NEW BRUNSWICK, N.J.,
Aug. 26, 2019 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) and its Janssen
Pharmaceutical Companies today announced they will appeal the
$572 million civil judgment entered
in Cleveland County District Court
in the State of Oklahoma's lawsuit
against opioid manufacturers. The Company is confident it has
strong grounds to appeal this decision.
The judgment disregards the Company's compliance with federal
and state laws, the unique role its medicines play in the lives of
the people who need them, its responsible marketing practices and
that since launch, DURAGESIC®, NUCYNTA® and
NUCYNTA® ER have accounted for less than one percent of
total opioid prescriptions in Oklahoma as well as the United
States.
"Janssen did not cause the opioid crisis in Oklahoma, and neither the facts nor the law
support this outcome," said Michael
Ullmann, Executive Vice President, General Counsel, Johnson
& Johnson. "We recognize the opioid crisis is a tremendously
complex public health issue and we have deep sympathy for everyone
affected. We are working with partners to find ways to help those
in need."
Judgment Not Consistent with Facts or the Law
The
decision in this case is flawed. The State failed to present
evidence that the Company's products or actions caused a public
nuisance in Oklahoma. The State's
claims violate fundamental principles of due process by seeking to
hold a company liable for conduct permitted under federal law and
regulations. It also disregards 100 years of precedent in public
nuisance law, which traditionally has been applied to resolve
property disputes, not lawsuits involving the sale of goods.
"This judgment is a misapplication of public nuisance law that
has already been rejected by judges in other states," said Ullmann.
"The unprecedented award for the State's 'abatement plan' has
sweeping ramifications for many industries and bears no relation to
the Company's medicines or conduct."
Appeal Process and Other Litigation
The Company will
move to stay enforcement of the judgment pending the resolution of
its appeal. The length of the appeal process varies from case to
case, taking into account time for post-trial motions, preparation
of the trial record and briefing to the appellate court. In this
case, it is anticipated to extend into 2021. The Company is
confident it has strong grounds for appeal.
The opinion in Oklahoma does
not have a binding impact on other courts, including those involved
in ongoing federal litigation, litigation in other states, or how
the Company approaches those matters given the different laws,
defendants and claims in these other cases. The upcoming federal
multidistrict litigation (MDL) currently scheduled for October 2019 includes multiple defendants and a
number of different claims. The Company remains open to viable
options to resolve these cases, including through settlement.
Janssen Prescription Pain Medicines
In addition to the
legal deficiencies of the State's case, the facts do not align with
or support the outcome of the trial.
Janssen developed two types of Schedule II prescription opioid
medicines – a patch and a crush-resistant tablet – designed to help
patients suffering from severe pain. DURAGESIC®,
NUCYNTA® and NUCYNTA® ER are U.S. Food and
Drug Administration (FDA)-approved and since launch, have accounted
for less than one percent of total opioid prescriptions in
Oklahoma as well as the United States. The FDA-approved labels of
these medicines provide clear information about their risks and
benefits.
The Centers for Disease Control (CDC) estimates nearly 50
million Americans suffer from chronic pain. These patients should
not be ignored.
Former Johnson & Johnson Affiliates
Several of
the State's allegations focused on Noramco and Tasmanian Alkaloids,
former affiliates of Johnson & Johnson, that produced and
supplied medical-grade ingredients for opioid pain medications. At
every stage of the supply chain, these companies were governed by
and complied with international and federal regulations and quotas.
These included importation and manufacturing quotas established by
the U.S. Drug Enforcement Administration (DEA) and FDA. The State
did not contest that these affiliates complied with the regulations
at all times.
Importantly, as suppliers, these former affiliates played no
role in the manufacturing, sales or marketing of the finished
products of other DEA-regulated manufacturers. Johnson &
Johnson sold Noramco and Tasmanian Alkaloids in 2016.
Oklahoma law bars liability for
the supply of these raw materials, and a comprehensive federal
regulatory program authorized and painstakingly regulated the
importation, manufacture and sales of those materials.
Johnson & Johnson Response to the Opioid
Crisis
The opioid crisis is a complex public health issue
that demands a public health response. The Company continues to
collaborate to help patients, families and communities in need.
Building on our legacy in public health, we are working with
frontline health care professionals, academic institutions,
policymakers, online communities and others to address the unmet
needs of those impacted by this crisis. To date, the Company has
sponsored independently developed education programs for tens of
thousands of doctors, nurses and pharmacists across America,
helping to better equip them to fight substance abuse and
addiction. The Company is also collaborating with academic
institutions to identify evidence-based best practices that can
empower nurses and other health care practitioners to effectively
respond to the opioid crisis at the community level. Based on more
than 130 years of experience, these collaborations are where the
Company can have the greatest impact.
Additional Information
Janssen Prescription Medicines
DURAGESIC®
(fentanyl transdermal system) CII is an FDA-approved transdermal
patch. DURAGESIC® has child-resistant packaging and is
part of an FDA-approved and required Risk Evaluation and Mitigation
Strategy (REMS) program, which outlines strategies to manage known
or potential risks associated with these products to help ensure
that the benefits of a drug outweigh its risks. Although Janssen
continues to make DURAGESIC® available, marketing of
this medicine ceased in 2008. For full prescribing information,
instructions for use, and medication guide for
DURAGESIC®, please visit http://bit.ly/duragesicPI.
Janssen marketed two forms of NUCYNTA® (tapentadol) -
an immediate release tablet and an extended-release tablet. Both
medicines are FDA-approved and NUCYNTA® ER was launched
with an FDA-approved REMS program. Janssen sold the U.S. marketing
rights for NUCYNTA® in April
2015. For full prescribing information and medication guides
for NUCYNTA® and NUCYNTA® ER, please visit
http://bit.ly/nucyntaPI and http://bit.ly/nucyntaER-PI.
Data presented at trial show DURAGESIC®,
NUCYNTA® and NUCYNTA® ER had low rates of
abuse and diversion. All brand marketing materials were submitted
to the FDA and company sales representatives were thoroughly
trained to provide accurate information on the risks and benefits
of these medications. In 2015, Janssen stopped marketing these
medications in the U.S., focusing its attention on other areas of
significant unmet medical need.
Other Litigation
As disclosed in the Company's most
recent Form 10-Q, the Company has been named in more
than 2,000 lawsuits brought by certain state and local
governments related to the marketing of opioids. Some of these have
been consolidated into a federal multidistrict litigation (MDL)
proceeding. Defendants include different companies spanning the
opioid supply chain, including manufacturers, distributors and
pharmacies. Two of those cases have been selected for an initial
trial beginning October 21, 2019.
Links
We invite you to learn more about the Company's
position on the litigation and public health initiatives at
https://www.factsaboutourprescriptionopioids.com/.
A summary of our legal arguments can be found in our Findings of
Fact & Conclusions of Law filing of July
31, 2019, available on our site at
https://www.factsaboutourprescriptionopioids.com/assets/pdfs/FindingsOfFactCOL_Filed073119.pdf.
About Johnson & Johnson
At Johnson & Johnson,
we believe good health is the foundation of vibrant lives, thriving
communities and forward progress. That's why for more than 130
years, we have aimed to keep people well at every age and every
stage of life. Today, as the world's largest and most broadly-based
health care company, we are committed to using our reach and size
for good. We strive to improve access and affordability, create
healthier communities, and put a healthy mind, body and environment
within reach of everyone, everywhere. We are blending our heart,
science and ingenuity to profoundly change the trajectory of health
for humanity. Learn more at www.jnj.com. Follow us at
@jnjglobalhealth.
About the Janssen Pharmaceutical Companies
At Janssen,
we're creating a future where disease is a thing of the past. We're
the Pharmaceutical Companies of Johnson & Johnson, working
tirelessly to make that future a reality for patients everywhere by
fighting sickness with science, improving access with ingenuity,
and healing hopelessness with heart. We focus on areas of medicine
where we can make the biggest difference: Cardiovascular &
Metabolism, Immunology, Infectious Diseases & Vaccines,
Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at
www.twitter.com/JanssenGlobal. Janssen Pharmaceuticals, Inc. is
part of the Janssen Pharmaceutical Companies of Johnson &
Johnson.
Cautions Concerning Forward-Looking Statements
This
press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995 regarding the
civil judgment entered in Cleveland
County District Court in the State
of Oklahoma's lawsuit against opioid manufacturers as well
as other litigation in other jurisdictions. The reader is cautioned
not to rely on these forward-looking statements. The information
contained in this press release is for informational purposes only
and should not be construed as a commitment by the Company to
engage in any specific strategy or course of action. Although the
Company plans to vigorously defend itself and appeal this decision,
due to the inherent uncertainty of litigation, the Company cannot
predict the timing, ultimate outcome or financial impact of this
matter, or any other ongoing or future litigation. The
forward-looking statements in this press release are based on
current expectations of future events. If underlying assumptions
prove inaccurate or known or unknown risks or uncertainties
materialize, actual results could vary materially from the
expectations and projections of the Janssen Pharmaceutical
Companies and/or Johnson & Johnson. Risks and uncertainties
include, but are not limited to: significant adverse litigation or
government action, including related to product liability claims;
economic factors, such as interest rate and currency exchange rate
fluctuations; competition, including technological advances, new
products and patents attained by competitors; challenges inherent
in new product research and development, including uncertainty of
clinical success and obtaining regulatory approvals; uncertainty of
commercial success for new and existing products; challenges to
patents; the impact of patent expirations; the ability of the
company to successfully execute strategic plans; the impact of
business combinations and divestitures; manufacturing difficulties
or delays, internally or within the supply chain; product efficacy
or safety concerns resulting in product recalls or regulatory
action; changes to applicable laws and regulations, including tax
laws and global health care reforms; trends toward health care cost
containment; changes in behavior and spending patterns of
purchasers of health care products and services; financial
instability of international economies and legal systems and
sovereign risk; increased scrutiny of the health care industry by
government agencies. A further list and descriptions of these
risks, uncertainties and other factors can be found in Johnson
& Johnson's Annual Report on Form 10-K for the fiscal year
ended December 30, 2018, including in
the sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," in the company's most
recently filed Quarterly Report on Form 10-Q and in the company's
subsequent filings with the Securities and Exchange Commission.
Copies of these filings are available online at www.sec.gov,
www.jnj.com or on request from Johnson & Johnson. Any
forward-looking statement made in this release speaks only as of
the date of this release. Neither the Janssen Pharmaceutical
Companies nor Johnson & Johnson undertakes to update any
forward-looking statement as a result of new information or future
events or developments. The Company expressly disclaims all
liability in respect to actions taken or not taken based on any or
all the contents of this press release.
View original
content:http://www.prnewswire.com/news-releases/johnson--johnson-to-appeal-flawed-opioid-judgment-in-oklahoma-300907154.html
SOURCE Johnson & Johnson