Qui Tam Attorney, False Claims Act Lawyer, Rory Delaney, Boston, Massachusetts


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Summary of Experience

Rory Delaney

Experienced in jury trials in all Massachusetts courts: federal and state.

Argued before the Federal Court of Appeals for the First Circuit.

Conducted over seventy jury trials in the last twenty years.


Represented successful whistleblowers in the following cases:

United States ex rel. Clarke, Mullins and Szudlo v. Aegerion Pharmaceuticals, Inc. et al. 13-11785 (D.Mass.)

Co-counsel in United States ex rel. Angela Ruckh v. CMC II, LLC et al. M.D. Fl. (No. 11-1303) resulting in a $347 million jury verdict.

United States v. Acclarent Inc. et al. 11-11217-WGY

United States ex rel. Westmoreland v. Amgen Inc., et al. (Civil Action No. 06-10972-WGY)

United States  v. Elan Corporation, PLC, et al.
04-11594-RWZ

United States v. Pfizer Inc
04-11780

United States v. Aggregate Industries, PLC

06-11379
(aka the “Big Dig” settlement)

Commonwealth of Massachusetts v. Boston Medical Center
03-12360

Commonwealth of Massachusetts v. Metromedic Health Center

03-11828

Experience in Notable Cases

United States ex rel. Clarke, Mullins and Szudlo v. Aegerion Pharmaceuticals, Inc. et al. 13-11785 (D.Mass.) (Settled September 22, 2017 $28.8 million)

Aegerion, of Cambridge, Massachusetts, has agreed to pay a $28.8 million civil penalty, more than $7 million in criminal fines and $4.1 million to the SEC in a global settlement to resolve allegations filed by three former company insiders. The case, filed just over four years ago in Boston federal court, alleged that Aegerion caused false claims by making false and misleading statements regarding its drug Juxtapid.

Juxtapid was approved solely for the treatment of HoFH, a rare and life-threatening high cholesterol disease, which affects literally one in a million people in the United States. However, Aegerion made misleading claims about the drug’s suitability for people who did not have HoFH but simply had stubbornly high cholesterol. In addition to the rarity of the disease, the drug cost government healthcare programs approximately $300,000 per year, per patient. After we alerted the FDA of false and misleading statements by the then CEO Marc Beer, the FDA issued a warning letter addressed to the CEO rebuking him directly:

OPDP FDA's Office of Prescription Drug Promotion requests that Aegerion immediately cease misbranding Juxtapid and introducing it into interstate commerce for unapproved uses for which it lacks adequate directions. Please submit a written response to this letter on or before November 22, 2013, stating whether you intend to comply with this request, listing any promotional materials (with the 2253 submission date) for Juxtapid that contain statements such as those described above, and explaining your plan for discontinuing use of such materials or, in the alternative, your plan to cease distribution of Juxtapid.”

I believe this settlement may be the first time that the SEC and the US Attorney’s office have simultaneously resolved a claim under both the SEC’s whistleblower program and the False Claims Act. Notwithstanding the substantial resolution, the civil case will proceed against certain individuals including the former CEO Marc Beer.

For the Department of Justice Press Release go to:

https://www.justice.gov/opa/pr/drug-maker-aegerion-agrees-plead-guilty-will-pay-more-35-million-resolve-criminal-charges-and

For the Securities and Exchange Commission press release go to:

https://www.sec.gov/news/press-release/2017-175

United States v. CMC II, LLC et al 8:11 CV 1303 SDM-TBM (M.D. Florida) ($347,000,000 jury verdict)


This case alleged the wholesale upcoding of reimbursement claims to Medicare and Florida Medicaid by a chain of skilled nursing facilities in Florida.  The relator, a nurse who worked at the defendants' skilled nursing facilities, alleged that the facilities provided substandard medical care and inflated billing codes submitted to government health care programs. 

During a four-week trial, in which Rory Delaney was co-counsel with Kellogg Hansen Todd Figel & Frederick, we presented evidence that:

  • Defendants falsified paperwork (MDS Assessments) for residents covered by Medicare and TRICARE by overstating residents’ medical needs and the amount of care provided to them. 
  • Defendants fraudulently inflated the Resource Utilization Group ("RUG") levels reported in MDS Assessments in order to increase their Medicare and TRICARE reimbursement rates.
  • Defendants routinely falsified MDS Assessments to report that they had completed care plans for their Medicaid residents, when in fact no such care plans even existed. 
  • To avoid detection of this fraudulent scheme, Defendants would routinely create generic, boilerplate care plans for residents many months after their admission, but shortly before scheduled audit periods.
  • Defendants routinely falsified the identities of the persons submitting MDS Assessments to facilitate their fraudulent scheme.

After two days of deliberations, the jury returned a verdict in the sum of $115 million dollars which was trebled by the judge under the False Claims Act.

U. S. ex rel. Lokosky v. Acclarent, Inc., Ethicon, Inc., and Johnson & Johnson Case No. 11-cv-11217 (WGY) (D. Mass.) (settled in July 2016 - $18,000,000)

BOSTON, MA—The relator, Melayna Lokosky, received a multimillion-dollar whistleblower reward in connection with the U.S. government’s $18 million settlement with Johnson & Johnson and its subsidiary Acclarent, Inc. The settlement resolves claims that Acclarent defrauded the federal government by fraudulently concealing the true intended use of the MicroFlow Spacer. The MicroFlow Spacer was approved as a device to deliver saline into the sinuses, but the complaint alleged that the true intended use was to deliver Kenalog 40, a corticosteroid.

Melayna Lokosky, is a former employee of Acclarent and Johnson & Johnson. During her employment, Ms. Lokosky learned that Acclarent was marketing the MicroFlow Spacer as a drug delivery device and, she alleged, internal company documents showed that drug delivery was always the goal. 

Ms. Lokosky’s complaint alleged that, once the MicroFlow Spacer was cleared by the FDA, Acclarent ignored both the limited scope of clearance to expand the cleared use and proceeded to market the products as drug delivery devices to be used with Kenalog-40. The companies settled claims that the false and misleading marketing of MicroFlow Spacer for off-label uses caused the government to pay millions in claims that would not have been paid had Acclarent truthfully disclosed the intended use. When Ms. Lokosky complained about the illegal marketing, Acclarent’s management team terminated her.
The settlement brings an end to the nearly five-year qui tam lawsuit against Johnson & Johnson and Acclarent. Ms. Lokosky was represented in the FCA matter by Rory Delaney and Ilyas J. Rona of Boston, Massachusetts; and Charles F. Kester of Calabasas, California.

DOJ press release is here.

United States ex rel. Westmoreland v. Amgen Inc., et al. (Civil Action No. 06-10972-WGY) (settled in December 2012)

After two years of scorched-earth litigation, Amgen reached an agreement with the federal government to settle the Westmoreland case and several other sealed cases. Amgen ultimately paid $762 million to the federal government in 2012.

The amended complaint was filed pursuant to federal and state False Claims Acts by a former Amgen employee.  The suit alleged, among other claims, that Amgen engaged in a variety of illegal kickback schemes, the effect of which was to cause millions of dollars of overbillings to government health insurance programs. It was alleged, for example, that Amgen illegally induced physicians to prescribe its anti-anemia drug Aranesp by encouraging physicians to bill insurers for the “overfill” placed in the pre-packaged vials of the drug.   

The suit also alleged that in some instances patients were given more Aranesp than medically indicated, because of the “overfill” billing potential, notwithstanding a “black box warning” from the FDA about the health risks of Aranesp, and the need for minimal dosing.   

Aranesp (darbepoetin alfa) is an erythropoiesis-stimulating agent (ESA) and injectable drug product developed and manufactured by Amgen to stimulate and boost the production of red blood cells in the body.  It was approved by the FDA in 2001 to treat anemia associated with chronic renal failure and in 2002 to treat chemotherapy-induced anemia in certain types of cancer patients.   

Aranesp has been a lucrative product for Amgen with total sales reaching over $11 billion dollars since the drug was first introduced into the marketplace.  To date, the federal Medicare program and the state Medicaid programs have paid billions of dollars for Aranesp.  However, Aranesp is not without risk to patients.  In 2007, the FDA issued “black box” warnings (the most serious warning on a drug’s label) that Aranesp treatment could increase the risk of death, serious cardiovascular events and increased tumor growth, and cautioned physicians to use the lowest effective dose to achieve blood counts in a range to avoid blood transfusions, but not higher.   


Please click here for Fourth Amended Complaint [ATTACHED TO THIS EMAIL]
Please click here for an external link (http://www.nytimes.com/2009/10/31/business/31drug.html )

United States v. Elan Corporation, PLC, et al.
Civil Action No. 04-11594-RWZ.
(Settled December 14, 2010)


The US Department of Justice announced the resolution of the False Claims Act investigation of Irish pharmaceutical manufacturer Elan Corporation, PLC (Elan) and its U.S. subsidiary. The companies have agreed to pay over $203.5 million to resolve criminal and civil liability arising from the illegal promotion of the epilepsy drug Zonegran. In a separate civil settlement, Japanese drug marketer Eisai, Inc. which purchased the drug from Elan, has already paid $11 million to resolve civil liability for off-label marketing of Zonegran.

Zonegran was approved by the Food and Drug Administration (FDA) as an adjunctive therapy for the treatment of partial seizures in epilepsy for adults over the age of 16, and was not approved for any other uses, including for example, seizures in children under the age of 16.

Pursuant to the agreement, Elan Pharmaceuticals, Inc. is to plead guilty to an information charging it with misdemeanor misbranding of Zonegran, in violation of the Food, Drug and Cosmetic Act. In addition, the company will pay a criminal fine of $97,050,266. Elan will also pay $102,890,517 to resolve civil allegations under the False Claims Act that the company illegally promoted Zonegran for a variety of uses that were not medically accepted indications.

Please click here for DOJ Press Release
Please click here for Complaint

Bloomberg Newslink: Please click here


United States ex. rel Blair Collins v. Pfizer Inc (Settled in September, 2009)


The United States, the Commonwealth of Massachusetts and numerous other states announced September 2, 2009 that Pfizer Inc will pay approximately $2.3 billion dollars to settle claims that, among other things, the company misbranded one of its pain killer drugs, promoted the off label use of numerous drugs, and paid kickbacks to doctors to induce or reward the prescription of Pfizer drugs.

As part of the settlement, Pfizer subsidiary Pharmacia & Upjohn Company, Inc. (“Pharmacia”) entered a guilty plea to a criminal information charging that the company “misbranded” the painkiller Bextra (valdecoxib) by promoting the drug for variety of conditions and at dosages other than those for which its use was approved by the Food and Drug Administration.  Bextra was withdrawn from the market in 2005 after concerns about its safety profile especially for cardiovascular risks in long term users of the drug

Please click here for an external link 


United States ex rel Dan Johnston v. Aggregate Industries Inc. (Settled in July, 2007)



The United States and the Commonwealth of Massachusetts settled a case brought by whistleblower Dan Johnston against Aggregate Industries Northeast Region, Inc. F/K/A Bardon Trimount and Aggregate Industries, Inc. ("Aggregate").

Aggregate paid over $42 million to resolve a criminal and civil investigation into Aggregate supplying 5,700 loads of out-of-specification or non-conforming "10-9" concrete to the Big Dig. As part of this Big Dig concrete settlement, Aggregate Industries Northeast Region pled guilty to criminal charges that it conspired to submit false or fraudulent claims to the Government for that concrete and will pay a criminal fine.

Aggregate also settled the Government's civil claims, initiated by whistleblowers, by paying over $15.5 million to the Government under the federal and state False Claims Acts. Together the Big Dig whistleblowers who filed qui tam suits under the False Claims Acts received close to 18% of that recovery. Aggregate also contributed over $27 million to a fund to be used for future repairs on the Big Dig and Aggregate has entered into a Compliance Agreement with the federal Department of Transportation.

Please click here for an external link


Rory Delaney :: Experience in Notable Cases




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