Author: AboutLawsuits

The United Kingdom’s medical agency will begin reviewing potential problems with metal-on-metal hip implants, due to growing concerns that they may cause non-cancerous tumors, swelling and other hip damage.  

The Medicines and Healthcare Products Regulatory Agency (MHRA) is expected to announce an official review of metal hip implants this week.

European health officials say that it appears that metal particles may shed into the body as a result of wear and tear on the implants, potentially causing the growth of non-cancerous tumors in the surrounding tissue, particularly in young women. Metal hip replacement problems also appear to cause damage to sinew and tissue in the areas where they are shed, reviewers say.

There are about 40,000 people in the U.K. who have received metal-on-metal hip replacement implants. The MRHA is expected to announce that any considered at risk will be given a blood test looking for high levels of metal compounds in their blood; a sign that their metal-on-metal hip implant may be shedding debris. If the high levels are found, it is possible they will have their implant replaced.

Health care professionals have increasingly been warning about metal-on-metal hip implant complications. The particles can damage soft tissue, cause inflammatory reactions and lead to bone loss. They are also concerned that many of them do not seem to settle correctly into the ball-and-cup arrangement, leading to pain and discomfort for implant recipients.

Last month, reports linked a particularly high failure rate to the DePuy ASR metal hip replacement system, which is now set to be phased off of the market. In the U.S., the FDA has received about 300 complaints of DePuy ASR hip problems since the beginning of 2008. Most of those involved situations where patients required additional surgery to replace the DePuy ASR hip implant.

Attorneys in the U.S. are now reviewing the potential for DePuy ASR metal hip replacement lawsuits for people who have suffered complications due to defective DePuy ASR implants.

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. In 2008, the MRHA determined that some metal-on-metal hip implants could lead to genetic damage.

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, in a recent editorial in the Journal of Arthroplasty, doctors were warned to avoid the use of metal hip implants, and said they should only be used “with great caution.”

Several major insurance companies say they may seek compensation from Toyota Motor Corp. for old accident claims where sudden acceleration problems with Toyota or Lexus vehicles may have been a factor. 

State Farm Insurance Cos., Allstate Corp, Geico and other major insurers say they may request that Toyota cover the cost of some of the accident claims dating back several years, which could allow them to reimburse drivers for deductibles paid in those cases. The move could cost Toyota millions, and comes as the company has agreed to pay a $16.4 million criminal fine for allegedly covering up the problem.

Insurers say they are going back through old accident files and finding incidents where drivers of vehicles that have been subject to a Toyota recall for sudden acceleration problems claimed that their vehicles sped out of control. Those accidents took place before insurers realized there was a defect in the vehicles.

Toyota has recalled nearly 9 million vehicles since September 2009, with 8.5 million recalled due to complaints that they can accelerate out of control. The acceleration recalls were done in waves, starting with 4.2 million recalled for problems involving the floormats, and then later recalls indicated that there was a mechanical or electrical problem with the gas pedals.

When insurers discover that defective vehicle problems are a key factor in an accident, they can request that the auto maker reimburse them for the claim, a practice known as subrogation. If the insurance company is successful obtaining reimbursement, they would then reimburse their insureds for any deductibles that may have been paid in the claims. However, this will likely be limited to limited to minor accident claims for property damage, as major Toyota accidents involving a personal injury from a defective vehicle would likely require a lawsuit to obtain reimbursement.

The gas pedal problems have resulted in a number of Toyota consumer class action lawsuits, Toyota injury lawsuits and Toyota wrongful death lawsuits filed by family members of people allegedly killed when their vehicles accelerated out of control. Earlier this month a number of federal Toyota lawsuits were consolidated and centralized as part of a multidistrict litigation (MDL) for pretrial proceedings in the U.S. District Court for the Central District of California. U.S. District Judge James Selna has scheduled the first MDL conference for May 13. Some estimates place the number of overall lawsuits against Toyota in state and federal courts at about 200.

In addition to the lawsuits, the U.S. Department of Transportation fined the company $16.4 million, accusing the Japanese automaker of covering up the problem for months; an accusation supported by what the government says are internal documents showing the company knew about the problems but waited before alerting the government and consumers. The company announced today that it intends to pay the fine.

A lawsuit was filed last week in Maryland by the families of two coal miners who were killed in a 2007 mine collapse.

The Maryland wrongful death lawsuit was filed in Allegany County Circuit Court by the families of Michael Wilt, 38, and Dale Jones, 51. The two men died in a high-wall collapse at Tri-Star Mining Inc. in Barton, when they were buried under 93,000 tons of rubble. It took rescue workers three days to recover their bodies.

The claim names as defendants several employees of Tri-Star Mining Inc., including owner George Beener; the land owner, BTC Developments, also owned by Beener; BTC Trucking; Dugan Associates, a consulting firm for the mine; Western Maryland Associates, which handled ground control planning and surface mine applications for the mine; Highland Engineering & Surveying Inc., which mapped the mine; and Bituminous Safety Services, Inc., which provided safety training programs for the miners.

The $8 million lawsuit charges the defendants with negligence, saying that the miners were told that it was safe to work at the base of the 275-foot high sheer wall created by strip mining in the pit. The company received multiple citations following the accident from the U.S. Mine Safety and Health Administration (MHSA) for failing to complete an inspection of the wall. The lawsuit alleges that if the inspection had been completed, it would have shown that the wall was unstable, and that its condition had been worsened by four days of raining before its collapse.

Tri-Star agreed in May to pay $105,000 in fines for six violations, which included criticisms of negligence from federal reviewers.

The lawsuit comes as national attention has focused on mine safety following a deadly explosion at Massey Energy Co.’s Upper Big Branch mine in West Virginia, which killed 29 people. A wrongful death lawsuit has already been filed in connection to the fatal mining accident by Marlene Griffith, the wife of William Griffith, one of the workers that died in the accident.

Federal investigators have found more than 60 serious safety violations at the company in just the one week since that explosion.

The FDA is considering whether to stop a diabetes drug safety trial due to concerns over the heart risks with Avandia, according to a report in the Wall Street Journal. The decision about whether to halt the trial will likely be linked to the agency’s view on the safety of the drug, and there is speculation that it may be a prelude to an Avandia recall.

FDA Commissioner Margaret Hamburg sent a letter to U.S. Senator Charles Grassley last week saying that the FDA is considering shutting down a comparative study on the side effects of GlaxoSmithKline’s Avandia and Takeda Pharmaceutical’s Actos diabetes drugs over concerns about the ethics of continuing the trial. If the study is shut down because the FDA deems exposing clinical subjects to potential Avandia health problems is unethical, it is an indicator that the FDA could recall Avandia for the same reasons.

According to the letter, first reported by the Wall Street Journal, the FDA has not yet made a decision on the clinical trial, called TIDE, which is comparing the two drugs’ heart risks. FDA officials have said that canceling the trials cannot be “de-linked” from the FDA’s view on the safety of Avandia, suggesting that if the trials are halted, the FDA may ask Glaxo to pull Avandia from the market.

Avandia (rosiglitazone) was approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years as concerns have mounted about the risk of serious and potentially life-threatening heart risks with Avandia. Some experts estimate that Avandia has caused between 60,000 and 200,000 heart attacks and deaths due to cardiovascular problems in the U.S. from 1999 to 2006.

A recent U.S. Senate report determined GlaxoSmithKline knew that Avandia caused heart problems, but failed to inform the U.S. drug regulators. The Senate report also revealed that some FDA drug safety reviewers have been calling for an Avandia recall since 2007. Senator Grassley is the ranking member of the Senate Finance Committee which issued the report after a two year investigation.

Concerns about the risk of heart problems with Avandia first gained widespread attention in May 2007, when a meta-analysis of 42 different clinical trials was published in the New England Journal of Medicine, suggesting that users of Avandia had a 43% increased risk of a heart attack.

In the United States, GlaxoSmithKline PLC currently faces thousands of Avandia lawsuits filed by former users of the drug who allege that the drug company failed to adequately research their medication or warn users about the serious side effects. Federal Avandia litigation has been consolidated into an MDL, or Multidistrict Litigation, for pretrial litigation in the U.S. District Court for the Eastern District of Pennsylvania, where the first trials are expected to begin later this year.

The number of illnesses from E. coli food poisoning dropped 12% in 2009, dipping to a five year low according to newly released federal statistics. 

The U.S. Centers for Disease, Control and Prevention (CDC) announced the decline in cases of E. coli on Thursday in a new report on 2009 food poisoning rates. The CDC said the drop brought E. coli poisoning incidents to their lowest numbers since 2004.

The CDC looked at nine different foodborne pathogens in the United States. While most remained flat, sickness from eating foods contaminated with E. coli O157:H7 dropped 12%. There was also a major drop in the number of illnesses caused by shigella bacteria, which is harder to track because it is believed that only about 20% of shigella illnesses are caused by contaminated food.

Federal health officials tracked food poisoning cases through data from 10 states collected by the Foodborne Diseases Active Surveillance Network, or Foodnet. The network has found that E. coli O157:H7 and Shigella illnesses have declined 41% and 55%, respectively, since it first started tracking foodborne illnesses in 1996. Salmonella food poisoning has only had a moderate decline of about 10% over the same time period.

CDC officials say that the decrease in E. coli illnesses is most likely due to improved safety measures in the meat and produce industries. E. coli O157:H7 is of particular concern because up to 10% of food poisoning from that particular strain of E. coli results in kidney failure.

E. coli O157:H7 is one of the more common causes of food poisoning in the United States. When left untreated, it can lead to dehydration and potentially life-threatening illness. While most healthy adults recover within a few week from E. coli food poisoning, young children and the elderly could be at risk for more severe illness. If the toxin enters the blood stream, E. coli could also lead to kidney failure known as Hemolytic-Uremic Syndrome (HUS).

The CDC reports that there are about 76 million cases of food-related illnesses reported every year, with more than 300,000 people hospitalized and 5,000 deaths. There were at least nine major recalls of beef products in 2009.

 A Virginia jury has awarded $6 million to the estate of a U.S. Navy officer who died of mesothelioma from asbestos exposure.

The wife of Petty Officer Robert Hardick filed the lawsuit over mesothelioma against John Crane Inc. and Garlock Sealing Technologies for Hardick’s death in March 2009. According to a report by the Newport News Daily Press, Hardick contracted mesothelioma from breathing asbestos fibers while serving on the U.S.S. Newport News, a Des Moines-Class heavy cruiser, and other ships from the 1950s through the 1970s.

The wrongful death lawsuit claims that the asbestos fibers were contained in parts provided to the Newport News Naval Shipyard by Garlock and John Crane. The Newport News Circuit Court jury divided the $6 million award between the two companies.

Mesothelioma is a rare and fatal form of cancer that is found in the lining of the chest and lungs. The only known cause of mesothelioma is asbestos exposure, and it is often not diagnosed until decades 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.

Asbestos was widely used in a variety of manufacturing and construction applications throughout the last century, particularly shipbuilding, with use peaking in 1973. Most uses of asbestos were banned 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 mesothelioma lawsuits are 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.

The U.S. Securities and Exchange Commission (SEC) has filed a lawsuit against Goldman, Sachs & Co. charging the financial institution with fraud for allegedly selling investors subprime mortgage securities that were doomed to fail. 

The SEC filed the Goldman Sachs fraud lawsuit on April 16 in U.S. District Court for the Southern District of New York, following an investigation that started in August 2008. The SEC claims that fraud involving Abacus investment products lead to at least $1 billion in losses and many analysts predict that the charges will lead to a number of financial fraud lawsuits from investors who may be entitled to a recovery.

According to the SEC, Goldman Sachs created a synthetic collateralized debt obligation (CDO), called Abacus 2007-AC1, which was backed by subprime mortgage securities. The SEC claims that Goldman Sachs said that the securities were selected by a third party called ACA. However, the SEC says that Paulson & Co., a hedge fund that was betting on the failure of subprime mortgage securities, heavily influenced which securities went into the portfolio.

The charges claim that Paulson picked securities doomed to fail, and Goldman Sachs packaged them and sold them to unwitting investors. Paulson bet on the securities failing and made $1 billion. Those who bought into Abacus on the belief that it was a sound investment lost about $1 billion.

Goldman Sachs pocketed about $15 million from Paulson in the deal, the SEC alleges. The Royal Bank of Scotland and IKB, a German bank, were the two investment banks who lost the most from the deal, various media sources reported over the weekend.

The SEC says that the deal was primarily structured by Goldman Sachs vice president Fabrice Tourre, who allegedly knew that Paulson was structuring its investment plans based on the belief that the securities it chose for the portfolio would fail. Tourre closed the deal with Paulson to create Abacus on April 26, 2007, the SEC claims. By late October, 83% of the securities in the CDO had been downgraded. By the end of January 2008, 99% had been downgraded.

“The product was new and complex, but the deception and conflicts are old and simple,” said the SEC’s Director of Enforcement, Robert Khuzami. “Goldman wrongly permitted a client that was betting against the mortgage market to heavily influence which mortgage securities to include in an investment portfolio, while telling other investors that the securities were selected by an independent, objective third party.”

Goldman Sachs released a statement after the charges were released denying all of the SEC’s claims. The company claims it lost $90 million in the deal and fully disclosed Paulson & Co.’s involvement.

The FDA is allowing several heart implants to go back on the market after a temporary recall of Boston Scientific defibrillators was issued last month due to unannounced manufacturing changes. 

The FDA said last week that Boston Scientific could resume sales of its implantable cardiac defibrillators (ICDs) after a 30-day review of the products. In March, Boston Scientific announced that it had inadvertently failed to inform the agency of two manufacturing changes in the devices, resulting in the recall. The action has sparked investigations by the Department of Justice (DOJ) and the Securities Exchange Commission (SEC).

Prior to the recall being issued, Boston Scientific was already under a legal cloud for earlier actions of its Guidant subsidiary, which recently plead guilty to DOJ charges that it attempted to cover up problems with defective defibrillator implants by not informing the FDA of design changes meant to fix flaws that were sometimes fatal to implant recipients. The company will pay a record $296 million medical device manufacturing criminal fine.

ICDs are implants that monitor patients for abnormal heart rhythms and deliver electric shocks to keep the heart beating at the proper rhythm. Boston Scientific said it issued the most recent ICD recall after it realized that it had made two manufacturing changes that were not approved by FDA, which is a regulatory requirement. Boston Scientific described the incident as a clerical oversight and said that there had been no safety issues related to the changes. The FDA must approve the changes before the devices can be put back on the market.

Boston Scientific announced what it said was an oversight in mid-March, sparking th 30-day review by FDA of the company’s documentation on the ICDs and the changes they made. After the review was complete, FDA has allowed the ICDs to go back on the market. However, the FDA reportedly found other issues and instances of oversights in how the company handles ICD manufacturing during the review. These issues are likely to be expressed in a future warning letter from FDA.

A settlement has been reached by parties involved in a fentanyl patch lawsuit stemming from the fatal overdose of an Illinois man on the powerful painkiller. 

Leigh Ann Cruse filed the wrongful death lawsuit in Madison County Circuit Court against a number of fentanyl pain patch manufacturers in 2007, including Johnson & Johnson, Janssen Pharmaceutical Products, and Alza Corporation. Cruse alleged that the companies were responsible for the death of her husband, Cliff Cruse, who died in April 2006 from a fentanyl overdose after using the pain patches for about a month.

The lawsuit originally included Tri-City Neurology Associates Ltd. and Dr. Syed Ali of Granite City as defendants, however they were dismissed from the lawsuit last month, according to a story in the St. Clair Record.

The fentanyl patch contains a powerful fentanyl gel, which is 100-times stronger than morphine. The gel is supposed to be contained within the patch and delivered in a regulated fashion through a membrane placed on the skin. The original Duragesic patch was designed and distributed by Johnson & Johnson, but the pain patch is now available from a number of generic drug makers.

The FDA has received reports of hundreds of fentanyl overdoses and deaths associated with the use of the Duragesic patch and generic pain patches. The deaths have been caused when too much of the medication was delivered through the membrane or as a result of manufacturing defects which allowed the fentanyl gel to leak directly onto the skin.

Cruse’s lawsuit charged the defendants with strict product liability, negligence, breach of warranty, among other claims. The case was scheduled for trial to being on April 19, and the parties reached a settlement of the fentanyl patch lawsuit on April 9. Terms of the agreement have not been disclosed.

Out of the first four fentanyl patch wrongful death lawsuits against Johnson & Johnson to go to trial over problems with their Duragesic patch, plaintiffs have been successful in each case, with juries awarding a combined total of more than $36 million in damages.

The findings of a new scientific study suggest that low levels of exposure to lead, far short of what is considered lead poisoning, could delay puberty in boys. 

The study was published online by the medial journal Pediatrics earlier this month. While the effects of delayed puberty on an individual level was only a few months, researchers said it could push more boys into the category of a “clinical delay” – puberty that does not start until age 13 or later – which could lead to depression, low self-esteem and eating disorders.

Researchers enrolled 489 Russian boys from 2003 through 2005, starting at ages 8 to 9, and monitored them through May 2008. They determined that the onset of puberty occurred six to eight months later in boys who had more than 5 milligrams per deciliter of lead in their blood.

The U.S. Centers for Disease Control and Prevention (CDC) consider 10 milligrams of lead per deciliter of blood to be the level of concern for exposure to lead. The CDC estimates that approximately 250,000 children in the U.S. have blood lead levels that high or higher.

One of the more common causes of lead exposure in the United States is lead paint, which was banned in 1978 due to the risk of severe and permanent brain damage and developmental problems, particularly in children. However, a number of older homes still contain the toxic paint on the walls, and if it flakes or peals off, young children could ingest the paint chips or breathe dust that comes from the paint, resulting in lead poisoning.

Lead paint poisoning can result in nervous system injury, brain damage, seizures or convulsions, growth or mental retardation, coma and even death for young children. Lawsuits over lead poisoning have been filed against landlords and property owners who failed to correctly clean up remnants of lead paint or properly minimize lead exposure to children living in their properties.

While high levels of lead exposure are often the focus of scientists, recent research has highlighted the effects of even low levels of exposure to lead on children. Other studies have tied low lead exposure to the development of kidney damage and depression and panic disorders.

The results of a new study seem to confirm that side effects of some drugs used to treat epilepsy and depression, such as Neurontin, Lamictal and other medications, may increase the risk of suicide. 

The epilepsy drug suicide study was published in the April 14 issue of the Journal of the American Medical Association (JAMA), backing up a 2008 determination by the FDA that anticonvulsants can double the risk of suicidal thoughts and attempts. The drugs are often prescribed “off-label” for unapproved uses such as the treatment of migraines, depression and bipolar disorder; conditions that already carry a higher risk of suicide.

Researchers from the U.S. took data from the HealthCore Integrated Research Database, which keeps extensive records on drug prescriptions and adverse side effects, and looked at about 300,000 patients ages 15 or older who took anticonvulsant medications between July 2001 and December 2006. The researchers found an increased risk of suicide among users of the anticonvulsants Neurontin, Lamictal, Trileptal, Gabitril and valproate when they compared them to the use of Topamax, an older anticonvulsant.

Researchers found a total of 868 suicidal acts or violent deaths among the users, including 801 attempted suicides, 26 suicides that ended in death and 41 violent deaths. They did not track suicidal thoughts and tendencies in the study. However, the findings do add weight to the FDA’s own investigations into the suicidal effects of anticonvulsants. In 2008, the FDA required Neurontin and similar epilepsy drugs to begin carrying label warnings alerting users to the risk of suicidal thoughts.

Despite the results, scientists have cautioned that the suicides are comparatively rare and that epilepsy patients should not stop taking the medications.  

The results of the study come just days after Pfizer settled a neurontin suicide lawsuit for about $400,000, which alleged the drug maker failed to adequately warn about the risk. In another recent case, Pfizer was found guilty of illegally promoting Neurontin for off-label uses, and ordered to pay $142 million in damages in a case brought by the Kaiser Foundation Health Plan Inc., a subsidiary of Kaiser Permanente.

A Baltimore City Circuit Court jury has awarded $7.4 million in a wrongful death lawsuit brought against three Baltimore police officers. 

The lawsuit was filed by the family of Dondi Johnson, Sr. 43, who died from complications from a fractured spine in 2005 after a ride in a police van while not wearing a seatbelt. The family claims that Baltimore Police Officer Nicole Leake drove the van recklessly, and also named officers Sendy Ferdinand and Michael Riser as defendants, saying the officers failed to properly strap Johnson into the van.

Johnson was arrested in November 2005 for public urination and the police officers placed him in handcuffs and put him in the van to be taken to the Central Booking and Intake Center in Baltimore City. During the drive, police officers say they stopped at the Northwest District station to allow Johnson to use the restroom. However, when they opened the van they found Johnson on the floor.

Johnson told the officers that he was in pain and took him to Sinai Hospital. He died two weeks later, suffering from a fractured spine.

The lawsuit by his family sought $100 million from the three police officers, and did not name the city as a defendant. The jury ruled that Ferdinand and Riser were negligent in their arrest and detainment of Johnson, and said that they should have just issued Johnson a citation. The jury found Leake to be grossly negligent in her driving of the van.

The jury awarded the family $7.4 million. It is unclear whether the city will pay the settlement or if it will make the officers pay. There have been no disciplinary actions taken against the three officers, and the city has not decided whether it will appeal the verdict, city officials told the Baltimore Sun.

The FDA is requiring Bayer Healthcare to update it’s marketing and advertisements for Yaz and Yasmin birth control pills to reflect new information about the risk of blood clots from Yaz and Yasmin that was recently added to the warning label. 

In an FDA letter to Bayer (PDF) approving new information the drug maker added about the relative risk of blood clots in women using Yasmin or Yaz compared to those using oral contraceptives that contain older progestins, the agency told Bayer that they must also promptly revise all promotional materials. The FDA indicates that the revisions must include “prominent disclosure of the important new safety information.”

Yaz and Yasmin are two similar birth control pills that are both manufactured by Bayer, containing drospirenone, a new “fourth” generation progestin. The drug maker faces a number of Yaz lawsuits and Yasmin lawsuits that allege the drug maker failed to adequately warn about the side effects of drospirenone, which could result in elevated potassium levels and lead to a condition known as hyperkalemia. In complaints, the newer type of progestin used in the birth control pills has been cited as the likely cause of an increased risk of blood clots and other serious side effects of Yaz and Yasmin.

A similar update to the Yasmin and Yaz warning label was made in Europe last month, to add information from studies that suggest the pills may carry a higher risk of blood clots than some other types of oral birth control that contain different type of progestin.

How Bayer advertises Yaz has been under close scrutiny by FDA since the company was cited for running deceptive ads that made unsubstantiated claims while drowning out information about the potential side effects with loud music. Early last year, Bayer was forced to run a $20 million corrective advertising campaign and is now required to submit any future Yaz advertisements to the FDA for approval before they are aired.

The U.S. Judicial Panel on Multidistrict Litigation has once again denied a request to consolidate and centralize all shoulder pain pump lawsuits, saying that despite the growing number of cases, there is not enough commonality to have the federal litigation transferred to one court for coordinated management. 

More than 100 shoulder pump chondrolysis suits have been filed in federal courts throughout the country against the manufacturers of disposable pain pumps, including I-Flow Corp., Stryker Corp., DJO, Inc., and other companies. They all involve similar allegations that the intra-articular use of pain pumps to deliver a combination of pain medications during the days after surgery can cause the progressive destruction of shoulder cartilage, causing new shoulder problems and potentially resulting in the need for shoulder replacement surgery.

Although the MDL panel rejected a similar motion to centralize the shoulder pump litigation in August 2008, when there were about 32 cases pending, a new motion was filed earlier this year, asking the panel to transfer the cases to one court for coordinated handling to avoid conflicting scheduling orders and rulings in the different courts where the cases are pending. However, the panel again rejected the request to establish a multidistrict litigation (MDL), saying the cases reflect lawsuits against a variety of different pain pumps made by a number of manufacturers using various different medications.

“Although the number of related actions has certainly grown, the issues that weighed against centralization in that earlier docket remain,” the panel explained in its decision. “An indeterminate number of different pain pumps made by different manufacturers are still at issue, as are different anesthetics made by different pharmaceutical companies.”

The panel said that individual issues of causation and liability are likely to overwhelm any efficiency that would be gained by consolidating the cases. The decision means that shoulder pump claims will proceed as individual cases, but some courts have consolidated small groups of cases.

The cases involve allegations that plaintiffs developed shoulder chondrolysis from the ambulatory pain pumps, which is a rare condition that involves the progressive loss of cartilage in the shoulder joint. Research has suggested that the intra-articular use of the pumps to deliver a combination of medications to manage pain after arthroscopic shoulder surgery, could cause this painful and debilitating condition. The cartilage damage is permanent, resulting in severe limitations on range of motion and use of the shoulder. In many cases, individuals who develop chondrolysis require a total shoulder replacement surgery.

The panel’s decision follows a January trial victory for plaintiff Matthew Beale against I-Flow Corp. An Oregon jury awarded Beale $4.75 million in a lawsuit that claimed that the On-Q Painbuster destroyed cartilage in his shoulder.

Earlier this month, it was reported that I-Flow settled five similar lawsuits as trial was set to begin, after it failed to get them dismissed by a federal judge in Ohio. The details of the settlements have not been disclosed.

In November 2009, the FDA required manufacturers of the pumps and the local anesthetics used with the devices 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.

A wrongful death suit has been filed against the Internal Revenue Service (IRS) by an Indiana man who claims that his wife committed suicide after being inappropriately targeted by a raid. 

The suicide lawsuit was filed by James Simon, 57, in U.S. District Court in Fort Wayne in February. On Tuesday the government responded to the lawsuit, saying that it was not responsible for his wife’s death.

According to the complaint, Denise Simon, 50, committed suicide on November 9, 2007. Records from the Allen County Coroner’s Office determined that the suicide was done via intentional carbon monoxide poisoning. Her death came three days after armed and armored IRS agents allegedly raided the Simon home while she was getting their daughter ready for school. James Simon, who maintains a residence in the Ukraine, was out of the country at the time of the raid.

Simon is involved in the telecommunications and satellite industry, and was part of a company known as Rimsat which went bankrupt in the 1990s after a satellite disagreement with the Russian Federal Space Agency. In 2007, his activities came under investigation by the IRS into farm subsidies, leading to a search warrant and raid on his home.

In a suicide note allegedly written by Denise Simon, she wrote that she was innocent of the charges, but had no faith in the legal system. Simon was a former president of the Fort Wayne chapter of the American Red Cross and a former board member of Stop Child Abuse and Neglect.

Simon charges that the IRS misstated facts in order to obtain a search warrant, invaded the family’s privacy, and caused intentional and unnecessary emotional distress resulting in liability for the death of his wife. He is seeking an undisclosed amount of damages.

A $30.3 million verdict returned in an asbestos exposure lawsuit was upheld earlier this month by a New Jersey appeals court. 

The court affirmed the February 2008 decision in favor of Susan Buttitta, who brought a mesothelioma lawsuit after the death of her husband, Mark, an advertising executive from Glen Ridge who used to work at a GM warehouse in the early 1970s. The original verdict, handed down by a Bergen County jury, may be the largest in the state’s history.

Originally filed against a large number of companies, only Borg-Warner Corp. and Asbestos Corp., Ltd. were left as part of the case by the time a verdict was returned. Other companies either reached a settlement with the plaintiff or were dismissed from the trial. Borg-Warner and Asbestos Corp. appealed the verdict on multiple counts, but the appellate court rejected them all.

Mark Buttilla allegedly developed mesothelioma from asbestos exposure both as a child, when his father worked at a GM warehouse and carried the fibers home on his clothing, and in the early 1970s, when he also worked at a GM warehouse in Englewood. The lawsuit alleges that Buttilla handled boxes covered with asbestos dust as part of his job. He died of the fatal asbestos cancer in 2002.

Mesothelioma is a rare form of cancer found in the lining of the chest and lungs, which is only known to occur as a result of exposure to asbestos. The disease has a very long latency period and is often not discovered until decades after exposure, leading to a limited life expectancy after diagnosis.

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. 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 exposure mesothelioma lawsuits are the longest running mass tort in U.S. history, with the first asbestos 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.

A Rhode Island jury has returned a defense verdict in the first trial out of about 3,000 product liability lawsuits filed over the Composix Kugel hernia patch.

The hernia patch lawsuit trial involved claims brought by plaintiff John Whitfield against Davol, Inc. and C.R. Bard, Inc., alleging that he suffered severe internal injuries as a result of problems with the companies’ Composix Kugel patch.

During a hernia repair surgery in January 2004, doctors implanted a Composix Kugel patch in Whitfield. At some point after the surgery, the hernia patch allegedly broke inside his body and caused Whitfield to develop multiple and severe injuries when it became intertwined with his hernia. Whitfield alleged that the patch caused bowel obstructions, severe abdominal pain and swelling, nausea, sickness, permanent bowel disfigurement, and other problems.

Following more than two weeks of trial, a jury in the U.S. District Court for the District of Rhode Island rejected Whitfield’s claim, returning a defense verdict. Although the jury found that the plaintiff established that Davol and Bard were negligent in the design of the Composix Kugel patch, they indicated that he did not prove that his damages were directly caused by or contributed to by the negligent design.

Whitfield’s trial was the first out of about 3,000 product liability lawsuits that have been filed against Davol and Bard over problems with different variations of the Composix Kugel patch, many of which have been recalled. All of the Kugel lawsuits involve allegations that the patch was defectively designed and that the manufacturers failed to warn patients and doctors about the health risks associated with the product.

Between 2005 and 2007, three separate Kugel patch recalls were issued for different sizes and models of the hernia mesh. The recalls were issued because of problems with a plastic ring in the mesh that was prone to break, potentially causing bowel perforations, chronic intestinal fistula and other internal injuries that often require additional surgery to remove the mesh.

There are more than 1,300 other Kugel lawsuits pending in the U.S. District Court for the District of Rhode Island, where all federal lawsuits have been centralized under Chief Judge Mary M. Lisi as part of a multidistrict litigation, or MDL. Another 1,774 lawsuits over the Composix Kugel patch have been centralized at the state level in Rhode Island Superior Court under Presiding Justice Alice B. Gibney.

Whitfield’s case was selected as one of four “bellwether” Kugel patch trials that were selected from the federal MDL for early trials. The parties and the court selected the four cases to gauge how juries will respond to evidence and witness testimony that may be presented in other cases throughout the Kugel mesh litigation.

The next lawsuit scheduled to go to trial is a claim filed by Christopher Thorpe, of North Carolina, and his wife, Laure, which is expected to begin June 9, 2010. Thorpe claims to have suffered an abdominal wall abscess and fistula allegedly caused by a broken Kugel patch ring. Eventually, doctors determined that the broken ring had become stained with bile and caused Thorpe to become septic. Thorpe required numerous surgeries to repair the damage and the lawsuit claims he continues to suffer physical pain.

According to earlier reports, there have been a handful of Kugel mesh settlements confidentially reached in individual cases. The outcome of the remaining bellwether Kugel trials could impact how the other cases are resolved, potentially resulting in an attempt to reach a global settlement of the litigation.

Hospitals throughout the country have been largely unable to prevent the spread of potentially life-threatening hospital-acquired infections, according to a new government report on the nation’s health care system. 

The U.S. Department of Health and Human Services (DHHS) released its 2009 national healthcare quality report this week, warning that postoperative sepsis, catheter-associated urinary tract infections and other preventable infections from hospitals are on the rise. The increases mean that more patients are at risk of prolonged hospital stays due to illness from infections, and more are likely to die from such infections.

According to federal reviewers, patient safety is one aspect of health care that is “performing particularly poorly.” Reviewers found that hospitals and the nation’s health care system overall are not devoting enough attention to patient safety, often because hospitals fail to share information due to fears that their professional reputations might be damaged or to avoid medical malpractice lawsuits.

The most alarming increase occurred in the rate of sepsis infections, which are a form of body-wide inflammation that results from the reaction to an infection. Symptoms can include high heart rate, a high respiratory rate, a high or low body temperature and elevated white blood cell count. Sepsis can cause organ damage and organ failure, and severe cases result in death about 20 to 35% of the time.

Specifically, government researchers determined that there was an 8% increase in the rate of sepsis infections acquired after surgery, a 3.6% increase in the rate of urinary tract infections from catheters and a 1.6% increase in overall hospital acquired infections over the last year. There was no change in the rate of infections acquired from central venous catheters. However, hospitals made huge inroads in the fight against postoperative pneumonia, with an 11.6% decrease in cases.

“It is evident that more attention devoted to patient safety is needed to ensure that health care does not result in avoidable patient harm,” researchers state in the report. “Systems for identifying and learning from patient safety events need to be improved.”

The report indicates that the sharing of information needs to be improved in order for hospitals to get control of the infection problem. Researchers also said that there also needs to be more work in understanding the processes and conditions that lead to the spread of hospital infections, and there needs to be more done to identify the practices that are the most effective in preventing the spread of those infections.

The CDC reports that there are more than 2 million hospital infections acquired each year, resulting in about 90,000 deaths annually. Another 1.5 million long term care and nursing home infections occur every year.

In recent years, there has been an increasing number of hospital infection lawsuits filed throughout the United States, as experts widely believe that most of these potentially life-threatening infections can be prevented if steps are taken by the hospital and staff. These steps could include improved methods of handling catheter during insertion, leaving them in for shorter periods and improved hygiene. Many hospitals have instituted new rules to ensure that hands are washed and increased efforts are being taken to keep areas lie the ICU more sterile and catheters clean.

New legislation introduced in Florida is designed to prevent unnecessary antipsychotic medication prescriptions to youths in the state’s foster care program.

The Gary Myers Bill, Senate Bill 2718, is named after a 7-year-old boy who hung himself in the bathroom of a foster home last April after taking Seroquel. A task force that investigated the incident found that the risks of suicide from Seroquel may not have been effectively communicated to Myers’ foster parents. The task force discovered that 13 percent of the state’s foster children were on antipsychotic medications, as compared to 4 to 5 percent of children in the general population.

If passed, the law would have volunteer guardians assigned by the Florida Department of Children and Families to oversee the mental health of each foster child. It would ban the inclusion of foster children in clinical trials and would require that the child be 11 years old for many medications. An independent review would be conducted before prescribing an antipsychotic to anyone under 11.

In addition, the bill would require counseling and a treatment plan for children with mental health issues and taking antipsychotics that would include a counselor explaining the possible side effects to the child, allowing them a final say in whether they are placed on antipsychotics.

The bill’s consideration comes after a recent study found that prescriptions of antipsychotics for very young children are increasing, and FDA drug safety reviewers are calling for more investigation into the side effects of Seroquel, Zyprexa and similar drugs.

Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales. Approved by the FDA in 1997 for the treatment of schizophrenia, it is also commonly used off-label for treatment of anxiety, obsessive dementia, compulsive disorders and autism. Seroquel has been used by more than 19 million people worldwide.

AstraZeneca currently faces thousands of Seroquel lawsuits that allege the company failed to adequately warn about the risk of weight gain and other metabolic side effects, which allegedly caused users to develop diabetes and other Seroquel health problems.

Atypical antipsychotics generate more than $12 billion in sales every year, with Seroquel leading the pack with nearly $4.45 billion in sales last year.

Consumer Reports magazine has issued a “Don’t Buy” warning for the 2010 Lexus GX 460 after test drivers discovered that a trailing throttle problem could cause the SUV to fishtail, potentially resulting in a rollover or serious accident for drivers. The warning, which is the first time the magazine has recommended consumers not buy a vehicle in nearly 10 years, has led Toyota to halt all sales for the vehicle. 

The Lexus GX 640 problems are known as trailing throttle or lift-throttle oversteer. According to test drivers at Consumer Reports, if the driver takes his foot off the gas while the vehicle is driving through a sharp turn, the rear end of the vehicle may begin to slide. On most vehicles, the electronic stability control system would detect the slide and stop it from happening, but it does not seem to be responsive enough to the problem on the Lexus SUV.

Test drivers said that it is a common maneuver for drivers, like when they take an off-ramp too fast, or realize they are in a sharper turn than they expected. Testers at Consumer Reports said they wouldn’t allow their families to ride or drive in the vehicles in their current condition. Consumer Reports said that the problem could lead to Lexus rollover accidents and serious personal injury or death.

The last time Consumer Reports issued a “Don’t Buy” warning was 2001, for the 2001 Mitsubishi Montero Limited.

Toyota, which has sold 4,787 GX 460s in the first quarter of this year, quickly halted sales of the SUV after the Consumer Reports warning, and before the National Highway Traffic Safety Administration (NHTSA) could become involved. The company claims that there have been no reports of Lexus GX 460 accidents related to the problem, and said they are determined to identify and correct the problem.

The NHTSA has said that it is in communication with both Toyota’s Lexus division and Consumer Reports about the problem. Toyota has said it has no plans to issue a Lexus GX640 recall for the vehicles sold, but will offer loaner vehicles to owners until they can fix the problem.

The problems with the Lexus GX640 are the latest in a serious of safety issues for Toyota, which has recalled millions of Lexus and Toyota vehicles in recent months over issues that may cause some cars to suddenly accelerate out of control.

Earlier this month, the government announced that it planned to fine the automaker more than $16 million for covering up the accelerator defects, which may have killed as many as 50 people. The company also faces a number of product liability lawsuits over the gas pedal problems, including several wrongful death claims and a number of Toyota class-action suits.