Medtronic-Hexagon Health Lawsuit Highlights the Struggle Between Doctors & Industry

Every so often, large medtech companies face allegations of exploiting physicians’ intellectual property. Some worry that this pattern threatens to stifle medical innovation — with large firms turning novel ideas into profits while leaving original inventors mired in lengthy legal battles.

This month, yet another physician accused a large industry incumbent of stealing her idea.

Hexagon Health — a hernia care company founded by Dr. Shirin Towfigh in 2015 — is suing Medtronic, alleging that the medical device giant copied Dr. Towfigh’s hernia mesh repair design and knowingly continued to sell the product even after the U.S. Patent Office formally granted Hexagon its patents.

While it’s unclear whether the case will make it to trial, the dispute highlights the struggle over who controls the future of hernia care, as well as who powers the dynamics that shape healthcare innovation, lawyers said. 

What is Hexagon Health?

In an interview, Dr. Towfigh said she founded Hexagon with the goal of improving patients’ abdominal and pelvic health. The company seeks to address gaps in hernia care — particularly for women, who have historically been underrepresented in research and product development for the condition, she noted.  

Dr. Towfigh — who remains a practicing surgeon in Beverly Hills — said that nearly 80% of her work is revisional hernia surgery. This work inspired her to develop a textile mesh with a fin-like shape to help prevent common complications that occur in patients undergoing hernia repair procedures.

Her designs are meant to benefit both male and female patients. For example, she believes her mesh designs improve treatment for men with inguinal hernias — a type of hernia occurs in the groin area when a part of the intestine or bladder protrudes through the lower abdominal wall. 

Traditional inguinal hernia mesh designs can erode or obstruct male genital structures, such as the genital nerve and the spermatic cord and its contents, and the genital nerve, resulting in unwanted complications like painful intercourse and testicular pain, Dr. Towfigh said.

She also noted that her products benefit women because they offer improved coverage in the femoral space, which is located on the upper thigh. Women are 10 times more likely than men to develop femoral hernia — which is the only type of hernia with a significant risk of death if misdiagnosed or not treated in a timely fashion.

Dr. Towfigh added that her designs are meant to reduce risk of damage caused by traditional hernia mesh products to women’s pelvic floor muscles, nerves and major blood vessels.

Hexagon began filing patents for Dr. Towfigh’s novel hernia mesh designs in 2015, the same year the company was founded. She has since been granted nine patents, she said.

What does the lawsuit allege?

In the complaint filed against Medtronic, Hexagon alleged that the medical device giant took Dr. Towfigh’s novel ideas and patented designs to develop its product Dextile. 

The complaint also stated that Dr. Towfigh spent six years in conversations with Medtronic to bring her textile mesh product to market. It said that the parties initially met in 2015 and signed a mutual non-disclosure agreement.

“I’ve known the Medtronic company and their people for many years. It was nice that they showed interest in my product — I’ve been traveling all over the world, meeting them in different venues to get to a point where this mesh can come to market,” she said.

Dr. Towfigh said she had several meetings with Medtronic leadership, including a trip to the company’s manufacturing facility in France. The purpose of these meetings was to discuss opportunities for Medtronic to collaborate with her and her patent-pending mesh product, she noted.

But in 2017, Medtronic filed its own patent for a hernia mesh product that Dr. Towfigh thinks closely mirrors her design. Medtronic’s product has a fin-like shape aimed at reducing post-surgical complications by ensuring more secure and stable placement during the procedure, similarly to Hexagon’s designs, the complaint said.

In a statement sent to MedCity News, Medtronic said it is actively reviewing the case, noting that the company “has a long history of respecting the intellectual property rights of other innovators.” 

What happens next?

One lawyer who is not involved in the case — Peter Sullivan, patent attorney and co-chair of the PTAB proceedings practice group at Foley Hoag — said Hexagon’s lawsuit stood out as an interesting case to him. This is because Dr. Towfigh is seeking not only financial damages for the patent infringement — but also to be listed as an inventor for Medtronic’s device.

“It’s actually not just a patent infringement case. The doctor and her company own patents, but they’re also seeking to be listed as investors on the Medtronic patents,” Sullivan remarked. “That’s a wrinkle you don’t normally see.”

He also said that he thinks the complaint makes a compelling case for not just patent infringement — but also outright copying.

“With infringement you don’t actually have to take anything. You just have to have something that’s like someone else’s stuff — you can be working completely independently. But in this case, there was a lot of crossing — business discussions about this new kind of mesh that would be an improvement over what the state of the art was. I think that that makes this a little more interesting, especially more interesting to a jury. Ultimately people want to have a compelling story for copying, not just infringement,” he explained.

Sullivan thinks the case will likely go through a couple of phases. The first phase will probably be that Medtronic moves to invalidate Hexagon’s patents, he said. 

When a company is accused of violating a patent, a typical defense is to argue that the patent should never have been granted in the first place, Sullivan explained. These disputes are typically handled by the Patent Trial and Appeal Board (PTAB), and if the reviewers decide to invalidate the patent, the infringement claim is moot.

But even if Hexagon’s patents do get invalidated, the case could still go forward, Sullivan pointed out. Dr. Towfigh is seeking to be listed as an inventor for Medtronic’s product, and this is a separate claim, he stated.

Sullivan noted that it’s too early to predict whether this case will go to trial.

“How a jury thinks about this will depend on what’s left of the case when they finally get to it — it’s a defendant’s job is to whittle away at all the claims, to see what could be limited, what can’t be, and go from there. But I think that it’s not the typical infringement case — you had this active collaboration going on, and I think that’s something that will be helpful for the plaintiffs if they ultimately get to a jury,” he remarked.

What does this mean for physicians?

Dr. Towfigh pointed out that her experience with Medtronic makes her feel wary of large incumbents and their ability to help physicians bring innovative ideas to market.

“There’s a sacred relationship between physicians and industry — especially surgeons, since we are at the patient level. We’re the ones who are operating, and we’re the ones who see where there’s good and bad and where there can be improvements in products,” she declared.

Without industry partners, it can be difficult for sole physicians to make an impact, Dr. Towfigh noted.

“I think most of us surgeons don’t really understand that there are situations where you can have excellent ideas and pitch them and do everything right — you got your patent filed and you got your NDAs — and yet, there are possibilities where there can still be a case of infringement,” she explained.

Dr. Towfigh added that she thought a large, publicly traded company like Medtronic would adhere to “higher ethical standards.” 

When asked to respond to Dr. Towfigh’s remarks, Medtronic opted not to provide further commentary.

Dr. Towfigh said her main concern is that in the future, surgeons with innovative ideas will not be able to trust major companies enough to divulge their ideas. Her lawyer agreed. 

“Medtronic’s improper use of Hexagon Health’s hernia mesh designs has cost Dr. Towfigh significant financial gain and created a disincentive for other physician-entrepreneurs to enter the medical device marketplace with innovative products for patients in need,” Nicholas Groombridge, Hexagon’s attorney and partner at Groombridge, Wu, Baughman & Stone LLP, said in a statement. “Medtronic has a history of infringing patents and failing to honor agreements with physician-inventors, and we look forward to addressing this matter in court.” 

Dr. Towfigh’s case is not the first time Medtronic has come under fire for alleged patent infringement. 

For instance, pediatric orthopedic and scoliosis surgeon Dr. Mark Barry sued Medtronic in 2014, alleging that the company infringed on two of his patents for spinal devices. Dr. Barry won $23.5 million when a federal judge ruled that Medtronic had copied his technology.

Also in 2014, Medtronic agreed to pay more than $1 billion to settle a patent dispute with Edwards Lifesciences, which alleged that Medtronic’s CoreValve product was violating the patent for its transcatheter heart valve. And just last year, a jury ordered Medtronic to pay $106.5 million to medical device company Colibri Heart Valve as the result of another patent infringement case.

Another patent lawyer said this type of infringement is nothing new.

“Unfortunately, large technology companies ripping off inventions of physicians is all too common,” said Andrew Bochner, managing partner at Bochner PLLC.

Bochner currently represents NYU Langone cardiologist Joseph Wiesel in a federal court case accusing Apple of using his patented atrial fibrillation monitoring tool in its Apple Watch without permission. Apple has delayed the case by filing multiple petitions to invalidate Dr. Wiesel’s patent, he said.

When discussing his client’s case with MedCity News earlier this year, Bochner noted that Apple’s multiple patent invalidation attempts were part of the company’s plan to battle “tooth and nail” in order to wear out its rivals with fewer resources. 

He noted that large companies in the tech and medtech spaces employ these tactics because most physicians or small companies can’t afford to keep up with the litigation. 

For Dr. Towfigh and other physician-innovators, this lawsuit underscores a broader challenge: ensuring that the next big medical breakthrough is protected, not co-opted.

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