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Foulston Law Office Blog

Wednesday, December 4, 2013

Final Bellwether Trial over Bard Avaulta Mesh Begins in Federal Court

DECEMBER 4, 2013By: Katherine Thomas

 

The last of the Bard bellwether transvaginal mesh trials began on December 3 in West Virginia federal court.  The Bard Avaulta mesh lawsuit was originally scheduled to be tried in November, but the judge on the case issued a notice postponing it for a month.  The Avaulta line of vaginal mesh products had been used to treat pelvic organ prolapse (POP) and female stress urinary incontinence before it was taken off the market by Bard in July 2012 rather than comply with FDA-mandated testing.

 

Why women file a Bard Avaulta mesh lawsuit

There are more than 4,800 transvaginal mesh lawsuits in the federal court system against New Jersey-based-C.R. Bard over the Avaulta line of mesh, which many women claim can erode, leading to organ damage and painful sexual intercourse.  The complaints against Bard involve similar allegations that the vaginal mesh was defectively designed and sold without adequate warnings about the risks associated with it. Bard officials pulled the Avaulta mesh off the market in 2012 after the FDA ordered manufacturers of transvaginal mesh to study rates of organ damage, infection, and other complications associated with pelvic mesh devices.

The lawsuits are pending before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia as part of a litigation. They were consolidated into multidistrict litigation with the goal of streamlining the pretrial process by conserving resources and judicial time.

As part of the coordinated pretrial proceedings, four cases were selected for early trial dates.  These cases are known as “bellwethers,” because they are designed to help the parties in the lawsuit gauge how juries are likely to respond to evidence that may be repeated throughout each case.

 

Results of Bard transvaginal mesh trials

The first bellwether trial began in July 2013.  The plaintiff, a nurse from Georgia, won a jury award of $250,000 in compensatory damages and $1.75 million in punitive damages, which are designed to punish the defendant for its actions in the manufacture and sale of the transvaginal mesh.  The nurse had alleged that the mesh damaged her organs and caused other ailments. In the second bellwether hearing the parties reached a settlement agreement during the first day of trial.  Bard agreed to pay an undisclosed amount to a North Carolina woman who said she experienced pain and suffering, permanent injury, and physical deformity because of the transvaginal mesh.  The third bellwether case was cancelled after the plaintiff voluntarily dismissed the case.

 

Pelvic mesh lawsuits coordinated as Multi-District Litigation

Judge Goodwin is also presiding over five other multidistrict litigations involving transvaginal mesh made by other companies, including American Medical System, Ethicon, Boston Scientific, Coloplast, and Cook Medical.  These companies face a combined total of over 30,000 lawsuits in the federal courts over injuries allegedly caused by the transvaginal mesh.

 

The legal proceedings for five of the multidistrict litigations are being handled in the U.S. District Court for the Southern District of West Virginia.  There is also a multidistrict litigation for Mentor Corp., another manufacturer of vaginal mesh, which has been established in the U.S. District Court for the Middle District of Georgia.

 For further information, contact the Foulston Law Firm by using the contact form at the top of the page. 


Friday, October 11, 2013

TRANSVAGINAL MESH SETTLEMENT TALKS BEHIND THE SCENE

 

October 10, 2013By: Ava Lawson

Bloomberg reports that several pelvic mesh manufacturers including C.R. Bard, Boston Scientific and Endo Health Solutions may be entering behind-the-scenes talks with plaintiffs in an effort to negotiate transvaginal mesh settlements. Insiders who are familiar with the ongoing vaginal mesh litigation told the news source that plaintiffs are hoping U.S. District Judge Joseph Goodwin, who is presiding over the federal suits, will appoint a settlement committee that would include legal counsel for both parties, including an attorney who facilitated a monstrous $246 billion tobacco-litigation settlement on behalf of state attorneys general.

The federal judge who is overseeing all pelvic mesh injury lawsuits consolidated in multidistrict litigations in West Virginia district court noted that vaginal mesh lawsuit settlement talks are taking place behind closed doors at the moment, and may also include defendants Cook Medical and Cotoplast, though this information has not been confirmed.

Possible transvaginal mesh settlements in the works

While the federal products liability litigation concerning serious and often debilitating transvaginal mesh complications has swelled to include more than 25,000 cases against six different manufacturers, many suspect that claims could easily exceed 50,000 in the coming months. Any settlement agreement would take into account a plaintiff’s medical expenses related to her injuries or mesh revision surgery, and would attempt to compensate for damages including lost wages, physical and emotional trauma, and loss of spousal consortium.

Carl Tobias, a teacher of products liability law at University of Richmond, VA told Bloomberg, “The liability seems pretty clear on these cases, so settlement makes sense.” Meanwhile, spokespersons for Boston Scientific, Cook Medical, Bard and others have declined to comment on any pending transvaginal mesh lawsuit settlements.

At present, there are six separate transvaginal mesh MDLs, all involving various types of mesh implants, surgical slings and patches. Though the devices are designed and manufactured by different companies, many of the allegations made by plaintiffs are similar in nature. Women who’ve filed a vaginal mesh lawsuit claim they’ve suffered chronic infections, painful sexual intercourse, mesh erosion, internal organ damage and other complications caused by faulty design or materials that were incompatible with human tissue.

Vaginal mesh lawsuit trial losses

Bard stopped selling its Avaulta pelvic mesh implants last year after the FDA ordered that all mesh manufacturers conduct additional studies on the safety and efficacy of its products. Bard has also negotiated settlements with some cases after jurors handed down two verdicts in favor of the plaintiffs.

In an Avaulta mesh lawsuit last year, a California state jury awarded a woman $5.5 million in compensatory damages for her injuries, of which Bard was liable for $3.6 million under California law. Under the guidance of Judge Goodwin, the first federal case against Bard was heard this past month. The Charleston, West Virginia panel decided Bard was liable for a Georgia woman’s organ damage and rendered a $2 million verdict for the plaintiff.

If Goodwin appoints a settlement committee, thousands of injured plaintiffs may finally achieve resolution of their claims and secure just compensation for their pain, suffering and other losses. However, the mesh litigation poses a challenge for potential settlement negotiators since they are faced with suits involving more than 50 different products (some of which have already been pulled off the market) made by several companies.

 


Thursday, October 3, 2013

LAWSUITS MOUNTING IN VAGINAL MESH DEFECTIVE PRODUCT LAWSUITS

More than 30,000 Women Have Filed Vaginal Mesh Defective Product Lawsuits

 

A medical product that was supposed to make women’s lives better has reduced the quality of life for many. Vaginal mesh and slings  have had a very negative impact on the lives of many women and now lawyers for Boston Scientific Corp. and two other companies making vaginal inserts to support women’s pelvic muscles have begun talks to deal with the defective product lawsuits that more than 30,000 women have filed so far.

As many as thirty to fifty percent of women may experience Pelvic organ prolapse in their lives and it occurs when a pelvic organ-such as your bladder-drops (prolapses) from its normal spot in your lower belly and pushes against the walls of your vagina. This can happen when the muscles that hold your pelvic organs in place get weak or stretched from childbirth or surgery. The medical device chosen to fix this problem in many women was vaginal mesh or a vaginal sling. Vaginal mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue.

The problem with this medical device is that it can begin to erode and damage other organs. In some cases the mesh breaks through the incision or intact vaginal lining. This results in symptoms such as bleeding, vaginal discharge, odor, and often scratching of the male partner with intercourse.

The FDA issued the warning that serious complications associated with the surgical meshfor transvaginal repair of POP were not rare. This was a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.

However despite the warnings from the FDA manufacturers kept producing and distributing the product. Now the lives of many women have taken a turn for the worse. This can be a difficult issue for some women to speak with a lawyer about. However not speaking up can mean forgoing any compensation to help repair or move on from the injury.


Monday, September 30, 2013

JURY RULES TAKEDA FAILED TO PROPERLY WARN ABOUT ACTOS RISKS - BLOOMBERG NEWS)

Bloomberg News

 

September 26, 2013

 

A Maryland jury ruled that Takeda Pharmaceutical Co. (4502) didn’t properly warn an ex-U.S. Army translator and his doctor about the risks of its Actos diabetes drug and ordered the company to pay more than $1.7 million in damages. A judge immediately threw out the verdict.

Jurors in state court in Baltimore deliberated more than six hours over two days before finding Asia’s largest drugmaker liable for the cancer death of Diep An, Michael Miller, one of An’s lawyers, said in an interview. Since jurors also found that An contributed to his death by smoking for 30 years, Judge Brooke Murdock set the verdict aside based on Maryland law.

“We consider the verdict to be a vindication of our claims that Takeda failed to properly disclose the risks of this drug,” Stuart Simms, another lawyer representing the An family, said today in an interview.

It’s the second time a U.S. jury has found that Osaka, Japan-based Takeda hid Actos’s links to bladder cancer. The drugmaker, which faces more than 3,000 suits over the drug, is preparing for trials in state courts in Las Vegas and Chicago and a federal court in Louisiana during the next four months.

“We believe we acted responsibly and we are pleased with the judgment in favor of Takeda,” Ken Greisman, a U.S.-based spokesman for Takeda, said in an interview.

Actos Sales

Sales of Actos peaked in the year ended March 2011 at $4.5 billion, accounting for 27 percent of Takeda’s revenue at the time, according to data compiled by Bloomberg. The drug is now available as a generic.

Former Actos users contend in court filings that Takeda researchers ignored or downplayed concerns about the drug’s cancer-causing potential before it went on sale in the U.S. in 1999, and misled U.S. regulators about the medicine’s risks.

U.S. Food and Drug Administration officials found in a 2011 review of a company-sponsored study that some Actos users faced an increased risk of developing bladder cancer or heart problems. The company pulled the drug off the market in France that year at the request of regulators. In Germany, the government removed Actos from its reimbursed list of drugs at the same time, the company said.

Takeda officials said in an e-mailed statement that the study FDA officials reviewed is continuing and final results are expected next year. Other information generated by the study showed that over time, patients’ risks of developing bladder cancer from the medicine decreased, they said.

Federal Trial

More than 1,200 suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges. The first of those cases goes to trial in January.

In April, A California jury ordered Takeda to pay $6.5 million in damages to a diabetic man who blamed the drug for his bladder cancer. The judge in the case later threw out the verdict and the family appealed.

Even though two juries have found Takeda failed to properly warn patients and doctors about the drug’s links to bladder cancer, Greisman said the drugmaker is pleased with the outcomes of the two cases.

“In both cases, Takeda has been victorious in the ultimate outcomes,” he said.

Bladder Cancer

In the Baltimore case, An’s lawyers argued the former U.S. Army translator took Actos to treat diabetes starting in 2007 and was diagnosed with “high-grade bladder cancer” in September 2011, according to court filings. He died in January 2012. Miller and Simms sought as much as $4 million in damages for his family.

Takeda’s lawyers presented evidence showing that An was a former smoker who consumed half a pack of cigarettes a day for 30 years before stopping in 1996. Researchers have found smoking increases the risk of bladder cancer, the lawyers said.

The company also argued it provided adequate warnings about the drug’s risks and noted the U.S. Food and Drug Administration had approved it and never demanded it be taken off the market.

The case is An v. Nieberlein, 24-C12003565, Circuit Court for the City of Baltimore, State of Maryland.

 


Monday, September 30, 2013

YAZ CONTINUES TO SETTLE CASES DESPITE DENYING LIABILITY

Yaz Lawsuit Settlements Total $1.4 Billion

September 30, 2013:

As of July 2013, Bayer Healthcare Pharmaceuticals, makers of the Yasmin and Yaz birth control pills, have settled claims reaching up to  $1.4 billion dollars.  At least 6,760 plaintiffs have reached  Yaz lawsuit settlements in the United States – despite Bayer continuing to deny any wrongdoing.

These drugs, Yaz, Yasmin and other birth control pills, contain the hormone drospirenone are alleged to have caused thousands of deaths, strokes, pulmonary embolisms and dangerously elevated potassium levels, among other problems. Though all oral birth control pills carry an increased risk of blood clots in the legs and lungs, the newer generation of contraceptives is thought to pose a greater risk.

The extent and severity of Yaz and Yasmin side effects has prompted calls for the FDA to order Bayer to withdraw the products from the market. After reviewing research on the risk of blood clots associated with Yaz and Yasmin, the FDA demanded that Bayer alter the prescription information for both pills. The revised label explains that the risk of side effects such as blood clots may be greater than with other contraceptives.

In light of the number of settlements and emerging litigation, women’s health campaigners want to see more done to warn the public not to use these drugs. Oral contraceptives containing drospirenone “can cause increased blood levels of potassium and (are) no more effective than other oral contraceptives in preventing pregnancy.”

Bayer claims there is ‘no increased risk’

Bayer points to a number of industry-funded studies that indicate no greater risk of  Yaz blood clots or other side effects commonly associated with oral contraceptives. After reviewing the research, the FDA stated that the benefits of Yaz and Yasmin outweigh the risks.

Oral contraceptives are the most popular form of birth control in the U.S. Most use a combination of estrogen and progestin to prevent ovulation.

Common side effects include:

  • bloating
  • irregular bleeding
  • headaches
  • breast tenderness
  • nausea

Because estrogen can cause coagulation – leading to blood clots and strokes – the estrogen dose has been lowered since oral contraceptives were first introduced, and drug makers have looked for ways to favor progestin instead.

Yasmin was launched in 2001. It was the first birth control pill to use drospirenone, a new type of progestin. Yaz followed in 2006. Part of their appeal was that neither pill caused bloating or weight gain, a common side effect of first and second generation oral contraceptives. By 2008, Yaz was the best-selling birth control pill in the country.

FDA warning

The same year, the FDA warned Bayer about misleading advertising tactics after a series of Yaz and Yasmin commercials promised false benefits and minimal risk. The company denied any wrongdoing but did run a series of corrective television commercials. Sales fell by 60 percent during 2010.

More Yaz lawsuit settlements expected

More than 5,400  Yaz lawsuits are currently pending in the U.S. Bayer began settling claims for blood clot injuries, and has now set aside $24 million for nearly 9,000 lawsuits alleging gallbladder injuries.

Several studies suggest the risk of blood clots posed by Yaz and Yasmin is 1.5 times higher than with other hormone-based contraceptives.

 


Thursday, September 5, 2013

LEARN ABOUT THE SIDE EFFECTS OF MIRENA

Mirena IUD Side Effects

Mirena is an intrauterine device (IUD) that is inserted into the uterus to prevent pregnancy. It is a hormonal birth control method that involves the release of progestin in order to suppress ovulation, thin the uterine lining, and prevent fertilization of an egg. Mirena is intended to offer long-term pregnancy prevention, and women may have the device in for up to five years before a replacement is needed. However, many serious Mirena side effects have been reported to the FDA. About 45,000 adverse events have already been reported.

Common Mirena IUD side effects

Possible side effects of Mirena IUD birth control can include:

  • Yellowing of the skin and eyes
  • Pain during intercourse
  • Infection (fever, chills)
  • Allergic reaction (trouble breathing, swelling of the facial region, hives)
  • Pale skin/easy bruising
  • Weakness
  • Extreme dizziness
  • Pelvic pain and cramps
  • Vaginal bleeding, sores, or discharge
  • Abscess
  • Embedment in the uterine wall
  • Erosion of the IUD

Some women have also experienced Mirena side effects like back pain, mood changes, weight gain, nausea, vomiting, and bloating. It’s also possible to experience heavy menstrual bleeding or breakthrough bleeding, along with other irregularities in menstruation.

Mirena can also cause ovarian cysts, which are abnormal growths of the ovaries that can rupture. If this complication occurs, internal bleeding and ovarian torsion may result.

IUD migration may lead to perforation of the uterus

                        The Mirena IUD is inserted by a healthcare professional, and it is intended to remain in place until the healthcare professional removes it. However, the uterine wall can be perforated, or punctured, by the IUD when the doctor inserts it. In addition, the FDA has received many reports of perforation that occurred at some point after insertion. This adverse event can lead to infection, organ damage, and adhesions.

Uterine perforation often requires surgery, and sometimes multiple surgeries may be needed. Scar tissue that develops as a result of surgery may cause infertility. Women who have experienced these Mirena IUD side effects have reported heart palpitations, nausea, vomiting, fever, and abdominal pain.

Migration of Mirena necessitates surgery

It’s critical for Mirena patients to see their healthcare providers upon experiencing any possible symptoms of uterine perforation. If treatment is delayed, the device can migrate further until it is outside the uterine cavity. This risk is heightened in women who have this birth control device inserted shortly after giving birth, particularly while they are breastfeeding.

Some women have suffered from intestinal perforation due to migration of the Mirena device. This can lead to abscesses, intestinal obstruction, and damage to other organs and tissues, along with adhesions and scarring. Patients might require surgical intervention to remove the IUD once it has migrated, and surgeries carry additional risks, such as adverse reactions to anesthesia and infections.

Pelvic inflammatory disease (PID) reported

Mirena side effects can also include pelvic inflammatory disease, which is a bacterial infection. Severe indications of PID include symptoms of shock, including fainting, as well as a high fever, vomiting, and severe lower abdominal pain. Some women may also have difficulty passing urine, fatigue, and a heavy, foul-smelling vaginal discharge. If it is left untreated, PID can lead to chronic pelvic pain, infertility, and an ectopic pregnancy.

If an ectopic pregnancy occurs, it is a potentially life-threatening situation that requires prompt medical care to remedy significant internal bleeding. It occurs when a fertilized egg is unable to travel through the fallopian tube. Emergency surgery is required to treat it.

More women using IUDs

It has been estimated that 15 million women worldwide have used the Mirena IUD, with 2 million women in the U.S. relying on the birth control device manufactured by Bayer. Positive reviews have noted the convenience of the device; unlike a pill, it does not need to be taken daily. Clinical trials have shown Mirena to be more effective in stopping pregnancy than oral contraceptives: the failure rate with Mirena, when working correctly, is less than 1% over five years.

In 2002, about 1.4 percent of contraceptives used were IUDs, whereas in 2010, IUDs made up about 10.4 percent of prescribed birth control.

Mirena FDA warnings

The FDA approved Mirena for consumer use in 2000. However, in 2009, the a Mirena FDA warning to Bayer, the manufacturer. The FDA noted a misbranding of the product, and stated that the company made misleading claims regarding its indications. Bayer had launched a marketing campaign that insinuated that the Mirena IUD would improve a couple’s intimacy and romance.

In that same warning letter, the FDA noted the potential for serious Mirena IUD side effects. The warning letter stated that Bayer had failed to adequately warn consumers of the side effects of the IUD, and that the company did not make accurate statements regarding the proper functioning of the device.

Mirena side effects prompt lawsuits

These potentially permanent complications have prompted many to file Mirena lawsuits against Bayer. Many of the lawsuits claim that the company failed to warn doctors and patients of the risks of the IUD device. Mirena lawyers for the plaintiffs have often cited migration of the device and the potential for uterine perforation as injuries for which Bayer is liable. Lawsuits allege that the company has claimed that these side effects are not common.


Friday, August 16, 2013

$2 MILLION VERDICT IN VAGINAL MESH CASE

Bard Loses $2 Million Verdict in Vaginal-Mesh Implant Trial

 

C.R. Bard Inc. was told by a jury to pay $2 million to a woman who alleged the company hid flaws within some of its vaginal-mesh implants in the first federal trial of claims over the devices.

Jurors in Charleston, West Virginia, deliberated about 12 hours over two days before finding Murray Hill, New Jersey-based Bard liable for injuries Donna Cisson blamed on its Avaulta line of devices. The jury awarded $250,000 in compensatory damages for Cisson’s injuries plus $1.75 million in punitive damages.

Bard, based in Murray Hill, New Jersey, still faces more than 8,000 other claims over its Avaulta devices, which Cisson and other women allege can cause organ damage and make sexual intercourse painful when the devices erode. Johnson & Johnson,Endo Health Solutions Inc. and Boston Scientific Corpface similar claims that their implants, threaded in place through vaginal incisions, shrink over time.

“This jury sent a message that Bard needs to change its ways,” Henry Garrard, one of Cisson’s lawyers, said after the punitive-damages verdict was announced. “The jury is telling them this kind of conduct won’t be tolerated.”

Bard officials said they dispute the jury’s finding that Cisson’s injuries were caused by the vaginal implant and will appeal.

‘Compelling Grounds’

“We disagree with the verdict reached by the jury and believe there are compelling grounds for reversal. We will appeal,” Scott Lowry, a Bard spokesman, said yesterday in an e-mailed statement. “Our Avaulta mesh products are safe and effective medical devices, cleared by the FDA.”

Bard fell 1.7 percent to $133.47 in New York Stock Exchange composite trading. The shares have gained 16 percent this year.

The implant cases against Bard and other manufacturers have been consolidated before U.S. District Judge Joseph Goodwin in Charleston for pretrial information exchanges. Goodwin, who presided over Cisson’s case, also will preside over an Aug. 19 trial. Two other trials are set for next month.

Bard officials pulled the Avaulta implants off the market last year after the U.S. Food and Drug Administration ordered all makers of the devices to study rates of organ damage, infection and pain during sex linked to their products.

A California state court jury last year found Bard liable for a woman’s injuries tied to an Avaulta implant in the first case to go trial in any U.S. court. Jurors ordered the company to pay $5.5 million in damages. Bard is liable for only $3.6 million of that award under state law.

Mesh Removed

Cisson, a public-health nurse from Toccoa, Georgia, got an Avaulta Plus implant in 2009 to buttress organs that were collapsing into her pelvic region, according to evidence in the case. Cisson had several surgeries to remove the mesh after she began suffering pain, bleeding and bladder spasms.

Her lawyers argued during the two-week trial that Bard officials put profits ahead of safety by ignoring warnings about defects in the Avaulta implants.

Bard officials knew the company was making the implants out of plastic which carried a warning that it shouldn’t be permanently implanted in humans, Garrard, an Atlanta-based lawyer, told jurors.

“You have not heard Bard come here and say we accept responsibility and want to make amends,” Garrard told jurors in the punitive-damages phase of the case. He urged them to return an award that would “get the attention” of the company’s executives in New Jersey.

‘No Intent’

Bard’s lawyer countered that company officials properly designed and manufactured the implants and had shown “no intent to harm” Cisson or other women with the mesh.

The company “complied with industry standards” in producing the implants and didn’t deserve to be punished, Lori Cohen, one of Bard’s lawyers, told jurors.

Jurors found that Bard officials defectively designed the Avaulta implants and failed to properly warn doctors and women about the mesh’s flaws. They also found that company officials ‘mishandling of the devices amounted to “malice, fraud or wantonness” that deserved punishment, according to the verdict form in the case.

“The economic cost of ignoring patient safety just got a little more expensive,” Paul Farrell Jr., a Huntington, West Virginia-based lawyer representing Cisson, said after the verdict was announced.

Under Georgia law, 75 percent of Cisson’s $1.75 million punitive-damages award will be handed over to the state’s general fund.

Cisson’s first trial, in July, ended in a mistrial after a witness began testifying about the devices’ marketing and removal from the market. Goodwin ruled earlier that plaintiffs couldn’t mention Bard had withdrawn the products.

The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 10-md-02187, and Cisson’s case is Cisson v. C.R. Bard Inc., 11-cv-00195, U.S. District Court, Southern District of West Virginia (Charleston).

 

 

 


Monday, June 3, 2013

Takeda Put Actos Sales Ahead of User Safety, Witness Says

By Jef Feeley - Mar 5, 2013 11:01 PM CT

Takeda Pharmaceutical Co. (4502), Asia’s biggest drug maker, put sales of its Actos diabetes drug ahead of concerns about consumer safety, a witness testified in the first trial over claims the medicine caused cancer.

In 2005 e-mails discussing whether regulators in the U.S. and Europe might seek warning labels about Actos’s potential links to bladder cancer, Takeda officials emphasized protecting the product rather than its users, Howard Greenberg, a clinical pharmacologist, said in state court in Los Angeles yesterday.

“There are multiple e-mails from different levels of Takeda management that indicate the product came first,” Greenberg told jurors in the first day of testimony about Jack Cooper’s claims over Actos.

Testimony in the trial comes about a month after Osaka, Japan-based Takeda won U.S. regulatory approval for Nesina, a replacement for Actos, which lost patent protection last year. Actos sales peaked in the year ended March 2011 at $4.5 billion for Takeda, accounting for 27 percent of the company’s revenue at the time, according to data compiled by Bloomberg.

The U.S. Food and Drug Administration approved Actos for the U.S. market in 1999 and the drug later became the world’s best-selling diabetes treatment.

European Regulators

Health regulators in Germany and France ordered Actos pulled off the market in 2011 after an analysis of a company-sponsored study showed some Actos users faced an increased risk of developing bladder cancer or heart problems.

Takeda executives said in a Feb. 11 statement the Actos study regulators reviewed is continuing and final results should be available next year. Other information generated by the study showed that over time, patients’ risks of developing bladder cancer from the medicine decreased, Takeda said.

Cooper, a retired cable splicer for Pacific Bell, was diagnosed with bladder cancer in 2011, according to court filings. He took Actos for more than four years. His lawyer told jurors in opening statements that Cooper had been in “good shape” before he started on the medication, regularly walking five miles, repairing his own roof and going deep-sea fishing with his grandchildren.

Takeda’s lawyer countered in her opening statement that Cooper’s history as a smoker and his gender put him at higher risk for developing bladder cancer. The disease is the fourth-most common cancer among men after prostate, lung and colon cancer, according to the Bladder Cancer Advocacy Network.

Internal Documents

Greenberg, testifying as an expert for Cooper, said he reviewed internal Takeda documents to prepare for his testimony, according to an online feed from Courtroom View Network. Greenberg said he formerly worked as a drug researcher for companies such Bristol-Myers Squibb Co. (BMY) and Johnson & Johnson (JNJ)’s Janssen Pharmaceuticals unit.

Among the files Greenberg reviewed was an August 2005 e-mail from Takeda executive Kiyoshi Kitazawa on regulators’concerns about Actos’ cancer links, the pharmacologist said.

In the e-mail, Kitazawa highlighted Actos’s value for colleagues who had analyzed what regulators might do in the wake of research showing that users may be at higher risk of getting bladder cancer. Takeda officials were worried that regulators would demand that the company add warnings about the illness to Actos’s label, according to the e-mail.

“Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally,” Kitazawa said.

Worst-Case

Takeda officials said that the “worst-case scenario”would be for regulators to mandate the inclusion of a bladder cancer warning on Actos’s label, according to the e-mail. Kitazawa urged colleagues to seek a “positive outcome” on the warning issue from “regulatory authorities,” the e-mail shows.

Under cross examination by Takeda lawyer Bruce Parker, Greenberg acknowledged that employee e-mails may not indicate the drugmaker’s corporate policies on issues such as patient safety. “I’d agree with that,” the pharmacologist said.

The case is Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court (Los Angeles).

 


Monday, June 3, 2013

MIRENA IUD LAWSUITS HEAT UP

As Mirena lawsuits continue to move forward in both state and federal courts, attorneys note that a new Mirena side effects study has found that the bleeding and spotting that sometimes occurs in the months after insertion of the levonorgestrel-releasing IUD (sold under the brand name Mirena) could not be relieved with medication. The study, published online April 5 in Obstetrics & Gynecology, was designed to identify a 25% reduction in the number of bleeding or spotting days for the first 3 months following insertion of the IUD. However, the study found that the administration of one of two drugs commonly used to treat heavy menstrual bleeding and menstrual pain only reduced the number of bleeding days by six and three, respectively.

This study is just another reminder of the Mirena side effects that can occur in women who use this IUD. In addition to the bleeding described in this report, numerous women who allegedly suffered more serious complications, including organ damage, infections and other problems associated with the spontaneous migration of a Mirena IUD

The Foulston Law Firm currently offers free legal evaluations to women who suffered serious Mirena side effects, including uterine perforations, stemming from the migration of Mirena.

Mirena IUD Lawsuits
The Mirena IUD was approved by the U.S. Food & Drug Administration (FDA) for contraception in 2000, and in 2009, for the treatment of heavy menstrual bleeding in women who wish to use an IUD as their method of birth control. The small, plastic t-shaped device is inserted into the uterus by a healthcare provider, where it may remain for up to 5 years, releasing a low-dose of the synthetic progestin, levonorgestrel. Since coming on the market, statistics from the FDA indicate that Mirena side effects have been cited in thousands of adverse event reports made to the agency. Device migration was the second most-common Mirena complication reported to the FDA.

According to a Transfer Order dated April 8th, the U.S. Judicial Panel on Multidistrict Litigation has transferred all federally-filed Mirena lawsuits to U.S. District Court, Southern District of New York for pretrial proceedings. According to the Order, more than 40 Mirena IUD lawsuits have been filed in 17 federal jurisdictions, all of which allege Mirena migrated away from its original position in the uterus, leading to uterine perforations and other serious Mirena side effects. Plaintiffs further allege Bayer Healthcare Pharmaceuticals failed to provide adequate warnings regarding the risk of device migration and related side effects. (In re: Mirena IUD Products Liability Litigation, MDL No. 2434 (JPML)

Court documents also indicate that at least 47 Mirena lawsuits are pending in New Jersey Superior Court. In August 2012, Bayer filed an application with the New Jersey Supreme Court seeking the establishment of a consolidated litigation for all Mirena IUD lawsuits filed in the state in Middlesex County. While the request was rejected, plaintiffs in in those claims recently filed a new application with the Court asking it to reconsider. ****

Alleged victims of Mirena side effects caused by spontaneous migration of the IUD may be entitled to file their own Mirena lawsuit seeking compensation for medical expenses, lost wages, pain and suffering, and more.

Contact the Foulston Law Office for more information on this topic.

 


Monday, June 3, 2013

ACTOS LITIGATION UPDATE

The Foulston Law Office is following the latest developments in the Actos trial currently in progress in Los Angeles. According to a Bloomberg News article published on March 6th, a clinical pharmacologist has testified that Takeda Pharmaceutical appeared to care more about product sales than patient safety.  This critical testimony suggests that Takeda knew the risk factors of Actos but failed to warn patients and their doctors.

Actos is a Type 2 diabetes medication that is the subject of thousands of lawsuits alleging that the drug caused bladder cancer. Users of this drug should be aware that there is a substantial amount of evidence indicating that drug may increase their risk of bladder cancer.

The Foulston Law Office offers free legal advice to Actos patients who feel that they were injured by use of this drug.

According to Bloomberg News, clinical pharmacologist, Howard Greenberg, testified  in Los Angeles state court in the case (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court (Los Angeles). In his testimony, Greenberg said that emails in 2005 revealed that Takeda officials cared more about protecting Actos than protecting patients; the emails discussed whether or not a warning label would be required by US and European regulators over a link to bladder cancer. “There are multiple e-mails from different levels of Takeda management that indicate the product came first,” Greenberg stated. One of the emails he reviewed in preparation for his testimony was written by Takeda executive Kiyoshi Kitazawa, who emphasized how valuable Actos was for the company and noted the implications of what regulators might do in light of research showing that the drug is linked to bladder cancer. “Actos is the most important product for Takeda and therefore we need to manage this issue very carefully and successfully not to cause any damage for this product globally,” Kitazawa wrote.

Plaintiff, Jack Cooper, was diagnosed with bladder cancer after taking Actos for over four years. His lawsuit is one of thousands filed over the drug, and alleges that Takeda knew about the cancer risks but failed to warn the public. Bloomberg News reports that Actos sales peaked at $4.5 billion as of March 2011; this accounted for 27 percent of Takeda’s total revenue at that time.

Actos was approved in 1999 and was once the world’s best-selling Type 2 diabetes drug, notes Bloomberg News. In 2011, the U.S. Food and Drug Administration (FDA) updated the safety label on Actos to warn that the drug may increase the risk of bladder cancer after one year of use.

A number of Actos lawsuits are pending in the U.S. District Court for the Western District of Louisiana as part of the multidistrict litigation (MDL) entitled In Re: Actos (Pioglitazone) Products Liability Litigation (MDL No. 6:11-md-2299). Judge Rebecca Doherty is presiding over the litigation.

For more information on this topic, please contact the Foulston Law Office.

 


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