Entries in Lawsuits (4)


FDA Rule Could Make Generic Drugmakers More Liable to Lawsuits

iStockphoto/Thinkstock(NEW YORK) -- A new rule could open the door for lawsuits against generic drugmakers, which are currently protected by a legal obligation to copy the formulas and labels of their name-brand counterparts.

The rule, proposed Wednesday by the U.S. Food and Drug Administration, would allow generic drugmakers to change their labels to reflect "newly acquired information," such as safety risks.

The proposal comes a week after the Supreme Court stripped Karen Bartlett of $21 million in damages awarded to her by a jury after she was burned and blinded by the generic painkiller Sulindac.

"I was numb," Bartlett said of the moment her lawyer delivered the news. "I don't even have words to describe it because I can't believe that they would do that."

Bartlett remembers little from the three months she spent at Massachusetts General Hospital in 2004 "wrapped up like a mummy" as the skin eroded over two-thirds of her body. She was diagnosed with Stevens-Johnson syndrome, a rare and sometimes fatal reaction triggered by certain medications, including nonsteroidal anti-inflammatory drugs such as Clinoril and Sulindac.

The ordeal left her disfigured and legally blind. She also has lung damage and difficulty swallowing, she said.

"I have no independence," said Bartlett, 53, who lives off disability checks for a fraction of the salary she once earned as a secretary at an insurance company in Plaistow, N.H. "This ruined my life, basically."'

At the time of Bartlett's reaction, Sulindac's label did not specifically warn about Stevens-Johnson syndrome, the Supreme Court acknowledged, although it did warn that the drug could cause "severe skin reactions" and "fatalities." But under federal law, generic drugs must be chemically identical to the FDA-approved brand-name drug and don the same warning label.

"Here, it is impossible for Mutual [the maker of Sulindac] to comply with both its federal-law duty not to alter Sulindac's label or composition and its state-law duty to either strengthen the warnings on Sulindac's label or change Sulindac's design," Supreme Court Justice Samuel Anthony Alito Jr. wrote in the majority opinion of the court.

Under the new rule, generic drugmakers could strengthen the language of their warning labels independently.

Consumer watchdog group Public Citizen applauded the FDA, having petitioned for a similar rule in 2011.

"Many potential hazards are not discovered until years after drugs have been on the market," Public Citizen's Health Research Group founder Dr. Sidney Wolfe said in a statement. "Yet, currently, generic drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk."

"The proposed rule is a classic example of harm reduction," Wolfe added. "When finalized after public comments, it will provide added protection to the tens of millions of people who regularly use generic drugs."

Copyright 2013 ABC News Radio


Mentally Disabled Couple's Legal Battle Ends with New Home

iStockphoto(RIVERHEAD, N.Y.) -- A newly married, mentally disabled couple's dream of living together -- up until now beset by legal troubles and care facilities that refused their wishes -- is about to come true. New York State is providing them with a home of their own.

Paul Forziano, 30, and Hava Samuels, 36, who both have mild to moderate mental disabilities, met seven years ago at a day program run by the Maryhaven Center of Hope, which is part of Catholic Health Services of Long Island. After they met, they immediately began telling their parents about their new friend. It wasn't long before they were calling each other "boyfriend" and "girlfriend."

On April 7, 2012, they married on Long Island's North Shore.

The wedding was initially pushed back because the couple wanted to be able to live together once they were married. So before their big day, their parents began trying to find a way for the two, who lived in separate group homes three miles apart, to establish a home together.

"They started dating, and gradually got more and more serious about each other," Paul's mother, Roseann Forziano, told "Four years ago they started talking about getting married. At the time I didn't know if people with developmental disabilities could be married. So I started doing research."

Forziano said that she "naively" approached the Independent Group Home Living Program (IGHL), which has housed her son since 2009, and asked if this could be facilitated. She told that the state-sanctioned nonprofit that ran the home told her that the couple would not be allowed to share a living space within the program.

Eventually the families would file a lawsuit in January 2013, claiming that the IGHL, the Maryhaven Center for Hope, where Hava lived, and the state were violating the couple's rights under the Americans with Disabilities Act, the Fair Housing Act and the 14th Amendment.

According to that suit, IGHL's clinical director had concluded that Paul and Hava were not capable of cohabitation. The director stated that if a person "cannot wash, cook, iron, and take care of money for themselves, then that person cannot take care of another person," according to the complaint.

Undeterred by this conclusion, Forziano and her husband decided to research the rights of their son and his wife-to-be.

"We went to the law library and looked up regulations," she said. "They said that agencies cannot deny people's civil rights. The state has to regulate the agencies, and ensure that they uphold [Paul and Hava's] civil rights."

Forziano said that she and her future in-laws then had her son and his bride-to-be assessed by psychologists at the YAI Agency in Manhattan to determine whether they were emotionally and mentally mature enough for a sexual relationship. The couple attended relationship counseling, and based on this, a psychologist from the Cody Center for Autism and Developmental Disabilities at Stony Brook University concluded that the couple's desire to marry was appropriate.

Still, the families continued to hit roadblocks in trying to secure housing for the couple with representatives from IGHL unresponsive to the couple's desires, according to the suit.

Ultimately Forziano and her husband, along with Hava's parents, decided that IGHL, Maryhaven and the state had failed to provide adequate assistance in finding Paul and Hava a home. That's when they decided to sue.

Norman Samuels, Hava's father, told that he and his wife, Bonnie, were repeatedly told by Maryhaven that they didn't feel Hava was clinically capable of being in a marriage.

"We were led to believe that in order to be married and cohabitate, they'd have to prove that they were [capable]. That is not valid," he said. "We were misled. We spent a year and half going through those steps, because we believed it had to be done that way."

Samuels said that that Maryhaven used an outdated mode of psychological analysis to establish whether Hava was able to consent to marriage and sexual relations -- a tool which he says is invalid. Maryhaven, he said, also refused to educate her.

"They said, 'We don't have the facilities to educate them.' That's not even valid," he told "They could have hired someone. They didn't want to do it. In our mind they were just against it all along."

Attorney Robert Briglio, who is representing the families, told that the homes where Paul and Hava reside are trying to maximize the homes' independent decision making, and that the state of New York must be held responsible for how they're run.

"[The state] funds these homes to provide Medicaid waiver services," he said. "That's the program under which the clients are residing. The New York State Office for People with Developmental Disabilities is responsible for that program. They use private agencies like these homes. That doesn't mean [the state is] not responsible for how that program is operated."

Representatives from IGHL declined to speak with regarding the case.

Christine Hendriks, a spokeswoman for Catholic Health Services of Long Island, said in a statement that Maryhaven Center of Hope has "supported and facilitated efforts" in which clients have expressed a desire to build a relationship in the hope it leads to marriage.

"There are instances where facilitating a marriage is not warranted, indicated or appropriate in our clinical setting," she said in a statement. "When a resident in our judgment is clinically incapable or lacks the requisite ability to consent to the marital relationship or requires a level of service and supervision where an accommodation is not possible, we cannot provide the services necessary to facilitate the marital relationship and cohabitation."

After years of the families' battling the system, the state last year finally came through for the couple when a vacancy opened up in a group home for the mentally disabled in Riverhead, Long Island, run by East End Disability Associates. The group home was asked if it could expand their home of eight residents to accommodate Paul and Hava, and it agreed.

This week, the couple was offered their own one-bedroom apartment in the home. They will move in sometime in July, according to Forziano.

"We went Monday to see it," she said. "They're very excited. They met the other individuals living in the home. We didn't want to throw them from the frying pan into the fire. We did research, had a psychologist go over there and to the guys that live there. Hava's figuring out where the TV is going to go!"

Although the state was eventually able to help the couple achieve their dream, the lawsuit will go on. Both IGHL and Maryhaven had a duty to encourage the couple's desire to marry and cohabitate, according to the complaint.

"The suit will continue, so the state will have to clarify its stance on married people with disabilities," Forziano said. "It's not just marriage, it's any civil right. You see that people are allowed to cohabitate, and IGHL won't, because they don't think it's a good idea. It has to be the same services across the board."

Copyright 2013 ABC News Radio


Doctors Sue Over ER Limits in Washington State

Ryan McVay/Photodisc/Thinkstock(OLYMPIA, Wash.) -- The American College of Emergency Physicians is suing the state of Washington in an effort to overturn the decision that low-income Medicaid patients will be limited to three non-emergency visits to the emergency room each year, which went into effect Saturday.

The suit seeks to get rid of the limit, which it says puts patients at risk.

The limit, which was created to reduce costs in emergency rooms, comes with a new list of 700 non-emergency symptoms, including difficulty breathing, dizziness, early-pregnancy hemorrhage, gall stones, abdominal pains and chest pains not related to a heart attack.

Patients with any of the 700 symptoms are urged to visit the regular doctor's office instead of the emergency room.

But doctors say patients may not be able to tell if their symptoms are indicative of an emergency.

"The ACEP is opposing the limit primarily because of the list of diagnoses that the state is proposing to be non-emergencies, like chest pains and heart arrhythmias and dysrhythmias, which can result in sudden death, sudden blindness, and hemorrhages during miscarriage," ACEP Washington Chapter president Steve Anderson said. "Their proposal is dangerous. It's almost funny it's so scary they would have them on the list."

The limit, which will cut $72 million in state and federal funds, is included in the 2011-13 Washington State budget.

"We want to save the state money. We want to work with the state," Anderson said. "But they were given a number to reach for the budget, and the only way to do so was to add diagnoses to the list that they originally decided were unquestionably emergencies. That's where we have to draw the line."

The Washington State Hospital Association (WSHA), the Washington State Medical Association (WSMA), and the Washington Chapter of the Academy of Emergency Physicians (WCAEP) have also released statements saying they object to the change.

"We share the state's goal of reducing preventable emergency room visits. However, this benefit limit is not a reasonable approach to the problem," read a statement on the WSHA website.

"[The list] contains many emergency conditions such as chest pain, women having miscarriages, and children who are ill and in pain," the statement read. "In addition, the list creates a public health concern as patients who have sexually transmitted diseases are being asked to wait until they can get a primary care office visit."

If a Medicaid patient comes in for a fourth emergency room visit with non-emergency symptoms, he or she will be treated, but the state won't pay the hospital. Instead, the hospital will have to pay for it.

Copyright 2011 ABC News Radio


High Court Hands Down Landmark Ruling for Insurance Companies

Brand X Pictures/Thinkstock(SAN DIEGO) -- The California Supreme Court ruled in favor of insurers Thursday in a case that promises to impact the legal landscape of medical damage civil suits.

In Howell v. Hamilton Meats & Provisions, the court voted 6-1 in favor of restricting whether an injured party can recover full medical costs billed by doctors and hospitals. The court ruled an accident victim can only recoup the discounted figures the victim's insurer negotiates with health care providers.

Rebecca Howell, injured when a Hamilton Meats truck made an illegal turn and slammed into her car, was seeking the full $190,000 in hospital fees billed to the insurer. However, the court overruled a previous decision in the case that limited her to the $60,000 the hospitals agreed to bill to her insurer.

While the decision is being hailed as a victory for insurance companies and business groups, it is seen as a devastating ruling to consumer rights and personal injury lawyers.

Copyright 2011 ABC News Radio

ABC News Radio