Current Events

A malfunction in a device from HeartWare International Inc. (HTWR) used to take over the heart’s beating action led to a patient death, U.S. regulators said. The company’s shares declined.

After the patient changed the battery in the left ventricular assist device, power dropped and blood flow fell, setting off a controller fault alarm, the report posted on the U.S. Food and Drug Administration’s website said. A family member found the woman unresponsive at her house, with the alarm blaring. The problem had persisted for at least three hours before it was addressed, according to a preliminary analysis.

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Rich Products has dramatically expanded a voluntary product recall to include all foods manufactured at its Waycross, Ga., facility, out of a concern they could potentially be contaminated with E. coli bacteria.

Rich recalled a number of Farm Rich Products last week after an E. coli outbreak sickened 24 people in 15 states. Two of the 24 cases, affecting consumers in New York State and Texas, have been linked to products included in the original recall.

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The second trial over claims Merck & Co. (MRK) hid risks that its Fosamax osteoporosis drug could cause femur fractures is scheduled to start next week after the plaintiff in the first case suffered a health problem.

The new trial, set to begin April 9 in federal court in Trenton, New Jersey, is among more than 3,300 lawsuits alleging Fosamax caused broken legs. Another 1,230 cases allege users sustained jaw-related injuries, Merck has said.

The first femur-fracture trial, which started last month in state court in Atlantic City, New Jersey, ended in a mistrial after the plaintiff, Christina Su, had a “serious health complication” unrelated to her use of Fosamax, Merck said in a March 18 statement on its website.

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A lawsuit filed against Ford Motor Co. alleges that several Ford and Lincoln vehicles manufactured between 2002 and 2010 are subject to unintentional acceleration and also lack "adequate fail-safe systems" to prevent crashes.

The suit filed Thursday in federal court in West Virginia seeks class-action status on behalf of consumers in 14 states.

It describes situations in which Ford's electronic throttle system allegedly caused vehicles to accelerate unexpectedly, leaving drivers unable to stop. It does not include any claims of wrongful death or personal injury.

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Syracuse, N.Y. – Workers at Rosewood Heights nursing home did not properly supervise residents at risk of choking on their food, putting them in danger of serious injury or death, according to a recent inspection of the facility at 614 S. Crouse Ave.

The 242-bed home was cited for 26 violations -- three of them classified as “immediate jeopardy,” the most serious type of infraction – in a Dec. 7, 2012 inspection recently published by the state Health Department on its website.

Twelve of the 26 violations were repeat problems. The federal Centers for Medicare and Medicaid Services, CMS for short, has fined the home $10,000 because of the violations.

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Doctor-owned businesses that act as middlemen between medical device makers and hospitals are “inherently suspect” and some of their practices may violate U.S. anti-kickback laws, a government inspector general said.

Daniel Levinson, the inspector general for the Health and Human Services Department, today issued an unusual “special fraud alert” about so-called physician-owned distributorships, or PODs. The companies sell medical devices that the doctor owners then use in surgical procedures on their own patients.

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Intuitive Surgical Inc. (ISRG), a maker of surgical robots used in more than 300,000 U.S. operations last year, must face claims it marketed the devices to doctors without providing adequate training, a judge ruled.

A Washington state court yesterday denied Intuitive’s bid to throw out a lawsuit over the death of a patient operated on using the company’s da Vinci surgical system, according to court filings. The judge found the state’s product-liability laws require medical-device makers to properly train physicians who buy their products.

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Johnson & Johnson is recalling all its OneTouch VerioIQ blood glucose meters in the U.S. because they do not provide a warning when a diabetic's blood sugar level is dangerously high. Instead, at a certain sugar level, the meters turn off.

The meters are made by J&J's LifeScan unit, which will issue a free replacement meter to all patients.

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Toyota Motor Corp. is recalling certain FJ Cruiser sport-utility vehicles from the 2007 through 2013 model years because of a possible flaw in the way their seat belts were installed.

The retractors for the vehicles’ front driver and passenger seat belts are mounted in rear-door panels, where cracks can form if the rear doors are forcefully closed repeatedly over a long period. If this happens, the seat belt retractor could detach, which would increase the risk of injury in a crash.

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A national survey shows how drug shortages led to treatment changes and delays.

Certain cancer drugs were in such short supply in 2011 that patients were going without, taking untested medications and were subjected to prescription errors because of changes in routine, finds a survey of health professionals published today.

Almost all of the 240 hospital and clinic pharmacists polled said they had to change or delay treatments because of the shortages, said the study, by researchers at St. Jude Children's Research Hospital in Memphis. It was published in the American Journal of Health-System Pharmacy.

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States are cracking down on specialty pharmacies, conducting surprise inspections and weighing proposals to require companies to obtain special permits to mix sterile drugs. The moves are in response to last fall’s deadly meningitis outbreak, which was linked to tainted steroid shots made by a Massachusetts pharmacy.

About a dozen states, including Maryland and Virginia, are considering legislation that would require stricter licensing requirements for specialty pharmacies, known as compounders.

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