Dallas Fort Worth Injury Lawyer Blog

U.S. District Judge James Beaty has rejected an attempt by Novartis to overturn the verdict in a Zometa jaw decay lawsuit. The trial unearthed evidence that suggests the drug maker’s employees intentionally covered up medical evidence of the bone drug’s side effects.

Novartis was trying to obtain a new trial in a defective drug product liability lawsuit brought by the family of Rita Fussman. The plaintiffs alleged in their lawsuit that the company failed to adequately warn consumers that side effects of Zometa could cause a condition known as osteonecrosis of the jaw (ONJ), where the jaw bone decays and dies.

Last year, a North Carolina jury awarded Fussman’s estate $13 million in compensatory and punitive damages, finding that the company intentionally withheld vital safety information from consumers.

The federal Judge rejected Novartis’ attempt, saying that the jury in the case had sufficient evidence to rule that Novartis could be subjected to punitive damages for intentionally misleading consumers by trying to conceal evidence of Zometa ONJ.

Furthermore the Court said that the jury was presented with “clear and convincing evidence” that Novartis managers intentionally initiated a cover-up of Zometa side effects, and then tried to subvert medical inquiries into the drug. The evidence pointed to the knowledge and approval of the cover-up by high-ranking Novartis officials.

The case was the first bellwether trial in the federal Zometa jaw decay litigation, which involves hundreds of lawsuits that have been consolidated along with similar claims involving Aredia, another chemotherapy drug, as part of a multidistrict litigation (MDL) in the U.S. District Court in Nashville. The case was seen as a test case for how juries would weigh expert testimony, evidence and arguments in future Zometa ONJ lawsuits.

One of the more damaging pieces of evidence presented during the trial was an internal email from a marketing executive that seemed to suggest the company suppressed a report outlining a number of cases where Zometa was linked to ONJ.

Novartis began warning doctors of the potential for jaw damage in 2005, but the lawsuit alleged that Novartis knew about the link much earlier, potentially as early as the 1980s. Fussman began taking Zometa in 2001.

The jury in the North Carolina federal court awarded the family $287,000 in compensatory damages and $12.6 million in punitive damages. However, a punitive damages cap in North Carolina will reduce that amount to three times the compensatory award. Due to tort reform laws, Fussman’s estate only received $1.3 million of the $13 million jury award. Fussman herself died in 2009 of breast cancer.

Aredia (pamidronate disodium) and Zometa (zoledronic acid) are treatments used to reduce bone complications associated with multiple myeloma and bone metastases from solid tumors. Although they are used to strengthen bones, the drugs are part of a class of medications known as bisphosphonates, which have been associated with an increased risk of osteonecrosis of the jaw. The debilitating and painful condition causes decay or death of the jaw bone, often resulting in the need for surgery to remove portions of the jaw.

There are about 600 Aredia and Zometa suits, which have all been consolidated and centralized in U.S. District Court in Nashville as part of a multidistrict litigation, or MDL, for pretrial proceedings. Another 150 lawsuits are currently pending in state courts in New Jersey.

The Zometa lawsuits are similar to more than 900 Fosamax jaw necrosis lawsuits that are pending against Merck & Co. over their oral bisphosphonate medication. Although Fosamax is used to treat osteoporosis and reduce the risk of bone fractures, long term use of the medication has also been linked to an increased risk of jaw osteonecrosis.

It has now been eighteen months (August 2010) since the DePuy Acetabular Hip Replacement System (ASR Hip) was recalled. Approximately 37,000 DePuy Acetabular Hip Replacement Systems were implanted in the United States.There are many folks who had hip replacement surgery with these one of these devices but remain unaware of the recall or whether or not their hip is defective. It is important for all those who may have been affected—and their family members—to understand the DePuy hip recall and its potential affect on their life.

The DePuy hip recall involves 29 models of the ASR 100 and 300 Acetabular Implants in cup sizes ranging from 44mm to 70 mm.

The DePuy ASR is a metal-on-metal hip replacement system developed in 2005. Physicians have been warning about problems with metal-on-metal hip implants, which can release metal particles into the body, known as metallosis. The metal particles can damage soft tissue, cause inflammatory reactions and lead to bone loss.

The hip system includes “ball and cup” components to copy the socket and ball of the femur in the human hip. Most hip replacements include both metal and plastic parts. But, the ASR Hip that was recalled was unique in that it puts a metal “ball” component in direct contact with a metal “cup.” This metal-on-metal contact may be at the heart of the problem with the medical device. These new hips achieved U.S. Food and Drug Administration approval to market the devices for use in 2005. They used a shortened approval system (501(k) process) to obtain FDA approval without having to undergo clinical trials.

Fixing the problem usually required the patient to undergo a painful and risky second surgery to replace the replacement. Reports appeared in the media about the problem as early as 2007, and the DePuy device manufacturers knew well before that of the reported issues with the devices. Yet, even after this time, patients were still given the device. Doctors investigating the evidence have explained that the company had significant data early on which indicated that these devices were failing at a far higher rate than other devices.

It wasn’t long before it became known that the DePuy hip defect was likely design-related. In other words it was not a problem with the actual manufacturing of the device but the whole idea of the device itself. Great idea on paper, crappy idea in practice. Even the surgeon that designed the hip admitted in 2008 that the company knew that there were problems with the hip early on. Yet, despite this knowledge the company continued to sell the device—raking in more than $5.4 billion in 2009 alone. It wasn’t until August of 2010 that the device was officially recalled by the FDA. Upon notice of the recall, the company admitted that 13% of all those who received the device may need revision surgery. Approximately 93,000 DePuy ASR hips were implanted worldwide,this amounts to 10-15,000 patients with problems currently. And this number is likely to increase as the failure rate increases with time and may eventually involve all of the 37,000 patients in the US, if they should live that long.

Johnson & Johnson now faces about 3,500 DePuy ASR hip lawsuits and another 500 lawsuits over its DePuy Pinnacle hip system, which are both metal-on-metal hip replacements.

All suits filed in federal district courts throughout the country over problems with the DePuy ASR hip have been consolidated for pretrial proceedings in the U.S. District Court for the Northern District of Ohio as part of an MDL, or multidistrict litigation.

What a mess, I would encourage all patients who have been implanted with a Metal on Metal hip to seek medical opinion and close monitoring of their device. We have not seen the end of the DePuy story and in fact the current number of lawsuits, may represent the tip of the iceberg.

A panel of federal judges is scheduled to meet in Savannah, Georgia to hear oral arguments over whether all federal Actos bladder cancer lawsuits should be consolidated under one judge for pretrial proceedings as part of an MDL, or multidistrict litigation.

All of complaints allege that the plaintiffs developed bladder cancer from Actos. The lawsuits allege that Takeda Pharmaceuticals failed to adequately research their type 2 diabetes drug or warn about the potential bladder cancer side effects of Actos.

The first Actos bladder cancer lawsuit was filed on July 29, 2011, but recently the number of cases has increased over the past four months.

A motion to consolidate the Actos bladder cancer litigation was filed on August 31, by plaintiff Glen Weant and his wife, Nina. At that time, only 11 lawsuits pending in 8 different federal district courts were idenified.

Weant requested that the federal Actos litigation be transferred to the U.S. District Court for the Southern District of Illinois before Judge G. Patrick Murphy. Since then, additional plaintiffs have filed responses proposing other U.S. District Judges to preside over the litigation.

Takeda’s attorneys agree that an Actos MDL should be formed to prevent contradictory rulings and duplicative discovery, the drug maker has proposed that the cases be consolidated in the Northern District of Illinois, where the drug maker is headquartered and where much of the company’s records are located. As an alternative, the drug maker proposed the Western District of Louisiana as an appropriate location for the Actos MDL to be centralized.

Actos (pioglitazone) was approved by FDA to treat Type 2 Diabetes in July, 1999. It is a once-a-day pill that increases the body’s sensitivity to insulin. The medication has grown in popularity in recent years, generating $4.3 billion in sales last year.

FDA officials began reviewing the potential risk of Actos bladder cancer problems in September 2010, after interim data from an on-going 10 year study found that users may face an increased risk the longer they take the drug.

Folks who are regular readers of my blog, have seen the articles I have written about regarding DePuy ASR Metal on Metal hips. Unfortunately, despite my best efforts to highlight this tragedy, we still get inquiries from potential clients who are unaware and uninformed about the dangers of metallosis.

We should be shocked at the intolerable and unacceptable suffering caused to thousands of patients fitted with faulty DePuy hip implants and we should demand urgent action from DePuy.

Many of the 96,000 Americans who had received the DePuy metal-on-metal hip replacements, unfortunately need one or more revision surgeries and they also report serious and systemic health problems extending beyond the initial complications caused by the device.

This issue has been described as a ticking time bomb facing many patients. This issue has been extensively documented in my previous blogs. There is no uniform methods or protocols to monitor the levels of cobalt, chromium and other toxic metals which have been recorded in patients with the metal-on-metal prostheses. Even if asymptomatic, many patients have toxic heavy metal levels and sooner or later will need to have the hip removed and replaced. This tragedy is just beginning to unfold.

Also the orthopedic doctors who had implanted these devices, and would still be doing them today, if it was not for the recall last August, are also mostly unhelpful in working up their patients. For all practicable purposes, my clients feel abandoned by their doctors.

Furthermore, DePuy, a subsidiary of Johnson and Johnson, one of the world's largest medical device and pharmaceutical company, has been eerily quiet. They created the mess and now they are missing in action. No corporate news is forthcoming and they are hunkered down in litigation, a siege mentality.

Do they want to settle, clean up the mess and become owners of the problem? Sadly no, they are playing games, waiting for the statute of limitation game to be played out. In the US, most states have a 2 year limitations to bring a product liability suit. For all practicable purposes, the 2 year statute should run by August 2012, 2 years after the recall. If by then, some experts believe, if you have not brought your product liability suit, you may be poured out and lose your day in court forever.

So it is down to the trial lawyers to wade through the mountain of paper that has been produced in discovery during this lawsuit and connect the dots. They are looking for the needle in the haystack, the "killer" documents that point the accusing finger at the company; the "smoking gun" documents that reveal that the company knew about the risks of metallosis and that their metal on metal design was flawed. That, despite having this critical knowledge they proceeded anyway, with conscious indifference, ignoring the risks and making a business decision that the sale revenue of the hips would cover any potential damages to be paid out in litigation.

This is a dangerous calculus, corporate history is littered with examples of this. This was tried with the Ford Pinto in the 1960's, and most recently with Merck's Vioxx, who were dinged by the Justice department to the tune of a billion dollars. Is that what happens in corporate boardrooms with the pencil pushers?

You would think the company would fess up, declare that while it was a good idea on paper, it did not translate into a usable and safe medical device. You would think as all responsible corporate companies, they would own their mistake and open up the check book and make compensation? No, that would be too easy, in this age of corporate greed, in this much maligned and malignant times, the DePuy ASR hips are a canker on the orthopedic world. Pox on you too DePuy.

What ever happened to the Johnson and Johnson of old? The time in distant memory, when there was the Tylenol tampering case, they owned the problem, took decisive steps and cleared all the shelves of the drug and immediately went on a media blitz warning patients of the dangers This was cited as text book damage control and was taught as a model for would be corporate types in business schools around the country, if not the world.

What ever happened to that company and that CEO? Alas, the company now, is no longer the company of yore. It has faded into the annals of time and regulated to the dusty pages of history books and tomes on corporate management. Nobody reads those books any more. You ignore history at your peril.

It is all about corporate greed, putting profits before people and short term gains and short term share price. The corporations of today are boxed in by the "quarter mentality." Everything is short term and the horizons are quarter to quarter. Nobody thinks of year over year or has a 5 year strategic business plan. The modern CEO is all about boosting the share price short term, maximizing short term profits and getting his stock options and then invariably the golden parachute when the chickens come home to roost, when the edifices built collapse around them and it turns out to be just smoke and mirrors and just a facade.

This is symptomatic of the larger world we live in, competition is killing us, the pace of innovation is proceeding at unparalleled speed, it is produce or perish at its maximum. We are losing the competive edge to China and soon this shall all pass. We need to stop and stake stock, are the companies looking to be a 1 year company or build something that lasts?

DePuy and Johnson and Johnson, do the right thing, you know what that is.

Happy Thanksgiving to all.

According to company e-mails, Bayer AG, Germany’s largest drugmaker, may have tried to market the Yasmin family of birth- control pills for unapproved uses and misled women about the health risks of the drugs.

Bayer unit officials discussed promoting the contraceptive known as Yaz, a spinoff of Yasmin, for treatment of all types of premenstrual syndrome, according to Bloomberg news. The FDA approved Yaz only for the most severe form of Pre Menstrual Syndrome (PMS), known as Premenstrual Dysphoric Disorder (PMDD).

Bayer faces more than 10,000 lawsuits over injuries allegedly caused by the contraceptives. The FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. Bayer’s contraceptives, which contain the hormone drospirenone, have been the focus of regulators who question their safety.

In October, the FDA warned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives. According to the FDA report, the FDA examined data on 835,826 women who took pills containing the hormone, including Bayer’s Yasmin line of birth-control pills. The FDA has scheduled its December 8 hearing on drospirenone- containing contraceptives, because of “the conflicting nature of the findings from six published studies evaluating this risk."

Injured women suing Bayer allege that internal company files show Berlex and Schering officials withheld some information from patients, doctors and the FDA about the drug’s risk for blood-clots. The plaintiffs also allege that company officials wrongfully claimed Yasmin and Yaz to be just as safe as rival birth-control pills.

In January, Bayer is scheduled to face the first mini trials, known as bellwether trials, of lawsuits in which Yaz and Yasmin are alleged to have caused blood clots, which can lead to pulmonary embolism, deep vein thrombosis, heart attacks and strokes. The trials are to take place in Illinois and Pennsylvania.

The FDA said Bayer made misleading claims about Yaz in television advertising, the drugmaker was forced to spend $20 million on correcting the ads. U.S. regulators said in 2008 that Bayer touted the pill’s effectiveness and downplayed “serious risks associated” with it in two 60-second television ads.

Bayer agreed to run new ads stating Yaz hadn’t been approved as a treatment for all forms of PMS or acne as part of a settlement of a claims brought by 27 U.S. state attorneys general.

Bayer bought Schering, then a rival German drugmaker, and its New Jersey-based Berlex unit for $21.8 billion to acquire the Yasmin line of contraceptives.

About 10,400 suits have been filed over injuries allegedly caused by the contraceptives, according to Bayer officials in an October filing with the U.S. Securities and Exchange Commission.

The federal cases are consolidated for pretrial purposes In Re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court for the Southern District of Illinois (East St. Louis).

Effective today, the diabetes drug Avandia will only be available through certified mail-order pharmacies. These new restrictions are designed to limit the number of people exposed to potential heart side effects of Avandia.

The FDA allowed Avandia to remain on the market last year, subject to a new risk evaluation and mitigation strategy (REMS). This special program limits sales of the medication to mail order and requires educational programs before it can be prescribed.

Today, is the last day Avandia will be available on retail pharmacy shelves. To continue receiving the medication after this week, healthcare providers and patients must enroll in the Avandia-Rosiglitazone Medicines Access Program.

These new restrictions also affect Avandamet and Avandaryl, which also contain the active pharmaceutical ingredient Rosiglitazone.

The retail market for Avandia has been severely restricted because of an increased risk of heart attacks and heart problems associated with the diabetes medication. According to experts, more than 100,000 heart attacks may have been caused by Avandia since introduction.

A “black box” warning was added to Avandia in the United States in November 2007, but according to many medical experts, the warning was not strong enough and they pressed for the FDA to ban Avandia. Medical studies had revealed that the risks greatly outweigh any minimal benefits.

Thousands of Avandia lawsuits have been filed on behalf of individuals who have suffered serious and sometimes fatal injuries. The complaints allege that GlaxoSmithKline failed to adequately research the side effects of their medication or warn about the potential heart risks. Avandia settlement agreements have been reached in many of the cases, but approximately 20,000 injury lawsuits are still pending in courts throughout the United States.

Actos (pioglitazone) was introduced as a treatment option for type 2 diabetes in July, 1999. And after problems were identified with Avandia, Actos rapidly became a blockbuster drug.

The Actos problems with bladder cancer first surfaced in September 2010, when the FDA released an early communication about interim data from an on-going 10 year study that found Actos users may face an increased risk of bladder cancer. And the risk apparently increased with the duration of use of the medication.

In June 2011, France recalled Actos after a review of public insurance data identified an increased incidence of bladder cancer with Actos use.

In the United States, new Actos cancer warnings were approved by the FDA in August 2011, indicating that patients who use the drug for more than a year may face an increased risk of bladder cancer. So far, the FDA has not issued a "black box" warning, but some experts think that this may happen, as seen with Avandia.

Actos lawsuits throughout the United States have have been filed against the drug manufacturer, Takeda Pharmaceuticals. The complaints allege that Takeda failed to provide adequately warnings for consumers or the medical community about the risk of bladder cancer. Many of the complaints also allege that Takeda should have recalled Actos from the market, arguing similarly to Avandia, the risk of bladder cancer outweighs the minimal benefits.

Hundreds of cases have been filed by Actos users diagnosed with bladder cancer after using the diabetes drug. A panel of judges is scheduled to meet on December 1 to decide whether all federal Actos lawsuits should be consolidated as part of an MDL, or multidistrict litigation.

Not a day goes by, before more bad news regarding the DePuy ASR and Pinnacle Hip Replacement and Recall issue percolates to the surface. As folks who have been following this story, the DePuy saga continues unabated. This week, our firm filed 3 DePuy ASR lawsuits, in the federal court MDL in Ohio. This is the federal court where the federal filed cases have been consolidated, for pretrial workup. And we are evaluating many more cases of DePuy ASR failures and metallosis.

On a more interesting note, this month Johnson & Johnson's Third Quarter Earnings Report was published. The quarterly earnings report outlines the various legal proceedings the Company is currently defending.

The report states that "[m]ultiple products of the Company's subsidiaries are subject to product liability claims and lawsuits in which claimants seek substantial compensatory and, where available, punitive damages." This material appears on page 18 of the 10K Report.

The report highlights lawsuits relating to the DePuy ASR hip replacements and the DePuy Pinnacle hip replacements. According to the 10-Q Report, as of October 2, 2011, there were approximately 3,500 pending lawsuits related to the ASR hip implants and 560 related to the Pinnacle hip systems. The 10-Q reports that litigation expenses and additional DePuy ASR hip recall costs of $223 million were recorded in the fiscal nine months of 2011.

The DePuy ASR hip implants and the Pinnacle hip replacements were manufactured by Johnson & Johnson. The lawsuits are filed In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation ("MDL No. 2197"), which is currently underway in the U.S. District Court for the Northern District of Ohio; and In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation ("MDL No. 2244"), which is currently underway in the U.S. District Court for the Northern District of Texas.

Johnson & Johnson Anticipates Increasing Litigation Over Recalled ASR Hips
The report also provides details regarding the impact of the ASR artificial hip recall, which was initiated in August 2010. The report states that "the number of pending lawsuits continues to increase. The Company continues to receive information with respect to potential costs associated with this recall" and has since established a "product liability accrual" in anticipation of product liability litigation settlements and costs associated with the ASR hip recall.

Our DePuy ASR Recall and Metallosis team, has been aggressively notifying the general public about the problems and risks associated with the Metal on Metal hips. As explained in the 30 plus articles that I have written, this is a huge problem and that we may be experiencing the tip of the litigation iceberg.

We can report with confidence that the federal ASR hip replacement lawsuits are increasing on a daily basis, as the knowledge of premature failure and the risks of metallosis, are being brought to the attention of the folks who underwent hip relacement with this type of hip model.

We get electronic notification each time a new DePuy ASR lawsuit is filed in the federal court overseeing this litigation. And our email box has been filling up with these notifications. There is an average of 20 new cases filed daily in the federal multidistrict litigation, In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation ("MDL No. 2197").

There are approximately 2,600 cases currently pending in the DePuy ASR MDL, in the U.S. District Court for the Northern District of Ohio. The Judicial Panel for Multi-District Litigation consolidated all federal cases arising from the DePuy ASR recall in December 2010.

There are over 1,000 related ASR hip cases pending in state courts. 37,000 Americans received the recalled ASR hip implants, and we predict that this litigation is likely to continue.

The U.S. Food and Drug Administration ("FDA") has received more than 5,000 complaints since January about metal-on-metal hip implants. According to the EDA, 75 percent of those complaints involved the recalled ASR XL Acetabular System and the ASR Hip Resurfacing System.

As a medical doctor and trial attorney, who represents clients who were injured by the ASR hip implants and my litigation team are actively filing cases in the DePuy ASR MDL on their behalf, I am not surprised the numbers of claims filed against DePuy, which is a subsidiary of the medical device and pharmaceutical giant, Johnson and Johnson.

It has now been fifteen months since the DePuy ASR was recalled. There are many differing statutes of limitations depending on which state the plaintiff lives in or had the orthopedic surgery. The majority of the states have a 1 or 2 year statute of limitations. Please click here to find out your states' statute of limitation for product liabilty.

Some of these statutes of limitations may have run in some states so it is important for any patient with a DePuy ASR or Pinnacle to get legal advice as soon as possible.

DePuy may wait until many of the state statutes of limitations have expired before begining to settle cases. They do not want the news of settlements, to cause a stampede of lawsuit claims from folks who have waited to then try to file lawsuits for compensation. Any settlement news will trigger an avalanche of DePuy ASR lawsuits.

Dr Shezad Malik Law Firm is writing this open letter to the FDA. We are requesting the U.S. Food & Drug Administration (FDA) to complete its ongoing safety review of Yaz, Yasmin and other birth control pills containing the synthetic progestin, drospirenone, as soon as possible.

Watch a tv video interview I did regarding one of my seriously injured Yaz client.

Recently, a FDA-funded study confirmed that women who use such birth control pills have an increased risk of blood clots (known as venous thrombosis) when compared to women using other hormonal contraceptives made with an older progestin called levonorgestrel.

In a report released October 27, the FDA warned that in the study, women taking pills with drospirenone were 75 percent more likely to experience clots compared to those taking other oral contraceptives.

These results were also confirmed by a recent Israeli medical study. Read the published article here. This is the second time this fall, that the FDA has issued a warning regarding increased blood clots risks associated with drospirenone-containing birth control pills. The latest FDA warning also came just days after the British Medical Journal published a separate study out of Denmark which found that women taking birth control pills with newer progestins, including drospirenone, may double their risk of suffering a blood clot compared to women using other hormonal contraceptives made with levonorgestrel.

Unfortunately, the FDA has not advised women to stop using Yaz, Yasmin and other birth control pills made with drospirenone. The agency has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for December 8, 2011, to discuss the safety of drospirenone birth control pills.

More than 9,000 lawsuits have been filed against Bayer Healthcare Pharmaceuticals, Inc., which markets Yaz and Yasmin in the United States, and Bayer Pharma AG, which manufactures drospirenone and ethinyl estradiol, the progestin and estrogen contained in Yaz and Yasmin. These women allege the following injuries including, strokes, pulmonary emboli, deep vein thrombosis, blood clots, and gallbladder disease.

Particularly worrisome is the number of gallbladder disease and gallstones we are seeing in young women, some as young as 16 years old. Typically the gallbladder disease is a disease of older women in their forties and it is extremely unusual to see such young girls with these types of side effects and to subject them to gallbladder surgery.

The exact mechanism of gallbladder disease and gallstones is not immediately apparent, medical experts think it may be due to the interaction between drospirenone diuretic and antimineralocorticoid action and ethinyl estradiol. It appears to be a signature disease side effect.

Over 7,000 such lawsuits have been consolidated in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) currently pending before the Honorable Judge David R. Herndon in the United States District Court for the Southern District of Illinois.

Drospirenone containing birth control pills: Yaz, Yasmin, Ocella, Safyral, Syeda, Yasmin, Zarah, Gianvi, Loryna.

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.

The steady drum beat of adverse medical reports and deadly side effects about the popular Yaz birth control pill and its variations continue to surface. Again another medical study has found that side effects of Yaz and Yasmin birth control increase the risk of a pulmonary embolism, deep vein thrombosis or stroke blood clot injury, when compared to older birth control pills.

Israeli researchers, in a report out this week, say they found that drospirenone-based birth control pills increased the risk of venous thromboembolism by as much as 65 percent. This is the latest new study published on-line this week by the Canadian Medical Association Journal. There has been a flood of new studies in recent weeks to confirm the risk of blood clots from Yaz birth control.

The study on more than 300,000 Israeli women, found that women taking Yaz and Yasmin, which contain the fourth-generation progestin drospirenone, were 65% more likely to suffer blood clots than women taking levonorgestrel and other so-called second generation oral contraceptives.

The newer birth control pills were only slightly better against third-generation birth control with a 43% increased blood clot risk. The study failed to find any evidence of increased risk of heart attacks or strokes.

Venous thromboembolisms most commonly form in the leg veins, but can travel to the lungs, where they cause a pulmonary embolism.

It has long been known that women on the Pill have a small, although higher-than-average risk of blood clots. But recent studies have suggested the risk may be relatively higher with pills containing drospirenone—which include Yaz, Yasmin, Beyaz and Safyral, along with their generic equivalents.

This study is only the latest evidence that the Bayer birth control Yaz and Yasmin pills are likely more dangerous than older birth control pills. Other medical studies in Europe and including one by the FDA, have come to similar conclusions.

Less than two weeks ago the FDA released a new drug safety report that found Yaz, Yasmin birth control side effects increased the blood clot risk by as much as 75% when compared to older oral contraceptives. That report was based on records for more than 800,000 U.S. women who used the Pill between 2001 and 2007.

A third study, published last month in the British Medical Journal, found that women taking newer birth control pills, including Yaz and Yasmin, may face twice the risk of developing blood clots when compared to women taking levonorgestrel birth control pills.

An FDA advisory committee is scheduled to examine the data surrounding the risk of health problems from Yaz and Yasmin at a meeting in December 8.

Drospirenone is a newer type of synthetic version of progesterone, that is used in combination oral contraceptives that also include estrogen. It was originally introduced by Berlex Laboratories in Yasmin. Once Berlex was acquired by Bayer Healthcare an updated version of Yasmin was introduced called Yaz. More recently, Bayer introduced a third version, marketed as Beyaz, which includes a folate supplement. Generic versions of Yaz and Yasmin are also now available from other manufacturers. Generic versions of Yaz and Yasmin include Ocella, Gianvi, Loryna, Safyral, Syeda and Zarah.

The findings of these recent studies appear to confirm the allegations brought in thousands of Yaz lawsuits and Yasmin lawsuits filed on behalf of women who experienced serious and sometimes deadly blood clots after using the birth control pills. The plaintiffs complaint alleges that Bayer failed to adequately warn about the increased risk of blood clots from Yaz and Yasmin. Furthermore the plaintiffs complain that Bayer placed their desire for profits ahead of patient safety by minimizing the known risk in aggressive direct-to-consumer advertisements for the birth control pills.

Bayer is aggressively defending itself, denying any liability and points to its own post-marketing studies that have failed to turn up a heightened clot risk with drospirenone contraceptives versus older ones.

According to the findings of a new medical study, presented at the North American Spine Society, Medtronic’s Infuse bone graft product maybe linked to an increased risk of cancer.

There is growing concerns over a potential risk of cancer from Medtronic Infuse, which contains rhBMP-2, a bioengineered bone growth protein. Research indicates that a higher-dose formulation of Infuse, known as Amplify, has been linked to a significantly higher number of cancers than were found among those who received a traditional bone graft.

The data had been given to the Food and Drug Administration by Medtronic when it sought approval to market a high-strength version of an existing bone growth product Infuse. Based on those study findings, the F.D.A. rejected that higher-dose formulation, known as Amplify, citing concern about cancer risks.

Patients implanted with rhBMP-2 were 2.5 times more likely to develop cancer within the next year than those who were not implanted with the Amplify product. That risk increased fivefold after three years. Types of cancer linked to Medtronic Infuse bone growth could include breast cancer, pancreatic cancer and prostate cancer.

While researchers indicate that Infuse is probably not a carcinogen itself, if it is linked to a higher cancer risk, it is probably as a cancer promoter.

The study, was headed by Dr. Eugene Carragee, editor-in-chief of the Spine Journal and a professor at Stanford University School of Medicine. Carragee authored a report in June that found that 10% to 50% of Infuse recipients experienced complications during the clinical trials, including cancer, pain, infections and sterility. Those problems were not mentioned in studies published by researchers with financial ties to Medtronic.

According to Dr. Carragee, doctors often administered Infuse off-label at levels significantly above the recommended dosages, ones that approach or exceed the amount of rhBMP-2 found in a dose of Amplify. “This information requires careful consideration because of the large number of patients receiving high doses” of Infuse, adding that he was particularly concerned about its use in certain patients like smokers or those with genetic factors that put them at higher risk for cancer.

Medtronic Infuse is used to encourage bone growth and replace spinal disks by filling the gaps between vertebrae. It was approved by the FDA in 2002.

Besides fears of sterility and cancer, Medtronic Infuse side effects are also suspected of including serious and life-threatening complications caused by airway compression when used “off-label” in the cervical spine.

A number of patients have had to receive respiratory support tracheotomies, insertion of feeding tubes, and additional surgery after experiencing problems with Medtronic Infuse after a cervical spine surgery.

This has often been caused by swelling of the neck and led to an FDA warning to healthcare providers in July 2008 that highlighted at least 38 reports of cervical spine fusion problems with Infuse. Most of these Medtronic Infuse problems occurred within 2 to 14 days after surgery.

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Medical data from a new FDA funded study indicates that the NuvaRing birth control may cause women to face a 56% higher risk of blood clots than those who take older birth control pills.

NuvaRing is a female birth control device consisting of a medicated flexible ring. NuvaRing releases a combination of etonogestrel and ethinyl estradiol through a ring that is inserted into the vagina once a month. The drugs are a combination of ethinyl estradiol and etonogestrel, which is known as a “third generation” progestin.

NuvaRing is a form of birth control that releases a combination of etonogestrel and ethinyl estradiol through a ring that is inserted into the vagina once a month.

Recently, the FDA released data from a birth control study that reviewed a range of female birth control products and compared them to older drugs to determine the risk of blood clots. Newer progestin-based birth control were found to carry a much higher risk of blood clots, or venous thromboembolic events (VTE), than older drugs like levonorgestrel.

Medical researchers looked at medical data on about 800,000 women from 2001 to 2007, and found that women who used NuvaRing were 56% more likely to suffer a VTE than their levonorgestrel-using counterparts. VTE includes deep vein thrombosis (blood clots in the legs) and pulmonary embolisms (blood clots in the lungs). Women were also at higher risk of arterial thrombotic events (ATE), which can include heart attacks and strokes.

FDA researchers suggested that use of the NuvaRing led to higher sustained exposure to estrogen, which could be the reason the VTE risk is higher. The same study found that drospirenone-based drugs like Yaz and Yasmin increased blood clot risk by 75%.

This data provides further scientific support for claims brought by hundreds of women throughout the United States, who have filed a NuvaRing lawsuit against the manufacturer, Organon and Merck, after suffering serious and fatal injuries from a blood clot. The complaints allege that the manufacturers failed to properly research the birth control ring or warn about the risk of health problems from NuvaRing.

Organon, a subsidiary of Merck, failed to conduct adequate studies that would have revealed the risk of blood clots from Nuvaring before it was introduced into the U.S. market, according to allegations by the plaintiffs. They claim that physicians would have never prescribed the Nuvaring had the true risks of blood clots and pulmonary embolism been properly communicated by the manufacturers.

MANUFACTURERS: Organon Pharmaceuticals USA Inc., Organon USA Inc., Organon International Inc., Schering Plough Corp., and Akzo Nobel NV.

All NuvaRing federal lawsuits have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, before Judge Rodney Sippel in the U.S. District Court for the Eastern District of Missouri. The first NuvaRing bellwether trials are expected to begin in 2012. The complaints all involve similar allegations that women suffered blood clots as a result of NuvaRing side effects, leading to injuries like a stroke, heart attack, pulmonary embolism, deep vein thrombosis (DVT) or sudden death. The claims argue that the drug makers failed to adequately research the birth control ring or warn about the potential increased risk of these serious problems.

The bellwether process is common in complex litigation involving a number of claims that raise similar allegations. By selecting a small group of cases for an early trial, the parties are able to get an idea how a jury is likely to respond to evidence and testimony that may be similar to what would be presented in other cases. The outcome of these trials often shapes the litigation and may ultimately lead to an agreement to settle NuvaRing birth control lawsuits by the drug maker.

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A group of medical researchers and scientists have determined that the potential risks from metal-on-metal hip implants may outweigh any health benefits provided by these devices.

This is because of higher revision rates are linked to the newer hip replacement designs and the mounting and growing concerns about metal ion blood poisoning, known as metallosis.

The California Technology Assessment Forum (CTAF) has released an assessment of the benefits and effectiveness of using metal on metal hip replacements as an alternative to total hip arthroplasty, and they concluded that the relatively new metal hip implants may not be worth the risk.

The assessment (PDF) is the third time the group has reviewed metal-on-metal hip implants, and the group says that questions and concerns about the technology that were present years ago are still important today.

Because of high revision rates and the risk of metallosis, caused by cobalt and chromium particles shed by metal-on-metal implants, the group concluded that “there is clearly no evidence that the potential benefits outweigh the potential risks.”

After they were introduced, metal-on-metal hip implants accounted for about 1/3 of the 250,000 hip replacements performed each year in the United States. Over the past two years, concerns have increased about metal hip replacement complications, resulting in use of the implants dropping to just 5% of the artificial hip market.

Research suggests that as the metal hip replacement ball and socket grind against each other, microscopic particles of cobalt and chromium are shed into the body, which results in metal poisoning. This metallosis may result in soft tissue damage, inflammatory reactions, bone loss, aseptic and local necrosis that may lead to the need for a hip revision surgery.

In May 2011, the FDA requested artificial hip manufacturers to provide more data on problems with metal poisoning and metal implants.

Attention on the metal-on-metal hip implant risks increased after the DePuy ASR hip recall in August 2010. The DePuy metal-on-metal artificial hip system is no longer available after more than 90,000 components were sold throughout the world.

More than 1,000 people have already filed a DePuy ASR hip replacement lawsuit due to complications caused by the recalled system. These lawsuits have been centralized in the Northern District of Ohio for pre-trial consolidation. To make matters worse, DePuy Orthopaedics additionally faces a growing number of DePuy Pinnacle hip lawsuits filed as a result of problems associated with their other metal-on-metal artificial hip implant. These lawsuits have been centralized in the Northern District of Texas, for pre-trial consolidation. To date a DePuy Pinnacle hip recall has not been issued, and these lawsuits also allege that these older system features similar design defects that increase the risk of early loosening or failure.