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Lisa Lee ’08

Law of the Lab

June 24, 2019

Lisa Lee always expected to become a doctor. It wasn’t so much that she wanted to go into medicine, but that’s what her parents wanted. Plus, she liked science and she was good at it. Her younger brother, her parents expected, would be a lawyer.

“Typical Asian parents,” says Lee. “To be successful, you either become a doctor or a lawyer.”

Then the plot twisted. 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. Today she is a lawyer, not a doctor, but she does help people who are sick or injured. As an associate attorney in the Boston office of Andrus Wagstaff, a national mass tort law firm, she represents clients who were severely injured because pharmaceutical or medical device manufacturers placed profits before people. In that role she strives to effect long-term changes, including making high-powered healthcare companies more accountable, with the goal of saving people from unnecessary pain and suffering in the future.

Finding The Right Career Chemistry

Lee was as surprised as anyone by her career pivot. To stand out from all of the biology majors applying to medical schools, she majored in chemistry, biochemistry, and molecular cell biology at UMass Amherst. But before applying, she did some soul searching. Was she really prepared to commit nearly a decade of her life to undergrad studies, medical school, residency, and internship?

“I needed a couple of years to decide if I really wanted to do that,” she says. “So, why not get a master’s in chemistry?” The decision led her to WPI and that life-changing course, Medicinal Chemistry, taught by Professor James Dittami. It explored the discovery and development of therapeutic agents—such as drugs, biologics, and medical devices— from a pharmaceutical research and development perspective. It also delved into the drug approval process overseen by the Food and Drug Administration (FDA). In other words, it sat right at the intersection of healthcare and law.

“The lightbulb moment came during class when he talked about lawyers doing something related to science,” says Lee. “It’s different from medicine, but it was an avenue I hadn’t considered. You have this stereotype in your head that science is as removed from law as you could get.”

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.

The Scientific Method

Kimberly Dougherty, a managing partner with Andrus Wagstaff and Lee’s boss, says that Lee’s science background, and her time spent at WPI, is especially helpful when speaking with potential expert witnesses. Dougherty remembers one such meeting where she and Lee spoke with a science professor who was a potential expert in a case. They talked with him about different materials—such as polypropylene— and how they impact the body. Dougherty walked away impressed with Lee’s expertise and her ability to guide the conversation.

“It adds significant value to have someone who’s able to speak their language and able to understand what they’re talking about at a high level, and able to translate to others who may not understand the science as well,” she says. “I don’t know that there are a lot of firms that have that caliber of knowledge and scientific background that can add to the value of the cases like we do with Lisa.”

Dougherty says that in her line of work, with its healthcare focus, it’s not uncommon to meet lawyers who originally set out to be doctors. She believes that for people like Lee, it’s a path where they can make an impact in a different but important way. “She is an advocate,” she says, “she is someone who believes in issues and is able to articulate them in a way that effects change.”

“She is an advocate,” she says, “she is someone who believes in issues and is able to articulate them in a way that effects change.”

Beyond her knowledge of science, Lee has found that being able to think like a scientist has also been helpful in her law career. “Having that logical, deductive thinking process is useful as an attorney,” she says. “With science, it’s a lot of trial and error. You try something, it doesn’t work; you try something else, it doesn’t work. And with law, although it’s not black and white, I’ve found that the fact that you can come up with multiple solutions for a problem is kind of similar to that trial-and-error aspect of science.”

Lee admits that the day-to-day aspects of her job can be bittersweet, if not heartbreaking. “Whenever I’m able to get some type of compensation for my clients I’m happy,” she says. “That being said, I don’t think any amount of compensation is really enough for what these women have gone through. If you ask them, ‘would you rather go back to how you were before your surgery, or would you rather have $10 million?’ they’d rather have their health back. It’s not something that you can really put a price on.”

Still, she knows she’s fighting for the greater good. “Maybe it’s willful ignorance—you want to close your eyes to it—but these huge companies … their whole motto is they want to help people get better. But when they break it down, they’re in it to make money. I’m not saying making money is a bad thing. But you don’t do it to the detriment of people’s health,” she says.

Lisa Lee may never be able to cure the system. But through her work, she hopes that by keeping corporations accountable now and in the years and decades to come, she can help save people from suffering unnecessary harm.