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Federal Food Archives - Carey Danis & Lowe

Carey Danis & Lowe Currently Evaluating Mirena Lawsuits: Lawyers Accepting Mirena Cases

By | Mirena, Pharmaceutical litigation, Uncategorized

Carey Danis & Lowe Currently Evaluating Mirena Lawsuits: Lawyers Accepting Mirena Cases

Lawyers at Carey Danis & Lowe have been closely following recent news regarding Mirena lawsuits. Following growing adverse event reports filed with the U.S. Food and Drug Administration (FDA) as well as increasing numbers of Mirena lawsuits being filed across the country, Lawyers at Carey Danis & Lowe are currently offering free legal evaluations of Mirena cases.

Manufactured by Bayer Healthcare Pharmaceuticals Inc. (Bayer), Mirena is a contraceptive device intended for long-term use of up to 5 years, and is recommended for use by women who have had at least one child. It is classified as an intrauterine device, or IUD, as use of Mirena involves uterine insertion.

The Mirena IUD is made of a polyethylene material in the shape of a T that houses a hormone reservoir. The hormone reservoir is responsible for the slow and small release of the hormone levonorgesterel. The Merina IUD works as a contraceptive device by producing a thicker than normal cervical mucus that blocks sperm ingress and fertilization.

The Mirena IUD has been linked to serious health complications, including the following:

  •  uterine wall or cervix perforation
  • device expulsion
  • device disengagement and travel to other parts of the body 
  • device embedding into the uterine wall
  • pelvic inflammatory disease (PID)
  • ectopic pregnancy
  • infertility

Individuals who have filed Mirena lawsuits claim that the Mirena IUD rooted into their uterine wall, at times breaching the uterine wall, and traveling to the abdomen and other parts of the body causing serious damage to internal organs. There are some cases wherein the Mirena IUD dislodged and traveled into the fallopian tubes. In cases where the Mirena IUD perforated the uterus or the cervix or dislodged and traveled to other areas of the body, individuals required surgery to remove the device.

In addition the health risks associated with use of with Mirena, the FDA along with patients who have used Mirena have cited the deceptive and misleading marketing strategies employed by Bayer in order to market the contraceptive device to women. The FDA wrote a letter to Bayer in December 2009 addressing Bayer’s Mirena marketing campaign, and noted that it was in violation of the Federal Food, Drug, and Cosmetic Act.

Bayer claimed in its Mirena marketing materials that the contraceptive device improved overall health and libido, which the FDA found to be unsubstantiated. With the evidence before it, the FDA concluded the opposite about Mirena in light of such side effects like headaches, nausea, weight gain, shifts in mood, and acne.

Lawyers at Carey Danis & Lowe recognize the importance of protecting consumers from negligent pharmaceutical companies who so clearly demonstrate more concern for profits than consumer health. In cases such as Mirena, lawyers at Carey Danis & Lowe are currently working hard to investigate Mirena cases and win our clients the justice they so deserve.

For a free legal evaluation regarding your Mirena lawsuit, contact Carey Danis & Lowe at 800.721.2519 today.

Transvaginal Mesh Safety Information Disclosure & Transvaginal Mesh MDL Grows Larger

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

Published September 11, 2012 on Carey & Danis

Transvaginal Mesh Safety Information Disclosure & Transvaginal Mesh MDL Grows LargerA manufacturer of transvaginal mesh products has recently been ordered in a vaginal mesh federal lawsuit to fully supply the safety information it imparted to the U.S. Food and Drug Administration (FDA) for the purpose of gathering whether the medical device manufacturer withheld any integral pieces of data regarding negative impacts on health from use of its transvaginal mesh product.

A superior court judge in New Jersey made the request of the transvaginal mesh manufacturer, Ethicon Inc., that it release documents on the subject of its clinical trial data and safety observations of its Gynecare transvaginal mesh products. In a report by Bloomberg news, it is understood that the FDA in 2007 mandated that, as adequate safety information was never recorded in regards to Ethicon’s Gynecare transvaginal mesh products, the medical device manufacturer remove such products from the market.

According to the Bloomberg report, Ethicon continued to sell its Gynecare transvaginal mesh products to patients in spite of the FDA mandate. Apparently, the total dismissal of such an FDA mandate is considered a violation of the Federal Food, Drug, and Cosmetic Act. Ethicon reported that, without receiving official FDA approval, they could market and sell the Gynecare transvaginal mesh products because they had received prior FDA approval on a similar transvaginal mesh product. The release of the Gynecare transvaginal mesh line has been referred to as a fast tracking process, one that eliminates the important safety checks via the FDA.

In a multidistrict litigation (MDL), presided over by Judge Joseph R. Goodwin in the U.S. District Court for the Southern Court of Virginia, it has been reported by a Drugwatch journalist that two Arkansas residents have filed a transvaginal mesh lawsuit against medical device manufacturer Boston Scientific Center. The Arkansas couple’s lawsuit makes the claim that Boston Scientific Center developed a transvaginal mesh product made out of materials that cause painful internal tissue inflammation.

Boston Scientific Center’s transvaginal mesh product under question is made out of a monofilament polypropylene that, according to the plaintiff, was known by the manufacturer to cause tissue damage. However, despite such knowledge, the medical device manufacturer made the decision to dismiss such important safety information in order to place the transvaginal mesh product on the market. In the plaintiff’s words, she has suffered enormously from receiving an implantation of Boston Scientific Center’s transvaginal mesh.

Transvaginal mesh is a medical device used as a reinforcing structure, and is especially useful in cases where a patient’s vaginal wall tissues can no longer support surrounding organs. In theory, the surgical implantation of transvaginal mesh should alter a patient’s life for the better, but such is often not the case due to medical device manufacturers releasing products onto the market that are understood to cause severe harm when surgically implanted.