Roads not keeping up with county population (Texas Hwy 105)

Gunn's Mazda after accident on TX 105 East

Jackie Majors still clings to the memory of her son when she drives the two-lane stretch of Texas 105 East where he was killed in a head-on collision a few months ago.

She had recently reunited with her birth son, Jerry Gunn, 19, who had years before been adopted. The night of Sept. 3, 2011, Majors lost the son she had just found and become close to, and she nearly lost three other family members.

The family was celebrating the upcoming wedding of Major’s daughter. Her husband, daughter and sister-in-law were riding in a Mazda two-door sedan that Gunn was driving. They were on their way to Conroe to pick up Jackie Majors for dinner.

Krystal Partridge, Majors’ daughter, barely remembers the crash. She does recall they had pulled out of a gas station onto Texas 105 East, behind an 18-wheeler going about 35 mph. Gunn wanted to pass the truck, she said, because the speed limit is 55 mph.

Gunn veered over to the other lane and sped up to pass, but the truck began picking up speed and may not have noticed the car was trying to pass, Partridge said.

A car was approaching in the distance, and Gunn tried to slow down to get back over, but the truck was in his way, she said.

Their car hit the oncoming Toyota head-on.

Majors’ husband had severe head trauma, four broken bones in his back, three broken ribs and a sliced speen. He was on life support for three days.

Her sister-in-law sliced her face, broke her jaw, and broke nearly a dozen bones in both her hands.

Partridge broke four bones in her back, her left arm and right leg. She also broke both shinbones, which pierced through the skin, causing her to lose so much blood she had to be rushed to Conroe Regional Medical Center so she could be stabilized enough for transport to Memorial Hermann Hospital-Texas Medical Center in Houston.

Gunn died at the scene.

Her guilt over the accident still haunts Majors, she said, because the wreck happened as her family was on their way to pick her up. She doesn’t want to think about losing one of her children and nearly losing another in the same wreck.

What she does want, she said, is for Texas 105 East to be widened so vehicles can safely pass each other instead of being forced into dangerous situations.

“Something really needs to be done about that road,” she said, “because I don’t want anyone else to go through what I did.”

Rising population, failing roads

While fatal wrecks caused by drunk driving are on the decline here because of crackdowns such as no refusal programs, Montgomery County’s roads are the biggest reason the county is still the deadliest per capita in Texas, officials say.

Fatal crashes in Montgomery County have decreased slightly over the last five years, but its rapidly growing population has helped it retain its title of the deadliest county in Texas. And Texas 105 is Montgomery County’s deadliest road, topping the list for the highest reported location of fatal crashes in 2007, 2008, 2009 and 2011, and placing second in 2010 and third in 2006.

Interstate 45, Texas 242 and FM 1314 also were consistently among the top fatal crash sites since 2006.

The state’s 11th-largest county, Montgomery County’s fatality rate has decreased slightly as its population has gone up, with an average of 1.8 fatalities per 10,000 people in 2006. That year, there were 74 fatalities, and the population was 392,500, according to Texas Department of Transportation data.

In 2010, the rate was 1.5 deaths per 10,000 people, but the county’s population was up to slightly more than 455,000, according to the U.S. Census Bureau.

The county’s many rural roads can’t handle the traffic that comes with a fast-growing population, and they can’t be expanded quickly enough to keep up, Department of Public Safety Trooper Erik Burse said.

“We’re a rural area that’s growing and we’re competing with all these big cities,” Burse said.

Montgomery County is “still a dangerous county to drive in,” said Assistant District Attorney Warren Diepraam, chief of the Vehicular Crimes Division for the Montgomery County District Attorney’s Office. “We’re basically a rural county, with a rapidly growing population.

In 2010, rural areas accounted for 56 percent of fatal crash sites in Texas. The two biggest factors are speed and alcohol.

Road conditions, construction plans

The state has many two-lane roads with high speed limits and low ditches near them, and the funds allocated to improve the state’s roads are “not enough,” said Richard Brown, area engineer for the Texas Department of Transportation.

There has been increased work done on Texas 105 East in recent years, he said, with the addition of left-turn lanes, signals and “rumble strips” with $250,000 in changes made in 2011, Brown said.

More money is planned for continued progress on the state highway, with a projected $7 million for adding alternating passing lanes and more left- and right-turn lanes to the 19-mile stretch, he said.

TxDOT has received 13 complaints related to Texas 105 since November 2010, according to its tracking system. Of those, eight related to the need for more traffic light signals, stop signs, additional lanes and turn lanes.

Complete expansion of Texas 105 East from two to four lanes is a project that may be completed in the next decade. The cost could be more than $150 million because of the expense to buy property rights of way near the road, said Stuart Corder, TxDOT director of transportation operations.

Where things get tricky is in finding money, because there’s only so much that can pay for improvements and new construction, Corder said.

“We do small things with time we have and the money we have,” he said. “Texas is very fast growing, especially the areas around Houston, and so we’re working as hard as we can with the money we have.”

Monitoring crashes and responding to citizen concerns can help TxDOT improve what it can, he said.

Cut and Shoot Mayor J.D. Roberts has made safety on Texas 105 East a priority over the past 12 years he’s served on the City Council and as mayor. Roberts joined the Montgomery County Mobility Committee eight years ago with the mission to improve the highway that runs directly through Cut and Shoot.

The committee is an informational outlet for city and school officials to meet and discuss roadway safety concerns and suggest solutions to TxDOT. Many of those changes have focused on Texas 105 East for more than a decade, Roberts said.

Improvements to the road are “a complicated issue,” Roberts said. “We have a dangerous situation, as well as our traffic.”

Traffic is often at a standstill from 4-6 p.m. most days, and the roadway is still dangerous even with the added signals and turn lanes, he said. Before the turn lanes were added, it was “nearly impossible” to turn because of the high volume of traffic.

County roads receive $1 million to $1.5 million in maintenance from the $4 million allotted annually to the budgets of each of Montgomery County’s four commissioners. With about 500 miles of roads north of Texas 105 in Precinct 1, Commissioner Mike Meador said there’s not enough money for road construction.

Money allotted for roads goes to repaving and repairing, along with mowing and litter maintenance services. Commissioners try to stay on top of rough road conditions in their precincts and make repairs when possible.

The opportunity for more money to fund road improvements looks bleak. County voters rejected a $200 million road bond in November, and Meador said another road bond is “not likely” in coming years.

“Basically, our roads in Precinct 1 and in Montgomery County are safe,” he said. “I think they’re all pretty safe if you drive the speed limit.”

Funding improvements to existing roads statewide is an ongoing problem, said state Sen. Robert Nichols, R-Jacksonville, whose District 3 includes North and East Montgomery County. During his eight-year tenure on the Texas Transportation Commission that ended in 2005, he “paid a lot of attention to safety.”

Back then, about 60 percent of vehicle fatalities in the state were on two-lane rural roads.

“There’s a lot of traffic on those two-lane rural roads,” he said. “They’re dangerous.”

In addition to the Legislature using money from the state’s transportation fund for other projects, the main reason for diminished funding, Nichols said, is the decreasing amount generated by the fuel tax. With cars achieving greater fuel efficiency every year, Nichols said, there’s barely enough money to continue road maintenance.

He proposed a bill during the last session for a constitutional amendment that would use the vehicle sales tax to finance work on roads and bridges. The bill didn’t pass, but Nichols said he plans to bring it before the Legislature again.

About $2.8 billion is generated annually in Texas from vehicle sales tax. That funding goes into the state’s general budget, Nichols said, so allotting a portion to transportation is a start.

“I think the public always likes fees to go to the service,” he said. “Why not let those fees go to infrastructure? Without cars, we wouldn’t have roadways. Everybody knows that we have to solve this problem.”

The healing continues

Majors and her family continue to heal physically and emotionally from the devastating wreck. Her husband walks with a limp, and her sister-in-law may need rods in her hands to help them completely heal.

Krystal Partridge postponed her wedding for a few weeks but after six surgeries, she married her Marine husband before he deployed to Afghanistan, going down the aisle in a wheelchair

Partridge began physical therapy Wednesday, another step in her long healing process.

As for Majors, her anger over the crash has been “placed on hold,” she said, to oversee the healing of her three family members who survived.

She relives the accident and the loss of her son every day, she said.

“They all should have been dead. I should have lost everyone in that car accident,” she said. “I don’t ever want to forget, because then he disappears.

“I don’t want his death to be in vain.”


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source: The Courier of Montgomery County (Waugh, 1/28)

Many Texas highways will soon get 75-mph speed limit

Good news for Texas leadfoots:

The speed limit will soon rise from 70 to 75 mph on nearly 1,500 miles of highway. The new limit was approved Thursday by the Texas Transportation Commission after studies on the roads determined that the change would be safe.

For Fort Worth-area motorists, the changes affect only out-of-town trips. For example, on a trip to Austin, drivers can save a few minutes by driving 75 mph on Interstate 35 south of Hillsboro. Same goes for those traveling to Abilene. They can go 75 mph on I-20 west of Weatherford.

But before you put the pedal to the metal, wait until you actually see the new speed limit signs, which will be posted in the coming days or weeks.

"The new speed limit is not official until the signs go up," warned Carol Rawson, Texas Department of Transportation traffic operations director.

Where will the new speed limits be?

I-10: 289 miles, El Paso, Gillespie, Kerr, Kendall, Bexar, Guadalupe, Caldwell, Gonzales, Fayette, Colorado, Austin, Jefferson and Orange counties.

I-20: 423 miles, Crane, Ector, Midland, Martin, Howard, Mitchell, Nolan, Taylor, Callahan, Eastland, Erath, Palo Pinto, Van Zandt, Smith, Gregg and Harrison counties.

I-27: 109 miles, Lubbock, Hale, Swisher and Randall counties.

I-30: 139 miles, Hunt, Hopkins, Franklin, Titus, Morris and Bowie counties.

I-35: 106 miles, Webb, Medina, Atascosa, Bexar, Hill and Cooke counties.

I-37: 130 miles, Nueces, San Patricio, Live Oak, Atascosa and Bexar counties.

I-40: 166 miles, Deaf Smith, Oldham, Potter, Carson, Gray, Donley and Wheeler counties.

I-44: 11 miles, Wichita County.

I-45: 143 miles, Walker, Madison, Leon, Freestone and Navarro counties.

Four other highways in Central Texas got the new speed limit late last year, all in the Austin area -- I-35 from Georgetown to Salado, and Texas 130, Texas 45 and U.S. 281 -- and a number of roads have had it for several years. Once the signs are up, Texas will have 3,063 miles of highway with a 75-mph limit.

And, of course, Texas is famous (safety advocates might say infamous) for its 80-mph limit on 521 miles of I-10 and I-20 in far West Texas.

That's a grand total of 3,584 miles where drivers can go 75 mph or faster.

While the higher threshold may be fun for speed freaks, state officials caution that being allowed to go fast doesn't necessarily mean you should.

But for those who feel comfortable driving 75 mph, tests conducted by state engineers have concluded that the roads are designed for that speed and that under current conditions the overwhelming majority of traffic is already going that fast -- illegally, for now.

"People should know we didn't make these decisions in a vacuum," said Texas Transportation Commissioner Bill Meadows of Fort Worth.

For the complete run-down, view here.

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source: Ft. Worth Star-Telegram (Dickson, 1/26)

Editor says tort-reform law hasn't benefitted Texas

(commentary by Tony Floyd, Managing Editor of Henderson Daily News)

Texas may not have been the first state to welcome tort reforms but I can’t imagine anyone embracing it with such wild enthusiasm as Texans over the past 20 years or so.

It was never hard to sell to the public because of all the promises of savings on insurance premiums touted by tort reform proponents, proving once again that everyone votes in their own self-interest when they pull the voting booth curtain.

During his failed presidential bid, Texas Gov. Rick Perry perpetuated the myth that implementing Texas-style tort reforms would go a long way toward curing what’s wrong with the healthcare system. Perry was polling at 1 percent going into the South Carolina primary.

He recommended that all states to do as Texas did in 2003 when lawmakers enacted legislation aimed at limiting the amount of money juries can award patients who win malpractice lawsuits against doctors and hospitals. The law capped non-economic (pain and suffering) damages at $250,000 in lawsuits against doctors and $750,000 against hospitals. Voters overwhelmingly approved a like-minded constitutional amendment later the same year.

Texans for Lawsuit Reform (TLR), whose political action committee has become a dominant financial engine for legislative races, has been at the forefront of tort reform efforts.

Its money tended to push out Democrats who, when considering civil justice issues, were more likely to side with the state’s trial lawyers.

Plus, tort reform’s battlefields have changed over the years, from trucking deregulation to workers’ compensation insurance reform, through the political campaigns that swung the Texas Supreme Court from a nine-member Democratic panel beholden to plaintiffs to a nine-member Republican panel beholden to TLR and like-minded people and business groups.

In the mid-1990s, TLR became a powerhouse, overshadowing older business groups and interests. When George W. Bush ran for governor in 1994, one of the four planks in his platform was tort reform. After he took office in 1995, he and the Legislature rewrote some of the state’s basic civil laws, changing the economics of suing for civil damages in Texas and putting serious hurt on trial lawyers.

According to media critic and news analyst Wendell Potter’s website, as a result of the 2003 tort reform law, malpractice liability insurers reduced their rates in Texas and, tort reform proponents say, the number of doctors applying to practice medicine in the state “skyrocketed.”

Reform proponents contend that in the first five years after tort reform was enacted, 14,498 doctors either returned to practice in Texas or began practicing here for the first time.

That’s impressive until one notes how Texas stacks up with the rest of the country in terms of physician growth in direct patient care. It appears that tort reform has not given Texas an advantage in competiting with other states for doctors, Potter wrote in his piece “The Myth of Tort Reform Benefits in Texas” on the website.

In 2008, the number of physicians in patient care per 10,000 civilian population in the United States was 25.7. At just 20.2 doctors per 10,000 people, Texas ranked near the bottom of the 50 states.

In fact, only nine states did worse. In 2000, three years before tort reform, Texas was still bringing up the rear, but not quite as badly. Back then, 11 states did worse.

It is true that medical malpractice insurance rates dropped in Texas after tort reform was enacted, but Texans would be hard pressed to claim any direct benefit — except, that is, for Texans who are doctors. Medical liability premiums have declined by nearly 30 percent since tort reforms were enacted.

A study published in The Dallas Morning News showed the average malpractice rate charged ob/gyns in Texas by the state’s largest domestic insurer of physicians fell from $53,752 in 2003 to $33,881 in 2011. Drops of similar percentages were found for doctors in family practice and general surgery.

Advocates of tort reform have long claimed that one of the reasons for escalating health care costs is that doctors over-treat and prescribe more medications and diagnostic tests than necessary out of fear of being sued. If Texans believed their own health insurance rates would go down once tort reform made these practices less prevalent, they have by now abandoned that notion, Potter wrote.

Truth is, chances of a Texas family saving a few bucks on premiums would be greater if they moved to another state.

According to Potter’s website, the average premium for family coverage in Texas was $14,526 in 2010. That’s $655 higher than the U.S. average. Those numbers indicate that doctors have not passed on their own insurance savings to patients and they are not practicing medicine any differently than before tort reform was enacted.

Not only are Texans paying more for their own insurance while doctors are paying less for theirs, their chances of getting employer-subsidized coverage is less than it would be if they lived elsewhere in the U.S.

Other new studies have found that a smaller percentage of employers in Texas offered coverage to their workers last year than in the U.S. as a whole (51 percent and 53.8 percent, respectively).

And the Texans who do have coverage through the workplace are contributing far more out of their own pockets for that coverage than people who live in most other states. In Texas last year, the average employee contribution toward company-sponsored coverage was $4,500. The U.S. average was $3,721.

Tort reforms that limit the amount that can be awarded for such noneconomic damages, as well as those that decrease awards by the amount of payments from third-party sources, aim to make it less worthwhile to pursue marginal cases, thereby reducing the number of such cases and inefficiencies in the tort system.

Other tort reforms seek to limit liability by making it more difficult to pursue cases against multiple defendants. Still other reforms focus on procedural changes, again making it less likely that marginal cases will be pursued.

In some cases, tort reforms have had the desired impact on Texas’ litigious business climate. As for when savings on insurance premiums will finally trickle down to the average working family, we could be in for a long, long wait.

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source: Henderson Daily News (Floyd, 1/23)

BMW recalling 89,000 Mini brand cars

Nearly 89,000 Mini brand cars, including the Mini Cooper line of vehicles, are being recalled in the U.S. because of faulty water pumps that can malfunction and potentially cause engine compartment fires.

The recall comes about three months after the National Highway Traffic Safety Administration opened a defects investigation, citing 12 reports of fires in the vehicles manufactured by BMW.

Five of the fires reportedly destroyed the cars, according to a NHTSA document. BMW said it is unaware of any injuries or accidents caused by pump malfunctions.

The vehicles being recalled include seven models of the Mini series, ranging in model years from 2007 to 2011. The company is recalling 235,535 worldwide, including 88,911 cars in the U.S.

"For us this is a pretty serious issue," BMW spokeswoman Nathalie Bauters said, noting that the company seldom issues full recalls.

Bauters said BMW will notify car owners by mail in February, and dealers will replace the water pumps free of charge.

The pump was designed to conduct heat away from the engine's turbocharger after the car is turned off. BMW, in a letter to NHTSA, said the pump's electronic circuit board can malfunction because of "certain design features" and in some cases overheat.

This can lead to the "smoldering of the water pump," BMW said. "It cannot be excluded that this may also lead to an engine compartment or vehicle fire."

Eric Noble, president of the CarLabs industry consulting firm in Orange, said BMW's reputation is unlikely to suffer much from the recall.

"I think this is relatively minor in terms of any impact it would have on Mini as a brand," Noble said.

"Mini buyers tend to love their Minis. This alone isn't going to change that."

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source: LA Times (Stevens, 1/17)

State attorney general sues drug company

Texas Attorney General Greg Abbott is pitted against one of the largest multinational pharmaceutical companies in a trial starting this week that could bring the state more than $1 billion - one of its largest potential awards since a multibillion-dollar tobacco settlement in 1998.

Abbott is charging that Johnson & Johnson Inc., its wholly owned subsidiary Janssen Pharmaceutical LLC and five other related companies defrauded the state in a "sophisticated marketing scheme" that caused the Texas Medicaid Program to pay too much for Janssen's schizophrenia drug Risperdal, the lawsuit says.

The state also questions the companies' marketing practices and alleges that the companies misled state health officials about the drug's effectiveness, the risk of side effects and its suitability for pediatric use.

The trial is scheduled to begin at 9 a.m. today in Judge John Dietz's 250th state District Court in Travis County.

The drug companies have denied the allegations in court documents and in a statement issued last week.

"Janssen is prepared to vigorously defend itself against these claims," the company said. "We are committed to ethical business practices and have policies in place to ensure that our products are only promoted for their FDA-approved indication. If questions are raised about adherence to our marketing and promotion policies, we act quickly to investigate the situation and take appropriate disciplinary action."

Texas got involved with Risperdal litigation about six years ago, when Abbott's office joined a lawsuit filed by corporate whistle-blower Allen Jones, who is a former employee of the office of the inspector general of Pennsylvania.

Jones has questioned the process for how Risperdal was approved in Texas and how that information was used by other states in their approval processes.

Jones filed suit in 2004 after his investigation in Pennsylvania led him to examine the companies' track record in Texas. As a whistle-blower plaintiff, he alleged that the companies overcharged the states and overstated the drug's effectiveness.

Risperdal, approved by the FDA in 1993, was one of Johnson & Johnson's top-selling drugs. Sales dropped off when Risperdal got generic competition in June 2008. Originally, the drug was only approved for adults, but later the FDA allowed it for children and the elderly.

Texas' case alleges that the drug companies prevented state health officials from receiving "truthful information about the safety, efficacy, appropriate uses and cost-effectiveness of Risperdal."

Risperdal - which once brought Johnson & Johnson more than $3.4 billion in annual sales - and similar antipsychotic drugs have been linked to increased risk of strokes and death in elderly dementia patients, seizures, major weight gain, onset of diabetes and potentially fatal high blood sugar, plus many more common but less-serious side effects. It also has been linked to lactation in some male patients, according to court documents.

The lawsuit says that Johnson & Johnson and its subsidiaries employed suspect tactics in order to sell Risperdal in the public sector, which promised to be especially lucrative. Eighty-five percent of Risperdal's revenue was projected to come from the public sector, because schizophrenic adults tend to be poor and uninsured.

"Understanding the need to obtain significant government buy-in to achieve their financial goals for Risperdal, defendants set their sights on a state with one of the largest Medicaid populations in the country - Texas," according to the filing by the state and Jones.

But getting a state like Texas to put a drug on a list of preferred medications - which the companies ultimately accomplished - can be a tremendous undertaking.

The lawsuit discusses the challenge for the companies to persuade decision-makers in Texas' public medical agencies to make the move - despite what it said was evidence that the drug is more expensive and no more effective than older medications, the state and Jones say in their lawsuit.

Johnson & Johnson and the related companies even created a special business unit called the Public Health Systems and Reimbursement Department designed to push the drug in the public sector, the lawsuit says.

The companies also had to navigate the Texas Medicaid Program's cost-savings measures , and to do so the companies employed a campaign that included misrepresentations about the drug's effectiveness and superiority over other drugs, the state alleges.

The state's case outlines allegations of kickbacks - "money going directly to key decision-makers," the lawsuit says - paid more than a decade ago to several doctors employed by the state's Health and Human Services Commission to give Risperdal preference over other antipsychotic drugs.

Jones' lawsuit claims that Risperdal became part of the treatment plan because of the drug companies' "improper influence" over Dr. Steven Shon, the former medical director for behavioral health at the Department of State Health Services. Shon had served as a paid Janssen consultant and traveled the country promoting the Texas plan. He denies the allegations in the lawsuit, however. And in 2006, he said: "I didn't personally benefit from this project."

Stephanie Goodman, a spokeswoman for the commission, said in an email last week that Shon resigned from the state in October 2006.

No state employees were named in the suit, but one of the doctors is accused of accepting an honorarium from Johnson & Johnson to fly around the country urging doctor colleagues in other states' Medicaid and mental-health programs to use Risperdal instead of other drugs, said Thomas Melsheimer, a Dallas lawyer who represents Jones and is co-counsel with the Texas attorney general in the case.

Jones' legal team also charged that the company perfected its marketing skills in Texas before reaching out to the other states in which it pushed for expanded Risperdal prescriptions.

Other states have already successfully sued Johnson & Johnson and its subsidiaries in Risperdal-related cases.

In October 2010, Louisiana got a ruling to receive $258 million from the drugmaker for violating the state's Medicaid Fraud Act.

And in June of last year, a judge in South Carolina issued an order for the defendants to pay $327 million, plus $73 million for the state's legal expenses, for misrepresentation of possible side effects of Risperdal.

Attorneys for South Carolina told The Associated Press that it was the biggest verdict in the country over the marketing of Risperdal.

By comparison, Melsheimer has said that he is seeking more than $1 billion against the companies, based on the large number of Texans who were prescribed the drug.

Texas' largest legal award came in 1998, when it won a $17.3 billion settlement from five tobacco manufacturers after suing to recover the state's cost of treating ill smokers.

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source: Austin American Statesman (Eaton, 1/8)

Family sues Johnson & Johnson, blaming Tylenol for son's death

PHILADELPHIA -- The little boy was 2 years old, and his name was River. On the night of July 22, 2010, he had a fever.

Mothers and fathers worry about little boys with fevers, so Katy Moore gave her son Very Berry Strawberry Children's Tylenol. Within 30 minutes, he was spitting up blood. By the next day, he was dead from liver failure.

In a lawsuit filed last month in Philadelphia Common Pleas Court, Daniel and Katy Moore of Ellensburg, Wash., southeast of Seattle, blame Tylenol's manufacturer, Johnson & Johnson Inc., and its McNeil Consumer Healthcare subsidiary, which has a plant and headquarters in Fort Washington, Pa. J&J officials including Chief Executive Officer Bill Weldon and other companies in the supply chain also are named as defendants.

McNeil's Fort Washington plant was closed in March 2010 after dozens of reports of manufacturing problems and warnings from the U.S. Food and Drug Administration. It won't open again until $100 million in improvements are completed and the FDA and a federal judge give their approval.

"Johnson & Johnson makes statements about their credo of putting patients first, but it's simply not true," said Philadelphia attorney Joe Messa, whose firm represents the family. "It is lip service, a marketing tool to tell the public and shareholders how wonderful they are."

In response, J&J said in a statement that while it empathized with the Moores, it strongly disagreed with the lawsuit's contention that the company was hiding its product problems at the time of River's death.

"As the makers of Tylenol (acetaminophen), we are deeply concerned about all matters related to our medicines, and we remain committed to providing safe and effective pediatric medicines," the statement said.

"While we are sympathetic to the pain and hardships suffered by the Moore Family, we must correct several of the allegations being made against our company in this suit. When McNeil Consumer Healthcare initiated several recalls for children's products in 2010, it communicated that information to the FDA, consumers, retailers and health care professionals. There were various reasons for those recalls, but they were not related to serious adverse events, as alleged in this suit."

On April 30, 2010, McNeil announced a voluntary recall of more than 136 million bottles of liquid infants' and children's products. A congressional hearing, which got considerable media attention, took place in May 2010.

The following month, there were media reports of congressional committee staff members and the FDA saying they were investigating a so-called "phantom recall," in which J&J quietly hired a company to buy all the McNeil-made Motrin that could be found on shelves in 2009 without publicity.

In May 2010, an FDA official said the agency checked on reports of a 6-year-old dying after taking cold medicines made by McNeil, but could not tie the events together.

Former McNeil employees told the Philadelphia Inquirer that problems from that era were due to a combination of increased work, staff cuts, and a change in upper management's approach. The company denied there was such a change.

Whatever the cause of the product problems, they manifested themselves in metal particles and incorrect doses in medicines and musty-smelling pills, among other issues.

"Although the public-health risk from these quality problems is low, these problems should never have occurred," FDA Deputy Commissioner Joshua Sharfstein testified at a hearing in May 2010, adding that quality-control "failures at the facility that caused them were unacceptable."

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source: News Observer (Sell, 1/5)