Milberg Court Win Creates Exception to Learned Intermediary Doctrine

Milberg attorney Tina M. Bullock recently scored a victory in court that not only was a major win for her client, but also was the first case in Mississippi to create an exception to the learned intermediary doctrine.

Tina’s client was implanted with an Orbera gastric balloon manufactured by Apollo Endosurgery, Inc. that is used to help patients lose weight. Her client experienced severe health complications from the device and filed a medical malpractice and products liability lawsuit against Apollo and other defendants.

In December 2020, the U.S. District Court for the Southern District of Mississippi denied Apollo’s Motion for Summary Judgment in the case. Apollo argued that the learned intermediary doctrine shielded the company from liability. However, the court accepted Tina’s argument that Apollo is not freed from liability in this case because the doctor who implanted the device lacked independence. On February 1, 2021 the Court denied Apollo’s request to reconsider its denial.

The Orbera Balloon System

The weight loss industry is lucrative. According to MarketResearch.com, the industry is worth $72 billion and forecasted to grow significantly.

The Orbera Intragastric Balloon System was approved for use in the United States in 2015 as a safe, non-invasive weight loss procedure. During an endoscopy, the device, a saline-filled balloon, is inserted into the stomach in order to encourage portion control. Apollo markets Orbera directly to consumers and targets states such as Mississippi where there are high rates of obesity.

To date, there have been at least 12 deaths from the use of weight loss balloons, including the Orbera and ReShape balloon systems. Apollo also owns ReShape, which it voluntarily pulled from the market in 2019. Since Orbera was approved, its labeling has been updated to include gastric perforations and death as known product risks.

The Client’s Injuries From Orbera

In 2016, the physician implanted the Orbera balloon in the patient. Apollo says the device is likely to produce nausea and vomiting after placement that can be treated with medication. However, the weight of the balloon caused violent, intractable vomiting in the patient that failed to respond to medication. The force of involuntary vomiting caused her esophagus to tear away from her stomach (i.e., a Mallory-Weiss tear). The balloon eventually ruptured the patient’s stomach and she underwent extensive surgical repair and required life support for nearly one year. The patient is grossly disfigured from scarring and still has multiple fistulas in her stomach due to the multiple infectious tracts that developed.

Learned Intermediary Exception

Mississippi follows the “learned intermediary doctrine,” which generally allows a manufacturer to avoid liability if they disclosed product risks to the physician. The general rule is that a drug or device manufacturer’s duty to warn only extends to physicians, and not to laymen.

In this case, Tina Bullock argued that the physician was a mere salesman and lacked the independent medical judgment to inform her client of Orbera’s risks. The so-called “salesman exception” is when a doctor acts as an agent of the medical device manufacturer. Thus, the manufacturer is no longer shielded from liability because the doctor is not exercising independent medical judgment.

Tina presented evidence showing that, on Orbera websites, Apollo directly advertised the physician as an Orbera Specialist™ and trademarked that as a specialty practice. She also showed that Apollo provided a complete marketing package for the weight loss balloons, including a life size poster of the physician with the balloon that was placed in his waiting room and TV ads in the local market.

The Court found Tina’s argument persuasive and held that the sales activities of the physician carved out an exception to the learned intermediary doctrine. In short, the Court agreed that the physician was so financially vested in the marketing of the Orbera balloon that he lost independence of judgment.

This is the first case in Mississippi to create an exception to the learned intermediary doctrine. The precedent-setting decision creates an important distinction in product liability cases that could help to reduce conflicts of interest in the medical device industry.