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 DIDN'T PROOFREAD!

Johnson & Johnson just can’t seem to do anything right. On top of all the quality-control problems that have led to tens of millions of product recalls for over-the-counter meds, syringes, contact lenses and hip replacement devices, now J&J is recalling more than 660,000 Sudafed packages because the labeling has an extra ‘not’ in the instructions. FOR REAL!!

A notice on the J&J web site says the McNeil Consumer Healthcare initiated the recall at the wholesale level “due to a typographical error in the directions section on the label, which incorrectly repeated the word ‘not’ as follows: ‘do not not divide, crush, chew, or dissolve the tablet.’ To date there have been no reports of adverse events caused by this labeling error.”

Proofreading is a big pet peeve of mine but I do sympathize with whoever made the typo. I’ve made my fair share. And in the grand scheme of things, it’s not as bad as the faulty hips that leech cobalt and chromium particles causing tissue death, musty smelling tablets, cracked syringes or contact lenses that cause stinging eye pain!

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.

DePuy ASR Hip Replacement Recall - CALL ME AT 215-790-7379 or EMAIL ME AT chomolash@sheller.com

DePuy has issued a recall for its ASR hip implants that will affect thousands of patients. If you've been harmed by the DePuy ASR hip replacement recall, filing a hip replacement lawsuit to seek compensation for your injuries is your right.
ASR hip replacement systems are the subject of a recall by manufacturer DePuy Orthopedics. DePuy ASR hip replacements have had an unusually high failure rate, and many people who have received DePuy hip replacements have had to undergo multiple, painful surgeries to replace the defective hip implant. If you've been harmed by a DePuy ASR hip replacement, it's your right to file a hip replacement recall lawsuit against DePuy and seek compensation for your injuries.

Do I Have Grounds for a Hip Replacement Lawsuit?
If you have received a DePuy ASR hip replacement since 2003 you may have grounds for a lawsuit against DePuy. The ASR hip replacements have an unusually high failure rate and can become loose and fracture the bone around the implant, the implant's ball and socket can become dislocated, and metal from the implant can even flake off and enter the bloodstream. Orthopedic specialists have been calling attention to the high failure rate of ASR hip replacements for years, and both DePuy and its parent company Johnson & Johnson have been warned by the FDA numerous times about defective products.

If you or a loved one received a hip replacement anytime after 2003 and has had any pain or complications resulting therefrom, please email or call Claudine Homolash at chomolash@sheller.com or 215-790-7379 for a free consultation.