Current Events

A sweeping internal investigation of General Motors released on Thursday condemned the company for its decade-long failure to fix a deadly safety defect, one that led to “devastating consequences,” including at least 13 deaths.

The report, written by the former United States attorney Anton R. Valukas, set off the dismissal of 15 G.M. employees, including a vice president for regulatory affairs and a senior lawyer responsible for product liability cases, and forced broad changes in how the company handles vehicle safety.

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General Motors on Thursday will release the results of its three-month internal investigation into the events leading up to this year’s recall of 2.6 million small cars with defective ignition switches.

The inquiry, conducted by Anton R. Valukas, a former United States attorney, is expected to name the people and departments within G.M. that he believes were responsible for the long delay leading up to the recall. Mr. Valukas may also recommend personnel changes or other corporate measures.

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California’s portion of the settlement, the largest of any state, is $7.1 million, Kamala Harris, the state’s attorney general, said in a statement.

GlaxoSmithKline Plc (GSK), the U.K.’s largest drugmaker, will pay $105 million to settle claims by California, New York and more than 40 other states that it illegally promoted asthma and antidepressant drugs.

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Leann Darrow has been waiting on her General Motors dealership for more than a month to get the defective ignition switch on her 2005 Chevrolet Cobalt replaced. She's been nervous about driving the car, but as of Monday, she was still waiting for an appointment to open.

"They told me they have over 150 vehicles on the waiting list and have received only five ignition switches," said Darrow, 53, of Pittsfield, Mass. "They were unable to tell me where I am on the waiting list ... unbelievable."

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Pfizer Inc. (PFE) agreed to pay $325 million to settle a lawsuit brought by health-care benefit providers who claimed the drugmaker marketed the epilepsy drug Neurontin for unapproved uses.

The settlement, which needs approval from a federal judge in Boston, would end a case over claims that the company’s Parke-Davis unit schemed to market the drug for unapproved conditions as early as 1994.

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Chicago, the third-biggest U.S. city, sued Johnson & Johnson (JNJ) and four other drug companies for allegedly pushing consumer use of opioid painkillers, creating addicts and driving up its costs.

“Since 2007, the city has paid for nearly 400,000 claims for opioid prescription fills, costing nearly $9,500,000, and suffered additional damages for the costs of providing and using opiates long-term to treat chronic non-cancer pain,” lawyers for the municipality alleged in a state court complaint filed yesterday in Chicago.

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The Food and Drug Administration has publicly released a huge amount of data on drug side effects that it hopes will lead to new applications and research.

Under its open FDA project, the agency has released more than 3 million reports on adverse drug events and medication errors recorded between 2004 and 2013. These kinds of reports were only available before through lengthy Freedom of Information Act requests.

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Medtronic Inc. (MDT), one of the world’s largest medical-device makers, was sued by Humana Inc. for allegedly marketing its Infuse bone-graft product for uses that weren’t approved by regulators and duping the insurer into covering those claims.

Medtronic paid doctors hundreds of millions of dollars to tout the safety and effectiveness of the Infuse product for a variety of spinal surgeries even though the U.S. Food and Drug Administration had limited its use to lower-back procedures, Humana said in a complaint filed May 30 in federal court in Tennessee.

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The Food and Drug Administration has finalized a guidance (PDF) that will help drug and biologics manufacturers bring products that treat unmet needs to the market faster than the usual approval pathways currently make possible.

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The Food and Drug Administration made good Thursday on a vow to heighten its oversight of sunlamps used in tanning salons, saying additional warnings are needed to educate consumers about the cancer risks involved.

The agency is reclassifying the devices from “low risk” to “moderate risk,” a designation that will require manufacturers to demonstrate to regulators that their products meet certain standards before they are allowed to market them.

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A Fresenius solution used in hemodialysis machines has been recalled because of concerns over bacteria contamination following a patient death.

The U.S. Food and Drug Administration issued a notice this week of the recall, saying it had received one report of death and two reports of injury that may be related to use of Fresenius NaturaLyte Liquid Bicarbonarte Concentrate. Lab testing identified Halmonas, a bacteria typically found in water with high salt concentration, in the product during its shelf life, the FDA said.

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