Drug and Medical Device Lawsuits

Blog: $1.2b J&J fine for Risperdal deceptive marketing likely to cause further problems

A post on stock market information Website Seeking Alpha says Johnson & Johnson will likely deal with significant public backlash going forward. An Arkansas jury recently concluded that the company used deceptive tactics to market antipsychotic drug Risperdal, which included hiding or minimizing the drug’s risks. A judge then issued a $1.2 billion fine.

The post says the fine leveled against Johnson and Johnson and subsidiary Janssen Pharmaceuticals is the largest ...

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FDA defends medical device approval process

An internal document from the U.S. Food and Drug Administration defends the agency’s rejection of European standards for approving medical devices, according to a report in the Minneapolis-St. Paul Star Tribune.

The FDA document amounts to the agency’s defense of its own practices, and describes 12 classes of allegedly “unsafe and ineffective” high-risk medical devices approved for sale in Europe but not the United States.

According to the Star Tribune, the United ...

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Surgeons association concerned about hip implants

The American Society of Orthopaedic Surgeons held an expert roundtable on the subject of metal-on-metal hips at the organization’s annual meeting in San Francisco, which took place in February.

The devices, which feature both a ball and socket coated in metal, have generated thousands of lawsuits nationally over both their high early failure rate, and their tendency to produce toxic metal ...

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Doctor: No advantage to dangerous implant

In testimony before the U.S. Food and Drug Administration, Dr. Michael Carome called for a ban on all vaginal mesh products, on the grounds that they have no advantages over other forms of treatment, yet cause a host of severe health problems.

Mesh implants are used to treat urinary incontinence and pelvic organ prolapse – a condition that results when weakened muscles provide inadequate support for internal ...

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J&J reports profit increase, despite troubles

Johnson & Johnson reports that its first-quarter profits increased by 12.5 percent, Bloomberg reports. That increase came despite the company’s problems with nearly 30 recalls for a number of nonprescription and prescription medicines, as well as medical devices.

That 12.5-percent increase came about primarily because of lower spending on research, sales and administration and a boost from selling rights to a drug, the report said.

According to the report, Johnson & ...

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Op-ed says more accountability needed for drug approvals

A recent opinion piece in the New York Times calls for more public access to the clinical data that government agencies such as the U.S. Food and Drug Administration use for making policy about medications.

Authors Peter Doshi and Tom Jefferson write that drug or medical device manufacturers are required only to share their data with regulators, who treat the data as secret, and not with independent researchers or academics.

That ...

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