify a hormone’s effects. Between 2002 and 2006 at least 40 women died from blood clots after using the company’s Ortho Evra birth control patch, most from blood clots. The company had claimed at the time that its product delivered a more constant, low dose of hormones. However, as it turned out, users of the patches were getting 60 percent more estrogen than women taking regular birth control pills.

However, the cases against NuvaRing have not held up in court. In most of these cases, judges said that the plaintiffs did not sufficiently prove that the rings were the cause of their blood clots. Furthermore, Merck officials have maintained that their products are safe, FDA-approved and a proper birth control method. More than 1,000 cases will go to trial in the federal court system starting this October.

Protecting Your Rights

Fighting a product liability case against a giant pharmaceutical company is no small task. First, it is important that victims of defective drugs understand their legal rights. Injured victims can file a product liability lawsuit seeking compensation for medical expenses, lost wages, cost of hospitalization, permanent injuries, disabilities, pain and suffering and emotional distress.

Families that have lost loved ones as the result of defective drugs or medical devices can seek compensation by filing a wrongful death action against the manufacturer. These drug manufacturers and medical device makers have a responsibility and a legal obligation to test their products before putting them in the market.

However, many are in a hurry to get their products out so they can start raking in the products. This type of corporate greed can be devastating for consumers who pay the ultimate price.

FDA Warns against Pradaxa in Patients with Mechanical Prosthetic Heart Valves

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The U.S. Food and Drug Administration (FDA) is warning against using the blood thinner Pradaxa in patients who have mechanical prosthetic heart valves. According to a news report in Cardiology Today, FDA is informing healthcare professionals and the public that dabigatran etexilate should not be used to prevent strokes in patients with mechanical prosthetic heart valves.

The FDA announcement came after a clinical trial in Europe that was halted after it was found that patients given Pradaxa or dabigatran etexilate were more likely to experience strokes and myocardial infraction forming on the mechanical heart valves compared with patients who were assigned warfarin. There was also more bleeding after valve surgery in Pradaxa users than in warfarin users. Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems.

Strong Pradaxa Warning Issued

The FDA release states that health care professionals should immediately stop using Pradaxa on any patient who has a mechanical heart valve. Also, the alert warns patients with all types of prosthetic heart valve replacements taking Pradaxa to talk to their doctor as soon as possible to determine the appropriate course of treatment. Patients should not stop taking blood thinners without first talking to their doctor because it could increase the risk of blood clots and stroke among patients.

Protecting Patients’ Rights

This study further points to the risks of Pradaxa. According to the U.S. Food and Drug Administration (FDA), there were more than 800 reports of problems with Pradaxa. Of those more than 500 involved excessive bleeding and 117 involved fatalities. It is the responsibility of drug manufacturers to ensure that their products are properly tested before they are put on the market. Anyone who has suffered serious side effects as a result of taking Pradaxa or anyone who has lost a loved one as a result of Pradaxa side effects would be well advised to contact an experienced defective product lawyer who will fight for their rights and ensure that the negligent drug manufacturer is held liable.

Texas Teenager Suffers Brain Damage after Smoking Synthetic Marijuana

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Emily Bauer, a 16-year-old girl, suffered severe brain damage after she smoked “Kush,” a synthetic marijuana product sold under the name “potpourri” by corner stores and gas stations in many states. According to a CNN report, synthetic marijuana is unregulated and its manufacturers are constantly changing the chemical in the compound to find a loophole and a way to sell the products each time it is outlawed. Just within 15 minutes of smoking Kush, Emily told her boyfriend she had a migraine and was going to lie down. She then suffered strokes, which put her in a psychotic state where she proceeded to “urinate on herself, run into walls, speak gibberish, hallucinate and act violent.”

Catastrophic Injuries

Doctors had to put the girl into an induced coma. Over the next few days, doctors did tests on Emily’s brain and found that she had strokes and that it had caused parts of her brain to permanently shut down. With no other way to go, her family consented to a complicated brain surgery to try and save their daughter. During this procedure, surgeons drilled a hole into her skull and inserted a tube to drain fluid from her skull. Emily survived, but doctors have said that she will never be her old self again and that her brain was permanently damaged.

The Need for New Laws and Public Awareness

Her family members and friends have launched a campaign to create public awareness about this so-called “legal weed,” which is commonly sold in common stores. The charity that Emily’s mother has started is called S.A.F.E. (Synthetic Awareness For Emily). States such as California, Pennsylvania and New Jersey have outlawed synthetic marijuana, but it is still legal in many other states.

It is appalling that manufacturers of these dangerous and defective products continue to sell them to make a quick buck without thinking about the catastrophic consequences they can have on consumers. In this case, a young girl with her whole life ahead of her was reduced to a vegetative state and suffered irreversible brain damage because she decided to try something that was perfectly legal. It is important that synthetic marijuana is outlawed in all states. I applaud Emily Bauer’s family members for starting their charity with the intention of preventing such a tragedy from striking another family.

Pradaxa Victim’s Husband Files Product Liability Lawsuit against Drug Maker

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California resident Debroah McNamar has filed a wrongful death lawsuit against Boehringer Ingelheim, manufacturer of the blood-thinning drug Pradaxa, which allegedly caused her husband’s death. According to news reports, McNamar’s lawsuit was filed on January 10, 2013 in the U.S. District Court for the Eastern District of California. The lawsuit alleges that her husband, Philip McNamar, was prescribed the drug for treatment of his atrial fibrillation in January 2010.

The Dangers of Pradaxa

Shortly after he started taking the medication, Philip McNamar allegedly suffered excessive bleeding and a ruptured abdominal aorta. The condition McNamar suffered was known as an “abdominal aortic aneurysm,” which occurs when the large blood vessel that supplied blood to the abdomen, pelvis and legs becomes abnormally large. Philip McNamar allegedly bled to death as a result of taking Pradaxa.

The lawsuit alleges that drug manufacturer, Boehringer Ingelheim, failed to warn consumers that there was no reversal agent for Pradaxa, which could stop the bleeding. For example, excessive bleeding can be reversed in patients taking warfarin with vitamin K injections. According to the U.S. Food and Drug Administration (FDA), there were more than 800 reports of problems with Pradaxa. Of those more than 500 involved excessive bleeding and 117 involved fatalities. McNamar’s lawsuit seeks damages for negligence, failure to warn, deceptive trade practices, design defect and wrongful death.

Drug Manufacturer’s Liability

Drug manufacturers have a responsibility to consumers to make products that are safe. In addition, they are also required to warn consumers and doctors about any types of risks or dangers posed by the drug. A majority of drugs today – whether they are over-the-counter or prescription – have risks and side effects. Some of these effects are relatively minor such as dry mouth or nausea. In the case of Pradaxa, there is an excessive and irreversible bleeding risk.

Consumers must receive all the information they need about the dangers and risks of a drug so they can make informed decisions with regard to their treatment. Anyone who has suffered serious side effects as a result of taking Pradaxa or anyone who has lost a loved one as a result of Pradaxa side effects would be well advised to contact an experienced defective product lawyer who will fight for their rights and ensure that the negligent drug manufacturer is held liable.

Drug Risk Resource Center Alerts Female Patients About Yaz®

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The Drug Risk Resource Center, a group that works to bring awareness about the risks of various types of medications, has noted that both the generic and name-brand versions of Yaz®, an oral contraceptive manufactured by Bayer, has been linked to a high level of risk for blood clots, heart attacks, and strokes.  Bayer is currently in settlement negotiations with many of the victims of these side effects.

History of Yaz® Lawsuits

Yaz® was introduced as a “third generation” progestin birth control method in the 1990s.  These drugs were marketed as lower-risk for patients who used oral contraceptives.  They appeared to have less side effects than the androgenic drugs that had been marketed earlier.

However, studies soon showed that progestin birth control actually carried a higher risk for blood clots, especially deep vein thromboses or DVTs and pulmonary embolisms, or clots in the lungs.  The FDA required the makers of these drugs to include warnings to users of potential risks.

The American College of Obstetricians and Gynecologists also released information that birth control pills containing drospirenone could pose an even higher risk of blood clots.  This means that Yaz® and its other forms such as Yasmin® and Ocella®, could cause a much greater risk of these serious and sometimes deadly side effects.

A University of Copenhagen study released in October of 2011 linked the hormones found in Yaz® to blood clots.  At the same time, the FDA released a study, “Combined Hormonal Contraceptives and the Risk of Cardiovascular Disease Endpoints,” that indicated that drugs such as Yaz® could result in a risk of blood clots that was 74 percent greater than the risk level for non-users.

Because of the lack of warning given to potential users and the resulting rise in serious side effects from taking these drugs, lawsuits are now being filed to compensate victims.  These lawsuits are part of a product liability claim that is based on false advertising and lack of information given by the manufacturer about these drugs.

Victims who have suffered blood clots, DVTs, or pulmonary embolisms after taking these drugs may now be entitled to compensation from the manufacturers due to the fact that the drugs have caused serious side effects and even deaths in some patients.

Can I File A Yaz® Lawsuit?

Any woman who has suffered a pulmonary embolism, DVT, or blood clot as the result of taking Yaz® or another form of the drug may be entitled to file a lawsuit for compensation.  Bayer has already set aside $750 million to settle the lawsuits arising from these drugs.

In order to facilitate the large number of expected claims, Yaz® lawsuits were consolidated into what is known as a class action or mass tort lawsuit.  In order to be a part of this lawsuit, victims must contact a personal injury attorney and discuss their rights with a lawyer.  By becoming a part of the Yaz® lawsuit, victims may be eligible to receive compensation for their injuries resulting from the use of Yaz® or a generic version of the drug.

Bayer to Settle Yaz Yasmin Cases for $110 Million

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German drug manufacturer Bayer AG will pay at least $110 million to settle approximately 500 lawsuits over claims that its Yaz and Yasmin birth control pills caused blood clots. According to a Bloomberg news report, the drug maker agreed to pay an average of about $220,000 per case to resolve the claims that the contraceptive pills caused dangerous side effects including blood clots that led to heart attacks and strokes. This case was the first that was set for trial out of more than 11,000 Yaz Yasmin lawsuits filed nationwide.


AOG-Whistleblower Lawsuit Confirms Actos Manufacturer Concealed Health Risks

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Actos manufacturer Takeda Pharmaceuticals has been struggling to contain allegations that it was aware of the numerous health risks associated with the anti-type II diabetes drug.  A new whistleblower lawsuit against the company is not likely to help matters.

The lawsuit filed by a former employee of the company alleges that Takeda Pharmaceuticals failed to report a number of incidents involving patients who used the drug, and went on to suffer heart problems.  Takeda Pharmaceuticals was required to report these incidents to the Food and Drug Administration’s Adverse Event Reporting System.  However, according to the whistleblower, Takeda Pharmaceuticals failed to include those incidents in which patients suffered heart failure, but did not require hospitalization, and did not die.

The lawsuit alleges that medical reviewers at the company were coerced to modify their professional opinion about the health concerns of Actos.  Takeda wanted to downplay any concerns about the health risks from Actos, and therefore, reviewers of the company were encouraged to blunt study findings. More

Aog- Yasmin Contraceptive Pills Linked to Risk of Blood Clots

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The oral contraceptive pill Yasmin belongs to a new generation of contraceptive pills, which also includes Yasmin’s predecessor, Yaz.  Currently, there are more than 11,000 lawsuits filed by Yasmin injury lawyers across the country, all alleging that women suffered a variety of injuries, especially blood clots, from the use of the pill.

Yasmin is an oral contraceptive pill that is manufactured by Bayer Healthcare Pharmaceuticals.  It was approved by the Food and Drug Administration in 2004. Yasmin differs from earlier, older contraceptive pills because it contains a combination of drospirenone and ethinyl estradiol, which is a form of estrogen.

The drug was a blockbuster from the moment it hit the market.  It was used not just as a contraceptive pill, but also to treat symptoms of premenstrual dysphoric disorder.  Teenagers also began using it to treat acne. More

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