In an order issued Monday, U.S. District Judge Rebecca Doherty said she plans to appoint lead attorneys for the consolidated cases after the March 22 status conference in her Lafayette, La., courtroom.

In December, the U.S. Judicial Panel on Multidistrict Litigation assigned Doherty to preside over dozens of lawsuits against Actos maker Takeda Pharmaceuticals America Inc., which is based in Deerfield, Ill. Plaintiffs’ attorneys expect to file several thousand claims against Takeda and its related companies on behalf of people who used the drug.

Takeda’s Japanese parent company, Takeda Pharmaceuticals Co. Ltd., halted sales of Actos in Germany and France last year. The U.S. Food and Drug Administration issued a warning about the drug’s possible cancer risks in 2010 but allowed sales to continue.

After the FDA approved Actos in 1999, Takeda co-promoted the drug in the U.S. with Eli Lilly & Co. Takeda took over responsibility for the drug’s marketing when the agreement between the company ended in 2006, attorneys for the companies said in court papers.

An FDA spokeswoman says information about a possible risk of bladder cancer associated with the use of Actos has been on its label since the drug was approved for treating Type 2 diabetes in 1999.

Takeda released a statement on Tuesday saying that it works hard to evaluate any potential risks associated with its products.

“Takeda is confident in the therapeutic benefits of Actos and its importance as a treatment for type 2 diabetes. As a science and evidence-based company, Takeda firmly stands behind the substantial data available confirming the positive risk/benefit profile of Actos, which includes twelve years of clinical and patient experience with the product,” the statement said.

The first lawsuit linking Actos to bladder cancer was filed against Takeda and Eli Lillly in July 2011, according to the companies’ lawyers.

Paul Pennock of Weitz & Luxenberg, a New York firm that represents dozens of people with Actos-related claims, said Judge Doherty is now handling roughly 150 of these suits. Thousands more could have federal claims filed in or transferred to Lafayette by the end of the year, he said.

“People should not run the risk of getting bladder cancer from treating their diabetes given the many other excellent therapies available,” Pennock said.

Thousands of other claims involving Actos are expected to be heard in California and Illinois state courts.

The lawsuits claim researchers have found that people who take Actos for more than a year are at increased risk of developing bladder cancer. The suits also accuse Takeda of concealing their knowledge of the cancer risks and failing to adequately warn consumer and health care providers.

Actos sales in the U.S. fell by roughly 3 percent last year, but the drug remained the best-selling Type 2 diabetes drug on the market, according to the health care information firm IMS Health. The firm says Actos accounted for $3.4 billion in sales in 2011, or nearly 84 percent of sales among drugs in the same class.

Source:  http://www.cbsnews.com/8301-505245_162-57377764/judge-sets-1st-hearing-for-diabetes-drug-lawsuits/

A Note From Jim Guest, President, Consumer Reports:

It’s a nightmare scenario. The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you.

This isn’t science fiction. Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled - 700 different products a year.

And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were “similar” to products already on the market.

 Tell Congress we don’t want to be guinea pigs anymore!

Every new prescription drug must undergo rigorous testing on humans before it can be sold, even if it is similar to another drug already in use. Not so with medical devices. Because of this loophole in our safety laws, more than 90 percent of medical devices aren’t safety tested before being sold nor are they routinely tracked afterwards to identify safety problems.

For example, a metal hip implant marketed by Johnson & Johnson was approved in 2005 without first undergoing clinical safety trials. It was recalled five years later after having a 1 in 8 failure rate in the UK, and releasing potentially toxic metals into the body. Countless patients had to undergo a second, painful ‘revision’ surgery.

It’s time safety standards for medical devices are as strong as those for prescription drugs! E-mail your members now!

The device industry has unleashed an army of lobbyists and they don’t want things to change. It will take a wave of consumers weighing in to make sure medical devices are safe and effective. Please take action, then forward this to friends and family. Thank you!

Sincerely,

Jim Guest
President, Consumer Reports
101 Truman Ave
Yonkers, NY 10703

If you have been a victim of a defective product, please contact an attorney at Slater Slater Schulman LLP  at (800) 251-6990 today to discuss your legal rights and options.

Dr. Georgiou’s advice? “Demand (don’t request) the genetic blood test to determine whether Plavix can be metabolized.“

Watch the entire video to learn more: http://www.myfoxtwincities.com/dpp/buzz/Plavix-Prescription-Perspective-Dr.-Georgiou-nov-29-2011

The benefits of pioglitazone, the active ingredient in Actos and other diabetes treatments, outweigh its risks in a limited group of patients with Type 2 diabetes, the London-based agency’s Committee for Medicinal Products for Human Use said yesterday in a statement on its website.

“These medicines remain a valid treatment option for certain patients with type 2 diabetes,” though there is a small increased risk of bladder cancer, the agency said. The risk could be reduced by “appropriate patient selection and exclusion,” including regular reviews of how well the drug is working for individual patients, the agency said.

The European agency’s backing supports the decision made by the U.S. Food and Drug Administration that Actos wasn’t linked to an overall increased cancer risk in all patients who took it. Actos had sales of 387.9 billion yen ($5 billion) in the last fiscal year, accounting for 27 percent of revenue. That makes it the best-selling product for Osaka, Japan-based Takeda, Asia’s largest drugmaker.

The European agency has been reviewing the possible cancer risk of Actos and other medicines containing pioglitazone since March. France’s drug regulator in June said it would pull Actos from the market, and its counterpart in Germany recommended that the EMA suspend marketing approval for the diabetes medicine throughout the 27-nation European Union. Actos was suspended in Mauritius.

Shares Gain

Takeda rose as much as 0.5 percent in Tokyo trading, and was 0.3 percent higher at 3,725 yen at 9:09 a.m. local time. The benchmark Topix Index advanced 0.9 percent. The shares have declined 6.8 percent this year.

Actos, which faces competition from cheaper, generic versions next year, became the world’s biggest-selling diabetes drug after a 2007 study linked rival pill Avandia, sold by London-based GlaxoSmithKline Plc, to a higher chance of heart risks. The EMA in September suspended sales of Avandia, while the U.S. regulator decided the medicine could continue to be sold with new warnings.

Both pills belong to the same drug class as Rezulin, which was made by Warner-Lambert Co. It was pulled from the market in March 2000 because of risks of liver cancer and sudden death. The Glaxo medicine had revenue of $680 million last year, less than half its peak in annual sales.

‘Stop Taking Actos’

Some doctors have already stopped prescribing Actos and other so-called thiazolidinediones, or TZDs, partly because patients are nervous about the risks.

Besides heart risks, the drugs have also been associated with fluid retention, weight gain and bone loss, said Neale Cohen, an endocrinologist at the Baker IDI Heart and Diabetes Institute in Melbourne.

“I don’t think doctors are going to continue to prescribe TZD-class drugs, and as far as my practice is concerned, I will tell my patients to stop taking Actos,” said Albert Levy, an endocrinologist at Mount Sinai in New York, in an e-mail. Levy has already taken his patients off Avandia, he said.

Deciding how to assess the benefits versus risks of TZDs is key, said David Kendall, the chief scientific officer of the American Diabetes Association. Patients who can’t control their blood sugar are at risk for more-serious complications of diabetes, such as blindness and the loss of limbs, Kendall said.

VAGINAL MESH BACKGROUND

Surgical Mesh is commonly used in pelvic floor surgery to treat both incontinence and prolapse. “Vaginal mesh kits” were introduced approximately seven years ago in an attempt to simplify and standardize the technique of vaginal mesh placement. Recently, however, the safety of these mesh kits has been called into question.

MESH INJURIES

Once the mesh is implanted it can move around the body, its frayed edges cutting through tissue and sometimes puncturing nearby organs. Some women have become septic, suffering infections so bad that the entire torso turns a deep purple. These infections attack a body from the inside, and if not treated promptly can lead to death. At least 10 women have reportedly died as a result of a punctured bowel and resultant septic infection.

Other more common injuries being reported due to vaginal mesh exposures are:

Prolapse recurrence

Infection

Erosion into vagina

Dyspareunia (painful sexual intercourse)

Internal bleeding

Vaginal scarring

Vaginal wall-narrowing

Urinary problems

Punctured bladder

Punctured uterus

Chronic postoperative pain

Incontinence

These injuries are caused by frayed edges of the mesh material and by movement of the patch within the body.

WHAT CAN BE DONE TO AVOID OR MINIMIZE THE INJURY?

First and foremost, alert your physician if you suffer any complications or symptoms that you think could be related to the placement of the mesh implant. We suggest you follow the advice of a qualified physician.

Failed mesh implants commonly require removal of the mesh. Unfortunately, this is much easier said than done. To remove the mesh, doctors must perform multiple surgeries as the mesh has to be taken out in pieces. Occasionally, it is impossible to remove all of the mesh because the mesh is impossible to separate from body tissue. In these cases, some or all of the mesh remains implanted for life.

It is not our intent to sound an unnecessary alarm. Pelvic floor prolapse is a significant quality-of-life issue for many women. Some women have a good experience after their vaginal mesh placement surgery, without experiencing any of the above-listed complications or symptoms. However, the number of women with bad results appears to be significantly higher than what was originally disclosed by the manufacturers of these medical products. Accordingly, women with these products in their body should be aware of symptoms indicating movement of the patch so that they can know when to seek medical care.

Finally, if this has happened to you contact one of our attorneys today.

Cerebral palsy is a problem that involves brain function and nervous system responses which enable it to affect an troubled person’s thinking, listening to, sight and activity. One known result in is fetal hypoxia, which can end result when a baby doesn’t receive sufficient oxygen during the delivery process.

The nation’s Institutes of Wellbeing identifies other actual physical symptoms of the various forms of cerebral palsy, including:

- Small muscles and joints, which may bring about an abnormal running (walking on toes and fingers or with legs touching are common illustrations)
- Muscle some weakness, limited movement as well as paralysis
- Twisting, writhing or even jerking of extremities
* Loss of physical coordination

A comprehensive neurological exam is the cornerstone of a cerebral palsy diagnosis. While there is absolutely no cure for cerebral palsy, various treatments can help to make person more impartial throughout life. Which means having the resources to utilize speech, physical as well as occupational therapists and medical specialists in order that a child with cerebral palsy provides lifetime access to the right tools and flexible equipment.

Medical Malpractice Law firms Help Families Assess Liability for a Kid’s Condition

Cerebral palsy in newborns can result from problems made by obstetricians, maternal nurses and other health care professionals. The health care crew that attends the birth possesses numerous tools to provide dire warnings about specific problems that may develop through labor and during supply.

Assessing whether a great avoidable birth injury caused irreparable problems for a newborn involves complicated legal and health concerns. But medical data may include potential signs that a brain injuries occurred during work or delivery (the medical term will be “neonatal encephalopathy”), including low blood glucose levels, seizures, poor oxygenation of the blood, poor reflexes, poor color or perhaps subnormal consciousness.

A consultation by having a medical malpractice attorney of The Law Offices of Slater, Slater, Rosenberger & Schulman, P.C. can help a family comprehend their legal possibilities and help decide if something went completely wrong that should not have occurred. In most cases, personal injury lawyers deal with cases on a a contingency basis, meaning that the majority of the costs of lawsuit are paid for with the law firm based on a percentage of any damages or perhaps settlements recovered.

Despite the popularity of MoM devices in the past decade, research has shown that the implants are prone to early failure with the metal components rubbing against each other and releasing metal particles into the body. In the recalled DePuy hip replacement, the ball rides out towards the edge of the cup (called “edge loading”), shedding cobalt and chromium particles. The more loose metal ions found in the body, the more likely it is that the hip replacement has failed and needs to be removed.

The area surrounding the artificial hip joint is the first affected by metal particles. In some cases, damage to surrounding tissue and bone may contribute to the loosening of a hip device. The metal ions may also make their way into a patient’s blood stream. Studies have shown that, when large quantities of metal ions are flowing through the body, deafness, blindness, neurological problems, headaches, weakness, and heart problems may result. Initial studies of the effects of certain quantities of metal ions in the body, while not conclusive, suggest that high levels of metal ions in the blood are a cause for alarm.

Hip replacement recipients with MoM and especially MoM DePuy hip replacements should regularly have their blood tested by a doctor or lab center for concentrations of metal ions. The results will indicate whether the hip device is failing and allow doctors to take steps to prevent further damage.

Patients should seek the advice of their orthopaedic surgeon if blood tests reveal high levels of metal ions. If the orthopaedic surgeon confirms that the MoM hip device is failing, the patient should seek legal advice.

That’s what 59-year-old Clayton Blosser of Newport News faced when he opened a letter last year that said the artificial hip he’d had implanted in 2006 was being recalled by the manufacturer.

“I thought, ‘You can recall my car, my GPS, my TV, but you can’t call my hip back, come on,’ ” he said. “I had to read it three times before I realized they were serious.”

Priscilla LeMoine of Suffolk received a similar letter in September announcing a recall of the artificial joint she received in 2007. The 69-year-old woman had been complaining that the device in her left hip had been slipping and popping and grinding for several years, causing pain that was close to driving her to a wheelchair.

Blosser had his artificial hip replaced with another model last month.

LeMoine had hers switched out in January, but that’s not the end of her travails: She has an identical model in her right hip.

LeMoine and Blosser are among the hundreds of DePuy ASR hip replacement patients across the country and dozens in Hampton Roads who have filed suit against the maker of the device, DePuy Orthopaedics, and its parent company, Johnson & Johnson.

Central to the case against DePuy is the fact that the manufacturer gained Food and Drug Administration approval for the hip using a process that bypassed clinical safety trials.

The courtroom saga is a small corner of a larger issue: The market for joint replacement is booming, and not just because people are living longer. Baby boomers put a premium on staying active as long as they can, jogging and biking long past previous generations. Another portion of the population carries too many pounds, which is hard on joints.

Hospital discharges for total hip replacement increased by one-third from 1996 to 2006, and are expected to grow an estimated 175 percent by 2030. That’s created a steady stream of new devices boasting better, quicker and longer-lasting qualities. The recalled DePuy hip device, though, begs a question:

Are medical devices adequately tested before bodies are cracked open to put them in place?

Williard Moody Jr., a lawyer who practices in Portsmouth, doesn’t think so.

He’s filed 15 cases against DePuy in federal district court and says he’s received hundreds of phone calls from people across the country. The cases have been transferred and consolidated in what’s called a “multiple district litigation” in a federal court in Ohio, where more than 500 cases have beenfiled against the manufacturer.

DePuy estimates that 93,000 people worldwide had the company’s implants between 2003 and 2010, and that the rate of revision after five years has been 12 to 13 percent. A British orthopedic organization released results in March of a study that showed an even higher revision rate, ranging from 21 percent after four years to 49 percent after six years.

That’s a lot of hips.

What aggravates LeMoine, who hired Moody to represent her, is how long it took for her to find out.

She had her right hip replaced in March 2007. She recovered fairly quickly from the surgery and followed that replacement with one in her left hip in July of that year.

“I was told it would last my lifetime,” she said.

The right one continued to feel fine, but the left gave her problems from the start. She could feel the ball move out of place in the cup device and hear it pop, grind and snap dozens of times a day.

One day she counted how many times she felt it pop out of place: 150.

It also hurt: “I was afraid to walk anywhere.”

She tried to make the best of it for a while, but the pain kept getting worse, leading her to curtail her work as a real estate agent.

“I knew something wasn’t right. Your body is telling you something is wrong, but they were telling me nothing was wrong. You begin to think you’re crazy.”

When she received the recall letter, it all made sense.

She had a bone scan and blood tests. The blood work showed she had elevated levels of chromium and cobalt, which doctors have said could be from the metal of the cup and socket rubbing together. That can lead to tissue death at the site of the implant, which leads to pain. The scan showed cysts in the area where the prosthesis was.

LeMoine decided to first have the left one removed since that was the most painful. She had it replaced with a plastic-and-ceramic device on Jan. 19.

She still doesn’t know what to do about her right hip, since she didn’t have as many problems with it. She continues to have her blood checked. She said if her blood levels continue to show high levels of cobalt and chromium, she’ll probably have the other one replaced too.

“I’m angry at DePuy for the time it took for them to recall it,” she said. “The worst part is not knowing what that metal content will do.”

A critical piece of the case lies in the way the FDA approved the DePuy device. Usually, pre-market approval requires clinical studies and investigations for safety and effectiveness. Under something called the 510(k) provision, however, devices that are “substantially” like ones already on the market do not need the same rigorous testing.

That’s how DePuy gained approval for the ASR in 2005. Most devices on the market at the time used a metal or ceramic material for the ball of the hip, and plastic for the cup.

The ASR used metal for both the cup and the ball, with the idea that the combination would last longer.

A disadvantage arose when the metal rubbing against metal produced debris that leached into the bloodstream and settled in the surrounding tissue, causing pain and tissue damage, according to the cases filed. The cup also was more difficult to align than typical models, according to the lawsuits.

Some countries have registries of joint replacements. The Australian Joint Registry issued seven reports to DePuy concerning the ASR starting in 2007, and the ASR was withdrawn from the Australian market in December 2009.

A registry of joint replacements in England and Wales also began raising red flags, and in August 2010, DePuy voluntarily recalled the device.

The FDA announced in February that it is re-evaluating metal-on-metal devices. Its website notes that there is “insufficient data” to track the long-term effects of metal in the bloodstream, and that some people might have a greater sensitivity to metal than others. The site noted there have been some reports of problems in the nervous system, heart and thyroid gland that might be linked to high metal content in the blood.

Mindy Tinsley, spokeswoman for DePuy, said in an email that the company is committed to addressing “reasonable and customary costs” of testing and treatment problems related to the recall, including revision surgery.

That offer didn’t stop the flood of lawsuits, most citing the length of time it took DePuy to recall the device and the process used to approve it.

Diana Zuckerman, president of the Washington-based National Research Center for Women & Families, is well acquainted with the 510(k) process.

The patient safety advocate has long argued against using the process to approve implanted medical devices. She and two colleagues did a study that was published in the Archives of Internal Medicine in February that examined recalled medical devices in Class I categories, those that can cause death or serious health problems if defective.

The study found that of 113 devices recalled from 2005 to 2009, 80 percent went through the 510(k) process.

“We got interested in this for the reason we knew there were a lot of implanted devices that were not required to be studied in clinical trials, and that seemed crazy,” Zuckerman said. “How do you explain that?”

The study didn’t include hip joint replacements, because problems with them don’t have the life-threatening potential of, for example, a faulty heart implant device.

But Zuckerman was interested in hip devices, too, and found that 158 of them had been recalled during the same period. Even if they aren’t life-threatening, poorly designed devices can cause a lot of suffering.

Zuckerman, 60, could speak from experience: She needed a hip replaced last year.

She was disappointed at how little she was able to find out, both as a regular consumer and as a researcher, when she tried to see which devices had the best records.

The United States does not have a registry of joint devices to track problems and alert the public, though an orthopedic association began a trial of one last December.

As with so many things in medicine, it often comes down to money. The more research, the more costly, and manufacturers have argued that more regulation would reduce and slow access to the latest medical technology.

Zuckerman knew enough from her research to stay away from the metal-on-metal hips. She also heard the ceramic ones squeak.

So she went with a metal-on-plastic device.

The manufacturer?

DePuy.

Is she happy with it?

“I was told within a few months, I’d be back to where I had been before,” Zuckerman said. “And it’s just not true.”

Dr. Boyd Haynes, an orthopedic surgeon in Newport News, encourages patients to do their homework before getting a joint replaced.

While some doctors say patients get bogus information or data that doesn’t apply to them, Haynes said, patients can help doctors find the right device for them by doing research on credible websites.

Because people are getting joint replacements earlier and living longer, there’s interest in devices that last. Haynes, who practices at the Orthopaedic and Spine Center in Newport News, said the metal-on-metal idea appealed to him at first for that very reason.

He said the devices seemed to work well for some people, but not everyone. About 8 to 10 percent of the patients he implanted with the device have returned for revisions – higher than the normal revision rate, which he said is less than 5 percent, but lower than what the registry studies were showing.

Terrie Edwards, administrator at Sentara Leigh Hospital in Norfolk, said the revision rate of the DePuy ASR there has been about 2 percent.

Other reasons for revision besides a defective device include poor after-care by the patient, problems with how the device was implanted, and simple wear and tear.

Haynes said it’s important to remember that the vast majority of joint replacements are successful, and the recall is no reason to avoid hip replacement or to shy away from innovation in general.

A technique he’s incorporated into his practice is the “Jiffy” hip, which replaces the joint through incisions made in the front of the hip rather than the side. That requires less cutting of muscle, and has a quicker recovery, he said.

Haynes did Blosser’s revision surgery in March at Bon Secours Mary Immaculate Hospital in Newport News using that method. Blosser said the difference between his first and second surgery “was like night and day. I knew immediately when I came back from recovery that I was good.”

LeMoine said her revision required one day in the same hospital instead of three. She’s still wondering what to do about her right hip, since she has a DePuy ASR implant there.

Blosser, who also is suing DePuy but is represented by a Florida attorney, said that when it comes to hip replacements, patients are at the mercy of their doctors, and doctors are at the mercy of manufacturers.

That leaves him with a question as his lawsuit wends its way through the court system:

“Are they making oodles of money by not testing stuff?”

Your change can make a difference in the well-being of three-year-old Owen who has cerebral palsy, a group of disorders affecting movement and muscle co-ordination.

Owen, who is unable to walk or talk, was born prematurely at St. Joseph’s Hospital, weighing just two pounds, two ounces. He spent four months in the neonatal intensive care unit at B.C. Children’s Hospital.

The Comox Valley lad undergoes physiotherapy, occupational therapy, speech therapy, massage and acupressure to manage his condition.

Thanks to the fundraising efforts of family and friends, Owen and his family are able to travel to the U.S. every couple of months for a therapy called the Anat Baniel Method, which is neuromuscular re-education treatment.

Though costly, the treatment and travel are well worth it, his family says.

There is also a clinic trial recently launched at Duke University for children with CP that uses stem cell treatments, which could lead to a brighter future for a child such as Owen.

A fundraising hot dog sale and bottle drive takes place this Saturday from 11 a.m. to 3 p.m. at the Courtenay Walmart. Proceeds will help fund neuromuscular therapy sessions for Owen.

The wife of Petty Officer Robert Hardick filed the lawsuit over mesothelioma against John Crane Inc. and Garlock Sealing Technologies for Hardick’s death in March 2009. According to a report by the Newport News Daily Press, Hardick contracted mesothelioma from breathing asbestos fibers while serving on the U.S.S. Newport News, a Des Moines-Class heavy cruiser, and other ships from the 1950s through the 1970s.

The wrongful death lawsuit claims that the asbestos fibers were contained in parts provided to the Newport News Naval Shipyard by Garlock and John Crane. The Newport News Circuit Court jury divided the $6 million award between the two companies.

Mesothelioma is a rare and fatal form of cancer that is found in the lining of the chest and lungs. The only known cause of mesothelioma is asbestos exposure, and it is often not diagnosed until decades after exposure. As a result of the long latency period, the cancer is very advanced when it is diagnosed and life expectancy with the disease is limited.

Asbestos was widely used in a variety of manufacturing and construction applications throughout the last century, particularly shipbuilding, with use peaking in 1973. Most uses of asbestos were banned in the mid-1980s. Despite the ban, the U.S. Centers for Disease Control and Prevention says that the number of mesothelioma deaths continues to rise each year due to the latency period, with the number expected to peak in 2010.

Asbestos mesothelioma lawsuits are the longest running mass tort in U.S. history, with the first asbestos exposure case filed in 1929. Over 600,000 people have filed lawsuits against 6,000 defendants after being diagnosed with mesothelioma, asbestosis or other asbestos-related diseases.