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Misconduct in the Pharmaceutical Sector - Johnson and Johnson


Johnson and Johnson

Johnson & Johnson - $3,38 Billion in Fines.
By Ronald Gibson

Johnson & Johnson, an American based medical devices, pharmaceutical and consumer packaged goods manufacturing company, was founded in 1886 by brothers Robert Wood Johnson, James Wood Johnson and Edward Mead Johnson, based on the idea to manufacture a line of ready-to-use surgical dressings. Two years later J&J pioneered the use of the first commercial first aid kits designed to help railroad workers, but soon became widely used to treat injuries by both corporate and household consumers. 1894 Marked the year in which J&J entered the soon to be lucrative baby business by selling maternity kits and the ever famous J&J Baby Powder.
Johnson & Johnson grew and expanded to include companies and brands like Ethicon (surgical sutures and wound closure devices), McNeil Consumer Healthcare (over-the-counter and prescription medicines like Tylenol), Janssen-Cilag (prescription medicines), Janssen Pharmaceuticals (healthcare innovation, research and development, diagnostics, products like Risperdal, Immodium) among the 250 subsidiaries they own and operate. Their turnover according to financial statements for 2016 was $71,89 Billion, with adjusted profit of $18,8 Billion.

I must state again that this article does not cover any awards or claims relating to personal injury claims, only those relating to legal, federal or ethical transgressions.

April 1995 - Ortho Pharmaceutical Corporation, a subsidiary of Johnson & Johnson, is fined $7,5 Million after pleading guilty to obstruction and corruptly persuading others to destroy documents relating to a Federal investigation of a prescription medication marketed as a wrinkle remover(Retinol-A).

December 2000 – LifeScan, a medical device company owned by J&J, paid a $60 Million fine after pleading guilty relating to Federal charges for selling defective blood-glucose meters.

April 2001 – Johnson & Johnson agree to a settlement of $840 Million after misleading clients into prematurely throwing away 1-Day Acuvue soft lenses by advising consumers to use them just once, even though the product is identical to regular Acuvue lenses, which may be worn as long as two weeks.

April 2010 - Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc., both subsidiaries of Johnson & Johnson, agree to pay $81 Million to resolve criminal and civil liability arising from the illegal promotion of the epilepsy drug Topamax, which was marketed for off-label psychiatric uses through a practice known as the "Doctor-for-a-Day" program. Under this program outside physicians were hired to accompany reps to the offices of other health care providers, and to act as speakers and thought leaders at functions during which they promoted Topamax for unapproved uses and doses.

April 2011 – As a result of The Securities and Exchange Commission laying charges against Johnson & Johnson for violating the Foreign Corrupt Practices Act for bribing public doctors in Greece, Poland and Romania and paying kickbacks to Iraq to illegally obtain business, and parallel criminal charges by the U.S. Department of Justice for the same offences, J & J agreed to settle for a penalty of $70 Million without admitting or denying the allegations.
https://www.sec.gov/news/press/2011/2011-87.htm, https://www.justice.gov/opa/pr/johnson-johnson-agrees-pay-214-million-criminal-penalty-resolve-foreign-corrupt-practices-act

October 2011 - Scios Inc., a subsidiary of Johnson & Johnson, pleaded guilty to a “misdemeanour” violation of the Food, Drug and Cosmetic Act after marketing their drug Natrecor (approved for “the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity”), marketing it for infusing chronic heart failure patients on a scheduled, serial basis. Their penalty – an $85 Million Criminal Fine that totally clashed with the “misdemeanour” plead.

November 2013 - Johnson & Johnson agrees to pay $2,2 Billion, yes….. BILLION, to end civil and criminal investigations into kickbacks to pharmacists and the marketing of pharmaceuticals for off-label uses of anti-psychotic drugs Risperdal and Invega, and Natrecor, a heart medication. To indicate how despicable their actions were, the marketing for off-label use was aimed at the most vulnerable sectors, elderly dementia patients and children and individuals with disabilities, in the process costing the US government medial insurance hundreds of millions. In the same process J&J paid Omnicare millions in kickbacks, a pharmacy specializing in supplying drugs to nursing home patients in the US. As part of the settlement, J&J agreed to plead guilty to one single misdemeanour violation for its promotion of Rispersdal.

March 2015 - McNeil-PPC, a subsidiary of Johnson & Johnson, pleaded guilty to a criminal charge of transgressing Good Manufacturing Practices in violation of the federal Food, Drug and Cosmetic Act. J&J agrees to pay a fine that amounts to $25 Million. On top of that the manufacturing facility was closed until remedial measures were implemented.

July 2016 - Acclarent Inc., a subsidiary of Johnson & Johnson, pays an $18 Million fine for causing health care providers to submit false claims to Medicare and several other federal health care programs by marketing and distributing its sinus spacer product (Relieva Stratus MicroFlow Spacer ) for use as a drug delivery device without U.S. Food and Drug Administration (FDA) approval of that use. FDA approval was granted for the device to be used with saline to maintain sinus openings following surgery, whereas it was marketed instead as a drug-delivery device for prescription corticosteroids, and was specifically designed and engineered for this use. This device is no longer commercially available in the US.

May 2017 – Johnson & Johnson agree to pay the state of Oregon an amount of $400,000 in settlement after being sued for hiding the recall of a faulty batch of Motrin without the public knowing, by hiring contractors to buy the product off shelves in 2009. This is known in the trade as a “phantom recall”. This was only discovered after contractors accidentally dropped an instruction sheet on the floor of a store.

Ongoing Department of Justice investigations relating to Johnson & Johnson.

For additional information on the Risperdal saga and the undisclosed enlargement of breasts in boys and men, and if you have some time, please read this 15 chapter report by The Huffington Post that reveals the depths sunk to in order to market this product, and the aftermath caused by undisclosed adverse effects.

As a matter of interest, Janssen Pharmaceuticals has paid a total of $106 Million to 141,294 doctors during the period August 2013 to December 2015 for promotional speaking, travel and lodging, consulting etc.

When anybody thinks of Johnson & Johnson, you think of baby products. Hopefully this article opens the eyes as to the wide range of industries they are involved with that play a role in our healthcare, and the apparent lack of concern with real accountability in the pursuit of profit.



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