[Ip-health] Illegal pricing practices - Lawsuit in developing countries??

[Klara Tisocki]

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[ Picked text/plain from multipart/alternative ]
Would anybody be able to give any example of similar  lawsuits (even if on =
much lower scale) from any developing countries in recent years?

  Klara Tisocki
  Consultant
  Philippines

  http://www.usdoj.gov/opa/pr/2007/September/07_civ_782.html
  FOR IMMEDIATE RELEASE
FRIDAY, SEPTEMBER 28, 2007
WWW.USDOJ.GOV
  CIV
(202) 514-2007
TDD (202) 514-1888

  Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Allegations=
 of Illegal Drug Marketing and Pricing  WASHINGTON =96 Bristol-Myers Squibb=
 Company (BMS) and its wholly owned subsidiary, Apothecon, Inc., have agree=
d to pay over $515 million to resolve a broad array of civil allegations in=
volving their drug marketing and pricing practices, United States Attorney =
Michael J. Sullivan announced today.
  The settlement was announced today by Assistant Attorney General for the =
Civil Division and Acting Attorney General Peter D. Keisler, United States =
Attorney for the District of Massachusetts Michael J. Sullivan, and United =
States Attorney for the Southern District of Florida R. Alexander Acosta.
  =93The integrity of our health care system rests on physicians being able=
 to make decisions based on the best interests of their patients,=94 said K=
eisler. =93This settlement reflects the Justice Department=92s strong commi=
tment to holding drug companies accountable for devising and implementing f=
raudulent marketing and pricing schemes that undermine that decision-making=
 process at the expense of federal health care programs for the poor and th=
e elderly.=94
  Sullivan added: =93Patients are entitled to unbiased decision-making from=
 their physicians and should not have to worry that financial inducements o=
r lavish entertainment have influenced their physicians=92 prescribing choi=
ces. Kickbacks are especially nefarious when they are used as part of a mar=
keting effort to convince physicians to prescribe drugs for uses that the F=
ood and Drug Administration has not determined to be safe and effective.=94
  =93The government alleges that Bristol-Myers Squibb, among other wrongdoi=
ng, fraudulently inflated the cost of a drug used primarily to reduce the s=
ide effects of cancer treatments and other generic drugs without regard to =
the increased costs borne by government health care programs or elderly and=
 indigent patients,=94 said U.S. Attorney R. Alexander Acosta of the Southe=
rn District of Florida. =93Corporations cannot continue to mislead the gove=
rnment into paying vastly exaggerated prices by exploiting a health care sy=
stem based on trust and fair play.=94
  Today=92s settlement covers a wide assortment of illegal marketing and pr=
icing practices.
  First, the Government alleged that, from approximately 2000 through mid-2=
003, BMS knowingly and willfully paid illegal remuneration to physicians an=
d other health care providers to induce them to purchase BMS drugs. BMS pai=
d the illegal remuneration in the form of consulting fees and expenses to p=
hysicians and other health care providers to participate in various consult=
ing programs, advisory boards, and preceptorships. Some of these programs i=
nvolved travel to luxurious resorts. The Government also alleged that, from=
 1994 through 2001, Apothecon knowingly and willfully paid illegal remunera=
tion such as stocking allowances, price protection payments, prebates, mark=
et share payments, and free goods in order to induce its retail pharmacy an=
d wholesaler customers to purchase its products. In both cases, the Governm=
ent alleged that, by paying this illegal remuneration to physicians and oth=
ers, BMS and Apothecon knowingly caused the submission of false and fraudul=
ent claims to
 the federal health care programs.
  Second, the Government alleged that, from 2002 through the end of 2005, B=
MS knowingly promoted the sale and use of Abilify, an atypical antipsychoti=
c drug, for pediatric use and to treat dementia-related psychosis, both =93=
off-label=94 uses. The Food and Drug Administration has approved Abilify to=
 treat adult schizophrenia and bi-polar disorder, but has not approved the =
use of Abilify for children and adolescents or for geriatric patients suffe=
ring from dementia-related psychosis. Indeed, the FDA has mandated that the=
 package for Abilify carry a =93black box=94 warning concerning its use in =
the treatment of dementia-related psychosis. Nonetheless, BMS directed its =
sales force to call on child psychiatrists and other pediatric specialists,=
 and the sales force then urged physicians and others providers to prescrib=
e Abilify for pediatric patients. BMS also created a specialized long term =
care sales force that called almost exclusively on nursing homes, where dem=
entia-related
 psychosis is far more prevalent than schizophrenia or bipolar disorder.
  Third, the Government alleged that both BMS and Apothecon set and maintai=
ned fraudulent and inflated prices for a wide assortment of oncology and ge=
neric drug products with the knowledge that federal health care programs es=
tablished reimbursement rates based on those prices. By reporting false and=
 fraudulent prices that were substantially higher than commonly and widely =
available prices in the marketplace, BMS and Apothecon created a =93spread=
=94 between the reimbursement rates for federal health care providers and t=
he actual prices for the drugs charged to its customers. The larger the spr=
ead on a drug, the larger the profit or return on investment for the provid=
er. Because reimbursement from federal programs was based on the fraudulent=
, inflated prices, the United States alleged that BMS and Apothecon caused =
false and fraudulent claims to be submitted to federal health care programs=
.
  Finally, the Government alleged that BMS knowingly misreported its best p=
rice for the anti-depression drug, Serzone. Under the provisions of the Med=
icaid Drug Rebate Statute, BMS was required to report to Medicaid the lowes=
t, or "best" price, for Serzone that it charged its commercial customers. I=
n making its mandatory best price reports, BMS knowingly failed to include =
the low prices at which it sold "private-label" Serzone to Kaiser, a large =
commercial purchaser. As a result, BMS denied the Medicaid program and cert=
ain Public Health Service entities the benefit of the lowest price in the m=
arketplace.
  Out of the settlement amount, the federal recovery is over $328 million, =
of which over $25 million constitutes disgorgement of profits under the Foo=
d, Drug and Cosmetic Act resulting from BMS=92s illegal promotion of Abilif=
y. BMS also will pay over $187 million to the Medicaid participating states=
, and $124,000 to certain Public Health Service entities.
  This settlement resolves in whole or in part allegations made in seven qu=
i tam actions brought under the False Claims Act. Those actions are: United=
 States ex rel. Richardson v. Bristol Myers Squibb, Civil Action No. 06-118=
21-NG (D. Mass.); United States ex rel. Piacentile v. Bristol-Myers Squibb =
Co., Civil Action No. 05-10196-MLW (D. Mass.); United States ex rel. Forden=
 v. Bristol-Myers Squibb Co., Civil Action No. 04-11216 -RGS (D. Mass.); Un=
ited States ex rel. Cokus v. Bristol Myers Squibb, Civil Action No. 01-1162=
7-RGS (D. Mass.); United States ex rel. Barlow v. Bristol-Myers Squibb, Civ=
il Action No. 04-11540-MLW (D. Mass.); United States ex rel. Ven-A-Care of =
the Florida Keys, et al. v. Apothecon, et al., Civil Action No. 00-10698-ME=
L (D. Mass.); and United States ex rel. Ven-A-Care of the Florida Keys, Inc=
. v. Bristol Myers Squibb Co., Civil Action No. 95-1354 (S.D. Fla.). The Ac=
t allows for private persons to file a qui tam or whistleblower suit on beh=
alf of the
 government. If the government is successful in resolving or litigating its=
 claims, the whistleblower may receive a share of the recovery. The various=
 relators will receive a total of approximately $50 million as their share =
of the settlement.
  As part of today=92s settlement, Bristol-Myers Squibb entered into a Corp=
orate Integrity Agreement with the Office of Inspector General of the Depar=
tment of Health and Human Services that, among other things, requires the c=
ompany to report accurate average sales prices and average manufacturer pri=
ces for its drugs covered by Medicare and other federal health care program=
s.
  =93Illegal drug marketing schemes and deceitful pricing by manufacturers =
will be vigorously pursued by OIG," said Daniel R. Levinson, HHS Inspector =
General. "We are committed to ensuring that beneficiaries participating in =
federal health care programs are not taken advantage of by those engaging i=
n unscrupulous practices.=94
  The investigation was conducted by the Boston offices of the Office of In=
spector General for the Department of Health and Human Services, the Federa=
l Bureau of Investigation, and the Food and Drug Administration's Office of=
 Criminal Investigations, along with Department of Justice Trial Attorney A=
ndy Mao of the Fraud Section of the Civil Division, District of Massachuset=
ts Assistant U.S. Attorneys Gregg Shapiro and Susan Poswistilo, and Souther=
n District of Florida Assistant U.S. Attorney Mark Lavine. The National Ass=
ociation of Medicaid Fraud Control Units participated in the negotiation of=
 the settlement, and the Corporate Integrity Agreement was negotiated by Ma=
ry Riordan of the Office of Inspector General at the Department of Health a=
nd Human Services.
  ###