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Lawsuit over GLP-1 drugs: over 900 cases
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The U.S. District Court of Eastern Pennsylvania is the site of recent multi-district litigation alleging GLP-1 drugs are dangerous and that pharmaceutical companies haven’t adequately warned users.
More than 900 cases from across the country culminated in a ‘science day’ with defendants Novo Nordisk and Eli Lilly
While celebrities and diabetes patients alike have heralded the swift success of Ozempic and similar drugs, more than 900 complaints have piled up, alleging injury from the medications.
Those nationwide complaints are at the center of first-of-its-kind mass tort lawsuit against glucagon-like peptide, or GLP-1, drugs, which mimic a natural hormone that slows the breakdown of food in the stomach, leads to a feeling of fullness and modulates blood sugar.
The multidistrict case began Sept. 4 in U.S. District Court for the Eastern District of Pennsylvania. At least one of the 929 cases against pharmaceutical companies Novo Nordisk and Eli Lilly involves a Pittsburgh plaintiff, in addition to numerous cases with ties to Western Pennsylvania.
The plaintiffs’ attorneys claim that GLP-1 drugs — specifically Ozempic, Wegovy, Rybelsus, Saxenda, Trulicity, Mounjaro and Zepbound — are dangerous, and that the companies behind them have provided inadequate warning about the risks in their labeling. Lawyers representing Novo Nordisk and Eli Lilly say there is no evidence the medications cause long-term harm.
The litigation marks a first for this class of drugs, the use of which has skyrocketed in recent years.
Nine million people in the U.S. had been prescribed some type of GLP-1 drug by the end of 2022, according to a 2023 analysis of health and drug trends. A recent poll by the Kaiser Family Foundation found the number of adults who have taken such drugs may be closer to 31 million.
Novo Nordisk’s Ozempic (generic name semaglutide, indicated for Type 2 diabetes) was the most commonly prescribed of the class, approved by the Food and Drug Administration in 2017. Semaglutide for weight management, sold by Novo Nordisk as Wegovy, was FDA approved in 2021. Eli Lilly’s diabetes-targeted Mounjaro, or terzepatide, was FDA approved in 2022.
Last week, both sides presented background information and science crucial to their arguments in the impending trial. Such “science days” can be held before large trials to familiarize those involved with data and existing science related to the case.
A trial date has not been set. Plaintiffs’ attorney Jonathan Orent said it could take years.
“Our hope is to be able to get to trial in the not-too-distant future,” he said after the science day session last week. U.S. District Judge Karen Spencer Marston, appointed by then-President Donald Trump, has been assigned to the case.
Central to the civil action is whether Novo Nordisk and Eli Lilly have adequately warned users about potential serious adverse gastrointestinal effects of the medications.
Of the 929 complaints that are part of the litigation against the pharmaceutical giants, 85% list gastroparesis as an alleged injury.
Gastroparesis occurs when the stomach muscles become weak or paralyzed, and food is unable to move through the digestive tract. When food remains in the stomach too long, it can lead to chronic nausea, vomiting and abdominal pain and may require surgery.
The plaintiffs are investigating “a significant number of local [Western Pennsylvania] cases,” Mr. Orent said.
The Food and Drug Administration’s Adverse Event Reporting System has logged more than 18,000 reports of adverse events in the U.S. related to Ozempic alone, including 123 deaths and reports of intestinal obstruction, pancreatitis, blindness, loss of consciousness and disability.
It’s unclear how Ozempic is linked to these adverse event reports; the FDA states on the site that the reports alone don’t represent a causal relationship between the drug and an adverse event.
Gastroparesis is a key point in the plaintiffs’ arguments. They have stated that thousands have suffered debilitating gastrointestinal symptoms from these drugs, some leading to disability, hospitalization and even death.
The burden of responsibility, lawyers for the plaintiffs argue, lies with the pharmaceutical companies to update label warnings based on additional evidence.
“If the hazard is serious, you have to warn about it, even if it’s infrequent,” said Paul Pennock, a plaintiffs’ attorney. “I think we’ll be able to prove that the warnings that existed really did not provide a succinct description of what’s happening.”
The defense reaffirmed that its labeling is adequate: Diana Watral, an attorney representing Eli Lilly in the case, said these warnings are all over related drug packaging and have been for a decade, since the company’s Type 2 diabetes drug Trulicity went on the market in 2014.
“It is critical that only sound science makes its way into the courtroom, and Lilly was pleased to share information about Mounjaro and Trulicity during Science Day,” said an Eli Lilly spokesperson via email. “As explained in our prior legal papers, Lilly does not believe these lawsuits have merit, and we are vigorously defending against these claims.”
Positioning both diabetes and weight as public health crises, the defense noted that 42% of all American adults live with obesity and 12% have diabetes. Katie Insogna, one of the lawyers defending Novo Nordisk, cited a 2021 FDA Review of Wegovy stating that lifestyle interventions for weight loss “are not effective in most patients,” and that there exists an “unmet medical need.”
“Today, GLP-1 medications are recommended by the American Diabetes Association and others in the field as a first-line treatment for patients with diabetes,” said Loren Brown, an attorney also representing Novo Nordisk. “That is because these medications have significant effects on … clinical outcomes, risk of death, heart attack and stroke.”
Because it renders the stomach less able to move food to the small intestine, gastroparesis can lead to blockages, malnutrition and dehydration, as nutrients are not fully absorbed.
In the lawsuit, plaintiffs state they represent clients allegedly taking this class of drugs and who have been hospitalized from chronic vomiting, debilitating abdominal pain and subsequent malnutrition related to their symptoms.
Among the cases is that of Ursula Brown, a 48-year-old woman with Pittsburgh ties who alleged in a civil complaint against Novo Nordisk that she experienced vomiting, dehydration, constipation, chills and body aches after taking Wegovy and visited West Penn Hospital multiple times in May 2023 for her symptoms, which recurred even after treatment.
According to the complaint, Ms. Brown was diagnosed with gastroparesis and continues to seek medical care for the condition. Attorneys allege that advertising and marketing for Wegovy failed to warn Ms. Brown of the true risk of the drug.
NBC previously reported that Novo Nordisk spent nearly half a billion dollars in advertising for Wegovy and Ozempic last year, while Eli Lilly spent $139 million advertising Mounjaro, more than 16 times what it spent in 2022.
The two sides disagreed about key scientific details in the case — namely, what constitutes gastroparesis versus delayed gastric emptying, which is how the drug naturally works, the defense said.
Delayed gastric emptying is essentially just what it sounds like: a slowing of the rate at which the stomach digests and empties food into the small intestine.
“Temporary delayed gastric emptying is known to be caused by these medicines,” said Mark Premo-Hopkins, an attorney representing Eli Lilly. “Our position is that it does not cause gastroparesis. Gastroparesis is not just delayed gastric emptying.” He continued: “The clinical symptoms of gastroparesis are common. They’re identical to and indistinguishable from symptoms of many, many other conditions.”
The defense also pointed out that gastroparesis is most commonly a complication of diabetes, and because semaglutide and terzepatide are used to treat diabetes, one can’t pin a gastroparesis diagnosis on the drug itself.
Outside the courthouse last week, plaintiff lawyers Mr. Orent and Sarah Ruane saw the acknowledgement by the defense that the drugs delay gastric emptying as a win for their case.
“I think it was a huge win today … to hear from the companies that nobody disputes that these drugs can cause the harm that has befallen more than 85% of this multidistrict litigation,” said Mr. Orent.
Mr. Orent and Ms. Ruane said they thought the defense focused heavily on the semantics of gastroparesis and intestinal blockage, but that when it comes time for the jury to meet those impacted by gastrointestinal conditions, those semantics won’t matter.
“There were a variety of terms thrown out today, but the practical reality of what our clients are going through, as far as hospitalizations, time away from work, inability to perform daily functions for their families, that’s all real,” said Ms. Ruane. “That’s all happening.”
In an emailed statement, a Novo Nordisk spokesperson said that patient safety is the company’s top priority and that it works continuously with the FDA to monitor the safety of its drugs.
“I don’t want us to lose sight of the fact that these medicines are doing important work,” said Mr. Premo-Hopkins during the session. “The known effects of these drugs are well-described by the FDA labeling and are known within the medical community.”
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https://www.post-gazette.com/news/h...es/202409080108
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