Dallas Fort Worth Injury Lawyer Blog

Texas DePuy Attorney Warns About Pinnacle Hip Lawsuits

Wed, 15 May 2013 19:26:11 -0600

According to experts, Johnson & Johnson, the parent company of DePuy Orthopaedics, is facing more than 4,000 lawsuits over the DePuy Pinnacle hip device. The 4,000 plus plaintiffs, allege that the DePuy Pinnacle metal-on-metal design is defective and prone to premature failure and metallosis caused by the release of metal trash as the metal components grind against each other.

DePuy ASR and Pinnacle Federal MDL

The DePuy Orthopaedics subsidiary is exposed to two separate gigantic multidistrict litigations, known as MDLs. The Depuy ASR lawsuits are centralized in the U.S. District Court for the Northern District of Ohio. The DePuy Pinnacle lawsuits are centralized in the U.S. District for the Northern District of Texas, Dallas division.

There more than 7,000 ASR metal on metal lawsuits pending in the U.S. District Court for the Northern District of Ohio. There are now 4,087 DePuy Pinnacle metal on metal lawsuits pending in the U.S. District for the Northern District of Texas, Dallas division.

Defects with DePuy Pinnacle and ASR Hips?

These metal-on-metal hip replacements, are composed of a metal femoral component (thigh bone) that swivels in a metal acetabular cup fixed in the pelvis, essentially a ball and cup configuration.

Plaintiffs allege that both implants release cobalt and chromium metal fragments locally into the hip joint leading to swelling, pain, fluid build up and destruction of the hip joint and hip muscles. This destructive process can cause the metal components to loosen and lead to early failure. Unfortunately for many patients, they will have to face risky hip revision surgery sooner rather than later.

DePuy Pinnacle History And 510k Process

The DePuy Pinnacle hip system was introduced in 2001, and the metal-on-metal device was used as the basis for the approval of the DePuy ASR hip implant in 2005. Johnson & Johnson obtained “fast track” 510k approval by declaring that the DePuy ASR and DePuy Pinnacle metal-on-metal hips have “substantially similar” designs.

The 510k approval process is extremely controversial and allowed hip products to be released on the market without the usual stringent pre market approval process,(PMA), by the FDA which is standard for medical devices. The government regulators essentially gave up in the process, ceding their oversight responsibility to corporate interests and big business.

In their rush to put profits over the health of thousands of American patients, many hip manufacturers followed Johnson and Johnson's lead and flooded the market with allegedly poorly constructed metal hip implants with little or no regulatory oversight.

Metal on Metal "Land Grab"

According to many experts, this modern day land grab mentality is largely responsible for today's debacle involving the whole metal on metal hip design.

In August 2010, DePuy issued an ASR hip recall after the hip manufacturer revealed that post-marketing data suggested that about 12-13% of the implants were failing within five years. Many experts have disputed that estimate, and have suggested that the DePuy ASR failure rate is significantly and alarmingly higher.

Biomet, Stryker, Smith and Nephew and Zimmer Lawsuits

Other metal on metal manufacturers are also under fire for allegedly selling defective hip implants without adequate testing. Two other multidistrict litigations (MDLs) have been established for all Biomet M2A Magnum hip lawsuits and Wright Medical Conserve Cup lawsuits.

2 DePuy ASR Verdicts

Only two DePuy ASR cases have reached a jury, a California case resulted in a plaintiff win of $8.3 million damage award and recently an Illinois state court resulted in a defense verdict.

According to experts, Johnson and Johnson will have no choice but to ultimately settle these defective hip cases because the cost of defending over 20,000 individual lawsuits will cripple the company and drag on potentially for years. It will boil down to an economic business decision by the corporate pencil pushers, to settle and move on. The only factors to consider will be how much and when.

Bard Avaulta Vaginal Mesh Heading to June 2013 Trials

Tue, 14 May 2013 19:33:14 -0600

The first of four separate federal trials involving problems with Bard Avaulta mesh will begin in June 2013. U.S. District Judge Joseph R. Goodwin ordered that the first four Bard Avaulta lawsuits in the federal MDL will be tried individually.

Judge Goodwin is overseeing the vaginal mesh injury cases in the U.S. District Court for the Southern District of West Virginia. Here all federal lawsuits over Bard Avaulta mesh have been centralized as part of an MDL, or multi-district litigation.

The first Bard Avaulta trial in the federal court system will involve a lawsuit filed by Donna and Dan Cisson. The first trial date is scheduled to begin on June 11, 2013.

Thousands of Trans Vaginal Mesh Lawsuits

These bellwether cases have been selected as test cases in the vaginal mesh litigation, which includes thousands of lawsuits filed over the Bard Avaulta mesh and other mesh products.

Judge Goodwin presides over five different vaginal mesh litigations involving products manufactured by C.R. Bard, American Medical Systems (AMS), Boston Scientific, Ethicon and Coloplast Corp.

These mesh injury cases involve allegations that the manufacturers sold dangerous and defective surgical mesh products used for transvaginal repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI). Plaintiffs allege that they suffered injuries when the mesh eroded through the vagina and caused severe complications.

According to the U.S. Judicial Panel on Multidistrict Litigation as of March 2013, Judge Goodwin’s West Virginia court is currently presiding over 1,956 Bard Avaulta lawsuits; 3,974 AMS vaginal mesh lawsuits; 2,317 Boston Scientific pelvic mesh lawsuits; 3,798 Ethicon Gynecare mesh lawsuits and 188 Coloplast bladder sling lawsuits.

What are Bellwether Trials?

Bellwether Trials are a small group of cases that are prepared for early trial dates in each of the proceedings. The outcome of these trials may help the parties resolve the litigation and pave the way to a global settlement. Three trials are scheduled to begin in December 2013 involving lawsuits filed over AMS mesh, Boston Scientific mesh and Ethicon Gynecare mesh.

Vaginal Mesh Verdicts

The bellwether Bard Avaulta MDL trials will be the first cases in the federal court system to go before a jury. In July 2012, a California state court jury awarded $5.5 million in damages to Christine Scott, who alleged that the Bard Avaulta mesh damaged her colon, resulting in at least eight additional surgeries.

In February, a New Jersey state court jury awarded $11.1 million damages to Linda Gross, who required at least 18 surgeries from Ethicon vaginal mesh injuries.

The number of lawsuits filed throughout the country has continued to increase since the FDA issued a warning in July 2011, indicating that thousands of women had reported suffering problems with vaginal mesh products. After a review of all available data, the FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery to repair pelvic organ prolapse.

Byetta, Januvia & Victoza Pancreatic Cancer Risk

Mon, 13 May 2013 19:38:50 -0600

Recent medical research suggests that certain type 2 diabetic medications, known as Incretin Mimetics, including Januvia, Janumet, Byetta, Bydureon and Victoza, are potentially linked to an increased risk of pancreatic cancer side effects when compared to other diabetes treatment.

Incretin Mimetic Investigation Timeline

April 18, 2013 – Institute for Safe Medication Practices (ISMP) released a disturbing report. ISMP, monitors FDA MedWatch reports, focused on Byetta, Victoza, Januvia, Onglza and Tradjenta. Based on the report, ISMP is calling for stronger alerts on the prescribing information, as well as new studies on the long-term effects of these diabetes treatment drugs and the association with thyroid and pancreatic cancer.

March 14, 2013 - FDA investigates reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes.

The FDA has is investigating Incretin Mimetic drugs including exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto).

March 26, 2013 – Research suggests popular diabetes drugs can cause abnormal pancreatic growth in humans. UCLA and University of Florida researchers examine pancreatic tissue of recent organ donors. Investigators reported that the pancreatic mass of those taking GLP-1[diabetes patients] was increased 40% compared to that of the other diabetes drugs or non-diabetic controls.

The study also identified precancerous growths in the pancreas of those who had been treated with GLP-1 agents and a six-fold increase in beta cells compared with the diabetes comparators.

February 25, 2013 – Glucagonlike Peptide 1–Based Therapies and Risk of Hospitalization for Acute Pancreatitis in Type 2 Diabetes Mellitus. A case study of Blue Cross/Blue Shield health plan insurance claims shows a 2.2-fold increased risk of hospitalization for acute pancreatitis among patients treated with sitagliptin (Januvia, Janumet, Juvisync) and exenatide (Byetta, Bydureon). Pancreatitis is generally considered a risk factor for pancreatic cancer.

Januvia History

Januvia was approved by the FDA in October 2006 for the treatment of diabetes. A study in 2011 found that using Januvia (sitagliptin) to treat type 2 diabetes may increase the risk of pancreatic cancer by 2.7 times.

The study was published in the journal Gastroenterology and compared the incidence rates of pancreas cancer reported by patients using one of several different diabetes medications. The researchers found there was a 2.7-fold likelihood the disease would be reported by sitagliptin users.

Actos Bladder Cancer $6.5M Verdict Tossed

Sun, 05 May 2013 11:07:58 -0600

The California state court judge has tossed last week's Actos bladder cancer verdict and has reversed the $6.5 million damage award. The judge issued a post-trial ruling rejecting key expert witness testimony.

Last week, the Los Angeles County jury awarded plaintiff Jack Cooper $6.5 million for his bladder cancer injuries from Actos side effects. The trial lasted more than 2 months and Cooper argued that Takeda Pharmaceuticals, the manufacturer of Actos, failed to adequately warn about the Actos cancer risk and claimed that use of the medication for more than two years resulted in his November 2011 diagnosis of bladder cancer.

Superior Court Judge Kenneth Freeman issued an Order tossing the jury verdict after determining that expert testimony was inadmissible. Judge Freeman determined that causation was not established in Cooper’s case. Judge Freeman said the medical expert (Dr Smith) relied on unreliable studies and did not give enough weight to Cooper’s risk factors. Cooper aged 60 and was a former smoker, a major risk factor which Takeda says probably played a larger role in his risk of bladder cancer than Actos.

The judge wrote “[I]nstead of his differential diagnosis being patient specific, based upon a review the patient’s medical history, clinical tests, biological and physiological markers, and physical examination of the patient, Dr. Smith rendered a diagnosis based upon speculation, conjecture and leaps of logic.”

Plaintiff to Plan Appeal

Cooper’s lawyers are likely to appeal the decision to strike the expert testimony that was the basis for the jury’s finding that Cooper specifically developed bladder cancer from Actos. If the trial judge is reversed on appeal, the jury damage award may be reinstated.

Actos Bladder Cancer Lawsuit Cases Continue

Actos (pioglitazone) was approved by the FDA in July 1999 for treatment of type 2 diabetes. The FDA ordered new bladder cancer warnings to the medication in 2011, warning that patients have an increased risk of bladder tumors after using the medication for more than year.

Thousands Actos bladder cancer lawsuits are filed in state and federal courts throughout the U.S. The plaintiffs allege that Takeda Pharmaceuticals failed to warn about the risk of cancer from Actos.

Federal Actos Bladder Cancer MDL

The federal Actos bladder cancer cases have been consolidated for pretrial proceedings as part of an MDL, or Multi-District Litigation. The MDL has been centralized before U.S. District Judge Doherty in the Western District of Louisiana. According to court order the first MDL bellwether trial is set for January 27, 2014. A second trial date is set for April 14, 2014.

New Report: Pancreatic Cancer Risk from Byetta, Januvia, Victoza

Sat, 04 May 2013 11:13:30 -0600

According to the Institute for Safe Medication Practices (ISMP)’s Quarter Watch report, the number of pancreatic cancer cases are increasing involving lethal side effects of Byetta, Januvia, Victoza and other diabetes drugs known as incretin mimetics.

ISMP evaluates adverse event reports submitted to the FDA, and the report, Perspectives on GLP-1 Agents For Diabetes, evaluated adverse event reports for exenatide (Byetta and Bydureon), liraglutide (Victoza), sitagliptin (Januvia and Janumet), saxagliptin (Onglyza) and linagliptin (Tradjenta).

The yearly adverse event report data ending June 2012, demonstrated that there were at least 1,723 serious adverse events submitted through the FDA’s MedWatch program. There were at least 105 pancreatic cancer cases and 831 reports of pancreatitis. Pancreatitis or inflammation of the pancreas gland is an important risk factor for the development of pancreas cancer.

There were 71 Byetta pancreatic cancer cases, 18 with Januvia and Janumet and 14 Victoza pancreatic cancer cases.

Byetta and Victoza Thyroid Cancer Risk

Byetta and Victoza are injected, and Januvia, Janumet, Onglyza and Tradjenta are taken orally. ISMP documented 14 cases of thyroid cancer with Byetta and 17 with Victoza, 1 Januvia case and none for the other oral medications.

According to experts, the number of adverse event reports submitted to the FDA only account for 1% to 10% of all problems associated with prescription medications, since the majority of all health side effects are never reported by doctors or patients.

According to ISMP, “We recommend updating the prescribing information to include stronger alerts based on adverse event data and new studies now available,” concluded the report. “Also, new studies of the long-term effects of GLP-1 agents (incretin mimetics) on human and primate pancreatic and thyroid tissues should be a major priority.”

What are Incretin Mimetics Januvia, Byetta, Victoza?

Incretin mimetics are a new class of drugs used to treat type 2 diabetes. Byetta (exenatide) was approved by the FDA in 2005, and is manufactured by Amylin Pharmaceuticals as a twice daily injection. Januvia (sitagliptin) was approved by the FDA in 2006 and and is manufactured by Merck as an oral medication, and as a combination pill containing Januvia and another diabetic medication metformin, under the brand name Janumet. Victoza (liraglutide) was approved by the FDA in 2010, and manufactured by Novo Nordisk as a daily injection. Onglyza (saxagliptin) was approved by the FDA in 2009 and is manufactured by Bristol-Myers Squibb and AstraZeneca. Tradjenta (linagliptin) is manufactured by Eli Lilly and Boehringer Ingelheim and approved for sale in 2011.

FDA Launches Incretin Mimetics Investigation

Recently, the FDA began an investigation into the potential pancreatic cancer risk associated with incretin mimetics. The investigation was prompted after a recent medical study identified pre-cancerous cellular changes in pancreatic tissue from users of the drugs.

Federal MDL Motion Filed

Recently, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation requesting that all Byetta, Januvia, Janumet and Victoza pancreatic cancer lawsuits to be consolidated in the US District Court for the Southern District of California, based in San Diego, for coordinated handling during pretrial proceedings.

Januvia, Janumet, Byetta, Victoza Heading to Federal MDL

Tue, 16 Apr 2013 14:35:14 -0600

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has received a request to consolidate all federal pancreatic cancer lawsuits. These were filed by patients using Januvia, Janumet, Byetta and Victoza incretin mimetic diabetic drugs and they allege that they developed pancreatic cancer.

The injured pancreatic cancer plaintiffs have requested that all cases be centralized before U.S. District Judge Battaglia in the Southern District of California for coordinated proceedings as part of multidistrict litigation. The plaintiffs would like one single MDL be created for all Byetta, Januvia, Janumet and Victoza lawsuits, as opposed to having four separate MDLs established.

What are Incretin Mimetic Class of Drugs?

These diabetes drugs copy the action of incretin hormones that cause the insulin release after a meal. These drugs have been linked to an increased risk of chronic pancreatitis, which is a powerful risk factor in subsequently developing pancreatic cancer.

Incretin mimetics are new diabetic drugs. Byetta (exenatide) was the first to be approved by the FDA in 2005, and is manufactured by Amylin Pharmaceuticals as a twice daily injection. Januvia (sitagliptin) is manufactured by Merck and approved by the FDA in 2006, as an oral medication, and a combination pill containing Januvia and Metformin was released in 2007 under the brand name Janumet. Victoza (liraglutide) is manufactured by Novo Nordisk, and received FDA approval in 2010 as a daily injection.

FDA Investigates Incretin Mimetic Manufacturers

The FDA has recently initiated an investigation into the pancreatic cancer risk associated with incretin mimetics drugs. European health safety officials have also initiated a similar review.

Januvia, Janumet, Byetta, Victoza Lawsuit Allegations

According to plaintiff allegations, the incretic mimetic manufacturers knew about the risk of pancreatic cancer and the diabetes drugs for years and that the drug manufacturers failed to provide adequate warnings to doctors or patients. The U.S. JPML is expected to schedule oral arguments on the motion at an upcoming hearing session on May 30 in Louisville, Kentucky.

Merck Starts 2nd Trial on Fosamax Broken-Leg Lawsuit

Tue, 16 Apr 2013 14:11:19 -0600

Merck & Co. (MRK) is defending a woman’s claim that its osteoporosis drug Fosamax weakened her femur, causing her leg to break when she fell in her driveway. This is the second Fosamax femur fracture injury claim going to trial. The first trial, in state court in Atlantic City, New Jersey, was called off after plaintiff Christina Su suffered a “sudden illness” that was unrelated to her use of Fosamax.

A three-week jury trial has started before U.S. District Judge Joel Pisano in Trenton, New Jersey. The plaintiff, Bernadette Glynn fell and injured herself in April 2009. Merck claimed that Glynn, 58, tripped over a chainsaw in her garage and that the fracture is typical of women with osteoporosis.

Fosamax and Femur Fracture Allegations

Glynn and her husband, Richard Glynn, residents, New York, sued Merck in September 2011, alleging Fosamax causes “serious and sometimes fatal injuries.” "While the drug increases bone-mass density, the effect doesn’t always correspond to a reduction in fracture risk." The compound can cause bones to become “highly mineralized, homogeneous, brittle.”

Merck, the second-biggest U.S. drugmaker, is alleged in more than 3,300 lawsuits that extended use of bisphosphonates such as Fosamax caused femurs to deteriorate in some patients. According to Merck, it faces another 1,230 cases alleging Fosamax caused similar fractures in jaws.

What is Fosamax?

Fosamax, was approved for sale in the U.S. in 1995, and generated sales of as much $3 billion a year until patent protection lapsed in 2008. The drug is often prescribed for osteoporosis in women and for cancer sufferers worried about fractures from weakened bones.

Femur or Thighbone Fractures

Researchers said in 2010 that Fosamax and other biphosphonates drugs may be linked to increased risks of thighbone fractures. As many as 94 percent of 310 patients who had an uncommon type of fracture to the thigh bone were also taking a bisphosphonate-based drug, according a September 2010 report in the Journal of Bone and Mineral Research. Most had taken the medicine for more than five years, according to the report.

FDA Information

“There is not a scintilla of evidence that Merck knowingly withheld from FDA or misrepresented to FDA any information related to the risk of femur fracture,” Merck said in the filing.

Osteoporosis Diagnoses ‘Skyrocket’

Fosamax and other osteoporosis drugs have become widely over-prescribed and diagnoses of osteoporosis have “skyrocketed” since the assessment method shifted from the use of clinical criteria such as prior bone fracture to testing bone-mass density instead, according to the complaint.

The company has won five of the seven cases decided by juries on the jaw claims. In February, a federal jury in New York ordered Merck to pay $285,000 to a woman who blamed the drug for her jawbone injuries.

The cases are Glynn v. Merck & Co., 3:11-cv-05304, U.S. District Court, District of New Jersey (Trenton); and Su v. Merck & Co., ATL-L-0789-11-MT, Superior Court of New Jersey (Atlantic City).

Mirena IUD Perforation Injury Federal Lawsuits New York Bound

Mon, 15 Apr 2013 14:52:30 -0600

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has issued an order to consolidate all Mirena IUD injury perforation injury lawsuits. This order applies to all cases filed throughout the federal court system. All Mirena IUD injury cases will be centralized before one judge as part of an MDL, or multidistrict litigation.

According to the JPML order, all defective Mirena IUD product liability lawsuits will be transferred to U.S. District Judge Cathy Seibel in the Southern District of New York for coordinated handling during pretrial proceedings.

What is Mirena IUD?

Mirena is a birth control T shaped plastic device manufactured by Bayer Healthcare. This plastic device is inserted into the uterus and is designed to prevent pregnancy. The IUD has been heavily advertised as a safer alternative to the birth control pill. Unfortunately many women have reported catastrophic injuries with the Mirena IUD, such as perforating the uterus, requiring repairative surgery and in severe cases hysterectomy.

Mirena IUD Lawsuits

The filed lawsuits all claim that women suffered Mirena IUD related injuries after the device migrated out of the uterus.
The lawsuits claim that Bayer failed to properly investigate the risk of side effects or warn women about the potential for suffering a Mirena IUD injury. The Mirena IUD device was designed for use by women who already had one child and the device was supposedly effective and left in place for 5 years.

Benefits of Mirena IUD MDL Centralization

Benefits of Mirena IUD MDL Centralization, include having one judge to oversee the litigation, reduces discovery (millions of pages of documents are expected in this litigation), avoids differing rulings from judges and serves the parties, in other words all the plaintiffs and defendants are in the same courthouse. Bayer Healthcare LLC is located in New York and other Bayer entities are located nearby in New Jersey, Connecticut and Pennsylvania.

Januvia and Januvia Pancreatic Cancer Risk?

Thu, 04 Apr 2013 13:48:31 -0600

Can You Die From Januvia Pancreatic Cancer? The short answer is; it depends. Some 25 to 30 million people in the United States have diabetes, and 80 million folks have medical condition known as pre diabetes.

And the numbers are increasing slowly but surely. And Type 2 or adult onset diabetes is generally considered a man made problem (excluding Type 1 diabetes which occurs in childhood and usually as a result of genetic factors, autoimmune disease and or environmental problems).

Januvia is a drug manufactured by Merck, and it is used to treat adults with type-2 diabetes. In September 25, 2009 the FDA issued a revision to the warning label of the drug Januvia or Janumet, a combination drug comprised of Januvia and Metformin, regarding Januvia side effects, including Januvia pancreatic cancer and Januvia thyroid cancer.

Januvia (sitagliptin) and Janumet (sitagliptin/metformin) are the first in a new class of oral diabetes medications, called dipeptidyl peptidase-4 (DPP-4) inhibitors that improve blood sugar control in patients with type 2 diabetes. Both medications have recently been linked to acute pancreatitis and pancreatic cancer.

Reports of pancreatitis associated with type 2 diabetes medications, including Merck’s Januvia and Bristol-Myers Squibb’s Byetta and Bydureon, have forced the Food and Drug Administration (FDA) to begin a safety review.

The FDA said they are “evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics." These cellular changes can lead to pancreatic cancer.

Scope of the Problem: 2011 National Diabetes Fact Sheet
Total prevalence of diabetes

Total: 25.8 million children and adults in the United States—8.3% of the population—have diabetes.

Diagnosed: 18.8 million people

Undiagnosed: 7.0 million people

Prediabetes: 79 million people

New Cases: 1.9 million new cases of diabetes are diagnosed in people aged 20 years and older in 2010.

Cost of Diabetes: Huge

$245 billion: Total costs of diagnosed diabetes in the United States in 2012
$176 billion for direct medical costs
$69 billion in reduced productivity

After adjusting for population age and sex differences, average medical expenditures among people with diagnosed diabetes were 2.3 times higher than what expenditures would be in the absence of diabetes.

Factoring in the additional costs of undiagnosed diabetes, prediabetes, and gestational diabetes brings the total cost of diabetes in the United States in 2007 to $218 billion.

$18 billion for people with undiagnosed diabetes
$25 billion for American adults with prediabetes
$623 million for gestational diabetes

If the FDA investigation and further medical studies do show a link between Januvia and Pancreatic Cancer, then you have your answer. The best way to treat diabetes is to avoid it in the first place with a sensible low carbohydrate diet, exercise and weight reduction. We eat way too much in the US, we have a sedentery lifestyle and we are all being poisoned by the food industry by foodstuffs with too much salt, sugar and fat. Mayor Bloomberg was right, ban sugary drinks and lable fast foods fat, sugar and salt content.

Tylenol Lawsuits Heading to Pennsylvania MDL

Wed, 03 Apr 2013 13:41:13 -0600

All federal Tylenol liver failure lawsuits are going to be centralized in federal multidistrict litigation (MDL). The MDL has been established for lawsuits filed in U.S. District Courts before Judge Stengel in the Eastern District of Pennsylvania.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a Transfer Order on April 1, consolidating all Tylenol product liability lawsuits. Injured plaintiffs have claimed that they suffered liver damage and liver failure due to the side effects of acetaminophen, the active ingredient in Tylenol.

Tylenol Allegations

The complaints involve allegations that Johnson & Johnson failed to adequately warn consumers about the liver toxicity of Tylenol, which has been linked to an increased risk of liver failure and in severe cases, patients have to undergo a liver transplant.

FDA Investigation

The FDA has stated that acetaminophen overdose is a leading cause of liver failure in the U.S., resulting in more than 50,000 emergency room visits, 25,000 hospitalizations and over 450 deaths annually. According to FDA experts, there were between 1,000 and 2,000 acetaminophen-induced liver failures each year.

McNeil Announces Reduced Tylenol Dosage

In July 2011, McNeil announced that it was lowering the maximum recommended dosage on Tylenol and other acetaminophen-based products from 4 grams per day to 3 grams per day. The decision came after the FDA announced new limits on acetaminophen levels in prescription painkillers like Vicodin and Percocet.

Benefits of Tylenol Centralization

Centralizing the Tylenol litigation before one court is designed to reduce discovery in a large number of cases, avoid conflicting rulings from different judges and to serve the convenience of the parties and the courts.

Once centralized, the court will set expedited trial dates, known as bellwether trials and if the plaintiffs are successful in proving their cases, then that may pave the way for a global settlement. Typically these complex pharmaceutical and defective medical device litigation takes 3-5 years to wind their way through the court system towards settlement.

FDA Investigates Pancreatic Cancer Link to Newer Diabetes Drugs

Wed, 27 Mar 2013 19:22:19 -0600

As a Texas medical doctor and Dallas Januvia/Byetta/Victoza dangerous drug Pancreatic Cancer attorney I am providing this latest information and investigation from the FDA.

According to the FDA notice, posted on March 14, the agency is:

“Evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes.”

FDA urges both patients and health care professionals to report adverse events involving incretin mimetics to the FDA MedWatch program.

Incretin Mimetics Under Investigation

This class of diabetes drugs, known as incretin mimetics, includes:
Exenatide (Byetta, Bydureon), Liraglutide (Victoza), Sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), Saxagliptin (Onglyza, Kombiglyze XR), Alogliptin (Nesina, Kazano, Oseni) and Linagliptin (Tradjenta, Jentadueto)

What are Incretin Mimetics?

Incretin mimetics known as glucagon-like peptide-1 receptor agonist, or GLP-1 agonist, and dipeptidyl peptidase-4 inhibitors, or DPP-4 inhibitors, mimic incretin hormones action, reduce glucagon levels, and inhibit an enzyme called DPP-4.

Incretin Mode of Action

Incretins are gut hormones or chemical transmitters that your body produces to stimulate insulin release in response to a meal. As your blood sugar rises, the drug stimulates your pancreas to release insulin. It also prevents your pancreas from releasing too much of another hormone called glucagon. Insulin and Glucagon hormones are involved in maintaining steady blood sugar levels.

Incretin Mimetics inhibit DPP-4, a protease enzyme that destroys the hormone GLP-1.

Sitagliptin, manufactured by Merck and sold under the name Januvia, received FDA approval in 2006. Saxagliptin (Onglyza), another DPP-4 inhibitor, was approved in July 2009, followed by Linagliptin (Trajenta) in 2011.

Cancer Links With Incretin Mimetics

One of the known side effects listed on the "Warnings and Precautions" section of the drug label is acute pancreatitis. According to a study published on February 25 in the journal JAMA, exenatide or sitagliptin doubled the risk of developing acute pancreatitis.

These drugs may also cause pancreatic duct metaplasia (pre-cancerous cellular changes). Previous research has indicated a connection of thyroid, colon, melanoma, and prostate cancer.

Medical Studies

A 2006 study found that “the use of DPP-4 inhibitors together with GLP-2 led to increased proliferation as well as elevated migratory activity. Therefore, the use of DPP-4 inhibitors could increase the risk of promoting an already existing intestinal tumor and may support the potential of colon cancer cells to metastasize.”

In 2010, researchers concluded that “although the data on the effects of DPP-IV inhibitors in humans are scarce, the increased risk of infections and the tendency towards a higher incidence of some tumors fall in line with experimental evidence suggesting the possibility of their adverse immunological and oncological effects.”

According to a 2011 study in the journal Gastroenterology “data are consistent with case reports and animal studies indicating an increased risk for pancreatitis with glucagon-like peptide-1 based therapy. The findings also raise caution about the potential long-term actions of these drugs to promote pancreatic cancer, and DPP-4 inhibition to increase risk for all cancers.”

In 2013, researchers warned DPP-4 “is implicated in regulation of malignant transformation, promotion and further progression of cancer, exerting tumor-suppressing or even completely opposite - tumor-promoting activities.”

The risk of pancreatic cancer and pancreatitis from Byetta and Januvia was demonstrated in a study published last month in JAMA Internal Medicine. The study suggested that taking the medications may double the risk of hospitalization due to pancreatitis and researchers expressed concern that this may ultimately caused some users to develop pancreatic cancer.

How Does Incretin Mimetics Promote Cancer?

DPP-4 is a tumor suppressor, so by inhibiting DPP-4, you are continuously inhibiting one of your body’s natural cancer suppressing mechanisms. According to Januvia’s drug information, the drug inhibits the DPP-4 enzyme for 24 hours, and you take it daily. So you are effectively permanently blocking the activity of a tumor suppressor gene.

Januvia, Byetta and Victoza Diabetes Drugs Risk For Pancreatic Cancers

Mon, 25 Mar 2013 15:38:19 -0600

According to a recent medical study, patients taking the newer diabetes drugs were affected by pancreatic cell growth and damage that may turn cancerous. The study, by UCLA Medical Center, provides evidence of increased pre-cancerous changes in diabetic patients using incretin mimetics drugs such as Januvia, Byetta and Victoza.

FDA Investigates Incretin Mimetics

According to the U.S. Food and Drug Administration, it was reviewing unpublished data by medical researchers which suggest that pre-cancerous cellular changes may be associated with Type 2 diabetes drugs known as incretin mimetics, including Bristol-Myers Squibb’s Byetta and Novo Nordisk’s Victoza.

Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

According to Public Citizen, a consumer watch dog, “these findings are in accord with the rapidly increasing number of reports to the FDA of pancreatic cancer in patients using incretin mimetics compared with diabetics using other drugs.”

Many Adverse Incretin Mimetics Safety Reports Since 2007

Doctors have been concerned that incretin mimetics may damage the pancreas since the FDA said in 2007 it received a high number of reports of pancreatitis in patients taking Byetta. The FDA issued a similar alert for Januvia in 2009. An analysis of insurance records published last month in the journal JAMA medical journal showed incretin mimetics, Byetta and Januvia may double a patient’s risk of pancreatitis.

UCLA Medical Study

The research showed that in humans, incretin therapy resulted in “marked” cell proliferation and damage, with a potential for evolution into cancer, the authors wrote.

What is Byetta and Januvia?

Januvia (sitagliptin) is a medication approved for the treatment of adults with Type-2 diabetes. It is one of the first in a new class of medications known as dipeptidyl peptidase-4 (DPP-4) inhibitors.

Byetta (exenatide) was introduced in April 2005, as a twice a day injection to help reduce blood sugar levels in type 2 diabetics. Bydureon, a longer-acting version of the medication, was approved in January 2012, allowing users to take one dose a week to regulate their diabetes.

Victoza, (liraglutide), mimics a hormone called GLP-1 to stimulate natural insulin production.

California Jury Hits J&J and DePuy: Must Pay $8.3 M on Defective Hip Lawsuit

Fri, 08 Mar 2013 18:59:12 -0600

The jury finally rendered a verdict today, in a hotly contested Johnson & Johnson defective hip lawsuit, being tried in California state court, Los Angeles. Johnson & Johnson (J&J)’s DePuy subsidiary unit was found liable for defectively designed metal-on-metal hip implant, in the first of 10,750 lawsuits over the device to go to trial.

Jury: Clear Message

The California jury sent a clear message today that Johnson & Johnson and DePuy put profit over safety by awarding Loren Kransky, the plaintiff in the California case of Kransky v. DePuy Orthopedics, $ 8.3 million for damages caused by Mr. Kransky’s implantation and revision of the recalled DePuy ASR XL hip implant.

DePuy ASR Public Health Disaster

J&J, recalled 93,000 of the DePuy ASR implants in August 2010, when it said 12 percent failed within five years. Last year, 44 percent failed in Australia within seven years.

“This is not an imperfect hip, this is a public health disaster,” Plaintiff Kransky’s attorney Michael Kelly said in closing arguments on Feb. 28. “Somebody needs to tell them, Don’t make Bill Kransky come to court. Build these things right. Don’t let this happen again.”

Beginning of the End of Metal on Metal Hips

Thousands of plaintiff patients have complained in court filings of dislocations, pain, and follow-up surgeries known as revisions. Kransky’s lawyers argued that DePuy failed to test the device adequately before selling it in the U.S. in 2005, hid and denied surgeon complaints of hip failures, and studied a redesign of the ASR before scrapping that effort in 2008.

J&J and DePuy aggressively marketed and allowed over 33,000 of these recalled hip implants to be distributed and implanted in patients across the United States, despite their knowledge that high levels of cobalt and chromium metal debris could cause a serious health threat for patients.

The Verdict Breakdown

Kransky’s lawyer Brian Panish had asked for compensatory damages of $5.3 million and punitive damages of as much as $179 million. The jury’s verdict, which came on the sixth day of deliberations, included $338,136 in damages for medical expenses and $8 million for physical pain and emotional suffering. There was no finding of gross negligence to support a punitive damage award.

“This is the first day of reckoning for DePuy,” Panish said after the verdict. “We’ve learned a lot from this trial. We’ll get punitive damages in the next trial.” According to a juror, David Vega, “I wanted punitive damages” based on the evidence that DePuy found the problem and took so long to resolve it.

J&J Appeal Planned

“We believe the ASR XL was properly designed, and that DePuy’s actions concerning the product were appropriate and responsible,” Lorie Gawreluk, a spokeswoman for DePuy, said in a statement. “We plan to appeal the jury’s decision on design defect depending the outcome of post-trial motions.”

The case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles).

DaVinci Robosurgery Implicated in Injuries and Death

Thu, 07 Mar 2013 19:24:37 -0600

According to plaintiff, Michelle Zarick, she complained of excessive vaginal bleeding and her doctor recommended hysterectomy. One option: robot surgery, described by her gynecologist as “the latest, greatest” technique available.

Zarick was told that with robotic surgery there would be less pain and bleeding. Five weeks later, Zarick felt something pop and saw her intestine protruding from her vagina. Now, four years later, the 41-year-old Zarick has a hip-to-hip scar from corrective surgery, constipation from damaged rectal muscles and a diminished sex life.

Zarick, filed suit in December against Intuitive in regard to her hysterectomy. “It forever changed my life for the worse.”
Robot systems made by Intuitive Surgical Inc. are linked to at least 70 deaths in informal incident reports sent to U.S. regulators since 2009.

Intuitive Surgical Inc., the Dominant Robotic Company

Intuitive, based in Sunnyvale, California, is the only company whose system is cleared in the U.S. for soft tissue procedures that include general surgery, prostate operations and gynecological surgery.

According to a company filing, the number of U.S. procedures done with the robots has grown to about 367,000 in 2012, compared with 292,000 in 2011 and 228,000 in 2010.

DaVinci Increases Surgical Costs

Tough new questions about safety raised in lawsuits and in adverse incident reports to the FDA may threaten the company’s growth. They come as the technology is already facing criticism for raising surgical costs at a time medical studies show no significant health benefits for the robots, compared with standard less-invasive operations.

FDA Adverse Reports

A review of adverse incident reports sent to the Food and Drug Administration since 2009 jumped to at least 115 in 2012 from 24 in 2009, while deaths rose to 30 from 11.

In 2011, an analysis published in the American Journal of Obstetrics & Gynecology found the complication occurs in almost two percent of robot hysterectomies, or more than twice the rate seen in conventional, less invasive surgery.

DaVinci Insulation Failures

A 2011 study in the American Journal of Obstetrics & Gynecology, done in a laboratory, found that certain types of insulation failed on the robot at as much as four times the rate of conventional minimally-invasive surgery equipment.

Last August, researchers from Memorial-Sloan Kettering Cancer Center reported three cases of blood vessel burns caused by insulation failures with the robot, all of which were caught and fixed before they caused major complications.

The case is Zarick v. Intuitive Surgical, Inc., 12-cv- 237723, Superior Court, Santa Clara County, California.

Texas Attorney Warns About Stryker Rejuvenate Hip Implants

Tue, 05 Mar 2013 17:12:14 -0600

As a Dallas, Texas Defective Metal on Metal Hip attorney, I have written extensively about the problems and the lawsuits filed against the manufacturers of metal on metal hips. It appears that the problems associated with the metal on metal hips is neither unique or limited to one manufacturer.

Johnson and Johnson's DePuy ASR and Pinnacle models, Biomet's M2a Magnum, Stryker Rejuvenate and ABG II models, Wright Conserve, Zimmer Durom cup and Smith and Nephew R3, have all been implicated as being defective, prone to early failure and subjected to revision surgeries.

The most recent recall involving Stryker hips took place quietly on July 4, 2012, while most Americans were busy with fireworks and apple pie.

Stryker Orthopaedics Heading to MDL Consolidation

Recently a motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federal product liability lawsuits over the Stryker Rejuvenate and ABG II modular-neck stem hip replacement systems. Plaintiffs are requesting that the litigation be centralized before one federal judge for coordinated handling during pretrial proceedings.

There are currently at least 30 Stryker Rejuvenate or ABG II modular hip lawsuits pending throughout the federal court system, with cases spread among 12 different U.S. District Courts.

Benefits of MDL Consolidation

MDL Centralization is stream lined to reduce repetative discovery among a large number of similar cases, designed to avoid conflicting rulings from different judges and to serve the convenience of the parties and witnesses.

The plaintiffs claim problems with the Stryker Rejuvenate or ABG II modular-neck stem, which was recalled in July 2012 amid reports of corrosion, fretting and early failure.

What is the Problem with Stryker Rejuvenate and ABG II modular-neck stem?

The Stryker Rejuvenate and ABG II hips are modular or multipart, featuring two pieces that fit inside each other to allow the surgeon to customize the length based on the patient. This design has been linked to an increased release of microscopic metal debris as the chromium-cobalt neck rubs against the titanium femoral stem.

Stryker Rejuvenate and ABG II Recall

A Stryker Rejuvenate recall was issued in July 2012, only four years after the hip replacement system was introduced, after medical data that revealed excessive hip failures. More than 53,000 Stryker Rejuvenate or ABG II modular-neck stems were sold before the recall, most of which had already been implanted in patients.

In January 2013, Stryker issued a follow up statement to physicians and patients, providing updated information and recommendations for folks who have one of the recalled Rejuvenate or ABG II stems. Stryker indicated that regular testing is necessary, even for those patients not yet experiencing device failure.

New Jersey State Consolidation

Similar consolidation has already been established in the New Jersey state court system, where all Stryker Rejuvenate lawsuits have been consolidated as part of a Multi-County Litigation (MCL) in Bergen County. A large number of complaints are expected to be filed in New Jersey, as that is the home state for the device manufacturer, Howmedica.

More than 80 lawsuits have been filed in Bergen County against Stryker Orthopaedics by patients claiming that the medical device maker sold them a defective hip implant that was later recalled from the market. The first suit against Stryker was filed last summer by a 66-year-old Florida woman who alleged that she replaced her right hip with Stryker’s device known as Rejuvenate, based on a promise that it would last for decades.

The device failed within months, however, causing severe pain to the woman and requiring her to undergo several surgeries, the lawsuit alleged. The devices were sold to these patients on the promise that they would last anywhere from 20 years to a lifetime. In the case of all the patients, however, the devices failed in less than two years.