Wilkey Legal Consultants, LLC (WLC), 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 protection (e.g. adverse exposure and property dimunition), 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., and is engaged in a joint venture with the U.S.-Vietnam Law Institute and CryptoLawLLC.
Robert N. Wilkey, Esq., Principal Attorney of WLC, has published over one-hundred law review and legal articles, and presently serves as a Senior Editor for Policy and Medicine Compliance Update, "a monthly publication providing comprehensive, up-to-date compliance information for pharmaceutical, biotechnology, and device manufacturers [providing] important news and analysis, with input from top compliance officers and healthcare Attorneys across the industry." Mr. Wilkey also presently serves as a legal consultant, guest lecturer, and frequent panelist, for various litigation and legal topics relating to medical device and pharmaceuticals, legal management solutions, litigation technology, and electronically stored information (ESI). Mr. Wilkey also presently serves as "Of Counsel" for a law-firm in Lancaster, PA.
Just Another Settlement or Something More: Examining J&J's West Virginia's Opioid Settlement, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 8.5 (May 2022), available HERE.
Alabama Pill Mill Case Gets to the U.S. Supreme Court: Does a "Good Faith" Defense Still Exist for Controlled Substances? by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 8.5 (May 2022), available HERE.
Antitrust, FDA and Sun Pharma - The End of the Line: A Consumer Protection Win and Signal to Generic Drug Manufacturers, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 8.5 (May 2022), available HERE.
Kicking the Can Down the Road: The Supreme Court Refuses to Address FCA Whistleblower Protections for Employees Protections, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 8.4 (April 2022), available HERE.
A Shift in Legal Strategy Results in Opioid Victory for New York, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 8.3 (March 2022), available HERE.
Pharma Bro Martin Shkreli Loses to the FTC, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 8.2 (February 2022), available HERE.
Opioids and the Ongoing Struggle for Accountability: The Oklahoma Supreme Court Reverses the J&J Opioid Decision, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 8.1 (January 2022), available HERE.
Opioids and the Ongoing Struggle for Accountability, California State Superior Court Refuses to Extend Public Nuisance Liability, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 8.1 (January 2022), available HERE.
Kickbacks Disguised as Charity, Teva Loses Bid to Dismiss the Copaxone Co-pay Charity Case, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 7.11 (November 2021), available HERE.
Expanding the War The DOJ’s Focus on Telemedicine and Heath Care Fraud Increases, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 7.9 (September 2021), available HERE.
All Things Are Not Equal: The Ninth Circuit Revives FDA Certification Fraud Claims Against Medtronic, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 7.8 (August 2021), available HERE.
The Never-ending Opioid Liability Nightmare California Extracts Another Multimillion-Dollar Settlement from Indivior Over Suboxone, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 7.7 (July 2021), available HERE.
Another Compliance Officer Blows the Whistle, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 7.6 (June 2021), available HERE.
The Day of Covid-19 Reckoning is Here: The Justice Department Focuses on Pandemic Related Fraud, by Robert N. Wilkey, Esq., Senior Editor, and Dr. Seth B. Whitelaw, Editor, Policy and Medicine Compliance Update, Vol. 7.5 (May 2021), available HERE.
Opioids Are Toxic for Consultants: McKinsey Settlement is a Warning to Industry Consultants, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 7.3 (March 2021), available HERE.
The Ongoing Insys Saga Enters a New Phase: Targeting Prescribing Physicians, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 7.2 (February 2021), available HERE.
Genetic Testing Meets the False Claims Act: AutoGenomics Settles with the DOJ, by Robert N. Wilkey, Esq., Policy and Medicine Compliance Update, Vol. 7.2 (February 2021), available HERE.
Co-pay Charity Doesn’t Always Pay Gilead’s False Claims Act Settlement, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 6.12 (December 2020), available HERE.
Shaped by the Pandemic The Justice Department Reasserts Compliance Authority under the False Claims Act, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 6.11 (November 2020), available HERE.
Blaming the Pandemic to Avoid High-Risk Litigation: J&J Employs a Novel Approach in the Talcum Powder Cases, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 6.10 (October 2020), available HERE.
A Setback for Drug Pricing Transparency The Legal Debate on Disclosures in TV Ads Continues by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 6.10 (October 2020), available HERE.
The DEA, Plaintiffs’ Counsel & Now Shareholders McKesson’s Opioid Woes Continue, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 6.8 (August 2020), available HERE.
Burning Down the House Lessons from the Insys Therapeutics Saga, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 6.1 (June 2020), available HERE.
Stepping out Teva and Allergan Play the Jurisdiction Card Trying to Escape Opioid Liability,, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 6.6 (June 2020), available HERE.
The Headache Continues Washinton State Brands J&J's Opioid Business as a Public Nuisance, Robert N. Wilkey, Esq., Senior Editor Policy and Medicine Compliance Update, Vol. 6.4 (April 2020), available HERE.
The Supreme Court Signals an End to the Blanket Deference for the FDA in Kisor v. Wilkie, Robert N. Wilkey, Esq., Senior Edior, Policy and Medicine Compliance Update, Vol. 6.4 (April 2020), available HERE.
It's Still Not Over - Judge Partially Reverses Convictions of Insys Executives, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 6.1 (January 2020), available HERE.
The Opioid Fallout Continues with a Call to Reform the the Multi-District Litigation ('MDL') Process, by Robert N. Wilkey, Esq., Senior Editor, and Dr. Seth B. Whitelaw, Editor, Policy and Medicine Compliance Update, Vol. 5.12 (December 2019), available HERE.
In 2019, WLC's legal scholarship on Vietnam's "Bamboo Firewall" is highlighted in the History of Vietnam and Socialist Republic of Vietnam-Ed, by Oguzhan Yilmaz, available HERE.
WLC's legal work on medical residents and employment rights is cited in Nicholas D. Lawson and J. Wesley Boyd, "How Broad Are State Physician Health Program Descriptions of Physician Impairment?" Substantive Abuse Treatment, Prevention, and Policy, Vol. 13:30 (2018), available HERE.
On November 14, 2018, the Superior Court of Pennsylvania (Court of Appeals), rules in favor of a WLC client involving a complex contract settlement dispute.
In 2017-2018, the firm's legal work on medical residents and employment rights was highlighted by the U.S. Department of Justice (DOJ), U.S. Third Circuit Court of Appeals, the Texas Court of Appeals, and the University of Pennsylvania.
WLC cases have been highlighted in various media, newspapers and publications including among others NPR, the Pittsburgh Post-Gazette, the Reading Eagle, the New Jersey Record, and various law reviews and secondary legal journals, such as the William Mitchell Law Review, Creighton Law Review, and John Marshall Journal of Technology.
On June 19, 2018, Robert N. Wilkey, Esq. argues a case before the Superior Court of Pennsylvania (Appellate Court), involving a complex civil legal issue involving the scope of proper settlement contract interpretation.
Opiod Case Tests the Boundaries of Liability -- Oklahoma, J&J and the "Mutant" Poppy Strain, by Robert N. Wilkey, Esq., Senior Editor, Policy and Medicine Compliance Update, Vol. 5.9 (September 2019). HERE.
The Final Chapter of Allergan's Failed Effort to Join Forces with the Saint Regis Mohawk Tribe (Or is It?), Robert N. Wilkey, Esq., Policy and Medicine Compliance Update, Vol. 5.6 (June 2019). HERE (forthcoming).
Intermountain Healthcare versus the Whistleblower, Robert N. Wilkey, Esq., Policy and Medicine Compliance Update, Vol. 5.5 (May 2019). HERE.
Gazing into the Crystal Ball (Part 2), Robert N. Wilkey, Esq., Policy and Medicine Compliance Update, Vol. 5.3 (April 2019). HERE.
Putting the Cart Before the Horse - The DOJ Extends Self-Disclosure Protection to Successor Companies, Robert N. Wilkey, Esq., Policy and Medicine Compliance Update, Vol. 5 (January 2019). HERE.
"We contacted Wilkey Legal Consultants, LLC, regarding a very complex employment lawsuit involving a highly regarded regional pharmaceutical company. The law-firm provided a workable budget and provided very substantive, objective and effective legal guidance in bringing about a very successful and positive outcome, which we absolutely would not have obtained otherwise." --- J.M (2017).
"We had contacted Attorney Wilkey and Wilkey Legal Consultants, LLC, involving a very complicated civil lawsuit that had spanned a number of years and prior to this time, had involved legal costs and expenses of thousands of dollars. Mr. Wilkey and his firm worked out an effective legal strategy to expedite a resolution to this case, worked out a very flexible budget, and provided consistent and regular updates throughout the entire process. In hind-sight, we wish that we had consulted with his firm before taking years and wasting valuable time and resources, especially where his firm was able to obtain an end result that others were not able or competent enough to achieve, very grateful to find and recommend this firm." --- Todd M. (2017).
A Tale of Bona-Fide Service Fees for PBMs - The Express Scripts Saga,
Robert N. Wilkey, Esq., Policy and Medicine Compliance Update, Vol. 4.11 (November 2018). HERE.
The Bane of Research -- Research Misconduct and False Claims,
Robert N. Wilkey, Esq., Policy and Medicine Compliance Update, Vol. 4.10 (Oct 2018). HERE.
Update: Closing the Loop on Allergan's Native American Gambit, Robert N. Wilkey, Esq., Policy and Medicine Compliance Update, Vol. 4.10 (Oct 2018). HERE.
Short: Equipment Loans and the Sunshine Act -- Are Process Based Assessments Working? Robert N. Wilkey, Esq., Michael O'Conner, Porzio Life Sciences Team, Policy and Medicine Compliance Update, Vol. 4.10 (Oct 2018). HERE.
When "Free" Really Isn' t Free - A Look at the Abiomed Case, Robert N. Wilkey, Esq., Life Science Compliance Update, Vol. 4.7 (July 2018). HERE.
It's Not Just Money - Theranos & SEC Come to Terms, Robert N. Wilkey, Esq., Life Science Compliance Update, Vol. 4.5 (May 2018). HERE.
Update - Allergan's Patent Transfer to Native Americans Lacks Merit, Robert N. Wilkey, Esq., Life Science Compliance Update, Vol. 4.5 (May 2018). HERE.
The Escobar Hurdle - False Claims, Materiality, and Dismissal, Robert N. Wilkey, Esq., Life Science Compliance, Vol. 4.4 (April 2018). HERE.
It's Not About All the Money - Medtronic's Infusion Multi-State Settlement Agreement, Robert N. Wilkey, Esq., Life Science Compliance, Vol. 4.4 (April 2018). HERE.
The FDA Continues Its Efforts to Reign in Rogue Stem Cell Therapy Companies, Robert N. Wilkey, Esq., Life Science Compliance, Vol. 4.3 (March 2018). HERE.
Uncle Same Wants His Money - First Coast Cardiovascular Institute as a Case Study in Repaying Overpayments Can Generate Liability in FCA Liability, Robert N. Wilkey, Esq., Life Science Compliance, Vol. 4.3 (March 2018). HERE.
One Purpose to Rule Them All - A Resounding "Yes" According to the District Court in U.S. EX Rel. Cairns, Robert N. Wilkey, Esq., and Seth Whitelaw, J.D., LLM., S.J.D., Editor for Life Science Compliance Update, Vol. 4.2 (February 2018). HERE.
The Ongoing Struggles of Norvartis' Global Compliance Function, Robert N. Wilkey, Esq., and Seth Whitelaw, J.D., LLM., S.J.D., Editor for Life Science Compliance Update, Vol. 3.12 (December 2017). HERE.
The 21st Century Cures Act Moves One Step Closer to Reality with FDA's Work Plan, Robert N. Wilkey, Esq., Life Science Compliance Update, Vol. 3.12 (December 2017). HERE.
The New Westward Expansion - Big Pharma Partners WIth Native Americans to Protect Patents, Robert N. Wilkey, Esq., Life Science Compliance Update, Vol. 3.12 (December 2017). HERE.
Even Distributors Are Not Immune - AmeriSourceBergen's Recent Compliance Struggles, Robert N. Wilkey, Esq., Life Science Compliance Update, Vol. 3.12 (December 2017). HERE.
Chester County's Vista highlights WLC's legal work involving Bitcoin and cryptocurrencies. HERE.
WLC launches BitCoinLawReview.Org, a comprehensive legal reference and jurisprudence compendium for Attorney, legal practitioners, and interested parties related to Bitcoin, cryptocurrencies, and the law.
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 Council ("EAC").
Taking Center Stage - Washington State's Medicaid Fraud Control Unit, and the False Claims Act and Celegene, Robert N. Wilkey, Esq., Life Science Compliance Update, Vol. 3.9 (Sept 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 (Sept 2017). HERE.
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 When 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.
Management of Human Resources Cohort (MHRC), Bellevue University, cites to WLC's work on medical residents and employment rights.
Into the Nexus – Anti-Kickback Statute (“AKS”) versus Value-Driven Health Care, Part 1: An Uncertain Future in a Dynamic Landscape, Robert N. Wilkey, Esq., Life Science Compliance Update, Vol. 3.7 (July 2017). HERE.
Professor 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 employment 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).
Punting on the Issue of FCA and Statistical Sampling, Robert N. Wilkey, Esq., Life Science Compliance Update, Vol. 3.7 (July 2017). HERE.
Genentech & Esobar: 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 Lifesciences?, 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-Kickback 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 Murky Future of Physician-Owned Distributorships ("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.
Co-Payment & Deductible Waivers as Illegal Inducements, Robert N. Wilkey, Esq., Life Science Compliance Update, Vol. 3.1 (Jan. 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 a 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.
Old Weapons with a New Purpose - Using Antitrust Laws to Control Drug Pricing, Robert N. Wilkey, Esq., Life Sciences Compliance Update, Vol. 2.12 (Dec. 2016). HERE.
Tracking Towards a Banner Year for FCPA and FCA Enforcement, Robert N. Wilkey, Esq., Life Science Compliance Update, Vol. 2.11 (Nov. 2016). HERE.
SEC Provides Explicit Whistleblower Guidance – Hunting Season Is Now Open, Robert N. Wilkey, Esq., Life Science Compliance Update, Vol. 2.11 (Nov. 2016). HERE.
NPAs and DPAs – An Enforcement Loophole or Compliance Incentive? Robert N. Wilkey, Esq. Life Science Compliance Update, Vol. 2.10 (Oct. 2016). HERE.
Helping the Patient – Co-Pay Reimbursement Can Be Okay in Certain Circumstances, Robert N. Wilkey, Esq., and Dr. Seth Whitelaw, Editor, for Life Science Compliance Update, Vol. 2.10 (Oct. 2016). HERE.
AseraCare – Even Courts Seek Second Medical Opinions, Robert N. Wilkey, Esq., Life Science Compliance Update, Vol. 2.9 (Sept. 2016). HERE.
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 (Aug. 2016). HERE.
A Mixed Bag – Implied Certification in False Claim Act Cases after the Escobar Decision, Robert N. Wilkey, Esq. Life Science Compliance Updates, Vol. 2.8 (Aug. 2016). HERE.
Unlikely Bedfellows: SEC Penalties When Industry Fails to Disclose FDA Recommendations for Clinical Trials, Robert N. Wilkey, Esq., Life Science Compliance Updates, Vol. 2.7 (July 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 Emp,oyment Rights of Medical Residents, 44 Creighton L. Rev. 705 (2011); see also Doe v. Mercy Catholic Medical Center, No. 16-1248 (3rd Circuit). HERE.
Dentsply v. Bates: Taking a “Bite” Out of False Claim Act (FCA) Violations for Lack of Evidence, Robert N. Wilkey, Esq., Life Science Compliance Updates, Vol. 2.7 (July 2016). HERE.
Thunderstruck - New OIG Guidance on Permissive Exclusion & Integrity Obligations, Robert N. Wilkey, Esq., Life Science Compliance Updates, Vol. 2.6 (June 2016). HERE.
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 (June 2016). HERE.
The FDA Shield – The Medtronic Infuse Case and the Latest Tango of Preemption Versus Liability, Robert N. Wilkey, Esq. Life Science Compliance Updates, Vol. 2.4 (2016). HERE.
That’s The Fact Jack – MedJack and Device Cybersecurity, Robert N. Wilkey, Esq. Life Science Compliance Updates, Vol. 2.4 (2016). HERE.
Be Careful What You Sign Up For – Implied Certification and the False Claims Act (FCA), Robert N. Wilkey, Esq., Life Science Compliance Update, Vol. 2.3 (2016) HERE
Flint Michigan: Time to Expand the Exceptions to Sovereign Immunity for Mass Torts, WLC, Vol. 2, Issue No. 1 (2016) HERE
Employment Wage Protection for Delivery Drivers of Online Mobile Food Ordering Companies, WLC, Vol. 1, Issue No. 10 (2015) HERE.
Expanding the Older Adults Protection Services Act in Pennsylvania, WLC, Vol. 1, Issue No. 9 (2015) HERE.
Teaneck H-Capital Advance a/d/b/a Yalber, Small Biz Finance Company Facing Suit in Philadelphia, North.Jersey.com, The Record (Bergen County, NJ), by Hugh R. Morley, December 3, 2015 HERE.
Small Business Loan Reporting via the Consumer Financial Protection Bureau (CFPB): Just a Matter of Time? WLC, Vol. 1, Issue No. 8 (2015) HERE.
Ethnic Capital: When Targeted Predatory Lending Goes Too Far, WLC, Vol. 1, Issue No. 3 (2015) HERE.
Robert N. Wilkey, Esq., MPP
Wilkey Legal Consultants, LLC
Eagleview Office Plaza
600 Eagleview Blvd., Suite 300
Exton, PA 19341
www.robertwilkey.com
Toll Free Number: (888) 598-1112
Local Number: (610) 465-7393
Facsimile: (484) 698-7961
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