According to Bloomberg.com, the company started selling the Gynecare Prolift device in March 2005, three years before the FDA approved the device in March 2008. From 2005 until May 15, 2008, the FDA received 123 complaints about vaginal mesh complications related to the Gynecare Prolift device.

Transvaginal mesh devices like the Gynecare Prolift device are used to treat symptoms related to stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Unfortunately, these devices can lead to vaginal mesh complications including SUI, POP, urinary tract infections and mesh erosion.

So far, more than 550 women have hired a transvaginal mesh lawyer in an effort to obtain financial compensation for losses associated with vaginal mesh complications. Each of these women has filed a transvaginal mesh lawsuit. However, now that information about Johnson and Johnson selling the device before getting FDA approval has been released, the company may face additional transvaginal mesh lawsuit plaintiffs.

Transvaginal mesh lawyer questions FDA approval process

According to the Bloomberg article, the FDA didn’t know about the Gynecare Prolift device until Johnson & Johnson sought approval for a related product in 2007. Johnson & Johnson said it put the device on the market without FDA approval because it was similar enough to an existing device that it didn’t need individual approval. This issue is at the heart of a transvaginal mesh lawsuit filed in California and other states.

Medical devices similar to existing devices can be “grandfathered” in through an approval system called 510 (k). This system allows companies to bypass device testing that could have uncovered vaginal mesh complications. The medical community and transvaginal mesh lawyer representatives have argued that this system is ineffective and dangerous to consumers.

Women seek compensation through transvaginal mesh lawyer

Women have sought a transvaginal mesh lawyer in an attempt to receive financial compensation for emotional, physical and financial losses.

In July 2011, the FDA reported a fivefold increase in deaths, malfunctions or injuries related to vaginal mesh complications. In September, an advisory panel suggested that transvaginal mesh devices be reclassified as “high risk” devices in need of human testing.

It is too soon to tell whether this information will result in additional transvaginal mesh lawsuit filings against Johnson & Johnson.

Through her Yaz lawyers, George accuses Yaz manufacturer, Bayer Corporation, of failing to alert her daughter and the general public to dangerous side effects of the birth control pills, including Yaz deep vein thrombosis and Yaz pulmonary embolism. George vs. Bayer Healthcare Pharmaceuticals was filed in the U.S. District Court, Southern District of Illinois (East St. Louis) on May 8, 2012.

FDA warns public of Yaz pulmonary embolism risk

Yaz and Yasmin are “fourth generation” progestin contraceptives. Unlike previous generations, these medications contain drospirenone. Even though this new generation of birth control hasn’t been studied extensively by the medical field, the Food and Drug Administration (FDA) has voiced concern about the possibility of users developing blood clot-related side effects like Yaz deep vein thrombosis.

A pulmonary embolism occurs when a blood clot develops in the lungs. This can lead to shortness of breath, a bloody cough, or death. Yaz was approved by the FDA in 2006. From the first quarter of 2004 though the third quarter of 2008, 50 individuals reported deaths that occurred as a result of using Yasmin and Yaz, prompting the medical community to take a closer look at Yaz and Yasmin side effects.

In October 2011, the FDA noted that a study of more than 800,000 women concluded that those taking contraceptives with drospirenone were 74 percent more likely to develop blood clots than those taking other oral contraceptives. Early in 2012, an FDA panel voted to emphasize the risk of blood clots, which can lead to Yaz pulmonary embolism and Yaz deep vein thrombosis, on drug labels.

Yaz side effects lawsuit joins MDL

George joins other plaintiffs in an Illinois multidistrict litigation (MDL) designed to quickly and effectively manage similar pending cases. In 2011, 6,600 actions were consolidated in the U.S. District Court, Southern District of Illinois (East St. Louis).

Judge David R. Herndon is presiding over the MDL.

Yaz lawyers allege Bayer did not issue adequate warnings

The five plaintiffs seeking a Yaz lawsuit settlement allege that they were unaware of the risks associated with the drug when they began taking it. The lawsuit asserts that the defendant in the lawsuit, Bayer, did not provide adequate warning about the dangers associated with their drug, even after reports of adverse effects in both Europe and the United States. In fact, Bayer continued to market its drug as an effective treatment for premenstrual dysphoric disorder (PMDD) and acne, even though there was no clinical evidence to support such statements.

Yaz lawyers also state in the complaint that Bayer was warned by the FDA three times, in 2003, 2008 and 2009, for overstating the benefits of the contraceptive and minimizing the risks associated with its usage, including the danger of Yaz blood clots and gallbladder disease. The plaintiffs’ Yaz lawyers go on to assert that as a direct result of the defendant’s “acts and omissions,” the plaintiffs were unknowingly exposed to risks that led to serious injury, medical care, lost income, and pain and suffering.

Yaz lawsuit settlement pursued by 4 Adults, 1 Minor

The plaintiffs in the recent complaint, which was filed in the U.S. District Court in the District of Minnesota on April 24, 2012, included four adults and one minor. Chastity Aasheim claims she suffered serious gallbladder disease and the eventual removal of her gallbladder in 2008, after using Yaz for approximately one year. Latasha Fields also developed gallbladder disease that resulted in the removal of her gallbladder in September, 2011, after using the oral contraceptive for more than nine years.

The third plaintiff, Tara Henderson, also had her gallbladder removed. In addition, Henderson became pregnant while taking Yaz, and now her baby child suffers from epilepsy. Amy Tousignant used Yaz for nearly two years before suffering a pulmonary embolism as a result of the drug. The final plaintiff, a minor, developed gallbladder disease and also had her gallbladder removed in September, 2011.

All of the plaintiffs, represented by Yaz lawyers, assert they suffered significant injury, pain, medical expense and lost wages as a result of their Yaz use. Now the plaintiffs are seeking a Yaz lawsuit settlement in excess of $75,000 for compensatory and special damages and disgorgement of profits.

Infant’s death allegedly caused by Zoloft PPHN

Though the Zoloft birth defects lawsuit was filed in state court, Pfizer, the manufacturer of Zoloft, filed a notice of removal on April 26, 2012, which moved the case to the U.S. District Court for the Eastern District of Pennsylvania. The removal is not likely to impair Kyle’s claims. On her deceased daughter’s behalf, Kyle is seeking both compensatory and punitive damages against Pfizer and SmithKline Beecham Corp.

Drug makers downplayed risk of defects like Zoloft PPHN

Zoloft (sertraline) is a member of the class of drugs known as selective serotonin reuptake inhibitors or “SSRIs.” The drug was approved by the FDA in 1991 and is one of the oldest SSRIs available. Zoloft has been one of the most prescribed antidepressants in the U.S., with almost 27 million prescriptions dispensed. In 2005, Zoloft’s sales totaled $3.3 billion.

Many of the patients taking Zoloft are women who became pregnant while using the medication. Central to Kyle’s lawsuit is the claim that Pfizer knew that its product posed significant risks to fetal development, but failed to adequately warn either pregnant women or physicians of the dangers. Kyle’s Zoloft birth defects lawsuit alleges that preclinical animal studies performed by Pfizer prior to Zoloft’s approval showed significant harm to fetuses when Zoloft was administered during pregnancy, including increased mortality and cardiac malformations. Birth injuries associated with Zoloft side effects include life-threatening cardiac conditions, spina bifida, persistent pulmonary hypertension (Zoloft PPHN), and limb deformations.

A 2007 study, published in the in the New England Journal of Medicine indicated that the risk of cardiac defects in babies exposed to Zoloft in the womb was 50 percent higher than in babies not exposed. Kyle argues that despite this and subsequent evidence, Pfizer did not actively discourage the use of Zoloft by women who were, or may have become, pregnant.

Propecia lawyer: high proportion of patients suffer side effects

Just how many Propecia users suffer side effects like erectile dysfunction? According to the plaintiff’s Propecia lawsuit, clinical studies have showed that as many as 39% of patients taking the drug have suffered some form of Propecia sexual dysfunction. In 50% of those patients, the side effects persist even after discontinuing the drug, as they did for this plaintiff. His Propecia lawyer describes how the plaintiff suffers pain and diminished enjoyment of life as a result of his sexual problems and cognitive impairment.

Propecia lawsuits consolidated in New York and New Jersey

So many patients have filed a lawsuit with allegations of side effects like Propecia erectile dysfunction that the actions have been consolidated in two states. In New York, lawsuits have been consolidated as multidistrict litigation (MDL) under Judge John Gleeson. In the MDL, consolidated lawsuits will undergo pre-trial proceedings en masse, conserving resources for defendants and plaintiffs and making the process more efficient. Each plaintiff’s Propecia lawyer will then have the chance to argue their case individually. Cases have also been consolidated in New Jersey, where proceedings will be coordinated to eliminate conflicts and generally speed along the process.

Did Merck hide evidence of Propecia sexual dysfunction?

Like the other lawsuits filed against Merck, the plaintiff’s Propecia lawsuit accuses Merck of willfully concealing evidence that Propecia causes significant, permanent injuries in a high percentage of patients. The plaintiff’s Propecia lawyer declares that both the plaintiff and his physician were misled by Merck, and that the physician would not have prescribed his patient Propecia had he been aware of the risks. The plaintiff seeks compensatory damages for the original cost of the drug and for the steadily increasing costs of dealing with Propecia sexual injuries.

The plaintiff’s wife is also listed as a plaintiff, and alleges that she has suffered loss of consortium as a result of her husband’s Propecia sexual dysfunction.

Device loosening necessitates Zimmer knee revision surgery

The Neilsons’ lawsuit states that on August 10, 2007, Michael Neilson was implanted with a Zimmer NexGen GSF LPS-Flex knee replacement. After his surgery, Neilson alleges that he began to experience Zimmer knee problems, including pain due to device loosening. On April 28, 2008, Neilson was forced to undergo Zimmer knee revision surgery. The plaintiffs’ complaint states that neither Neilson nor his doctor was capable of detecting device loosening prior to the plaintiff’s symptoms.

Plaintiffs allege Zimmer knee problems

The Neilsons’ lawsuit states that the plaintiff’s Zimmer knee problems are a result of negligence, failure to warn, design defect, manufacturing defect, breach of express warranty, unjust enrichment, and violation of consumer protection statutes. The plaintiffs request punitive, compensatory, statutory and exemplary damages as compensation for ongoing medical costs, economic losses, pain and suffering, and emotional distress. Ernestine Neilson claims loss of consortium and requests related damages.

MDL consolidates Zimmer knee lawsuits with similar complaints

On August 8, 2011, the Judicial Panel on Multidistrict Litigation ruled that Zimmer knee lawsuits with common points of fact should be consolidated into multidistrict litigation. The MDL, which is headquartered in in the U.S. District Court for the Northern District of Illinois, originally included 28 cases but has since added many tag-along complaints. The Neilsons’ lawsuit is slated to be the next to join, as they have adopted the MDL Short Form Complaint.

But for many of those patients, clear skin came with a terrible price: Accutane inflammatory bowel disease (IBD). Many Accutane users found themselves suffering from severe cramps, diarrhea, vomiting, or bleeding. They sought medical help and found that they had developed IBD: an inflammation of the digestive tract or bowels. Many consulted Accutane lawyers.

There are several forms of IBD: the two most commonly cited in Accutane side effects lawsuits are Accutane ulcerative colitis and Accutane Crohns disease. Both of these conditions can cause ulcers and bleeding of the digestive tract or bowels, intestinal blockages, and bowel rupture. In many cases, the patient is forced to undergo surgery to remove all or part of the damaged colon.

Accutane inflammatory bowel disease warning not added till 2003

Many Accutane users who developed inflammatory bowel diseases did not realize at first that the drug was the cause of their illness. Manufacturer Pfizer did not add warnings for IBD to the Accutane label until August 2003, and even then, someone who had previously taken Accutane wouldn’t automatically have known about that new warning.

That argument was at the crux of plaintiff Kamie Kendall’s Accutane case. Kendall began taking Accutane in 1997 at the age of 12. Two years later, she was diagnosed with ulcerative colitis. Neither she nor her doctor realized that her condition could be caused by Accutane, since the IBD warning was not added to the drug’s label until four years after her diagnoses. She therefore continued taking the drug, even after her diagnosis. It wasn’t until years later, when she saw a magazine advertisement about the side effects of Accutane, that she realized there was a link between the drug and her illness.

Kendall’s case went to trial, and in 2008, a jury awarded her $10.5 million. However, Pfizer appealed the decision, and the case will be sent to retrial.

Settlements in many Accutane side effects lawsuit

Some lawsuits filed by Accutane lawyers have resulted in big payouts to plaintiffs. The highest amount was $25 million, awarded to plaintiff Andrew McCarrell by a jury.

But there have also been high-profile plaintiffs who lost their cases, most notably actor James Marshall (known for roles in the film “A Few Good Men”). Marshall took Accutane and was subsequently diagnosed with ulcerative colitis, but was denied compensation by a jury because he had a previous history of gastrointestinal illness.

Recent Accutane lawsuit consolidations

There are currently more than 7,000 lawsuits alleging some form of Accutane inflammatory bowel disease making their way through the courts. A number of these lawsuits, filed by Accutane lawyers, have been consolidated into an MDL in Florida and mass torts in Pennsylvania and New Jersey.

Pradaxa is a blood thinner used to reduce the risk of stroke in patents with a certain type of heart abnormality. Although effective for this purpose, Pradaxa side effects are harmful and can lead to bleeding, brain hemorrhaging, inflammation of the stomach and death.

Pradaxa Warning Looks Into Serious Bleeding

On Dec. 7, 2011, the FDA announced that it was looking into post-market reports regarding Pradaxa side effects. Specifically, the FDA is looking into reports about individuals who have experienced serious bleeding events as a result of taking Pradaxa.

In a large clinical trial of 18,000 people, major bleeding events occurred at similar rates in patients taking Pradaxa and those who were taking warfarin, an anticoagulant that has been on the market for more than 50 years. The FDA is working with Pradaxa manufacturer, Boehringer Ingelheim, to determine if this incidents are occurring at abnormal rates. The FDA suggested inappropriate dosing, drug interaction or other clinical factors may be contributing factors to reports of Pradaxa bleeding.

The FDA suggested those taking Pradaxa contact their health care provider if they experience the following Pradaxa side effects: unusual bleeding of the gums; frequent nose bleeds; heavier than normal menstrual bleeding; pink or brown urine; coughing up blood; or red or black stool.

Pradaxa Warning Issued Not Long After Drug Approval

The FDA issued its 2011 communication about Pradaxa side effects 14 months after the drug was approved.

Although the 2011 Pradaxa warning brought attention to Pradaxa bleeding, the FDA did not advise patients to stop taking Pradaxa without talking to their health care professional. The FDA also stated that “Pradaxa provides an important health benefit when used as directed and recommends that health care professionals who prescribe Pradaxa follow the recommendations in the approved drug labels.”

Actos lawsuit includes wrongful death cause of action

The plaintiff alleges that many years of Actos use led to a diagnosis of bladder cancer in her spouse and his eventual death from the disease. The plaintiff, Linda Ruff, states in the complaint that her husband used Actos for many years to treat type II diabetes, unaware of the association between Actos and bladder cancer. Her spouse, Evan Ruff, was diagnosed with bladder cancer in January 2010. He died from the disease in September 2010, after what the plaintiff describes as “severe and permanent personal injuries, surgical procedures, pain, suffering and mental anguish resulting in death.”

The plaintiff also asserts in the complaint that warnings regarding a link between Actos and bladder cancer were “vague, incomplete or otherwise inadequate,” when her spouse began taking the medication. The defendants in the case, Takeda Pharmaceuticals and Eli Lilly, also did not provide adequate warnings to the medical community, including the deceased’s physician. Had Evan Ruff known of the dangerous association between Actos and cancer, he would have chosen another course of treatment for his diagnosed type II diabetes, the plaintiff in the case states.

Actos cancer has long history

The association between Actos and bladder cancer is not new. When the drug was first approved by the FDA in 1999 to treat type II diabetes, the complaint asserts that Takeda knew of pre-clinical evidence that suggested further research into the cancer link was warranted. However, Takeda made, distributed and sold the drug without conducting additional clinical research on the potential dangers of the drug.

It was not until 2011 that health agencies began tuning into the cancer risk. During that year, the drug was removed from the market in France and Germany. However, the Actos recall was limited to those countries, despite concerns over the drug worldwide. That same year, the FDA issued a warning to the general public regarding Actos cancer, stating use of the drug for one year or longer increased the risk of a bladder cancer diagnosis. No Actos recall was issued in the U.S. at that time, but doctors were advised to find another course of treatment for diabetes patients with a history of bladder cancer.

These warnings came too late for Evan Ruff. As a result, his spouse is seeking punitive, exemplary and compensatory damages in excess of $75,000.

Drug-brain interactions lead to Chantix suicide lawsuit claims

Chantix, a drug designed to help people quit smoking, targets the brain’s nicotine receptors and reduces the amount of dopamine released, thus diminishing the satisfaction normally derived from smoking. However, the drug’s interaction with a patient’s brain can also cause dopamine levels to plunge to such low levels as to cause depression. This side effect has led to hundreds of FDA reports filed by patients experiencing severe Chantix depression, anxiety, and suicidal thoughts and behavior.

Plaintiff is the alleged victim of Chantix depression

According to her complaint, Norris began taking Chantix in June 2007 – several months before the Food and Drug Administration (FDA) issued a public health advisory in February 2008 regarding suicide as a side effect of the drug. Soon after beginning course of treatment with Chantix, Norris allegedly experienced serious injuries and damages, including serious anxiety, severe Chantix depression, erratic behavior, irritability, agitation, paranoia, suicidal ideation, and finally, a suicide attempt that required hospitalization.

Chantix lawyer charges Pfizer with gross negligence and fraud

With the help of her Chantix lawyer, the plaintiff adopted and incorporated by reference all common allegations from the Chantix MDL’s Master Consolidated Complaint. Norris claims negligence, negligence per se, design defect, failure to warn, breach of express and implied warranties, fraudulent misrepresentation and concealment, gross negligence, unjust enrichment, and violations of state consumer fraud and deceptive trade practices acts. She requests global prayer for relief and tolling of limitation period, as well as punitive damages and other compensation for her injuries.