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Los Angeles Defective Drugs Law Blog

FDA Works With China To Strengthen Its Regulatory System

Last week, the FDA's Christopher Hickey wrote about efforts to ensure medical-product safety when it comes to imported medical products from China. Hickey is the FDA's country director for the People's Republic of China. It's his job to make sure that medical devices and related products made in China and imported into the U.S. meet our standards for quality and safety.

The risks are somewhat obvious.

Glaxo, other large pharmaceuticals, continue to commit fraud

Forbes recently published an interesting article titled "Is Big Pharma Addicted To Fraud?" Author Erika Kelton discussed the fraudulent ways pharmaceutical companies, such as GlaxoSmithKline, sell their products, including using bribery, falsified research and illegal marketing tactics.

Glaxo, a pharmaceutical company that manufactures a number of drugs, including type 2 diabetes drug Avandia, has been accused of fraud on numerous occasions by multiple governments. Most recently, Chinese authorities investigated the company for allegedly using a Shanghai travel agency to funnel bribes. The company has also been under scrutiny for:

  • Improperly conducting research at its Shanghai development center
  • Marketing prescription drugs for unapproved treatments
  • Providing kickbacks to companies and individuals who promote Glaxo's sales

Avandia lawsuit settled for $229 million

Last year, GlaxoSmithKline settled an Avandia lawsuit brought by the majority of U.S. states. The states alleged that Glaxo was guilty of healthcare fraud because it marketed products for uses unapproved by the U.S. Food and Drug Administration and failed to provide adequate safety data to the FDA regarding Avandia. Glaxo accepted criminal responsibility and settled for $3 billion.

Eight states, however, refused to sign off on the settlement agreement. Those states recently settled their Avandia lawsuit with GlaxoSmithKline for $229 million. Unfortunately, like the earlier settlement, Glaxo has been able to avoid admitting liability for its actions that have harmed thousands of individuals.

India bans Actos. Should the U.S. follow suit?

Last month, India made a safety move that has many people applauding and others asking "why?": It banned Takeda Pharmaceuticals' popular diabetes drug Actos as well as two other drugs, Analgin and Deanixt. Actos will be banned until "clinical data proves it has no risks," according to India Today.

India isn't the first country to ban the sale of Actos; France has also banned the drug after multiple studies linked it to an increased risk of bladder cancer. Unfortunately, the dangerous drug continues to be prescribed as an off-patent drug in the U.S. The FDA's main action against Takeda was to require the company to include a bladder cancer warning on the drug's label.

Mirena lawsuits: Ectopic pregnancy

A New York woman has brought a lawsuit against Bayer Pharmaceuticals, alleging that its Mirena intrauterine device (IUD) caused her ectopic pregnancy. The woman asked her doctor to implant the IUD in 2009. In 2011, she discovered that the IUD had migrated away from her uterus and toward the colon. Furthermore, the woman had become pregnant, and the fetus was developing outside of her uterus.

Surgeons had to remove the woman's IUD, ovary, fallopian tube and the fetus. The plaintiff now has permanent damage and faces thousands of dollars in medical bills.

She is not alone. Mirena has been shown to cause increased risk of ectopic pregnancy when compared with women taking other forms of birth control. Ectopic pregnancy occurs when the egg implants in the fallopian tube, cervix, ovaries or abdomen. Most ectopic pregnancies cause miscarriages and can lead to dangerous hemorrhaging.

Supreme Court: Generic drug manufacturers not liable for drug defects

At the end of June, the U.S. Supreme Court issued an opinion on an important case regarding whether injured patients can bring defective drug lawsuits against generic drug makers. In a 5-4 decision, the Court ruled in favor of the generic drug makers, holding that they are not liable for defective designs since they are not in control of those designs.

Under federal law, generic drug manufacturers are required to make exact copies of brand name drugs. Therefore, the Court held, Mutual Pharmaceutical Company could not be held responsible for unsafe drug claims involving its generic version of the brand-name drug Clinoril, a pain medication. The Court's ruling overturned a New Hampshire jury decision, which had awarded a woman $21 million for a debilitating skin disease she suffered from taking the pain medication.

FDA denies drug approval of cancer treatment from AVEO

As many of our readers know, the Food and Drug Administration is strict when it comes to approving drugs for the consumer market.  This mostly has a lot to do with the fact that the FDA risks liability when it approves a drug that turns out to be unsafe for consumers.  Despite recent pressure to release new cancer treatment drugs, the FDA announced this month that it would not be approving the new drug from AVEO because of inconclusive data surrounding a recent drug study.

In the letter from the FDA to AVEO Oncology, the government agency explained its decision based on an inability to interpret the results from the study.  The FDA stated that the data was inconsistent when it came to progression-free survival and overall survival amongst participants.  There was also an imbalance in post-study treatments which made risk assessment almost impossible.

FDA takes second look at diabetes drug to determine side effects

In 1999, the Food and Drug Administration approved the diabetes drug Avandia for the market. It was supposed to be better than similar treatments by increasing the body's sensitivity to its own insulin. Sales boomed and it quickly became the world's biggest-selling treatment for type 2 diabetes. In 2006 alone, GlaxoSmithKline Plc, the drugs manufacturer, grossed $3.2 billion in sales.

But when European regulators withdrew the drug from European markets because of concerns surrounding heart attacks and stroke, the FDA quickly looked into claims that the drug could have considerably serious side effects. It heavily restricted the use of Avandia which eventually led to a decline in sales and a rise in the number of lawsuits against the pharmaceutical company.

FDA pushing for tougher regulations on tanning beds

The Food and Drug Administration along with other agencies across the United States have been warning the public about the risk of skin cancer from UVA and UVB exposure for quite some time now. Studies abound have proven that repeated exposure to high levels of these rays can damage the skin, causing serious side effects as a result. These warnings are especially true for tanning beds which have come under some scrutiny in the last few years for increasing the number of skin cancer cases in the U.S.

Considered to be a low risk medical device, tanning beds can be found in just about every city in the nation, including thousands just here in California alone. And while the FDA does have certain safety regulations for these devices, the agency is now say that they may not be enough to keep people safe from harm.

Recall underway for drug after particulates found at manufacturer

Novartis, the second-largest generic pharmaceutical company, has found its way into the media again this month after a subsidiary manufacturer, Sandoz, discovered what appeared to be particulates in some of its batches of Methotrexate Sodium. While the manufacturer does not believe these particles to be microbial contaminants, they do feel that they could be a health hazard and have issued a voluntary nationwide recall as a result.

This isn't the first time that California residents have been alerted to contamination incidences such as this. Readers of our blog know them all too well and are familiar with Novartis' history of potential negligence.

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