J&J warned over illegal hip, knee device sales

By Parija Kavilanz, senior writer


NEW YORK (CNNMoney.com) -- The Food and Drug Administration has hit another Johnson & Johnson unit -- medical device maker DePuy Orthopaedics -- with a warning letter for selling hip and other joint products without the agency's approval.

The FDA said in the letter that the company has been selling its TruMatch Personalized Solutions System, which makes artificial knee products, and the Corail Hip System without "market clearance" and in violation of the Federal Food, Drug, and Cosmetic Act.

The agency said DePuy should immediately stop selling the Corail products or face further enforcement action, which could include product seizure, injunction or civil penalties.

The FDA said it will only evaluate whether these products can be legally marketed to consumers after DePuy submits information for approval.

Johnson & Johnson (JNJ, Fortune 500) has come under intense FDA scrutiny over the past year.

The company's McNeil Consumer Healthcare unit, which makes well-known cold and pain drugs such as Tylenol and Benadryl, has received negative inspection reports and warning letters tied to manufacturing lapses at its U.S. factories.

In May, McNeil shut a plant in Fort Washington, Penn., after the company recalled millions of children's Tylenol and other drugs that were made at that facility.

In this latest warning letter, the FDA has given Depuy 15 days to correct the violations.

DePuy Orthopaedics says it is "reviewing the letter to understand the FDA's concerns and will respond to their request for information." To top of page

Frontline troops push for solar energy
The U.S. Marines are testing renewable energy technologies like solar to reduce costs and casualties associated with fossil fuels. Play
25 Best Places to find rich singles
Looking for Mr. or Ms. Moneybags? Hunt down the perfect mate in these wealthy cities, which are brimming with unattached professionals. More
Fun festivals: Twins to mustard to pirates!
You'll see double in Twinsburg, Ohio, and Ketchup lovers should beware in Middleton, WI. Here's some of the best and strangest town festivals. Play
Index Last Change % Change
Dow 18,241.03 -44.71 -0.24%
Nasdaq 5,094.92 4.13 0.08%
S&P 500 2,128.71 -2.11 -0.10%
Treasuries 2.21 0.02 1.01%
Data as of 11:09am ET
Company Price Change % Change
Apple Inc 132.74 1.35 1.03%
Hewlett-Packard Co 35.35 1.52 4.49%
Bank of America Corp... 16.74 0.00 0.03%
AT&T Inc 34.88 -0.20 -0.56%
Micron Technology In... 27.59 0.69 2.57%
Data as of 10:54am ET
Sponsors

Sections

Philip Morris and British American Tobacco have filed lawsuits against the British government over a law that bans brands from cigarette packages. More

Chelsea Clinton took the stage during Internet Week New York to discuss a new report that looks at the state of women around the world. More

More than 3.5 million people's sexual preferences, fetishes and secrets have been exposed after dating site Adult FriendFinder was hacked. More

Sarah Kauss launched S'well to rid the world of plastic water bottles. In five years, she's sold 4 million of her stainless steel bottles. More

Rents increased 4% in April from last year while home values only rose 3% during the same time period. More