Author: AboutLawsuits

A Hitachi Coil Nailer recall has been issued after 15 people in the U.S. and three people in Canada reported suffering an injury from the defective nail guns. 

The U.S. Consumer Product Safety Commission (CPSC) and Health Canada announced a recall of the Coil Nailer on March 11, saying that the nail guns have a defective feeder mechanism that sometimes fires out the nails sideways. The CPSC and Health Canada warned that the nail guns pose a serious injury hazard to the users or bystanders.

In the U.S., Hitachi Koki Co. Ltd. has received 37 reports of nails being fired out of the gun sideways, 15 of those cases resulted in injuries. The CPSC said that the most frequent injuries were to the eyes, in some cases resulting in partial blindness. Canadian officials also reported three injuries, one of which also resulted in partial blindness.

The nail guns are used to fire nails into wood, drywall and other materials. Coil nail guns hold long, flexible nail strips that allow them to carry more of a nail payload than traditional stick nail guns. They fire the nails into surfaces pneumatically.

About 65,000 Hitachi Coil Nailers have been affected by the recall; 50,000 in the U.S. and 15,000 in Canada. All of the recalled nail guns have a model number of NV83A2, which can be found on the body. The recall affects coil nailers manufactured between October 2002 and September 2005. The manufacturing date can be found at the end of the serial number on the end of the handle. The first digit represented the month and the second digit represents the year. Months January through September correspond with numbers 1-9, while October, November and December are represented by the first letter in the name of the month. The year is represented by the last digit of the year (2 for 2002, 3 for 2003, etc.).

The coil nailers were sold at Lowe’s, Home Depot and other home improvement stores nationwide, as well as online through Amazon.com from November 2002 through March 2006 for between $350 and $400.

The CPSC and Health Canada recommend that consumers immediately stop using the recalled coil nailers and contact Hitachi Koki U.S.A., Ltd. for a free repair at www.hitachipowertools.com.

A “Black Box” warning has been placed on the anti-blood clotting drug Plavix, alerting patients and health care professionals that the drug may not work effectively in some patients due to genetics. This could cause serious or life-threatening injuries for individuals given the medication to reduce the risk of heart attack, unstable angina, stroke or cardiovascular death among those with cardiovascular disease.

The FDA announced the Plavix boxed warning warning on Friday, warning doctors that they should consider another anti-clotting drug for patients who are confirmed to be poor metabolizers of Plavix through genetic testing. The FDA said a genetic test is available which will determine whether patients are able to metabolize Plavix efficiently.

The black box warning is the most stringent warning label the FDA can require on a drug.

Plavix (clopidogrel) is a blood thinner that prevents blood platelets from sticking together to form clots. It is a blockbuster medication, generating annual sales of over $6 billion for Bristol Myers Squibb Co. and Sanofi-Aventis.

In August 2009, researchers from the University of Maryland identified a gene variant found in about one-third of the population that may signal a reduced effectiveness of Plavix. The people with the CYP2C19 variant have reduced functioning of a liver enzyme that is supposed to covert Plavix from its inactive form to its active form, potentially making Plavix ineffective at reducing the risk of blood clots.

The genetic variant is found in about 30% of Caucasians and blacks, and up to 60% of Asians. Simple genetic tests using DNA from blood or saliva can identify poor Plavix metabolizers. The tests are estimated to cost about $500, however, identifying poor Plavix metabolizers could prevent patients from being unnecessarily exposed to risk of Plavix side effects, such as an increased risk of gastrointestinal bleeding, ulcers and a possible increase in the risk of heart attacks or strokes for those with high cholesterol or high blood pressure.

Bristol Myers Squibb Co. and Sanofi-Aventis currently face a number of Plavix lawsuits filed by plaintiffs who claim that the drug maker failed to adequately warn about problems associated with use of their drug.

About 2,500 Massachusetts nursing home residents are being given powerful and sometimes dangerous antipsychotic medications like Seroquel and Risperdal that they do not need, according to federal investigators.

Data released recently from the Centers for Medicare and Medicaid Services found that 28 percent of all nursing home residents in Massachusetts were given antipsychotic drugs. Of those, 22 percent had no medical condition that required antipsychotic medication, raising suspicions that many were given the drugs as “chemical restraints” by nursing homes or to treat dementia, which the FDA has said can be dangerous and potentially lethal.

According to an analysis done last week by the Boston Globe, experts say that the quality of care at a nursing home can sometimes be directly related to how many antipsychotics they dole out to their residents. In homes with high quality staffing and care, the number of residents prescribed antipsychotics can be as low as 2% or 3%. In care facilities with low levels of staff and poor training, as many as 87% of the residents might be prescribed Seroquel, Risperdal, Zyprexa or other antipsychotic drugs.

The findings come as the Department of Justice (DOJ) has decided to intervene in a whistleblower lawsuit against Johnson & Johnson for allegedly taking part in a nursing home drug kickback scheme intended to get facilities to push the use of their medication, Risperdal, onto elderly patients.

The DOJ filed a civil False Claims Act compliant against Johnson & Johnson (J&J) on January 15, saying that the company paid millions to Omnicare, Inc. as kickbacks for prescribing its drugs to nursing home patients. Last year, Omnicare settled charges brought against it by the government for allegedly paying kickbacks to nursing homes to prescribe the drug. At that time, the Justice department investigators indicated that the illegal nursing home drug kickbacks were hidden as data fees, education fees and as payments to attend Omnicare meetings.

Risperdal, Seroquel and most other antipsychotics are not approved for treatment of dementia, and patient advocates have been pushing nursing homes to reduce the use of the drug among elderly due to the health risk and a lack of actual health benefits. According to a recent report from the United Kingdom, side effects of Risperdal and other similar antipsychotics, like Seroquel, Zyprexa and Abilify, could be linked to as many as 1,800 deaths and 1,620 strokes per year in elderly patients with dementia.

The FDA has repeatedly warned against the casual prescription of antipsychotics to elderly patients, particularly those with dementia. In 2005, the FDA required antipsychotics to carry a “black box” warning that the drugs were connected to an increased risk of premature death in elderly dementia patients. The warning is the most stringent labeling requirement possible under federal law.

FDA inspectors have identified a number of quality control and training issues at Amylin Pharmaceutical’s Byetta manufacturing plant in Ohio, just as the agency prepares to decide whether to approve a new formulation of the diabetes drug and concerns mount about potentially serious side effects of Byetta. 

According to an FDA inspection report (pdf) released last week, raw materials used to make Byetta were not properly inspected coming into the plant, and workers in a variety of positions at the West Chester plant, near Cincinnati, Ohio, have not been properly trained to ensure quality control.

Byetta is a type 2 diabetes drug that is manufactured and distributed jointly by Amylin and Eli Lilly & Co. The drug is used to control blood sugar levels and is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels. The drug makers are currently seeking approval for a new long-acting formulation of the drug, which would allow users to take one injection per week, instead of the current twice-daily dosing regimen. A decision on the drug approval is expected this week.

According to the FDA’s inspection report, the plant failed to establish or follow procedures designed to prevent contamination of drug products that are supposed to be sterile. The plant also failed to test in-process materials properly for quality and purity, and did not follow up on investigations into unexplained discrepancies and failures of batches of drugs.

The inspection report follows an FDA warning issued in January about off-label promotional statements for Byetta at a conference in June.

The production issues also add to recent concerns about potential health problems with Byetta, which has been linked to a risk of kidney failure and pancreatitis. In November, the FDA issued a new warning indicating that they have received at least 78 post-marketing reports that link Byetta kidney problems, including 62 cases where the users experienced kidney failure. And in October 2007 and August 2008, the FDA issued safety alerts about reports of Byetta pancreatitis cases, including severe reports of hemorrhagic pancreatitis and necrotizing pancreatitis, which can be fatal.

Amylin and Eli Lilly also currently face a number of Byetta lawsuits involving allegations that the drug makers failed to adequately warn about the risk of pancreatitis and kidney failure.

Tylenol, aspirin and other common over-the-counter pain killers may cause hearing loss in men, according to the results of a recent study. 

The study, published this month in the American Journal of Medicine, found that men who took acetaminophen, the active ingredient in Tylenol, or other pain relievers known as nonsteroidal anti-inflammatory drugs (NSAIDs), like aspirin and Ibuprofin, face an increased risk of hearing loss. Scientists found that the longer the pain killers are used, the higher the risk in most cases.

“Regular use of analgesics, specifically aspirin, NSAIDs, and acetaminophen, might increase the risk of adult hearing loss, particularly in younger individuals,” researchers concluded. “Given the high prevalence of regular analgesic use and health and social implications of hearing impairment, this represents an important public health issue.”

The study included nearly 27,000 men between the ages of 40-74 who worked in the health profession. Researchers found that, overall, men under 60 years old who take Tylenol or other acetaminophen-based medications at least twice a week were 22% more likely to suffer hearing loss than those who do not. Men who took NSAIDs like Ibuprofen were 21% more likely to suffer hearing loss, and men who took aspirin were 12% more likely. The most at-risk group included men between the ages of 45 to 50 years old, who had a 99% increased risk of hearing loss if they took Tylenol. Men from the same age group had a 61% increased risk of hearing loss if they took Ibuprofen regularly, and a 33% increased risk if they took aspirin regularly.

Researchers found that there was no appreciable difference in hearing loss after the age of 60.

Scientists who conducted the Tylenol and NSAID hearing study pointed out that there have been tests in animals that found that the use of some pain killers can decrease blood flow to the cochlea, the part of the inner ear which is the primary source of human hearing. It contains tiny hair cells suspended in fluid that move when sound vibrations enter the inner ear. The nerves in the cochlea transmit the motions to the brain, which interprets them as sound.

The researchers said that the study was the first time acetaminophen had been studied for hearing loss.

The study comes as the FDA is taking a closer look at over-the-counter pain killers. In April 2009, the FDA announced that it would require more stringent liver injury warnings on Tylenol and NSAIDs, which include aspirin (marketed as Bayer), ibuprofen (marketed as Advil and Motrin), naproxen (marketed as Aleve, Naprosyn, Anaprox and Naprelan) and ketoprofen (marketed as Orudis and Oruvail).

Millions of Americans, both adults and children, use these drugs for pain relief and to reduce fevers. They are also commonly combined with other ingredients in many common cold medicines.

DePuy Orthopaedics, a division of Johnson & Johnson, has indicated that its ASR metal-on-metal hip replacement system, has been linked to a high failure rate and the device will be removed from the market.

While the company initially indicated that the DePuy ASR hip cup was being phased out due to low sales numbers, a letter was sent to doctors on March 6 warning about a potential risk of ASR hip replacement problems. Many patients have experienced hip failures soon after the device was implanted, leading to an additional expensive and painful hip replacement surgery.

According to a report by the New York Times, some medical experts have said that a DePuy ASR cup recall should have been issued earlier, claiming that the failures are linked to a design problem that makes them difficult to implant.

DePuy officials say that ASR hip implant failures are most likely to occur in patients of smaller stature, including women and individuals with weak bones. The FDA has received complaints from about 300 recipients since 2008, most of whom had to undergo another round of hip surgery to replace the defective ASR hip implants.

The ASR is a metal-on-metal hip replacement system. Health care professionals have increasingly been warning about problems with metal-on-metal hip implants, which can shed metal particles into the body. The particles can damage soft tissue, cause inflammatory reactions and lead to bone loss.

Last year, U.K. researchers studied 660 patients who had received metal hip implants from DePuy Orthopaedics and found that 3.4 percent suffered from adverse reactions to metal debris. Surgeons are warning that one to three percent of all metal on metal hip implant recipients may experience hip implant problems, and possibly need to have the devices replaced, due to metallic debris.

DePuy announced it would phase the devices out by late 2010. However, the hip implants have already been put into thousands of people’s bodies worldwide. DePuy said the withdrawal was not caused by the problems, saying that the failure rate was new information.

All of the major orthopedic medical device companies manufacture their own version of “metal on metal” hip implants, and several have said that the metallic debris problem does not pose a significant risk. However, an increasing number of orthopaedic surgeons and experts disagree. In a recent editorial in the Journal of Arthroplasty, the medical journal warned doctors to avoid the use of the metal hip implants, and said they should only be used “with great caution.”

As a result of the increased reports of problems, product liability lawyers are investigating and reviewing potential DePuy ASR metal hip replacement lawsuits for individuals who received the device and experienced complications, including hip replacement failure or other hip problems.

A class action lawsuit over Yaz and Yasmin birth control has been filed in Canada against Bayer Pharmaceuticals on behalf of women who were prescribed the birth control pill, alleging that the drug maker hid the risk of serious and potentially life-threatening side effects of Yaz and Yasmin. 

The Yasmin and Yaz class action lawsuit was filed earlier this week in the St. Catharines, Ontario, by Christine Lovelace and Jennifer Demunnik. Both women say that Yaz and Yasmin cause health problems above and beyond those caused by other typical oral contraceptives.

In the United States, about 1,100 Yaz lawsuits and Yasmin lawsuits have been filed on behalf of individual women who allege that they suffered injuries that were caused by the birth control pills, such as a stroke, heart attack, pulmonary elbolism, deep vein thrombsis, gallbladder disease and other injuries.

Lovelace alleges that she suffered a transient ischemic attack, also known as a “mini-stroke,” last fall after taking Yaz for several months. She was temporarily paralyzed on her left side and could not communicate. She has mostly recovered, but still suffers hand and foot nerve damage. Demunnik alleges that she developed gallstones after a year and a half on the birth control pill and had to have her gallbladder removed from Yaz.

Yaz and Yasmin are similar pills that are both manufactured by Bayer, containing a combination of ethinyl estradiol and drospirenone, a new type of progestin. Drospirenone, or drsp, impacts the body’s normal mechanism of regulating a balance between salt and water, which could result in elevated potassium levels. This can cause a condition known as hyperkalemia, which is linked to potentially life-threatening heart problems and other health issues.

The lawsuits over Yaz and Yasmin have suggested that the oral contraceptives have been responsible for at least 50 deaths in the U.S. alone.

The Canadian Yaz class action lawsuit claims that Bayer knew, or should have known, that the birth control pills carry a higher risk of side effects than other birth control pills. The lawsuit is seeking $487,000 for each Canadian woman prescribed Yaz or Yasmin, and an additional $20 million in punitive damages against Bayer.

There have been at least four Canadian Yaz and Yasmin class action lawsuits filed against Bayer in Canada. In the United States, all federal Yaz litigation has been consolidated for pretrial proceedings in a multidistrict litigation (MDL), under Chief Judge David Herndon in the U.S. District Court for the Southern District of Illinois.

A Class 1 medical device recall has been issued for Abiomed, Inc.’s AB5000 Circulatory Support System after it was determined that the device, which keeps the heart pumping in cases of heart failure, can suddenly stop operating without warning.

The FDA sent out an AB5000 Circulatory Support System recall notice this week, after Abiomed sent letters to customers alerting them of the problem last month.

The computer in the device can shut down, and the system can stop pumping a patient’s heart without warning, according to the FDA statement. Although there have been no injuries reported in connection to the defective circulatory support systems, the action has been classified as a Class 1 recall because of the risk of serious injury or death.

Abiomed circulatory support systems are used to keep the right, left, or both sides of a patient’s heart pumping after heart failure temporarily until the natural heart rhythm can be restored. The device itself is linked to a portable computer console which allows the patient mobility.

The recall affects the Abiomed AB5000 Circulatory Support System, catalog number 0015-0000, with serial numbers AD5001 through AD5496. Systems with serial numbers AD5006 and AD5018 are exempt from the recall. The systems were manufactured and sold from May 2003 through December 2009 by the Massachusetts-based company.

The company contacted customers via letter on January 27, 2010. The FDA requests that any health care professionals or patients who experience an adverse medical event or reaction while using this device contact FDA’s Medwatch Adverse Event Reporting Program at http://www.fda.gov/medwatch.

The FDA is warning that health care professionals may have been sold a counterfeit surgical mesh under the C.R. Bard brand name, which could put patients in danger.

The counterfeit surgical mesh warning, issued on March 11, alerts health care providers and consumers that someone is distributing fake polypropylene mesh products. The FDA is uncertain whether these copycats are safe to use on patients, as they have not been evaluated or approved by the agency. The FDA warns that it does not know if the patches are durable or even sterile.

The counterfeit surgical products have been falsely sold under the C.R. Bard/Davol brand name in a variety of sizes. The FDA has confirmed that the meshes are not manufactured by C.R. Bard, but did not release any information on who might be producing or selling the fake medical devices or whether anyone had been injured by a counterfeit mesh.

Health care providers should be on the lookout for Bard Flat Mesh 2” x 4” sheets with lot numbers 48HVS036 and 43APD007; 10” x 14” sheets with lot numbers HUSD0629 and HURL0336; 3” x 6” sheets with lot numbers 43HPD027, 43HPD032, HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSF0763, 43IOD011 and 43IPD038; 6” x 6” sheets with lot number 43FQD327.

Surgical mesh is used by surgeons to shore up weakened soft tissue in the body to prevent hernias or rupturing. The meshes being counterfeited are sold as flat sheets of polypropylene.

Davol, a subsidiary of C.R. Bard, Inc. currently faces a number of legal problems over some of their real surgical mesh products. More than 1,000 Kugel Hernia Mesh lawsuits have been filed against the companies by individuals who say they suffered injuries due to defective meshes. At least three separate Kugel hernia patch recalls were issued by Bard and Davol between December 2005 and January 2007 for different types of hernia mesh, which have been associated with problems like intestinal pain, bowel perforation, intestinal fistula and additional surgery to remove the mesh. All of the lawsuits involve allegations that plaintiffs suffered severe injuries and potentially life-threatening complications from hernia surgery repairs caused by defective mesh manufactured by C.R. Bard, Inc. and Davol.

Any health care providers who believe they have received counterfeit surgical meshes should not use the products and should contact the FDA’s Office of Criminal Investigation at http://www.fda.gov/OCI.

The FDA indicated this week that it is still investigating a potential link between unexplained femur fractures and osteoporosis drugs, like Fosamax, Actonel, Boniva and Reclast, but questions whether such a causal connection exists. 

A Drug Safety Communication was released by the FDA on March 10, indicating that while the agency will continue to review new information and update the public once their investigation is complete, the data examined at this point has not shown a “clear connection” between the oral bisphosphonate medications and a risk of atypical subtrochanteric femur fractures reported among some users of Fosamax.

The risk of Fosamax femur fractures have been highlighted in a number of recent news reports and published case studies that suggest the oral bisphosphonate medication may be responsible for a growing number of unexplained, low-impact femur fractures.

A study published in the May/June 2008 issue of the Journal of Orthopedic Trauma found a pattern of femur fractures among Fosamax users that was 98% specific to the osteoporosis drug, involving low-energy fractures that were typically caused by falls from a standing height or less. The study also found that the average duration of Fosamax use was longer among those who had signs of these specific femur fractures than those who did not.

In addition, a Fosamax fracture case study published in September 2009, in the Journal of Bone and Mineral Research examined a patient suffering from rheumatoid arthritis with multiple risks for bone fractures who took Fosamax for eight years and developed femur fractures. The report found that the patient had an imbalance between bone resorption and bone formation at the site of a rare femur fracture known as a spontaneous bilateral subtrochanteric/diaphyseal fracture, which suggested a possible connection to the osteoporosis drug.

However, the FDA says that in June 2008 it requested information on all available case reports and clinical trial data. The information, supplied by bisphosphonate drug manufacturers, did not show an increase in the risk of femur fractures, the FDA said in its statement.

“The FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue,” the FDA communication states.

Merck & Co. issued a statement following the release of the FDA communication, saying that Fosamax has been repeatedly tested and is safe, but also noting that there have been cases of Fosamax users developing a jaw deteriorating codition known as osteonecrosis of the jaw, or ONJ.

“When talking about reports of potential side effects, it’s important to keep in mind that these events can and do occur in people who have never taken one of these medicines,” said Dr. Michael Rosenblatt, M.D., Chief Medical Officer of Merck. ”But we are committed to continuing to study these reports, and to provide updates on what we learn. Based on what we know now, we believe that the benefits of bisphosphonates outweigh potential risks.”

A number of Fosamax femur fracture lawsuits have been filed against the drug maker alleging that it failed to adequately research their medication or warn users about the risk of the bone breaks.

The FDA is recommending that healthcare professionals continue following drug label recommendations for oral bisphosphonates while the review continues. FDA also recommends that patients continue to take prescribed oral bisphosphonates unless told to stop by their health care provider.

Fosamax (alendronate sodium), is a member of a class of drugs known as bisphosphonates, and is prescribed for treatment of osteoporosis. Fosamax was approved by FDA in October 1995, and has been used by more than 20 million people. The drug generated over $3 billion in annual sales for Merck before it became available as a generic last year.

Merck & Co. faces about 1,000 Fosamax lawsuits over ONJ. The federal Fosamax cases have been consolidated into a multidistrict litigation (NDL) for pretrial proceedings in the U.S. District Court for the Southern District of New York. In December, District Judge John Keenan, overseeing the cases, ruled that femur fracture lawsuits over Fosamax should be handled separately, due to the differences between those cases and the Fosamax ONJ lawsuits.

A “black box” warning has been added to Baxter Healthcare and Cangene Corporations’ platelet deficiency drug, WinRho SDF, after the FDA determined the drug has caused a condition in some patients that led to lethal cases of anemia and multi-organ failure.

The FDA, Cangene and Baxter alerted health care professionals on Wednesday that some patients being treated for immune thrombocytopenic purpura (ITP) have died after taking WinRho SDF due to complications from intravascular hemolysis (IVH).

IVH can cause severe anemia, failure of the kidneys and other organs, and respiratory distress. WinRho SDF side effects have proven lethal in some patients, particularly those over the age of 65 with other life-threatening conditions.

ITP is a syndrome in which the patient has a decreased number of blood platelets due to the immune system attacking them with antibodies, which can lead to bleeding, easy bruising, or the leaching of blood from capillaries into the skin and mucous membranes. WinRho SDF was first approved in the U.S. by FDA in 1995, and is made from human plasma.

The black box warning, the most stringent labele warning that the FDA can mandate for a drug, warns health care professionals that patients should be closely monitored in a health care setting for at least eight hours after being put on the drug. It also recommends several urine analyses be performed over several hours.

The warning also includes a list of symptoms that patients should be aware of, which could indicate the onset of IVH, including:

• Back pain
• Shaking and chills
• Fever
• Discolored urine  

If symptoms arise, a battery of post-laboratory tests should be performed. A lack of symptoms in the first few hours does not mean that IVH will not occur at a later time. The drug carried a warning against IVH previously, but now that warning will be placed prominently on the label with a black border on all WinRho SDF packaging.

If symptoms arise, a battery post-laboratory tests should be performed. A lack of symptoms in the first few hours does not mean that IVH will not occur at a later time. The drug carried a warning against IVH previously, but now that warning will be highlighted by a black border on all WinRho SDF packaging.

Later this month, a panel of federal judges will hear additional arguments about whether to centralize more than 100 shoulder pain pump chondrolysis lawsuits filed in federal district courts throughout the United States by plaintiffs who allege that the use small pumps to infuse pain medication following arthroscopic surgery destroyed their shoulder cartilage.

When the U.S. Judicial Panel on Multidistrict Litigation meets on March 25, it will be the second time the panel has been asked to consolidate and centralize shoulder pump lawsuits for pretrial litigation. The panel rejected a previous request by plaintiffs in August 2008, saying that the number of different manufacturers of pain pumps and different medications used in the devices made coordination for pretrial litigation inappropriate. At that time, about 30 cases had been filed.

According to a hearing order issued last month, there are currently at least 104 cases pending in 27 different federal district courts in 20 states. Minnesota, Arizon and Oregon have the largest number of cases filed, and a group of plaintiffs have proposed that all of the federal cases be transferred to the U.S. District Court for the District of Minnesota for pretrial litigation.

All of the suits involve similar allegations that plaintiffs developed chondrolysis of the shoulder after their doctors used a pain pump to deliver a combination of pain medications directly into the shoulder joint via catheter during the days after surgery. Although the FDA has never approved the pumps for this purpose, plaintiffs argue that the manufacturers encouraged doctors to use the pain pumps instead of oral pain medications, without warning about the risk of these debilitating complications.

In November 2009, the FDA required manufacturers of the pumps and the local anesthetics to add new warnings about the risk of chondrolysis from should pain pumps. The recent warnings were designed to alert healthcare professionals that the use of pain pumps following shoulder surgery to infuse medication directly into the joint increases the risk of chondrolysis, particularly involving the shoulder.

If a multidistrict litigation, or MDL, is formed for the pain pump chondrolysis lawsuits, all of the cases will be assigned to one judge for pretrial proceedings to eliminate duplicate discovery, inconsistent rulings from different judges in different courts and to serve the convenience of the parties, the witnesses and the court.

The lawsuits could be costly for the medical device manufacturers if the first shoulder pump trial is any indicator. In January, a jury in Oregon ordered the maker of the I-Flow On-Q Painbuster shoulder pump to pay nearly $4.75 million to a man who developed the progressive loss of cartilage after he received the pain pump.

Hundreds of residents of a New Jersey town have filed a toxic tort lawsuit against E.I. DuPont and Royle Systems Group for allegedly releasing dangerous contaminants into the community around Pompton Lakes and refusing to clean up the mess. 

The Pompton Lakes, New Jersey environmental tort lawsuit was filed on March 4 in the Superior Court in Passaic County, N.J. More than 350 residents of the Passaic County borough are expected to eventually file claims involving allegations that DuPont and Royle caused homes to lose value and exposed residents to hazardous chemicals due to toxic releases from a munitions factor DuPont operated there from 1902 to 1994. Royle had an equipment manufacturing facility on part of the site from 1976 through 2009.

The claims are supported by New Jersey Department of Environmental Protection reports in 2008, which determined chemicals released by the facility into the local groundwater were vaporizing in the soil and then seeping into residents’ homes through the basements. In 1998, DuPont allegedly sent letters to residents saying there was no reason to suspect that there was vapor intrusion.

State environmental investigators have determined that residents in the area affected by the vapor intrusions have elevated rates of kidney cancer and non-Hodgkin’s lymphoma. Both health problems have been linked to PCE and TCE; chemicals used at the facilities to degrease machinery. However, the state said it could not make a direct causal link between the chemicals and the elevated cancer risks.

Since then, DuPont has agreed to install venting systems in Pompton Lake homes that would remove the vapors. The company is expected to submit plans for the installation of the systems in June.

Groundwater contamination from the facility has been confirmed by groundwater testing since the 1980s, and DuPont has been sued repeatedly by local residents who have used the courts to force the company to perform cleanup operations on the site.

The newest lawsuits claim that DuPont and Royle knew or should have known since the 1990s that there was risk of vapor intrusion by toxic chemicals released into the groundwater. They also claim that the companies took no real steps to remove or reduce the risk of exposure to residents.

A wrongful death lawsuit has been filed against nurses at the Memorial Hospital in Belleville, Illinois, alleging that they ignored numerous complaints from a woman who eventually died due to complications with a respiratory infection. 

The nurse negligence lawsuit was filed last month in St. Clair County Circuit Court by Cletus Schmittling, whose wife, Carole Schmittling, died at the hospital on February 12, 2008. The lawsuit names the hospital and nurses Josefina Nance and Cathy Allen as defendants.

Schmittling was a resident of the Memorial Convalescent Center, which is managed by the hospital, when she began to show signs of a respiratory infection, according to a story in the St. Clair Record. In early 2008, she made numerous complaints to the nursing staff about her health, but the lawsuit alleges that those complaints were ignored.

The litigation claims that Scmittling, in the span of three days, from January 24 through 26, complained that she had been coughing up blood, that she was too tired to perform physical therapy, that she felt ill and that she feared that a previous respiratory infection was returning. Nurses indicated that her blood oxygen level dropped from 97% to 92%, and that she had a temperature that ran as high as 100 degrees. Cletus Schmittling also alleges that he complained to the nurses about his wife’s health.

He accuses the nurses at the hospital of medical malpractice for ignoring his wife’s complaints and failing to report her declining condition to her doctor. The lawsuit says that Scmittling was suffering from Acute Respiratory Distress, which the nurses should have recognized and reported to her doctor.

The lawsuit charges the nurses and the hospital with negligence, and seeks compensatory damages in excess of $150,000.

Researchers are ready to move forward with additional testing of a possibly vaccine for mesothelioma cancer after a new study indicates that the experimental drug was safe for human use. 

The investigational vaccine was tested by researchers in the Netherlands, who examined the drug’s effect on 10 patients and determined that it induced an immune system response to mesothelioma tumors. The results of the study were published in this month’s edition of the American Journal of Respiratory and Critical Care Medicine.

Mesothelioma is a rare form of cancer found in the lining of the chest and lung. The only known cause of mesothelioma is asbestos exposure, and it is often not diagnosed for 20 to 40 years after exposure. As a result of the long latency period, the cancer is very advanced when it is diagnosed and life expectancy with the disease is limited.

The investigational vaccine takes antigen from a mesothelioma patient’s tumors and infuses it into the patient’s own dentritic cells, which are a type of immune system cell. Researchers say that they hope to be able to increase survival time in patients with mesothelioma, and eventually would like to develop a full vaccine for people who have are at risk of developing mesothelioma due to asbestos exposure.

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 United States in the mid-1980s. Despite the ban, the U.S. Centers for Disease Control and Prevention says that the number of mesothelioma deaths continues to rise each year due to the latency period, with the number expected to peak in 2010.

Asbestos litigation is the longest running mass tort in U.S. history, with the first asbestos exposure 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.

Class action litigation springing from Toyota recalls over unintended acceleration could end up costing the company $3 billion or more, according to an Associated Press report.

The Japanese automaker currently faces at least 89 Toyota class action lawsuits sparked by recalls involving problems with Toyota gas pedals and brakes. An analysis done by the Associated Press estimates that the company’s legal bills on those cases alone could top $3 billion, and that does not include the costs of a number of individual Toyota accident personal injury lawsuits, product liability lawsuits and wrongful death lawsuits that have also been filed against the company.

Toyota has recalled about 9 million Toyota and Lexus vehicles since September 2009. About 8.5 million of those vehicles were recalled due to problems with sudden acceleration, which the National Highway Transportation Safety Administration (NHTSA) says have been involved in as many as 52 deaths. More than 400,000 additional Toyota Prius and Lexus HS250h vehicles have also been recalled due to brake problems.

The Toyota class action suits, which could represent as many as six million different Toyota owners, allege that the company misrepresented the value of its vehicles by concealing the accelerator problem from consumers and investors. The lawsuits say that, as a result, the resale value of their Toyota and Lexus vehicles has plummeted. Toyota resale values are often used as a selling point of the company’s vehicles. If the company has to pay Toyota owners even as little as $500, the cost could quickly balloon in to the billions.

Later this month, the U.S. Judicial Panel on Multidistrict Litigation will decide whether to consolidate all federal lawsuits against Toyota into a multidistrict litigation (MDL), where the cases will be centralized in one federal court for pretrial litigation.

Last month Toyota became the target of probes by both federal prosecutors and the Securities and Exchange Commission (SEC). Both federal investigators and the SEC are looking into how the company reacted to complaints about Toyota accelerator problems, and are questioning whether the company attempted to cover up or downplay the seriousness and number of incidents being reported.

The company’s woes over the gas pedal problems may not end there. Many critics have said that the Toyota acceleration problem is due to an electronics flaw, which the company has denied. It has developed fixes for the problems that included replacing floor mats and installing devices to prevent the pedal from getting physically stuck due to friction. However, the NHTSA says it has received at least 60 reports from Toyota owners who received the fixes, but are still suffering from sudden acceleration problems.

The FDA is refusing to reverse a warning about loss of smell from Zicam, which led to a recall last summer for the over-the-counter cold remedy’s nasal sprays and gels.

According to a regulatory filing with the Securities Exchange Commission (SEC) filed by Matrixx Initiatives, Inc., the makers of Zicam, the FDA is standing by their position that zinc-based Zicam nasal sprays and gels put users at risk for losing their smell, a condition known as anosmia. The FDA reaffirmed their position after Matrixx filed a response in November 2009 to the original warning letter.

On June 15, 2009, the FDA recommended that consumers stop using Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs Kids Size after the agency identified at least 120 reports of people who lost their sense of smell. Within hours of the warning, Matrixx Initiatives issued a Zicam recall.

In the aftermath of the recall, FDA inspectors discovered 800 reports of Zicam problems that Matrixx Initiatives failed to forward to the agency, in violation of federal regulations.

At the time of the recall for Zicam, the FDA indicated that Matrixx Initiatives would not be permitted to market the cold remedy until they submit data establishing that they are safe and effective. Zicam was not approved by the FDA when it was first introduced, as it was classified as a homeopathic product, which is a designation usually reserved for herbal remedies. However, once the health concern was identified, the FDA was able to force the company to have the product approved, regardless of classification.

The company has twice asked the FDA to retract the warning, most recently in November, saying that they do not believe the products pose a danger. The FDA has refused both times. Matrixx Initiatives officials say they are weighing their remaining options.

Matrixx Initiatives faces a number of Zicam class action lawsuits and Zicam injury lawsuits that allege the company knew the products were dangerous and continued to market them anyway. The company also faces lawsuits from investors who say that the company falsely represented its products by hiding the anosmia complaints. The SEC is also investigating the company’s actions.

In October, the U.S. Judicial Panel on Multidistrict Litigation consolidated the federal Zicam litigation for pretrial proceedings in the District of Arizona. All of the lawsuits over Zicam contain similar allegations that zinc gluconate, the single active ingredient in nasal Zicam cold remedies, is toxic to the tissue inside the nose and can cause damage to a user’s ability to smell, detect odors or taste.

Federal regulators are preparing to issue a warning to parents about potential baby sling problems after receiving reports that at least seven babies have suffocated in the harness-like devices.

U.S. Consumer Product Safety Commission (CPSC) Chairman Inez Tenenbaum said on Tuesday that the agency would issue a warning on the safety of all baby slings sometime later this week.

“We know of too many deaths in these slings and we now know the hazard scenarios for very small babies,” Tenenbaum said. “So, the time has come to alert parents and caregivers.”

The seven infant baby sling suffocation deaths have occurred over the last 11 years, and there have been other deaths of infants in slings that have been classified as Sudden Infant Death Syndrome (SIDS), which generally refers to unexplained infant deaths. This year, according to Consumer Reports, at least two infants have suffocated in baby slings manufactured by Infantino of San Diego, California.

The Infantino baby sling deaths include 6-day-old Derrick Fowler of Oregon, who suffocated against his mother while she was shopping, and a 7-week-old boy from Philadelphia who also suffocated while in the sling being held by his mother. In both cases, the mothers were unaware that their infants were in trouble until they looked into the sling to check on them.

Consumer Reports placed the baby slings on its list of products parents should not buy for their babies in April 2009, saying that the bag-like shape of the slings can lead to the infant’s smothering without the mother being aware of it. At that time, there were only four suffocation deaths known to be connected to the use of the slings.

In 2007, CPSC announced an Infantino SlingRider baby sling recall due to the risk of the straps breaking. The recall was issued after the company received eight reports of children falling out of the slings. One of the infants suffered a fractured skull. Chairman Tenenbaum did not say that the upcoming baby sling warning would specify any one baby sling product.

Another 169 former patients of Dr. Mark G. Midei who received a stent implant at St. Joseph Medical Center in Towson, Maryland have been informed that they may have undergone a procedure they did not need.

After notifying 369 patients about unnecessary stent procedures by Dr. Midei late last year, St. Joseph Medical Center confirmed Tuesday that additional letters were sent last month, according to a report in the Baltimore Business Journal. This brings the total number of confirmed unnecessary stent implants by Dr. Midei to 538, and many anticipate that more St. Joseph stent letters are likely to be sent as other procedures are reviewed.

The letters inform former St. Joseph patients that their coronary stent procedure may not have been needed, even though they were told by Dr. Midei that the stent was implant because of severe coronary blockages. The stent surgery problems at St. Joseph Medical Center were uncovered as part of an on-going federal investigation of Medicare fraud and other health law violations involving the financial relationship between the hospital and an affiliated group of cardiologists. While St. Joseph hospital initially denied that any patient care was impacted, they are no longer making such statements, and have since started reviewing all procedures performed by Dr. Midei between May 2007 and 2009.

Dr. Midei, who led the hospital’s cardiac catheterization unit, has denied any wrongdoing. The hospital stripped him of his position at the hospital last summer without explanation, and at least three other executives have left their jobs amid the investigation.

The stent procedures, which are designed to prop open arteries that are significantly blocked, can cost $10,000 or more. Typically it is necessary for there to be at least a 70% artery blockage for a stent implant to be necessary, and many patients who have received these letters were originally told that they had blockages over that amount. However, after a subsequent review of records from the procedure, many of the patients were found to have blockages that were well under 50%, which is generally considered “insignificant.” Some patients who received stents had blockages as low as 10%.

St. Joseph coronary stent lawsuits have been filed by individuals and the hospital also faces a stent surgery class action lawsuit seeking to force the hospital to pay for a review of patient records and to impose certain requirements on the hospital before they can perform stent procedures.

A Louisiana jury has issued a $1.2 million verdict on behalf of 16 workers who filed a radiation exposure lawsuit against Exxon Mobile Corp. 

The lawsuit was filed by Louisiana employees of Intracoastal Tubular Services (ITCO) who were contracted to clean used oil drilling pipes for Exxon. The plaintiffs claimed that the pipes had naturally occurring radioactive material in them that increased the workers’ risk of developing cancer, according to report by Bloomberg News.

The employees worked on the site near Harvey, Louisiana between 1977 and 1992, and the owner of the property successfully sued Exxon in 2001 for radioactive contamination connected to the pipe cleaning work. Originally, a jury hit Exxon with $1 billion in punitive fees in the 2001 lawsuit, but that was later reduced to $112 million, which Exxon paid with interest after failed attempts at an appeal.

The lawsuit by the 16 workers included allegations that Exxon failed to warn them of radiation danger because the company feared that the property would be reclassified as a hazardous waste site, which could have cost Exxon hundreds of millions of dollars.

The Gretna, Louisiana jury’s decision awarded the plaintiffs between $10,000 and $175,000 each after a five-week trial. None of the workers have been diagnosed with a radiation-related illness. The lawsuits were filed over Exxon allegedly exposing them to increased risk. The company has settled several claims by workers who actually developed cancer or other radiation exposure health problems.

The jury rejected plaintiff requests to issue punitive damages or to force the company to pay $1.3 million for future medical monitoring.