If you were injured by a Lap-Band, you can bring an Allergan Lap-Band lawsuit, but personal injury claims against the manufacturer face a serious federal preemption barrier that has defeated most plaintiffs. The device carries the FDA’s most rigorous approval, and courts have repeatedly thrown out cases that ask a jury to second-guess what the agency already cleared. The one clear success against Allergan so far was a government-backed whistleblower case about fraud and off-label marketing, which ended in a $3.5 million settlement in 2018.
Injuries That Drive These Lawsuits
The Lap-Band is an adjustable silicone band placed around the upper stomach to restrict food intake. Complications are well documented in the FDA’s own approval data. In the original U.S. pivotal trial of 299 patients, 51% experienced nausea and vomiting, 34% had gastroesophageal reflux, 27% had abdominal pain, and 24% experienced band slippage or pouch dilatation. Nine percent required reoperation, and 25% eventually had the entire system removed.1FDA. LAP-BAND System PMA Supplement
Long-term outcomes are worse. A 14-year follow-up in the Journal of Obesity reported a 30.5% reoperation rate.2National Library of Medicine. Fourteen-Year Long-Term Results After Gastric Banding A separate study found that 71% of patients had their bands removed within ten years.3DS Surgery. Lap Band Removal Between 2006 and 2014, roughly 90% of total spending on gastric banding devices went to adjustments, replacements, or removals rather than initial implantation.4National Center for Health Research. Gastric Lap Bands: What You Need to Know
The specific complications named in lawsuits include:
- Band slippage or erosion of the band into the stomach wall, sometimes requiring partial removal of the stomach
- Esophageal dilation causing chronic reflux, difficulty swallowing, and regurgitation
- Erosion into surrounding organs, including the liver, and tissue death in portions of the stomach and small intestine
- Tubing breaks, port displacement, and infections at the access-port site
- In rare cases, fatal complications, including massive hemorrhaging during removal surgery
What Plaintiffs Allege Against Allergan
Product liability suits against Allergan generally rest on four overlapping theories: defective design, failure to warn patients and doctors about known risks, negligence in testing and manufacturing, and deceptive marketing of the device as a safe long-term weight loss solution despite evidence of high complication and failure rates.5The Jurewitz Law Group. Allergan Lap-Band
Damages sought typically include medical expenses for corrective surgeries, lost wages, pain and suffering, and in some cases punitive damages.5The Jurewitz Law Group. Allergan Lap-Band
Why These Cases Are Hard to Win
The FDA approved the Lap-Band in 2001 under Premarket Approval number P000008, its most demanding review process, and expanded approval in 2011 to patients with a body mass index as low as 30 who had a weight-related health condition.4National Center for Health Research. Gastric Lap Bands: What You Need to Know6FDA. Recall Search Result for Lap-Band That approval status is what makes these lawsuits so difficult.
Under the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act, and the Supreme Court’s 2008 ruling in Riegel v. Medtronic, state-law claims that impose requirements “different from, or in addition to” what the FDA required are preempted. Translated into practice: a jury generally cannot be asked to decide that an FDA-approved device was defective or that its FDA-approved warnings were inadequate.
To survive preemption, a plaintiff must fit through what courts call a “narrow gap” by pleading a “parallel claim,” meaning conduct that both violates a specific federal requirement and independently supports liability under state law.7Findlaw. Glennen v. Allergan, Inc. Vague allegations that Allergan failed to follow FDA rules, without pointing to specific violations backed by inspection reports or warning letters, tend to lose.
Glennen v. Allergan, Inc., decided by a California appeals court in 2016, illustrates the problem. The plaintiff alleged the Lap-Band eroded into her stomach and liver, killed tissue in portions of her stomach and small intestine, and caused hemorrhaging during removal surgery that left her with brain damage. She argued Allergan was negligent in training her surgeon. The court dismissed the case, finding she had not identified where Allergan’s training deviated from what the FDA required, and that letting a jury weigh in on FDA-approved training would displace the agency’s authority.7Findlaw. Glennen v. Allergan, Inc.
The One Clear Win: The Schwartz Settlement
Not every case against Allergan has failed. In April 2018, Allergan agreed to pay $3.5 million to settle a False Claims Act whistleblower lawsuit, United States ex rel. Schwartz and Tinsley v. Allergan, in the U.S. District Court for the District of Maryland.8HHS Office of Inspector General. Allergan to Pay $3.5 Million to Settle False Claims Act Allegations
The government alleged that between 2008 and 2010 Allergan knowingly sold Lap-Bands with defective access ports, concealed the defects from the FDA and the public, and failed to maintain required complaint files. It further alleged that between 2008 and 2012 Allergan promoted the device for two procedures the FDA had not approved and paid doctors through workshops, training events, and advisory boards to encourage those off-label uses. About $3.3 million went to the federal government, roughly $200,000 to state Medicaid programs, and the whistleblowers received approximately $594,000.9Medical Malpractice Lawyers. $3.5M Settlement in Lap-Band False Claims Act Whistleblower Lawsuit
Worth noting: this was a fraud case brought on behalf of the government, not a personal injury case brought by patients. It did not compensate individuals who were physically harmed by the device.
The Fitzer Case Is Still Pending
A separate False Claims Act case, United States ex rel. Fitzer v. Allergan, Inc., remains active in the same Maryland federal court. As of January 2025, a judge granted partial summary judgment authorizing 254 medical procedures to proceed toward trial, while dismissing a number of others on evidentiary and causation grounds.10GovInfo. Fitzer v. Allergan, Memorandum Opinion Filings continued as recently as May 2025, with no trial date or settlement announced.11CourtListener. Fitzer v. Allergan, Inc. Docket The court has noted that the earlier Schwartz settlement expressly excluded the claims raised in Fitzer, though the parties dispute the extent of any overlap.
Suing Allergan Is Not the Same as Suing Your Surgeon
Two different kinds of Lap-Band lawsuits often get confused. A product liability claim targets the manufacturer and alleges the device itself was defective or that Allergan failed to warn about its dangers. That is the type of case blocked by preemption. A medical malpractice claim targets the surgeon or hospital and alleges that a specific doctor made errors during the procedure, such as improper band placement, unintended organ damage, or failure to obtain informed consent.12Arfaa Law Group. Lap Band Surgery Malpractice
Malpractice claims require expert testimony that the surgeon fell below the applicable standard of care and that the deviation caused the injury. They do not raise the FDA preemption issue at all. In some situations both types of claim can coexist for the same patient, but the defendants, legal standards, and hurdles are entirely different.
Deadlines and a Practical Complication
Every state imposes a statute of limitations on product liability and malpractice claims, and those deadlines vary. Many states apply a discovery rule that delays the clock until the patient knew or reasonably should have known about the injury and its cause.13Justia. Statutes of Limitations and the Discovery Rule For an implanted device where complications may not appear for years, that rule can be decisive.
Many states also enforce a statute of repose, which creates an absolute cutoff regardless of when the injury was discovered. In Nunn v. Biomet, an Indiana court dismissed a hip implant case because the plaintiff filed more than ten years after receiving the device, even though the injury emerged later.14Cumberland Trial Journal. The Complexity of the Discovery Rule in Medical Device Cases Many Lap-Band patients received their devices more than a decade ago, so repose deadlines are a real risk.
There is one more wrinkle specific to Allergan. Allergan sold its obesity intervention division to Apollo Endosurgery in October 2013 for up to $110 million,15PR Newswire. Apollo Endosurgery Announces Acquisition of Obesity Intervention Division From Allergan and Allergan itself was later acquired by AbbVie. At least one legal analysis has questioned whether product liability claims against Allergan specifically remain viable given those corporate changes.16Hughes & Coleman. Allergan Lap-Band Lawsuit Anyone considering a claim should have a lawyer confirm both the applicable filing deadline in their state and which entity is the correct defendant before assuming a case can move forward.