dcsimg Life Sciences

Life Sciences

Emerging, middle-market and established companies alike require sophisticated legal representation that is cost-effective and capable of responding to the rapidly changing demands of regulators and customers. As counsel to domestic and global life sciences companies at every stage of development, the Life Sciences industry group at McGuireWoods offers clients a single, coordinated team of lawyers with deep, varied experience. Our clients recognize that they are treated as firm clients and not as those of a single practitioner or office location.

We counsel clients in all major areas of law affecting life sciences businesses and at every step in the product lifecycle. We provide guidance on corporate transactions and matters involving company structure and formation, financing, facilities acquisition and leasing, and vendor contracts. We have extensive experience in healthcare and life sciences-related regulatory requirements, including compliance audits and policies, FDA notification and approvals, development of pricing programs, and reimbursement and third-party payor processes.

Regulatory policies walk hand in hand with legislative mandates. In conjunction with our full-service public affairs subsidiary, McGuireWoods Consulting, we provide strategic communications and government relations guidance that helps businesses and industry coalitions shape pending legislation and respond to state and federal initiatives.

When disputes or law enforcement investigations arise, we provide aggressive defense against allegations of theft, product liability and mass torts. We represent clients facing government inquiries and administrative actions involving a broad range of issues, from securities disclosures and financial accounting rules to data privacy, antitrust and other compliance requirements. We also investigate and vigorously pursue counterfeiters, gray marketers and abusers of supply chain systems.

As life sciences businesses grow and transform, capital sourcing and other forms of financing become an important concern. We represent clients in negotiations with private equity investors, commercial banks and other financial institutions. Similarly, our depth of experience in public offerings and middle-market mergers and acquisitions adds value to growth and technology companies when exploring liquidity events.

While life sciences businesses share many of the same concerns as companies in other industries, these issues must be addressed in the context of this highly regulated sector of the economy. Our multidisciplinary team of lawyers provides broad-spectrum, coordinated counsel on all major areas of law affecting clients’ operations and strategy. These core areas of service include labor and employment, intellectual property, state and local taxation, and international trade. Our experience in these and other areas of law enables us to provide prompt, effective counsel in the dynamic life sciences marketplace.

CONTACTS

Kathleen H. Dooley Partner T: +1 704 343 2347
Raj Natarajan Partner T: +1 704 343 2330
Results 1-20 of 122
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RESULTS DEPEND ON A VARIETY OF FACTORS UNIQUE TO EACH CASE. PRIOR RESULTS DO NOT GUARANTEE OR PREDICT A SIMILAR OUTCOME.

Representative Matter

Medical device and pharmaceutical manufacturers

Representation of medical device and pharmaceutical manufacturers in outsourced manufacturing arrangements.
Representative Matter

Medical device, OTC and pharmaceutical manufacturers

Counseled and represented medical device, OTC and pharmaceutical manufacturers pre, during and post product recalls.
Representative Matter

Various life sciences clients

Counsel clients regarding Medicare and Medicaid Anti-Kickback issues, Medicare coverage and payment issues, and HIPAA issues raised by the storage, receipt or transmission of patient health information.
Representative Matter

Various life sciences clients

Advising on compliance with the UK Bribery Act including policy advice and drafting, risk assessment, audit, training, monitoring, investigation and defence, and the civil claims associated with criminal liabilities.
Representative Matter

Large generic drug company

Representing large generic drug company in multi-jurisdictional product liability litigation involving its fentanyl transdermal system.
Representative Matter

Pharmaceutical and medical device contract manufacturers

Regularly represent pharmaceutical and medical device contract manufacturers in negotiation of outsourced manufacturing agreements for medical devices, pharmaceuticals and biotech products.
Representative Matter

Medical device companies

Represented medical device companies in FDA audits, clinical trials under the jurisdiction of the FDA, numerous pricing and other competition law issues in the allergy treatment marketplace (human, vet and source materials), foreign joint ventures and selling, and child-proof packaging.
Representative Matter

Former general counsel of large pharmaceutical services and products company

Represent former general counsel of large publicly traded provider of pharmaceutical services and products in False Claims Act, and related criminal investigation involving allegations of illegal purchasing arrangement with manufacturer of pharmaceuticals.
Representative Matter

Generics pharmaceutical company

Defended generics pharmaceutical company against patent infringement claims asserted in lawsuits filed in the U.S. District Court for the Northern Districts of Illinois and the Northern District of West Virginia by the manufacturer of the brand name treatment for seizure disorders utilizing the active ingredient divalproex.
Representative Matter

Japanese medical device company

Representation of Japanese medical device company in 510(k) and PMA processes including comprehensive approval, post-market compliance, and marketing support.
Representative Matter

Generic pharmaceutical companies

Advises various generic pharmaceutical companies regarding the protection of business and intellectual property assets, including trademark availability, patentability, noninfringement, patent validity and freedom to operate opinions.
Representative Matter

One of the world's leading generic pharmaceutical companies

Represents one of the world's leading generic pharmaceutical companies in numerous Paragraph IV ANDA Patent Litigation actions under the Hatch-Waxman Act.
Representative Matter

World-class academic and health care system

Represent world-class academic and health care system in multi-plaintiff litigation arising from allegations that falsified genomic research was allowed to proceed to clinical trials with the enrollment and treatment of cancer patients.
Representative Matter

Large U.S. pharmaceutical company

Advising a large U.S. pharmaceutical company on the separation of the UK subsidiary from its U.S. parent company, with respect to the introduction of new benefit plans and secondment arrangements for the CEO.
Representative Matter

Mezzanine fund

Represented a provider of mezzanine capital in its mezzanine investment in a lab company, which the lab company used to help fund an acquisition.  
Representative Matter

One of the world's leading suppliers to the life science industries

Represented one of the world's leading suppliers to the life science industries, based in Switzerland, in the acquisition by tender offer of an NYSE-traded chemicals company for $1.2 billion.
Representative Matter

Indiana-based bank owned SBIC Fund

Representation of an Indiana-based bank owned SBIC Fund on a bridge financing in a developer of drugs for ovarian and lung tumors.
Representative Matter

Leading generic and specialty pharmaceutical company

After a three week jury trial, obtained a unanimous defense verdict for one of the world's leading generic and specialty pharmaceutical companies.
Representative Matter

Leading generic and specialty pharmaceutical company

Representation of a pharmaceutical manufacturer in a wrongful death case, obtaining a defense verdict after an hour of deliberation.
Representative Matter

Major life sciences organization

Advising on UK data protection requirements in relation to medical research and patient records for drug trials, working as part of a team of European lawyers to provide coordinated advice to a major life sciences organisation.
Results 1-20 of 122
Results 1-25 of 87
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Brad Alexander Brad L. Alexander
Sr. VP and Director, Georgia Gov. Relations McGuireWoods Consulting LLC
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5811
F: +1 404 443 5682
vCard
Ashley Allen Ashley K. Allen
Counsel
One James Center
901 East Cary Street
Richmond, VA 23219-4030

T: +1 804 775 1918
F: +1 804 775 1061
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Mark E Anderson Mark E. Anderson
Partner
434 Fayetteville Street
Suite 2600
Raleigh, NC 27601

1345 Avenue of the Americas
7th Floor
New York, NY 10105-0106

T: +1 919 755 6678
F: +1 919 755 6581
vCard
George J Barry III George J. Barry III
Partner
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5734
F: +1 404 443 5753
vCard
Evan Bayh Evan Bayh
Partner
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

T: +1 202 828 2825
F: +1 202 828 3331
vCard
Scott Becker Scott Becker
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 750 6016
F: +1 312 920 6135
vCard
Maurice A Bellan Maurice A. Bellan
Partner
2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

T: +1 202 857 2400
F: +1 202 828 2981
vCard
Samuel C Bernstein Samuel C. Bernstein
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 849 8222
F: +1 312 698 4571
vCard
Micheal L Binns Micheal L. Binns
Associate
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5748
F: +1 404 443 5698
vCard
William J Boddy William J. Boddy
Associate
11 Pilgrim Street
London EC4V 6RN
United Kingdom

T: +44 20 7632 1625
F: +44 20 7632 1638
vCard
Ginny Boland Ginny Boland
Asst. VP, Strategic Communications McGuireWoods Consulting LLC
One James Center
901 East Cary Street
Richmond, VA 23219-4030

T: +1 804 775 1907
F: +1 804 775 1061
vCard
Ryan Bonistalli Ryan E. Bonistalli
Associate
One James Center
901 East Cary Street
Richmond, VA 23219-4030

T: +1 804 775 1014
F: +1 804 698 2036
vCard
Alex J Brackett Alex J. Brackett
Partner
One James Center
901 East Cary Street
Richmond, VA 23219-4030

T: +1 804 775 4749
F: +1 804 698 2089
vCard
Bryan C Brantley Bryan C. Brantley
Partner
EQT Plaza
625 Liberty Avenue
23rd Floor
Pittsburgh, PA 15222-3142

T: +1 412 667 7983
F: +1 412 667 7971
vCard
Meggan Michelle Bushee Meggan Michelle Bushee
Associate
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146

T: +1 704 343 2360
F: +1 704 805 5085
vCard
Holly Carnell Holly Carnell
Associate
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 849 3687
F: +1 312 698 4504
vCard
Karen L Carroll Karen L. Carroll
Associate
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5620
F: +1 404 443 5757
vCard
Andrew J Cataldo Andrew J. Cataldo
Partner
Promenade
1230 Peachtree Street, N.E.
Suite 2100
Atlanta, GA 30309-3534

T: +1 404 443 5725
F: +1 404 443 5795
vCard
Jeffrey J Chapman Jeffrey J. Chapman
Partner
1345 Avenue of the Americas
7th Floor
New York, NY 10105-0106

T: +1 212 548 7060
F: +1 212 715 6277
vCard
Michelle M Christian Michelle M. Christian
Associate
One James Center
901 East Cary Street
Richmond, VA 23219-4030

T: +1 804 775 1187
F: +1 804 698 2001
vCard
Geoffrey C Cockrell Geoffrey C. Cockrell
Partner
77 West Wacker Drive
Suite 4100
Chicago, IL 60601-1818

T: +1 312 849 8272
F: +1 312 698 4572
vCard
J. D Costa J. D. Costa
Associate
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146

T: +1 704 343 2236
F: +1 704 353 6192
vCard
Patrick A De Ridder Patrick A. De Ridder
Partner
One James Center
901 East Cary Street
Richmond, VA 23219-4030

11 Pilgrim Street
London EC4V 6RN
United Kingdom

T: +1 804 775 4369
F: +1 804 698 2221
vCard

T:+44 20 7632 1716
F: +44 20 7632 1638

Dorothea W Dickerman Dorothea W. Dickerman
Partner
1750 Tysons Boulevard
Suite 1800
Tysons Corner, VA 22102-4215

2001 K Street N.W.
Suite 400
Washington, DC 20006-1040

T: +1 703 712 5387
F: +1 703 712 5242
vCard

T:+1 202 857 1721
F: +1 202 857 1737

Kathleen H Dooley Kathleen H. Dooley
Partner
201 North Tryon Street
Suite 3000
Charlotte, NC 28202-2146

T: +1 704 343 2347
F: +1 704 444 8755
vCard
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Event

6th Annual Medical Device and Life Sciences Conference

Tuesday, November 18, 2014
Chicago, IL
Speaking Engagement

Legal and Regulatory Summit on Generic Drugs

July 24-25, 2014
New York, NY
Speaking Engagement

5th Annual Conference on Biosimilars

June 4-6, 2014
New York, NY
Event

Healthcare Litigation Conference

May 29, 2014
Richmond, VA
Event

Healthcare Litigation Conference

April 8, 2014
Chicago, IL
Speaking Engagement

BioCentury This Week

Safety v. Competition (Federal Trade Commission Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition February 4, 2014 Overview)

February 16, 2014
Event

Corporate Integrity Agreements

10 Key Points for the Healthcare Industry

January 31, 2013
Complimentary Webinar
Event

4th Annual Medical Device and Life Sciences Conference

Innovation, Investing and Regulatory Issues

November 8, 2012
Chicago, IL
Speaking Engagement

2012 International Medical Device Industry Compliance Conference

Global Anti-Corruption Trends: The Value of Ethics and Compliance

May 10, 2012
Speaking Engagement

Healthcare and Life Sciences Litigation

Responding to Increased False Claims Act Enforcement

March 15 - June 6, 2012
Event

9th Annual Healthcare & Life Sciences Private Equity & Finance Conference

Growing Investments and Executing Transactions During Times of Change

February 22 - 23, 2012
Chicago, IL
Event

HIPAA and Litigation

May 24, 2011
Speaking Engagement

PLI Antitrust Law Institute 2011

Recent Decisions and Their Impact on Antitrust Enforcement and Litigation

March 17-18, 2011
Results 1-20 of 33
Results 1-20 of 145
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Legal Alert

EU Medical Device Rules Continue to Progress

FDA Life
May 27, 2014
Legal Alert

EU Medical Device Rules

New Rules Are Nearly There But Not Quite

FDA Life
May 15, 2014
Legal Alert

FDA’s Recent Two-Pronged Attack on Drug Shortages

Four Things to Know about FDA’s Proposed Rule

December 11, 2013
Legal Alert

Drug Quality and Security Act

What You Need to Know

December 4, 2013
Legal Alert

Illinois Expands Penalties for Healthcare Fraud

September 23, 2013
Legal Alert

FDA Seeks to Tighten Drug Import Regulation

August 9, 2013
Legal Alert

FDA Attempts To Secure The Border

Proposed FSMA Rules Aim To Even Playing Field Between Domestic And Foreign Food Suppliers

August 6, 2013
Results 1-20 of 145