This week, the FDA decided that the January 2013 recall of Hamilton Medical’s T1 ventilator deserves the designation of a Class I recall, warning of serious injury or death. The small, portable ventilator is designed to provide intermittent breathing support to adults and pediatric patients. However, a problem with the T1 software causes a miscalculation of the required oxygen for pediatric patients with high airway resistance and low lung function, resulting in a limited delivery of oxygen. On January 11, according to the FDA, Hamilton Medical mailed a letter notifying its customers of the problem and informed them that the firm is working on a software revision. The recall covers devices manufactured and distributed from February 2012 through December 2012 with version 1.1.2 or lower software.

Eli Lilly and Company will stop all ongoing mid- and late-stage trials in rheumatoid arthritis for its experimental drug tabalumab because of a lack of efficacy. Tabalumab, a key part of Lilly’s pipeline, is an anti-B cell activating factor monoclonal antibody. It was in a late-stage trial for efficacy enrolling more than 500 patients with moderate-to-severe rheumatoid arthritis who have an inadequate response to one or more tumor necrosis factor inhibitors. The drugs failure to meet the endpoints in the most recent trials follows the failure in late 2012 to show efficacy in a separate trial enrolling more than 900 patients with moderate-to-severe rheumatoid arthritis who had an inadequate response to methotrexate therapy. A third trial, studying the drug’s efficacy in rheumatoid arthritis patients with or without background disease-modifying anti-rheumatic drug therapy, is no longer recruiting patients and Lilly announced it will discontinue all development of tabalumab as a therapeutic for the disease. The company, however, is pursuing other indications for the drug.

In the second trial of multi-district litigation alleging that the bone drug Fosamax causes jaw deterioration, a New York federal jury ruled that Merck failed to properly warn of Fosamax’s risk and awarded $285,000 in damages to the plaintiff while rejecting the plaintiff’s argument that Fosamax was a defective product. This is the second verdict against the company in a series of seven trials; Merck won the other five. Overall, more than 4,000 lawsuits are pending in federal and state courts arising out of injuries allegedly caused by the drug, designed to reduce bone turnover and lower the risk of fractures associated with osteoporosis. Use of the medication over long periods of time has been linked to the gradual decay of certain bones, especially the jaw and femur bones. Merck’s Fosamax won approval in 1995 as the first bisphosphonate to treat and prevent osteoporosis in older women; in 2010 the company was forced to make a label change to the drug reflecting the increased risk of osteonecrosis of the jaw.

The first new vaccine for tuberculosis in more than 90 years, while effective in adults, failed a mid-stage clinical trial in infants, disappointing researchers and a large consortium of partners. Developed by the University of Oxford, the TB vaccine candidate MVA85A was designed to boost immune responses in infants already primed by the widely used BCG vaccine. Although the vaccine was safe and well tolerated in 2,797 infants living in the Western Cape province of South Africa, data published in The Lancet show that a single dose of MVA85A is not sufficient to confer statistically significant protection against TB in infants who had been vaccinated at birth with BCG. A new vaccine is needed because BCG has a limited and short-lived effect, and does not protect against pulmonary TB, the most common form of the disease, killing 1.4 million people a year. Resistance to BCG is also a growing problem. The trial was conducted by the University of Cape Town’s South African Tuberculosis Vaccine Initiative and funded by Aeras, a nonprofit biotech with a social mission to develop TB vaccines, The Wellcome Trust, and the Oxford-Emergent Tuberculosis Consortium, a joint venture between the University of Oxford and Emergent BioSolutions.

Physcians were warned this week by the U.S. Food and Drug Administration that a counterfeit cancer drug was shipped from Medical Device King to medical practices in the United States. FDA lab tests confirmed that at least one batch of the cancer drug contained no bevacizumab, the supposedly active ingredient. The counterfeit version of Roche’s Altuzan, an injectable form of bevacizumab, is not even approved by the FDA for U.S. distribution. The version approved for sale in the United States is marketed by Genentech under the name Avastin, and does not have the Roche name or logo on the label. The FDA is requesting health care providers to stop using medical products from Medical Device King, Pharmalogical, and Taranis Medical and to contact FDA’s Office of Criminal Investigations to arrange for collection of the products. Similar counterfeit warnings against distributors Quality Specialty Products, Montana Health Care Solutions, Clinical Care, Volunteer Distribution, and Bridgewater Medical were issued last year.