Legal Issues

Johnson & Johnson unit sued over Norian SRS death

Johnson & Johnson’s Synthes unit, a maker of tools and implants to treat damaged bones, has been sued by the family of a woman who died during an unapproved trial of a bone cement, Bloomberg reports.

It’s an ironic development for Johnson & Johnson, which recently purchased Synthes for $19.7 billion, largely in the hopes it would help offset revenue losses related to a series of recalls and legal problems over ...

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Lopez McHugh attorney takes on pharmaceutical giant

The Pennsylvania Record reports that attorney Michael Katz of Lopez McHugh has filed a product liability claim against GlaxoSmithKline, on behalf of a New York woman who alleges the pharmaceutical company’s anti-Lyme Disease vaccine harmed her.

Katz filed the civil action July 9 at Philadelphia’s Common Pleas Court, also naming Smithkline Beecham Corp. and various subsidiaries as defendants.

The complaint alleges that the plaintiff’s problems originated with a series of LYMErix vaccinations ...

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Antidepressant makers commit ethical breaches

An entry on the blog The Poptort.com mentions a civil complaint by the U.S. attorney’s office in Boston against drug maker Forest Laboratories, alleging the company defrauded the government out of millions of dollars by illegally marketing Celexa and Lexapro, two versions of the anti-depressant, “citalopram,” for unapproved uses in children and adolescents.

Doctors are allowed to prescribe drugs for uses not approved by the FDA, but it’s illegal for companies ...

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Former FDA official says agency hid evidence of Stevens-Johnson Syndrome

In an interview with Truthout, a U.S. Food and Drug Administration drug reviewer described an atmosphere in which professionals tasked with evaluating the safety of drugs are pressured to look the other way when they see a problem. Failing to do so, he said, often brings about official retaliation from the agency.

Ronald Kavanagh B.S.Pharm., Pharm.D, Ph.D., is quoted as saying: “FDA’s response to most expected risks is to deny them and wait until there is irrefutable evidence postmarketing, and then ...

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GSK settlement has lessons for consumers

According to a Consumer Reports blog entry, the recent historic $3 billion settlement against pharmaceutical giant GlaxoSmithKline carries some important lessons for consumers.

Prescribing a drug “off-label,” or for a purpose different from the use specified in its U.S. Food and Drug Administration approval, is legal. But promoting a drug for off-label use is not.

And apparently GSK did exactly that, through tactics that included misrepresenting research data to show benefits and ...

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Researcher on fracking study has industry ties

According to a Scientific American story, the lead researcher on a study that found no connection between the hydraulic fracturing method of natural gas extraction and groundwater contamination turned out to have significant financial ties to the natural gas industry.

The article says that the study out of the University of Texas last February had drawn criticism for being too easy on the natural gas industry.

Hydraulic fracturing, commonly known as ...

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