Defective Medical Devices

The Food and Drug Administration conducted approximately half the state food safety audits it promised in the two years leading up to the recent peanut salmonella outbreak.

Documents sent to Congress by the FDA show the agency did not perform any of the required audits of state-run food inspections in five states during the 2007 and 2008 budget years. The FDA was also unable to say whether the audits were conducted at all in 11 additional states, including Georgia and Texas, where the salmonella was traced to two peanut plants owned by the Peanut Corporation of America.

The FDA audits are a crucial part of the government’s ability to ensure that food is inspected properly by states that contract with the FDA to perform safety checks.

Pitman, Kyle & Sicula is a Wisconsin personal injury law firm handling faulty product cases through out the state.  Our personal injury lawyers have successfully represented injured people in almost every county. We know Wisconsin.

According to the U.S. Food and Drug Administration, Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

The recall applies to the following lot number and product information:

– Lot Number 813900
– ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin

Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall.

Click here for the entire FDA news release.

Pitman, Kyle & Sicula is a Wisconsin personal injury law firm handling cases through out the state.  Our personal injury lawyers have successfully represented injured people in almost every county. We know Wisconsin.

Monday was a big day in the world of drug litigation law.   The United States Supreme Court heard oral arguments in the Wyeth v. Levine case.

The case is about a lot of stuff but it started out as a medical malpractice/improper administering of a drug case:

The case came from Vermont, where a guitarist, Diana Levine, won a $6.8 million judgment against Wyeth after misadministration of its drug Phenergan caused gangrene and required the amputation of her hand and forearm. The anti-nausea drug is normally injected into muscle, but the label also provides directions for intravenous use.

The case is before the United State Supreme Court because there is a difference of opinion between state law and federal law:

In February, an 8-1 court found that federal law, which explicitly pre-empted state regulation of medical devices, implicitly blocked private negligence lawsuits as well.  In 2006, by contrast, the Vermont Supreme Court found no conflict between federal law and the judgment against Wyeth.

Keep track of this case.  It’s pretty big news in the world of personal injury attorneys.

-Attorney Jonathan Groth

Pitman, Kyle & Sicula is a Wisconsin personal injury law firm handling cases through out the state.  Our personal injury lawyers have successfully represented injured people in almost every county. We know Wisconsin.