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Cosmetic Act Archives - Carey Danis & Lowe

Lawyers at Carey Danis & Lowe Currently Evaluating Mirena Cases

By | Mirena, Pharmaceutical litigation, Uncategorized

Published February 20, 2013 by PR Web

St. Louis, Missouri (PRWEB) February 20, 2013

Lawyers at Carey Danis & Lowe Currently Evaluating Mirena CasesTo address the increasing number of adverse event reports associated with the use of the Mirena intrauterine device manufactured by Bayer(1), lawyers at Carey Danis & Lowe have launched a new website with useful information for individuals who may have used the Mirena IUD or know someone who has used the contraceptive device.

The new webpage has information about health complications associated with use of Bayer’s Mirena IUD. In Carey Danis & Lowe’s investigation into patients who have used the Mirena IUD, the most common health complications linked to use of the contraceptive device are the IUD embedding into the uterine wall, IUD tissue perforation, and ectopic pregnancy.(2)

The information provided on the Mirena IUD website is intended to assist patients who have used the IUD and individuals who know someone who has used the contraceptive device with understanding the IUD’s health complications and exploring legal options offered by Carey Danis & Lowe.

In addition to launching a new Mirena IUD webpage, lawyers at Carey Danis & Lowe are closely watching a lawsuit filed against Bayer in a Pennsylvania federal court.

According to a Bloomberg News report,(3) a new Mirena IUD lawsuit has been filed against Bayer in the U.S. District Court for the Eastern District of Pennsylvania in Philadelphia. The plaintiff who filed the lawsuit alleges that Bayer Healthcare Pharmaceuticals, Inc. failed to supply information and warn the public and healthcare providers about the health problems associated with use of the Mirena IUD, including the device embedding into surrounding tissue and ectopic pregnancy among others.

The plaintiff in the case known as Prendergast v. Bayer Pharmaceuticals Corp. is a Pennsylvania women who received a Mirena IUD, and subsequently had surgery to remove the contraceptive device after experiencing serious complications.(3) Among her other claims in the lawsuit, Ms. Prendergast alleges that the German pharmaceutical company employed misleading and deceptive marketing to advertise the Mirena IUD as a safe medical device.

In response to the Pennsylvania Mirena IUD lawsuit, a Bayer spokesperson said that the pharmaceutical company “will vigorously defend itself against claims regarding Mirena”, according to Bloomberg News.

The Pennsylvania Mirena IUD lawsuit is not the first circumstance wherein Bayer’s Mirena marketing campaign has fallen under scrutiny for its deceptive strategies. The U.S. Food and Drug Administration (FDA) in 2009 wrote a letter to a Bayer executive that pointed to unsubstantiated marketing language that claimed Mirena would improve happiness, health, and one’s romantic life.(4)

In its letter, the FDA stated that no such evidence existed linking Mirena to health improvements, and in fact, they had evidence that demonstrated the opposite, that Mirena use led to a decline in health due to certain side effects. As a result of outrageous claims supported by no evidence of any kind, the FDA ruled that Bayer’s Mirena marketing strategy violated the Federal Food, Drug, and Cosmetic Act.

To learn more about the serious health risks linked to use of Bayer’s Mirena IUD, the Mirena deceptive advertising campaign, and legal options for those who have used the Mirena IUD, contact a lawyer at Carey Danis & Lowe, or visit the new Mirena IUD webpage.

Resources:
(1)http://www.adverseevents.com/drugdetail.php?AEDrugID=3893&BrandName=MIRENA

(2)http://www.bloomberg.com/news/2013-01-28/bayer-sued-over-alleged-hidden-risks-of-mirena-contraceptive-1-.html

Carey Danis & Lowe is a plaintiff’s litigation firm based in St. Louis, Missouri with law offices across the United States in Illinois, Missouri, and Florida. Carey Danis & Lowe specializes in defective drug and pharmaceutical litigation and class action lawsuits. The Carey Danis & Lowe team is comprised of experienced attorneys working alongside knowledgeable professional staff that includes medical doctors, nurses, and information technology specialists. Contact Carey Danis & Lowe at 800-721-2519.

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.

Abbott to Pay $1.6B to Settle Depakote Claims

By | Depakote, Pharmaceutical litigation, Uncategorized

The following article was originally published on May 8, 2012 by Chicago Tribune.

Abbott Laboratories said Monday it will pay $1.6 billion to settle federal and state claims that it illegally marketed the anti-seizure medication Depakote for uses not approved by the Food and Drug Administration.

As part of the settlement agreement, North Chicago-based Abbott said it would pay $800 million to resolve civil cases brought by federal and state governments, $700 million in criminal penalties and $100 million to states to resolve consumer protection matters.

The company will to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for misbranding. Abbott also agreed to a five-year probationary period in which it must report any probable violations of the law to the probation office, according to the U.S. Department of Justice.

Illinois Attorney General Lisa Madigan said the state will receive $20 million as part of the deal.

The settlement was expected by investors. Last year, Abbott earmarked $1.5 billion to cover projected costs of the settlement, and set aside another $100 million in April for the same purpose.

Shares of Abbott finished Monday up 10 cents, at $62.51.

Abbott, Chicagoland’s largest company as measured by market capitalization, plans to spin off its legacy drug business into a separate, publicly traded firm called AbbVie this year. It said in a release that certain compliance measures and certification requirements will transfer to the new company.

“We are pleased to resolve this matter and are confident we have the programs in place to satisfy the requirements of this settlement,” Abbott General Counsel Laura Schumacher said in a statement.

“The company takes its responsibility to patients and health care providers seriously and has established robust compliance programs to ensure its marketing programs meet the needs of health care providers and legal requirements,” Schumacher said.

Depakote, an anti-seizure and mood-stabilizing drug, was first approved by the FDA in 1983 to treat certain seizures in adults and children older than 10. Since then, the drug has been approved to treat other types of seizures, manic episodes of bipolar disorder and for the prevention of migraine headaches.

The Justice Department said in a release that the company illegally marketed Depakote for uses including for treatment of schizophrenia, agitated dementia and autism.

Though doctors can prescribe drugs “off-label,” as the practice is known, companies are prohibited from marketing them to treat conditions that are not approved by the FDA.

Abbott said it had been under investigation for four years in connection with the sale and promotion of Depakote stretching back to 1998.

The investigations led by the federal government and states’ attorneys general were based partly on whistle-blower lawsuits filed in federal courts in Illinois, Virginia and the District of Columbia that accused Abbott of illegally promoting Depakote. Those suits also alleged that the company gave doctors and pharmacists illegal kickbacks to talk about off-label uses of the drug to boost sales.

The first suit, filed in 2007 by former Abbott saleswoman Meredith McCoyd, accused the drug maker of encouraging her and other salespeople to promote the drug in nursing homes and public mental health centers, where most patients were covered by federal health care programs, including Medicaid.

The Justice Department intervened in those suits to determine whether the company’s marketing of the drug violated civil and criminal laws.

In a release, the Justice Department said Abbott admitted that from 1998 to 2006, it “maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use.”

From 2001 to 2006, it said, the company marketed the drug for use in combination with anti-psychotic drugs to treat schizophrenia, though its own clinical trials showed Depakote provided no benefit.

“Today’s settlement shows further evidence of our deep commitment to public health and our determination to hold accountable those who commit fraud,” said James M. Cole, Deputy Attorney General. “We are resolute in stopping this type of activity and today’s settlement sends a strong message to other companies.”

The Abbott settlement is one of a string of recent enforcement actions pursued by the FDA, which has ramped up its investigation of off-label drug marketing, ensnaring several other large drugmakers within the last several years.

In November, GlaxoSmithKline PLC said it would pay the U.S. government $3 billion to settle civil and criminal charges for illegal marketing of diabetes drug Avandia and others.

In 2009, Pfizer Inc. paid $2.3 billion for similar allegations about its painkiller Bextra, and Eli Lilly & Co. settled for $1.4 billion the same year for Zyprexa, used to treat schizophrenia.