Atlanta Personal Injury Lawyer

New Tranvaginal Mesh MDL Created For Coloplast Implants

M. Brandon Smith — Mon, 08 Apr 2013 22:20:00 GMT

Yet another set of transvaginal mesh cases have been consolidated into an MDL, or multidistrict litigation, as the result of an order issued by a federal judicial panel at the beginning of August 2012. This latest transvaginal mesh MDL involves devices that were manufactured by Coloplast Corp.

The creation of the MDL means that all lawsuits in federal courts involving Coloplast transvaginal mesh will be consolidated before a single judge for the purposes of pre-trial issues such as discovery and motions. Then, each case will be transferred back to its original jurisdiction where the plaintiff will have the opportunity to try the case.

Currently, there are at least 65 lawsuits involving Coloplast mesh products that have been filed across the United States. These lawsuits allege defects in the design of transvaginal mesh products that are used to surgically repair pelvic organ prolapsed and stress urinary incontinence. Those defects, the plaintiffs allege, have led to pelvic pain, infections, protrusion of the mesh device, and a host of other complications.

The Coloplast MDL is only the latest in a string of federal cases related to transvaginal mesh products. Already in West Virginia (where these cases have been consolidated as well) there are four other MDLs involving C. R. Bard, Boston Scientific, Ethicon/Gynecare and American Medical System and their respective transvaginal mesh devices. A sixth MDL involving Mentor ObTape is before a Judge Land in The Middle District of Georgia.

Originally posted at The Legal Examiner by M. Brandon Smith

Update on Actos' Link To Bladder Cancer and Other Related Dangerous Drugs

M. Brandon Smith — Sun, 07 Apr 2013 02:18:00 GMT

A leading diabetes treatment drug, Actos, has been the subject of heightened interest recently due to its being implicated in an increased incidence of bladder cancer among patients taking the drug, the announcement of the launch of its generic counterparts, and a recent consolidation of federal lawsuits against its manufacturer.

Just within the past month, the generic version of Actos has been approved by the Federal Drug Administration. Mylan Pharmaceuticals Inc. announced its launch of the generic version of Actos and Actoplus Met. Teva Pharmaceuticals Industry has also gained approval to manufacture and market generic versions of Actos and Actoplus Met.

Pioglitazone, or Actos, is in a class of medications called thiazolidinediones. Actos is manufactured by the Japanese pharmaceutical company, Takeda Pharmaceutical Co. Ltd. Pioglitazone is used as an adjunct to diet and exercise to treat type 2 diabetes mellitus. The drug works by increasing a cell's sensitivity to insulin, thus enabling the body to uptake sugar from the blood into the cells.

While the mechanism by which piolglitazone causes an increase in bladder cancer is unknown, it has been postulated that an increased sensitivity to insulin may also be a factor in the increased risk of cancer because cancer cells are also affected by insulin. Other animal studies indicate that pioglitazone may cause development of crystals in the bladder — resulting in irritation which could be a factor in cancer development.

Recent studies have corroborated the link between Actos, or pioglitazone, and a heightened risk of developing bladder cancer. In two of the most recently reported studies, researchers at the University of Pennsylvania determined that patients who took Actos had an increased risk of bladder cancer. The incidence of bladder cancer rose as the length of time of the patients' usage of the drug increased. In July, 2012, a Canadian study by the University of Alberta School of Public Health reported a similar increase — by 22% — in the occurrence of bladder cancer among Actos users.

Because of the link between the use of Actos and bladder cancer, Consumer Reports has recommended that patients not take Actos, or it generic counterparts.

In July, 2012, Judge Rebecca F. Doherty set the schedule for bellwhether trials in which the subject of the litigation is the link between Actos and bladder cancer. Bellwhether trials are used when there is large number of lawsuits centering on a common cause or claim. It is a way for the courts to manage these actions, and give the parties a guide as to the course of future litigation. In scheduling the first trial for November, 2013, Judge Doherty is allowing for ample discovery time in the case of the federal Actos lawsuits.

Other drug combinations containing pioglitazone are Actomet Plus, Actomet Plus XR, and Duetact

Originally posted at The Legal Examiner by M. Brandon Smith

Update: Actos Cases Linked To Bladder Cancer Set For First MDL Trial

M. Brandon Smith — Fri, 05 Apr 2013 02:05:00 GMT

A group of lawsuits that contend the diabetes drug, Actos, carries an increased risk of bladder cancer are set for an initial trial in Louisiana beginning in 2014.

In December, the U.S. Judicial Panel on Multidistrict Litigation assigned Doherty to preside over dozens of lawsuits against 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.

Multi District Litigation (MDL) allows that all preliminary parts and discoveries relating to the case will be held in one court.

Aside from this, there is currently an Actos Trial underway in California Superior Court that started in March of 2013.

Although sales of Actos were halted in France and Germany last year, the FDA issued a warning about the possible cancer risk in 2010, but allowed sales to continue.

“Information about a possible risk of bladder cancer associated with Actos use has been on the drug label since it was first approved for Type 2 diabetes in 1999,” according to an FDA spokeswoman.

The first lawsuit linking bladder cancer to Actos was filed against Takeda and Eli Lily in July 2011. More than 10,000 claims are outstanding. Some are expected to be heard in California and Illinois State Court.

The company recently released a statement saying it works hard to evaluate any potential risks associated with any of its products.

Whistleblower Allegations

A newly filed lawsuit alleges that executives of maker Takeda Pharmaceuticals also tried influencing and hiding negative data.

A former medical reviewer for Takeda Pharmaceutical has filed a False Claims Act lawsuit claiming the pharmaceutical giant failed to report health risks to regulators and directed reviewers to "change their professional opinion" over health concerns of their diabetes drug Actos.

Originally posted at The Legal Examiner by M. Brandon Smith

New MDL Created For Pradaxa Injury Cases

M. Brandon Smith — Thu, 04 Apr 2013 22:25:56 GMT

The number of lawsuits involving Pradaxa internal bleeding claims has increased so dramatically that the United States Judicial Panel on Multidistrict Litigation created an MDL to centralize pre-trial issues. The MDL—or “Multidistrict Litigation”—will be centralized in the Southern District of Illinois, with Judge David R. Herndon as the presiding judge.

At the time that the Judicial Panel issued their order creating the MDL and transferring existing cases to the Southern District of Illinois, there were already 21 cases that had been filed in Federal District Courts to which the order applies. Another 19 cases are likely to “tag along” with the transfer. All of these cases allege similar issues with the drug Pradaxa and were filed against different divisions of Boerhringer Ingelheim. Judge Herndon is already overseeing litigation involving Yasmin and Yaz, another large pharmaceutical products liability litigation.

The creation of this MDL means that the cases that have already been transferred to the Southern District of Illinois—and any new cases that might be transferred there in the future—will be consolidated for purposes of pre-trial issues. This means greater efficiency for both the parties, as well as the courts, in carrying out discovery and filing pre-trial motions. Once the cases reach the moment of trial, they will be transferred back to the courts in which they originated, where each plaintiff will have their day in court.

As the Judicial Panel highlighted in its order, the lawsuits all involved common factual issues, focused primarily on allegations that the plaintiffs suffered severe bleeding and other injuries as a result of taking Pradaxa and that the defendant pharmaceutical company did not provide sufficient warnings about the risk of bleeding to physicians. There is no treatment to reverse the anti-coagulant effects of Pradaxa, meaning that the drug has caused life-threatening conditions, permanent disability and even deaths.

Originally posted at The Legal Examiner by M. Brandon Smith

AARP Warns Patients How To Help Prevent Medical Errors and Medical Malpractice In Hospitals

M. Brandon Smith — Thu, 04 Apr 2013 22:05:36 GMT

The number of patients that die each year due to preventable hospital errors is equal to four full jumbo jets crashing each week. While hospitals are capable of great medical feats, they are also riddled with daily errors that claim lives.

More than a decade into the fight against medical errors, there is little reason to think the risks have declined considerably for the 37 million people that are hospitalized annually. When, in fact, recent studies have shown a problem that is bigger and more complex than ever thought. A study in January, regarding Medicare patients, suggested that hospital staff failed to report an estimated 86 percent of harms done to patients. If most harms, that are inflicted on patients are not reported, they can never be tracked or corrected, pointed out the Health and Human Services Department study.

In a more recent study, built on the previous HHS study, researchers found that one in seven suffered serious or long-term injuries or died, as a result of hospital care. About 44 percent, according to researchers were in fact preventable.

Sure, there has been notable progress such as utilizing checklists to reporting hospital infection rates on state Web sites. Still, though, the question remains how close can hospitals ever come to being error-free? The answer is controversial depending on who you ask. But most importantly YOU need to play an active role in your medical care as much as you can.

Below are tips to help protect you and loved ones from hospital errors.

Advocates agree that patients can lessen their risk of harm by monitoring their care. Ask questions and if you don’t understand the answer, seek clarification.

Carry a notebook – sounds easy enough, right? Write down all your medications (prescription and non-prescription), why you take them and who they were prescribed by. When possible, include contact information. Take it a step further and use this same notebook to take notes during doctor visits or hospital stays.

Make sure your doctor is aware of any allergies and adverse reactions you have had to medicines in the past.

When your doctor writes a prescription, make sure you can read it. And that you know what it is. If you can’t read it, chances are the pharmacist can’t read it either.

Hand sanitizer – this is a no brainer, always have a bottle with you and use it frequently. Ask healthcare workers that have direct contact with you if they have washed their hands, this is the single most effective way to prevent infection.

Bring an advocate – a family member or friend – particularly during check-in and discharge. Some hospitals have a staff person or advocate you can consult. If you hire your own, check their credentials.

Referrals – ask your doctor for a person recommendation before seeking out a specialist.

Surgery Prep – make sure that you and your doctor and surgeon all agree on exactly what is going to be done. For instance, if you are having surgery on your left hand, make sure that all involved know it’s the left hand. It might sound silly, but it happens.

Follow up – if you have a test and don’t get a response, follow up. Don’t assume that no news is good news.

Lastly and most importantly, we all have a tendency to use the Internet to self asses what is wrong with us. But still see your doctor and do visit a reliable Web site such as www.MayoClinic.com or www.WebMD.com.

Originally posted at The Legal Examiner by M. Brandon Smith

MDL 2428 (In re: Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation)

M. Brandon Smith — Thu, 04 Apr 2013 21:50:39 GMT

A panel of judges have recently agreed to consolidate all GranuFlo lawsuits, according a press release issued April 1, 2013. The U.S. Judicial Panel on Multidistrict Litigation on March 29, 2013 issued a transfer order consolidating 11 federal claims to MDL 2428 (In re: Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation). These and future federally filed cases will now be consolidated in the U.S. District Court for the District of Massachusetts.These GranuFlo lawsuits assert claims against Fresenius Medical Care claiming the company failed to adequately warn patients about the 6 to 8 fold increase in the risk of cardio events such as cardio arrest, heart attacks and sudden cardiac death.

GranuFlo and NaturaLyte are dialysis treatments used across the United States in dialysis clinics. Fresenius Medical Care is the manufacturer of GranuFlo and NaturaLyte. According to an internal memo that was first circulated within Fresenius on November 4, 2011, patients who undergoGranuFlo treatment are 6 to 8 times more likely to suffer heart attack or sudden cardiac death. Patients may suffer heart attack from the moment they are hooked up to the dialysis machine and up to 48 hours after undergoing treatment. Fresenius Medical care treats more than a third of the Americans who receive dialysis.

In an internal memo sent by Fresenius Medical to its own dialysis centers, the company warned them that “failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest,” according to an article in the NY Times. Fresenius did not tell the FDA about this information and failed to tell other dialysis centers that used its GranuFlo and NaturaLyte products. Instead, it was kept secret until an internal document was anonymously leaked to the FDA. In March 2012, the FDA issued a Class I recall of GranuFlo and NaturaLyte. This is the most serious type of recall the FDA can issue and signifies there is a “reasonable probability that the use of or exposure to the product will cause serious negative health consequences or death.”

Childers, Schlueter & Smith continue to investigate and file dialysis injury lawsuits on a nationwide basis. If you have suffered a heart attack or if you have lost a family member to sudden cardiac event after undergoing dialysis, we can help. Contact the attorneys of Childers, Schlueter & Smith for a free case evaluation and consultation. Our experienced dialysis injury attorneys will work closely with you and fight for legal rights.

Originally posted at The Legal Examiner by M. Brandon Smith

Styker’s Rejuvenate and ABG II Modular-Neck Stem Recall-New Cases Still Being Evaluated

M. Brandon Smith — Mon, 25 Mar 2013 11:37:40 GMT

Many problems have been associated with the faulty Stryker hip implant recall. According the FDA, they have received numerous reports from patients about serious side affects associated with the Stryker Rejuvenate and ABG II modular-neck stems hip implants.

On July 6, 2012, Stryker voluntarily recalled its Rejuvenate and ABG II modular-neck stems. The problems patients were having with the faulty hip implants include:

Necrosis
Metallosis
Osteolysis
Loosening of implant
Hypothyroidism
Damage to bone and tissue surrounding the hip joint
Infection
Inflammation
Hip replacement failure

The Stryker Rejuvenate System was approved in 2008 for sale by Stryker. The faulty metal on metal hip implant device was designed to promote quicker installation with varieties of component designs. The necks are composed with heavy metal cobalt and chromium. The Rejuvenate and ABG II devices were designed to employ a two-piece modular neck and stem for enhanced flexibility and stability. According to Stryker, this design allows surgeons to choose a range of femoral neck and stem combinations and make it unique to each patient. However, the results of these recalled hip implants have been devastating. Components of the recalled hip implant contain metal and this can lead to fretting. This can then send particles into the patient’s tissues and even bloodstream.

Those patients who have any problems associated with Styker’s Rejuvenate and ABG II modular-neck stems may be entitled to compensation. Our Georgia Hip Implant Recall Lawyers are offering free personal injury lawsuit consultation to victims affected by Stryker’s faulty hip implants. If you or someone you love has been affected by Styker’s Rejuvenate and ABG II modular-neck stems, please contact our Georgia Hip Implant Recall Lawyers. Our Georgia Hip Implant Recall Lawyers can provide helpful insight with these devastating injuries and suggest options you should consider.

Originally posted at The Legal Examiner by M. Brandon Smith

Senior Citizen Drives Drunk; Kills and Crashes With No Remorse

Darren Tobin — Fri, 25 Jan 2013 10:51:01 GMT

Michael O. Snider, a 70 year old Stone Mountain resident, decided that crashing into tens of vehicles was not only ok, it was warranted when he told police that "I [Snider] do whatever I want." According to the AJC, Snider drove drunk through two counties as he bobbed and weaved his Ford truck through and at cars. After causing eight wrecks in DeKalb County, Snider then allegedly caused at least eight more wrecks in Gwinnett before causing a fatal wreck near Snellville on Wednesday night.

His hit and runs will be prosecuted in either a DeKalb or Gwinnett state court. He was charged with vehicular homicide, DUI, causing serious injury by vehicle, reckless driving and following too closely, jail records show. Additional charges are expected to be filed in DeKalb County. What make this twist even more disturbing is apparently this is the first time Snider faces any criminal charges, as he has no known criminal history according to police records.

Drivers called 911 as Snider continued on his spree. He finally crashed his truck into a Gwinnett County restaurant (John Boy’s Home Cooking) tWednesday night, but not before causing the death of a woman close to his age.

Snider rear-ended Mintiwab Woldeyhans of Loganville car, pushing the vehicle under a flatbed truck at U.S. 78 at Walton Court, near Snellville. 69-year-old Mintiwab Woldeyhans of Loganville, died at the scene of the wreck and the car’s driver, 51-year-old Yeshihareg Abebe of Grayson, was transported to the hospital in critical condition, according to police.

According to DeKalb County police reports obtained by The Atlanta Journal-Constitution and a victim, Snider showed no remorse after striking the first of many vehicles in his path. Cpl. Ed Ritter with Gwinnett County police said that Snider didn't seem to care. At his first court appearance yesterday morning, Snider was ordered held without bond until a preliminary hearing scheduled for Feb. 1, Gwinnett sheriff’s Lt. Sean Smith said.

The first person who police believe Snider hit was Adama Keita, of Decatur. Keita was at a red light after exiting I-285 at Covington Highway when his Nissan 350Z was hit from behind around 7:30 p.m. Wednesday night. According to Keita, after drunkenly stumbling out of his truck, Snider offered Keita money. Worried that Snider was going to leave the scene of the wreck, Keita said he called police a second time.

As for 51-year-old Yeshihareg Abebe of Grayson, Cpl. Ed Ritter described Abebe’s injuries as “life-threatening.”

Hit and Run charges are serious charges which carry serious criminal penalties. The fact that Snider drove drunk and hit as many people as he did, including causing the death of poor Mintiwab Woldeyhans, will make the district attorney's job easier in putting Snider away in prison for what would likely be a multi-year or lifetime sentence. Sadly, the criminal sanctions can only do so much for the families that grieve and/or who have been injured by Snider the drunk driver. These families can at least find some comfort in filing civil action claims in DeKalb and Gwinnett state court for monetary damages. Snider's insurance as well as the victims insurance who Snider hit should pay for the damage and suffering.

If you or someone you know has been hit by a drunk driver or been injured in a hit and run, your life could have changed. If you have any questions or wonder how the process works, you may wish to contact us at 800-641-0098.

Originally posted at The Legal Examiner by Darren Tobin

Hip Implant Update: The FDA Demands Proof That Metal-On-Metal Hip Devices Are Safe And Effective

M. Brandon Smith — Thu, 17 Jan 2013 09:55:57 GMT

For several years as metal-on-metal devices have failed at alarming rates and a question has been repeatedly asked but not yet answered: Is there a lack of a clinical advantage with metal-on-metal bearings?

Today the New York Times reports that the question must be answered by industry or the FDA is going to require these Metal-On Metal (MoM) devices to be withdrawn from the market.

The harms associated with cobaltism and metallosis are significant. Many of the known harms associated with the following devices have resulted in many patients being seriously harmed and led thousands of lawsuits across the country:

Depuy’s ASR device [Recalled in August of 2010-but claims are still being filed]
Depuy’s Pinnacle Cup (metal Insert)
Stryker Corporation’ Rejuvenate modular hip
Zimmer Holdings, Inc.’s Durom Cup
Wright Medical Technologies Conserve Cup
Biomet Inc.’s M2A Magnum Hip Replacement

Some recommendations were made after two days of hearings back in June 2012 with thousands of pages of supporting documentary evidence questioning the metal on metal hip systems. The material is archived and may be found here: 2012 Meeting Materials of the Orthopaedic and Rehabilitation Devices Panel

For more information on the FDA's most recent announcement and recommendations on January 17, 2013 review our comprehensive post: MoM Hip Implant Update: The FDA Issues New Guidelines For Patients That Have Metal-On-Metal Devices: Who Is Most At Risk?

For those metal-on-metal him implant patients that are still unrepresented we encourage them to speak to a lawyer about their legal rights and if warranted, file a claim before their statute of limitation expires.

In the estimation of Childers Schlueter and Smith, LLC the harms and value of each timely prosecuted hip implant claim will include future considerations. The average claimant of a defective MoM hip implant device will have been exposed to high levels of Chromium and Cobalt that will require years of monitoring and treatment. Questions will persist into the future: Will there be long term affects from exposure, such as impaired renal function, impaired hearing, adverse neurologic effects, unwanted conditions effecting the heart, and/or a potential impact to the thyroid gland or lymphoma? These are all questions that must be addressed and considered.

Individual considerations of particular circumstances are evaluated including the possible uncertainty of the longstanding effects of metallosis, cobalt and chromium. Each represented client has claims that are different and are evaluated individually on a case by case basis. (Ie. We are representing single individuals and not participating in a Class Action with our clients. Our experience in handling these claims show the injuries and harms are just too great to handle them in any other way)

If you have questions or just want to be more informed, call our hip implant lawyers toll free at 1-800-641-0098 or 404-419-9500. You can also find out more information by visiting our website: www.cssfirm.com The lawyers at Childers Schlueter and Smith LLC are available to answer your questions and explain your legal options.

Originally posted at The Legal Examiner by M. Brandon Smith

Stryker advises clinical examination on all patients with ABG II modular-neck or Rejuvenate system

Darren Tobin — Mon, 07 Jan 2013 11:34:13 GMT

The hip implant systems Rejuvenate and ABG II modular-neck were recalled in June 2012 by Stryker. Recently on January 3, 2013, Stryker announced several important developments concerning these two recalled hip implant systems.

In a letter to surgeons, Stryker says that surgeons should consider conducting a clinical examination on all patients who had the ABG II modular-neck or Rejuvenate system implanted. Performing these clinical examinations are recommended on patients who have not even experienced any pain or swelling. Surgeons should also have follow up examinations on all affected patients.

Stryker has partnered with Broadspire Services, Inc., a third party claims administrator, to help manage any requests for reimbursements of costs relating to this recall. The company is going to reimburse patients for any revision surgery, treatment, testing and any other costs relating to the recall.

The potential hazards associated with the ABG II modular-neck hip stems and the Rejuvenate systems include corrosion and/or fretting about the modular neck junction which may lead to an increased metal ion generation in the surrounding joint space; the excessive metal debris and/or ion generation.

Patients may experience hypersensitivity and or an allergic reaction which can result in the need for revision surgery. An Adverse Local Tissue Reaction (ALTR) can occur when there is contact between metal ion and tissues and structures during an implant’s service life. ALTR is the inflammation of associated tissues experiencing metallosis, pain, and/or necrosis. Fretting may lead to increased metal debris in the joint space. This can then lead to osteolysis and then can result in the necessity for revision surgery.

Those who have been affected by this recall or have questions may wish to contact us our experienced attorneys with Childers Schlueter & Smith LLC, or at (800) 641-0098.

Originally posted at The Legal Examiner by Darren Tobin