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Federal officials crack down on Phillips’ Colon Health for making unsupported claims

American justice series

Bayer’s dietary supplement Phillips’ Colon Health is making unsupported claims that it can prevent diarrhea, constipation, gas and bloating but the company does not have reliable scientific evidence to support those claims, according to the Department of Justice. Federal officials took aim at Bayer in a motion filed last week, referencing the company’s multimillion dollar marketing campaigns using both print and television advertisements featuring “the Colon Lady,” who asks people about their colon health. As a result, consumers have spent hundreds of millions of dollars on Phillips’ Colon Health, the motion claims. The government’s crackdown on Bayer stems from a ... Read More

NHTSA’s failure to address GM ignition switch problem detailed in Congressional report

GM recall

Federal auto safety regulators fell under scathing criticism again this week following the release of a House committee report that underscored their failures in policing General Motors (GM) while consumer complaints about defects and accident reports piled up in the National Highway Traffic Safety Administration’s (NHTSA) database. “The agency’s repeated failure to identify, let alone explore, the potential defect theory related to the ignition switch — even after it was spelled out in a report the agency commissioned — is inexcusable,” the House Energy and Commerce Committee concluded in its report. The report blames NHTSA for failing to notice a ... Read More

Lawsuit filed against Pfizer related to testosterone replacement drug

Depo testosterone

Pfizer’s testosterone replacement treatment Depo-Testosterone has become the subject of lawsuits questioning the safety and efficacy of the drugs after reports of heart attacks, strokes and blood clots in patients treated with the hormone. The lawsuit filed on behalf of Alvaro Roman Gutierrez alleges that Pfizer and its unit Pharmacia & Upjohn Co. LLC, conducted a “disease mongering” campaign to exaggerate the problem of low testosterone levels in men in order to boost sales of Depo-Testosterone. Gutierrez claims that Pfizer and Pharmacia & Upjohn spent millions of dollars to promote its drug to consumers and, along with other drug companies not ... Read More

Whistleblower lawsuits accusing Merck of mumps vaccine deceptions will proceed to court, judge decides

whistleblower

Two lawsuits accusing Merck & Co. of lying about the efficacy of its mumps vaccines to keep competitors from introducing similar vaccines to the market will be proceed to trial after a federal judge in Pennsylvania refused to dismiss the suits. U.S. District Judge C. Darnell Jones II ruled that one of the lawsuits, filed by a pair of whistleblowers who worked as virologists for Merck, provided enough evidence that the pharmaceutical giant lied about the vaccine’s efficacy to the federal government. The judge also ruled that the other lawsuit, filed by a group of physicians and direct buyers, could ... Read More

Pfizer skirts patent lawsuit but Lipitor diabetes lawsuits continue to mount

lipitor

A U.S. District judge has dismissed an antitrust lawsuit accusing drug makers Pfizer and Ranbaxy Laboratories of conspiring to delay sales of generic versions of their best selling cholesterol-lowering statin drug Lipitor. Judge Peter Sheridan said that the plaintiffs, retailers and distribution companies that bought Lipitor from Pfizer did not provide enough details to convince him that Pfizer and Ranbaxy had violated patent agreements. The lawsuit stems from a 2008 settlement of a patent settlement reached between Pfizer and Ranbaxy regarding Ranbaxy’s plan to make generic versions of Lipitor. Under that agreement, Pfizer agreed to drop damage claims against Ranbaxy, ... Read More

Former NECC pharmacist arrested on criminal charges stemming from fungal meningitis outbreak

syringe

A man was arrested last week as part of an ongoing investigation into the deadly fungal meningitis outbreak linked to a Massachusetts compounding pharmacy by the Justice Department’s Civil Division and U.S. Attorney’s Office for the District of Massachusetts. Glenn Adam Chin was attempting to board a plane to Hong Kong when federal authorities arrested him on one count of mail fraud. According to the Department of Justice, the maximum sentence under the statute is 20 years in prison followed by three years of supervised release and a $250,000 fine. The U.S. Attorney’s Office and the Civil Division’s Consumer Protection ... Read More

Whistleblower lawsuit targets medical companies, professionals for unnecessary spinal surgeries

osha whistle

The U.S. government has intervened in a whistleblower’s False Claims Act lawsuit against a Michigan neurosurgeon, a spinal implant company, two distributors, and the companies’ owners, alleging that the defendants conspired to perform medically unnecessary and excessive surgeries on patients for profit. The Justice Department also said that in addition to taking over the whistleblower lawsuit, it has filed a separate complaint against the same defendants for engaging in an illegal kickback scheme that put profits above patients’ needs. The whistleblower lawsuit was filed under the qui tam provisions of the False Claims Act by Dr. Caty Savitch and Dr. ... Read More

Judge allows whistleblower’s False Claims Act lawsuit against Novartis to move forward

osha whistle

A New York federal judge has rejected Novartis Pharmaceutical Corp.’s bid to dismiss a whistleblower lawsuit alleging the company engaged in illegal kickback schemes involving two of its drugs, which resulted in false claims to Medicare and 27 state Medicaid programs. The lawsuit, filed under seal by whistleblower David Kester in 2011, was amended by the U.S. government in January, about nine months after it chose to intervene and take over the case as the U.S. False Claims Act allows it to do. Mr. Kester worked for seven years as an account manager for Novartis, a position that required him ... Read More

Researchers raise safety concerns about nanoparticles in sunscreens, baby power

powder 3

Nanoparticles, or the tiny bits of particles produced when a mineral is broken down into smaller and smaller bits, have been present for years in consumer products from baby powder to sunscreens, however they may ultimately do more harm than good. For an example, chemistry professor Jerry Harris with Northwest Nazarene University refers to asbestos, a mineral that became widely used in the United States in the 20th century as insulation because it was affordable and was efficient at absorbing sound when milled down. However, decades later it was discovered that inhaling nanoparticles of asbestos could cause lung cancer, mesothelioma, ... Read More

North Carolina church bus crash victims sue tire maker over alleged tire defect, blowout

North Carolina church bus crash - WBIR image

Survivors of a North Carolina church bus crash joined family members of those killed in a lawsuit against the manufacturer of the tire that is alleged to have caused the crash and the estate of the bus driver, who was also killed. The lawsuit, filed last week in Iredell County Superior Court, alleges that Hankook Tire Co., which made the front left tire that blew out and caused the driver to lose control, is to blame because it “knew or should have known … that the subject tire’s design and/or manufacture resulted in a defective product which exposed vehicle occupants ... Read More