Current Events

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.

Click here to read more.

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.

Click here to read more.

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.

Click here to read more.

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.

Click here to read more.

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.

Click here to read more.

The Food and Drug Administration is warning doctors that a compounding pharmacy is recalling dozens of lots of the Roche drug Avastin after receiving reports of eye infections among patients.

The FDA said Wednesday that Clinical Specialties of Martinez, Ga., has received five reports of eye infections from physicians who used the drug to treat macular degeneration, a common vision disorder in seniors.

Click here to read more.

Intuitive Surgical Inc (ISRG)., the maker of robots used in 367,000 U.S. operations last year, is facing accusations in lawsuits that it put patients at risk by marketing the machinery to doctors without providing adequate training.

Company e-mails introduced in a lawsuit filed against Intuitive in Kitsap County, Washington, suggest salesmen lobbied hospitals to scale back doctor training. One manager’s e-mail lauded a salesman for persuading a hospital that five supervised operations were too many. In another, a manager told a sales team not to “let proctoring or credentialing get in the way” of meeting goals on the number of robot surgeries.

Click here to read more.

Diabetes drugs including Merck & Co. (MRK)’s Januvia, Bristol-Myers Squibb Co. (BMY)’s Byetta and Novo Nordisk A/S (NOVOB)’s Victoza are being scrutinized by U.S. regulators for a potential link to pancreatic cancer.

The Food and Drug Administration is reviewing unpublished findings by a group of academic researchers that suggest pre- cancerous cellular changes may be associated with Type 2 diabetes drugs called incretin mimetics, according to a statement today from the agency. The findings suggest the class of medicines may be linked to the risk of developing an inflammation of the pancreas tied to cancer and kidney failure that was previously reported in some of the medicines.

Click here to read more.

The Food and Drug Administration on Tuesday toughened a warning it made last year about the potential risks of azithromycin, a commonly used antibiotic that can cause changes in the electrical activity of the heart that may lead to a fatal irregular heart rhythm in some patients.

The risks, which have been noted in the warning labels on the drug since March 2012, were quantified in greater detail in a study published last spring in the New England Journal of Medicine that was led by a professor of preventive medicine at Vanderbilt University.

Click here to read more.

A jury in Los Angeles on Friday ordered Johnson & Johnson to pay more than $8.3 million in damages to a Montana man in the first of more than 10,000 lawsuits pending against the medical products maker in connection with a now-recalled artificial hip.

The 12-member panel, however, declined to issue punitive damages, saying the company’s DePuy orthopedics unit, which made and marketed the all-metal device, did not act with fraud or malice. The implant, known as the Articular Surface Replacement, or A.S.R., was recalled in mid-2010.

Click here to read more.

After Michelle Zarick complained of excessive vaginal bleeding, her doctor found growths in her uterus that needed to be removed. One option: robot surgery, described by her gynecologist as “the latest, greatest” technique available.

With nimble robotic instruments doing the delicate work usually performed by doctors hands-on, there would be less pain and bleeding, she was told.

Click here to read more.