Articles Posted in dangerous drugs

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A recent case from the Supreme Court of New Jersey involved a products liability action filed against the major pharmaceutical maker that is now known as Roche in connection with its Accutane drug.  Accutane is the brand name for the drug isotretinoin. The drug was originally developed by Hoffmann-La Roche labs and was used to treat a severe skin condition known as nodular acne.  It was also used in some cases to treat a form of skin cancer.

pillsWhile the drug was effective at treating acne, it had some serious side effects associated with it.  In some cases, it would lead to severe birth defects.  For this reason, women taking the drug had to be counseled against becoming pregnant while taking it, and also needed to either abstain from sex entirely or use what were considered effective contraceptives.  Condoms were not considered sufficient when not used in conjunction with another method of birth control.  For this reason, Accutane is considered a teratogen, meaning it can cause birth defects. Continue reading

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The U.S. Food and Drug Administration is a federal regulator without a key regulatory power: Recall. blindinglight

That’s why when investigators with the agency confirmed there were high levels of a potentially lethal toxin in toddler teething tablets, there was really nothing they could do other than announce it. The manufacturer of the tablets refused to issue a recall, and the FDA was powerless to force them to do so.

This could soon change. At least, that is the hope of lawmakers supporting the Recall Unsafe Drugs Act. This measure, H.R. 1108, would give the FDA the authority to order mandatory recalls on dangerous drugs and homeopathic products. The measure would revise the current law for the FDA to be allowed to issue mandatory recalls for products it does not directly regulate. The proposed law would also give the agency the power to issue mandatory recalls of pharmaceuticals that have been shown to cause serious health consequences and/or death.  Continue reading

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Two drug companies have been ordered to pay $67 million over false claims made regarding the efficacy of cancer drug Tarceva, the U.S. Justice Department announced.whitepills

The drug is approved for some patients who suffer from non-small cell lung cancer or pancreatic cancer. However, OSI Pharmaceuticals LLC and Genetech Inc. reportedly misled consumers about how effective the drug was in treating non-small cell lung cancer.

This settlement was reached after allegations that between January 2006 and December 2011, the two drug makers promised the product would be effective for non-small cell lung cancer patients. What they failed to disclose was that research had shown it only worked if the patients hadn’t ever smoked or had any sort of mutation in their epidermal growth factor receptor. The latter is a protein that has been traced to the spread of cancerous cells. Continue reading

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Trial is underway in one of the first lawsuits heard by a jury regarding drug manufacturer Johnson & Johnson’s subsidiary Synthes Inc. using a type of bone cement absent FDA approval on the spines of patients who later died in surgery, just moments after they were injected with the compound.spine

The wrongful death lawsuit, filed in a Washington state court, focuses on the intentional off-label use of the bone cement which was known to be risky. What should have been a routine procedure to treat back pain for a 67-year-old patient in 2007 ended up killing her. Patient’s family sued Synthes, the surgeon and the hospital for use of the bone cement, known as Norian, even though it wasn’t approved for use in back pain surgery.

Many are closely watching the development of this case, making it high-stakes not just for the parties involved but for future plaintiffs as well. It’s being covered by Courtroom View Network (CVN). Plaintiffs allege the manufacturer marketed Norian for use in spinal surgeries, despite a company physician characterizing such use as akin to “human experimentation.”  Continue reading

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When the U.S. Supreme Court in 2011 handed down its decision in Pliva v. Mensing, it essentially left a large group of people – those who use generic prescription drugs – without any recourse if those drugs proved dangerous or defective.

Pills pouring from a medication bottle

Generally, it’s been held that makers of brand name drugs can’t be liable for generic drugs because they don’t actually make them. The Pliva decision made it so that generic drug makers can’t be liable for failure to warn (a key in any defective drug case) because by federal law, generic drug makers don’t write the labels. The labels are written by the brand name manufacturers and then approved by the U.S. Food & Drug Administration.

All this makes it interesting that the California Supreme Court will be taking on the issue of “innovator liability,” also known as brand manufacturer liability for generics in the case of T.H. v. Novartis Pharm. Corp. You see, California is one of the few states where courts have held that brand name manufacturers could in fact be liable for dangerous generic drugs. That ruling was handed down in Conte v. Wyeth, in which a California appeals court determined the brand name maker of a drug called Reglan, used to treat gastroesophageal reflux disease, could be found liable for injury caused by the generic version. The California Supreme Court declined to review that decision, so it’s been generally accepted in that state.  Continue reading

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Yates v. Ortho-McNeil-Janssen Pharma., Inc, a case from the United States Court of Appeals for the Sixth Circuit, involves a plaintiff who began going to her OB/GYN when she was 17 years old in 2004. She first went to the doctor because she was sexually active and was experiencing menstrual cramps.

untitled-1238929-mHer doctor spoke with her about her choices for contraceptives and discussed the risks associated with each of the options.   One of the choices for birth control was ORTHO EVRA and another was Depo-Provera. The doctor testified that she customarily warned all patients about the risks of taking birth control before writing a prescription. Continue reading

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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

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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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