Cozen O’Connor: Sacunas, Abby L.

Abby L. Sacunas

Member

Philadelphia

(215) 665-4785

(215) 701-2472

Recent Publication:

How Smart is it for Medical Devices to Learn New Tricks? The FDA Seeks Feedback On Its Proposed Regulatory Framework for Artificial Intelligence/Machine Learning-Based Medical Devices [Products Liability Prevention & Defense Blog]

In the shadow of the FDA’s new Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device, manufacturers are left to contemplate enhanced product liability exposure. AI-powered devices ingest new data and adjust accordingly – a feature that could result in entirely...

Abby Sacunas focuses her practice on business disputes, products liability and antitrust prevention and defense. She successfully represents clients in the life safety, pharmaceutical, medical device, telecommunications and athletic equipment industries, and is consistently recognized as a “Pennsylvania Super Lawyer Rising Star.” As national trial counsel for certain of her clients and acting outside general counsel to others, Abby has extensive experience litigating in state and federal forums throughout the United States where she has obtained everything from full defense verdicts to summary judgment decisions on behalf of her clients. She additionally counsels clients on labor and employment, regulatory and compliance issues as a way to proactively manage and limit risk, especially given the rise in trade secret, privacy, data and cybersecurity concerns. Abby is the managing editor of the Products Liability Prevention & Defense Blog, which provides regular updates on product liability trends, decisions and litigation prevention tactics for defendants and potential defendants.

Abby’s antitrust work involves mergers, government investigations, litigation, and counseling. She routinely advises clients in a variety of industries with respect to merger clearance and related due-diligence, general counseling on antitrust, consumer protection and advertising issues, litigation, and legislative issues.

Abby acts as outside general counsel to entrepreneurial businesses, skillfully and proactively navigating risk while representing the full scope of their commercial business interests. This includes but is not limited to, managing labor issues and disputes, defending and enforcing non-competition, non-solicitation and confidentiality agreements and litigating other employment-related claims.  Abby also assists startups and entrepreneurs as a team member of COpilot, Cozen O'Connor’s multidisciplinary initiative designed for emerging companies to gain insight from corporate, litigation, intellectual property and employment attorneys, download corporate formation documents and connect with funding sources.

Abby serves on the board of directors for the Riddle HealthCare Foundation, a charitable organization that encourages philanthropic support of Riddle Hospital in Media, Pa. She is a member of the Pennsylvania Bar Association, the American Bar Association and an active member of the Pennsylvania Bar Association's Women in the Profession Committee. Abby earned her law degree from Syracuse University College of Law in 2005, magna cum laude, where she was elected to the Order of the Coif, was a member of the Syracuse Law Review and earned a Corporate Counsel Certificate from the Center for Law and Business Enterprise. She earned her undergraduate degree from Syracuse University, cum laude.

Experience

Product Liability
 
Successfully defended medical device manufacturer against design and manufacturing defect
claims. Obtained early dismissal of warning claim and extracted an expert admission of no
manufacturing defect claim. Drafted strong summary judgment briefs and motions to exclude, which
while pending, leveraged a favorable resolution.
 
Proactively manage risk for consumer product manufacturers, component part manufacturers,
distributors, and retailers by providing regulatory compliance advice concerning, among other things,
relevant product testing and certification requirements, quality control process and procedure
documentation, as well as print and online advertising, packaging, and product-related warnings.
Additionally, review and advise on consumer complaint processes and procedures to ensure
regulatory compliance and limit risk.
 
Successfully litigated manufacturing and design defect cases throughout the country involving
serious burn injuries, toxic brain injuries and deaths resulting from fire and toxic exposures, wherein
plaintiffs sought damages in excess of $100 million.
 
Obtained unanimous jury verdict for a leading manufacturer of consumer safety products in Illinois
state court wherein plaintiff sought compensatory and punitive damages and raised unique rescue
doctrine issues of the first impression in the jurisdiction.
 
Obtained dismissal of several product liability actions seeking compensatory and punitive damages
against medical device manufacturer, wherein plaintiffs claimed serious personal injuries, following
targeted discovery and before incurring costs of a trial.
 
Secured defense verdict for consumer product manufacturer in wrongful death product liability
action seeking millions in damages in rural Alabama. Diligent discovery and expert fire modeling
undermined plaintiff’s allegations defeating design defect and related claims.
 
Obtained summary judgment for a product manufacturer whose product was alleged to have
proximately caused five deaths. The court held that the plaintiffs failed to establish a product defect
and/or that the alleged product defect was the proximate cause of the plaintiffs’ deaths.
 
Antitrust Litigation
 
Represent generic pharmaceutical manufacturer in price fixing litigation pending in the Eastern
District of Pennsylvania.
 
Represented renowned independent concert promoter in a multimillion-dollar private antitrust action
alleging, inter alia, monopolization, attempted monopolization, and tying in violation of Sections 1
and 2 of the Sherman Act. In addition to successfully defeating summary judgment, this action has
involved the supervision of extensive and voluminous e-discovery, the handling of numerous
depositions of high-level executives and popular music artists, and a tremendous amount of fact
gathering and analysis.
 
Defend manufacturer and distributor of flight helmets in complex antitrust litigation pending in the
District of Delaware.
 
Represent healthcare transportation broker in dual antitrust proceedings pending in the Central
District of California
 
Outside antitrust counsel to healthcare providers providing advice and counsel on proposed joint
ventures and mergers.
 
Data Breach and Cybersecurity
 
Represent major corporations in data breach litigation. Recently obtained dismissal of data breach
lawsuit filed against major communications and entertainment company.
 
Business Litigation
 
Obtained preliminary injunctive relief enabling enforcement of exclusive importation and distribution
agreement with the foreign defendant in federal court on behalf of a wine and spirits importer.
 
Successfully defended claims alleging a violation of Real Estate Seller Disclosure laws, unfair
competition, and fraud against realtor and property owner for purported failure to disclose a preexisting
condition prior to a sale of real property. Pointed discovery supported a targeted motion for
summary judgment, the filing of which led to a favorable resolution of all claims.
 
Secured favorable judgments resulting in precedential opinions in both State and Federal Court on
behalf of the major multi-media company on issues involving the application of the First Amendment
to the right to protest on private property.
 
Successfully represented offerors and bidders in connection with public procurements totaling tens
of millions of dollars, including advice and counseling as well as litigation at the administrative and
appellate levels.
 
Employment Litigation
 
Successfully enforced non-competition, confidentiality and non-disclosure agreements on behalf of
employers.
 
Obtained early dismissal of USERRA claim filed by a former employee.
 
Successfully defended and obtained dismissal of wage and hour claims filed by former employees.
 
 

News

64 Cozen O'Connor Attorneys Named Pennsylvania Super Lawyers and Rising Stars

May 21, 2019

Super Lawyers has selected 64 Cozen O'Connor attorneys to the 2019 Pennsylvania Super Lawyers and Rising Stars lists.

Fifty-four Cozen O’Connor Attorneys Named 2018 Pennsylvania Super Lawyers and Rising Stars

June 12, 2018

Super Lawyers has named 54 Cozen O'Connor attorneys to its 2018 Pennsylvania Super Lawyers and Rising Stars lists.

Mesh Ruling Signals Tough Road For Non-Pa. Cases In Philly

August 09, 2017

Abby Sacunas, a member of the firm's Commercial Litigation Department, was quoted in Law360's article, "Mesh Ruling Signals Tough Road For Non-Pa. Cases In Philly."

Abby Sacunas Participates In Twitter Chat On Major Product Liability Cases With Law360

August 15, 2014

Abby Sacunas, a member of the Commercial Litigation Department, participated in a Law360 Twitter chat titled, ''The Product Liability Landscape: What Do You Need To Know?'' The discussion addressed some of the major product liability cases currently pending before courts across the country, as well as some cases likely to generate headlines later this year.

Publications

How Smart is it for Medical Devices to Learn New Tricks? The FDA Seeks Feedback On Its Proposed Regulatory Framework for Artificial Intelligence/Machine Learning-Based Medical Devices [Products Liability Prevention & Defense Blog]

May 29, 2019

In the shadow of the FDA’s new Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device, manufacturers are left to contemplate enhanced product liability exposure. AI-powered devices ingest new data and adjust accordingly – a feature that could result in entirely...

ALERT: U.S. Supreme Court Grants Certiori to Decide Whether FDA Excluded Warnings Pre-Empt State Law Claims [Products Liability Prevention & Defense Blog]

June 28, 2018

The U.S. Supreme Court today agreed to consider a Third Circuit ruling that revived litigation over Merck's alleged failure to warn about a risk of femoral fractures from its osteoporosis drug Fosamax.  The precise question presented on appeal is “whether a state-law failure-to-warn claim is...

What Manufacturers Need To Know About “GDPR” – The New EU Privacy Law

June 19, 2018

Abby Sacunas, a member in the firm's Commercial Litigation Department, and Ude Lu, an associate in the firm's Intellectual Property Department, published "What Manufacturers Need To Know About “GDPR” – The New EU Privacy Law," for the DVIRC Newsletter.

Third Circuit Issues Precedential Ruling on Express Preemption for Hybrid Medical Devices [Products Liability Prevention & Defense Blog]

March 20, 2018

The Third Circuit has become the first U.S. Court of Appeals to address the application of the express preemption provision in the Medical Device Amendments of 1976 to hybrid medical devices. Hybrid medical devices are devices which contain differently classified components. In Shuker v. Smith...

State Court Relies Upon Supreme Court’s Bristol-Meyers Squibb Decision to Vacate Jury Verdict Against J&J [Products Liability Prevention & Defense Blog]

November 14, 2017

The Supreme Court limited a striking vulnerability for product manufacturers in Bristol-Myers Squibb Co. v. Superior Court of California this summer when it ruled that out-of-state plaintiffs could not simply claim injuries that were similar to residents to support specific jurisdiction, but must...

Enforcing Arbitration Clauses In Product Packaging [Law360]

July 21, 2017

Abby Sacunas, a member of the Commercial Litigation Department, published, "Enforcing Arbitration Clauses In Product Packaging," in Law360.

Supreme Court Solidifies Specific Jurisdiction Analysis To Dismiss Product Claims Filed Against Non-Resident Defendant, Bristol-Myers Squibb Co. [Products Liability Prevention & Defense Blog]

June 26, 2017

Product manufacturers routinely hauled into court in far away, inconvenient jurisdictions can breathe a little easier with the Supreme Court’s decision this week in Bristol-Myers Squibb Co. v. Superior Court of California. A group of plaintiffs, most of whom were not California residents, sued...

SCOTUS Decisions May Provide A Roadmap to Enforcing Arbitration Clauses Included In Product Packaging [Products Liability Prevention & Defense Blog]

June 13, 2017

It is open opinion season at the U.S. Supreme Court, and two recent decisions pertaining to the enforceability of arbitration clauses provide guidance to manufacturers looking to bind consumers through the use of product packaging. In Kindred Nursing Centers Limited Partnership v. Clark, No....

Lack of Specificity May Kill Parallel State Law Product Claims, But Not Fraud Claim [Products Liability Prevention & Defense Blog]

May 11, 2017

A Michigan district court judge determined last week that product liability claims against an FDA approved medical device manufacturer were preempted by federal law, but allowed the plaintiff’s claim of fraud against the manufacturer, Medtronic, Inc., to proceed at the state level. Although the...

New FDA Draft Guidance on Benefit-Risk Factors Affecting Medical Device Compliance, and Enforcement [Products Liability Alert]

August 08, 2016

Abby Sacunas and Jillian Flax discuss the U.S. Food and Drug Administration recently released draft guidance to clarify the benefit and risk factors it may consider in compliance and enforcement actions involving medical devices.

FDA Issues New Draft Guidance Requiring Modifications to Medical Device Tracking Labels [Products Liability Prevention & Defense Blog]

August 04, 2016

The Food and Drug Administration released draft guidance last week revealing its intent to better track medical devices, from pacemakers to condoms, through an amendment to its 2013 “UDI (unique device identifier) Rule”.  The draft guidance is intended to assist both labelers and FDA-accredited...

2016 DTSA: Providing Manufacturers with New Avenues to Protect Trade Secrets

July 14, 2016

Abby L. Sacunas and Jeffrey D. Feldman discuss the Defend Trade Secrets Act of 2016 and its impact on manufacturing companies with trade secrets related to a products or services used in, or intended for use in, interstate or foreign commerce.

Product Liability Law Will Adapt To Driverless Car Regs [Law360]

June 30, 2016

Abby Sacunas, a member of Cozen O'Connor's Products Liability practice, discusses driverless car regulations in Law360.

New Weapon For Manufacturers: Defend Trade Secrets Act of 2016 [Products Liability Prevention & Defense Blog]

June 23, 2016

On May 11, 2016, President Barack Obama signed the Defend Trade Secrets Act of 2016 (the “DTSA”), which provides a federal civil cause of action to manufacturers for the misappropriation of trade secrets under the Economic Espionage Act.  While the DTSA substantially mirrors the protections afforded...

U.S. DOT Moving Closer to Certification of Driverless Cars [Products Liability Prevention & Defense Blog]

June 13, 2016

Motor vehicle design continues to make significant technological leaps incorporating a number of automated features, with many manufacturers pioneering the concept of driverless cars. What was once the stuff of science fiction is making significant headway towards full-scale production and...

Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure [Products Liability Prevention & Defense Blog]

June 02, 2016

Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad.  This situation presents an important cautionary tale and one that is not strictly limited to medical...

Case Provides Blueprint For Controlling Liability [Today's General Counsel]

April 21, 2016

Abby Sacunas, a member of Cozen O'Connor's Product Liability practice, discusses the Seventh Circuit's decision in Thornton v M7 Aerospace in Today's General Counsel.

The FDA’s New Guidance on Cybersecurity Risks for Medical Devices [Corporate Counsel]

March 03, 2016

Jillian Thornton Flax and Abby Sacunas, both members of Cozen O'Connor's Products Liability practice, discuss the FDA's new guidance on cybersecurity risks for medical devices in Corporate Counsel.

Litigation In The Marijuana Industry Lights Up [Law360]

February 09, 2016

Abby Sacunas, a member of Cozen O'Connor's Products Liability practice, discusses litigation in the marijuana industry in Law360.

The Fairness in Class Action Litigation Act of 2016 – What It Can Mean For Consumer Product Manufacturers [Products Liability Prevention & Defense Blog]

January 19, 2016

Last year, the chairman of the House Judiciary Committee, Bob Goodlatte (R. Va.), proposed the Fairness in Class Action Litigation Act of 2015-2016 (H.R. 1927).  The Act passed the House last week on January 8, 2016, and is presently before the Senate. If passed, the Act will amend the federal...

What the United States Supreme Court’s Decision in DirecTV v. Imburgia Means For Your Consumer Agreements and Arbitration Clauses [Products Liability Prevention & Defense Blog]

December 23, 2015

Last week, the United States Supreme Court issued its opinion in DirecTV v. Imburgia, 577 U.S. ___ (2015).  This decision is important for manufacturers of consumer products because it fortifies the ability to incorporate and rely upon arbitration clauses as a way to reduce risk and overall...

A Step by Step Guide To Maximizing The Use of Social Media In Defending Product Liability Claims [Products Liability Prevention & Defense Blog]

December 04, 2015

As most people are aware, social media has become pervasive in the daily lives of the vast majority of Americans.  Social media provides us with an instantaneous way to share our thoughts and experiences with others.  Doing so creates an electronic history that is stored and preserved, and, as the...

Whose Choice Is It Anyway? Split Decisions Over Choice of Law and The Impact On Your Defense Strategy [Products Liability Prevention & Defense Blog]

November 27, 2015

Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, has been embroiled in a mass tort MDL in Philadelphia for its anti-psychotic drug, Risperdal, for almost a year now.  So far in 2015, the juries have split – three in favor of plaintiffs one in favor of the defense, and the issue that...

Litigation In The Marijuana Industry Lights Up [Products Liability Prevention & Defense Blog]

November 09, 2015

The country’s first products liability class action has hit the marijuana industry with the filing of various tort, strict liability and contract claims against LivWell, Inc. in Colorado state court last month.  The complaint purports to define two classes—a medical class and a recreational...

In Pa., No Duty to Advise of Optional Safety Devices [Law360]

November 04, 2015

Abby Sacunas discusses the Eastern District Court of Pennsylvania’s decision to dismiss plaintiff’s negligence and §402(B) strict liability claims on summary judgment in Morello v. Kenco Toyota Lift.

FTC Announces Red Light on Unqualified "Green Approved" Seals [Products Liability Prevention & Defense Blog]

October 21, 2015

Updated to clarify that this post is not about Green Seal, Inc. but the environmental seals or certifications warned against in a recent FTC update. Manufacturers of consumer products labeled with unspecified environmental certification seals (“green seals”) may find themselves subject to...

Morello v. Kenco Toyota Lift: No Duty to Advise Of Optional Safety Devices [Products Liability Prevention & Defense Blog]

October 15, 2015

Just last week, the Eastern District of Pennsylvania dismissed plaintiff’s negligence and §402(B) strict liability claims on summary judgment in Morello v. Kenco Toyota Lift, et al.  The court reserved dismissal of the §402(A) and related breach of implied warranty claims pending Daubert hearings....

Morello v. Kenco Toyota Lift: No Duty to Advise Of Optional Safety Devices [Products Liability Alert]

October 15, 2015

The Morello court specifically addressed whether a forklift seller could be liable for injuries in negligence, strict liability or breach of warranty caused by an industrial forklift which did not include accessories such as lights or chimes when operating in reverse.

Volkswagen Defeated? [Products Liability Prevention & Defense Blog]

September 24, 2015

Last week, on September 18, 2015, the EPA issued a News Release revealing that Volkswagen Group of America (“Volkswagen”) sold cars incorporating a “defeat device” as defined in the Clean Air Act (“CAA”) to purposefully evade federal and state emissions and environmental laws and regulations.[1]  In...

Welcome [Products Liability Prevention & Defense Blog]

September 17, 2015

Welcome, and thank you for joining Cozen O’Connor on the Products Liability Prevention and Defense Blog, or, as we like to call it, the PLPD blog. This blog is intended to provide regular updates on product liability trends, decisions and litigation prevention tactics for defendants and potential...

Will the Supreme Court Take a Stand on Standing in BP Case? [The Legal Intelligencer]

September 18, 2014

It is axiomatic that to certify a class, plaintiffs must show all members satisfy Article III standing and Rule 23 requirements. While federal courts "do not require each member of a class to submit evidence of personal standing, a class cannot be certified if it contains members who lack standing" to pursue the claim(s) asserted, according to Halvorson v. Auto Owners Insurance, 718 F.2d 773 (8th Cir. 2013).

Threading the 'American Needle': The Supreme Court Adopts a New Standard of Concerted Action Under the Sherman Act [Litigation Alert!]

May 27, 2010

Threading the 'American Needle': The Supreme Court Adopts a New Standard of Concerted Action Under the Sherman Act - Litigation Alert! - In a unanimous decision likely to transcend its unique factual background, on Monday, the United States Supreme Court in American Needle, Inc. v. National Football League, et al., established a new test for determining whether related parties are single entities for purposes of establishing an agreement, combination or conspiracy in violation of Section 1 of the Sherman Act.

The Santa Ana Wind-Driven 2007 Southern California Wildfires: A First-Party Factual and Legal Analysis of the Santa Ana Wind-Driven Wildfires [Cozen & O'Connor Whitepaper]

November 14, 2007

The Santa Ana Wind-Driven 2007 Southern California Wildfires: A First-Party Factual and Legal Analysis of the Santa Ana Wind-Driven Wildfires - Cozen & O'Connor Whitepaper -

Events & Seminars

Past Events

The Power of Creative Planned Giving

February 15, 2018 - Media, PA

2017 Health Law Year In Review

December 06, 2017 - Philadelphia, PA

2017 Drug & Device Defense Forum

October 24, 2017 - Philadelphia, Pa

Emerging Legal Issues in Health and Pharmaceutical Law

October 10, 2017 - Indianapolis, IN

DRI: Product Liability Conference

February 08, 2017 - Las Vegas, NV

Drug & Device Defense Forum

December 13, 2016 - Philadelphia, PA

2016 Greater Philadelphia Manufacturing Summit

October 19, 2016 - Drexel Hill, PA

Legal Series: Product Liability for 2015

March 20, 2015 - Webinar

Education

  • Syracuse University College of Law, J.D., magna cum laude, 2005
  • Syracuse University, B.A., cum laude, 2002

Awards & Honors

Pennsylvania Super Lawyers "Rising Star" 2011-2019

Pro Bono Honor Roll of the First Judicial District of Pennsylvania 2007

JD Supra's Readers' Choice Awards Top Authors Medical Device Industry 2017  

  • New Jersey
  • Pennsylvania
  • Pennsylvania Supreme Court
  • Supreme Court of New Jersey
  • U.S. District Court -- Eastern District of Pennsylvania
  • U.S. District Court -- Middle District of Pennsylvania
  • U.S. District Court -- New Jersey
  • U.S. Court of Appeals for the Fourth Circuit
  • American Bar Association
  • Defense Research Institute
  • Insurance Society of Philadelphia
  • Pennsylvania Bar Association
  • Philadelphia Bar Association
  • Riddle HealthCare Foundation Board of Directors