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Nola.com March 28, 2011 Nola.com March 30, 2011 WWLTV March 24, 2011 Slidell woman's case against generic drug manufacturer has attention of U.S. Supreme CourtPublished: Monday, March 28, 2011, 4:10 PM Updated: Monday, March 28, 2011, 4:15 PM By Ramon Antonio Vargas, The Times-Picayune NOLA.com  David Grunfeld, The Times-Picayune Julie deMahy of Slidell, developed a severe nervous system disorder after ingesting a medication that she alleges did not properly warn her of potential side effects. She sued the manufacturer, and now her case to pursue damages goes before the U.S. Supreme Court for what will be a landmark decision.But, from 2002 to 2007, the 61-year-old Slidell woman took a generic medication to treat acid reflux disease. The drug caused her to suffer a severe neurological movement disorder that killed her ability to drive and work. It was a side effect deMahy says the medicine’s manufacturer did not properly warn her of, so she sued the company for damages. On Wednesday, lawyers will argue before the U.S. Supreme Court for her right to seek them. Depending on what the high court eventually determines, deMahy may be responsible for a momentous change in the pharmaceutical industry. The justices are using her case to decide, once and for all, whether generic drug makers can be sued for not warning patients about serious risks on their drug labels even if they comply with federal requirements that their labels need to only match their brand-name equivalents’. “It’s hard to imagine a little person like myself has all this activity going on,” deMahy said recently. “I’m just now understanding the impact of all of this.” Prior to her illness, DeMahy, who grew up in New Orleans before moving to Slidell in 1975, raised a son, Robert, now 35, and a daughter, Marcy, 39. She organized galas and served as an officer for Slidell’s Le Cotillion, an organization that presents and honors college-aged debutantes, for years. She earned her living as a secretary at a local physician’s office. “My mom cooked dishes; counseled people who lost loved ones; went to (parent-teacher association) meetings; volunteered for everything in Slidell,” Robert deMahy remebers. “She was a totally different person.”  A permanent disorder Lawyers Brian L. Glorioso, left, and Kristine K. Sims flank Julie deMahy as they discuss her case.The specialist diagnosed deMahy with acid reflux disease and to treat it prescribed her metoclopramide, often sold as Reglan. DeMahy had her physician boss refill it as needed. The drug worked, and deMahy stopped taking it when the heartburn disappeared a few years later. But then, her shoulders, right arm and head began to shake violently. She involuntarily blinked excessively and struggled to speak and write. Scared, deMahy visited a neurologist in Dallas. The doctor asked her if she had ingested metoclopramide for an extended period of time, and after she said yes, the neurologist diagnosed her with tardive dyskinesia, a permanent disorder marked by involuntary, repetitive twitches. DeMahy could no longer work effectively or drive safely and retired to her home. She began taking medications designed to limit her shaking — and sought legal counsel. Claim not dismissed Slidell-based lawyers Kristine K. Sims, Brian L. Glorioso and Richard A. Tonry II knew deMahy had a case against the manufacturers of the metoclopramide she took, Actavis Inc. of Delaware. When deMahy ingested their drug, Actavis ran an approved label describing tardive dyskinesia as a rare side effect. However, by then, numerous medical studies had shown that the risk was great. According to the research, up to 20 percent of patients using the drug long-term could suffer the disorder. Sims, Glorioso and Tonry filed suit on behalf of deMahy in Louisiana’s 22nd Judicial District, which serves St. Tammany and Washington parishes. Officials moved the case to the federal court’s Eastern District of Louisiana in New Orleans. Actavis asked the court to toss deMahy’s claim immediately. Government regulations call for them to have the same label on metoclopramide as is on Reglan, which did not warn about tardive dyskinesia while deMahy’s acid reflux was being treated, they argued. But a district judge has since refused to dismiss the lawsuit. So has a panel of 5th Circuit U.S. Court of Appeals judges. In Sims’ words, “The (metoclopramide) created a situation 10 times worse than it was supposed to treat. ... Ms. deMahy got a home incarceration sentence for nothing.” The courts consolidated deMahy’s case with a similar one filed by a Minnesota woman against another maker of metoclopramide. If the U.S. Supreme Court rules favorably for the plaintiffs, the companies would be forced to settle the suits or try them in a courtroom. Resolution could be far DeMahy has been told to expect a finding from the high court in the summer. If her claim survives, it could take another year before it is resolved. Nowadays, her children, friends and neighbors take turns driving her to stores, church and doctor’s appointments. Donations from an organization assist in paying off the $6,000 a month it costs for the pills that calm deMahy’s involuntary movements. The meds help, but they’re not always enough. In January, deMahy’s body twitched as she climbed into her bed, and she fell. She lay on the floor for several hours until Robert coincidentally came over for a visit, found her, and lifted her up. Another time, deMahy leaned over to kiss one of her grandchildren, who sat atop a beanbag chair. A tremble sent deMahy tumbling, and she tore her rotator cuff. “Luckily,” she said, “I didn’t fall on him.” Ramon Antonio Vargas can be reached at rvargas@timespicayune.com or 985.898.4827. © 2011 NOLA.com. All rights reserved. Slidell woman's generic drug case is argued before U.S. Supreme CourtPublished: Wednesday, March 30, 2011, 10:30 PM By Jonathan Tilove, The Times-Picayune NOLA.com  The Supreme Court heard arguments Wednesday in a case that will determine whether a Slidell woman can sue a generic drug company that failed to warn her about the debilitating potential side effects of a drug she was taking for acid reflux.
Charles Rex Arbogast, The Associated Press archive.U.S. Supreme Court Justice Sonia Sotomayor was photographed in Chicago on Jan. 31. At issue is whether federal law, which requires generic drugs to bear the same warning labels as their brand-name equivalents, effectively precludes generic manufacturers from taking steps that might have provided Julie Demahy with adequate warning that her extended use of the acid reflux drug metoclopramide could lead to her developing a severe and irreversible neurological disorder known as tardive dyskinesia. The generic drug manufacturers -- Actavis and Pliva -- are asking the Supreme Court to find that Demahy and a similarly situated Minnesota woman, Gladys Mensing, should not be able to bring failure-to-warn claims against them in state court when those companies had met the letter of federal law. But, Washington, D.C., attorney Louis Brogard argued that the generic companies can and should have provided information to the Food and Drug Administration about risks associated with the drug that went beyond what was on the label, and should have asked the FDA to require that the labels be changed on both the brand name drug and their generic equivalents.  Jonathan Tilove, The Times-Picayune. Kristine Sims, Brian Glorioso and Richard Tonry II of the law firm of Tonry, Brinson & Glorioso in Slidell were photographed outside the U.S. Supreme Court after making their arguments Wednesday. Deputy Solicitor General Edwin Kneedler, representing the position of the U.S. government, also pleaded on behalf of Demahy's right to sue, contending that the federal laws intended to promote generic drugs "do not absolve a manufacturer of his responsibilities after entry onto the market to maintain the safety of the drug and the adequacy of the label."
In their questioning, the justices seemed, as usual, pretty evenly divided on the case, with Justice Sonia Sotomayor asking the most pointed questions of New York attorney Jay Lefkowitz, who pleaded the case on behalf of the manufacturers. "Do you think Congress really intended to create a market in which consumers can only sue brand-name products?" asked Sotomayor. "Because if that's the case, why would anyone ever take a generic? "Why would Congress or the FDA intend to treat the two differently?" she asked. "I understand that from the consumer's point of view it may not make a lot of sense, but what Congress specifically said is that a generic has to bear the same label and it is because they do have different purposes, different functions," replied Lefkowitz. "Congress said that whenever there is a brand drug on the market that no longer is protected by its patent monopoly, but has been selling for $10 or $20 a pill, we want to have generics selling for pennies for the pill, and they've given branded and generics different obligations," Lefkowitz said. David Grunfeld, The Times-Picayune. Julie Demahy of Slidell was photographed Friday. Lefkowitz said the FDA decided that it should tell generics when to change their labels, "because we don't assume the generics are going to know when the label should change because they don't have the same basis of clinical testing and results." Justice Antonin Scalia, who would be expected to side with the generic companies in this case, carried that line of reasoning further, suggesting that the folks at these generic companies are, in essence, "this guy who graduated from high school." "This is a generic manufacturer, he doesn't know anything about science," said Scalia. "He knows how to replicate this pill exactly, that's all he knows." Brian Glorioso, part of the Slidell legal team from the firm of Tonry, Brinson & Glorioso that brought the suit on behalf of Demahy, said that Scalia's depiction was a gross mischaracterization of a generic drug industry that is huge and sophisticated and fully capable of tracking potential problems with the medications it produces. Glorioso said there was nothing in the federal law that precluded Pliva and Actavis from knowing the hazards associated with long-term use of the generic equivalents of the brand-name drug Reglan, and with reporting those concerns to the FDA and seeking a label change.  "They had an obligation to trigger an FDA consideration of a stronger label," said Glorioso.
Glorioso was joined by attorneys Richard Tonry II and Kristine Sims of Demahy's legal team in watching the arguments Wednesday. Glorioso said afterward that they had texted Demahy to let her know how the arguments went, and that she was going to listen to a recording of them online with her son. They said she wanted to be there in person Wednesday, but her physical condition, particularly after a recent fall, didn't permit it. Her attorneys said Demahy is now on a drug that costs $6,000 a month, and she must travel to Texas for treatment. The highlight of the arguments for Sims was Sotomayor's questions, which she said cut to the heart of the case. "Sotomayor rocks," Sims said. Jonathan Tilove can be reached at jtilove@timespicayune.com or 202.383.7827. © 2011 NOLA.com. All rights reserved. Supreme Court to hear Slidell woman's case against generic drug maker . wwltv.comPosted on March 24, 2011 at 5:39 PM Updated Thursday, Mar 24 at 6:05 PM For full video click here SLIDELL, LA - The United States Supreme Court will hear a Slidell woman's case against a generic drug manufacturer next week. Julie Demahy's doctors and attorneys believe long term use of a generic drug led to Parkinson's-like side effects. "My case it's mostly neck up, and in my right arm," Julie Demahy said inside her home Thursday afternoon. She will be unable to attend the Supreme Court hearing because of her condition, called Tardive Dyskinesia, a neurological movement disorder. Julie Demahy takes drugs to minimize the symptoms, which she describes as "jerking," but for now there is no cure. She said, the jerking caused her stop working, stop driving and makes virtually everything harder. "It's very difficult to do minor tasks," Julie Demahy said. "I'm not able to babysit my grandchildren, so I'm missing out on a lot of things." From 2002 to 2006, Julie Demahy said, she took Metoclopramide, the generic form of the drug Reglan, for acid reflux. She began noticing side effects, she added, in 2007. "No one should have to go through this," she added. Her attorneys sued the generic drug manufacturer, a Delaware company named Actavis. Attorneys argue, Actavis knew of the possible side effects of Metoclopramide years ago, but failed to warn people like Julie Demahy. "The evidence is pretty clear," attorney Brian Glorioso said. "from what we have seen, that the drug manufacturer had knowledge, prior to Ms. Demahy taking this drug, that these side effects would occur in long term use." "The risk of developing Tardive Dyskinesia was much greater, in fact, 100 times greater than what was on the label," attorney Kristine Sims added. For now, companies making generic drugs are not liable for damages like companies making name brand drugs, and that is what Julie Demahy and her attorneys hope the U.S. Supreme Court will change. "I think it would be an absurd result," Brian Glorioso said, "for the Supreme Court to hold the name-brand manufacturers to one standard and the generics to another." If the high court rules in Julie Demahy's favor, she and potentially many others, would then be allowed to sue the generic drug manufacturers for damages in state court. Arguments are Wednesday, March 30. Attorneys for Julie Demahy said, they hope to get a ruling from the Supreme Court this summer.
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