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Johnson & Johnson Warned Over Marketing of Two Devices

Aug 25, 2010 | Parker Waichman LLP

In the newest in a string of debacles surrounding drug giant Johnson & Johnson (J&J), it just received a warning letter from the U.S. Food and Drug Administration (FDA) stating it is illegally marketing two products, wrote Daily Finance.

We’ve previously written that J&J is expecting more legal fallout from its recalls of children’s Tylenol and other over-the-counter medicines. According to a prior Wall Street Journal report, J&J said in a recent regulatory filing it received “civil investigative demands” from various state authorities regarding the recalls. J&J has been under scrutiny since April 30, when its McNeil Consumer Healthcare unit recalled more than 40 varieties of children’s Tylenol and other medicines. That recall was just one of six McNeil issued for its cold and pain relief products over the past year.

The New Jersey-based company has been hit with a federal subpoena from the U.S. Attorney’s Office for the Eastern District of Pennsylvania. The Journal also wrote that Congress is investigating the recalls, which have spawned numerous lawsuits. The FDA's Office of Criminal Investigations is looking at the McNeil recalls, with executives testifying for a Congressional committee, said Daily Finance. According to CNNMoney sources, the FDA might bring criminal charges against executives at those J&J companies that issued recalls over manufacturing violations, added Daily Finance.

In a filing with the Securities and Exchange Commission (SEC), J&J disclosed it received multiple subpoenas from federal prosecutors requesting documents “broadly relating to” both the recent recalls and inspections of two factories and said it received demands from multiple State Attorneys General Offices relating to the same issues.

In its letter to J&J’s DePuy Orthopaedics, the FDA said it became aware that the firm is advertising its TruMatch without marketing clearance or approval and in violation of the Federal Food, Drug, and Cosmetic Act, wrote Daily Finance. The TruMatch Personalized Solutions System, a state-of-the-art CT scanner, provides detailed three-dimensional images of a patient’s knee prior to implant surgery, said Daily Finance.

The FDA asked J&J to submit the data needed to receive marketing approval writing, "The FDA will evaluate the information you submit and decide whether your product may be legally marketed," quoted Daily Finance.

The other product, the Corail Hip System, was cleared for cementless use only, said the FDA; however, J&J marketed the system for two unapproved uses, which were detailed in a brochure it had posted on its website, said Daily Finance. DePuy must advise the FDA in 15 days as to how it will correct the violations and must also provide details on how it will prevent these and similar violations in the future, wrote Daily Finance.

Yesterday, we wrote that in its ninth recall this year, J&J recalled millions of its 1 Day Acuvue Contact Lenses, which were sold in Japan and two dozen other countries, citing the Associated Press (AP). J&J announced it received complaints from its customers in Japan complaining of stinging or pain when inserting the lenses, said the AP. The firm believes about 100,000 boxes are involved; each box contains 30 or 90 lenses.

The problem is likely the result of an equipment failure that occurred when lenses are rinsed during production. A substance used during manufacturing was not removed during the rinse process, explained the AP.

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