Nursing homes are big business, and some private Wall Street investment firms have taken notice. In recent years, large groups have been gobbling up nursing homes, which they use to rake in millions of dollars in profits. But often, those profits come at a devastating price to nursing home residents, who must bear the brunt of an investment firm’s cost-cutting efforts.

According to a report published in Monday’s New York Times, private equity firms like the Carlyle Group and Warburg Pincus, have been buying nursing homes by the hundreds. Once they have acquired a home, these private companies often employ aggressive cost cutting measures to increase profits. Often, this means reducing nursing staff, and cutting budgets for supplies, activities and even meals. As a result, an environment is created that is ripe for nursing home neglect.

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A defective Simplicity crib was blamed for the death of a 9-month-old infant more than two years ago, but even though the Consumer Product Safety Commission (CPSC) investigated that child’s death, it issued no recall. Instead, the CPSC waited until last Friday to recall more than 1 million hazardous Simplicity and Graco cribs. By then, the cribs had killed two more children. But even those deaths might not have been enough to prompt the CPSC to take action. Instead, the CPSC only issued the crib recall after learning that a newspaper was about to print a story exposing it’s failure to take action against the faulty cribs after the first tragic death.

On Friday, the CPSC issued a recall for 1.2 million Simplicity and Graco cribs because a flaw in the design of the cribs allowed parents to install the drop rail upside down. When this happened, the drop rail could separate from the crib, creating a gap into which a child could fall and suffocate. The recall was so urgent that in issuing it, the CPSC warned parents not to allow their child to sleep in the defective cribs “for one more night” until they obtained and installed a repair kit.

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Leiner Health Products, a drug maker that produces store brand over-the-counter medications and vitamins for retailers like Wal-Mart, Target, CVS and others, has been accused by the Food & Drug Administration (FDA) of falsifying and manipulating test results on its products. The accusations led the FDA to raid the company’s Fort Mill, South Carolina manufacturing facility earlier this month. The FDA is investigating the California-based company to see if it committed criminal violations of the Food, Drug and Cosmetic Act.

The FDA raided Leiner’s Fort Mill factory on September 5. The raid was the culmination of an investigation that the FDA had begun in January after employees at Fort Mill notified the agency of violations at the plant. The FDA said its subsequent inspections revealed serious violations that substantiated most of the employees’ claims. Those violations included manipulating and falsifying purity test results; not obtaining data to support expiration dates; not obtaining data supporting the quality and safety of products; not recalling defective drugs already on store shelves; and failing to document out-of-specification test results.

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The largest crib recall in US history was announced today by the Consumer Products Safety Commission (CPSC), after two infants died of suffocation while sleeping in the defective cribs. About 1 million cribs made by Simplicity Inc. – including some of the country’s top-selling models – are included in the recall. But even as it issued the recall, questions arose regarding the CPSC’s response to various complaints about the defective cribs that the agency had been hearing for the past two years.

The CPSC said that the drop rail on the recalled cribs can detach, creating a dangerous gap where children can be trapped and suffocated. The deaths of a 9-month-old and a 6-month-old have already been blamed on the hazardous cribs, and the CPSC is investigating a fatal incident involving a 1-year-old child to see if one of the cribs contributed to that death. The CPSC said that it was also aware of 7 other instances of infant entrapment and 55 other accidents involving the cribs. The deaths occurred because the cribs’ drop rail was improperly installed due to its poor design.

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aby’s Bliss Gripe Water, a drink sold as an antidote to colic and other ailments that plague infants, is being recalled because it is contaminated with the intestinal parasite Cryptosporidium. The Food & Drug Administration ordered the recall after a 6-week old infant became sick after drinking Baby’s Bliss Gripe Water.

Cryptosporidium is a parasite that lives in the intestines of infected humans or infants. The parasite is found in soil, food, water or on surfaces that have been in contact with infected human or animal feces. The parasite causes diarrhea, dehydration, weight loss, stomach cramps or pain, fever, nausea and vomiting. It can be particularly dangerous for young children, who are more susceptible to the effects of dehydration.

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The Food & Drug Administration (FDA) is poised to change the way it monitors drug safety, following Senate passage of a bill that gives the agency more power to police medications already on the market. The legislation, which was approved by the House on Wednesday and is expected to be signed by President Bush, would make the FDA much less dependent on the drug industry for safety information, and gives the agency more power to take action against defective drugs.

Consumer advocates are praising the new bill, which requires the FDA to take a more active role in monitoring the safety of drugs once they are approved and on the market. Defective drugs are estimated to kill 15,000 people every year. Under the current law, the FDA approves new drugs after they have been tested on just a few thousand people. Then, the agency waits to see if the approved drug causes any problems. And often, the FDA must rely on pharmaceutical companies to bring safety issues to its attention. As a result, dangerous side effects sometimes go unnoticed for years before the FDA does anything about a defective drug.

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The Consumer Product Safety Commission (CPSC) has too little money, staff and power to prevent hazardous toys from reaching American children. That was the message the head of the CPSC brought to Capital Hill yesterday during a hearing on toy safety. But while many agreed that the CPSC needs more power and money, other information revealed at the hearing indicated that the agency is often too slow to enact toy recalls.

“Our little agency has been ignored by Congress and the public for way to long,” Nord told a House Energy and Commerce Subcommittee yesterday. She said that the CPSC needed the authority to require US companies to certify that imported toys are safe. Such a move, Nord told Congress, would go a long way to insure toy safety. With a staff of only 400, Nord said the CPSC can do little right now to force US toy makers to improve their quality standards.

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Facing a rising tide of lawsuits over its Ortho Evra birth-control patch, Johnson & Johnson has always maintained that the patch is a “safe and needed” form of contraception. But the hundreds of plaintiffs suing the pharmaceutical company feel otherwise, with most of them claiming that Johnson & Johnson had prior knowledge that the Ortho Evra patch had a higher risk of causing blood clots, stokes and heart attacks than oral contraceptives. Unfortunately for Johnson & Johnson, at least two former employees of the company have backed up those allegations.

When Ortho Evra was introduced in 2002, Johnson & Johnson touted the once-weekly patch as a convenient alternative to daily oral contraceptive pills. The drug’s original safety label stated that the patch’s health risks were similar to those related to oral contraceptives. But in 2005, the Food & Drug Administration (FDA) warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then in 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer blood clots as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning.

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Reeling from criticism that it doesn’t do enough to protect the public from defective drugs, the Food & Drug Administration (FDA) has started to publish a “drug safety newsletter”. The FDA said the new quarterly publication is part of an ongoing effort to keep the medical community informed about drug safety issues.

The newsletter is part of the FDA response to savage criticism it received in a report published last year by the Institute of Medicine that faulted the agency’s drug safety record. The report cited the FDA’s apparent inability to pass on critical safety information on marketed drugs to healthcare providers in a timely and efficient manner. Every year, the FDA receives more than 400,000 reports of adverse drug side effects, but the Institute of Medicine said that the FDA’s “dysfunctional” structure hampered the release of such information.

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The Castleberry’s Food Company plant that was responsible for an outbreak of botulism poisoning this summer reopened yesterday. In July, four people in Texas and Indian became ill after eating Castleberry’s botulism-tainted hot dog chili sauces. The chili sauce botulism outbreak ultimately forced Castleberry’s to recall over 90 varieties of canned products manufactured by its Augusta, Georgia plant.

Castleberry’s Food said that the Food & Drug Administration had told the company that it could reopen the plant. The Augusta factory was forced to close on July 21 after it was determined that a malfunctioning production line had produced the botulism-laced chili sauce. To guard against the formation of botulism toxin, canned foods are heated during processing to kill the bacteria. A cooker on the malfunctioning line was dropping cans into cool water before they were ready. While 400 Castleberry’s employees were able to report to work yesterday, the company said that the production line responsible for the botulism contamination would remain closed. The hot dog chili sauce will be produced by a contractor at another plant.

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