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)

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)

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)

Daughters say patient safety compromised at Dallas VA Hospital

Patient safety at the Dallas Veterans Administration Hospital is again being called into question.

Considered to be the agency's worst facility in 2004, the Dallas VA Hospital has received more than 30 certification agency complaints in the last three years.

And now, there are two more.

Two daughters agreed to discuss the deaths of their fathers and the conditions they say no veteran should have to endure.

The Veterans Administration is the largest health care system in the nation, serving more than eight million veterans a year. VA officials in Washington D.C. pledge “to never compromise the safety, security or well-being of veterans."

Sydney Schoellman says the government has shattered that pledge.

Her father, Korean War veteran Gary Willingham, trusted his care to doctors at the Dallas VA hospital. In November 2010, Willingham went to the VA for what his daughter believed would be a short operation to remove a tumor from his neck.

But six hours after surgery began, Schoellman said two doctors finally emerged. "They never really admitted that anything went terribly wrong,” she said. "They kind of just padded around that."

Schoellman said what they did tell her is that her father had lost a lot of blood, and that they had accidentally clamped off his carotid artery for six minutes.

When she and her family were allowed to see Willingham, she said she was in shock.

"What we saw wasn't the man we grew up with," Schoellman said. "That wasn't the man that we'd seen how many hours earlier." With his carotid artery clamped and his brain starved of oxygen, Willingham had, in effect, suffered a debilitating stroke. Schoellman's once-energetic father was now bedridden and would spend the next year before he died unable to eat or drink on his own. Outraged, Schoellman started to dig, asking for the detailed surgical notes from the day of the operation.

"I was informed by one of the employees at the Dallas VA that I should get those records before they disappeared," she said. Deep in the surgical notes Schoellman said she found a disturbing revelation: The carotid artery had been clamped not for six minutes — as she said she was told — but for 15 minutes.

"If we had known it was 15 minutes, we wouldn't have allowed the things that went on. We would have let him end his life with dignity and the grace he lived it with before the surgery," Schoellman said.

Willingham's family has since filed a formal complaint and a legal claim against the Dallas VA for improper care. Tammie Wilson has also filed a complaint with the Dallas VA, saying her father — decorated Vietnam vet Gary McGrew — was stripped of his dignity as well.

Admitted to the Dallas VA this past February with two broken arms, Wilson said her father agonized for hours without pain medicine. "They just dawdled and dawdled, and it might have been six hours in-between," Wilson said. "I would just keep going out to the nurses' station saying, "Please, please!' They would respond slowly, if at all."

Wilson said no one seemed to be aware that her father was in his final stages in a fight with cancer. She said nurses were still trying to feed him in the minutes he was taking his last breaths.

"Here comes this nurse, stirring up the same pills and the same apple sauce he had spit out the night before because he couldn't even take a drink of water," Wilson said.

Administrators at the Dallas VA have declined to discuss either of the complaints with News 8, saying they either can't due to pending legal action or to lack of proper authorization.

They also say the complaints filed against them with the Joint Commission, the hospital accreditation agency, have been investigated and closed. They said the VA "maintains a safe and sanitary environment" and "invite families to discuss their concerns and complaints ... through several means available to them."

Schoellman said the only means left for her family is the courts, along with her ability to speak out for the veterans who cannot. "These are some of the greatest national treasures that we have, and they walk in every day, and these families are blindsided by the pain and the agony of losing someone at the hands of people who are never held accountable," Schoellman said.

Last fall, News 8 investigated complaints about quality of care at the Dallas VA. The Inspector General with the Veterans Administration last fall also found excessive wait times and irregularities with referrals and appointments.

Rep. Eddie Bernice Johnson (D-Dallas) said her office has also received complaints.

"While I am unable to comment directly on any information I have received from my constituents, many of these complaints pertain directly to the quality and timeliness of patient care," Johnson said. "The VA’s own Inspector General reports — which are public record — bear out the delays and shortcomings in patient care."

“I have repeatedly expressed my concerns to the VA in Dallas and in Washington D.C., in direct response to those complaints," the congresswoman added. "The single most important responsibility of the VA is to meet the health challenges that our veterans face. While I have worked directly with [VA] Secretary [Eric] Shinseki's office on numerous occasions within the past year, the VA at the local and federal levels have not responded impartially to these complaints. It has always been my hope that the leadership at the VA would have taken their own initiative to address these issues. I will do everything necessary to address the concerns of my constituents and patients of the VA North Texas Healthcare System. So long as the VA’s ability to meet those challenges remains in question, I will not rest until these issues are resolved.”

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Source: WFAA (AP, 6/10)