Johnson & Joshnson Archives - Carey Danis & Lowe

CA & WA Attorneys General Sue J&J

By | Transvaginal Mesh, Uncategorized

transvaginal mesh lawsuitThe Attorney General of California and Washington state filed separate transvaginal mesh lawsuits targeting Ethicon and Johnson & Johnson (J&J). Their lawsuits claim that the pharmaceutical giant knew of the serious risks associated with their vaginal mesh products, but the company hid this knowledge. By doing so, Ethicon and J&J violated consumer safety, according to the lawsuits.

Lawsuits Pending in Federal Court

These lawsuits come as thousands of similar cases remain pending in a federal court in West Virginia. Ethicon and J&J are defendants in a multidistrict litigation (MDL) in the US District Court for the Southern District of West Virginia. The MDL is In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation, MDL no. 2327.

As of late June 2016, there are over 32,000 transvaginal mesh lawsuits pending in the Ethicon MDL.

J&J Responds to Lawsuits

J&J reacted to the actions of these two Attorneys General by issuing a statement emphasizing that neither they nor their subsidiary, Ethicon, committed any wrongdoing in developing, manufacturing, and marketing their pelvic slings.

The company plans to defend itself against these claims.

Do you have a pelvic sling case?

You can discuss your case with one of our experienced attorneys. We offer free, no obligation case evaluations. Call 800.721.2519, or complete our confidential online form.

Some Previously Approved Medical Devices are Skirting Past FDA Evaluation

By | Defective Medical Device litigation, Hip/Knee Replacement, Transvaginal Mesh, Uncategorized

Published May 8, 2012 on TMD

A loophole in federal law requires the FDA to approve some previously-recalled medical devices.

Now, the agency says it wants to see that changed.

Defective hip implant devices and transvaginal mesh devices went to market despite significant concerns over the safety of earlier models. In addition, thousands of Americans have been injured as a result. Sadly, a loophole in federal law could be to blame.

By law, the Food and Drug Administration is not required to review or approve medical devices that are “substantially equivalent” to previously approved models, so long as the prior model was not taken off the market pursuant to an FDA or court order. Since the device’s prior models were approved, and still available, the law allowed the new devices to skirt past the FDA without evaluation.

However, some regulators are calling on Congress to change this. This past February, the FDA’s chief medical-device regulator asked Congress to close this loophole stating that a medical device is five times more likely to be recalled for having safety problems if it is based on an earlier model that had a known design flaw.

His remarks came just weeks after House Democrats introduced a bill that would allow the FDA to reject medical devices if previous models had been subject to manufacturer recalls. The bills’ sponsors say the change will go a long way toward protecting patient health and safety.

Medical device manufacturers, however, see the proposal as unnecessary regulation. The Advanced Medical Technology Association, which lobbies on behalf of medical device makers, indicated that the proposed bill “will not contribute to patient safety.”

Further, most companies choose to issue a voluntary recall before their products become subject to FDA or court action.

Unsurprising, the bills’ sponsors strongly disagree. Each year, on average, the FDA approves 28 medical devices whose design is based on a previously recalled model. Although not all prove to be as dangerous or notorious as the DePuy hip implant or Johnson & Johnson’s transvaginal mesh, many still cause serious injuries.

It remains to be seen what actions Congress will take. Additional regulation and red tape may hinder the ability to move medical devices onto the market to help those who need them. On the other hand, without proper evaluation, defective devices could and do prove harmful to consumers they are intended to benefit.