ANTITRUST

“We can have democracy in this country, or we can have great wealth concentrated in the hands of a few, but we can’t have both.”

– Louis Brandeis

HILLIARD SHADOWEN has been a DRIVING FORCE IN OBTAINING HUNDREDS OF MILLIONS IN CASH SETTLEMENTS FROM BIG PHARMA FOR delaying GENERIC DRUG ENTRY AND ARTIFICIALLY raising PRICES OF ESSENTIAL MEDICATIONS.

Our victories challenging “pay for delay” patent settlements led the American Antitrust Institute to award us its national accolade for Outstanding Antitrust Litigation Achievement in Private Law Practice.

Hilliard Shadowen has pioneered the litigation of complex antitrust cases against some of the world’s largest pharmaceutical companies for various anticompetitive schemes. The firm’s experience and expertise in developing and prosecuting these cases is second to none. We obtain maximum results for individuals, businesses, and organizations that have suffered economically as a result of anticompetitive behavior. We fight and win on all playing fields— locally, statewide, nationally, or internationally.

Gilead

Gilead and its coconspirators have engaged in a long-running scheme to restrain competition with respect to some of the most important drugs used to treat Human Immunodeficiency Virus (“HIV”) infection—a disease which, if left untreated, destroys the immune system, leading to Acquired Immunodeficiency Syndrome (“AIDS”) and eventual death.

CASE: PETER STALEY, et al., vs GILEAD SCIENCES, INC., et al.,

DOCKET NO.: 3:19-cv-02573

COURT: DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA SAN FRANCISCO DIVISION

Through an array of anticompetitive practices—including horizontal agreements constituting per se violations of the antitrust laws—Gilead has acquired and maintained a monopoly in the market for drugs that comprise the modern HIV treatment regimen known as “combination antiretroviral therapy” (“cART”).

The scheme has enabled Gilead and its coconspirators to unlawfully extend patent protection for their drugs, impair entry by would-be generic competitors, and charge exorbitant, supracompetitive prices for the drugs that people living with HIV need to survive.

 

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Gilead Complaint

Niaspan

FILED: APRIL 15, 2013

Hilliard & Shadowen is co-lead counsel on behalf of a proposed class of end-payors against AbbVie for allegedly entering into unlawful agreements to delay the market entry of generic substitutes of its lipid disorder drug, Niaspan.

CASE NAME: In re: Niaspan Antitrust Litigation
DOCKET NO.: 2:13-md-02460

COURT:U.S. DISTRICT COURT, EASTERN DISTRICT OF PENNSYLVANIA

The Niaspan case was filed on April 15, 2013 and is now consolidated in the Eastern District of Pennsylvania. This case is a proposed class action alleging defendants entered into anticompetitive “pay for delay” patent settlement agreements for the blockbuster drug Niaspan. Niaspan is a once-a-day prescription formulation of extended-release niacin used for treating mixed lipid disorders.

Plaintiffs allege that the brand-name drug manufacturer used its monopoly profits to pay-off potential competitors to refrain from introducing less expensive generic equivalents of the drug for up to eight years, causing consumers and health plans to pay hundreds of millions in overcharges.

 

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Complaint
Court Ruling Denying in Part Defendants’ Motion to Dismiss

Aggrenox

FILED: NOVEMBER 20, 2013

Hilliard & Shadowen has filed a complaint on behalf of a proposed class of end-payors alleging defendants’ entered into an anticompetitive “pay for delay” agreement that delayed the market entry of a lower-priced generic equivalent for the drug, Aggrenox.

CASE NAME: In re: Aggrenox Antitrust Litigation
DOCKET NO.: 3:14-MD-02516

COURT: U.S. DISTRICT COURT, DISTRICT OF CONNECTICUT

The Aggrenox case was filed on November 20, 2013 and has been consolidated before the District of Connecticut. Aggrenox is a extended-release capsule of dipyridamole indicated to lower the risk of stroke in people who have had transient ischemic attack or stroke due to blood clot.

The Aggrenox complaint alleges that defendants’ entered into an anticompetitive “pay for delay” agreement that is delaying for seven years any lower priced generic equivalent from entering the market and forcing consumers and health plans to artificially inflated prices for the drug.

 

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Complaint
Court Ruling Denying in Part Defendants’ Motion to Dismiss

Nexium

FILED: AUGUST 24, 2012

Hilliard & Shadowen is co-lead counsel representing a class of end-payors and consumers alleging that AstraZeneca entered into unlawful agreements to delay competing generic substitutes of its heartburn-drug Nexium, preserving for AstraZeneca up to approximately $3 billion per year in monopoly revenue.

CASE NAME: In re: Nexium (esomeprazole) Antitrust Litigation
DOCKET NO.: 1:12-md-02409

COURT: U.S. DISTRICT COURT, DISTRICT OF MASSACHUSETTS

The Nexium case was filed in the Eastern District of Pennsylvania on August 24, 2012. The case was consolidated with related actions and transferred to the District of Massachusetts. One of the most prescribed drugs in America, Nexium is a prescription drug for the healing and maintenance of erosive esophagitis and treatment of symptomatic gastroesophageal reflux disease (heartburn).

The Nexium complaint alleges that defendants engaged in anticompetitive conduct by entering into so-called “pay for delay” agreements that delayed for more than six years less expensive generic equivalents of the drug, preserving for AstraZeneca up to approximately $3 billion per year in monopoly revenue. Plaintiffs allege that defendants’ unlawful conduct robbed consumers and health plans of the benefits of generic competition, forcing them to pay hundreds of millions more for a drug at artificially inflated prices.

Loestrin

FILED: AUGUST 24, 2012

Hilliard & Shadowen is co-lead counsel representing a class of end-payors and consumers alleging that AstraZeneca entered into unlawful agreements to delay competing for generic substitutes of its heartburn-drug Nexium, preserving for AstraZeneca up to approximately $3 billion per year in monopoly revenue.

CASE NAME: In re: Loestrin 24 Fe Antitrust Litigation
DOCKET NO.: 1:13-md-02472

COURT:U.S. DISTRICT COURT, DISTRICT OF RHODE ISLAND

The Loestrin case was filed in the Eastern District of Pennsylvania on April 5, 2013. After proceedings before the Judicial Panel on Multidistrict Litigation, this case is currently pending in the District of Rhode Island. Loestrin 24 Fe is an oral contraceptive.

The Loestrin complaint alleges that defendants engaged in anticompetitive conduct—entering into a so-called “pay for delay” agreement—which prevented a less expensive generic equivalent of Loestrin 24 Fe from entering the market for more than to four years. The complaint further alleges that after paying to delay generic competition, the makers of Loestrin 24 Fe used the time to convert prescriptions of Loestrin 24 Fe to their other branded products, such as Lo Loestrin Fe and Minastrin 24 Fe. Due to the defendants’ unlawful agreements, health plans and consumers were overcharged hundreds of millions of dollars more for Loestrin 24 Fe.

 

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Complaint
Defendants’ Motion to Dismiss Brief
Plaintiffs’ Opposition to Motion to Dismiss Brief

Actos

FILED: DECEMBER 31, 2013

Hilliard & Shadowen is lead counsel representing end-payors against Takeda alleging that it engaged in anticompetitive conduct that blocked competitive threats to its two blockbuster anti-diabetic drugs, ACTOS and ACTOplus Met.

CASE NAME: UFCW v. Takeda Pharmaceutical Co. Ltd, et al.
DOCKET NO.: 1:13-cv-09244

COURT:DISTRICT COURT, SOUTHERN DISTRICT OF NEW YORK

The ACTOS case was filed on December 31, 2013 and is currently pending in the Southern District of New York. The case involves two the blockbuster anti-diabetic drugs, ACTOS and ACTOplus met.

The ACTOS complaint alleges first that the brand manufacturer obtained unlawful monopoly protection by fraudulently representing to the FDA that the ACTOS drug was claimed by patents that unambiguously covered different drug products. The complaint also alleges that defendants entered into an anticompetitive “pay for delay” settlement agreements for both ACTOS and ACTOplus met, causing consumers and health plans to pay overcharges for drugs that should have had available lower priced generic equivalents a year and half prior.

 

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Complaint

Lidoderm

FILED: NOVEMBER 12, 2013

Hilliard & Shadowen, along with its co-counsel, represent a proposed class of end-payors in a case against Teikoku Pharma USA for allegedly entering into unlawful agreements with potential competitors to delay the market entry of generic substitutes of the pain patch, Lidoderm.

CASE NAME: In re Lidoderm Antitrust Litigation
DOCKET NO.: 14-md-02521

COURT:DISTRICT COURT, NORTHERN DISTRICT OF CALIFORNIA

The Lidoderm case was filed on November 12, 2013, and is currently pending in the Northern District of California. Lipoderm is a lidocaine-containing pain patch for the treatment of pain associated with post-herpetic neuralgia.

The Lidoderm complaint alleges that defendants’ entered into anticompetitive “pay for delay” settlement agreements. Plaintiffs allege that these agreements delayed the availability of less expensive generic equivalents for over a year and half, forcing consumers and health plans to pay millions in overcharges.

 

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Court Ruling Denying in Part Defendants’ Motion to Dismiss

Suboxone

FILED:MARCH 1, 2013

Hilliard & Shadowen is co-lead counsel on behalf of a proposed class of end-payors against Reckitt Benckiser, alleging that the company engaged in anticompetitive strategies to preserve its monopoly over its addiction-treatment drug, Suboxone.

CASE NAME: In re: Suboxone (Buprenorphine Hydrochloride and Nalaxone) Antitrust Litigation
DOCKET NO.: 2:13-md-02445

COURT:DISTRICT COURT, EASTERN DISTRICT OF PENNSYLVANIA

The Suboxone case was filed in the Middle District of Pennsylvania on March 1, 2013. All related actions were then consolidated and transferred to the Eastern District of Pennsylvania. Suboxone is a combination drug product for the maintenance treatment of opioid dependence.

The Suboxone complaint alleges that the brand manufacturer used a series of anticompetitive tactics to thwart generic competition, which included: “product hopping” from a tablet to a film formulation, destroying demand for its own tablet by raising its price and publically announcing safety concerns (no legitimate safety concern was found by the FDA); and filing baseless “sham” citizen petitions with the FDA to delay lower priced generic tablets from reaching the market. Due to this anticompetitive scheme, consumers have been robbed of the benefits of generic competition to the tune of at least some $500 million annually.

 

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Complaint
Court Ruling Denying in Part Defendants’ Motion to Dismiss

Solodyn

FILED: JULY 22, 2013

Hilliard & Shadowen represent a proposed class of end-payors against Medicis for alleged anticompetitive conduct in an effort to prevent patients from receiving lower-priced generic equivalents to Solodyn at the pharmacy..

CASE NAME: In re: Solodyn (Minocycline Hydrochloride) Antitrust Litigation
DOCKET NO.: 1:14-md-02503

COURT:DISTRICT COURT, DISTRICT OF MASSACHUSETTS

TThe Solodyn case was filed in the Eastern District of Pennsylvania on July 22, 2013 and later transferred to the District of Massachusetts. Solodyn is a prescription drug for the treatment of acne.

The Solodyn complaint alleges that defendants used an multi-faceted, anticompetitive scheme to thwart generic competition. As alleged in the complaint, this scheme is one in which defendants filed baseless “sham” citizen petitions with the FDA; initiated and maintained “sham” patent suits against multiple potential generic competitors; entered into a so-called “pay for delay” agreements with generic competitors; and “hopped” to different dosage strengths in effort to prevent patients’ from receiving a lower priced generic equivalent at the pharmacy. Due to the defendants’ conduct, consumers and health plains sustained substantial damages in the form of overcharges.

Ranbaxy

FILED: MAY 12, 2015

Against a backdrop of reliable generic drug manufacturing, there is one clear exception: rogue generic drug maker Ranbaxy Laboratories.

CASE: MEIJER, INC., and MEIJER DISTRIBUTION, INC. vs RANBAXY INC., RANBAXY LABORATORIES, LTD., RANBAXY U.S.A., INC., and SUN PHARMACEUTICAL INDUSTRIES LTD.
DOCKET NO.: 1:15-cv-11828

COURT: DISTRICT COURT, DISTRICT OF MASSACHUSETTS

This case is about how Ranbaxy recklessly stuffed the generic drug approval queues with grossly inadequate applications, deceived the FDA into granting tentative approvals to lock in statutory exclusivities to which Ranbaxy was not entitled and brandished these undeserved exclusivities to exclude others while its own applications floundered, all at the direct expense of U.S. drug purchasers.

It is one thing for a corrupt company to run its affairs so poorly that it is unable to make, and document, a minimally acceptable product, thus hurting its own sales and profitability. But it is quite another thing for that company to recklessly and fraudulently bog down the FDA generic approval process, wrongfully acquire the ability to preclude or stall the efforts of other generic companies that are responsibly seeking to enter U.S. markets and delay generic entry while it struggles to get its own act together. When that happens, the harm is visited directly and only on U.S. drug purchasers.

 

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Ranbaxy Complaint

Glumetza

 

This Complaint explains how the Defendants’ blatant violation of the federal antitrust law allowed them to charge more than 50 times the competitive price and steal more than $2.8 billion from drug purchasers.

CASE: FWK HOLDINGS, LLC, vs BAUSCH HEALTH COMPANIES INC., SALIX PHARMACEUTICALS, LTD., SALIX PHARMACEUTICALS, INC., SANTARUS, INC., ASSERTIO THERAPEUTICS, INC., LUPIN PHARMACEUTICALS, INC., and LUPIN LTD.,

DOCKET NO.: 3:19-cv-05426

COURT: DISTRICT COURT, NORTHERN DISTRICT OF CALIFORNIA

The Defendants sell diabetes prescription drug Glumetza. Fair competition would have limited the price of a 30-day supply to less than $55. Defendants instead were able to charge $3,000.

This Complaint explains how the Defendants’ blatant violation of the federal antitrust law allowed them to charge more than 50 times the competitive price and steal more than $2.8 billion from drug purchasers.

 

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Glumentza Complaint