Moderna lures Novartis' top lawyer to be its own as COVID-19 vaccine rollout raises legal risks

Shannon Thyme Klinger, currently Novartis' chief legal officer, will become Moderna's top lawyer as the biotech's COVID-19 vaccine rollout picks up steam. (Novartis)

Moderna has found a new chief legal officer with a decade of Big Pharma experience as its COVID-19 vaccine rollout kicks into gear.

Shannon Thyme Klinger, the Novartis chief legal officer who took on the Swiss pharma’s top lawyer job in the wake of the Michael Cohen scandal, will become Moderna’s legal mastermind on June 1, the Massachusetts biotech said Monday.

Klinger will replace Lori Henderson, who joined Moderna in 2018 from contract research and manufacturing organization Albany Molecular Research. Moderna disclosed Henderson’s plans to retire in an October securities filing.

Klinger first joined Novartis in its Sandoz generics unit back in 2011. She rose to Novartis’ executive committee in March 2018 as its chief ethics, risk and compliance officer. At the time, the Swiss drugmaker added additional weight to this ethics role as it was facing several doctor kickback accusations for its practices in different parts of the world.

Merely weeks into that role, news broke on Novartis’ $1.2 million payment to former President Donald Trump’s ex-personal lawyer, Michael Cohen, in a contract that spanned a year from 2017 to 2018. Klinger was further promoted to general counsel, succeeding Felix Ehrat, who took the fall for the scandal.

RELATED: Novartis revamps bonus pay as ethics rise to top priority at scandal-hit drugmaker

Under Klinger’s tenure, Novartis achieved major legal milestones in 2020. Last year, the Swiss company wrapped up several kickback and charity donation fraud allegations with settlements totaling $1.3 billion. These included an important $729 million settlement that allows Novartis to conclude a whistleblower case that claimed it used sham speaker programs and events as disguise for briberies to boost prescriptions of its drugs.

Moderna could use a top lawyer with that kind of deep life sciences background as the biotech enters the commercial stage with its COVID-19 vaccine.

“Shannon’s deep global experience in the pharmaceutical industry in both the general counsel and ethics and compliance roles are critical to Moderna as we pivot to a broad international and commercial footprint,” Moderna CEO Stéphane Bancel said in a statement Monday.

RELATED: With new settlement, Novartis has shelled out $1.3B for kickbacks, bribery and price fixing this year

As Moderna—and other companies—roll out their COVID-19 shots in different parts of world, the potential risks for litigation around side effects significantly increase, lawyers at Sidley Austin recently warned. Not to mention that Moderna’s shot, based on the novel mRNA technology that had never seen a marketed product before, has only gathered months of data on a shortened timeline due to the urgency of the pandemic.

Government campaigns to promote speedy vaccinations could drive what the lawyers called a “tidal wave” of adverse events reports, some of which may well evolve into lawsuits. And the protection from the U.S. PREP Act that offers “immunity for activities related to COVID-19 countermeasures” may be limited, they noted.

RELATED: Look out, pharma. A 'tidal wave' of side effect reports is coming amid COVID-19 vaccine rollouts

Klinger didn’t specifically have experience handling vaccine issues, at least not at Novartis; the Swiss drugmaker traded off its non-influenza vaccine portfolio for GlaxoSmithKline’s oncology pipeline and sold the influenza vaccine business to CSL in 2015, before Klinger hopped from Sandoz to the bigger Novartis group.

But Klinger’s familiar with COVID-19 work from an ESG perspective. Her legal team and the public affairs group at Novartis were behind a program that offers 15 Novartis drugs to treat COVID-19 at zero profit to 79 low- and middle-income countries.

Klinger’s job at Novartis will be filled on an interim basis by Thomas Kendris, currently global head of litigation and U.S. president, the company said Friday. Novartis is now evaluating internal and external options for a permanent replacement.