Parker Waichman LLP

J&J Warned Over Marketing of Two Devices

Illegally marketing two products. In the newest 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 […]

Johnson & Johnson Marketing

Illegally marketing two products. In the newest 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

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 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.

Need Legal Help Regarding Johnson & Johnson Marketing?

The personal injury attorneys at Parker Waichman offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Positive: Professionalism I was pleased with how they handled my case from beginning to end. They were also very good with providing information and returning calls.
Daisy Figueroa
2 years ago
5 Star Reviews 150
Mrs Michele Josama is very helpful and patient. It is such a pleasure dealing with her. Great job Parker Waichman!!!
marc rene
5 years ago
5 Star Reviews 150
Hi my name is Jillian and I was represented by Michelle Josama and she was absolutely fantastic she is approachable she’s cordial she’s respectful knowledgeable and she gets the job done if anyone needs someone to represent them Michelle Josama is the one thank you so much Michelle and God bless you you’re doing a great work
Gillian Doeman
4 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038