Following a recent enquiry I received in connection with the status of “Ozempic Litigation” I thought that it would be a timely subject to discuss in our next malpractice minute. Many patients are now seeking this new “medication fix” to lose weight.
Being able to evidence documentation in the patient’s record that proper consideration was given to whether or not the patient was an appropriate candidate for this medication and that they understand all the pros and cons, including possible side effects, will be an essential element of not only defending any future lawsuit against Ozempic at the physician level but also winning them.
Ozempic (semaglutide) is a prescription drug and Type 2 diabetes injection approved by the U.S. Food and Drug Administration. It is also used to reduce the risk of major cardiovascular events in adults with Type 2 diabetes who already have cardiovascular disease.
The drug belongs to the glucagon-like peptide 1 (GLP-1) receptor agonist class of medications. More recently, some healthcare providers are also prescribing off-label as a weight loss drug. Currently, Ozempic has not been approved by the Food & Drug Administration (FDA) for weight loss.
Drugwatch is an organization which provides information on high-risk medical products and health issues, helping people take legal action if they’ve been injured. According to Drugwatch, as of June 2024, there were 101 personal injury lawsuits pending from plaintiffs who claim damages as a result of alleged negative side effects of taking Ozempic for weight loss. The claims allege numerous side effects of Ozempic for weight loss.
These negative side effects of Ozempic for weight loss include gastroparesis, ileus, intestinal blockage or obstruction and gallbladder disease. Some of these injuries are alleged to be serious and permanent.
The cases are pending in MDL 3094 before Judge Karen Marston in the Eastern District of Pennsylvania. As of today, the claims in the Ozempic lawsuits focus on the drug manufacturers, Nova Nordisk and Eli Lilly but it’s likely to be only a matter of time before physicians too are brought into the fray.
You can find a perspective from one of the class action law firms representing the plaintiffs here. In essence, the claims made as part of the Ozempic litigation allege failure to warn of potential negative side effects of Ozempic.
A recent article from Advisory Board (AB) daily newsletter, what you need to know about the Ozempic baby boom, points out that gastrointestinal problems are not the only side effects from Ozempic. According to AB, some health experts have said that weight-loss drugs, including Ozempic, can impact the effectiveness of birth control because they slow digestion. This, in turn, can affect how food and medication are absorbed in the body.
AB goes on to quote Neha Lalani, a board-certified endocrinologist practicing in Texas who suggests that slow digestion “…causes oral birth control pills to not be absorbed consistently, especially each time the dose of GLP-1/GIP+GLP-1 agonists are stepped up. This is resulting in failure of oral birth control pills.” According to Lalani, she recommends people use alternative methods of birth control while on weight-loss medications.
Beyond the question of whether it impairs the effectiveness of birth control pills, there are also questions like, "Is Ozempic safe during pregnancy or contraindicated?" Based on patient experiences, questions have also been raised as to whether it can cause suicidal ideation. A preliminary evaluation from the FDA has not found evidence for this and so far no Ozempic lawsuit is based on this allegation.
The Food and Drug Administration does require Ozempic to carry a box warning of the risk of thyroid C-cell tumors. The warning says that “In rodents, semaglutide (Ozempic) causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC).
Whether it causes similar risk for humans has not been determined but the boxed warning points out that OZEMPIC is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). As a result, it is important to counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors.”
Becker’s GI & Endoscopy also has some interesting comments for gastroenterologists on how Ozempic and delayed stomach emptying can impact a patient getting ready for surgery.
The Diabetes Obesity & Metabolism Journal of Pharmacology & Therapeutics also has an interesting article following a study on weight regain and cardiometabolic effects after withdrawal of semaglutide. The aim of the study was to explore changes in body weight and cardiometabolic risk factors after treatment withdrawal.
The study concluded that one year after withdrawal of once-weekly subcutaneous semaglutide 2.4 mg and lifestyle intervention, participants regained two-thirds of their prior weight loss, with similar changes in cardiometabolic variables. Findings confirm the chronicity of obesity and suggest ongoing treatment is required to maintain improvements in weight and health.
Finally, as the attached article from Modern Aesthetics suggests, Ozempic is being used for aesthetic reasons as well as medical reasons. Not every story is a good one with sunken cheeks and facial hollowing presenting complications from rapid weight loss requiring subsequent aesthetic procedures including fat transfers, fillers and lasers. All of these are factors that need to be considered.
Despite these risks, a recent article in the Philadephia Inquirer quoting an analysis from data-analytic company Trilliant Health reported that a record number of Americans have begun taking this type of prescription medication for weight loss and diabetes in recent years. U.S. doctors wrote more than nine million prescriptions for Ozempic and similar medications in the last three months of 2022. The numbers continue to grow.
An appeal from Professor Steve Powis, a national medical director of NHS England warns that weight loss drugs “...are not intended as a quick fix for people trying to get ‘beach body ready’” and “should only be prescribed for those with severe obesity, type 2 diabetes or health problems as a result of their weight.” Powis goes on to warn of the “dangerous complications these drugs can cause when abused.”
A recent Ozempic lawsuits timeline put out by Drugwatch is helpful in outlining what’s happened to date. The focus right now is on the drug companies and it’s worth pointing out, they are taking a defensive posture. However, as with most of the big pharma litigation, physicians are rarely left unscathed.
All the while there are viable claims against the ‘deep pockets’, those claims will likely have an easier path to victory, but once known complications and contraindications become clearer, claims for medical malpractice will likely follow. Those healthcare providers who are now exercising caution before prescribing and effectively counseling patients on the risks vs the benefits will find those claims to be much easier to defend in the event of a lawsuit.
As the legal process begins its consideration of Ozempic and other GLP-1s, it’s important that healthcare providers remain current on the risks of these medications and clearly and completely disclose those risks to their patients. As with many litigation risks when it comes to medicine, ensuring that the patient makes an informed decision when beginning a new medication and that the informed consent is properly documented are always questions that will come under scrutiny.
A successful defense will be one where the healthcare provider can demonstrate they exercised good judgment in prescribing the medication in the first place, that they were complete in their counsel, diligent in their documentation and timely in their follow-up.
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