Generic drug makers fight rule on health risk warnings

WASHINGTON — Companies that make generic drugs, the medications most Americans buy, are fighting to kill a proposed federal regulation that would require them for the first time to warn patients of all the known health risks of each drug they sell.

The proposed rule change by the Food and Drug Administration "would be nothing short of catastrophic," said Ralph G. Neas, president of the Generic Pharmaceutical Assn., an industry trade group. It could raise healthcare costs and "create dangerous confusion" for doctors and patients, he said.

At issue is a legal loophole created by Supreme Court rulings that drew a sharp distinction between brand-name drugs and lower-cost generics, which are the same products but usually are marketed under their chemical names.

In 2009, the high court confirmed drug makers could be sued if they failed to warn patients that a brand-name drug carried a serious potential health risk.

The decision upheld a $7-million jury verdict for Diana Levine, a Vermont violinist whose lower arm was amputated after she was injected with an anti-nausea drug made by Wyeth. The drug sometimes caused gangrene if injected into an artery.

But the Supreme Court majority flipped when confronted with a generic drug that also caused a horrible side effect.

Last year, a 5-4 ruling tossed out a $21-million verdict awarded by a lower court to Karen Bartlett, a New Hampshire woman who was disfigured, badly burned and nearly blinded after she had a rare, but previously reported, reaction to a prescription painkiller.

Had Bartlett taken the brand-name drug Clinoril for her shoulder pain, she would have won her claim. But her pharmacist gave her the generic drug sulindac. And at the time, the product label did not warn patients or their doctors of the rare reaction, known as Stevens-Johnson syndrome.

Nonetheless, the court ruled generic makers were shielded from lawsuits such as Bartlett's.

Justice Clarence Thomas, who cast a key vote, reasoned that because federal regulations say generics must be exact copies of the approved brand-name drugs, their makers cannot revise or update warning labels when new risks come to light. And so, he said, they cannot be sued for failing to warn consumers.

The dissenters said this made little sense. "Nothing in the court's opinion convinces me that … Congress intended these absurd results," said Justice Sonia Sotomayor.

In November, the FDA proposed to fix the problem by allowing generic makers to change their warning labels when reports of new problems arise.

"In the current marketplace, approximately 80% of drugs dispensed are generic drugs," the agency said. "Accordingly, there is a need for [generic drug producers] to able to independently update product labeling to reflect certain newly acquired safety information."

The proposed rule change would extend legal liability as well. Any company that makes generic drugs would have an "independent responsibility to ensure its product labeling is accurate and up-to-date," the FDA said.

The proposal met fierce opposition from the generic drug industry. Its members said they "cannot support a proposed rule that undermines public health merely to facilitate litigation against generic drug companies by the plaintiff's bar."

Neas, who heads the industry group, noted that generics had lowered many Americans' healthcare costs. A study by the independent IMS Institute for Healthcare Informatics said generics had lowered healthcare costs by $1.2 trillion over the last decade.

Neas formerly led the Leadership Conference on Civil Rights and the liberal advocacy group People for the American Way, and he was credited with helping organize a national campaign that helped derail the Supreme Court nomination of Judge Robert Bork in 1987.

Neas described his group's fight against the proposed rule change as a national public education campaign.

"Our aim is to get the facts out there," he said. "This will go for some time. I don't believe this [proposed] rule benefits anyone in the healthcare system."

The FDA had planned to complete work on the proposal after hearing comments through January. It agreed to postpone the deadline until March in response to complaints from the generic drug makers. But the rule change has the backing of congressional leaders who follow health policy. They include Rep. Henry A. Waxman (D-Beverly Hills), cosponsor of the 1984 Hatch-Waxman Act, which is credited with spurring the widespread adoption of generic drugs.

"Patients should have the same rights to seek compensation if they are injured by a drug, regardless of whether it is a brand-name or a generic," Waxman said in an interview. "It doesn't make sense," he said, to have patients' rights depend on which version of a drug they took.

A growing number of drugs are sold only as generics. That shift argues for changing the federal warning rules, said Dr. Michael Carome, director of Public Citizen's Health Research Group, a nonprofit organization.

"Many potential hazards are not discovered until years after drugs have been on the market," he said. "The proposed rule would remedy this public health problem" by requiring generic makers to disclose new safety risks as they are known, he added.

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Source: L.A. Times (Savage, 2/16)

Six Flags blames roller coaster company for fatal Texas Giant accident

Six Flags claims the Texas Giant train involved in a fatal accident in July was a “defective product that was unreasonably dangerous in design, manufacture, distribution and promotion."

Rosa Esparza, a 52-year-old grandmother, died instantly when she fell from the roller coaster. Her family is suing Six Flags and Gerstlauer Amusement Rides, the German firm that made the roller coaster trains.

Arnd von Waldow, an attorney representing Gerstlauer, said he was surprised Six Flags blamed Esparza’s death on the company in a court filing Friday. He said Six Flags was not a passive customer.

“This roller coaster was built according to the specific design specifications and was reviewed, tested and approved by Six Flags,” von Waldow said. “Six Flags was intimately involved in the design and production of this roller coaster. ... Six Flags had this designed exactly the way Six Flags wanted it to be designed.”

The Arlington amusement park’s allegations against the ride company don't signal the end of the Texas Giant.

A Six Flags spokeswoman wrote in an email that the ride is safe after additions, including seat belts, were made after the accident.

“We reopened the ride last fall following the addition of incremental and overlapping safety measures that included redesigned restraint-bar pads from the manufacturer and new seat belts,”

spokeswoman Sharon Parker wrote. “The Texas Giant is safe to ride, and we look forward to opening the park for our 2014 season next week."

The original Texas Giant, a record-setting wooden roller coaster, opened at Six Flags in 1990. It closed after two decades and was rebuilt as a steel hybrid roller coaster.

The park closed the renovated ride for about two months last summer for an internal investigation and redesign. In addition to seat belts, lap bar pads were added before the ride reopened in September.

Von Waldow blamed Esparza's death on the failure of Six Flags to follow safety procedures. He pointed to witness statements in the police investigation saying that it appeared Esparza’s lap bar was too high.

If the lap bar is touching the rider’s abdomen and legs, there isn't a danger of the person falling out, von Waldow said.

He said the ride maker has photos of Six Flags engineers in Germany hanging upside down from a roller coaster train exactly like the one involved in the Texas Giant fatality.

“If they followed these procedures, this accident never would have happened,” von Waldow said.

Esparza fell 75 feet from the roller coaster train in the opening moments of the ride.

In Friday’s court filing, Six Flags says it “followed all of the recommended operation and maintenance procedures on the ride as set forth by ... [Gerstlauer] and believe they met the standard of care with regard to the inspection, maintenance and operation of the ride.”

After the accident, test seats were installed at the entrance to the Texas Giant so riders can see whether they will fit safely in the trains. When the ride reopened, Six Flags said in a written statement that “guests with unique body shapes or sizes may not fit into the restraint system.”

An early deposition in this lawsuit questioned whether Esparza’s larger size should have raised questions about the fit of the lap bar.

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Source: Dallas News (Mosier, 2/20)

Overdosing on pain reliever acetaminophen

Acetaminophen, the active ingredient in Tylenol, is one of the most popular pain relievers in the United States, but a new report by ProPublica finds acetaminophen may have caused the deaths of more than 1,500 people over 10 years.

The parents of a 12-year-old boy, Davy, told ProPublica that they took him to the hospital after treating him for a sore throat for a week with maximum strength Tylenol sore throat medicine. The hospital found that Davy had liver damage from the acetaminophen, and was declared brain dead a few days later.

"The key issue with acetaminophen is really what they call the narrow margin of error. It's the narrowest margin of error between the dose that can (help) you and the dose that can harm," said T. Christian Miller.

If users take the recommended daily dose, it's a pretty safe medicine.

"If you go over that and not too far, you can get in trouble," said Miller. When taken in larger than recommended doses, acetaminophen can damage or destroy the liver.

"What makes Tylenol unique is it's really a pretty safe medicine at the recommended doses, but if you go over two pills, four pills, six pills, eight pills over a number of days, depending on your condition, you can get into trouble with things like liver damage and even death," said Miller.

The U.S. Food and Drug Administration is still struggling to identify the number of pills over the recommended dose that could be seriously detrimental to users.

"The number they put out right now is studies show that anywhere from about four pills over, to eight pills over of extra strength, taken over several days, can get you into trouble.," said Miller. "A one-time dosage of about four times (over the recommended dose) can also get you into trouble in terms of liver damage and fatality."

Another couple Miller and his ProPublica colleague spoke to were the parents of 5-month-old Brianna Hutto, who was given Tylenol.

"The doctor then comes in and says I figured it out. It's acetaminophen poisoning. She's been poisoned by Tylenol. Her liver is failing. Her enzymes are high," Brianna's mother told ProPublica.

"How did this happen? How did she get poison or whatever from medicine that's always given, that we were told to give?" said Brianna's father.

The unfortunate story of Brianna underscores the dangers of Children's Tylenol versus Infants' Tylenol. Counter intuitively, Infants' Tylenol has a higher concentration of acetaminophen.

"What happened is the major manufacturers of acetaminophen, like Tylenol and others, were selling two different concentrations of infants' and children's, and the infants' was three times more concentrated than the children's," said Miller.

"So if you mixed up the dosage, in other words, if you gave your infant baby Infants' Tylenol at a Children's Tylenol level, you could end up poisoning them completely accidentally. That happened a number of times over 15 years, and that's what happened with the Hutto's."

CNN's medical team points out that if taken in its recommended doses, users are safe to take Tylenol, and this is not just a Tylenol problem. Acetaminophen is in hundreds of other medications, and Tylenol has a new cap that warns users about the ingredient, and to use it safely.

Tylenol said in a statement to CNN:

"As the makers of tylenol®, we understand that consumers have a need to know about the medicines they take and we have a responsibility to help them make informed choices, including helping them to understand both the benefits and the risks. When taken as directed, acetaminophen (the active ingredient in tylenol®) has one of the most favorable safety profiles among over-the-counter pain relievers. However, when an overdose is taken, it can result in serious liver damage. Consumers should always read the label on the medicines they take, never take more than the recommended dose, and talk to their doctor if they have any questions or concerns. Visit us at http://www.getreliefresponsibly.com for more information."

For people at home with Tylenol, with Infants' Tylenol and Children's Tylenol,

"If you're a parent, the number one thing is to follow what the label says. And as of now, that label is: If you have a kid under 2, call your doctor for recommendations. So that's what parents should do right now, is follow the label as it's labeled, and be careful when administering doses to their kids," said Miller.


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Source: CNN (Tapper, 9/23)

Man who bought alcohol for a minor gets 90 days in jail

(BONHAM, TEXAS) -- A Texoma mother who lost her son in a drunk driving accident wants the adults who buy alcohol for minors to face harsher punishments after she says the man who bought alcohol for her son that day got off way too easy.

Thomas Calame Robinson and his friend Jesse Runyon were killed in December of last year when Robinson took the wheel after a night of drinking. The alcohol was purchased by 24-year-old Jeremy Horton who was sentenced Wednesday to 90 days in jail.

Tamberly Robinson says her son was the love of her life.

All she has left of her 18-year-old son Thomas are pictures and memories.

Tamberly Robinson said that her son was "full of joy and happiness, he lived every day as if it were his last, he was a good kid, but like most kids he made a mistake and he paid dearly for his mistake and so did his friend."

On December 7th last year Thomas took the wheel with passenger 17-year-old Jesse Runyon after drinking alcohol that 24-year-old Jeramie Horton bought for the group of minors - two 30-packs of beer and a handle of vodka. Police say Thomas was driving at a high speed and lost control of the car, killing both of the boys. Tamberly said a text message confirmed Horton had supplied the boys with alcohol.

Tamberly Robinson " I saw it on his phone when I got it back from DPS that said here I go playing the hero again and now the hero got 90 days in jail and 2 boys are dead my son and his friend."

Robinson says the punishment doesn't fit the crime.

Tamberly Robinson said, "The laws aren't tough enough for the people that are buying alcohol for our children because our children are dying."

But Fannin County District Attorney Richard Glaser told Alexandra Carter this is the first time he's put someone in jail for providing alcohol to a minor.

Richard Glaser, " We insisted upon it in this case because of the serious consequences. We wanted to send a message to the young people in Fannin County that they need to stop and think before they either purchase it from friend or buy it from a friend because terrible things can happen."

Tamberly says she's writing lawmakers and starting a movement for harsher penalties for those who provide alcohol to minors.

Robinson, " and that's just a pain I wouldn't want anyone else to go through, but if and when it happens I would like them to have a greater sense of justice than what we got.

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Source: KXII (Carter, 8/23)

State to Feds: We Won't Enforce Insurance Reforms

Though Texas will join 26 other states in defaulting to a federal marketplace for purchasing health insurance — a major component of the Affordable Care Act — it is one of only six that will not enforce new health insurance reforms prescribed by the law. It's a decision some say could lead to confusion over who's responsible for protecting Texas insurance consumers.

Because Texas did not create its own state-based marketplace, known as a health insurance exchange, under the Affordable Care Act, it must use a federally facilitated one instead. By federal law, the state must enforce provisions and regulations related to the insurance exchange and market reforms unless it notifies the federal government that it cannot or will not. If a state does not enforce those reforms, the federal Centers for Medicare and Medicaid Services will step in to do it.

Texas, Arizona, Alabama, Missouri, Oklahoma and Wyoming have all notified the federal government that they will not be policing the health law. John Greeley, a spokesman for the Texas Department of Insurance, said his agency cannot enforce regulations tied to the federal insurance exchange or market reforms because it is not authorized to do so.

"We can't act on anything that doesn't exist in state law," he said.

Officials with CMS, who sent a letter to TDI acknowledging the state's decision, declined to comment for this story.

Stacey Pogue, a health policy analyst with the liberal Center for Public Policy Priorities, said she doesn't believe TDI's hands are tied. In the past, she said, the agency has responded to federal laws by "taking actions that ensure that they do have oversight."

The practical effects of the state's decision are not entirely clear yet. In the first show of autonomy, Texas was not required to comply with a federal request for information about its insurance plans. Most states defaulting to the federal health insurance exchange had to submit that information by July 31.

In the states that will not enforce the exchange and market reforms, the federal government will have to review insurance forms and respond to consumer complaints about health insurance, said Kevin Lucia, an assistant research professor with the Georgetown University Health Policy Institute’s Center on Health Insurance Reforms. Those duties, he added, are “typically reserved for state insurance departments.”

Pogue said the state's decision could create an “administrative burden” for insurance plans and could result in confusion for Texans who purchase health insurance under the federal exchange. For instance, she said, if people worry their insurance providers are discriminating against them based on their gender — a practice banned by the federal reforms — they may not know whether to report a complaint to CMS or to TDI.

“There’s all this opportunity to be bounced back and forth, which is a burden for consumers,” she said. If consumers have to report insurance violations to the federal government, that could prevent TDI from having a complete picture of consumers’ experience with insurance providers, she added.

“Consumers can be experiencing a lot of problems on the market that the state regulator doesn’t know about,” Pogue said.

Greeley said TDI has worked to make sure “insurers understand what their responsibilities are” under the ACA. And he said even if the state does not enforce federal regulations, TDI will still work to protect insurance consumers.

“Anybody that buys an insurance policy in Texas — no matter what line or how they got to it — can come to the Texas Department of Insurance for their questions,” he said.

David Gonzales, executive director of the Texas Association of Health Plans, said it’s unclear what impact the state's decision could have on insurance companies.

“I suspect it will be more of a burden for some plans than for others,” he said.

Pogue said inefficiencies could stem from the state’s refusal to enforce insurance reforms. TDI is the agency best equipped to regulate insurance plans in Texas, she said.

“Without a doubt they are the appropriate body,” she said.

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Source: Texas Tribune (Luthra, 8/07)

Car Insurance Rates Are Higher Based On Education, Report Says

People may be paying higher auto insurance rates if they didn’t go to college or work blue-collar jobs, according to a new report from the Consumer Federation of America (CFA)

The CFA found major auto insurance companies like GEICO, Farmers, Liberty Mutual, and Progressive charge higher rates from drivers who only have a high school diploma or a lower-status job.

Liberty Mutual, for example, charges a high school graduate 10 to 13 percent more that a college graduate, according to the report.

Companies must be doing this for a reason, but the CFA doesn’t offer any. It is unclear how education and occupation affects the level of risk involved when driving a car. Do people with less education or lower-level jobs get into more accidents? If that’s the case, then why don’t other companies like Travelers, USAA, State Farm, and Allstate use education or work status to calculate their rates? There could be a trade-off, like taking into consideration claim history, credit score, and whether the company also insures your house, business, etc., instead.

A 2012 survey showed the majority of American consumers believes using occupation or education to set rates is unfair.

CFA says it is working to stop the discriminatory factors used in calculating auto insurance premiums. The group seems to assert that giving auto quotes based on occupation is akin to a quote based on race.

“The American public knows that it is unfair for auto insurers to use factors like education and occupation in setting rates,” said J. Robert Hunter, CFA’s Director of Insurance, a former Texas Insurance Commissioner and former Federal Insurance Administrator. “In effect, auto insurers are discriminating on the basis of income and race. States should prohibit the use of these demographic factors that bear no logical relation to insurer risk.”

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Source: Opposing Views (Fruchtnicht, 7/28)

Elder abuse claim adds new liability risk for doctors

A physician who allegedly failed to refer a patient to a specialist can be liable for elder abuse, a California appeals court has ruled. The decision by the Court of Appeal for the State of California, 2nd Appellate District, said doctors can be sued for elder abuse for their outpatient treatment of seniors, regardless of whether they had “custodial obligations” to the patient.

Legal experts say the ruling broadens liability for doctors who treat older patients and exposes them to additional legal penalties when negligence claims arise. Plaintiff attorneys in states with similar elder abuse laws probably will use the California ruling as fuel to expand physician liability in their jurisdictions, legal analysts said.

“This is going to open the door for medical malpractice plaintiffs over the age of 65 to start pleading elder abuse in addition to medical malpractice,” said attorney Cassidy C. Davenport, who represents Pioneer Medical Group, the defendant in the case. “This is going to allow them to circumvent tort reform statutes” since elder abuse is not included in such medical liability reforms.

In the California case, Elizabeth Cox, 83, began receiving care at Pioneer Medical Group in Cerritos in about 2000, according to court documents. Several health professionals treated her for onychomycosis, which limits mobility and indirectly impairs peripheral circulation.

In 2007, Cox’s vascular issues worsened, and a Pioneer family physician diagnosed her with peripheral vascular disease, according to court documents. The patient’s condition continued to deteriorate, and she visited Pioneer Medical Group at least seven more times during the next two years complaining of various aliments associated with peripheral vascular disease. She was admitted to a hospital with gangrene in 2009, and her right leg was amputated. She died from blood poisoning in 2010, court documents say.

In 2011, Cox’s daughters sued Pioneer Medical Group and several staff members for elder abuse. The plaintiffs said the medical group’s continued failure not to refer Cox to a vascular specialist constituted abuse and neglect.

The medical group contended it was not liable for elder abuse because doctors treated Cox as an outpatient, and liability for elder abuse “requires assumption of custodial obligations.” The group argued the alleged conduct constituted only professional negligence and not the “reckless neglect” required for an elder abuse claim. A lower court ruled in favor of Pioneer, throwing out the case.

Appeals judges reversed. They sent the case back to the lower court, allowing the elder abuse claim to move forward against Pioneer Medical Group. Whether the defendants’ conduct was reckless is for a jury to decide, the judges said.

“The jury may view defendants failure to refer Mrs. Cox to a vascular specialist as deliberate indifference to her increasingly urgent medical needs without regard for the excessive risk to which they exposed her by their failure to seek appropriate specialized care,” the May 24 opinion said.

Pioneer Medical Group in July asked the California Supreme Court to review the decision. At this article’s deadline, the court had not said whether it would accept the case.

Investigations stem from adult protective laws

The California Medical Assn. was disappointed with the decision, saying it blurs the lines between conduct that falls under the state’s Medical Injury Compensation Reform Act and the Elder Abuse Act. The CMA issued a friend-of-the-court brief in support of Pioneer Medical Group.

“The opinion really will hurt the goals of both MICRA and the Elder Abuse Act,” said Alicia Wagnon, CMA legal counsel. “The facts of this case are so clearly professional negligence. That [these actions] can also be deemed elder abuse is simply wrong, and it really eviscerates MICRA’s definition and the purposes of MICRA.”

All states have some form of adult protective services statutes that authorize and regulate investigation of elder abuse cases. Generally, APS laws establish a system for the reporting and review of elder abuse claims and for the provision of social services to help victims, according to the American Bar Assn.’s Commission on Law and Aging. Most jurisdictions also have separate elder abuse laws that provide for civil or criminal damages in cases of elder abuse and neglect, either by individuals or institutions.

The intent of such laws is to prevent custodians from abusing and taking advantage of elderly patients, Davenport said. She notes the majority of elder abuse claims arise in the nursing home context and involve repeated acts of ignoring an elderly patient’s basic needs such as adequate food and water.

“We have an aging population in nursing homes [who are at risk] for being abused physically and financially,” she said. Elder abuse laws are intended “as an incentive to go after those who are abusing these elders. It wasn’t to say elders get extra incentive to sue the physician for medical malpractice.”

The California ruling confirms that physicians should be held responsible for recklessly failing to provide necessary medical care, said Clay Robbins III, the plaintiffs’ attorney.

“Merely because a person withholding [medical care] also happens to be a physician should not have bearing as to whether that individual should be responsible for the enhanced remedies under the act,” he said.

Jury awards not covered by insurers

The ruling is concerning for physicians who treat elderly patients, said William E. Hopkins, a health law attorney and partner at Brown McCarroll in Texas.

“Physicians are now on notice that they’re not just being judged on a negligence standard; they’re now being judged on negligence and this other standard,” he said. “I would not be surprised if [elder abuse] is pled in most cases where there’s some level of medical negligence with elderly people.”

Hopkins said Texas has an elder abuse law similar to California’s, and that he can foresee a similar case playing out in his state.

“This is the kind of case that certainly will have plaintiffs lawyers’ minds working with regard to, “Is this something I should be pleading?’ ” he said. “They’re going to pull the elder abuse act in their state and see if this kind of argument applies.”

If the decision stands, physicians found liable of elder abuse would be forced to pay jury awards out of pocket, Davenport said. Insurance policies generally do not cover elder abuse claims. Fear of such payments probably would lead to more settlements, she said.

The decision jeopardizes doctors’ professional medical judgment and could negatively affect patient care, said Bret C. Perry, an Ohio medical liability defense attorney who defends physicians, assisted-living facilities and nursing homes.

“The practice of medicine and decisions made on a daily basis by physicians and health care professionals cannot be legislated, and those decisions clearly fall within the purview of professional judgment,” he said in an email. “If this ruling is permitted to stand, I can foresee a chilling effect and negative impact on the future of medical care for the elderly and potentially an exodus of professionals leaving the state due to this type of potential liability.”

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Source: Amed (Gallegos, 7/22)

FDA reconsiders generic drug warning labels

In a recent post, I noted the Catch-22 that the Supreme Court insists Congress created with its fast-track approvals for generic drugs. Those who are injured by a brand-name drug can win compensation from the manufacturer if they can show the drug was unreasonably dangerous or that its warning label didn't disclose the risks properly. But those injured by a generic medicine can't hold the manufacturer liable as long as the drug maker used the same active ingredients and displayed the same warnings as the brand-name drug.

The Food and Drug Administration has been considering changes to its labeling rules aimed at giving generic drug users more protection. And last week, the Obama administration filed notice that the FDA's efforts are coming closer to bearing fruit.

According to the notice, the FDA is working on a rule that would "revise and clarify procedures for changes to the labeling" of approved drugs, whether they be name brand names, generics or biologics. The change would either enable or require -- it's not clear from the limited information released by the FDA -- drug makers to make public possible changes to their warnings while the FDA was considering them. And it would make clear that both the brand-name and the generic versions of the drug would have to change their warning labels in the event that the FDA acted on a proposed change emanating from either camp.

The FDA is expected to formally propose its new rule sometime in September.

At issue is something called a "changes being effected" supplement. When drug makers learn of adverse reactions to their products or have new reasons to doubt the adequacy of their warning labels, they're obligated to inform the FDA. The makers of brand-name drugs can seek approval for new warnings and are allowed to alert the public about such developments through a "changes being effected" supplement before the FDA acts.

Generic drug makers aren't allowed to do that, however, even though they are required to tell the FDA about new evidence that might demand a change in their warning labels. They have to wait until the FDA formally decides that the warning label for that drug -- and its brand-name counterparts -- must be changed. If the brand-name version is no longer being marketed, the FDA has some flexibility to work with the makers of generic versions to update their labels, a spokeswoman for the FDA said.

The notice filed Wednesday says the FDA's new rules "would create parity" between brand-name and generic drug makers "with respect to submission of [changes being effected] labeling supplements." That strongly suggests generic drug makers would be able to make unilateral changes to their warning labels too.

The implication of the new rule is that it would reopen the door to lawsuits by such victims as Karen Bartlett, who was disfigured and nearly blinded by an adverse reaction to a generic anti-inflammatory drug. The Supreme Court overturned a New Hampshire jury's decision to award Bartlett $21 million, saying that as long as the drug manufacturer complied with federal requirements to use the same formulation and warning label as the brand-name product, it could not be held liable under New Hampshire law for selling an unreasonably dangerous drug. Justice Samuel A. Alito Jr. said the state law put generic drug makers in an impossible bind because the only way they could avoid liability for products that prove to be unreasonably dangerous would be to change the warning labels that federal law forbids them to alter.

The FDA's new approach, however, may permit generic drug makers to give supplemental warnings about new or heightened risks before the agency formally approves changes to the label for the brand-name and generic versions of the drug. That, in turn, would invite lawyers for injured patients to argue in court that generic drugs were unreasonably dangerous if they could have carried such an extra warning but didn't.

The trade association for generic drug makers sounded a cautious note about the FDA's minimally detailed proposal. "Our members have a long history of working closely with FDA to ensure that Americans have access to safe, affordable generic medicines, and we look forward to working with FDA on this important issue," said Ralph G. Neas, head of the Generic Pharmaceutical Assn.

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Source: Opinio L.A. (Healey, 7/08)

The Texas Fertilizer Plant Explosion Wasn't an Accident

Almost everyone in America knows the names of the two young terrorists allegedly responsible for the April 15 Boston Marathon bombings, but few can identify the owner of the fertilizer plant that exploded in West, Texas, two days later. Both are culpable of killing innocent people, but the media, along with government regulators and law enforcement agencies, poured much more time and resources into finding the two Tsarnaev brothers than they did in investigating Donald Adair. Crime in the streets (particularly by terrorists) is big news but crime in the suites rarely makes headlines.

Why isn't the American public calling for the arrest, conviction, and imprisonment of Adair, the owner of the West Fertilizer Company in West, Texas, where an explosion on April 17 killed 14 people, left 200 others with injuries (including burns, lacerations, and broken bones), flattened houses and a 50-unit apartment building, destroyed a nursing home, damaged a local school, and left a crater 93 feet by 10 feet?

The explosion was so devastating that investigators, almost two months after the incident, are unable to definitively determine the exact cause of the explosion. But it is possible that Adair -- who also owns Adair Grain (the parent company of West Fertilizer) and Adair Farms, including about 5,000 acres of cropland and grassland in the area, worth several million dollars -- consistently flouted the law and common sense safety measures that put both his employees and the surrounding community at risk.

When 84-year-old Eula Bingham, OSHA chief under President Jimmy Carter, heard the news about the West, Texas, explosion, she thought, "Oh my god a fertilizer plant." According to Bingham, "fertilizer plants are well known as the most horrible, explosive places in the world." Adair had ample opportunity to know and follow the law and certainly knew the consequences of failure.

After 9/11 companies like Adair's were required to inform the government of chemicals that could be used in terrorist attacks. West Fertilizer stored large quantities of anhydrous ammonia and ammonium nitrate, in the middle of a small town. The company failed to tell the Department of Homeland Security that it was storing 270 tons of ammonium nitrate (the same chemical that Tim McVeigh used to bomb the Oklahoma city federal building in 1995, which left 168 people dead) as required by law.

The U.S. Pipeline and Hazardous Materials Safety Administration fined the factory in 1985 for mishandling storage of anhydrous ammonia. In 2011, the same agency cited the firm for "not having a security plan" and for improperly planning to transport anhydrous ammonia and issued a fine of $5,250.

The federal EPA last inspected the plant in 2006 and assessed a fine of $2,300 for failing to update a risk management plan. The company responded in 2011 with an updated but misleading plan, stating that its chemicals did not pose a risk or fire or explosion, and claiming that the "worse-case scenario" was a 10-minute release of gas or a leak from a broken house, neither of them harmful to human.

The company also reported contradictory information to state agencies. It filed reports with the Department of State Health Services that it had not stored ammonium nitrate on site until 2012. Yet it reported to the Texas Commission on Environmental Quality that it had a "maximum annual through put" of 2400 tons, or 4.8 million pounds of ammonium nitrate after the department found that it was operating without a permit.

Adair ran a fertilizer company that stored tons of highly explosive ammonium nitrate, failed to follow government safety guidelines and -- laws or no laws -- shirked his basic responsibility to prevent a foreseeable, preventable and tragic disaster. Is he any less a killer than the Boston bombers?

If so, Adair shares that responsibility with others. There are at least 2,500 facilities around the country that could each put over 10,000 people at risk in the event of an accident, according to a recent Congressional Research Service memo. Last year alone, 1,270 people died in over 30,000 chemical spills and accidents.

Corporate lobby groups have consistently opposed common sense safeguards for our food, consumer products, environment, drugs, and workplaces. They've spent billions of dollars in campaign contributions, lobbyists and donations to conservative think tanks and front groups to oppose and weaken these and other safety laws and gut the budgets of government agencies set up to enforce them. Their resistance delayed life-saving protections for decades in some cases. The chemical industry has been one of the most effective lobby groups in this regard. In the 1970s, for example, the industry lobbied Congress to prohibit OSHA from regularly inspecting workplaces with fewer than 10 employees in industries with low reported injury rates. Fertilizer plants are included on the list of exempted industries. This may be why OSHA hadn't inspected the West Fertilizer plant since 1985.

The chemical industry opposed a 1981 OSHA "hazard communication" rule requiring employers to label toxic chemicals used by workers on the job. The common sense rules would have put "virtually unmanageable burdens on small manufacturers," according to Ralph Engel representing the Chemical Specialties Manufacturers Association. Engle claimed that "workers would be just as safe without this regulation." It's hard to imagine workers able to take proper precautions when they don't know about the dangers of the poisons they work with.

The chemical industry successfully delayed federal "right to know" legislation requiring disclosure of toxic chemicals to workers and nearby communities until a 1984 gas leak at a Union Carbide factory in Bhopal, India exposed 500,00 people to toxic gas that killed nearly 4,000 and disabled many more. The disaster created public demand for action that overwhelmed industry opposition and led to the Emergency Planning and Community Right to Know Act of 1986. Eugene Humphrey, representing the Organic Chemical Manufacturers Association, testified before Congress that disclosing the existence of dangerous chemicals would burden small business and wouldn't "significantly improve the protection of human health or the environment."

In 1992, the Fertilizer Institute, another trade group, successfully lobbied for a "retail exemption" rule that allows facilities storing large amounts of dangerous chemicals to avoid strict OSHA and EPA regulation if they sell more than half of their chemicals to "end users," including farmers. It is possible that West Fertilizer claimed this exemption, even though the amount of anhydrous ammonia stored at the facility would otherwise have required extensive precautions.

In 2009 the chemical industry -- joined by major business lobby groups such as the U.S. Chamber of Commerce and the American Farm Bureau -- spent $51 million pressuring Congress to oppose legislation that would have tightened security standards on chemical factories, fertilizer depots and water-treatment plants. The lobbying effort included "mining companies, refiners, paint makers, explosive fabricators and fertilizer plants," according to Bloomberg News. The industry -- including such giant firms as Dow Chemical and DuPont -- donated $34 million to political candidates in the last three elections, two-thirds of which went to Republicans. "If enacted, it could lead to disruption in our nation's food supply," the U.S. Chamber of Commerce and 25 other groups representing companies that mine, refine fuels, mill grains or make fertilizer, wrote in a letter to congressional leaders. The CEOs of these corporations, and the heads of their corporate industry lobby groups, don't intentionally want to see Americans killed or injured by unsafe workplaces, dangerous consumer products, and unhealthy toxic chemicals that destroy people's health. But by pushing Congress and state governments to weaken safety and health standards, and to slash budgets for inspection and enforcement, they make it inevitable that many Americans will needlessly die, suffer injuries, and ruin their health.

Business lobbies want to be free from government rules. Unfortunately, their freedom leads to tragedy for workers, families and communities.

Texas prides itself on the lack of rules for businesses. Texas is the only state that doesn't require companies to have workers compensation insurance. Houston is one of the few cities that have no zoning laws to create buffers between schools, homes and toxic chemical manufacturers. Texas doesn't have a state fire code and prohibits small counties from having local codes allowing fire marshals to inspect and prohibit the storage of highly flammable and explosive chemicals near homes and schools. According to the New York Times, some Texas counties even cite the lack of local fire codes as a reason for companies to move there.

Texas lawmakers have also recently sought to further weaken the state environmental agency that oversaw the West plant and reduced its budget by $305 million. Even after the explosion, Texas Governor Rick Perry claimed that more government oversight and more safeguards aren't needed.

The harsh reality is that none of the state or federal agencies has enough budget and staff to routinely inspect and enforce the laws on the books. For example, OSHA's tiny staff of around 2,400 inspectors is spread so thin that it would take more than 90 years to conduct even cursory inspections of all eligible workplaces in Texas.

We can't depend on government agencies to police every company and workplace to guarantee our safety and health. We have to expect businesses -- big and small alike -- to obey the law and take every precaution, whether required by government or not, to prevent the kind of needless death and destruction that happened in West, Tex. That is both their legal and moral responsibility, the social contract they agree to in order to stay in business and make a profit.

If they put profit before people, and allow greed or indifference to put lives at risk, they should be punished, even if an OSHA, EPA, or FDA inspector hadn't visited their operation for the past six months, year, or five years.

Corporate criminals rarely get caught. But even when they do, they rarely suffer sufficient consequences to deter them or their counterparts from routinely flouting health and safety laws. And even when they are found guilty, the fines are rarely big enough to make them change their ways.

Last year, for example, a serious violation of the federal Occupational Safety and Health Act drew an average penalty of $2,156. State-level OSHA agencies imposed an average $974 penalty for a serious violation. The median penalty in fatality cases investigated by federal OSHA was a meager $6,625. Corporations view these as just a cost of doing business, not a real deterrent.

Corporate lobbies routinely block laws that would impose stiffer penalties -- and would thusly serve as real incentive for businesses to change their behavior rather than cut corners, flout the law, and put human lives at risk.

America's criminal justice system operates on a double standard -- one for the rich and one for everyone else. According to federal law, someone caught using illegal food stamps goes to jail for one year. Senator Lindsey Graham, one of the architects of the bipartisan immigration bill, recently told reporters that employers who hire an undocumented worker will "get fined heavily, lose your business or may go to jail." It's hard to imagine Graham making the same argument about employers that flout workplace safety laws or the Clean Air Act.

By using their political clout to oppose and weaken health and safety laws, by violating laws because they don't think they'll get caught, and by viewing the small fines and sanctions they will face as simply a cost of doing business, America's corporate executives do more harm to society -- more deaths, more injuries, more chronic health problems -- than all the lunatics, sociopaths, and spouse abusers who kill and injure people by pulling the triggers of their guns.

Perhaps if corporate executives saw a significant number of their counterparts on the nightly news being handcuffed and sent to jail for violating laws meant to protect workers, consumers, and the environment, they would be more likely to make sure that their companies met the health and safety standards embodies in our laws.

Surely Donald Adair did not want to see his friends and neighbors in West suffer death and injury from explosion in his fertilizer plant. But he is culpable nonetheless for flouting the laws and shirking responsibilities that would make such explosions less likely. The explosion -- and thus the deaths and injuries -- was preventable. Perhaps people in West, Texas give Adair a pass because he's a local man who runs a small family-owned business. Does that make him any less of a killer?

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Source: The Blog (Dreier, 6/4)

Texas senator says 0.05 blood alcohol limit ‘not realistic’

Don’t expect Texas’ legal blood alcohol limit for drunken driving to fall to 0.05, at least not while state Sen. John Whitmire, D-Houston, is still running the Senate Criminal Justice Committee.

“It’s just not realistic, if you’re going to drink at all,” said Whitmire, who was chairing that same committee in 1999 when Texas joined a nationwide movement and lowered the limit from 0.1 to the current 0.08. A woman weighing 120 pounds or less can reach a 0.05 blood alcohol limit with just one drink, studies show.

Meanwhile, the Texas office of Mothers Against Drunk Driving said a 0.05 limit would save lives in the long run.

The National Transportation Safety Board staff recommended the lower threshold as one of several recommendations aimed at reducing drunken driving.

Angela Tidwell, law enforcement program specialist for the Texas office of MADD, said the recommendation isn’t aimed at stripping people of their right to drink.

“We’re not trying to be prohibitionists,” she said. “We just want everyone to get home safe.”

Austin Police Chief Art Acevedo said in a statement Tuesday the idea was worth exploring, but he stopped short of endorsing it.

“APD is aware that this issue is being discussed at the national level,” Acevedo said. “It is a standard that has been adopted in other Western nations and an issue worthy of robust exploration and debate.”

Whitmire said that those campaigning in 1999 for the 0.08 blood alcohol content threshold said that would be as low a limit as they would seek. The lobbyist for MADD, Whitmire said, told him “you’re not going to see us again on this.”

What needs to happen, he said, is more education about the dangers of driving while intoxicated, and encouragement for people to use a designated driver. Whitmire said, only half-jokingly, that setting the limit at 0.05 would have the effect of criminalizing mouthwash.


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Source: Austin American-Stateman (Chang, 5/14)

To text or not to text

A proposed statewide law banning texting while driving may make Texas roads safer — but the question is if it’s enforceable.

The bill that would make cellphone texting while driving illegal passed its final reading in the Texas House on Thursday, April 18, by a vote of 97-45. The Senate will review the bill next, and if it is successful there, it will go to Gov. Rick Perry.

The governor vetoed a similar bill in 2011.

The current bill, HB 63, was sponsored by Rep. Tom Craddick, R-Midland. It is referred to as the Alex Brown Memorial Act in honor of West Texas teen Alex Brown, who was texting when she died in a vehicle accident in 2009.

If the bill becomes law, a driver caught texting would face a $100 fine for a first offense and a $200 fine for a second offense.

Lubbock County Sheriff’s Office spokesman Lt. Bryan Taylor said he isn’t familiar with the bill’s language but personally supports any legislation that gets drivers off their phones.

“I think it’s gonna save lives,” Taylor said. “The whole concept is beneficial.”

As written, the bill would still allow people to look up phone numbers and talk on their cellphones. This aspect of the bill might cause problems for lawmen trying to enforce it.

An email sent to Craddick’s office asking why he didn’t include all cellphone use in the bill wasn’t immediately answered.

Lubbock Police Department Sgt. Jason Lewis said he hadn’t read the bill, but if people are still allowed to use their phones for some functions it could make enforcing the law a challenge.

Trying to determine just what a driver is doing on the phone could be difficult, but Lewis has an example to illustrate where it wouldn’t be. He said if an officer sees a driver sitting through a green light while using a phone, it’s pretty obvious what the driver is doing.

Taylor agreed with Lewis that the proposed law may pose enforceability issues for officers if suspected texters refuse to allow police to look at their phones to obtain definitive proof they were texting while driving.

Currently, Lubbock has a city ordinance that prohibits the use of electronic devices in active school zones. Some Texas cities have already enacted ordinances that are stricter than Lubbock’s ordinance or the proposed bill.

Amarillo enacted an ordinance last year that made cellphone use illegal while driving.

Amarillo Police Department spokesman Cpl. Jerry Neufeld said APD officers have written 25 tickets to violators of the ordinance since February.

If the bill becomes law, Amarillo’s ordinance will be voided because municipalities can’t make ordinances that are more strict than state laws.

Neufeld said his department isn’t worried about whether or not the bill is signed into law, and APD generally doesn’t comment on pending legislation.

“We’ll just follow the rules that are given to us,” he said.

The Texas Department of Public Safety isn’t commenting on the pending legislation either, according to Sgt. Bryan Witt. He deferred comment on the matter to Tom Vinger, the department’s spokesman in Austin.

DPS does not take positions on any proposed legislation, Vinger said in an email. Further, in certain cases, a department employee may provide testimony or serve as a resource witness during a committee hearing as requested by a member of the Texas Legislature.

He was unsure if any member of DPS had testified before the House on this matter.

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source: Lubbockonline (Loesch, 4/20)

Mass. pharmacy recalling some compounded products

BOSTON— A Massachusetts pharmacy issued a voluntary recall Monday of some of its sterile compounding products after "foreign matter" was found in drug vials during an unannounced inspection by state and federal officials.

Pallimed Solutions Inc., of Woburn, was also ordered by the state board of pharmacy to stop all sterile compounding activities until further notice.

Most of the recalled items were used to prepare erectile dysfunction treatments for patients who have difficulty taking drugs orally. The company said fewer than 800 patients were involved.

The company described the recall as a precautionary measure and said it had received no reports of any illnesses or injuries. It also said it would continue with nonsterile compounding.

The Massachusetts Department of Public Health said it requested the recall after a joint inspection on Friday by the state pharmacy board and the U.S. Food and Drug Administration.

"The cease and desist was issued after foreign matter was observed in vials of injectable drugs," the Department of Public Health said in a statement.

Pallimed also was ordered to place all its compounded sterile products into quarantine while the investigation continued.

The company said there was no indication the products were tainted or unsafe. The state also said there were no reports of any patient harm.

A message was left with the FDA.

Massachusetts stepped up unannounced inspections of compounding pharmacies after a deadly fungal meningitis outbreak last year was linked to an injectable steroid produced at another Massachusetts company, New England Compounding Center.

That outbreak was responsible for 720 illnesses in 20 states, including 48 deaths, according to the most recent update from the Centers for Disease Control and Prevention.

Framingham-based NECC ceased operations in October and surrendered its license to the Massachusetts board.

Pallimed Solutions is a 7-year-old company that does business as Pallimed Pharmacy and has about 15 employees, according to its website. It said it regretted any impact on customers and that patient safety was its top priority.

"By undertaking this recall action, Pallimed will move forward to ensure that our products always meet the highest standards of safety and customer expectations," the company said in its statement.

On Nov. 27, the state ordered Pallimed to temporarily stop production of sildenafil citrate — the active ingredient in Viagra — for human use after inspectors found it had been prepared with improper components. The company said those issues were administrative in nature and had been resolved, and Monday's announcement was unrelated.

The state said the earlier order was still in place, pending the board's acceptance of a corrective plan.

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Source: WFAA (AP, 3/25)