Product Liability

July 15, 2011

Yaz Injury Update: New Jersey BellWether Trials To Start

As a Yaz, Yasmin and Ocella side effect and blood clot attorney, and Texas Medical doctor I am providing this update regarding the bellwether trial status for the New Jersey State MDL litigation trial schedule.

The first trial dates for any Yaz, Yasmin or Ocella lawsuits pending in New Jersey state court will begin in the fall of 2012, with at least two cases to be selected as test cases out of hundreds of claims pending in the state.

There are about 1,000 Yaz, Yasmin and Ocella product liability lawsuits pending in New Jersey state courts involving claims that women suffered serious or deadly injuries as a result of side effects of Yaz, Yasmin or Ocella birth control, containing the fourth-generation progestin drospirenone which are all manufactured by Bayer.

All of the suits involves claims that Bayer failed to properly research their birth control pills or adequately warn about the increased risk of serious and life-threatening injuries from the birth control pills containing drospirenone, causing stroke, heart attack, pulmonary embolism, and deep vein thrombosis.

According to a case management order issued July 8 by New Jersey Superior Court Judge Martinotti, the first Yaz trial in New Jersey state court should be ready to go before a jury on September 10, 2012. A second trial date has been set for November 27, 2012.

The parties have been directed to identify a pool of 18 cases that may be selected for an early trial date, known as bellwether cases. Judge Martinotti has asked each side to select three cases involving allegations of pulmonary embolism, three involving claims of gall bladder injury and three involving allegations of venous thromboembolism, such as a deep vein thrombosis (DVT).

In addition to the cases pending in New Jersey state court, more than 6,000 other cases are pending in federal court and other state court systems. The federal Yaz litigation has been centralized as part of a multidistrict litigation (MDL) before Judge Herndon in the U.S. District Court for the Southern District of Illinois.

At least three trial trial dates are anticipated in the federal MDL, one involving a pulmonary embolism, one involving a gallbladder injury and one involving a venous thromboembolism, with the first Yaz trial in federal court expected to begin early next year.

QUICK FACTS: YAZ LAWSUITS ALLEGATIONS

Throughout the United States, a number of Yaz birth control lawsuits have been filed against Bayer Healthcare Pharmaceuticals, Inc., which was formerly known as Berlex, Inc. and Berlex Laboratories, Inc., claiming that the drug makers:

Failed to adequately warn consumers and the doctors about the potential risk of Yaz side effects.

Failed to adequately test and research Yaz birth control before placing it on the market, which could have shown that patients would face an increased risk of heart attacks, strokes, pulmonary embolism, deep vein thrombosis and other life-threatening health problems.

Failed to issue a Yaz recall or remove the birth control pill from the market after it became apparent that it is an unreasonably dangerous drug, for which the harmful side effects outweigh any potential benefits provided over other available birth control pills.

Aggressively marketed Yaz and encouraged misuse and overuse despite the known Yaz dangers to maximize profits at the expense of patients’ health.

The drug makers had access to all the facts concerning the potential Yaz problems, and ignored the connection between their drug and deadly side effects. Yaz safety concerns were hidden and misrepresentations were made to to convince consumers and doctors to use the birth control pill instead of other available products. This increased the drug makers’ profits at the expense of women throughout the United States. Another example of corporations putting profits before people.

In complex litigation involving a large number of claims with similar underlying facts, early trials are useful in helping the parties gauge the strengths and weaknesses of their cases, and may help facilitate a possible Yaz settlement agreement that includes other lawsuits in the litigation.

July 14, 2011

Vaginal Mesh Injury Lawsuits

by Dr. Shezad Malik

As a Vaginal Mesh Defective Product Lawsuits attorney, and Texas Medical doctor I am providing this important update.

According to a safety communication issued by the Food and Drug Administration, Women who have vaginal surgery to fix a gynecologic condition called pelvic organ prolapse may wind up with more problems than benefits if a plastic mesh is used.

The FDA said it plans to convene an advisory committee to determine whether to ban the mesh – manufactured by Mass-based Boston Scientific Corp., Covidien PLC of Mansfield, and several other companies – for this procedure.

About 100,000 women with pelvic organ prolapse are treated with plastic mesh each year, but in most cases, according to the FDA, the condition can be treated successfully without mesh.

Mesh-related problems reported to the FDA include painful sexual intercourse, infections, urinary problems, and bleeding, usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it.

Boston Scientific, is one of several companies that already face lawsuits over the mesh. Dozens of women who said they endured painful complications after the company’s mesh was implanted filed complaints last year in a California court, and many of the cases are now being transferred to jurisdictions across the country where the plaintiffs live.

Covidien, a company incorporated in Ireland with its corporate headquarters in Mansfield, supplies mesh to Bard, which markets it to health care providers to treat pelvic organ prolapse.

According to attorneys who represent more than 100 women in a complaint against Bard lodged in federal court in West Virginia, said the manufacturers initially designed the mesh for hernia repair. While regulators gave companies clearance to market it for pelvic organ prolapse repair, they did not look to see if, mechanically or otherwise, these products worked in the pelvis. “They should have known that they needed to check and test.’’
In 2008, the FDA announced that problems could be associated with transvaginal placement of the mesh, which is used along with surgical stitches to support sagging pelvic organs such as the bladder, uterus, and bowel after they have been lifted back out of the vagina, where they descended. From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for pelvic organ prolapse repair, five times as many as the agency received from 2005 to 2007. It also received three reports of deaths that were related to the mesh placement procedure.

Recent studies indicate that about 10 percent of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half require additional surgeries to remove the mesh. Sometimes, the mesh becomes so intertwined with scar tissue that it cannot be removed. Furthermore, the FDA found that the mesh does not make the surgery any more effective.

According to Dr. William Maisel, the FDA’s deputy director of the Center for Devices and Radiological Health, “The evidence we reviewed calls into question the clinical benefit of mesh, and it certainly shouldn’t be used routinely for all transvaginal prolapsed repairs.”
In 2010, 75,000 women had vaginal surgery with mesh to repair pelvic organ prolapse. That surgery was performed three times as often as abdominal surgical mesh repair, according to the FDA, since it does not require a painful incision through the skin and offers a less painful recuperation for women.

The FDA cited studies showing abdominal mesh repair for pelvic organ prolapse led to vaginal erosion in 4 percent of women within 23 months of surgery. The FDA urged patients with the condition to ask their surgeon about all treatment options, including those without mesh, before having the operation.

The reassessment of surgical mesh comes as FDA reviews its fast-track system for clearing medical devices, which has been largely unchanged since the 1970s. Like 90 percent of medical devices sold in the U.S., pelvic mesh was cleared under the FDA’s fast-track system, which grants market approval in 90 days to devices that are considered low-risk.

Medical device manufacturers have spent the last year lobbying the FDA and Congress to speed up device approvals as the government reviews the process. Safety advocates say the agency has been overusing the system and clearing high-risk devices that should be subject to more testing.

According to Dr. Diana Zuckerman, the agency should have required the studies it is now contemplating before mesh products were approved. “If they had been required to go through the more rigorous approval process, similar to that for prescription drugs, it would have been obvious years ago that surgical mesh has more risks than benefits in many types of surgery,” said Zuckerman, who directs the National Research Center for Women & Families.

The FDA will hold a meeting in September to discuss studies that would identify which patients benefit most from mesh implants. The FDA will ask panelists at the meeting whether pelvic surgical mesh should be reclassified as a high-risk device.

Surgeons began using mesh to repair hernias in the 1950s, and over the next 40 years they adapted the technique for women’s health conditions. FDA cleared the first mesh for prolapse in 2002, but since it was similar to devices that had been used for decades it did not have to undergo human testing.

The mesh was approved through the FDA’s 510(k) process, which calls for companies to prove that a product is “substantially equivalent” to one already on the market — usually without clinical studies on patients. The approval process is currently being scrutinized by the Institute of Medicine on behalf of the FDA.

Among the manufacturers are Boston Scientific Corp., American Medical Systems Inc. (now part of Pennsylvania-based Endo Pharmaceuticals) and Coloplast. Other companies making the mesh include Cook Medical, Covidien PLC, C.R. Bard Inc., and Ethicon, a division of Johnson & Johnson.

July 13, 2011

Actos Bladder Cancer Injuries

by Dr. Shezad Malik

Is an Actos recall in the works? As an Actos Bladder Cancer attorney, and Texas medical doctor I am providing this Actos update.

Actos (pioglitazone) is one of the world’s widely prescribed diabetes medications. Also marketed in combination with glimepiride (Duetact) and metformin (Actoplus Met, Actoplus Met XR), Actos is used by millions of patients with Type-2 diabetes. The drug works by controlling blood glucose levels through its action with insulin.

Now, Actos has also been linked to life-threatening side effects. In June 2011, the Food and Drug Administration (FDA) issued a warning to alert patients and healthcare professionals of an increased risk of bladder cancer associated with Actos. This followed another FDA warning, issued in June 2007, with reports of liver damage and cardiovascular problems among patients taking Actos.

If you have been diagnosed with bladder cancer or another condition you feel may be linked to taking Actos, the FDA recommends that you schedule an appointment with your doctor immediately.

Bladder Cancer Risk and Actos Usage

The FDA issued its Actos bladder cancer warning after an interim analysis of a 10-year epidemiological study conducted by the drug’s manufacturer, Takeda Pharmaceuticals. The analysis showed no increased risk of bladder cancer among users as a whole. The longest-term users of Actos and those with the highest cumulative dose of the drug showed increased levels of bladder cancer.

A separate study of Actos, conducted in France, has also linked the drug to bladder cancer. The FDA is aware of these findings and has stated that it intends to conduct a thorough review of the study and its findings. The agency has also stated that it will continue monitoring data from Takeda’s ongoing study.

In the meantime, the FDA has advised patients that taking Actos for longer than a year puts them at risk. The FDA recommends that patients with active bladder cancer avoid taking Actos. Physicians should use caution when prescribing Actos to patients with a history of bladder cancer, weighing the benefits of the drug to the risk of recurrence.

The FDA has also provided the following tips for patients:

Taking Actos may increase your odds of developing bladder cancer
Go to a doctor if you notice that your urine is red in color or if you see blood; if you are experiencing an extreme urge to urinate or pain while doing so; or if you are experiencing pain in your lower abdomen or back
Do not take Actos if you are receiving bladder cancer treatment
Report any side effects you notice to the FDA MedWatch program
Read the medication guide you get with your Actos prescription, which contains detailed information on risks associated with the drug
These warnings and recommendations will appear on the Warnings and Precautions section of the drug’s label, and in the accompanying medication guide.

Actos Side Effects and Potential Injuries

The FDA’s latest Actos warning follows another warning issued in June of 2007. At that time, the agency issued a “black box warning” requiring the manufacturers of Actos and Avandia (known as thiazolidinediones) to include warnings alerting patients and their doctors of cardiovascular and liver problems linked to the drug. Black box warnings appear on the packaging of drugs and are the strongest action taken by the FDA short of a recall.

These warnings were issued after the findings of a Cleveland Clinic study showed that thiazolidinedione use increased the risk of heart attack by as much as 42 percent. The findings also showed an increased risk of hepatitis, liver inflammation, elevated liver enzymes (an indication of liver damage) and liver failure.

July 12, 2011

Yaz Pulmonary Embolism PE

by Dr. Shezad Malik

As a Yaz, Yasmin and Ocella Blood Clot side effect and wrongful death attorney, and Texas medical doctor I am providing this update.

In one of the latest court battles pitting consumers against a giant drugmaker, thousands of victims are alleging Bayer did not provide adequate warnings about the health risks associated with Yaz, and they are blaming the drug for causing blood clots, heart attacks, strokes and sudden deaths.

Yaz and its predecessor, Yasmin, are oral contraceptives, including widely used generics such as Ocella, that contain a combination of the estrogen ethinyl estradiol and a synthetic hormone drospirenone. Both drugs were made by Berlex Labs, which was acquired in 2006 by Bayer Healthcare, the U.S. division of Bayer AG. The Food and Drug Administration approved Yasmin in 2001, and five years later they allowed Berlex to begin selling Yaz, another version of the drug.

The two pills, backed by heavy marketing campaigns, quickly became best-sellers, generating billions in annual sales for Bayer. When they were approved by the FDA, the pills were considered safer than older forms of oral contraceptives because they were taken for 24 days rather than the usual 21. But there were concerns about the health risks associated with drospirenone. A year after Yasmin went on the market, the nonprofit consumer advocacy group Public Citizen placed the drug on its list of “Do not use pills.”
The group warned consumers that Yasmin did not work better than older oral contraceptives that were less likely to cause dangerous side effects like blood clots. Sidney Wolfe, director of Public Citizen’s Health Research Group, said “When you have enough evidence to suggest that there is no unique benefit and there are unique risks, that should be it.”
In the case of Yaz, the product liability lawsuits claim that Bayer provided inadequate warnings about the health risks for women taking the drospirenone-containing birth control pills.

Yaz Pulmonary Embolism PE Risks
It is important to understand that if you are taking Yaz birth control, you are at a higher risk of Yaz pulmonary embolism. Women in the following categories have an even higher risk for Yaz related pulmonary embolism:

If you are over the age of 35
If you smoke more than 15 cigarettes per day
If you have a family or personal history of pulmonary embolism or blood clots
Yaz Death
Pulmonary embolism usually results in death because the emergency units cannot reach the patient in time. A staggering statistic is that 33 percent of all untreated pulmonary embolism attacks result in death. It is hard to process that the death may have been prevented with adequate information and packaging. Women should have been informed of the increased risks involved with taking Yaz birth control including PE and death.

More than 1,000 lawsuits have been filed in Bergen County — one of four courts where the mass tort litigation will be heard. Thousands of other cases are filed in courts in Philadelphia, California and Illinois.

In June, FDA regulators acknowledged new evidence that raised more questions about the safety of Yaz and birth control pills like it, including the top-selling generic Ocella. The agency posted a notice on its website saying it was aware of studies recently published in the British Medical Journal that showed oral contraceptives containing drospirenone were two to three times more likely to cause blood clots than other birth control pills.

July 7, 2011

Multaq Study Stopped: Linked to Other Heart Problems

by Dr. Shezad Malik

As a Multaq Dangerous Drug attorney and Texas medical doctor, I am providing this information on a drug company sponsored trial of its drug Multaq, which was halted because of increased cardiovascular side effects and injuries.

Sanofi, maker of dronedarone (Multaq), has stopped its phase 3b trial of its antiarrhythmic drug due to an increase in cardiovascular events seen in patients with permanent atrial fibrillation – an unapproved indication for the antiarrhythmic drug. The PALLAS trial was testing the drug in patients with permanent atrial fibrillation (AF) and at least one other cardiovascular disease risk factor; at present, dronedarone is approved in patients with nonpermanent AF.

According to the primary medical investigator, “. . . there was a significant increase in major cardiovascular events, and in our study that was defined as a composite of stroke, MI, systemic embolism, or cardiovascular death. . . . These were pretty important events.”

Multaq, is approved for patients with the non-permanent kind of atrial fibrillation. The trial, known as the PALLAS study, was testing Multaq’s usefulness in patients with permanent atrial fibrillation (more than 6 months of the abnormal rhythms).

Dronedarone has faced a range of criticisms since its approval in the US in July 2009, including questions about its safety/efficacy tradeoff and the design and execution of the ATHENA study. Just last week, newspapers in France reported that French health authorities had concluded that the efficacy of dronedarone was “insufficient”—an opinion that could lead to the drug being dropped from the country’s drug reimbursement formulary.

Dronedarone, sold by sanofi-aventis, is currently approved to treat atrial flutter and paroxysmal or persistent – but not permanent atrial fibrillation.

The phase 3b trial, called PALLAS, had enrolled 3,148 patients with permanent atrial fibrillation, with 70% showing symptoms for more than two years, according to a company statement. Sanofi did not specify the cardiovascular events seen in the dronedarone-treated patients, or the magnitude of the increase.

In January, sanofi-aventis and the FDA warned that reports of acute liver injury associated with the drug had been received. The statement noted that patients with permanent atrial fibrillation and “vascular risk factors” are at high risk for cardiovascular events.

An earlier trial of dronedarone in patients with relatively severe heart failure, called ANDROMEDA, was halted early when mortality in patients receiving the drug was found to be twice that seen in the control group.

Sanofi-aventis has alerted healthcare professionals to several reports of liver function test abnormalities and hepatocellular injury in patients treated with its atrial fibrillation drug dronedarone (Multaq). The Dear Healthcare Provider letter included two post-marketing case reports of acute liver failure that required transplantation, occurring at four-and-a-half and six months after the start of dronedarone therapy. The patients – both female and about 70 years old – had had normal hepatic serum enzymes before starting the drug.

In the letter, sanofi-aventis instructed healthcare professionals to tell patients to immediately report any symptoms suggestive of hepatic injury. According to the FDA, these include anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching.

Periodic liver enzyme tests, especially in the first six months of treatment, should also be considered, according to the FDA, although it is unknown whether such a strategy will prevent the development of liver injury.

Dronedarone’s prescribing information will be updated to include the guidance from the Dear Physician letter, and will be distributed after the FDA approves it. The agency confirmed that a warning about potential liver injury will be added to the drug’s label.

According to the FDA, from the drug’s approval in July 2009 through October 2010, about 492,000 prescriptions for dronedarone were dispensed and about 117,000 patients filled prescriptions at U.S. pharmacies.

The drug was approved with a Risk Evaluation and Mitigation Strategy to prevent use in patients with severe heart failure or in those with less severe heart failure who were recently hospitalized for the condition. Such patients had a doubling in the risk of death in a placebo-controlled study.

July 6, 2011

AMS Vaginal Sling Lawsuits

by Dr. Shezad Malik

As a Texas Bard Avaulta litigation and Product Liability Attorney and Texas medical doctor, I am providing this update.

Laura Jones, of El Paso, Texas, has filed a lawsuit against American Medical Systems (AMS) over problems with vaginal mesh manufactured by the company. Jones had an AMS vaginal sling implanted in June 2009 to restore normal vaginal structure. Following the pelvic organ prolapse surgery, Jones experienced severe pain, urinary problems and had to undergo surgeries to have the AMS surgical mesh removed. The complaint was filed last month in Los Angeles Superior Court by against AMS and a number of other unnamed manufacturers.

According to Jones’ lawsuit, the transvaginal sling eroded, shrunk and part of it extruded into her vagina. The complaint alleges that AMS failed to warn patients about the risk of vaginal mesh side effects, claiming that the manufacturer should be held responsible under theories of strict liability, negligence, breach of implied and express warranty, fraud, misrepresentation and violating California consumer protection laws.

Recently, several AMS vaginal mesh lawsuits have been filed for women who experienced problems after receiving pelvic organ prolapse products. The FDA issued a warning about vaginal mesh complications in October 2008, indicating that more than 1,000 people had reported experiencing problems with products made by at least nine different manufacturers. Recently a medical study revealed that there were more complications with the vaginal mesh slings. In the study published in the New England Journal of Medicine, researchers found that vaginal mesh surgery brought better results for treating pelvic organ prolapse, but carried risks of surgical complications and other problems after surgery, including pain during sex and new urinary incontinence.

Last year, settlements were reached in a number of Mentor ObTape vaginal mesh lawsuits filed by women who experienced problems after receiving that product. The product made by a subsidiary of Johnson & Johnson. The complaints alleged that the complication rate associated with Mentor ObTape mesh could be as high as 18%. The Mentor ObTape was removed from the market in 2006, three years after it was introduced.

Over the past year, a growing number of Bard Avaulta vaginal mesh lawsuits have also been filed by women who have experienced problems. All of the complaints involve similar claims that C.R. Bard’s Avaulta Anterior and Posterior BioSynthetic Support System, which was introduced in 2007, was negligently designed and that the company failed to warn patients of possible complications that can result in severe pain and disfigurement.

In October 2010, the federal Bard Avaulta litigation was consolidated as part of an MDL for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia.

July 5, 2011

Chantix Increases Heart Attacks

by Dr. Shezad Malik

As a Texas Chantix side effect and Product Liability Attorney and Texas medical attorney, I am providing this update.

New medical research suggests that Chantix side effects increases the risk of heart attacks, strokes and other cardiovascular events.

Pfizer’s smoking cessation drug Chantix raises the risk of suffering a cardiac event by 72%, according to a study published in the Canadian Medical Association Journal.

Researchers found that those who took Chantix were substantially more likely to suffer heart problems than those who took a placebo, and two of the co-authors suggested that the findings were strong enough that the FDA should consider a Chantix recall due to the risk of heart attack and stroke.

The study comes just three weeks after the FDA issued a drug safety communication about the risk of heart problems from Chantix, warning that the smoking cessation drug might increase the risk of certain cardiovascular events, including the risk of heart attack, among individuals who had cardiovascular disease. The U.S. Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section of the Chantix physician labeling. The patient Medication Guide will also be revised to inform patients about this possible risk.

The warning risk of a heart attack or stroke from Chantix is just the latest of serious side effects associated with the drug. Warnings about the risk of life-threatening psychological side effects of Chantix, which increases the risk of suicide, was added to a black box on the medications label two years ago.

Chantix (varenicline) was approved in the United States by the FDA in 2006 as a prescription medication to help people quit smoking. The prescription medication designed to help people stop smoking already holds the title of being the drug associated with the most FDA adverse event reports of any prescription medication in the United States.

A number of Chantix lawsuits have been filed in courts throughout the United States on behalf of individuals who have died or suffered serious injuries as a result of a suicide or unusual behavior allegedly caused by Chantix.

June 26, 2011

DePuy ASR and Pinnacle Metal on Metal Hips

by Dr. Shezad Malik

As a DePuy ASR and Pinnacle Metal on Metal Hips attorney, I am providing this update. It is in our nature to want the latest and greatest — whether it is a faster car, a smarter computer or a smaller cell phone, and this applies equally to medicine, where we want the newest and presumably safer drugs and medical devices.

But medical innovation can become a trap for the unwary; we are now seeing this playing out with deadly consequences for thousands of patients who are using the 4th generation birth control pills Yaz and Yasmin over the safer 3rd generation older contraceptive pills and those folks who now are the recipients of metal on metal artificial hips.

The metal-on-metal hips, were regarded by hip manufacturers and surgeons as a technological break through over previous designs that used both metal and plastic. Now the FDA (who had been asleep at the wheel) and medical researchers are panicking to determine how many implant recipients have been injured by the devices.

The Food and Drug Administration recently ordered manufacturers of all metal hips to undertake emergency studies of patients. The rush to implant the latest and greatest, and patients’ demand shows how innovation’s siren call led a product promoted as a breakthrough without convincing evidence that it was better or even as good as existing options.

In 2010, DePuy, the orthopedics division of Johnson & Johnson, recalled one of its all-metal hips, the ASR, which was failing at a high rate. Furthermore, another DePuy product, the Pinnacle (which has not yet been recalled) is now under scrutiny for excessive failures. Another manufacturer, Zimmer Holdings, also briefly halted sales of one of its metal models, the Durom. DePuy, Zimmer and other companies continue to deny that there are any problems with their products.

THE modern artificial hip, which was developed in the 1960s, uses a simple design. A metal “ball” made of cobalt and chromium replaces the top of the thigh bone, while a “cup,” typically made of plastic, serves as an artificial hip socket. By the 1990s, the devices were considered highly effective, with studies then finding that implants still worked a decade after surgery in 95 percent of patients.

By 2008, metal on metal hips were used in one out of every three hip replacements, of approximately 250,000 hips implanted annually in the United States. By using a metal cup, which is thinner than a plastic one, a surgeon could implant a bigger ball component, which was assumed to be less likely to dislocate than a smaller one. But recent research, demonstrates that such oversized components may be the reason the devices shed metallic debris.

As the number of affected patients nationwide increased, it became apparent that the devices had not been properly tested. Under F.D.A. regulatory rules, most all-metal hips do not have to undergo clinical trials before sale. They are tested in labs on machines that simulate millions of steps to study the forces exerted by years of motion. According to testing experts, all-metal devices proved worse than metal-and-plastic ones to small variations in how they were implanted, with components sometimes striking together and generating debris.

The devices, as a group, are twice as likely as metal-and-plastic ones to require early replacement, according to data from Australia’s orthopedic registry, one of the most comprehensive databases on implants. Most importantly, damage from debris generated by metal implants in some patients, has caused crippling tissue and muscle damage, and has produced neurological problems, a condition known as metallosis.

It is estimated, about 500,000 patients in the United States may have gotten an all-metal hip, and thousands will have painful early-replacement procedures. The lawsuits against DePuy and other makers of all-metal hips may emerge as the largest product liability cases of this decade.

June 25, 2011

Supreme Court Immunizes Generic Drug Manufacturers

by Dr. Shezad Malik

As a Dangerous and Defective Drug attorney, I am writing this opinion piece, regarding the latest US Supreme Court Generic Drug Decision, which in my humble opinion is disastrous to Patient Safety. The case is PLIVA, Inc. v. Mensing.

On June 23, 2011, the United States Supreme Court ruled in a 5-4 decision that Generic Drug Manufacturers cannot be sued for failing to warn consumers of the possible side effects of their defective products, as long as they use the same warnings on the brand-name drugs. This decision is absurd on its face; this means that brand-name drug manufacturers can be held responsible for their failure to warn consumers about the dangers, but generic manufacturers are now provided an all encompassing shield that brand-name manufacturers do not have.

The seriousness and ramifications of this opinion cannot be understated. The Court’s decision now prevents millions of Americans, who have been seriously injured by generic drugs, from seeking compensation for their injuries. Generic drug manufacturers have a huge business in the United States. This opinion immunizes those drug manufacturers from liability. Another win for Big Pharma, and the consumer gets it again.

June 23, 2011

Actos Bladder Cancer Warning & Side Effects

by Dr. Shezad Malik

As an Actos Side Effects Lawsuit and Piaglitazone Bladder Cancer Lawyer, I am writing this Actos update, regarding the Actos dangerous drug cancer side effects.

Actos (pioglitazone) is a medication manufactured and sold by Takeda Pharmaceuticals for treatment of Type 2 diabetes. The drug is part of the same class of medications as Avandia (rosiglitazone), which has been linked to an increased risk of heart attacks.

What is Actos?

Actos or Pioglitazone is used with a diet and exercise program and sometimes with other medications, to treat type 2 diabetes. Pioglitazone is in a class of medications called thiazolidinediones. It works by increasing the body’s sensitivity to insulin, a hormone that controls blood sugar levels. Pioglitazone is not used to treat type 1 diabetes or diabetic ketoacidosis.

Fast FDA Facts About Actos

*Sold as a single-ingredient product under the brand-name Actos. Also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact).

*Used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes mellitus.

*From January 2010 through October 2010, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies.

Diabetes Drug Actos Bladder Cancer Risks

The FDA has issued a new warning of increased bladder cancer risk associated with use of the diabetes drug Actos (pioglitazone).The agency’s warning comes five days after Germany and France pulled Actos from the market.

The warning comes after a review of data from a five-year analysis of an ongoing study of Actos by the manufacturer, Takeda Pharmaceuticals.The results show that although there was no increased risk of bladder cancer among Actos users overall, there was an increased risk of bladder cancer among those who had used the drug the longest. There was also a greater risk of bladder cancer among Actos users who had been exposed to the highest cumulative dose of the drug.

According to the FDA, Actos should not be prescribed to people with bladder cancer or people with a history of bladder cancer.Some medical experts believe that an Actos recall is imminent or that new warnings about the risk of bladder cancer from Actos should be added to the medication.

Research Data Summary

To address the long-term risk of bladder cancer associated with pioglitazone use, the drug manufacturer (Takeda) is conducting a ten-year, observational cohort study in patients with diabetes who are members of Kaiser Permanente Northern California (KPNC) health plan. Patients selected in this study had diabetes mellitus and were ≥40 years of age at study entry. The study group included 193,099 patients with diabetes.

The primary outcome of the cohort study is an incident (new) diagnosis of bladder cancer identified from the KPNC cancer registry. A planned five-year interim analysis was performed with data collected from January 1, 1997 through April 30, 2008.

The results showed that after adjusting for risk factors, there was no significant increase in the risk for bladder cancer in patients ever exposed to pioglitazone compared to patients never exposed to pioglitazone.

But, the risk of bladder cancer increased with increasing dose and duration of pioglitazone use. Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk. The hazard ratio after more than 24 months of pioglitazone use was 1.4. Based on these data, FDA calculated that duration of therapy longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100,000 person-years follow-up, compared to never use of pioglitazone.

Possible signs or symptoms of Actos bladder cancer may include:

Blood in the Urine
Pain During Urination (Dysuria)
Frequent Urination
Feeling of Need to Urinate Without Results
Although it appears that information about the risk of Actos cancer problems has been known to the manufacturer for some time, inadequate warnings were provided to consumers and medical doctors. Further, it appears that the manufacturer may have placed their desire for profits ahead of patient safety by failing to adequately warn about the potential risk of bladder cancer. As a result, consumers diagnosed with bladder cancer may be able to obtain compensation through an Actos lawsuit.