FDA Recalls Alere INRatio and INRatio2 Monitor Systems

Yet another recall has been made on the heels of serious and traumatic device malfunctions- nearly 19,000 reports, to be exact. The recall for Alere INRatio and INRatio2 by the Food and Drug Administration has been upgraded to a Class I recall, meaning use of the product could cause serious or adverse health consequences and even death.

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S&P pays $77 Million to Settle Charges: “Quis Custodiet Ipsos Custodes?”

This question, attributed to the 1st Century Roman satirist Juvenal, originally referred to enforcing marital fidelity and controlling a wife's behavior. Over the centuries however, it has more frequently been asked by citizens in regards to those who exercise power and judgment over them.

Case in point – credit rating agencies.

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Xolair : The Potential Cancer Connection and Rise of Lawsuits

By now, the adverse effects of the asthma medication Xolair® have been well-reported by sources including WebMD, Lung Disease News and the Food and Drug Administration. Most serious among these complications are chest pain, heart attacks, “mini-strokes,” blood clots, brain issues and a severe, life-threatening allergic reaction known as anaphylaxis. There is even some evidence that it may increase the risk of cancer - which may have to do with its mechanism of action, or how the medication works in the body.

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BP OIL SPILL ALERT - BP’s Appeal Rejected by the Supreme Court

On Monday, December 8, 2014, the Supreme Court of the United States rejected an appeal filed by BP. The company must now honor the settlement agreement it negotiated and pay claims.

This Order finalizes the settlement agreement and holds BP accountable, ensuring compensation to businesses and individuals who were victims of the 2010 Deepwater Horizon Oil Spill. There is no cap on the settlement and all claims that fit the settlement program’s criteria will be paid.

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Stryker Hip Lawsuit Settlement – Time Is Running Out

The big news for 4,000 Stryker hip lawsuit plaintiffs is that a settlement was reached in November 2014. The company has agreed to set aside an initial $1 billion in order to pay compensation to patients who experienced medical problems due to the failure of their Stryker Rejuvenate or ABG II Modular hip replacements.

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Shakeup At Takata Resulting from Airbag Lawsuits

In the wake of injury lawsuits and a federal criminal investigation over exploding air bag inflators, management at manufacturer Takata is undergoing a major restructuring. The current company president, Stefan Stocker, announced that he is abdicating in favor of chairman Shigehisa Takada.  Additionally, Stocker, Takada and at least three other high-ranking executives will see their paychecks shrinking by as much as half as client automakers cancel orders and legal troubles continue to mount.

So far, the recall of its airbags has cost Takata $400 million.

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DuPont Can’t Back Out of Agreement to Compensate Those Injured by DuPont’s Chemical Used in Teflon

Éleuthère Irénée du Pont de Nemours started out as the sole manufacturer of gunpowder and explosives to the Crown in late 18th-Century France, the son of minor nobility. Their connection to royalty did not serve the DuPont family well in the wake of the French Revolution. Fleeing to the United States in 1799, DuPont established a new company. Over the next two centuries, Éleuthère's descendants and the company he founded have achieved levels of wealth, power and influence that his father (personal physician to King Louis XV's mistress, Madame de Pompadour) could not have imagined.

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Supreme Court Denies BP's Bid to Undo Settlement

A decision by the United States Supreme Court saw through all the BP smoke and mirrors, denying the oil company’s petition for review, and leaving intact a landmark settlement for the people and businesses of the Gulf Coast, arising out of the disastrous 2010 spill.

If anyone had any doubt about what BP intended, you only need to look at one exchange between attorney Mike Juneau, on behalf of the Claims Administrator, and BP:

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Xolair Approval - Not So Fast, Say British Health Authorities

Earlier this year, the U.S. Food and Drug Administration, medical authorities in the E.U. and Health Canada approved the controversial asthma drug, Xolair, for the treatment of hives, or urticara, a painful skin condition marked by pink, itchy rashes. This drug has been implicated in an increased risk of suffocation from anaphylaxis (a blockage of the air passage caused by throat swelling among other side effects). Drug makers Genentech and Novartis are finding that approval for this purpose in Great Britain is not quite as easy, however.

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Testosterone and Increased Risk of Heart Attacks: Contradictory Evidence?

In November of 2013, a research study, carried out at a Veteran's Administration facility, appeared in the Journal of the American Medical Association. The conclusion:

“Among a cohort of men in the VA health care system who underwent coronary angiography and had a low serum testosterone level, the use of testosterone therapy was associated with increased risk of adverse outcomes” (Vigen, et. al.)

In other words, the use of supplemental testosterone appeared to be connected with heart attacks among the research subjects.

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Morcellator Uterine Cancer -- When a Hysterectomy Turns Deadly

Under normal circumstances, a hysterectomy – the surgical removal of a woman's uterus – is a fairly routine procedure. Though it is major surgery that entails a certain amount of risk and requires a convalescent period of up to five days, complications are relatively rare.

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While Rome Burns . . . FDA Fails to Respond to Morcellators and Uterine Cancer

According to legend, the half-mad Emperor Nero played his fiddle while the Eternal City was being consumed by flames. This story has little basis in historical fact (first, Nero actually did take some action to contain the fires raging in the city, and secondly, the fiddle wasn't invented until some 10 centuries later), but it serves as an apt metaphor for modern America – particularly when it comes to medical products that are causing injury and death and a corrupt government so beholden to corporate interests that it fails to regulate in any meaningful way.

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