Source: http://www.robertwilkey.com/home/news-and-articles/
Timestamp: 2019-04-22 02:25:31+00:00

Document:
The Bane of Research -- Research Misconduct and False Claims, Robert N. Wilkey, Esq. Policy and Medicine Compliance Update, Vol. 4.10 (October 2018). HERE.
Update: Closing the Loop on Allergan's Native American Gambit, Robert N. Wilkey, Esq. Policy and Medicine Compliance Update, Vol. 4.10 (October 2018). HERE.
Short: Equipment Loans and the Sunshine Act -- Are Process Based Assessments Working? Robert N. Wilkey, Esq. Policy and Medicine Compliance Update, Vol. 4.10 (October 2018). HERE.
WLC provides legal consultation support involving the proper scope of discovery involving electronically stored information ("ESI").
WLC is pleased to announce that Robert N. Wilkey, Esq. has received a Three-Year appointment by a Chester County Township Board of Supervisors, to serve on its Five-Member Environmental Advisory Committee ("EAC").
Taking Center Stage - Washington State's Medicaid Fraud Control Unit, The False Claims Act, and Celegene, Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.9 (September 2017). HERE.
Fresenius to the U.S. Government: When it Comes to the FCA, You Snooze You Lose, Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.9 (September 2017). HERE.
WLC represents a Plaintiff involving a complex employment dispute and a pharmaceutical company.
Independant Review Organizations ("IRO") and Conflicts of Interest - Much Ado About Nothing or a Serious Problem, Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.8 (August 2017). HERE.
A New Application of Escobar: Gilead or Half-Truths Can be Actionable Under the FCA, Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.8 (August 2017). HERE.
A Murky Future for Off-Label Promotion: Part I: New Leadership at the FDA Brings Change, Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.8 (August 2017). HERE.
In 2017, WLC obtains a favorable decision before the Pennsylvania Superior Court on behalf of a corporation involving a partnership business related dispute.
In 2017, WLC successfully obtains favorable judicial relief on behalf of a family involving a complicated mortgage foreclosure matter.
Into the Nexus - Anti-Kick Back Statute ("AKS"), Versus Value Driven Health Care, Part I: An Uncertain Future in a Dynamic Landscape, Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.4 (July 2017). HERE.
Punting on the Issue of FCA and Statistical Sampling, Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.7 (July 2017). HERE.
Prof. Spencer Waller, Director of the Institute for Consumer Antitrust Studies, Loyola University Chicago School of Law, cites to WLC's work on medical residents and employments rights in How Much of Health Care Antitrust is Really Antitrust? Loyola University of Chicago Law Journal, Vol. 48, Issue No. 3, pp. 643-666 (Spring, 2017).
In 2017, Wilkey Legal Consultants, LLC, obtains a six-figure judgment on behalf of a Plaintiff involving a fraudulent commercial real estate and conveyance transaction.
In 2017, Wilkey Legal Consultants, LLC provides litigation consulting support on behalf of group of Plaintiffs' claims involving the Rackeeter Influenced and Corrupt Organizations Act ("RICO"), against a cross-state and multi-defendant enterprise.
In 2017, Wilkey Legal Consultants, LLC provides litigation consulting support on behalf of a group of class action Plaintiffs involved a large regional utlity company.
Genentech & Escobar: Using Materiality to Escape False Claims Liability, Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.6 (June 2017). HERE.
The 21st Century Cures Act: Is it Worth the Cost for Life Sciences?, Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.6 (June 2017). HERE.
A Port in Any Storm - Adding New Harbors to the Anti-Kick Back Statute, Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.5 (May 2017). HERE.
Project Exclusion: The OIG's Latest Attempt to Make its Exclusion Authority Real, Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.4 (April 2017). HERE.
The Murkey Future of Physican- Owned Distribtorships ("PODS"), Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.4 (April 2017). HERE.
Teva - Using Legitimate Distributor Payments to Conceal Bribes , Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.4 (April 2017). HERE.
Do DPA's Work? - The BioMet Case Study , Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.3 (March 2017). HERE.
2017 Trending Towards a Banner Year for Industry Compliance, Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 3.2 (Feb. 2017). HERE.
Not All Discounts Are Equal: Evaluating When Discounts May Be Construed as Unlawful, Robert N. Wilkey, Esq., and Dr. Seth Whitelaw, Editor, Life Science Compliance Update, Vol. 3.1 (Jan 2017). HERE.
The Texas Court of Appeals on December 14, 2016, in legal opinion evaluating the employment rights of medical residents, cites to Robert N. Wilkey, The Non-Negotiable Employment Contract — Diagnosing the Employment Rights of Medical Residents, 44 Creighton L. Rev. 705 (2011). See Tex. Tech. Univ. Health Scis. v. Enoh, No. 08-15-00257-CV (Tex. App. Dec. 14, 2016). HERE.
On June 9, 2016, the U.S. Department of Justice (DOJ), in an Amicus Brief to the Third Circuit Court of Appeals, cites to Robert N. Wilkey, The Non-Negotiable Employment Contract — Diagnosing the Employment Rights of Medical Residents, 44 Creighton L. Rev. 705 (2011). See Doe v. Mercy Catholic Medical Center, No. 16-1248 (3rd Circuit). HERE.
In November 2016, Wilkey Legal Consultants, LLC provides litigation consulting services involving a pharmaceutical patent infringement matter.
Helping the Patient - Co-Pay Reimbursement Can by Okay in Certain Circumstances, Robert N. Wilkey, Esq. and Dr. Seth Whitelaw, Editor, Life Science Compliance Updates, Vol. 2.10 (Oct 2016). HERE.
AseraCare - Even Courts Seek Second Medical Opnions, Robert N. Wilkey, Esq., Life Science Compliance Updates, Vol. 2.9 (September 2016). HERE.
In August 2016, Wilkey Legal Consultants, LLC successfully files and argues a Petition to Open Judgment, to which the Court granted on behalf of a PA Corporation.
Railroad Retirement Board (RRB) First to Double-Down on DOJ's Civil Penalties for FCA Violations, Robert N. Wilkey, Esq., Life Science Compliance Updates, Vol. 2.8 (August 2016). HERE.
In June-July 2016, Wilkey Legal Consultants, LLC serves as local counsel on behalf of a national law firm involving commercial and consumer finance, lending, and transactional claims.
Thunderstruck – New OIG Guidance on Permissive Exclusion & Integrity Obligations, Robert N. Wilkey, Esq., Life Science Compliance Updates, Vol. 2.6 (June 2016). HERE.
In May 2016, Wilkey Legal Consultants, LLC, represents a Pennsylvania corporation involving commercial disparagment claims.
Breathing Life into Privilege – Internal Corporate Investigations, Attorney-Client Privilege, and the False Claims Act, Robert N. Wilkey, Esq., Life Science Compliance Updates, Vol. 2.5 (2016). HERE.
On April 26, 2016, the University of Pennsylvania, Department of Computer Science, cites to Robert N. Wilkey, The Non-Negotiable Employment Contract — Diagnosing the Employment Rights of Medical Residents, 44 Creighton L. Rev. 705 (2011). See Rebecca Baumher, Minimizing Bias in Residency Matching: A Study in Non-Standard Random Walks, HERE.
In April 2016, Wilkey Legal Consultants, LLC, represents a Philadelphia corporation involving a number of complex breach of contract and failure to perform claims.
In March 2016, Wilkey Legal Consultants, LLC, represents a corporation involving a complex environmental, remediation and contamination matter.
In Jan-Feb 2016, Wilkey Legal Consultants, LLC, provides legal representation on behalf of a corporate executive in a complex employment matter involving a Fortune 100 company.
Wilkey Legal Consultants, LLC, located in Exton, PA, is a Chester County-based complex civil litigation and consulting law firm focused on class action, mass-tort, and large-scale claims, involving pharmaceuticals, medical devices, commercial banking, finance, and lending, consumer protection, environmental, technology, employment, education reform, and civil rights based issues (e.g. Asian-American issues), providing litigation services to Chester, Montgomery, and Delaware County, and throughout Pennsylvania, including specialized and tailored consulting services to firms in the U.S.
In November 2015, Wilkey Legal Consultants, LLC provides regulatory, consulting, and industry guidance regarding the recent U.S. District Court case of Prevor v. FDA, No. 13-1177 (RMC) (D.D.C. 2015), and its impact on the regulatory classification of combination products.
Robert N. Wilkey, Esq. is the Principal Attorney of Wilkey Legal Consultants, LLC (“WLC”) located in Exton, PA, with over a decade of class action, mass tort, and complex civil litigation, including pharmaceuticals, medical devices, and consumer healthcare related matters, and provides FDA regulatory, consulting, and litigation based services to firms in the area and throughout the country. Mr. Wilkey is involved in various labor reform and whistle-blower advocacy related projects involving medical residents for claims and grievances before the Accreditation Council for Graduate Medical Education (ACGME), the effectuation of maximum hour legislation, whistle-blower protection and employment based reforms for medical residents and health-care professionals.
Robert N. Wilkey, Esq. is the Principal Attorney of Wilkey Legal Consultants, LLC (“WLC”) located in Exton, PA, with over a decade of class action, mass tort, and complex civil commercial litigation experience, including claims involving Federal and State laws involving unfair trade practices and consumer protection; banking and lending standards, credit services and truth in lending regulations, breach of good faith and dealing claims, and breach of fiduciary duties. Mr. WIlkey holds a BA/MPP from Brigham Young University and a JD from the University of Iowa College of Law, and currently provides regulatory, legal, and consultation and litigation services to individuals, corporations, industry, non-profits, school districts, and government entities.
In October 2015, Wilkey Legal Consultants, LLC provides regulatory and industry guidance regarding the FDA's Proposed Rule regarding "intended use" by way of the Federal Register, dated 9/25/15.
University of Iowa College of Law, and has over a decade of experience with class action, mass tort, and complex civil litigation. Mr. Wilkey is a strong advocate for labor and employment rights of medical residents, including providing employment based support to medical residents for claims and grievances before the Accreditation Council for Graduate Medical Education (ACGME), the effectuation of maximum hour legislation, whistle-blower protection and employment based reforms for medical residents and healthcare professionals.
Robert N. Wilkey, Esq. is the Principal Attorney of Wilkey Legal Consultants, LLC (“WLC”) located in Exton, PA, with over a decade of class action, mass tort, and complex civil commercial litigation experience, including claims involving Federal and State laws involving unfair trade practices and consumer protection; banking and lending standards, credit services and truth in lending regulations, breach of good faith and dealing claims, and breach of fiduciary duties. Mr. Wilkey is an advocate for Asian American based domestic and international issues.
In October 2015, Wilkey Legal Consultants, LLC provides regulatory and industry guidance regarding the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. § 360k(a) and cybersecurity involving medical devices.
Robert N. Wilkey, Esq. is the Principal Attorney of Wilkey Legal Consultants, LLC (“WLC”) located in Exton, PA, with over a decade of class action, mass tort, and complex civil litigation experience. Mr. WIlkey holds a BA/MPP from Brigham Young University and a JD from the University of Iowa College of Law, and currently provides regulatory, legal, consultation and litigation services to corporations, industry, non-profits, school districts, and government entities.
In October 2015, Wilkey Legal Consultants, LLC provides regulatory and industry guidance regarding the Tenth Circuit Court of Appeals case in Caplinger v. Medtronic, Inc. et. al., 784 F.3d 1335, 2015 U.S. App. LEXIS 6630 (10th Cir. 2014).
In October 2015, Wilkey Legal Consultants, LLC successfully files and argues a Petition to Open Judgment, to which the Court granted on behalf of a PA Corporation.
In October 2015, Wilkey Legal Consultants, LLC serves as counsel in a civil complex property disclosure and claims related matter.
In September 2015, Wilkey Legal Consultants, LLC joins with a Chicago based SEO legal content based provider in providing complex civil litigation and consultation services.
In September 2015, Wilkey Legal Consultants, LLC, serves as counsel in a complex civil judgement and recovery matter.
On September 21, 2015, by way of a client feedback survey and on a scale of 1-10 (10 being the highest), Wilkey Legal Consultants, LLC, received exemplary marks for overall experience, communication, cost-effectiveness, and reliability.
In September 2015, Robert N. Wilkey, Esq. accepts an editorial position with a DC based healthcare law and policy publication, focusing on pharmaceutical, medical device, compliance, regulatory, FDA, and product liability based related issues.
In September 2015, Wilkey Legal Consultants, LLC, serves as counsel on behalf of a regional trucking company.
In September 2015, Wilkey Legal Consultants, LLC serves as counsel in a complex civil litigation foreclosure matter against a national lending institution.
In September 2015, Wilkey Legal Consultants, LLC, serves as co-counsel in a professional liability matter involving breach of good faith and fidiciary claims against an accounting firm.
In September 2015, Wilkey Legal Consultants, LLC, serves as counsel on behalf of a full-service advertising company involving breach of contract claims.
In August 2015, Wilkey Legal Consultants, LLC, serves as pro-bono counsel to an Asian-American family involving a family custody matter.
In August 2015, Wilkey Legal Consultants, LLC, serves as co-counsel on behalf of a Philadelphia Corporation against a major lending institution, seeking claims for unfair trade practices and consumer protection laws, banking, good faith and fair dealing, and fiduciary matters.
On July 23, 2015, Wilkey Legal Consultants, LLC, locates to the Eagleville Office Plaza, in Exton, PA.
On April 18, 2015, Volunteer Participant in Lawyers Concerned for Lawyers (LCL) Annual Conference, Harrisburg, PA.
In 2014, Rashed Hasan, MD, FAAP, in “How to Build Your Bright Future Today: A Comprehensive Guide to Prepare Physicians for the Current Health Care Era” Archway Publishing, 2014, cites to Robert N. Wilkey “The Non-Negotiable Employment Contract — Diagnosing the Employment Rights of Medical Residents", 44 Creighton L. Rev. 705 (2011).
On April 27, 2014, Volunteer Participant in Lawyers Concerned for Lawyers (LCL) Annual Conference, Harrisburg, PA.
In 2013, Katherine Bischoping and Elizabeth Quinlan, in “Health and Safety Issues in Precarious Cultural Work" E-Journal of International and Comparative Labour Studies, Volume 2, No. 2 May-June 2013, Adapt University Press, cites to “"Federal Whistleblower Protection: A Means to Enforcing Maximum Hour Legislation for Medical Residents", William Mitchell Law Review, Vol. 30, Issue 1 (2003).
On November 2, 2012, Scholarship Recipient and Conference Invitee to CCGP's Conference on "Problem Gambling and the Law."
In 2012, both Minn. Stat. sec. 181.931 (Notice of Termination) and Minn. Stat. § 181.932 (Disclosure of Information by Employees), cites to "Federal Whistleblower Protection: A Means to Enforcing Maximum Hour Legislation for Medical Residents", William Mitchell Law Review, Vol. 30, Issue 1 (2003).
In August 2011, Labor and Employment Relations Association, Newsletter, references "The Non-Negotiable Employment Contract — Diagnosing the Employment Rights of Medical Residents", 44 Creighton L. Rev. 705 (2011).
On May 31, 2011, The Workplace Professor Blog, highlights the "The Non-Negotiable Employment Contract — Diagnosing the Employment Rights of Medical Residents", 44 Creighton L. Rev. 705 (2011).
In February 2011, Quan Hien Nguyen, "Vietnamese Law: A Guide to Sources and Commentary", cites to "Vietnam’s Anti-Trust Legislation and Subscription to E-Asean: An End to the Bamboo Firewall Over Internet Regulation?" 20 J. Marshall J. Computer & Info. L. 631 (2002).
In 2009, Merit Buckley, "Imposing Liability in the United States Medical Residency Program: Exhaustion, Errors, and Economic Dependence", 12 DePaul J. Health Care L. 305 (2009), cites to: "Federal Whistleblower Protection: A Means to Enforcing Maximum Hour Legislation for Medical Residents", William Mitchell Law Review, Vol. 30, Issue 1 (2003).
In 2008, Robert R. Elder, Expanded Hospital Liability Under the Federal False Claims Act: An Unexpected Solution to the Resident Duty Hour Controversy, 5 Ind. Health L. Rev. 53 (2008), cites to: "Federal Whistleblower Protection: A Means to Enforcing Maximum Hour Legislation for Medical Residents", William Mitchell Law Review, Vol. 30, Issue 1 (2003).
In 2006, Clark J. Lee, Symposium: Bridging The Racial Divide in Health Care: Eliminating the Racial and Ethnic Disparities in Health Status, COMMENT: Federal Regulation of Hospital Resident Work Hours: Enforcement with Real Teeth, 9 J. Health Care L. & Pol'y 16, cites to "Federal Whistleblower Protection: A Means to Enforcing Maximum Hour Legislation for Medical Residents", William Mitchell Law Review, Vol. 30, Issue 1 (2003).
In April 2005, Chenglin Liu, Research Guide on the Trading Systems in the Asian-Pacific Region: APEC, ASEAN and their Members, New York University Law, cites to "Vietnam’s Anti-Trust Legislation and Subscription to E-Asean: An End to the Bamboo Firewall Over Internet Regulation?" 20 J. Marshall J. Computer & Info. L. 631 (2002).
In 2002, the term "Bamboo Firewall" originates in "Vietnam’s Anti-Trust Legislation and Subscription to E-Asean: An End to the Bamboo Firewall Over Internet Regulation?" 20 J. Marshall J. Computer & Info. L. 631 (2002), to describe Vietnam's Regulatory Internet and Management policies.

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