Consumer groups said Tuesday that a federal court decision could threaten the effectiveness of saferproducts.gov, a relatively new federal database of unsafe products.
The ruling, by Judge Alexander Williams Jr. of United States District Court in Maryland, sided with a manufacturer who sued to keep its name out of the database, arguing that the complaint against it was confusing and contradictory and therefore should not be published.
The manufacturer, whose name and product remain anonymous, submitted medical data to the Consumer Product Safety Commission, which maintains the database, showing that the information in the database was “materially misleading.” The commission staff agreed, but the manufacturer argued that the corrected reports perpetuated the errors, and it filed a lawsuit.
Judge Williams, in a decision dated July 31 but made public on Monday, ruled that the safety commission’s decision to publish the complaint was “arbitrary and capricious” and that it could influence a consumer’s behavior, despite a disclaimer stating that the safety commission doesn’t endorse the findings.
On Tuesday, several consumer groups filed an appeal of the judge’s decision to keep some files sealed, as well as parts of the judge’s ruling. They also contested the judge’s decision to allow the manufacturer to proceed under the pseudonym “Company Doe.”
“The price that we pay for secrecy in cases like this is it can open the door to lots of litigants,” said Scott Michelman, an attorney for Public Citizen, one of the groups filing the appeal. “I do not expect this to be the last time that a company tries to keep a report of one of its products out of the database.”
In a prepared statement, the safety commission said, “The decision published yesterday concerning one incident reported to the saferproducts.gov consumer database does nothing to change the agency’s statutory mandate and enduring commitment to provide the public with a timely and searchable database of incidents involving consumer products. Consistent with the decision, the Commission did not post the individual report.”
Judge Williams dismissed allegations that the decision would set off a flood of lawsuits by companies trying to stay off the database. “The prospect of successful challenges to the database does not threaten to categorically compromise the Commission’s consumer safety mission,” the judge wrote. “In sum, there is ample middle ground between the foundation this opinion lays and the apocalypse the Commission predicts.”
The database is the result of 2008 legislation that gave the safety commission more money and authority after numerous product recalls, including children’s toys from China.
The database, which went online in March, allows consumers, and others, to file complaints of injury, or potential harm, for all types of products except for food, drugs, cosmetics, cars and guns. More than 11,000 reports have been filed to the database so far. Before incident reports are posted, manufacturers are given a chance to respond, and if they can show that the entire report or part of it is not accurate, the report is supposed to be redacted or not posted on the database.
_______________________
Source: The New York Times (Martin, 10/24)
Wednesday, October 31, 2012
Monday, October 29, 2012
Is Texas ready for 85-mph speed limit?
LOCKHART, Texas — For drivers who feel the need for speed, Wednesday is a big day in Texas.
A new 40-mile stretch of Texas 130 toll road bypassing Austin's east side will open with an 85-mph speed limit -- highest in the United States.
"I think people will routinely pass me going 100. Regardless of the speed limit, there's always going to be people who want to go past it," said Jeff Gibeaux, a civil engineer in Lockhart who plans to take the high-speed road to Austin on occasion.
While most states have raised speed limits gradually in recent years, Texas is going at it full throttle.
Since 2002, the Texas Department of Transportation -- at the urging of state lawmakers -- has raised the speed limit to 75 or 80 mph on nearly 6,507 miles of road.
Most of the increases have occurred since 2011, when a new state law broadened which roads qualified for higher speeds.
The speeds are now posted not only in rural areas but also on major roads such as Interstate 20 and Interstate 35 just outside Dallas-Fort Worth and other major metro areas.
On about 1 in 12 miles of Texas roadway -- including interstates, small highways and farm-to-market roads -- motorists may now legally travel at speeds once considered excessive and dangerous.
Safety experts in the U.S. and Europe warn that fatalities and injury accidents are likely to rise. Texas' fatality rate is already higher than the national average, with 3,015 people killed on roads in 2011.
"You need to take measures to counteract an anticipated increase in deaths," said Veronique Feypell de la Beaumelle, an analyst with the International Transport Forum, which publishes a road safety annual report with crash data from the U.S. and 31 other countries.
But state officials say they don't necessarily expect more carnage. On the contrary, they point to statistics showing that fatalities are declining along some West Texas highways that were the first to get higher limits.
They say their methods of studying a road before raising a speed limit are scientifically sound, although they are applied differently in various parts of the state.
Less certain is whether motorists have the proper training, or the self-discipline, to drive safely on a high-speed road. State officials say they are developing ways to promote better driving habits.
Last week, the Transportation Department began installing 3,400 signs reading "Left lane for passing only" on highways with a speed limit of 75 mph or more. The same message was flashed on more than 700 electronic highway signs statewide.
"We're going to have to teach Texans how to drive these safer speeds," said Bill Meadows of Fort Worth, a Texas Transportation Commission member.
Meanwhile, as lawmakers encourage the Transportation Department to raise speed limits in one county after another, researchers at organizations such as the Insurance Institute for Highway Safety are taking issue with some of the state's guiding principles for determining when to raise a speed limit.
State officials have said they generally believe that motorists will drive at a comfortable speed, regardless of the posted limit, so it's important to set limits near the thresholds at which people are already traveling. But that philosophy can conflict with a belief held by critics who say drivers go whatever speed they think they can get away with and often exceed posted speeds because they perceive them to be conservative.
Economics are a factor, too.
The new section of Texas 130 toll road is being built by a private developer known as State Highway 130 Concession Co. Llc., which is led by the U.S. arm of Spain-based Cintra. Texas 130 is part of the Austin area's Central Texas Turnpike System. The developer is spending $1.4 billion on the project for the right to collect tolls through Nov. 11, 2062. To protect its investment, the group is paying Texas an extra $100 million in return for setting an 85-mph limit, according to the contract.
The idea is to attract more motorists to the road with the promise of higher speeds, which in turn generates more toll revenue.
Speed studies
State law requires the Transportation Department to perform a speed study before raising the limit on a stretch of road but lets the agency decide how to go about it.
Two of the agency's top safety officials demonstrated the process for the Star-Telegram this month on a stretch of Texas 130 that is already open north of Austin. There, the limit was raised to 80 mph this year, and the road could be a candidate for 85 mph in the near future, they said.
The first step in the speed study was for the pair of state employees to conduct a "trial run" of the 19-mile stretch. Darren McDaniel, a speed zone engineer for the department's Austin district, was given the task of driving the length of the road in a department pickup. Carol Rawson, director of the state's traffic operations division, sat in a passenger seat and took notes on McDaniel's speed.
McDaniel purposefully avoided looking at his speedometer and focused instead on driving at a speed he felt comfortable with -- most of the time, he was going 80 to 82 mph.
The two were helped in their work by a couple of gadgets installed in the truck: a digital instrument to help Rawson track the speed without having to continuously look at the dashboard and an inclinometer mounted on the dash that was programmed to sound an alarm if the truck took a curve with too much gravitational force.
The duo also took notes on factors such as visibility on the road and the amount of clear space available on the shoulders and in the median, in case a motorist has to take evasive action.
Texas highways are typically designed to accommodate speeds of at least 70 mph -- the state's default limit until a speed study can be conducted, six months or more after a road opens to the public.
But roads can be designed for higher or lower speeds.
For example, a small portion of the planned Chisholm Trail Parkway in southwest Fort Worth is being designed for 50 mph to ensure that traffic goes relatively slowly through some old neighborhoods.
And, as with the Texas 130 extension, roads can be designed to accommodate 85-mph limits from their first day open to traffic.
The next step in the speed study was taking a sample of at least 125 randomly selected cars to determine how fast people are traveling on the road -- typically known as an 85th percentile test.
McDaniel and Rawson parked their truck on an overpass in Pflugerville near Austin and, using a laser gun like what police use to issue traffic tickets, they determined that 85 percent of the vehicles on this stretch of Texas 130 were traveling 83 mph or less.
As a result, the road was a candidate for an 80- or 85-mph speed limit, they said.
The idea is to set a speed limit so that 85 percent of motorists are obeying the law. Rawson said it's a commonly accepted standard in traffic-engineering circles that 85 percent of drivers are traveling at a safe, comfortable speed -- regardless of the posted limit.
"Most people drive what's safe and prudent, because we know people aren't wanting to hurt themselves," she said.
"They're not wanting to get into a crash. Most importantly, they want to get where they're going, so generally they're going to drive a speed that's reasonable, and that's what we're looking for."
'A moving target'
A top official at the Insurance Institute for Highway Safety, a research organization that tracks collision data throughout the U.S., said placing so much weight on the 85th percentile standard is leading states such as Texas to raise speed limits beyond reasonable levels.
"The 85th percentile is a moving target," institute President Adrian Lund said. "People do pay attention to the speed limit: They use it as a guideline and figure out how much faster they can go without getting a ticket. Gradually, you end up with the same number of people exceeding the speed limit that you had before. There's an assumption that the government is always conservative, so if 85 is the speed limit, then 90 and 95 must be safe, right?"
Higher speed limits could hit Texans in the pocketbook, too. If accidents increase, the cost of auto insurance will go up, David Snyder, vice president of the American Insurance Association predicted in a 2011 column that ran in the Star-Telegram.
Texas' fatality rate is already higher than the national average, and Texans pay some of the highest insurance rates.
Lawmakers' mandate
In April 2011, a state House transportation committee approved a bill that gave the Transportation Department power to raise the speed limit to 75, 80 or 85 mph on thousands of miles of the highway system, as long as a speed study was conducted on at least one place in each segment of roadway.
The bill, which eventually became law, also eliminated lower speed limits for trucks and for all traffic at night.
The lone vote against the bill was from Rep. Yvonne Davis, D-Dallas.
"When you've got as many inexperienced drivers on our highways as we do, the last thing you want is people going 75, 80, 85 mph," Davis said this month in an interview. "I thought the whole notion of raising the speed limit that high was crazy."
The bill passed without comment, although Davis said it was clear in the Capitol hallways that the measure had plenty of support -- particularly among rural lawmakers who were hearing from constituents that they wanted to legally drive faster.
"It probably started with the rural representatives," Davis said. "But these speed limits are in urban centers, too."
Support for higher speeds tends to be particularly strong in cities that stand to benefit economically from the lure of traffic, although projects such as the Texas 130 extension can also brew controversy.
About 30 miles southeast of Austin, the new Texas 130 extension leads to Lockhart, a city of about 13,000 that is known for its barbecue joints.
Residents aren't too happy that the speed limit on the frontage roads of U.S. 183 running parallel to the Texas 130 extension has been lowered from 65 to 55 mph.
State officials have said the lower limit is needed because commercial development is springing up along the frontage roads, creating a safety issue for motorists pulling in and out of driveways.
But many residents say the real motivation is to force traffic onto the 85-mph toll road.
And on the toll road, there is little opposition to the 85-mph limit.
"We're thrilled about it," said Wendy Ramsey, owner of Wendy R Gift Shop on the town square. She regularly drives 80 mph on the portion of Texas 130 that's already open and, beginning Wednesday, she fully expects to drive 85 mph on the new part of the toll road.
"There's so few cars on 130 at this point," she said, "that right now it seems safe."
_______________________________
Source: Star-Telegram (Dickson, 10/22)
A new 40-mile stretch of Texas 130 toll road bypassing Austin's east side will open with an 85-mph speed limit -- highest in the United States.
"I think people will routinely pass me going 100. Regardless of the speed limit, there's always going to be people who want to go past it," said Jeff Gibeaux, a civil engineer in Lockhart who plans to take the high-speed road to Austin on occasion.
While most states have raised speed limits gradually in recent years, Texas is going at it full throttle.
Since 2002, the Texas Department of Transportation -- at the urging of state lawmakers -- has raised the speed limit to 75 or 80 mph on nearly 6,507 miles of road.
Most of the increases have occurred since 2011, when a new state law broadened which roads qualified for higher speeds.
The speeds are now posted not only in rural areas but also on major roads such as Interstate 20 and Interstate 35 just outside Dallas-Fort Worth and other major metro areas.
On about 1 in 12 miles of Texas roadway -- including interstates, small highways and farm-to-market roads -- motorists may now legally travel at speeds once considered excessive and dangerous.
Safety experts in the U.S. and Europe warn that fatalities and injury accidents are likely to rise. Texas' fatality rate is already higher than the national average, with 3,015 people killed on roads in 2011.
"You need to take measures to counteract an anticipated increase in deaths," said Veronique Feypell de la Beaumelle, an analyst with the International Transport Forum, which publishes a road safety annual report with crash data from the U.S. and 31 other countries.
But state officials say they don't necessarily expect more carnage. On the contrary, they point to statistics showing that fatalities are declining along some West Texas highways that were the first to get higher limits.
They say their methods of studying a road before raising a speed limit are scientifically sound, although they are applied differently in various parts of the state.
Less certain is whether motorists have the proper training, or the self-discipline, to drive safely on a high-speed road. State officials say they are developing ways to promote better driving habits.
Last week, the Transportation Department began installing 3,400 signs reading "Left lane for passing only" on highways with a speed limit of 75 mph or more. The same message was flashed on more than 700 electronic highway signs statewide.
"We're going to have to teach Texans how to drive these safer speeds," said Bill Meadows of Fort Worth, a Texas Transportation Commission member.
Meanwhile, as lawmakers encourage the Transportation Department to raise speed limits in one county after another, researchers at organizations such as the Insurance Institute for Highway Safety are taking issue with some of the state's guiding principles for determining when to raise a speed limit.
State officials have said they generally believe that motorists will drive at a comfortable speed, regardless of the posted limit, so it's important to set limits near the thresholds at which people are already traveling. But that philosophy can conflict with a belief held by critics who say drivers go whatever speed they think they can get away with and often exceed posted speeds because they perceive them to be conservative.
Economics are a factor, too.
The new section of Texas 130 toll road is being built by a private developer known as State Highway 130 Concession Co. Llc., which is led by the U.S. arm of Spain-based Cintra. Texas 130 is part of the Austin area's Central Texas Turnpike System. The developer is spending $1.4 billion on the project for the right to collect tolls through Nov. 11, 2062. To protect its investment, the group is paying Texas an extra $100 million in return for setting an 85-mph limit, according to the contract.
The idea is to attract more motorists to the road with the promise of higher speeds, which in turn generates more toll revenue.
Speed studies
State law requires the Transportation Department to perform a speed study before raising the limit on a stretch of road but lets the agency decide how to go about it.
Two of the agency's top safety officials demonstrated the process for the Star-Telegram this month on a stretch of Texas 130 that is already open north of Austin. There, the limit was raised to 80 mph this year, and the road could be a candidate for 85 mph in the near future, they said.
The first step in the speed study was for the pair of state employees to conduct a "trial run" of the 19-mile stretch. Darren McDaniel, a speed zone engineer for the department's Austin district, was given the task of driving the length of the road in a department pickup. Carol Rawson, director of the state's traffic operations division, sat in a passenger seat and took notes on McDaniel's speed.
McDaniel purposefully avoided looking at his speedometer and focused instead on driving at a speed he felt comfortable with -- most of the time, he was going 80 to 82 mph.
The two were helped in their work by a couple of gadgets installed in the truck: a digital instrument to help Rawson track the speed without having to continuously look at the dashboard and an inclinometer mounted on the dash that was programmed to sound an alarm if the truck took a curve with too much gravitational force.
The duo also took notes on factors such as visibility on the road and the amount of clear space available on the shoulders and in the median, in case a motorist has to take evasive action.
Texas highways are typically designed to accommodate speeds of at least 70 mph -- the state's default limit until a speed study can be conducted, six months or more after a road opens to the public.
But roads can be designed for higher or lower speeds.
For example, a small portion of the planned Chisholm Trail Parkway in southwest Fort Worth is being designed for 50 mph to ensure that traffic goes relatively slowly through some old neighborhoods.
And, as with the Texas 130 extension, roads can be designed to accommodate 85-mph limits from their first day open to traffic.
The next step in the speed study was taking a sample of at least 125 randomly selected cars to determine how fast people are traveling on the road -- typically known as an 85th percentile test.
McDaniel and Rawson parked their truck on an overpass in Pflugerville near Austin and, using a laser gun like what police use to issue traffic tickets, they determined that 85 percent of the vehicles on this stretch of Texas 130 were traveling 83 mph or less.
As a result, the road was a candidate for an 80- or 85-mph speed limit, they said.
The idea is to set a speed limit so that 85 percent of motorists are obeying the law. Rawson said it's a commonly accepted standard in traffic-engineering circles that 85 percent of drivers are traveling at a safe, comfortable speed -- regardless of the posted limit.
"Most people drive what's safe and prudent, because we know people aren't wanting to hurt themselves," she said.
"They're not wanting to get into a crash. Most importantly, they want to get where they're going, so generally they're going to drive a speed that's reasonable, and that's what we're looking for."
'A moving target'
A top official at the Insurance Institute for Highway Safety, a research organization that tracks collision data throughout the U.S., said placing so much weight on the 85th percentile standard is leading states such as Texas to raise speed limits beyond reasonable levels.
"The 85th percentile is a moving target," institute President Adrian Lund said. "People do pay attention to the speed limit: They use it as a guideline and figure out how much faster they can go without getting a ticket. Gradually, you end up with the same number of people exceeding the speed limit that you had before. There's an assumption that the government is always conservative, so if 85 is the speed limit, then 90 and 95 must be safe, right?"
Higher speed limits could hit Texans in the pocketbook, too. If accidents increase, the cost of auto insurance will go up, David Snyder, vice president of the American Insurance Association predicted in a 2011 column that ran in the Star-Telegram.
Texas' fatality rate is already higher than the national average, and Texans pay some of the highest insurance rates.
Lawmakers' mandate
In April 2011, a state House transportation committee approved a bill that gave the Transportation Department power to raise the speed limit to 75, 80 or 85 mph on thousands of miles of the highway system, as long as a speed study was conducted on at least one place in each segment of roadway.
The bill, which eventually became law, also eliminated lower speed limits for trucks and for all traffic at night.
The lone vote against the bill was from Rep. Yvonne Davis, D-Dallas.
"When you've got as many inexperienced drivers on our highways as we do, the last thing you want is people going 75, 80, 85 mph," Davis said this month in an interview. "I thought the whole notion of raising the speed limit that high was crazy."
The bill passed without comment, although Davis said it was clear in the Capitol hallways that the measure had plenty of support -- particularly among rural lawmakers who were hearing from constituents that they wanted to legally drive faster.
"It probably started with the rural representatives," Davis said. "But these speed limits are in urban centers, too."
Support for higher speeds tends to be particularly strong in cities that stand to benefit economically from the lure of traffic, although projects such as the Texas 130 extension can also brew controversy.
About 30 miles southeast of Austin, the new Texas 130 extension leads to Lockhart, a city of about 13,000 that is known for its barbecue joints.
Residents aren't too happy that the speed limit on the frontage roads of U.S. 183 running parallel to the Texas 130 extension has been lowered from 65 to 55 mph.
State officials have said the lower limit is needed because commercial development is springing up along the frontage roads, creating a safety issue for motorists pulling in and out of driveways.
But many residents say the real motivation is to force traffic onto the 85-mph toll road.
And on the toll road, there is little opposition to the 85-mph limit.
"We're thrilled about it," said Wendy Ramsey, owner of Wendy R Gift Shop on the town square. She regularly drives 80 mph on the portion of Texas 130 that's already open and, beginning Wednesday, she fully expects to drive 85 mph on the new part of the toll road.
"There's so few cars on 130 at this point," she said, "that right now it seems safe."
_______________________________
Source: Star-Telegram (Dickson, 10/22)
Monday, October 22, 2012
FDA: More drugs may be linked to meningitis outbreak
The Food and Drug Administration initially said it received reports of three new cases of infections tied to two additional products made by the New England Compounding Center (NECC). It later corrected its statement, saying it had reports of two cases.
One involves the steroid triamcinolone acetonide, which is different from the steroid implicated in the existing meningitis cases. A patient who may now have meningitis received an epidural of the medication, the FDA said.
The other case involves a medication that is injected into the coronary arteries to temporarily paralyze the heart during open-heart and transplant surgery. Two patients who received the medication, called cardioplegic solution, during heart-transplant surgery, subsequently developed fungal infections, the agency said.
As a result of the cases, the sterility of any injectable drugs made by the NECC, including ones used in eye and heart surgery, “are of significant concern and out of an abundance of caution, patients who received these products should be alerted to the potential risk of infection,” the agency said in a statement posted on its Web site.
Steven Immergut, an FDA spokesman, said the agency didn’t know how many additional patients are affected and how many will need to be notified. The agency is working with the now-shuttered company to “get more information on the distribution of their products,” he said in an e-mail.
Until now, the meningitis infections have been linked to contaminated vials of one NECC steroid drug — methylprednisolone acetate. About 14,000 people received injections of that medication. As of Monday, 212 people have been received diagnoses of fungal meningitis linked to the tainted drug, two others have ankle infections and 15 have died, according to the Centers for Disease Control and Prevention.
The FDA has not confirmed that the two additional products were contaminated or that the three infections were caused by NECC products, according to its statement. The agency said it was possible there may be other explanations for the patients with fungal infections.
But the FDA said it is advising doctors to follow up with any patient who received “any injectable product” made by the NECC, including drugs used in eye surgery or cardioplegic solution bought from or produced by the company.
Doctors should inform patients who received the NECC products about symptoms of possible infection and tell them to contact a health-care provider immediately if they experience symptoms.
All of the company’s products have been under a voluntary recall by the company on Oct. 6. As part of that effort, the company attempted to contact all health-care providers and facilities that received its products, the FDA said. The agency had previously advised health-care providers and facilities to check their purchase records to see whether they bought any products from NECC and urged them not to use any products from the company.
In a statement issued Monday, the NECC said it was reviewing the FDA’s expanded advice to health-care practitioners. The company, which is a compounding pharmacy, said it was continuing to cooperate with officials from the FDA, the CDC and the Massachusetts pharmacy board.
“As we have said, we will respect those public agencies’ processes for investigations and will not comment while they are underway,” the company said.
Federal regulators said they are working with company officials to produce a specific list of injectable drugs that could be posted as soon as possible.
“A large portion of NECC’s products were injectables,” said the FDA’s Immergut. The company, which had a 71-page product list, makes more than 2,000 products, from pain medications such as fentanyl to such commonplace items as mouthwash to all-purpose nipple ointment to treat soreness and infection in nursing mothers.
The FDA said the company’s topical products, such as lotions, creams and eyedrops not used in surgery, pose lower risks and don’t require patient follow-up. The firm’s annual revenue is about $8 million, according to company spokesman Andrew Parven.
_____________________
Source: The Washington Post (Sun, 10/15)
Monday, October 15, 2012
Company linked to meningitis scare besieged as deaths rise
The Centers for Disease Control and Prevention (CDC) said another person died from meningitis, the second death in Indiana. The number of cases of the disease reported reached 201 in 14 states, according to the CDC and state officials.
Illinois reported its first case of meningitis from a steroid injection and New Hampshire officials reported that state's first four confirmed cases from the outbreak, which showed no signs of abating.
Tennessee is the worst affected state with six deaths and 52 cases followed by Michigan with three deaths and 41 cases, including one case of an infection that has not been confirmed as meningitis.
As federal and state authorities scrambled to contain the outbreak, investigators were trying to determine how the medication produced by New England Compounding Center was contaminated and whether its sprawling drug supply business complied with licensing laws.
A series of emails between the company and a clinic in Mississippi reviewed by Reuters show that NECC sold drugs without requiring physicians to supply individual patient prescriptions. The customer confirmed that NECC supplied the clinic with drugs without patient names or prescriptions, which are required by a number of states including Massachusetts, where the company is based.
The emails also indicate that NECC referred business to a sister company, Ameridose LLC, despite a statement by Ameridose earlier this week that the two operated separately.
NECC has recalled the suspect product, surrendered its license to operate in Massachusetts and suspended operations. Ameridose also has temporarily suspended operations.
"NECC's intent has always been to operate in compliance with our licenses in the states where we do business," the company said in a statement.
FEDERAL CRITICISM
The U.S. Food and Drug Administration is investigating NECC and there have been calls from some in Congress for a criminal investigation of the company.
"FDA considers this to be one of our top priorities and we are dedicating many resources to this investigation," the agency said in a statement late on Friday. Federal regulators have come under criticism for failing to prevent the outbreak by closely regulating drug compounding companies such as NECC, which prepare medications for clinics and doctors largely outside federal oversight. The FDA has said the law does not give it adequate authority to do so, leaving regulation largely to the states. "This outbreak began at a compounding pharmacy and the Food and Drug Administration has very limited authority over what these facilities produce," said a spokesman for the Health and Human Services Department in Washington. "We urge Congress to give FDA the authority it needs to ensure these kinds of outbreaks do not happen again."
NECC faces mounting threats from states as well. Several states are investigating the company and at least two - Michigan and Massachusetts - have said the company violated their regulations, according to a Reuters survey.
Some 14,000 patients received the suspect steroid medications, which were shipped to 76 facilities in 23 states as long ago as May.
Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms include headache, fever and nausea. Fungal meningitis is a rare form and is not contagious.
Cases of meningitis have been reported in Tennessee, Michigan, Florida, Idaho, Illinois, Indiana, Maryland, Minnesota, New Jersey, North Carolina, Ohio, Texas, Virginia and New Hampshire.
________________________________
Source: Yahoo News (McCune, 10/15)
Wednesday, October 10, 2012
When implanted medical devices go wrong, who pays?
.jpg "Cole Legal Group | Texas Medical Malpracitce Lawyer")
As the number of costly, high-profile recalls rises, along with pressure to cut their own spending, insurers are starting to pin more of the responsibility on manufacturers.
If they succeed, medical device makers - already worried about weaker global demand for many of their products and the impact of a new U.S. tax on their profits - will have even more costs in the wake of product recalls, the biggest of which can already lead to billions of dollars in expenses.
"The (insurance) plans are being more aggressive. The reason it gets so much more focus now is because there are so many cases," said Mark Fischer, chairman of Rawlings & Associates, a unit of the Rawlings Group that helps insurance companies recoup payments from the party that was deemed at fault for claims, a legal service known as subrogation.
In recent years, more than a hundred medical devices were recalled out of concern they could cause serious injury or death.
Rawlings is one of the largest firms providing claims recovery services for the healthcare industry, along with Trover Solutions Group, both based in Louisville, Kentucky. Others include HealthCare Subrogation Group and Meridian Resource Company.
Rawlings is currently retained to pursue more than 30 mass tort cases related to healthcare, compared with an average of about three in a given year just a decade ago, Fischer said.
"There has been a drastic increase in the number of cases being pursued," he said. Insurers tend to hire Rawlings when there are enough cases being filed over a product to warrant multi-district litigation status.
Fischer helped recover funds for insurers from claims on Sulzer Medica's defective hip implants in 2000 and Medtronic Inc's faulty Fidelis defibrillator leads in 2007.
In the Fidelis case, Medtronic settled U.S. lawsuits covering more than 9,000 individual personal injury cases for $221 million, according to their regulatory filings.
Fischer then pursued Medtronic to recover money for clients like WellPoint Inc that had paid doctors and hospitals for treatment relating to the defective leads, or wires that connect an implantable defibrillator to the heart.
He expects a settlement - the first collected from a medical device maker - to be signed by year's end, but would not give a dollar amount.
WellPoint spokeswoman Lori McLaughlin said the insurer routinely tries to collect from manufacturers on recall-related health claims.
Aetna Inc, the nation's third largest insurer, said it has managed to wrest reimbursement from drug and device markers, and has negotiated payments to patients for costs from defective or recalled products, without providing details.
Trover Solutions Chief Executive Robert Bader reckons that about 80 percent of health insurers turn to firms like his to pursue manufacturers in recall cases.
"It's the fiduciary responsibility of the insurer to recover members' premiums from the manufacturer. It's a highly specialized process and so a lot of them outsource," Bader said.
The government's Medicare health plan for the elderly recovers part of the money it paid for recall-related medical services once a settlement is reached, said spokeswoman Kathryn Ceja. She would not give details on how it pursues those funds.
FALLOUT OVER THE RIATA RECALL
A 2010 recall of Riata defibrillator leads by St. Jude Medical could become the next tug-of-war between insurers and medical device makers over who picks up the tab.
Some 79,000 U.S. heart patients still have the lead implanted in a blood vessel leading to the heart. Deciding on how to proceed is tricky since removing the leads may be riskier than leaving them in.
The Food and Drug Administration in August said all Riata patients should receive medical imaging tests to see whether the insulation covering the thin wires eroded, exposing the cables and making them more prone to short-circuit, as well as making the surrounding tissue vulnerable to heat damage.
The agency did not say how often imaging tests should be performed. But ordering just one test per patient will add millions of dollars to the cost of their care.
A single fluoroscopy - which shows a real-time, continuous X-ray image on a monitor - for each Riata patient could cost between $7.9 million and $45.3 million overall, based on a Reuters review of the procedure's cost at different hospitals.
Doctors say more than one X-ray would be needed to monitor the leads, which can remain in a patient's body for many years. Dr. Bruce Lindsay, section head of Cardiovascular Medicine at the Cleveland Clinic, said doing an annual imaging study would probably be sufficient.
Even before the FDA guidelines, Medicare covered the extra cost of imaging studies in almost every instance, doctors say. But some private insurers had balked.
"I've had to call (insurers) constantly and justify it," said Dr. Martin Burke, director of the Heart Rhythm Center at the University of Chicago Medicine.
"We're definitely finding more problems (with Riata leads), but surveillance has gone up. We're finding more because we're looking more," he said.
St. Jude spokeswoman Amy Jo Meyer said the company has expanded its regular warranty to include a baseline fluoroscopic or X-ray screening if a patient's insurer does not cover it. Paying for additional imaging would be reviewed on a case-by-case basis.
"It would not be in device makers' best interest to balk at paying these costs. In the end, they do have to stand behind their products and these products do sometimes fail," said Debbie Wang, an analyst with Morningstar.
TALLYING THE COSTS
Burke and colleagues estimate that Medtronic's Fidelis recall cost Medicare some $287 million over five years for monitoring or replacing the leads, according to a study published in the Heart Rhythm Journal.
Medtronic spokesman Chris Garland said the company gave a credit to patients for its recalled Fidelis leads, plus $1,200 for "reasonable unreimbursed medical expenses." He would not say how many people received the replacement and additional funds.
The Fidelis case was just one out of 113 medical device recalls between 2005 and 2009 classified as serious enough to cause significant health problems or death, according to an analysis published in the Archives of Internal Medicine last year. Most involved devices that correct heart problems.
The study found that 24,000 patients underwent procedures in 2005 related to problems with devices from Medtronic or from Guidant, now part of Boston Scientific Corp.
"We expect manufacturers to take reasonable responsibility for costs associated with a recall of their products to prevent the healthcare system from absorbing the impact," said Aetna spokeswoman Tammy Arnold.
_________________________
Source: Reuters (Sherman, 10/8)
Monday, October 1, 2012
When Non-Driving Factors Affect Auto Insurance Premiums
Automobile insurers may use factors unrelated to driving, like education and occupation, in determining rates.
Now, a consumer group is urging state insurance commissioners to restrict insurers’ ability to use those factors, arguing that the result has been unfairly high rates for lower-income drivers. Stephen Brobeck, executive director of the Consumer Federation of America, said in a call this week with reporters that premiums should mainly reflect factors like accidents, speeding tickets and miles driven.
The federation analyzed auto insurance premiums quoted on the Web sites of the five largest insurers (State Farm, Allstate, Geico, Progressive and Farmer’s) to price minimum liability coverage in five cities. Using an example of coverage for a 35-year-old woman with a good driving record, the study obtained quotes while varying characteristics like marital status, education level, occupation, home ownership and gaps in insurance coverage. Her driving record was the same in all instances.
The group found that in most cases, annual premiums were much lower if the woman was a married homeowner with a college degree, a professional job and continuous insurance coverage. In four of the examples, the premiums fell by at least 68 percent.
Premiums tended to be high if the woman was single, rented in a moderate-income area, had a high school degree, worked as a bank teller or clerical worker and had a gap in insurance coverage.
The analysis first obtained quotes for the “standard” example — a 35-year-old single bank teller with a high school degree and good credit record who rents a house in a moderate-income Zip code. The hypothetical woman had driven 15 years with no accidents or moving violations, and sought the minimum required liability coverage on a 2002 Honda Civic. Then, the researchers changed the criteria to see what the impact was on the quoted premium.
For instance, the “standard” quote of $2,696 from Progressive, for coverage in Baltimore, fell to $2,212 when the woman’s status was changed from single to married. And when all the criteria were changed to more a “favorable” status, the quote dropped to $718.
J. Robert Hunter, insurance director at the consumer federation, said a difference of nearly $2,000 based on non-driving factors is “patently unfair” and “actuarially unsound.”
Jeff Sibel, a spokesman for Progressive, said the insurer “works to price each driver’s policy as accurately as possible, so that every driver pays the appropriate amount based on his or her risk of having an accident.” He added: “To do this, we use many different rating factors, which sometimes include non-driving factors, that have been proven to be predictive of a person’s likelihood of being involved in a crash. Because different insurers use different information, which can cause rates to vary widely, we encourage consumers to shop around to find the combination of price and service that’s best for them.”
Alex Hageli, director of personal lines for the Property Casualty Insurers Association of America, disputed the federation’s position in an e-mail, saying that data have shown “consumers’ age, marital status, place of residence and occupation to be among the best predictors of future loss.” When such factors are “blended together” with criteria like driving experience, previous claims and vehicle age, he said, “these factors help to ensure that low-risk consumers can be better identified and pay less for insurance. In the final analysis, consumers benefit when insurance underwriting and rating decisions are based on a wide variety of fair and objective factors.”
Loretta Worters, spokeswoman for the Insurance Information Institute, an industry group, said in an e-mail, “What’s missing from the C.F.A.’s analysis is that every one of these factors that they attack is correlated, and highly correlated, with loss.”
Mr. Hunter of the consumer federation said his concern with using factors like occupation and education is that such factors are “surrogates” for criteria that states aren’t allowed to use in setting premiums, like income. At the very least, insurers should give less weight to non-driving factors in setting premiums, he said.
Los Angeles had the lowest quotes, he said, because California limits the use of non-driving factors in setting insurance rates. It is up to state insurance commissioners and legislatures to take action, he said, because auto insurance is regulated at the state level.
“We’re not trying to say get rid of these entirely,” he said. “We’re saying, you have to look at the combined effect and study these factors more carefully.”
Using non-driving factors drives up premiums, and forces many working families to drive without insurance, even though they risk paying fines or criminal charges for doing so. “Many low- and moderate-income citizens can’t afford required insurance because insurers use unfair rating factors,” he said.
__________________________
Source: The New York Times (Carrns, 9/28)
Now, a consumer group is urging state insurance commissioners to restrict insurers’ ability to use those factors, arguing that the result has been unfairly high rates for lower-income drivers. Stephen Brobeck, executive director of the Consumer Federation of America, said in a call this week with reporters that premiums should mainly reflect factors like accidents, speeding tickets and miles driven.
The federation analyzed auto insurance premiums quoted on the Web sites of the five largest insurers (State Farm, Allstate, Geico, Progressive and Farmer’s) to price minimum liability coverage in five cities. Using an example of coverage for a 35-year-old woman with a good driving record, the study obtained quotes while varying characteristics like marital status, education level, occupation, home ownership and gaps in insurance coverage. Her driving record was the same in all instances.
The group found that in most cases, annual premiums were much lower if the woman was a married homeowner with a college degree, a professional job and continuous insurance coverage. In four of the examples, the premiums fell by at least 68 percent.
Premiums tended to be high if the woman was single, rented in a moderate-income area, had a high school degree, worked as a bank teller or clerical worker and had a gap in insurance coverage.
The analysis first obtained quotes for the “standard” example — a 35-year-old single bank teller with a high school degree and good credit record who rents a house in a moderate-income Zip code. The hypothetical woman had driven 15 years with no accidents or moving violations, and sought the minimum required liability coverage on a 2002 Honda Civic. Then, the researchers changed the criteria to see what the impact was on the quoted premium.
For instance, the “standard” quote of $2,696 from Progressive, for coverage in Baltimore, fell to $2,212 when the woman’s status was changed from single to married. And when all the criteria were changed to more a “favorable” status, the quote dropped to $718.
J. Robert Hunter, insurance director at the consumer federation, said a difference of nearly $2,000 based on non-driving factors is “patently unfair” and “actuarially unsound.”
Jeff Sibel, a spokesman for Progressive, said the insurer “works to price each driver’s policy as accurately as possible, so that every driver pays the appropriate amount based on his or her risk of having an accident.” He added: “To do this, we use many different rating factors, which sometimes include non-driving factors, that have been proven to be predictive of a person’s likelihood of being involved in a crash. Because different insurers use different information, which can cause rates to vary widely, we encourage consumers to shop around to find the combination of price and service that’s best for them.”
Alex Hageli, director of personal lines for the Property Casualty Insurers Association of America, disputed the federation’s position in an e-mail, saying that data have shown “consumers’ age, marital status, place of residence and occupation to be among the best predictors of future loss.” When such factors are “blended together” with criteria like driving experience, previous claims and vehicle age, he said, “these factors help to ensure that low-risk consumers can be better identified and pay less for insurance. In the final analysis, consumers benefit when insurance underwriting and rating decisions are based on a wide variety of fair and objective factors.”
Loretta Worters, spokeswoman for the Insurance Information Institute, an industry group, said in an e-mail, “What’s missing from the C.F.A.’s analysis is that every one of these factors that they attack is correlated, and highly correlated, with loss.”
Mr. Hunter of the consumer federation said his concern with using factors like occupation and education is that such factors are “surrogates” for criteria that states aren’t allowed to use in setting premiums, like income. At the very least, insurers should give less weight to non-driving factors in setting premiums, he said.
Los Angeles had the lowest quotes, he said, because California limits the use of non-driving factors in setting insurance rates. It is up to state insurance commissioners and legislatures to take action, he said, because auto insurance is regulated at the state level.
“We’re not trying to say get rid of these entirely,” he said. “We’re saying, you have to look at the combined effect and study these factors more carefully.”
Using non-driving factors drives up premiums, and forces many working families to drive without insurance, even though they risk paying fines or criminal charges for doing so. “Many low- and moderate-income citizens can’t afford required insurance because insurers use unfair rating factors,” he said.
__________________________
Source: The New York Times (Carrns, 9/28)
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