• Women’s Health Law Info

08/12/2014

Luvena Lawsuit by FDA Seeks to Curtail Sales

FDA Luvena Lawsuit

Audet & Partners, LLP reports that the U.S. Food and Drug Administration (FDA) has filed a lawsuit in the United States District Court for the Central District of California against Laclede, the manufacturer of Luvena vaginal moisturizer, to enjoin future sales of the Luvena product. In taking this extraordinary action, the FDA has alleged that Luvena falls within the FDA designation as a "New Drug."  Because Laclede failed to seek and obtain necessary FDA approval for a "new drug," the FDA... Read More
08/07/2014

Luvena False Advertising Lawsuit Investigation

Luvena False Advertising Class Action

Audet & Partners, LLP is investigating claims against the California drug manufacturer, Laclede, Inc. (“Laclede”) for personal and economic injuries to consumers arising out of the use and purchase of its line of prebiotic vaginal products. Laclede marketed, manufactured, and distributed the following Luvena products as part of its prebiotic vaginal product line: • Luvena Prebiotic Vaginal Moisturizer and Lubricant • Luvena Prebiotic Enhanced Personal Lubricant • Luvena Prebiotic Feminine Wipes • Luvena Prebiotic Daily Therapeutic Wash The Luvena package label and accompanying package insert advertises the following... Read More
08/04/2014

Hysterectomy Device Recalled Amid Cancer Fears

Johnson & Johnson Hysterectomy Device Recalled

Audet & Partners, LLP reports that Ethicon Endo-Surgery Inc., a unit of Johnson & Johnson, is voluntarily asking doctors to return a device used in performing hysterectomies in thousands of women.  Ethicon's Morcelex device, used in certain laparoscopic surgeries, has come under FDA scrutiny because of the potential of such devices to spread cancerous fibroids. The class of devices known as morcellation devices, which includes Ethicon's Morcelex device, is used in many hysterectomy procedures to break non-cancerous fibroids into smaller fragments... Read More
07/22/2014

Transvaginal Mesh Lawsuits Targeting C.R. Bard May Soon Settle

Transvaginal Mesh Lawsuits

Audet & Partners, LLP has learned that Covidien, a medical device manufacturer that supplied material to C.R. Bard that was incorporated into transvaginal mesh products, recently announced that they will set aside $180 million to cover losses expected in connection with transvaginal mesh lawsuits. Thousands of vaginal mesh lawsuits are currently pending against C.R. Bard in federal multidistrict litigation centered in West Virginia.  There is speculation that C.R. Bard may soon settle many of these claims, and the company would then be... Read More
04/09/2014

Mirena IUD Lawsuit Alleges Dangerous Postpartum Insertion of Device

Mirena IUD Lawsuit

A 27-year old woman has sued Washington University School of Medicine for injuries associated with her Mirena IUD, which was inserted immediately after she gave birth as part of the University’s clinical study. Her lawsuit claims the post-birth Mirena IUD caused her to require two surgeries and medication for life. Deanna Delancy, of St. Louis, had the Mirena IUD inserted free-of-charge as part of Washington University’s “Contraceptive CHOICE” program, as reported by the St. Louis Post Dispatch.  The stated purpose of... Read More
04/03/2014

Transvaginal Mesh Global Settlements on the Rise

Transvaginal Mesh Lawsuits

Coloplast, Inc. may be considering settling a number of transvaginal mesh lawsuits against it for $16 million, Bloomberg reports.  If Coloplast A/S, one of the smaller manufacturers of mesh devices, proceeds with the settlements, legal experts predict an impending global settlement of similar lawsuits against other mesh manufacturers. Coloplast A/S, a Danish medical device company, has reportedly agreed to pay $16 million to settle various lawsuits covering approximately 400 women who sued for injuries caused by the company’s transvaginal mesh device,... Read More
03/20/2014

Pay-for-Delay Lawsuit Involving Nexium Reopened by Federal Court

Pay for Delay Nexium Lawsuit

In the Nexium pay-for-delay multidistrict litigation accusing drug companies of violating antitrust laws by agreeing to delay entry of a generic version of AstraZenca’s heartburn drug Nexium, federal Judge William Young may be reconsidering some of his orders granting the summary judgments to drugmakers. The case stems from the 2008 pay-for-delay deal struck between AstraZeneca, who manufactures the brand name heartburn drug Nexium, and generic-drug makers Ranbaxy, Inc., Teva Pharmaceuticals Ltd. and Dr. Reddy’s Laboratories, Inc. (the “Generic Manufacturers).  Under the... Read More
03/05/2014

Transvaginal Mesh Lawsuit Update

Thousands of lawsuits have been filed by women across the country who underwent transvaginal mesh surgeries to repair pelvic organ prolapse and stress urinary incontinence following serious injuries from the procedures.   The lawsuits allege that various manufacturers failed to safely design and test the vaginal mesh devices and did not adequately warn women about the risks of injury. The complainants have alleged serious injuries resulting from implantation including chronic pain, organ perforation, infection, and device erosion. The transvaginal mesh multi-district... Read More
12/02/2013

Mirena IUD Lawsuit Survives Motion to Dismiss in Louisiana

A Louisiana woman’s Mirena lawsuit against Bayer Pharmaceuticals will continue after a federal judge recently denied Bayer’s motion to dismiss. Latoya Thompson had the Mirena intrauterine device (IUD) inserted in June 2011, at which time she claims she began experiencing pain and other problems.  The device “dislocated” (fell out on its own) approximately a week later.  In May 2012, Ms. Thompson was hospitalized for her symptoms. On May 22, 2013, Ms. Thompson and her husband sued Bayer for her injuries under the... Read More
12/02/2013

Bellwether Trials Set in Transvaginal Mesh Litigation Prompt Reports of Mass Settlement

In coming months, several transvaginal mesh lawsuits are scheduled for bellwether trials.  Transvaginal mesh lawyers expecting thousands of cases against major mesh manufacturers may settle before trial. According to court documents, the following cases are currently scheduled to go to trial against in the coming months against transvaginal mesh manufacturers: MDL No. 2187 | Jones  v. C.R. Bard, Inc. (2:11-cv-0114): December 3, 2013 MDL No. 2325 | American Medical Systems, Inc. (case still to be decided):  April 7, 2014 MDL No. 2326 | Fawcett,... Read More