A Food & Drug Administration (FDA) warning letter says that Medtronic Inc. waited too long to issue a recall of its  SynchroMed II  Drug Pumps, and did not respond properly to reports of problems with MiniMed Paradigm Insulin Pump.

The FDA warning letter stemmed from an inspection of Medtronic’s Puerto Rican facility where the pumps are made that occurred from  November 12, 2008 through December 15, 2008. The company has 15 working days from the date it received the warning letter to respond to the FDA.  The FDA letter warned Medtronic that failure to promptly correct  violations could result in regulatory action being initiated without further notice. (more…)

Medtronic Inc. says a falsified Infuse Bone Graft study has been named in a federal subpoena issued by the Boston U.S.  Attorney’s office. According to Reuters, the federal subpoena is one of two Medtronic disclosed yesterday in  a  filing with the Securities and Exchange Commission (SEC).

In addition to information on the Infuse study, Reuters is reporting that  U.S. prosecutors are also seeking information about “contracts, research grants, speaking and education programs, and payments for certain named physicians.”  The second subpoena was issued from the New Jersey Attorney General.   That subpoena is  “seeking documents related to clinical studies, its financial arrangements with certain physicians, and clinical research done by certain physicians and health care providers.”   The company did not say if the two subpoenas were related, Reuters said. (more…)

At least 70 people across the country have been sickened with E. coli O157:H7 associated with frozen, prepackaged Nestle Toll House cookie dough.

According to the Centers for Disease Control (CDC), the outbreak spans 30 states.  Of those sickened,  30  have been hospitalized,  and  7 developed hemolytic uremic syndrome (HUS).  None have died.   The majority of those sickened – 66%  – are under the age of 19, and three quarters  are female. (more…)

Defective Chinese drywall has driven New Orleans Saints head coach Sean Payton and his family from their Mandeville, Louisiana home.

According to CBSSports.com, Payton says at least 80 percent of the walls in his home are made with the Chinese drywall.  Payton told reporters that his family has experienced  five computer failures, three microwave oven panel failures, and have had an entire set of phone lines replaced. His wife’s sterling silver jewelry has even been black from corrosion caused by the drywall fumes. (more…)

Consumers are being warned about a recall of Orangatang Skateboard Wheels distributed by Loaded Boards Inc., of Beverly Hills, Calif.  Anyone with these skateboard wheels should stop using them immediately and contact Loaded Boards Inc. or any authorized dealer for a free replacement.

According to the Consumer Products Safety Commission (CPSC), the recall involves about 1200 sets of Orangatang “In-Heat” skateboard wheels. They were sold in two styles: 75mm/purple/83a durometer and 75mm/orange/80a durometer. The words “orangatang,” “In Heat,” and the size and durometer are written on the sidewall of the wheel. The wheels were sold in sets of four at authorized Loaded Boards/Orangatang Wheels dealers nationwide from March 2009 through April 2009 for about $55 per set. (more…)

More bad news for Matrixx Initiatives on the Zicam front.  According to a Wall Street Journal report, last week’s Food & Drug Administration (FDA) warning on several Zicam nasal cold remedies seems to have attracted the attention of the Securities and Exchange Commission (SEC).

According to The Wall Street Journal, the SEC has asked Matrixx to provide documents and information relating to the FDA warning.  On Tuesday, the company said it didn’t know what the SEC was looking into but would cooperate fully, the Journal said. (more…)

A federal judge’s decision to  dismiss class action allegations against insurers in the Katrina Canal Breaches Consolidated Litigation means that some Hurricane Katrina victims have more time to file lawsuits if they are unhappy with the way a property insurance claim was settled, the New Orleans Times-Picayune reported recently.

Last Tuesday in New Orleans, U.S. District Court Judge Stanwood R. Duval Jr. granted a request by insurers to be severed from the consolidated litigation. According to the Times-Picayune, the Judge ruled that disputes against insurers were individual, and not suitable to be handled as part of a class action.  When a class action petition fails to get certified, or  some defendants are severed from the proceedings, individual plaintiffs can file their own lawsuits. (more…)

Crane Bathtubs with a Whirlpool are being recalled today because of an entrapment and drowning hazard.

The recall includes about 5,500 Crane Bathtubs manufactured by Crane Plumbing LLC.  According to the Consumer Products Safety Commission, a  bather’s hair can become entangled in the drain covers, causing the bather’s head to be held under water, which can result in drowning. (more…)

The Securities and Exchange Commission (SEC) has filed two civil securities fraud complaints against a brokerage and four individuals who allegedly helped Bernard Madoff raise money from investors.  Once complaint names California-based investment adviser Stanley Chais – who ran three feeder funds that funneled money to Madoff – with securities fraud.  Another names Cohmad Securities Corp.,  its chairman Maurice J. Cohn, chief operating officer Marcia B. Cohn, and registered representative Robert M. Jaffe.

Both SEC complaints seek injunctions, financial penalties and court orders requiring Cohmad, the Cohns, Jaffe and Chais to disgorge their allegedly ill-gotten gains. Both complaints were filed in U.S. District Court for the Southern District of New York. (more…)

Consumers are being warned not to eat pistachios sold under the brand names California Prime Produce and Orange County Orchards.  According to the Food & Drug Administration (FDA), the pistachios were recalled by Setton Pistachio of Terra Bella Inc., because of possible Salmonella contamination.

The recalled Setton pistachios were received and repacked by Orca Distribution West Inc.,  of Anaheim, California. According to a notice on the agency’s website, the FDA visited Orca as part of its audit checks to follow up on Setton Pistachio’s recall. The FDA found that products subject to Setton Pistachio’s recall had been repacked and distributed by Orca under the California Prime Produce and Orange County Orchards brands. Orca has not made a public announcement regarding these products. Therefore, the FDA is alerting consumers so that they can take appropriate action. (more…)