Katy E. Koski

Partner

For more than 20 years, Katy Koski has represented companies in the heavily regulated life science space, including manufacturers, distributors, and sellers in the pharmaceutical and medical device industries. She is a partner in the firm’s Business Litigation & Dispute Resolution Practice and a member of the Health Care & Life Sciences Sector.

Katy has represented life science companies in jury and bench trials in state and federal courts throughout the United States addressing complex claims involving fraud, unfair competition, product liability, intellectual property, mass torts, and false claims. In addition to representing client interests at trial, Katy counsels clients in developing and executing strategies to address and exit high-profile and “bet the company” litigation, including in multi-district litigation (MDLs) and other coordinated proceedings involving thousands of plaintiffs.

Foley’s pharmaceutical practice includes representing clients in some of the largest MDLs threatening the industry. Most recently, Katy served with other Foley lawyers as national coordinating counsel representing a pharmaceutical distributor, Anda, Inc. as well as generic pharmaceutical manufacturers in defense of claims asserted in the national opioid litigation. The opioid litigation includes claims brought by state, county, and local governments, third-party payers, and private individuals in state and federal courts throughout the 50 states. Katy works with clients to conduct early assessment of the claims, the relative pressures on each company’s business interests, as well as the role each company has among the many defendants named in each suit to devise appropriate litigation and settlement strategies.

In addition to the large-scale attacks on the pharmaceutical and device industries generally, Katy also counsels and represents individual companies facing product liability claims targeting key products in a client portfolio. From ADHD medication to heart valves and blood processing devices, Katy’s depth of knowledge of and experience with the regulations and controls in the life science industry make her a trusted advisor to clients as they consider options in protecting their product line.

Representative Experience

  • National and trial counsel for a pharmaceutical wholesale distributor, in nationwide litigation relating to the distribution of prescription opioid medications, including more than 1,000 cases brought by states, cities, counties, tribes, and private parties seeking recovery in connection with the opioid abuse crisis.
  • National counsel for generic pharmaceutical manufacturers in national opioid litigation; federal MDL currently pending in the Northern District of Ohio.
  • Served as national coordinating and trial counsel for generic pharmaceutical manufacturers in nationwide Average Wholesale Price litigation brought on behalf of individual States and the United States in state and federal courts around the country. The claims challenged drug pricing practices under state and federal tort law as well as state and federal false claims act provisions.
  • Counsel for generic pharmaceutical manufacturers in claims brought by the Attorneys General of Mississippi and Louisiana, as well as a federal qui tam action, regarding federal Medicaid regulations.
  • National counsel for LivaNova USA, Inc. and affiliated entities in product liability litigation alleging personal injuries caused by the use by surgeons of the legacy Mitroflow Aortic Pericardial Heart Valve in patients with congenital heart defects and other valve disorders. Obtained summary judgment on all claims pursuant to federal preemption under the Medical Device Amendments to the FDCA.
  • Represent various pharmaceutical manufacturers and distributors, as regional counsel, in defense of product liability claims including failure to warn, design and manufacturing defects. Successfully defeated multiple claims on federal preemption grounds.

Awards and Recognition

  • Selected for inclusion in the Massachusetts Super Lawyers – Rising Stars® (2005  2008, 2010  2011, 2013  2016).
  • The Legal 500 recognized Katy for her work in life sciences (2016).
  • Elected to membership in the International Association of Defense Counsel (IADC). This invitation-only membership is comprised of the world’s leading corporate and insurance lawyers and insurance executives

Affiliations

  • Boston Bar Association
  • American Bar Association
    • Women in Products Liability Subcommittee
  • Defense Research Institute
    • Drug and Medical Device Section

Thought Leadership

  • Frequent writer and speaker on topics affecting FDA regulated business and products, and issues concerning litigation prevention, assessment, and management, among other topics
04 January 2024 Health Care Law Today

Acetaminophen MDL: Judge Excludes All of Plaintiffs’ Causation Experts Pursuant to Newly-Amended FRE Rule 702

On December 1, 2023, amendments to Federal Rule of Evidence (FRE) 702 geared toward emphasizing and explaining the responsibility of the judge as a “gatekeeper” for expert testimony took effect.
12 October 2023 Events

Top Trends to Watch in Pharmaceutical Litigation

As the Health Care & Life Sciences sector continues to evolve, organizations across the country should be mindful of recent trends in pharmaceutical litigation.
07 August 2023 Health Care Law Today

Regulatory Alert: DEA’s New Controlled Substance Theft or Loss Rule Includes a New Deadline and May Require Changes to Corporate Compliance Systems

On July 24, 2023, a new final rule from the Drug Enforcement Administration became effective, with important consequences for companies and individuals registered to manufacture, distribute, or dispense controlled substances.
19 July 2023 Manufacturing Industry Advisor

Product Liability

In this video, Katy Koski a partner in Foley’s Business Litigation & Dispute Resolution Practice Group, discusses how Foley can tailor a litigation strategy to help achieve your business goals.
18 July 2023 Health Care Law Today

Complex Healthcare Litigation Toolkit: The Use of Plaintiff Fact Sheets and Summary Jury Trials

On May 15 and 30, 2023, the Northern District of California conducted two “summary jury trials in a pharmaceutical lawsuit brought by patients who claimed that taking the U.S. Food and Drug Administration (FDA)-approved HIV/AIDS medication developed and manufactured by defendant Gilead Sciences Inc. resulted in kidney and bone damages.
17 July 2023 Article

Now What: Recent Supreme Court Decision Opens the Door for Expanded Corporate Personal Jurisdiction

On June 27, 2023, the United States Supreme Court issued its decision in Mallory v. Norfolk Southern Railway Co. (600 U.S. ___, slip op.), finding that when defendant Norfolk Southern registered to do business in Pennsylvania, it thereby consented to jurisdiction in Pennsylvania’s courts…for any lawsuit, even one originating outside Pennsylvania.