Sean K. Burke is vice chair of the Products Liability and Toxic Torts division of Duane Morris' Trial Practice Group. Mr. Burke is a trial attorney representing clients nationally in complex products liability and commercial litigation matters. He has tried cases before juries in both state and federal courts.
He regularly represents manufacturers of medical implant devices and pharmaceuticals in product liability cases, including serving as lead counsel in consolidated multi-plaintiff matters in both federal court (MDL) and state courts in California, Illinois, and Tennessee—many of which involved hundreds of claimants. Mr. Burke guides clients through all aspects of MDL and state court coordinated proceedings, including management of complex pleadings, discovery issues, bellwether trials and settlement programs. Mr. Burke also has experience representing companies in defense of toxic tort and environmental litigation.
He also litigated dozens of matters across the country involving trade secret litigation, the breach of non-competition and other restrictive covenants, and commercial contract disputes. He has experience counseling clients on hiring issues. Mr. Burke served a one-year secondment, working on site for a Fortune 500 company, serving as national counsel for their business and employment related litigation.
Mr. Burke also represents and counsels clients in the gaming industry, with a focus on the horse racing industry, in a broad range of matters involving state regulatory compliance, contract negotiations, and litigation.
He is admitted to practice in the District of Columbia, Pennsylvania and New Jersey as well as six different United States District Courts. Prior to rejoining Duane Morris, Mr. Burke served as law clerk for the Honorable Joel H. Slomsky of the U.S. District Court for the Eastern District of Pennsylvania. He is a 2007 magna cum laude graduate of Villanova University School of Law, where he was managing editor of special projects for the Villanova Law Review and elected to the Order of the Coif, and a cum laude graduate of Catholic University of America.
Representative Matters
Lead counsel for medical device manufacturer in multi-district litigation (MDL) pending in Arkansas involving claims of product defect relating to orthopedic hip implants.
Represents retailer in Federal MDL claims alleging that prenatal use of acetaminophen causes autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD).
Obtained a defense verdict following a two week jury trial for medical device manufacturer client facing claim that metal-on-metal hip implant products were unreasonably dangerous. Assisted in obtaining complete affirmance of verdict from the Missouri Court of Appeals, Eastern District, on issues including the exclusion of prior deposition testimony and a jury instruction given on the unavoidably unsafe doctrine. Donald S. DeLine v. Wright Medical Technology, Inc., et al., No. 14SL-CC01443, Mo. Cir., St. Louis Co. (2016), affirmed 540 S.W.3d 441 (Mo. Ct. App. 2018).
Lead trial counsel defending medical device manufacturer against claims of product mislabeling and design defect in three week jury trial in state court in Seattle, Washington. Obtained defense verdict on ultimate issues of liability.
Obtained a no payment dismissal on behalf of a medical device manufacturer of a claim filed by a South Dakota resident alleging receipt of mismatched sized components resulting in the failure of a shoulder implant.
Obtained summary judgment on behalf of medical device client in California state court on statute of limitations grounds developed through deposition testimony elicited from patient and her surgeon as to the timing of the discovery of the cause of the alleged injury.
Obtained no payment dismissal on behalf of a biologics company filed in Louisiana state court alleging the company promoted the product for an indication contrary to the label.
Served a one-year secondment on-site for a Fortune 500 company serving as national counsel for business dispute and restrictive covenants litigation.
Negotiated and obtained over twenty favorable settlements on behalf of office services client in defense of commercial litigation disputes initiated by customers and lending partners.
Obtained dismissal of $1 million claim filed by customer against office services client alleging claims of breach of contract, negligence, and fraud related to purchase of office equipment.
Assisted in bringing claims on behalf of food product manufacturer against vendor for breach of contract which resulted in favorable settlement.
Raritan Baykeeper v. Sayreville Seaport Associates – defending federal environmental claims against remediator / developer concerning $2 billion brownfield redevelopment project; won dismissal of all claims under federal abstention doctrine that was later reversed and remanded by appeals court.
Represented horsemen association in negotiations with racetrack ownership over agreement to provide funding for backstretch improvements, which resulted in construction of new barns and other renovations.
Represented and assisted in obtaining a settlement for an injured thoroughbred racing jockey in claims against the race track where the injury occurred and against the manufacturer and distributor of an artificial racing surface.
Counsels clients in the gaming industry on regulatory, compliance, and marketing issues associated with development and launch of new products.
Medical Device and Pharmaceutical Litigation
Commercial Litigation
Horse Racing and Gaming Law
Admissions
- Supreme Court of the United States
- Supreme Court of Pennsylvania
- Supreme Court of New Jersey
- District of Columbia Court of Appeals
- U.S. District Court for the Eastern District of Pennsylvania
- U.S. District Court for the District of New Jersey
- U.S. District Court for the Eastern District of Wisconsin
- U.S. District Court for the Western District of Wisconsin
- U.S. District Court for the District of Colorado
- U.S. District Court for the Eastern District of Arkansas
- U.S. District Court for the Western District of Arkansas
- U.S. District Court for the Northern District of Indiana
- U.S. District Court for the Eastern District of Texas
- Pennsylvania
Education
- Villanova University Charles Widger School of Law, J.D., magna cum laude, 2007
- Managing Editor of Special Projects, Villanova Law Review
- Order of the Coif - Catholic University of America, B.A., cum laude, 2004
Experience
- Duane Morris LLP
- Partner, 2017-present
- Associate, 2009-2016; 2007-2008 - U.S. District Court for the Eastern District of Pennsylvania
- Law Clerk to the Hon. Joel H. Slomsky, 2008-2009
Professional Activities
Voting Member on ASTM International Committees for Additive Manufacturing (F42) and Medical Surgical Materials and Devices (F4)
Honors and Awards
- Lawdragon 500 Leading Litigators in America, 2022-2025
- Listed in Washington, D.C. Rising Stars, 2015-2021
- Listed in Pennsylvania Rising Stars, 2012 and 2013
- Recipient of the ALI-ABA Scholarship and Leadership award, given to the graduating student who the faculty feels has best demonstrated a combination of academic achievement and leadership in the law school community.
Selected Publications
- Co-author, "FDA Issues Draft Guidance on Predetermined Change Control Plans for Medical Devices," Duane Morris Alert, September 23, 2024
- Co-author, "Third Circuit Creates Circuit Split on Preemption Issue Regarding Pesticide Product Labeling," Duane Morris Alert, September 4, 2024
- Co-author, "Consumer Product Safety Commission Finds Amazon Liable for 'Fulfilled by Amazon' Products," Duane Morris Alert, August 5, 2024
- Author, "Plan Ahead to Protect Your Innovation: Product Liability Risks for Medtech Startups," MD+DI & QMed, July 2, 2024
- Co-author, "New FDA Draft Guidance Documents Stand to Alter the 510(k) Process for Medical Devices," Duane Morris Alert, October 3, 2023
- Co-author, "FDA Issues Draft Guidance on Pre-market Submissions for Patient-Matched Guides to Orthopedic Implants," Duane Morris Alert, August 16, 2023
- Co-author, "FDA Issues Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," Duane Morris Alert, June 1, 2023
- Co-author, "FDA Issues Final Guidance on Clinical Decision Support Software," Duane Morris Alert, October 21, 2022
- Co-author, "The Importance of 510(k) Evidence to Ensuring a Fair Trial," AdvaMed, June 23, 2021
- Co-author, "3D Printing and Its Implications for the Auto Industry," 3DPrint.com, January 12, 2021
- Author, "Mitigating Litigation Risks with 3D Printing in Life Sciences," 3DHeals, October 17, 2020
- Co-author, "Department of Health & Human Services Clarifies Broad Scope of Immunity Protection Under the PREP Act," Duane Morris Alert, April 24, 2020
- Author, "3D Printing of PPE and Other Medical Devices," Medical Device and Diagnostic Industry, April 16, 2020
- Author, "When Innovation Outpaces Regulation," SME, March 4, 2020
Author, "Emerging Product Liability Concerns for Medical 3D Printing," MD+DI & QMed, April 2, 2019
Media Hits
- Quoted, "Court Weighing Admissibility of Device-Approval Process," New Jersey Law Journal, November 8, 2021
- Quoted, "In Hot-Button Case, New Jersey Supreme Court to Weigh Admissibility of FDA Device-Approval Process," New Jersey Law Journal, November 1, 2021
- Quoted, "It's Time to Flip the Script on Medical Device Liability Jury Trials," Medical Device and Diagnostic Industry, September 30, 2021
- Featured, "Interview with Sean Burke: Product Liability," 3DHEALS, July 27, 2021
- Featured in "AMS 2020: Panels on 3D Printing in Implants and Orthopedics, Regulation in Additive Medical Devices," 3DPrint.com, February 25, 2020
Selected Speaking Engagements
- Speaker, "The Legal Perspective on Risk Tolerance for Aortic Related Devices," Greenberg Stent Summit, September 4, 2024
- Speaker, "When Innovation Outpaces Regulation," MassMEDIC Annual Conference, December 6, 2022
- Speaker, "When Innovation Outpaces Regulation: Products Liability Considerations for Additive Manufacturing," MassMEDIC FDA 2022 Preview, February 1, 2022
- Speaker ,"The Legal Landscape in Healthcare 3D Printing," 3DHEALS, Webinar, July 29, 2021
- Speaker, "Legal Impacts of COVID-19 on the Life Sciences," American Society of Artificial Internal Organs Annual Conference, Washington, D.C., June 10, 2021
- Speaker, "Lessons Learned from Recent Headlines and Court Rulings on Products Liability Cases Across Industries," Duane Morris COVID-19: Navigating Forward Webinar Series, April 22, 2021
- Speaker, "Regulatory and Legal Trends in Medical 3D Printing," Additive Manufacturing Strategies Online Summit, February 10, 2021
- Speaker, "Cybersecurity for 3D Printed Medical Devices," 3DHEALS, Webinar, January 21, 2021
- Speaker, "How COVID-19 Is Affecting Life Sciences and Medical Technologies," Duane Morris Webinar, April 16, 2020
- Speaker, "The Business of 3D Printing: Medicine, Dentistry and Metals," Additive Manufacturing Strategies, Boston, February 11, 2020
- Speaker, "Drug and Device Verdicts-Trends and Developments on Product Liability Litigation Impacting the Pharmaceutical and Medical Device Industries," Engineer Seminar Series at the Food and Drug Administration, January 28, 2020
Speaker, “Law and Medical Devices: The Complex, Interdigitated, Essential and Evolving World” The Biomedical Engineering and Materials Roundtable of the National Academy of Sciences, Washington, D.C., March 25, 2019
Speaker, "Drug and Med Cross-Examination 101," 23rd Annual Conference on Drug & Medical Device Litigation, New York City, November 28, 2018
Speaker, "Drug & Medical Litigation Boot Camp," American Conference Institute, The Bellevue Hotel, Philadelphia, PA, July 30, 2018