Author: AboutLawsuits

A wrongful death lawsuit has been filed against the owners and various manufacturers of a house boat in Utah, which allegedly killed one person and sickened others with carbon monoxide poisoning. 

The carbon monoxide lawsuit was filed by the family of Glenn Howeth, 62, of Winslow, Arizona. Howeth died in June 2008 on a house boat on Lake Powell, which plaintiffs say had a carbon monoxide leak that caused everyone onboard to fall ill.

The lawsuit names Aramark Corp., which owned and operate the boat, as a defendant, as well as the manufacturer, Twin Anchors Marine Limited, and several companies designed in making various components; including Centek Industries Inc., Marine Technologies and Westerbeke Corp.

Plaintiffs allege that the carbon monoxide on the boat was caused by a generator and trapped inside. The boat’s carbon monoxide detectors failed to detect the buildup of potentially lethal gases, and members of the family fell ill when the gas reached toxic levels.

Howeth was the first to realize there was a problem when he heard his grandson vomiting. However, he allegedly suffered a fatal accident brought on by carbon monoxide exposure on the boat after he woke up the rest of the family and summoning help by radio.

Carbon monoxide is invisible, tasteless and odorless, which can result in prolonged exposure. Carbon monoxide poisoning is the most common cause of poisoning in the U.S., with 40,000 people injured by undetected leaks each year. Symptoms of carbon monoxide exposure include headaches, nausea, light headedness, and flu-like symptoms, which are often mistaken for some other illness, resulting in prolonged exposure.

Results of a new study suggest that patients are more likely to die in a crowded hospital than in one that has less occupancy.  

The mortality risk study, published in the March issue of the journal Medical Care, was conducted by researchers from the University of Michigan. The researchers looked at a number of factors that could affect the risk of dying in a hospital, including occupancy, nurse staffing levels, seasonal influenza and weekend admissions.

According to data gleaned from 166,920 patients admitted to 39 hospitals in Michigan over a three year period, patients in crowded hospitals have a 5.6% higher risk of death than patients in hospitals with low occupancy levels. But researchers said there appears to be no specific occupancy level where there is a clear jump in mortality, and the amount of crowding which results in increased mortality appears to vary from one hospital to another.

Researchers also found that having higher nursing staff levels decreased the risk of death by 6%, being admitted on a weekend increased the risk of death by 7.5 percent, and being admitted during flu season increases the risk of death by 11.7 percent.

This latest study follows the results of emergency room delay research published in November 2009 in the Archives of Internal Medicine that found that delays in treatment are worsening as hospital emergency rooms are becoming more and more crowded. The study found that just over 75% of patients being seen within the recommended time frame, and also determined that the number of patients being seen in a timely manner is decreasing by about 0.8 percent every year.

Delays could have a ripple effect, resulting in higher rates of morbidity and mortality in hospitals.

Orthopedic surgeons have released a new report that highlights the risk of problems with Zimmer NextGen knee replacement systems, which have been found to have a high rate of failures and revisions. 

At the American Academy of Orthopaedic Surgeons annual conference in New Orleans earlier this month, data was presented by a group of knee surgeons at Rush University Medical Center in Chicago, who said that design problems with the Zimmer NexGen knee replacement has caused an abnormally high rate of loosening that often requires additional revision surgery.

The orthopedic surgeons looked at the two year results of 108 knee replacement surgeries involving the Zimmer NexGen CR-Flex Porous Femoral knee replacement system, which uses a component that attaches to the bottom of the thigh bone without traditional cement to glue it in place. The researchers found that nearly 9% required revision surgery and that 36% showed signs of the replacement knee loosening, concluding that the Zimmer NexGen knee problems were linked to the design of the implant, and were not related to the surgeon, the surgical approach or the type of patient receiving the knee implant.

According to a report in The Wall Street Journal, surgeons have previously brought these issues to Zimmer’s attention and called for the company to remove their NexGen knee replacement product from the market. However, Zimmer Holdings, Inc. has not been responsive to their request and issued a statement standing behind the safety of the NexGen CR-Flex Porous component after the data was presented.

Zimmer has previously faced criticism over the design of their Durom Cup hip implants, which are used during hip replacement surgery and have been associated with a number of complications. In July 2008, a temporary Zimmer Durom Cup recall was issued after the company acknowledged that some doctors experienced high failure rates with the artificial hip implant.

Prior to the recall of that hip implant, the device maker dismissed reports of problems with the Durom Cup, leading a prominent Los Angeles orthopedic surgeon, Dr. Larry Dorr, to present data to members of the American Association of Hip and Knee Surgeons in April 2008 about the higher-than-expected rate of revisions with the Durom Cup. Zimmer then conducted an investigation and found that some surgeons were experiencing hip failure rates as high as 5.7%, leading them to pull the artificial hip from the market until further warnings and instructions on special surgical techniques needed to implant the Durom Cup. The company now faces a number of lawsuits from hip replacement patients who experienced problems with the Zimmer Durom cup, and have reportedly reached settlements in some of the cases.

Since the data was presented earlier this month about the Zimmer knee replacement problems, some product liability lawyers have begun investigation potential Zimmer NexGen replacement knee lawsuits for individuals who have experienced complications, such as loosening of the knee implant or revision surgery.

The U.S. Supreme Court has issued a ruling that limits the way whistleblower lawsuits can be filed on behalf of the government. 

The court issued a 7-2 decision on Tuesday in Graham County Soil and Water Conservation District et al. v. United States ex rel. Wilson (pdf), determining that whistleblowers cannot file lawsuits based off of information that is already publicly available in state or local documents.

The U.S. government and attorneys for the whistleblower, a former secretary for Graham County in North Carolina, had argued that the restrictions only applied to federal audits and administrative reports made public, since the government could not possibly monitor all state and local public documents for signs of wrongdoing.

The question arose in a whistleblower lawsuit filed by Karen Wilson, an employee of the Graham County Soil and Water Conservation District, who charged the county with fraud in its handling of federal relief funds after a 1995 storm. A federal judge initially threw out her whistleblower suit because a Graham County audit had already revealed some of the problems. However, the U.S. Court of Appeals for the 4th Circuit reversed the decision, saying that the provisions only applied to federal reports that had been made public.

At issue in the case was whether the term “administrative” means that the exclusionary provision under the U.S. False Claims Act applies to records available at the state and local level. The federal government and the original plaintiff argued that the provision should be limited to federal reports, saying that if it extended to all information made public down to the local level, it would effectively gut the whistleblower law.

Whistleblowers who report a false claim against the government may be entitled to 15% to 25% of any money that the government recovers from the offenders under the qui tam provision of the False Claims Act. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

The high court determined that the False Claims Act does not support an interpretation that the law limited what should be considered public disclosure to only federal records. Justice John Paul Stevens, writing for the majority, pointed out that quite often the Department of Justice (DOJ) can not monitor all of the federal reports made public for signs of wrongdoing, but those reports would still be exempt from use by a whistleblower to bring a lawsuit on behalf of the government.

 “Just how accessible to the Attorney General a typical state or local source will be, as compared to a federal source, is an open question,” Justice Stevens wrote. “And it is not even the right question. The statutory touchstone, once again, is whether the allegations of fraud have been ‘publicly disclosed,’ not whether they have landed on the desk of a DOJ lawyer.”

 Justices Stephen Breyer and Sonia Sotomayor dissented. Sotomayor said that the wording of the False Claims Act should be limited to federal application, and that if Congress had intended for public disclosure to apply to state and local sources, the act should have said so specifically.

The ruling’s effect will be limited on whistleblower lawsuits brought regarding Medicare and Medicaid fraud, due to language in the recently passed health care reform package that specifies state and local records are not considered public disclosures for the sake of the False Claims Act. Justice Stevens said that the new language will only apply to future cases, however, and not lawsuits that have already been filed.

A Philadelphia jury awarded $6 million in damages earlier this month in a wrongful death bedsore lawsuit filed against a nursing home and hospital, including $5 million in punitive damages for the facilities’ willful or reckless disregard for the well-being of others. 

The lawsuit was filed by the widow of Joe N. Blango, a former resident of Hillcrest Convalescent Home, in Wyncote, Pennsylvania, who died in 2008 of complications from bedsores after being released from Jeanes Hospital. The family accused both facilities of failing to detect and treat the bedsores which resulted in Blango’s death.

The Common Please Court jury awarded the plaintiff, Shirley Blango, $1 million in damages in early March. According to a report in the Philadelphia Inquirer, a punitive damage award of $5 million was returned two weeks later, which are extremely rare in nursing home negligence lawsuits.

The family alleged that medical staff at Jeanes Hospital treated Blango for a week in May 2006, but failed to diagnose that he was suffering from a urinary tract infection, leaving him susceptible to further injury. He was transferred to Hillcrest Convalescent Home to recover, where he stayed for two weeks. After his condition worsened, he was returned to the hospital for further treatment. He was released three days later by Jeanes Hospital to return home. The lawsuit claims that both facilities failed to diagnose the bedsores that eventually killed him.

In addition, the lawsuit says that Blango suffered from malnourishment and lost 28 pounds during the ordeal. His wife cared for him for two years, but he failed to recover from the bedsores, the suit claims.

Jeanes Hospital is owned by Temple University Health System, which has said that it plans to appeal the verdict.

Bedsores, also known as pressure sores or decubitus ulcers, occur as a result of a lack of blood flow to an area of the skin caused by prolonged pressure on one area of the body. They most often develop in places with prominent bones beneath thin layers of skin, such as the heels, elbows and tailbone. The open sores often afflict nursing home residents and hospital patients with limited mobility who have trouble, or are unable, to move independently.

Most medical organizations consider bed sores to be a preventable condition that are easily treated if detected early through proper diligence on the part of medical staff and care providers. Failure to prevent, identify, or properly treat bedsores can result in life-threatening infections that enter the bloodstream, known as sepsis.

Medical device manufacturer Boston Scientific is facing renewed scrutiny from the federal prosecutors and the Security Exchange Commission (SEC) for an implantable heart defibrillator recall it issued earlier this month after failing to get FDA approval for manufacturing changes. 

According to internal documents obtained by the Wall Street Journal, the Department of Justice (DOJ) has issued subpoenas and the SEC has started an informal inquiry into the medical device manufacturer’s actions, following a recall issued for all of their implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) on March 15.

The company said it issued the 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, which is also investigating the recall, must approve the changes before the devices can be put back on the market.

Both the DOJ and SEC are asking the company to turn over documents concerning its discovery that they had not received FDA approval for the changes. They are also looking for records of Boston Scientific’s communications with stockholders, doctors and regulators about the recall.

The new probes comes as Boston Scientific is already dealing with DOJ criminal charges against Guidant LLC, a Boston Scientific subsidiary, for allegedly hiding information regarding catastrophic failures of its Ventak Prizm 2 DR and Contak Renewal ICDs that, in some cases, resulted in death. Boston Scientific announced last November that it intends to pay $296 million in connection with the charges against Guidant. The DOJ says it expects that Boston Scientific is likely to enter a guilty plea in connection with the charges.

The criminal charges are related to earlier defibrillator manufacturing changes that prosecutors say were done to cover up deaths from defective defibrillator designs. The DOJ charges say that Guidant failed to inform the FDA of the changes in order to avoid scrutiny. The company continued to find problems with its defibrillators, and prosecutors say the company sent product updates to physicians that it did not send to FDA, as required by law, and even after other problems with other ICDs developed, the company did not issue a warning about the failures until June 2005.

The Prizm series, which was included in the criminal investigation, is also one of the units affected by the latest recall for unapproved manufacturing changes. Other defibrillator lines affected by the recall include the Cognis, Confient, Livian, Renewal, Teligen and Vitality ICDs and CRT-Ds.

Bayer has indicated that it will update its European warning label to provide additional information on the risk of blood clots from Yasmin side effects.

The label will be updated to include new information from four epidemiological studies, which provide conflicting information on the risk of Yasmin blood clots compared to other birth control pills containing levonorgestrel. Two of the studies, which were sponsored by Bayer, found that the risk of venous thromboembolism among users of Yasmin was comparable to the risk found in women who use levonorgestrel-containing combined oral contraceptives, such as Microgynon 30. However, two other recently published studies found that the risk of blood clots from side effects of Yasmin was higher than with levonorgestrel.

Yasmin is a newer type of birth control pill that contains a “fourth” generation progestin known as drospirenone. The progestin is only found in Yasmin, a newer formulation of the drug marketed as Yaz birth control, a generic Yasmin marketed as Ocella and a lower dose version marketed as Yasminelle. In recent months, concerns have increased about the risk of blood clots from Yaz and Yasmin, which can lead to potentially life-threatening injuries such as a stroke, heart attack, pulmonary embolism, deep vein thrombosis (DVT) or death.

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 known to cause serious heart problems and other health issues.

Shortly after Yasmin was introduced, the U.S. consumer advocacy group Public Citizen listed Yasmin on its list of “DO NOT USE” drugs because it contains drospirenone, which could increase the health risks and because there is no evidence that the drug is any better than older contraceptives that are available.

A number of Yaz blood clot lawsuits and Yasmin blood clot lawsuits have been filed throughout the United States alleging that the drug maker failed to adequately research their medications or adequately warn about the risks associated with the popular pills compared to other forms of birth control.

Last summer, an independent study published in the British Medical Journal found that women taking Yasmin, Yaz or other birth control pills containing drospirenone face a 6.3 times increased risk of blood clots when compared to women who were not on the pill. By comparison, women who took oral contraceptives containing levonorgestrel had the lowest risk of blood clots, with just below a fourfold increase over those not taking a birth control pill.

Despite mounting concerns about the risk of blood clots from Yasmin and Yaz, Bayer continues to stand behind their popular birth control pills. In a press release issued Friday to announce the new European warning label, Bayer indicated that they have identified “several methodological issues” in the two recently published retrospective studies that suggested the risk of blood clots with Yasmin may be higher. The drug maker indicated that these issues need to be clarified before a final conclusion on the Yasmin blood clot risk can be made.

“Yasmin’s positive benefit/risk profile remains unchanged,” said Kermal Malik, M.D., Chief Medical Officer at Bayer Schering Pharma in the press release. “We are convinced that Yasmin is a good choice for women seeking convenient and reliable contraception if they use the product as directed.”

The new European warnings come as Swissmedic, the medical agency for Switzerland, announced that Yasmin and Yaz will remain for sale in the country, despite the risk of blood clots. The Swiss agency began investigating the extent of Yaz and Yasmin side effects last year, after one young woman was killed and another was seriously injured from a pulmonary embolism on Yaz. World Radio Switzerland reports that while Swissmedic found that the risk of thrombosis is higher with Yaz and Yasmin, the risk remains “within reasonable limits.”

Some FDA scientists are indicating that their warnings about the risks of radiation exposure from CT scans were ignored by FDA managers, leading to unnecessary health problems and dangers for patients. 

The allegations are expected to be presented at two days of public hearings beginning today in Gaithersburg, Maryland. The FDA hearings will focus on reducing the risks of unnecessary radiation exposure. However, a story by the New York Times says that a number of FDA scientists will use the conference to expose how some agency managers failed to heed their concerns that overuse of radiation scanning procedures was endangering the public.

The New York Times received documents from FDA scientists and medical officers showing that agency experts objected to plans to approve an application by General Electric that would allow the use of CT scans to look for colon cancer, but those objections went unheard. The application, however, is still under review.

Concerns about radiation exposure risks were sparked by a revelation late last year that more than 200 patients were subjected to overexposure to radiation at Cedars-Sinai Medical Center in Los Angeles. The FDA uncovered numerous other cases at different hospitals as a result of the Cedars-Sinai investigation, leading to a new radiation exposure reduction initiative announced in late February.

The initiative seeks to reduce the risk of radiation exposure from medical procedures through promotion of the safe use of medical devices, by providing support for informed clinical decision-making, and by making patients more aware of their total radiation exposure. The FDA is also considering increased requirements for computed tomography (CT) scanners and fluoroscopic devices that would call for increased safeguards and training to protect against radiation overexposure.

But Dr. Julian Nicholas, a gastroenterologist working under contract for the FDA, said he was forced out when he suggested that approving CT scan for colon cancer screening could lead to more Americans being overexposed to radiation. Nicholas and others say they will present their concerns at the public hearing, where they will be on the record.

In December, FDA issued interim guidance on radiation exposure for health care professionals and radiologists. The guidance advised them to review procedures and CT scan settings, and to be thorough in checking the amount of dosage prescribed for each CT scan patient.

Federal regulators say they have begun an investigation into the potential environmental impacts of Bisphenol A (BPA), a chemical used in many types of plastic bottles and other consumer products, including a review of what BPA may be doing to our water supply. 

The U.S. Environmental Protection Agency (EPA) issued a press release on Monday announcing a BPA action plan and said it plans to add BPA to its list of chemicals of concern, giving the EPA greater regulatory power over its use.

BPA is used to make many plastic products hard and shatterproof. Originally developed as a form of synthetic estrogen, it is used in the manufacture of many consumer products, such as bottles, cups, can liners, baby products and other food containers.

Exposure to BPA is suspected of causing hormonal changes by impacting the human endocrine system. It has also been linked to cancer, heart disease, diabetes, and obesity. Some research has suggested that BPA side effects can cause developmental abnormalities and other problems over time in infants and young children.

In it’s action plan, EPA said while BPA is generally not present in humans or the environment in the high amounts that usually indicates a chemical regulators need to worry about, a number of studies that have looked at the low-dose exposure to BPA have raised concerns over the effects of BPA water contamination.

In January, the FDA recommended that parents take “reasonable steps” to reduce infant exposure to BPA. The FDA is conducting a health risk review of BPA, despite having deemed the material safe previously. The BPA re-evaluation was started in June after the agency received substantial criticism from outside groups, politicians and its own scientists.

“We share FDA’s concern about the potential health impacts from BPA,” said Assistant Administrator Steve Owens, from EPA’s Office of Prevention. “Both EPA and FDA, and many other agencies are moving forward to fully assess the environmental and health impacts to ensure that the full range of BPA’s possible impacts are examined.”

Under the EPA’s new BPA Action Plan, the agency says it intends to:

• Add BPA to the Concern List, meaning BPA represents an unreasonable risk of injury to the environment.
• Order data collection on U.S. water supplies to determine how much BPA Americans are being exposed to in their drinking water.
• Evaluate the possibly disproportionate effect BPA has on children.
• Find ways to reduce unnecessary BPA exposure and releases into the environment while further studies are being conducted.

The EPA said that rulemakings putting the parts of the plan into effect would begin in the fall of 2010.

There are also growing calls for a ban on the use of BPA by states, municipalities and by federal lawmakers. U.S. Senator Charles Schumer has introduced legislation intended to ban BPA in infant products, and there are bills calling for BPA bans currently under consideration in several states. In February, the state of Maryland banned BPA in cups and bottles used by children ages 4 and younger. The state of Minnesota and the city of Chicago have already passed BPA bans.

More than 180,000 Evenflo Top-of-Stair child safety gates have been recalled after the manufacturer received numerous reports of the wooden gates breaking, which could cause children to fall down flights of stairs. 

The Evenflo gate recall was announced on March 25 by the U.S. Consumer Product Safety Commission (CPSC) and Health Canada after 142 reports were filed of slats on the gates breaking or detaching, resulting in a fall hazard for children. Evenflo has received at least two reports involving children who fell down steps after gaining access through a broken Top-of-Stair gate.

Overall, the company said that four children suffered minor bumps and bruises to the head and seven children received other minor scratches, scrapes and bruises as a result of the defective child safety gates. However, there have been no serious injuries reported in connection to the recalled Evenflo safety gates.

The recall affects the Evenflo Top-of-Stair Plus Wood Gates. About 150,000 were sold in the U.S. and another 33,000 were sold in Canada. The model numbers of the recalled gates are 10502 and 10512 and can be found on the bottom rail.

The gates were made from October 2007 through July 2009 and sold at retailers nationwide, including Toys ‘R’ Us, Burlington Baby Depot and Kmart through March 2010 for about $40.

The CPSC recommends that consumers stop using the recalled gate and contact Evenflo to receive a new replacement gate at safety.evenflo.com.

The FDA and state health officials from Louisiana and Mississippi are recalling some raw oysters in order to stop a food poisoning norovirus outbreak that has sickened nearly a dozen people. 

The oyster recall was announced by the FDA and the Louisiana Department of Health and Hospitals on March 27, after reports of illnesses began to surface. The recall was sparked by 11 people falling ill at a conference in Jackson County, Mississippi after eating the raw oysters on March 10. Mississippi health officials confirmed that victims were suffering from norovirus, which can cause gastroenteritis.

The recalled oysters were harvested from Area 7, near Port Sulphur, Louisiana, in the Gulf of Mexico near the mouth of the Mississippi River. The oysters were harvested between March 6 and March 24 and sold nationwide.

All shellfish sold to retailers and food service operators should have a tag or label indicating where it was harvested. Consumers who are unsure of where raw oysters they purchased were harvested should contact the place of purchase.

Louisiana health officials have shut down the harvesting area to protect the public and investigate the potential source of contamination that led to the viral outbreak.

Symptoms of gastroenteritis from norovirus in humans can include nausea, vomiting, diarrhea, stomach cramping and sometimes low-grade fevers, chills, headaches, muscle aches and tiredness. The symptoms hit suddenly, and last for about several days.

Anyone who has eaten raw oysters harvested from Area 7 in the affected time period should contact their state health department and health care professionals.

A new, detailed case study of a woman with diabetes is offering a close look at how the side effects of Byetta could be linked with acute pancreatitis. 

The case study was published in the medical journal Endocrine Practice by doctors from the Department of Internal Medicine of Fairview General Hospital, in Westlake, Ohio, near Cleveland. The doctors say that it is the most thoroughly documented example of a case of acute pancreatitis from Byetta, which is a type 2 diabetes drug manufactured and distributed jointly by Amylin and Eli Lilly & Co.

Byetta (exenatide) 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. In recent years, FDA adverse event reports have raised concerns about a link between Byetta and pancreatitis, including severe cases of necrotizing pancreatitis and hemorrhagic pancreatitis, which have resulted in several deaths.

In the new case study, doctors detailed the development of acute pancreatitis in a 64-year-old woman who did not drink or smoke, but who had diabetes and hypertension. She was prescribed Byetta about one month before she was admitted to the hospital due to gastrointestinal problems including pain and rectal bleeding. Symptoms began two days after she began taking Byetta, and she was diagnosed with pancreatitis after doctors performed a battery of tests and scans. She stopped taking Byetta just days before she was admitted to the hospital, and her condition then began to improve.

The researchers concluded that her condition was the result of a probable association with Byetta. However, the doctors indicate that they are still not sure what causes the Byetta side effect.

Concerns about pancreatitis from Byetta first surfaced in 2007, when the FDA issued an alert indicating that the drug had been linked to at least 30 reports of acute pancreatitis. In August 2008, the FDA notified doctors about six more cases of severe pancreatitis with Byetta, including two deaths. Following the FDA announcement, the drug makers disclosed that they were aware of at least four other pancreatitis deaths among Byetta users.

Amylin and Eli Lilly currently face a number of Byetta pancreatitis lawsuits involving allegations that they failed to adequately research their medication and warn about the risk of pancreatitis from the diabetes drug.

Engine fire risks have led General Motors Co. to recall about 5,000 Chevrolet Express and GMC Savana passenger and cargo vans from their 2010 model year. 

The vans, manufactured and sold in February and March, are suspected of having a faulty alternator that could cause an engine fire. The GM van recall has led the company to halt production of the vehicles until they can be certain they have solved the problem with the design.

The recalls were announced on Friday, affecting all heavy Express 2500 and 3500 series vans with vehicle identification numbers (VIN) that end in A1129327 through A1142523. GMC Savana 2500 and 3500 series vans being recalled have VINs that end with A1128784 through A1901915.

GM said that about 1,300 of the vans had been sold to fleet customers, while the rest were sold as individual units. The company is recommending that drivers stop using the vans, park them away from other vehicles and buildings, and disconnect both battery cables. The company has not released information on when it would call the vans back to dealerships to be repaired.

In addition to the vans, about 1,400 AC Delco heavy duty alternators are also being recalled. The alternators were placed in 2005-2010 Express or Savana vans in February and March as replacement alternators. The affected alternators have part numbers 15200110; 15288861; 15263859 and 15847291. GM is recommending that drivers of vehicles with these alternators, or if the alternator was replaced in February or March and they cannot identify the part number, stop using them and follow the same safety recommendations as the recalled Express and Savana vans.

The company did not indicate whether there had been any fire incidents or injuries in connection to the defective alternators.

Photo Courtesy of IFCAR via Wikimedia Commons

The first trial out of about 3,000 Kugel mesh lawsuits is set to begin today in federal court, involving allegations that a defective hernia patch caused a Missouri man to suffer severe internal injuries. 

The Kugel mesh hernia patch trial, which involves a claim filed by plaintiff John Whitfield, will be held in the U.S. District Court for the District of Rhode Island before Chief Judge Mary M. Lisi, who is presiding over pretrial litigation for all federal cases involving similar allegations.

The case is the first of four “bellwether” Kugel patch trials, which parties and the court will try to use to gauge how juries will respond to evidence and witness testimony that may be presented throughout the other cases in the Kugel mesh litigation.

During a hernia repair surgery in January 2004, Whitfield had a Kugel patch implanted that was manufactured by Davol, Inc., a division of C.R. Bard, Inc. At some point after it was implanted, the hernia patch allegedly broke inside his body and caused Whitfield to develop multiple and severe injuries after it became intertwined with his hernia. The mesh allegedly caused bowel obstructions, severe abdominal pain and swelling, nausea, sickness, permanent bowel disfigurement, and other problems.

Eventually, Davol and C.R. Bard issued a Kugel mesh recall for the hernia patch model that was implanted in Whitfield as a result of multiple reports of similar problems. Between 2005 and 2007, three separate recalls for Kugel mesh were issued for different sizes and models of the hernia patch. 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.

Whitfield is charging Davol with several counts of negligence, breach of warranty and liability, seeking compensation for medical expenses, permanent disfigurement, economic losses, and pain and suffering. He is also seeking punitive damages against the company for what the lawsuit claims was a complete indifference or conscious disregard for the safety of others.

Whitfield’s trial is one of more than 1,300 which have been consolidated and centralized under Lisi as part of a multidistrict litigation, or MDL. There are also another 1,774 hernia mesh lawsuits which have been filed in Rhode Island Superior Court, on the state level, under Presiding Justice Alice B. Gibney. The first of those lawsuits is expected to go to trial in July

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

A panel of independent advisors to the FDA is recommending that the federal regulatory agency either ban tanning beds for everyone under the age of 18, or require parental consent. The recommendations are aimed to protect children and teens from UV radiation exposure and the heightened risk of skin cancer from tanning beds. 

The recommendations came on Friday, during hearings by the FDA’s General and Plastic Surgery Devices Panel over concerns about tanning bed side effects. Several skin cancer studies have found an increased risk of problems from tanning beds, and the World Health Organization (WHO) recently reclassified tanning beds as a known carcinogen.

Currently, the FDA barely regulates indoor tanning facilities, classifying the ultraviolet radiation emitting beds as Class 1 medical devices; the same category as bandages and tongue depressors.

After a day of hearing testimony from proponents and critics of increased tanning bed regulation, the panel indicated that the risks are so great that there should be a prohibition on tanning bed use by minors, or that steps should be taken to ensure that parents and teens are aware of the potential side effects of tanning beds by requiring indoor tanning facilities to obtain parental consent before allowing a child or teen to use their tanning beds.

The panel also recommended more stringent and obvious skin cancer warnings for tanning beds and facilities. The panel is an advisory committee for FDA, and while the recommendations are not binding, the agency generally follows advisory committee recommendations.

The Skin Cancer Foundation, one of the groups calling for tighter restrictions, applauded the recommendations.

“The skin cancer and dermatologic communities came together and presented compelling personal stories and rigorous scientific evidence demonstrating the dangers of indoor tanning,” said Dr. Allan Halpern,  the Skin Cancer Foundation’s vice president. “The Advisory Panel made excellent recommendations and now it’s up to the FDA to take action.”

Just days before the hearing, FDA staffers released a tanning bed safety report for attendees of the hearing, which pointed out that there is growing evidence, including recent medical studies, that tanning beds cause skin cancer.

One of the studies was by WHO itself in July 2009, which indicated that use of tanning beds before the age of 30 increases the risk of skin cancer by 75%. As a result of the study, WHO reclassified ultraviolet radiation from tanning beds and other sources as a definite carcinogen. Previously, they were considered “probable” carcinogens.

Some studies have shown that the use of tanning beds by young adults results in eight times the risk of developing melanoma, a deadly form of skin cancer once found mainly in the elderly, but which has increasingly become a problem for younger adults. The American Cancer Society says that melanoma, the most dangerous form of skin cancer, is diagnosed in about 69,000 Americans each year and causes about 8,650 deaths annually. Less dangerous, but more common, basal and squamous cell carcinomas affect more than one million Americans each year and cause about 2,000 deaths annually.

The FDA report states that a growing number of children are counted among the ranks of tanning bed users, with nearly 10% going to indoor tanning businesses in 1999. The report also expresses concerns by some researchers that as many as 95% of indoor tanning customers are exceeding the recommended safe time in tanning beds.

Concerns over tanning bed cancer has resulted in bipartisan legislation aimed at lowering tanning bed cancer risks. The Tanning Bed Cancer Control Act, was introduced in late January by U.S. Representatives Carolyn Maloney (D-New York) and Charlie Dent (R-Pennsylvania). The bill would allow federal regulators to set controls on the amount of ultraviolet radiation emitted by tanning beds as well as set limits on the amount of time users can use the devices.

A federal jury in Boston has found that Pfizer violated U.S. racketeering laws by illegally promoting off-label uses of its epilepsy drug Neurontin, and the drug maker may be forced to pay more than $142 million in damages in the case.

The Neurontin lawsuit, brought by Kaiser Foundation Health Plan, Inc. and Kaiser Foundation Hospitals, charged Pfizer with illegal promotion of Neurontin for migraines, bipolar disorder and other conditions. The plaintiffs alleged that they were forced to overpay $90 million for the medication, which did not perform as advertised.

The U.S. District Court jury in Boston deliberated for two days after a month-long trial, and awarded the plaintiffs $47.36 million in damages. However, since the charges include claims that Pfizer violated the federal Racketeer Influenced and Corrupt Organizations Act (RICO), the jury award is automatically tripled, meaning that if the ruling stands Pfizer would have to pay $142.1 million in total.

The case is just one of about 1,200 lawsuits over Neurontin that Pfizer is facing. Most of the lawsuits have been brought by individual plaintiffs who say that Neurontin side effects increase the risk of suicide. In 2008, the FDA required Neurontin and similar epilepsy drugs to begin carrying label warnings alerting users to the risk of suicidal thoughts.

While doctors are free to prescribe drugs for uses not approved by the FDA, manufacturers are prohibited from marketing the drugs for such uses that they have not established are safe and effective. In 2004, Parke-Davis, a division of Warner-Lambert that was acquired by Pfizer, paid $430 million to the U.S. Justice Department over claims that they were illegally promoting Neurontin for off-label uses, including control of mood swings. Last fall, Pfizer paid the Justice Department $2.3 billion to settle a number of off-label marketing claims which included its marketing of Neurontin.

Neurontin (gabapentin) is an epilepsy medication approved by the FDA in 1983, which generated $387 million in sales for Pfizer in 2008.

The first Neurontin lawsuit to go to trial, which involved a claim brought by the family of Susan Bolger, who committed suicide in 2004 after taking the drug, was dropped last summer before a verdict was ever returned.

All federal lawsuits involving Neurontin have been consolidated before U.S. District Judge Patti B. Saris, and the next Neurontin lawsuit trial is scheduled to begin next week in the same court.

The Missouri Supreme Court has limited the use of damage caps for medical malpractice lawsuits in that state, adding to a recent trend in other courts nationwide, some of which have struck down malpractice damage caps altogether after finding that they violate an individuals right to have a trial by jury. 

In an opinion issued on Tuesday, the state’s highest court stopped short of ruling that Missouri medical malpractice damage caps are unconstitutional, instead deciding to limit them to injuries that have occurred only after the law was passed in 2005. All pre-2005 injuries should be exempt from the cap, the judges determined, according to a story in the Joplin Globe.

Medical malpractice lawsuit caps, which override jury decisions on how much plaintiffs can be awarded for non-economic damages, have come under fire from courts and attorneys across the country. Critics say that the caps, set by lawmakers, violate the constitutional right to a trial by jury, because they allow the legislature to step on the toes of jury decisions regarding how much a victim should be awarded as compensation for pain and suffering caused by negligent medical care.

Proponents of the caps say that they help prevent doctors from leaving the states and keep medical malpractice liability insurance rates down.

The Missouri ruling on the state’s malpractice cap comes the same week that the Georgia Supreme Court struck down Georgia medical malpractice caps as unconstitutional, siding unanimously with critics who say that it is a violation of the right to trial by jury. It also follows a decision in February by the Illinois Supreme Court, which struck down Illinois medical malpractice award limits in that state on similar grounds.

California was the first state to enact a damage cap in 1975, specifically limiting the non-economic damages in medical malpractice lawsuits. According to the National Conference of State Legislatures, as of 2005 ten states capped recoveries specifically on medical malpractice cases and another 22 have caps that are not limited to medical malpractice. About a dozen states also have caps on punitive damages.

A new study by California regulators has found that many household pesticide labels lack basic information needed for consumers to safely use them and avoid the risk of injury. 

The report, presented this week at the national meeting of the American Chemical Society, is the result of an investigation by reviewers at the California Environmental Protection Agency (CalEPA). According to a MedicineNet.com story, the researchers concluded that the labels of many pesticides could lead to consumers using too much and exposing them to dangerous pesticide side effects.

CalEPA researchers looked at the labels of a number of products that contained para-dichlorobenzene (pDCB), including mothballs, mildew prevention products, and products designed to protect domesticated birds from lice and mites. Researchers found that the labels all contained information on the minimum amount necessary for the products to be effective, but they contained no data on the maximum amounts that would be safe to use.

Researchers also said that the labels do not tell pDCB users how long they need to air out clothing that has been stored with mothballs in order for them to be safe to wear. They said they are concerned that people could be taking the clothing out of storage, where it has been absorbing pDCB fumes from mothballs for an extended period of time, and then wear them immediately.

The findings are of concern in the wake of recent national studies that found that some people, particularly minority groups, have increased levels of indoor air pollutants, including pDCB, which is only used in residential products in California.

Para-dicholrobenzene is a chlorine and benzene based chemical used as a pesticide and a deodorant. It is common in mothballs, disinfectants and urinal cakes. It is not easily soluble in water and has a strong odor. The U.S. Department of Health and Human Services has determined that pDCB probably causes cancer, but there is no direct evidence. Both the U.S. Environmental Protection Agency (EPA) and the U.S. Occupational Safety and Health Administration (OSHA) have placed limits on exposure in drinking water and on exposure in the workplace. California has determined that the chemical is a known carcinogen.

Animal testing has resulted in liver and kidney tumors when exposed at high levels, and consuming pDCB induces vomiting in human adults.

Medication errors caused by prescription mistakes could be reduced by a factor of seven if doctors switched to electronic prescriptions, according to a new study conducted in New York. 

The study was performed by researchers from the Weill Cornell Medical College in New York City and published in the February issue of the Journal of General Internal Medicine. The researchers found that primary care practices that switched to electronic prescriptions, or e-prescriptions, saw a seven-fold reduction in the number of preventable medication mistakes. The primary benefit was the elimination of illegible handwriting, according to doctors who conducted the study.

The researchers looked at 12 primary care practices in the state of New York, six of whom switched to a system where the doctor filled out prescriptions by computer. The six practices that used e-prescriptions saw the rate of prescribing errors drop from 42.5 mistakes per every 100 prescriptions, to 6.6 errors out of every 100 over the course of one year. Practices which continued to use hand-written medication prescriptions actually saw the number of errors increase marginally, from 37% to 38%.

The study did not find a significant difference in the number of what researchers referred to as “near misses,” mistakes that could have potentially caused actual harm to patients but were discovered before patients received the medications or did no harm when the patients took them. Facilities using e-prescriptions had a near miss rate of 1.5% at the beginning of the study and 1.3% after one year. Primary care practices without e-prescriptions saw the number of near misses rise, however, from 1% to nearly 3%.

Researchers say that the study, federally funded by the Agency for Healthcare Research and Quality, was small, and recommended that more expansive studies should be conducted.

According to a 2006 report by the National Academies of Science’s Institute of Medicine, there are about 1.5 million medication errors every year that result in injuries. These mistakes are largely preventable and could be caused by a doctor prescribing the medication incorrectly, the pharmacy filling the wrong dosage or by nurses dispensing a different patient’s drugs.

A $10 million wrongful death lawsuit in Maryland has been filed against Baltimore County police by the family of a bipolar man who died after being struck with a Taser stun gun. 

The police Taser lawsuit was filed by the family of Ryan Lee Meyers, who died in March 2007 after being Tasered by police in his home. The lawsuit charges Baltimore County Police and three officers with wrongful death, negligence and police brutality, according to a story by WJZ-13.

The police were called to Meyers’ home in Middle River by family members who said he had become unstable and violent with a baseball bat. Police who arrived said Meyers, who had bipolar disorder, was uncooperative and threatened them with the bat, requiring them to use their Taser guns to subdue him. However, the family claims in the police brutality lawsuit that Meyers did not have the bat when police Tasered him, and say they may have shot him with the Taser weapon more than once.

Questions over the death of another Maryland man, Jarrell Gray, two years ago sparked a task force investigation into the Baltimore County Police Department’s use of Tasers. The task force, while acknowledging that Tasers could be useful, determined that Baltimore County police had an over-reliance on Tasers and recommended that the weapons, which are promoted as non-lethal, should be considered deadly weapons. The task force was called for by County Councilman Vincent Gardina, a former police officer who raised concerns that county police were using Tasers too frequently instead of restraining their use of force.

Scottsdale-based Taser International has vigorously defended the safety of the weapons. Last fall, however, the company issued a memo to police agencies throughout the United States warning about the potential Taser heart risks, recommending that officers avoid chest shots.

Taser guns are designed to incapacitate neuromuscular function by delivering a shock that uses Electro-Muscular Disruption technology. Many law enforcement agencies have deployed the weapons to allow police to incapacitate someone who poses a threat, but there have also been a number of reports of overuse and abuse of the weapons, which could have fatal consequences.

Taser has said it issued the warning not because it believes that the weapons are dangerous, but as a means of legal risk management for law enforcement agencies using their weapons. However, critics have characterized the recommendations as a passive admission that Taser stun guns can cause heart attacks. Taser has disagreed with this interpretation of their recommendations.

In 2008, Amnesty International released a report on Taser police use, calling for departments throughout the United States to stop using Taser guns or to strictly limit their use to life-threatening situations. The human rights group linked 334 deaths to the use of Taser guns between 2001 and August 2008. Amnesty noted that 90% of the Taser deaths examined involved people who were unarmed and did not appear to present a serious threat to the officers. A large number of the fatalities involved misuse of the weapons, including multiple Taser shocks or exposing suspects to prolonged shocks.