Johnson & Johnson . . .ANOTHER RECALL!

Johnson & Johnson is yanking two lots, or about 57,000 bottles, of its Topamax epilepsy drug (100 mg tablets). These were distributed in the U.S. last fall and winter, but J&J’s Ortho-McNeil Neurologics unit believes only about 6,000 are still circulating. Topamax has recently been in the news because on March 4, 2011, the FDA informed OB/GYN doctors and neurologists about new data demonstrating that infants born to women treated with Topamax during pregnancy have an increased risk for developing cleft palate or cleft lip.

Interestingly, Topamax is also widely prescribed “off-label” for weight management, or night eating. The drug has an appetite suppressant effect.

Why are the lots being pulled? There were four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole), a chemical used in wooden pallets that transport and store packaging materials.

J&J maintains no adverse events have been reported. In any event, this latest recall adds to a long and impressive list of products that J&J has pulled over the past year due to assorted manufacturing gaffes - tens of millions of over-the-counter meds, including Tylenol, Motrin and Benadryl; contact lenses, syringes and hip replacement devices.

Makes you wonder who’s in charge of manufacturing these drugs and whether J&J is properly overseeing their manufacture? This could potentially become a big issue for J&J -- let’s not forget the recent whistleblower, Cheryl Eckard, who was the catalyst for an investigation into GlaxoSmithKline’s plant in Cidra that ultimately led to GSK receiving a $750 million fine for manufacturing adulterated medicines.  The whistleblower received $96 million for reporting the misconduct. Watch out J&J ... you could be next!

Claudine Q. Homolash, Esq. is a partner at Sheller, P.C. who represents pharmaceutical whistleblowers, as well those injured by dangerous pharmaceutical products and medical devices. She can be contacted at (215) 790-7379 or at chomolash@sheller.com

J&J Accused of Fraud - Risperdal

A former Johnson & Johnson sales manager accused the health care giant of concocting various schemes to defraud federal and state Medicaid programs in a lawsuit that was filed in 2005, but only recently unsealed amid a transfer of the litigation from a federal court in Pennsylvania to another in Massachusetts.

The lawsuit was filed by Scott Bartz, a New Jersey resident who worked as a sales compensation manager from 1999 until 2007, when he alleges he was terminated in retaliation for repeatedly complaining about illegal marketing practices. His lawsuit also names the Omnicare nursing home operator and McKesson, the pharmaceutical wholesaler.

In his Complaint, Bartz charged J&J manipulated sales data; reported false prices to various government health programs, and paid kickbacks, such as rebates, so its Risperdal Consta antipsychotic and Razadyne Alzheimer’s treatment would be more widely prescribed. He also alleged J&J practiced channel stuffing, an accounting gimmick used to boost sales to distributors at year’s end.

The lawsuit, which is one of many filed in federal court in Boston that accuse J&J of such practices, has been amended twice, but the latest version remains under seal. The feds, however, have not intervened, or joined, his lawsuit. For his trouble, Bartz suffered a heart attack at age 44, despite being in good health, due to the stress associated with filing on-the-job complaints and was unable to find work, prompting his lawyers to help arrange for loans, according to court documents.

Last November, J&J disclosed talks were being held with the feds about settling charges of illegal marketing of its Risperdal antipsychotic after denying claims contained in a separate lawsuit that made claims similar to those alleged by Bartz. The lawsuit was disclosed by Omnicare in a filing with the Securities and Exchange Commission and first reported by Dow Jones.

SHELLER P.C. represents many people who have been injured by the drug Risperdal and its related version, Invega.