While pursuing a graduate degree at WPI she took a class that opened her eyes to the intersection of science and law, forever altering her career path.
Throughout the class, her interest grew. She spoke about it with Dittami, who, she recalls, helped open her eyes to the career possibilities out there. He continues to emphasize to students the importance that science can bring to law.
“I know of several attorneys who earned backgrounds in science and then applied that knowledge to the practice of law,” he says. “They are in high demand in firms dealing with food and drug law, which also encompasses the areas of biologics, medical devices, dietary supplements, etc. A detailed understanding of the science behind how these products work and a thorough knowledge of the regulatory framework are invaluable tools in fields including food and drug law, patent law, manufacturing, pharmacovigilance, and regulatory affairs. They are essential skills and their importance to matters concerning products regulated under the Food, Drug, and Cosmetic Act cannot be overemphasized.”
While at WPI, Lee was drawn to patent law. She envisioned a future where she would be part of a system of checks and balances that helps ensure that companies live up to their legal obligations regarding their products. Her background in science could actually give her a leg up in law, and she would be able to complete law school more quickly than medical school. “Plus,” she says, “it was still an accepted profession to my parents.”
She received her MS in chemistry from WPI in 2008, and went on to earn a law degree at Northeastern University. After graduation her interests shifted from patent law, to how companies move forward with their intellectual property: in particular, their legal obligation to test and validate their patented products, and to monitor any complications that may arise from their use. She began working in mass torts, a type of law that involves many plaintiffs with different injuries who pursue litigation against one or more defendants under a common theory of liability. Today, in her job with Andrus Wagstaff, science regularly informs her work. “I represent patients who have been severely injured or [represent families of those] potentially even killed from the use of medical devices and pharmaceuticals,” she says.
Protecting Patients Through Law
One of the devices Lee has focused on is known as transvaginal mesh. Made of polypropylene, the mesh is designed to treat urinary incontinence and weakened pelvic muscles. It is sometimes prescribed when a patient is diagnosed with stress urinary incontinence or pelvic organ prolapse, which occurs when the muscles that surround the pelvic organs, including the bladder and uterus, become weak or loose.
In April, the FDA ordered an immediate halt to sales of certain transvaginal mesh products. The order applies to products made of polypropylene mesh that were sold to help with anterior compartment prolapse. The FDA determined that the manufacturers failed to demonstrate reasonable assurance of safety and effectiveness, the premarket standard since the reclassification of the devices by the FDA in 2016.
Lee has worked on multimillion dollar settlements for more than 1,000 women injured by these devices. The mesh was originally approved by the FDA for hernia repair, but the manufacturers of the device sought out other uses to increase their profits. That’s where things started to go wrong, Lee says. Because the device had received FDA approval for a different though similar use (hernia repair), use in the vagina went through a less stringent approval process, called a 510(k), which required no testing. (A documentary, The Bleeding Edge, on Netflix talks about this process and about this device).
The issue, Lee says, is that while the two uses may be similar, the biology of the two environments where the mesh is implanted—the abdomen vs. the vagina—is quite different. “The abdomen is very sterile,” she says. “The vagina is not. It is an acidic environment filled with bacteria, among other things.”
“The way the injury is related to the product is very science heavy, very medical heavy,” she says. “So with my background in science, the learning curve is a lot less steep for me.”
She says she’s seen an array of injuries caused by the mesh, attributable to the material’s pore size and its weight. In some cases, the polypropylene can stiffen to the point where is begins eroding the patient’s bowels. Often, surgery is required to repair the damage. In other cases, she says, the mesh has contracted and caused the urethra to close. That, too, results in surgery and the possibility of chronic pain.
“The transvaginal mesh litigation certainly put the spotlight on how inadequate the standard of substantial equivalence is for such medical devices,” she says, “but there are other defective medical devices still on the market with undoubtedly more to come. Sadly with our current system, issues with defective medical devices are being discovered after the damage has already been done. I hope that the American public becomes more informed about the FDA 510(k) process and demands change from our government. In the meantime, I continue to be committed in doing my part to represent people who are injured by these defective medical devices to make sure their voices are heard.”
Her science knowledge has helped her immeasurably in understanding causation, liability, and damages. For example, the mesh can be manufactured in a number of ways. Sometimes it’s machine cut, other times it’s cut by laser. Different types of processing can affect the material’s integrity, leading to injuries. “The way the injury is related to the product is very science heavy, very medical heavy,” she says. “So with my background in science, the learning curve is a lot less steep for me.”
While her graduate work at WPI was mainly in inorganic chemistry, she read countless medical journal articles. That, too, has helped her in her work, whether it’s quickly processing information or understanding her client’s medical records.