Articles Posted in dangerous drugs

According to a recent news article from the Washington Post, a federal watch group reports the United States Food and Drug Administration (FDA) exercised “lax” judgment and made “questionable” decisions to be accommodating to the pharmaceutical maker Boehringer Ingelheim when reviewing its application for the anticlotting medication known as Pradaxa.

pillsSome of the specific claims were that FDA set loose safety standards for use during the drug company’s human clinical trials for Pradaxa and also that FDA did not require manufacturer to provide a complete and appropriate warning to prospective patients about the health risks of Pradaxa. Continue reading

Brinkley v. Pliva, Inc., a defective drugs case from the United States Court of Appeals for the Eighth Circuit, involved plaintiff whose doctor prescribed the brand-name drug Reglan to treat her Gastro Esophageal Reflux Disease (GERD). Plaintiff’s pharmacist substituted the generic drug metoclopramide, which was manufactured by defendant. This occurred in 2002.

medication pills.jpgPursuant to Federal Food Drug, and Cosmetic Act (FDCA), manufacturers of generic medications are required to prove their drugs are the same as the brand-name equivalent in design and labeling. Generic drug makers are not permitted to add any additional warnings.

In 2004, the United States Food and Drug Administration (FDA) approved the Reglan maker’s request to add two additional bold statements to the labeling warning the product should not be taken for more than 12 weeks. Defendant did not add these additional warnings to its generic product.
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According to a recent news article from CBS Boston, the founders of a Framingham compounding pharmacy and 12 other employees have been charged with racketeering and second-degree murder.

caduceus-1219484-m.jpgCourt papers indicated the compounding pharmacy was only licensed to manufacture small numbers of specific drugs for individual patients. This is the same pharmacy that was linked to a 2012 meningitis outbreak allegedly caused by tainted steroids made by defendants. In that incident, 64 people died and 750 more became seriously ill after taking the drugs.

As part of an investigation into this defective drug manufacturing incident, authorities found records filled with obviously fake names of patients such as “Bud Weiser,” “Filet O’fish,” and “Baby Jesus.” There were instructions by company founders that the names used in official logs should resemble real names and not be obviously false, though it appears employees did not follow this advice. The fake names are part of an alleged plan to defraud the FDA and avoid reporting requirements.
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Drug manufacturers have an obligation to alert patients to any potential side effects associated with a particular medication. However, because of the way the laws are written, those who make and distribute generic drugs are actually prevented by law from alerting the public to potential problems.

The U.S. Food and Drug Administration (FDA) has been considering making a change to remove this limitation and allow generic drug manufacturers to issue warnings. This could also mean these entities might face liability if those warnings are later shown to be inadequate.

However, according to the Wall Street Journal, the FDA ultimately decided to delay its new final rule addressing the issue. medication pills.jpg

A Boston dangerous drug lawyer knows consumers deserve to understand the risk they assume when they take any medication. Drug warning labels should provide comprehensive data on potential side effects that could present a risk to patient health. Additionally, there needs to be accountability when drugs cause dangerous side effects.
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A plaintiff attorney’s failure to register for the multi-district litigation’s case management/electronic case file system resulted in the dismissal of the plaintiff’s case against the makers of menopause drug Prempro. The decision was recently upheld by the U.S. Court of Appeals for the Eighth Circuit in Freeman v. Wyeth, et al..
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The disappointing conclusion is why our product liability attorneys in Massachusetts always stress these types of cases require a legal team with experience and proven success. We are experienced with multi-district litigation involving pharmaceutical firms, and remain committed to excellent representation of our clients’ interests from beginning to end.

In the Freeman case, the plaintiff filed her lawsuit in early 2009 against Wyeth Pharmaceuticals Inc. She alleged she developed breast cancer after using a drug called Prempro, which is used to treat certain symptoms of menopause.
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A pain medication known as Darvocet has been on the market since 1972, when it first received approval from the U.S. Food & Drug Administration. Less than six years later, the medical community acknowledged a link between the drug (a combination of propoxyphene and acetaminophen) and heart trouble. The concerns were serious enough that the United Kingdom pulled it from shelves.
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Here in the U.S., however, the FDA simply required the new drug application holder change the labels to include a “Black Box Warning.” It also required the drug manufacturer to undertake a clinical trial to assess the connection between the medication and certain heart complications. Generic drug manufacturers continued to produce the drug, too. It wasn’t until 2010 the agency finally determined the risks of the drug outweighed the benefits and pulled it from shelves.

Since then, there have been a number of lawsuits filed against the makers of Darvocet. Our Boston defective product attorneys know some of these cases have floundered because they have been brought against generic drug manufacturers.
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When a patent expires on a medication, drug companies can produce generic versions of the drug to sell to the public. Unfortunately, this can create significant legal complications. In 2011, a court decision established that generic drugmakers cannot make changes to product labels even if the drugmaker is alerted to side effects. The label can be changed only if the brand-name drug manufacturer alters it to warn the public of the risks. As a result, generic drug manufacturers shouldn’t be held legally responsible for failure to warn patients about the risks of a medication. perscription-drugs-2-1160103-m.jpg

An experienced Boston dangerous drugs lawyer knows failure to warn is normally legal grounds for a defective product lawsuit when a drug turns out to be dangerous. However, since the generic drugmaker cannot be sued, the question becomes: who can the patient hold liable? The answer, it turns out, may be the manufacturer of the original brand name drug.
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Payne v. Novartis, an appeal argued before the United States Court of Appeals for the Sixth Circuit, involved a woman and her husband who sued Novartis, a drug manufacturer, for failing to warn her that its drugs could cause serious damage to her jaw. Those two drugs were Aredia and Zometa.

pills4.jpgAs your Boston pharmaceutical negligence lawyer can explain, Aredia and Zometa are in a class of biophosphate drugs given to patients with cancer to prevent pathological fractures and bone pain. The drugs are administered intravenously. During the early 2000s, members of the medical community discovered a connection between taking biophosphates and developing a serious medical condition known as osteonecrosis of the jaw (ONJ).

ONJ is a condition that causes the gums to be eaten away until the bone is exposed. The gums and the bone then die. This is an extremely painful condition that resulted in doctors having to remove part of the patient’s jaw.
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According to recent article, the makers of Nuvaring are warning Canadian patients that this form of birth control may not be safe for many women. According to the drug company, women who smoke and are over 35-years-old or have had at least one serious heath condition, including blood clotting issues, high blood pressure, or diabetes, could be at a risk for serious illness if they use the Nuvaring as a form of birth control.

medical-instruments-3-1033916-m.jpgThe Nuvaring is a ring that is inserted into the vagina that continuously releases hormones to prevent pregnancy. This drug has been shown to have serious side effects, including increased risk of heart disease, strokes and dangerous blood clots. According to the manufacturer, it is now known that the drug can lead to other serious side effects, including painful joints, blisters, hearing loss, swelling, and intestine problems.

As your Boston dangerous drug lawyers can explain, one of the most serious side effects is blood-clotting issues. Blood clots can form in the veins of the legs in a condition known as deep vein thrombosis. These clots can then break free from the leg veins and travel through the blood system into the heart and lungs. When a clot enters the lungs, it is known as a pulmonary embolism, or PE. A PE is often fatal for the patient.
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Our Boston defective product attorneys know that handling these types of cases requires very close attention to detail and a thorough understanding of ever-evolving law related to these actions.

gavel7.jpgIn Johnson v. Teva Pharmaceuticals USA, Inc. et al, the plaintiff alleged that metoclopramide, the generic name for Relgan, caused her to develop the neurologic condition known as tardive dyskinesia.
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