In one study, revealed this week at the annual meeting of the Society of Gynecologic Surgeons, researchers indicate that cure rates and patient satisfaction were the same whether a woman used a transvaginal surgical for treatment of pelvic organ prolapse, or if the problems were resolved by a procedure using her own tissues. However, women who were implanted with a vaginal mesh suffered more complications.

Another study published this week in the Journal of the American Medical Association (JAMA) found that about one out of every ten women who received a vaginal mesh experience erosion, and many eventually suffer stress urinary incontinence in later years.

Researchers at the conference conducted a three-year follow up on 65 women, but women in the clinical trial suffered so many vaginal mesh exposures, in which the mesh erodes its way into the vagina, that the researchers cancelled further enrollment in the program. According to the researchers, 15.6% of women with vaginal mesh experienced mesh erosion.

No differences were noted in whether the procedures improved their ways of life, findings which echo concerns by the FDA, which has indicated that the agency has been unable to find evidence of any benefit in using vaginal mesh for pelvic organ prolapse.

In the JAMA study, researchers from the University of Utah School of Medicine collected data on 215 women over seven years who had various treatments for POP. They found little difference in the risk of anatomic and symptomatic failure and the onset of stress urinary incontinence between women who received a transvaginal mesh and those who did not. They did find that women who received the mesh had a 10.5% probability of mesh erosion after seven years.

The researchers concluded that the risk of mesh erosion should be calculated into healthcare professionals’ recommendations on how a woman should address POP problems.

In July 2011, the FDA issued a warning after receiving at least 2,874 reports of problems with vaginal mesh products between January 2008 and December 2010.  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 for treatment of pelvic organ prolapse.

In early 2012, the FDA sent a letter to several manufacturers of these products, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products, and establish whether they pose an unreasonable risk of injury for women.

Thousands of women throughout the U.S. are currently pursuing vaginal mesh lawsuits against manufacturers of the medical devices, alleging that the transvaginal surgical mesh products are dangerous and defectively designed, carrying a risk of severe and debilitating health problems. The lawsuits have been brought by women who allege that they have experienced mesh erosion, damage to internal organs, infections and other side effects.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has established separate consolidated proceedings in the federal court system for cases involving different manufacturers, with Multidistrict Litigations (MDLs) centralized in the U.S. District Court for the Southern District of West Virginia for all Bard Avaulta mesh lawsuits, American Medical Systems (AMS) vaginal mesh lawsuits, Boston Scientific pelvic mesh lawsuits, Ethicon Gynecare mesh lawsuits and Coloplast sling lawsuits.

Several cases pending in state courts throughout the country have already gone to trial, with a California court awarding $5.5 million in damages to a woman who experienced complications with a Bard Avaulta mesh in July 2012, and a New Jersey state court jury awarded $11.1 million in damages in February, including both compensatory and punitive damages for problems with Ethicon’s Gynecare Prolift mesh.

Nearly 1,000 product liability lawsuits have been filed throughout the country by individuals who experienced problems with Zimmer NexGen knee implants, alleging that certain components were defectively designed and prone to fail within a few years.

In August 2011, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal Zimmer NexGen knee lawsuits brought throughout the federal court system before Judge Rebecca R. Pallmeyer in the U.S. District Court for the Northern District of Illinois, as part of an MDL or multidistrict litigation.

The cases were consolidated for pretrial litigation to avoid contradictory pretrial rulings, reduce duplicative discovery and help facilitate the efficient litigation of the cases. As part of the coordinated proceedings, a small group of cases are being prepared for early trial dates. Known as “bellwether” cases, the trials are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.

According to minutes (PDF) from a telephone conference between Judge Pallmeyer and lawyers involved in the Zimmer knee replacement lawsuits late last month, each side will identify case picks for the trial pool by June 20, 2013. To be eligible for one of the early trial dates in the Zimmer NexGen MDL, a case must have been trasferred into the proceedings before January 25, 2013 and the plaintiffs must have provided a completed Fact Sheet with medical authorizations by April 25.

Case specific discovery will be conducted on the cases between July 2013 and January 2014, with the parties proposing in February 2014 which cases should be selected for the first trial. Following expert witness disclosures, discovery and challenges, Judge Pallmeyer indicates that the first case will be trial ready by January 2015.

According to the most recent case list (PDF) released by the U.S. JPML, there were at least 988 lawsuits involving the Zimmer NexGen knee system pending before Judge Pallmeyer as of May 15. The complaints involve various components, including the Zimmer NexGen LPS-Flex, Zimmer NexGen CR-Flex, Zimmer NexGen GSF LPS-Flex, Zimmer NexGen GSF CR-Flex and Zimmer NexGen MIS Tibia component.

The Zimmer NexGen system was first introduced in 1995, with most components later approved without extensive trials or FDA investigation into their safety through the 510K fast-track approval program, which only requires that devices be “substantially equivalent” to medical devices already on the market to obtain marketing approval.

All of the complaints involve similar allegations that plaintiffs experienced problems with certain Zimmer knee replacements, which were allegedly caused by design defects or Zimmer’s failure to provide accurate information about the risk of problems.

Several hundred product liability lawsuits have been filed against Novartis that allege the drug maker failed to adequately warn about the side effects of Zometa, as well as the similar drug Aredia.

Zometa (zoledronic acid) is a treatment used to reduce bone complications associated with multiple myeloma and bone metastases from solid tumors. Although it is used to strengthen bones, Zometa is a member of a class of medications known as bisphosphonates, which have been associated with an increased risk of the jaw bone weakening and deteriorating.

The complaints allege that the medication increases the risk of osteonecrosis of the jaw (ONJ), a debilitating condition where the jaw bone decays and dies, resulting in exposed portions of bone inside the mouth and often requiring surgery to remove parts of the jawbone.

Following a 13-day trial in New Jersey state court, a jury ruled that Novartis provided adequate warnings in a case brought by Beverly Meng. This was at least the second Zometa lawsuit to go to trial in New Jersey state court and the ninth case nationwide.

While Novartis has successfully defended the safety of their drug in several cases, many of the lawsuits have resulted in substantial damage awards after juries determined that evidence suggested that the drug maker’s employees intentionally covered up evidence of the Zometa side effects.

Last year, a New York state court jury awarded $10.5 million in Zometa damages, including $450,000 in compensatory damages and $10 million in punitive damages, which were designed to punish Novartis for failing to warn about the risk of jaw decay from Zometa.

In 2010, a North Carolina federal court jury awarded $13 million for a Zometa jaw injury, which was subsequently upheld by U.S. District Judge James Beaty, who found that there was sufficient evidence for the jury to find that Novartis should be subject to punitive damages for intentionally misleading consumers and trying to conceal evidence of ONJ from Zometa.

In the federal court system, all lawsuits over Zometa and Aredia have been consolidated in the U.S. District Court for the District of Nashville for pretrial proceedings, as part of an MDL or multidistrict litigation.

The cases are similar to hundreds of 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.

A GoPump and GoBlock pain pump recall was issued on May 10, after at least five complaints were received, including several that involved serious adverse effects. The manufacturer has indicated that they now understand the cause of the problems and have begun to correct the issue.

Surgical pain pumps are used to patients following larger incision surgeries. The pumps are made to run for several days following surgery to deliver local anesthesia to the area in pain. They also are used to block pain to specific parts of the body by delivering anesthesia directly to the site.

The devices are designed to offer patients pain relief without relying on narcotic pain medications. It delivers anesthesia while providing patients with an opportunity to be more mobile and complete normal daily activities sooner.

High flow rates in a surgical pain pump can put a patient at higher risk for toxicity and other serious injuries, such as seizure, dysrhythmia and even death as a result of the rapid influx of medication. Rapid delivery of the anesthesia poses a greater risk to patients with low body mass and the elderly, who may be affected by the medication more easily.

The surgical pain pumps are manufactured by Symbios Medical Products in Indianapolis, Indiana. The recalled products were manufactured prior to July 2012 and distributed between April 1, 2012, and April 30, 2013. The GOPump and GOBlock kits were manufactured with flow control components which seem to be faulty.

This is the second GOPump recall this year. In March, the FDA declared a class I recall for GOPump Elastromeric Infusion Pump kits for flow problems as well.

Symbios has notified it’s distributors and clinical providers of the affected product codes and lot numbers involved in the national recall. The company states they began recall action immediately following receipt of information concerning product safety and operation problems.

For more information concerning the recall contact Symbios 317-225-4447 ext 25 or visit www.symbiosmedical.com.

Researchers from Kaiser Permanente published a report in the medical journal Spine, which indicates that long-term use of powerful painkillers may increase the risk of erectile dysfunction by 50%.

The study looked at the records of more than 11,000 men in Oregon and Washington who were part of the Kaiser Permanente Health Plan.

Researchers discovered that men who had long-term prescriptions for opioid-based painkillers were 50% more likely to also have prescriptions for drugs designed to treat erectile dysfunction.

Less than 7% of men who did not take the painkillers needed treatment for erectile dysfunction. However, the findings do not establish a causal link between the painkillers and erectile dysfunction.

The researchers concluded that the dose and duration of opioid use, as well as age, depression and other factors were associated with evidence of erectile dysfunction. The researchers said that the findings could be important in the decision making process for men considering the long-term use of opioid painkillers.

Opioid analgesics are powerful painkillers that work on the opioid receptors in the nervous system and gastrointestinal tract. Some are natural, based off of opium derived from poppies, and others are synthetic. They include drugs like OxyContin, Vicodin, Dilaudid, morphine, and fentanyl, among many others. They are the oldest known class of painkillers in the world.

The study came out about the same time as 43 attorneys general sent a letter to the FDA calling for a new black box warning to be placed on opioids. The warning would alert pregnant women to the risk of their unborn child becoming addicted to painkillers taken while pregnant and then suffering from withdrawal symptoms upon birth.

A black box warning is the most stringent label warning the FDA can require a drug to carry.

An Avon popcorn maker recall was announced by the U.S. Consumer Product Safety Commission (CPSC) on May 16, after at least 20 reports were received of the plastic microwave bowls overheating while making popcorn, including several instances where the Avon bowls burst into flames

The CPSC warns that if the popcorn makers are left in the microwave too long, they may ignite. This poses a risk of fires and a serious burn hazard for consumers.

The recall consists of Avon’s microwave popcorn maker with item number 474-105. The popcorn maker has a clear tub and a vented yellow lid and measures 6 inches high by 7.5 inches in diameter and is equipped with 3 feet at the base of the tub. The clear plastic tub has the phrases “DO NOT REMOVE WITH BARE HANDS. HOLD UNIT WITH GLOVES” and “USE IN MICROWAVE ONLY” molded into the plastic lid and underside of the bowl. The bowls have a “Made in Taiwan” label located on the underside.

The plastic microwave bowls were manufactured in Taiwan by Okay Enterprise Co., Ltd, of Kunshan City, Taiwan and imported by Avon products Inc., of New York, New York where they were sold by independent sale representatives and online at www.avon.com from October 2012 through February 2013 for roughly $13.

The CPSC recommends that consumers immediately contact Avon at (800) 367-2866 to receive a copy of the updated instructions on how to properly use the microwave bowls. Consumers may also obtain the new instructions by contacting an Avon representative or by visiting the company’s website at www.avon.com and navigating to the Product Recall section at the bottom of the page for further detail.

Researchers from the University of California, San Francisco, say for-profit dialysis centers continued to give patients large amounts of a class of anemia drug known as Erythropoiesis-stimulating agents (ESAs), even after a 2007 black box warning was added by the FDA warning that they should be using as little of the drugs as possible on their patients.

The study, published in the JAMA Internal Medicine medical journal on May 15, looked at the use of ESAs from February 1, 2007, before the warning was added, and compared the usage rates to those on February 1, 2008, after the warning.

Researchers found that both non-profit and for-profit dialysis centers showed reductions in use, but for-profit centers only dropped from 9,000 units per week to 8,300 units per week, while non-profit use of ESAs dropped from 5,600 units per week to 5,000 units weekly.

Experts say that it was not until 2011, when Medicare bundled all dialysis treatment costs together, so that there was no additional profit in using ESAs, that for-profit use dropped to levels comparable with non-profit use. However, there has been no study yet verifying that assumption.

Anemia Drug Health Risks

Aranesp (darbepoetin alfa), Epogen (Epoetin alfa) and Procrit (Epoetin alfa) are ESAs prescribed to patients with kidney disease, anemia, HIV and cancer to stimulate bones to increase the production of red blood cells. They are also prescribed to patients preparing to undergo major non-heart surgery to reduce the number of transfusions such patients must receive. Amgen manufactures all three drugs, though Procrit is sold and marketed by Johnson and Johnson.

In 2008, Aranesp sales were $3.1 billion, and Procrit accounted for $2.46 billion in sales. However, following studies that suggested the drugs carry serious, sometimes deadly side effects, sales have dropped in recent years.

The FDA issued a public health advisory regarding the drugs in 2007, saying that the Anemia drugs could increase the risk of injury or death at high doses. The FDA required the black box warning to alerting patients to the cardiovascular health risks. The black box warning is the strongest label warning the FDA can require of a medication.

The drugs are already restricted under an FDA-required risk evaluation and mitigation strategy (REMS). Doctors and hospitals that wish to prescribe the drugs will now have to undergo special training to identify high risk users and negative side effects.

A $762 million settlement was reached in December to resolve an Amgen whistleblower lawsuit, which alleged the drug maker illegally promoted the medication. The lawsuit claims Amgen encouraged doctors to use the drugs by overfilling vials by as much as 25 percent. It also alleges the drug company offered doctors discounts to use the drugs in large volume.

Other scandals surrounding the anemia drug involve Amgen offering false information regarding the safety of the drug. The company is reported to continue the use of lobbyists in congress to pressure lawmakers and the FDA to overlook claims of potential severe side effects, such as an increased risk of cancer and stroke.

In a press release issued today, DePuy Orthopaedics, Inc. indicated that it is stopping sales of the Ultamet metal-on-metal and Complete ceramic-on-metal hip systems, which include the same metal liner that is designed exclusively for use with the DePuy Pinnacle hip in a metal-on-metal configuration.

In addition to citing low sales for the metal liner, the company noted that proposed FDA regulation of metal-on-metal hip implants was a factor in discontinuing sales.

The FDA has called for metal hip manufacturers to go through more stringent clinical trials and premarket approval processes before placing artificial hip products on the market. Part of the reason the agency was pushed to its decision was due to an August 2010 recall of the DePuy ASR metal-on-metal hip implant that affected more than 93,000 artificial hip systems worldwide and led to thousands of lawsuits against the company.

The DePuy Pinnacle hip system was introduced in 2001, with some variations containing the metal liner. The metal-on-metal configuration was used as the basis for the approval of the DePuy ASR hip implant in 2005, with Johnson & Johnson obtaining “fast track” 510k approval by maintaining that the DePuy ASR and DePuy Pinnacle metal-on-metal hips feature “substantially similar” designs. However, the DePuy Pinnacle was also approved under the FDA’s controversial 510k system as a substantial equivalent to older metal hips, which has allowed both designs to be implanted in thousands of people without federal regulators requiring stringent clinical trials to examine the safety of the design.

The company’s press release says that the Pinnacle Cup is not affected by the discontinuation, indicating that the Pinnacle will continue to be offered with both medical-grade plastic and ceramic liners.

DePuy Pinnacle Hip Lawsuits and Calls for Recall

More than 4,000 product liability lawsuits have been filed throughout the federal court system by people who have experienced problems with the DePuy Pinnacle hip when it was implanted with the metal liner. The lawsuits allege that as the metal parts rub against each other, metallic debris is released into the body, which may cause the artificial hip to loosen and ultimately fail.

Many of these complaints allege that a DePuy Pinnacle hip recall should have been issued after post-marketing reports made it clear that an unreasonable number of patient were experiencing complications within a few years of surgery.

Although Johnson & Johnson’s DePuy subsidiary has kept the Pinnacle metal liner on the market, most doctors have abandoned use of all metal-on-metal configurations due to concerns about the safety.

DePuy acknowledges the sharp decline in the use of metal-on-metal hip replacement systems worldwide that is driving it to consolidate its products. The company says that metal-on-metal systems now make up less than 2% of those implanted annually in the U.S. and Europe; a 90% decline industry-wide since 2007.

All Metal-on-Metal Hips Under Investigation

In recent years, the FDA has increased scrutiny of metal-on-metal hips in response to concerns about the effects of metallic debris that may be released as the metal parts rub against each other, potentially causing tissue damage and metal blood poisoning, also known as metallosis.

In January, the FDA released new guidance for metal-on-metal hip replacements that called for them to go through the PMA process. The agency told doctors that metal-on-metal hip replacement systems should only be used if other artificial hip implants were not appropriate, and called on manufacturers to prove that their implants were safe enough to stay on the market.

Thousands of individuals throughout the United States are currently pursuing product liability lawsuits against the makers of metal-on-metal hip replacement systems. In addition to lawsuits over the DePuy Pinnacle, a substantial number of DePuy ASR hip lawsuits, Biomet M2A Magnum Hip lawsuits and Wright Conserve Cup lawsuits are pending nationwide.

At least 14 lawsuits have been brought in New Jersey courts by individuals who allege that they suffered liver damage or liver failure from side effects of Tylenol, and the number of cases is expected to continue to mount.

According to a request (PDF) made by lawyers for Johnson & Johnson on April 22, the drug maker is seeking to establish centralized management for the cases before one judge in Middlesex County, indicating that it will help “avoid duplicative discovery and inconsistent rulings, and to conserve judicial resources and promote the interests of justice” while the matters remain at an early stage in the litigation process.

The request comes about one month after all Tylenol liver injury lawsuits filed in the federal court system were consolidated before Judge Lawrence Stengel in the Eastern District of Pennsylvania, as part of an MDL or multidistrict litigation.

At the time the federal Tylenol litigation was centralized on April 1, there were 27 different lawsuits involving Tylenol and liver damage pending in federal courts throughout the country. However, Johnson & Johnson indicates that at least another 33 lawsuits have been identified in weeks after the cases were consolidated.

According to a Notice to the Bar (PDF) posted by the Acting Administrative Director of the New Jersey Courts on May 10, anyone wishing to comment on or object to the application should provide such comments or objections in writing before June 10, 2013.

Tylenol and Liver Injury

Tylenol is one of the most widely used over-the-counsel painkillers in the United States, containing acetaminophen as the active pharmaceutical ingredient.

The lawsuits allege that Johnson & Johnson and their McNeil-PPC, Inc. subsidiary failed to adequately warn consumers about the risk of liver damage from Tylenol.

Acetaminophen overdose is one of the leading causes of liver failure in the United States, resulting in an estimated 50,000 emergency room visits, 25,000 hospitalizations and over 450 deaths annually, according to federal health officials.  In a 2002, an FDA advisory committee found that there were between 1,000 and 2,000 acetaminophen-induced liver failures each year.

In July 2011, Johnson & Johnson announced that it was lowering the maximum recommended dosage on Tylenol and other acetaminophen-based products from 4,000 mg per day to 3,000 mg per day. The decision came after the FDA announced new limits on acetaminophen levels in prescription painkillers like Vicodin and Percocet. But over-the-counter painkillers and drugs with acetaminophen went unaffected.

Johnson & Johnson’s McNeil-PPC subsidiary is headquartered in Skillman, New Jersey, leading the drug maker to speculate that additional lawsuits will be filed in the state and that there will be geographical disbursement of the parties in cases, leading to the need for centralized management.

Johnson & Johnson Opposed MDL for Federal Tylenol Litigation

Although Johnson & Johnson initiated the request to centralized the New Jersey litigation, the drug maker actually opposed the formation of a Tylenol MDL in the federal court system, suggesting that the consolidated proceedings were not warranted or justified, even though there were nearly two times the number of cases pending in federal courts.

The drug maker argued that the Tylenol warning label has provided information about the potential risk of liver damage caused by acetaminophen since at least 2005, and maintained that consolidating the cases in federal court was inappropriate because the cases will center on the individual facts of each case, such a whether the plaintiffs took Tylenol, how much they took, and whether they had other problems that could have caused liver failure.

Following a hearing before the U.S. Judicial Panel on Multidistrict Litigation in late March, the federal Tylenol litigation was centralized for pretrial proceedings before Judge Stengel, who has scheduled an initial conference for May 21, to address matters relating to the organizational structure of the MDL and discovery proceedings in the cases.

Although the cases have been centralized for pretrial litigation, if Tylenol liver injury settlement agreements or other resolutions are not reached during the MDL, each individual lawsuit may be remanded back to the U.S. District Court where it was originally filed for trial.

The complaint (PDF) was filed by Robin Tasler in the U.S. District Court for the Southern District of California last month, indicating that Linda Blaylock died in April 2011 of pancreatic cancer after using the popular diabetes drugs for a number of years.

Byetta, Bydureon, Januvia and Janumet are all members of a class of diabetes drugs known as incretin mimetics, which recent studies have linked to an increased risk of pancreatic cancer and pancreatitis.

According to the diabetes drug pancreatic cancer lawsuit, Blaylock took Byetta, Bydureon, Januvia and Janumet at various times between 2008 and March 2011. All of the drugs work in a similar fashion, stimulate the production of insulin when blood sugar is rising and stopping the pancreas from releasing too much glucagon.

Tasler alleges that the makers of the diabetes drugs failed to adequately warn doctors or patients about the potential risk of pancreatic cancer. The complaint seeks damages against Merck, Amylin Pharmaceuticals and Eli Lilly and Co. for failure to warn, designing a defective drug, negligence, breach of warranty, negligent misrepresentation and fraudulent concealment.

Diabetes Drug Pancreatic Cancer Lawsuits

Byetta (exenatide) was the first member of this class approved by the FDA, introduced by Amylin Pharmaceuticals and Eli Lilly in 2005 as a twice daily injection. Januvia (sitagliptin) was introduced by Merck the following year as an oral medication, and a combination pill containing Januvia and the older diabetes medication metformin was introduced in 2007 under the brand name Janumet. Bydureon is a longer-acting version of Byetta that is injected once weekly, which was introduced early last year.

The medications are widely used among individuals with type 2 diabetes, generating billions in annual sales. Januvia and Janumet are among the best selling medications for the global pharmaceutical company Merck, with Janumet sales reaching over $1.3 billion in 2011 and Januvia sales hitting $919 million during the first quarter of 2012 alone. Byetta sales were reported at $710 million in 2010 and were expected to reach $1 billion by 2015.

In March, the FDA launched an investigation into the potential pancreatic cancer risk associated with the diabetes drugs. The safety review was initiated after results of a recent study identified pre-cancerous cellular changes in pancreatic tissue taken from individuals treated with incretin mimetics. European health officials have also launched a similar review.

Tasler’s complaint joins a growing number of Byetta lawsuits, Januvia lawsuits and Janumet lawsuits filed in courts throughout the U.S. so far this year.

Last month, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking to consolidate and centralize all pancreatic cancer lawsuits involving Byetta, Victoza, Januvia or Janumet. At least 53 cases are currently pending in 7 different U.S. District Courts.

If an MDL is established, Tasler’s wrongful death lawsuit will also be transferred to the same judge for coordinated pretrial proceedings. The U.S. JPML is expected to schedule oral arguments on the motion to be heard during an upcoming hearing session on July 25 in Portland, Maine.