Current Events

As the number of medical-device recalls has rapidly increased, so has the complexity of the recalls. That is raising questions about safety and risks for hospitals that mostly still track and locate faulty products manually.

There were 1,190 recalls of medical devices in 2012, nearly double the 604 recalls reported to the Food and Drug Administration in 2003.

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The settlement between the hospital where Thomas Eric Duncan received treatment for the deadly Ebola virus and his surviving relatives remains confidential. Yet, the settlement illustrates some of the legal limitations of the state’s tort reform law.

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DETROIT — General Motors pressured a supplier to continue producing a substandard ignition switch a decade ago and leaned on the company to improve it even though it could not be fixed, a newly disclosed email shows.

The switch, made by Delphi, has become the focus of a safety crisis at G.M. and is linked to at least 33 deaths and dozens of injuries.

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Honda Motor Co. (7267) said it failed to report more than 1,700 claims of injury or death involving its cars to U.S. regulators, a violation that would be one of the biggest in history and could lead to a fine of $35 million.

In a synopsis of an internal review filed with the National Highway Traffic Safety Administration, Honda yesterday blamed the underreporting on “inadvertent data entry or computer programming errors” that spanned 11 years. NHTSA hasn’t made the audit documents public yet as it continues an investigation.

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Sun Pharmaceutical Industries Ltd. has recalled 68,000 bottles of the antidepressant Effexor (venlafaxine), in the second recall of the drug this year, the Food and Drug Administration (FDA) said.

In both instances, the recalled drug was manufactured at the Indian generic drug maker’s plant in Halol in the state of Gujarat. The drugs were recalled after they failed to dissolve properly in quality tests, the Wall Street Journal reports. The earlier recall, in June, was for 252,000 bottles of Effexor.

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The Food and Drug Administration strengthened its warnings Monday against the use of a controversial uterine surgical technique, recommending that doctors avoid using laparoscopic power morcellators to remove uterine growths in the vast majority of women because of the risk of spreading hidden cancers.

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When it was learned this year that General Motors had long failed to notify regulators and the public about fatal ignition-switch defects, the outrage in Congress was bipartisan. Recent reports in The New York Times that the Japanese manufacturer Takata hid deadly airbag defects are also sure to inspire rebukes from members of both parties. Takata has rebutted the reports, but lawmakers have appropriately scheduled a hearing for Thursday and called for a criminal inquiry by the Justice Department.

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Washington - As Americans shop in the health insurance marketplace for a second year, President Obama is depending more than ever on the insurance companies that five years ago he accused of padding profits and canceling coverage for sick.

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The attorney general of Arizona said on Wednesday that the state has filed suit against General Motors, claiming that that automaker had defrauded the state's consumers of an estimated $3 billion.

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Pharmaceutical companies, medical device makers and academic medical centers would no longer be able to withhold the results of clinical trials under rules proposed by the U.S. Department of Health and Human Services.

While millions of Americans participate in trials of experimental drugs and devices to help find new treatments for themselves and others, the findings often aren’t made public, said Harlan Krumholz, a cardiologist and health policy professor Yale University in New Haven, Connecticut, and head of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation.

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The new airbag propellant was supposed to be the next big thing for Takata in 1998.  An engineer for the company, Paresh Khandhadia, declared it "the new technological edge" in an interview with a trade magazine then.

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