According to an order issued Tuesday by the U.S. Judicial Panel on Multidistrict Litigation, all four vaginal mesh MDLs will be assigned to Chief Judge Joseph R. Goodwin.

In recent months, a growing number of lawsuits over problems with vaginal mesh and bladder sling products have been filed against manufacturers of the medical devices, which are used transvaginally to treat pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).

The complaints allege that design defects with the mesh products can cause women to experience painful and debilitating complications, such as infection and erosion of the mesh through the vagina.

Public awareness about the risk of vaginal mesh problems increased last year, after the FDA issued warnings about an increasing number of adverse event reports associated with the products. In July 2011, the FDA issued transvaginal mesh warning, indicating that they have been unable to find any evidence that transvaginal mesh kits used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.

There are currently about 84 AMS vaginal mesh lawsuits pending in 19 federal district courts throughout the United States; 23 Boston Scientific pelvic mesh lawsuits pending in 14 different district courts; and 37 Ethicon or Gynecare mesh lawsuits pending in 22 different district courts.

All of these cases will be transferred to the Southern District of West Virginia, where Judge Goodwin will preside over pretrial proceedings. Judge Goodwin was assigned to the three new MDLs, as he already presides over more than 330 Bard Avaulta mesh lawsuits that have been transferred to his court since that MDL was formed in October 2010.

Each of the vaginal mesh MDLs will be kept separate, because they involve different manufacturers. However, putting all of the litigation before one judge will help reduce scheduling conflicts, eliminate conflicting pre-trial rulings and serve the convenience of the witnesses, the parties and the courts.

The warning was issued by the FDA on February 8, in a Drug Safety Communication that indicates the class of drugs known as proton pump inhibitors (PPIs) have been associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD).

PPIs reduce the amount of acid in the stomach and are used to treat gastroesophageal reflux disease (GERD), as well as heartburn, ulcers in the stomach and small intestines, as well as inflammation of the esophagus. Drugs that belong to the class include AcipHex, Dexilant, Nexium, Prevacid, Prilosec (and generic omeprazole), Protonix, Vimovo and Zegerid.

The FDA warns that health care providers should consider the possibility that patients are suffering from CDAD when they experience diarrhea that does not improve while taking a PPI. The agency indicates that new label warnings for all PPIs are under development.

Symptoms of CDAD include:

• Diarrhea that does not improve
• Watery stool
• Abdominal pain
• Fever

In some cases, CDAD can develop into more severe intestinal problems. It is caused by bacterium known as Clostridium difficile (C. difficile) which is often associated with hospital infections.

The warning comes as studies increasingly link PPIs like Nexium and Prilosec to bone fractures.

In May 2010, the FDA warned that there may be an increased risk of bone fractures from PPI heartburn medications. That warning was updated by the FDA in March 2011, indicating that the risk of broken bones from Nexium appears to be linked to high doses of the medication used over long periods of time. Over-the-counter versions of the drugs did not appear to be affected, according to the federal drug regulators.

Public Citizen, a prominent consumer advocate group, has called for black box label warnings to be added to all PPIs, alerting people that the drugs have been linked to bone breaks and can cause consumers to develop a dependency on the drugs. 

Over the past two years, a growing number of individuals throughout the United States have filed a Nexium lawsuit after suffering a hip fracture or other bone problems. The complaints allege that AstraZeneca failed to adequately research their blockbuster medication or warn consumers and doctors about the risk of bone fractures.

A tibial component that is part of the Zimmer NexGen knee replacement system, could be breaking loose from the cement used to bond it to the surrounding bone, causing the implants to fail, according to the findings of researchers from the Mayo Clinic.

The researchers are expected to present their findings today at a meeting of the American Academy of Orthopaedic Surgeons, according to a Dow Jones newswire report.

After examining data on 1,373 knee replacements conducted between 2000 and 2011 where the component was used, researchers found that nearly 4% of the implants failed. Approximately half of those Zimmer knee replacement problems were due to a phenomenon called isolated debonding. Researchers indicated that it was the first time they had seen this problem in implants used at the Mayo Clinic.

Zimmer officials have indicated that the component was only 1.2% of the company’s tibial sales and that high-volume users of the component, which has not yet been publicly named by the researchers or Zimmer, have not complained of any similar problems.

As a result of problems with their knee replacement components, the company currently faces about 200 Zimmer NexGen knee lawsuits filed by individuals who have experienced complications after receiving several different types of implants.

All of the lawsuits involve similar allegations that plaintiffs experienced problems following knee replacement surgery as a result of design defects with certain Zimmer NexGen components. Plaintiffs claim to have suffered catastrophic implant failures, often resulting in the need for revision surgery to remove or replace the implants because they failed far in advance of their projected lifespan. Zimmer allegedly downplayed and understated the risk of Zimmer NexGen knee problems.

In August, the U.S. Judicial Panel on Multidistrict Litigation ordered that all complaints filed in federal district courts throughout the country involving Zimmer NexGen knee replacements be transferred to Judge Pallmeyer in the U.S. District Court for the District of Northern Illinois as part of an MDL.

The study, which was funded by Johnson & Johnson, the manufacturers of the new medication Xarelto, was presented last week at the American Stroke Association’s International Stroke Conference in New Orleans.

According to researchers from Australia, users of Xarelto were one-third less likely to experience brain bleeding than patients given warfarin, an older blood thinner also known as Coumadin, when the drug was prescribed for the treatment of atrial fibrillation. However, Xarelto, like its pharmaceutical cousin, Pradaxa, belongs to a new wave of blood thinners that require less monitoring, but may cause severe bleeding problems that are more difficult to treat.

Pradaxa (dabigatran) is a blood thinner that was just introduced in October 2010, as an alternative to warfarin for prevention of strokes among individuals with atrial fibrillation. The medication has been heavily promoted by the manufacturer, Boehringer Ingelheim, and it quickly grew to be widely used.

Xarelto, Pradaxa and other newer anticoagulents are designed to be easier to use, since they do not require the monitoring associated with warfarin use. However, if severe bleeding problems do occur with warfarin, they can be treated by an infusion of Vitamin K, and there is no easy fix for bleeding problems with Pradaxa, and similar medications like Xarelto.

In December, the FDA announced that it was launching a safety investigation into reports of severe bleeding events with Pradaxa, after a surprising number of deaths and severe injuries were submitted to the agency’s adverse event reporting system during the first year Pradaxa was on the market.

There has been growing alarm among experts about the safety of the drug, and some researchers have recently questioned the validity of the drug’s pre-approval clinical trials, saying that they were so flawed that the FDA should have never approved Pradaxa for the market.

The Institute of Safe Medication Practices (ISMP) reported that the FDA received hundreds of complaints about Pradaxa problems just weeks after it was released, mostly related to bleeding events in elderly patients.

A growing number of individuals throughout the United States are now considering a potential Pradaxa lawsuit against Boehringer Ingelheim after suffering problems like internal bleeding, hemorrhages, heart attacks, strokes and sudden death.

The acetylcysteine solution recall was announced publicly February 2, but hospitals were notified of the problems December 20.

While the recall was originally limited to hospitals, it has now been extended to the patient level, in case there are patients who have the drug. However, there have been no reports of injuries or adverse effects associated with the recall vials.

Acetylcysteine is used to prevent liver injury after someone has suffered an overdose of Tylenol or its active ingredient, acetaminophen. It is also given as an inhalant to treat abnormal or thick mucous secretions.

Inhaled glass particles from a vial of the drug could cause airway obstruction that may result in patients choking, wheezing, coughing, contracting infections and suffering other complications, some of which could be life-threatening.

The recall affects one lot of Acetylcysteine Solution, USP, 20% in 30 mL vials. The vials are from Lot 1877093 with NDC #0054-3026-02. They have an expiration date of June 2013. They were manufactured by Roxane Laboratories, Inc. and distributed by Bedford Laboratories.

Patients are advised to check the lot number and return the drug to their pharmacist if it is one of the vials that have been recalled. The recall calls for hospitals, emergency rooms, clinics and doctors’ offices not to use the product for patient care and advises them to quarantine affected vials for return.

Patients and customers with questions can call GENCO Pharmaceutical Services at (800) 950-5479 and select menu option 1. The recall calls for adverse events to be reported to the FDA’s MedWatch adverse event reporting program.

Merck previously had a full website at http://www.Propecia.com, containing information about the popular oral medication designed to treat male pattern baldness.

As of February 8, Merck now displays a message that the propecia.com “website is not currently available”, providing links to the current prescribing information, patient product information, the Propecia Persistence Program and a link encouraging visitors to report any negative side effects of Propecia to the FDA’s MedWatch program.

In recent months, a growing number of men have filed a Propecia lawsuit against Merck, alleging that they are failing to warn about the risk of erectile dysfunction, loss of libido, infertility, anxiety, depression and other sexual problems allegedly caused by Propecia side effects.

The current Propecia warning label indicates that some men have experienced sexual dysfunction after taking the medication, but suggests that the problems are temporary and resolve after men stop using the drug.

Although Merck has been forced to revise the warning label in many other countries, disclosing that post-marketing reports have indicate some men have experienced long-term sexual problems from Propecia, the drug maker has not yet provided similar warnings in the United States.

If new warnings are issued by the drug maker, it is likely that the Propecia litigation will pick up considerable steam, as more men are likely to contact a product liability lawyer after learning about the potential connection between the hair loss drug and their sexual problems.

On February 3, the U.S. Consumer Product Safety Commission (CPSC) reannounced a York International furnace recall for a number of its Coleman, Coleman Evcon and Red T label furnaces.

The furnaces were originally recalled in 2004, due to overheating and the risk of fire. However, since the recall was announced there have been at least 366 reports involving incidents believed to be linked to the furnaces. Some of those involved extensive property damage due to fires.

At the time of the original recall, affecting about 226,000 furnaces used specifically in manufactured homes, the CPSC determined that the furnaces were overheating, causing the heat-exchanger to crack and burn through. In some cases the furnace wrapper burned as well, causing nearby ignitable substances, like drywall, to catch fire. At that time, there were only 27 reports of fires. To date, no one has been reportedly injured by the furnace fires.

The recall affects Coleman, Coleman Evcon and Red T brand furnaces with the model numbers DGAM075BDD, DGAT070BDD, DGAT075BDD, DLAS075BDD, DGAM075BDE, DGAT070BDE, DGAT075BDE, DLAS075BDE, DGAM075BDF, DGAT070BDF, DGAT075BDF and DLAS075BDF. The affected furnaces are silver with white access panels and have “Coleman,” “Coleman Evcon” or “Red T” labels in the middle of the front access panel. The model number can be found on the faceplate, which is located on the left inside surface behind the lower panel and can be reached by removing both front access panels.

The furnaces were sold as original equipment installed in manufactured homes and as replacement furnaces for homes manufactured between 1995 and 2000.

The CPSC recommends that any consumers with the recalled furnaces in their homes stop using them immediately and have it inspected and repaired. Consumers can contact Unitary Products Group (UPG), a subsidiary of York International, for a free inspection and repair. Consumers with questions can contact UPG by calling (888) 665-4640, or by visiting the company’s website at www.dgatprogram.com.

The hip and knee implant manufacturer has admitted in court filings that it bribed doctors in government hospitals in Greece over the last decade.

The admission of guilt comes as part of a deferred prosecution agreement, which allows Smith & Nephew to avoid an actual conviction that may have barred the company from doing business with U.S. health care programs.

According to an agreement filed on Monday in U.S. District Court in Washington, the Smith & Nephew settlement calls for the company to pay $16.8 million in fines to the Justice Department and $5.4 million to the Securities and Exchange Commission (SEC) as part of a civil suit. The company will also have to undergo corporate monitoring and participate in any bribe investigations. If the company stays clean for three years the charges will be dropped.

The $9.4 million in bribes occurred from 1998 to 2008, prosecutors say. The Greek doctors were bribed through marketing services sent by fake companies set up for the purpose of funneling cash from Smith & Nephew to the surgeons as a reward for promoting and using their implants.

The investigation suggests that bribery is widespread among implant manufacturers, as one e-mail from to a Smith & Nephew vice president complained that other companies were paying more in bribes.

Smith & Nephew officials have indicated that the individuals involved in the scandal are no longer with the company.

The company currently faces a growing number of lawsuits over Smith & Nephew Journey knee replacements, which have been filed by consumers who allege the company manufactured, promoted and sold a defective component that caused them to experience problems within a few years of their surgery. The lawsuits stem from a number of Smith & Nephew recalls that have been issued in recent years for different components involved in the knee replacement system.

Nearly 40,000 Journey Uni Tibial Baseplates were recalled in early 2010, due to a number of reported failures, which suggested that the component may have a tendency to fracture or break. This could result in severe pain and instability, often resulting in the need for surgery to revise the Smith & Nephew knee replacement or replace the base plate.

In February 2011, a study was presented to the American Academy of Orthopaedic Surgeons that found that 16% of Smith & Nephew Journey-Deuce knee implants began to fail within 21 months and 39% of recipients reported poor results after receiving the implant.

The asbestos lawsuit was filed last month in St. Clair County Circuit Court in Illinois by Betty Ruth Rhodes, who worked as a laborer for several companies from 1958 until 1990, including Borg Warner, Speedway Manufacturing and Rhodes Camper Sale.

Rhodes alleges that direct exposure to asbestos at the job site contributed to her developing lung cancer. She also indicates that she suffered second-hand asbestos exposure from her father and husband, who carried fibers home on their clothes or in their hair. Her father worked at International Harvester in Illinois and her husband worked as a millright from 1956 through 1992 at Reynolds Metal Company, ITT and Alcoa.

According to allegations raised in the complaint, Rhodes has suffered permanent disability and disfigurement, physical pain, mental anguish, loss of potential earnings and medical costs from asbestos lung cancer. She is seeking compensatory, economic and punitive damages of more than $450,000.

Asbestos was widely used in a variety of manufacturing and construction applications throughout the last century, with use peaking in 1973. Most uses of asbestos were banned in the mid-1980s.

When inhaled, asbestos fibers can cause asbestosis, lung cancer and mesothelioma. Although the problems have most commonly been seen among individuals who worked in direct exposure, a growing number of lawsuits over second-hand asbestos exposure have been filed in recent years by family members or loved ones who worked around the toxic substance.

Asbestos litigation is the longest running mass tort in U.S. history, with the first case filed in 1929. Over 600,000 people have filed lawsuits against 6,000 defendants after being diagnosed with mesothelioma, asbestosis or other asbestos-related diseases.

According to a report by the U.K.’s Telegraph, a study to be presented next month at the British Hip Society conference will include findings that suggest the metal particles shed by metal-on-metal hip replacements could cause chromosomal changes, which may lead to kidney cancer and bladder cancer.

The findings are the latest blow to the safety of the once-popular implant designs, which have been the subject of massive recalls and a number of product liability lawsuits filed by individuals who allege that they are prone to fail within a few years after surgery.

The study, which is currently underway, involves research on 72 patients who received all-metal hip implants. Researchers are expected to say that 17 of those patients had genetic damage to their bladders and three were diagnosed with cancer. The researchers say the numbers suggest a significant portion of metal hip implant patients could be affected, with one in five showing some genetic damage.

The most likely culprit of such damage is metal debris made up of cobalt and chromium, which is shed into the body when metal hip implant parts rub against each other. The particles have been linked to tissue damage, tumors, high metal ion blood counts and metal blood poisoning, known as metallosis.

Already some experts suggest problems with metal-on-metal hip replacements could cost medical device manufacturers billions in legal costs. If 20% of all metal hip implant recipients actually suffer genetic damage due to metallosis from their implants, it could lead to massive litigation on a global scale.

Some companies, like DePuy Orthopaedics, a division of Johnson & Johnson, already face a staggering number of metal hip implant lawsuits. In August 2010, a DePuy ASR metal hip implant recall affected 93,000 implants worldwide and about 40,000 sold in the United States.

Approximately 3,500, of those individuals who received the implant in the U.S. have already filed a DePuy ASR hip lawsuit against Johnson & Johnson and DePuy. As more hip implants fail over time, the number of people filing product liability claims against manufacturers is likely to increase.

At the time of the recall, DePuy and Johnson & Johnson, their parent company, suggested that about 12% of the ASR hip implants will fail within five years. However, more recent data from the National Joint Registry for England and Wales indicates that nearly a third of patients will experience problems within six years and other estimates suggest that as many as half of all individuals who received the recalled hip system may eventually experience loosening or failure of their implant.

In May 2011, the FDA asked device manufacturers to obtain more information about the level at which the metal particles shed by hip replacements becomes dangerous, how much metal they actually shed and what the potential side effects of metallosis are.