Life Sciences

Life Sciences Articles by Topic: Off-Label Promotion

No class action status in CA Vioxx lawsuit

  • Pharma Compliance Alert, Issue 19, May 13, 2009

    Los Angeles Superior Court Judge Victoria G. Chaney denied class action status to plaintiffs...

Smith & Nephew receives subpoena from DOJ

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 14, April 27, 2009

    The Department of Justice subpoenaed documents relating to Smith & Nephew’s ultrasound...

Third former device employee pleads guilty to misbranding

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 14, April 27, 2009

    Shane Doyle, 32, of Winchester, MA, pleaded guilty to felony misbranding, according to the...

Biomet under investigation for possible fraud

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 14, April 27, 2009

    Government investigators are examining allegations that Biomet improperly sold, promoted, and...

Former Pfizer sales manager pleads guilty to misbranding

  • Pharma Compliance Alert, Issue 13, April 1, 2009

    Mary Holloway, 47, of Branchburg, NJ, pleaded guilty to violating the Food, Drug, and Cosmetic Act...

Merck updates grand jury investigation

  • Pharma Compliance Alert, Issue 12, March 25, 2009

    A grand jury is investigating Merck’s research, marketing, and selling activities for its...

Stryker under investigation for alleged illegal promotion

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 11, March 16, 2009

    A Massachusetts grand jury is investigating a Stryker subsidiary’s promotion of its human...

Former sales rep alleges J&J, Janssen pushed off-label promotion

  • Pharma Compliance Alert, Issue 10, March 11, 2009

    Johnson & Johnson and its subsidiary Janssen Pharmaceutica directed sales representatives to...

Judge rules J&J and Janssen misled physicians

  • Pharma Compliance Alert, Issue 10, March 11, 2009

    Johnson & Johnson and its Janssen Pharmaceuticals unit must pay West Virginia roughly $4.5...

DOJ investigating Medtronic marketing

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 10, March 9, 2009

    The Department of Justice (DOJ) is investigating Medtronic’s promotion of its cardiac...

Amgen, Wyeth sued for alleged illegal marketing

  • Pharma Compliance Alert, Issue 9, March 4, 2009

    A whistleblower lawsuit partially unsealed in Massachusetts accuses Amgen of engaging in illegally...

DOJ sues Forest for False Claims Act violations

  • Pharma Compliance Alert, Issue 9, March 4, 2009

    Forest Laboratories allegedly improperly marketed its antidepressants Celexa and Lexapro for...

Justice Department joins suits against J&J

  • Pharma Compliance Alert, Issue 8, February 25, 2009

    The Department of Justice (DOJ) joined two whistleblower lawsuits filed against Johnson &...

Device sales rep pleads guilty to misbranding

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 7, February 16, 2009

    Justin Demming, of Wadsworth, OH, pleaded guilty to felony misbranding of a medical device...

States, Bayer settle case alleging deceptive advertising

  • Pharma Compliance Alert, Issue 6, February 11, 2009

    Bayer entered into a settlement with 27 states to resolve allegations it deceptively marketed its...

FDA's final guidance clarifies reprint guidelines

  • Pharma Compliance Alert, Issue 6, February 11, 2009

    In January, the FDA provided some much needed guidance for the pharmaceutical industry about when...

Compliance 'critically important to industry'

  • Pharma Compliance Alert, Issue 6, February 11, 2009

    Pharmaceutical manufacturers must make sure compliance and ethics are fully integrated into their...

Pfizer Bextra settlement could top $2B

  • Pharma Compliance Alert, Issue 5, February 4, 2009

    A $2.3 billion estimated settlement could eclipse Eli Lilly?s $1.4 billion payment to resolve...

GSK sets aside $400M for possible settlement

  • Pharma Compliance Alert, Issue 5, February 4, 2009

    GlaxoSmithKline (GSK) is preparing to settle an ongoing investigation into the company’s...

Lilly to pay $1.4B for alleged off-label promotion

  • Pharma Compliance Alert, Issue 3, January 21, 2009

    Eli Lilly’s tab for allegedly promoting its antipsychotic Zyprexa for off-label uses topped...

FDA finalizes guidance on reprints

  • Pharma Compliance Alert, Issue 2, January 14, 2009

    Pharmaceutical and medical device manufacturers will find it easier to distribute journal articles...

Court dismisses off-label suit against Amgen

  • Pharma Compliance Alert, Issue 52, December 31, 2008

    Amgen will not have to face a lawsuit from seven small health benefit plans that claimed the...

PhRMA releases new DTC advertising guidelines

  • Pharma Compliance Alert, Issue 50, December 17, 2008

    Five months after updating its Code on Interactions with Healthcare Professionals, the...

Court documents: AstraZeneca knew about Seroquel diabetes risks in 2000

  • Pharma Compliance Alert, Issue 49, December 10, 2008

    It just got tougher for AstraZeneca to defend itself in lawsuits centering on its antipsychotic...

FDA warns AstraZeneca for alleged off-label promotion

  • Pharma Compliance Alert, Issue 49, December 10, 2008

    An AstraZeneca sales representative allegedly promoted the company’s antipsychotic Seroquel...

Citizen group accuses device makers of illegal online marketing

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 49, December 8, 2008

    The Prescription Project, a non-profit watchdog group, petitioned the FDA to require Abbott...

Former medical device manager pleads guilty to misbranding

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 48, December 1, 2008

    Darnell Martin, 35, of Chicago, pleaded guilty to one count of making a false statement and one...

Nevada AG claims pharma companies marketed products deceptively

  • Pharma Compliance Alert, Issue 47, November 26, 2008

    Nevada Attorney General Catherine Cortez Masto filed suit against Wyeth and Pfizer, claiming...

Court documents allege physician asked J&J to finance research center

  • Pharma Compliance Alert, Issue 47, November 26, 2008

    Documents produced as part of a class action lawsuit against Johnson & Johnson (J&J) claim...

FDA warns Protherics for Web page, fact sheet

  • Pharma Compliance Alert, Issue 47, November 26, 2008

    Protherics Inc.’s Web page and fact sheet for its investigational new drug Voraxaze misbrand...

Shionogi direct mailers misleading, FDA says

  • Pharma Compliance Alert, Issue 47, November 26, 2008

    Shionogi USA Inc.’s Professional NDC Sheet and a Cardinal Health NDC Sheet (direct mailers...

Government investigating off-label use of Medtronic device

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 47, November 24, 2008

    The Department of Justice (DOJ) is looking into the off-label use of Medtronic’s Infuse Bone...

Pharma settlements help DOJ recover $1.34B in FY 2008

  • Pharma Compliance Alert, Issue 46, November 19, 2008

    The Department of Justice (DOJ) recovered $1.34 billion through fraud and false claims settlements...

Florida judge dismisses RICO case against AstraZeneca

  • Pharma Compliance Alert, Issue 46, November 19, 2008

    AstraZeneca will not face racketing charges related to its promotion of the antipsychotic Seroquel...

DOJ recovers $1.34B in fraud, false claims in FY 2008

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 46, November 17, 2008

    The Department of Justice (DOJ) recovered $1.34 billion through fraud and false claims settlements...

DOJ investigating AtriCure marketing

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 46, November 17, 2008

    The Department of Justice (DOJ) is investigating allegations that AtriCure, Inc., improperly...

Scrutiny of Vytorin marketing continues

  • Pharma Compliance Alert, Issue 45, November 12, 2008

    The Department of Justice (DOJ) and 35 state attorneys general are investigating how Merck and...

Amgen brochure misleading, FDA warns

  • Pharma Compliance Alert, Issue 44, November 5, 2008

    Amgen’s direct-to-consumer patient brochure for Senispar tablets improperly omits and...

Lilly nears federal Zyprexa settlement

  • Pharma Compliance Alert, Issue 43, October 29, 2008

    Eli Lilly’s total legal expenses for suits relating to its antipsychotic medication Zyprexa...

Pfizer to settle Bextra, Celebrex claims for $894M

  • Pharma Compliance Alert, Issue 42, October 22, 2008

    Pfizer has agreed in principle to pay $894 million to settle all lawsuits related to its...

Congress investigating Bayer advertising claims

  • Pharma Compliance Alert, Issue 42, October 22, 2008

    Representatives John Dingell (D-MI) and Bart Stupak (D-MI) continue to examine pharmaceutical...

Pfizer accused of suppressing Neurontin study

  • Pharma Compliance Alert, Issue 41, October 15, 2008

    Pfizer marketing executives allegedly knew Neurontin, an epilepsy drug, did not effectively treat...

FDA warns Bayer about YAZ ads

  • Pharma Compliance Alert, Issue 41, October 15, 2008

    Two 60-second direct-to-consumer advertisements for Bayer’s birth control pill YAZ overstate...

LabCorp receives FDA warning letter

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 1, October 13, 2008

    Laboratory Corporation of America (LabCorp) is illegally marketing a blood test to detect ovarian...

Eli Lilly to pay $62M for improperly marketing Zyprexa

  • Pharma Compliance Alert, Issue 40, October 8, 2008

    Eli Lilly agreed to pay $62 million to 32 states and the District of Columbia to resolve...

Florida becomes ninth state to sue Merck because of Vioxx

  • Pharma Compliance Alert, Issue 40, October 8, 2008

    Florida alleges Merck deceptively marketed and promoted Vioxx by failing to disclose its side...

GSK settles Paxil suit

  • Pharma Compliance Alert, Issue 40, October 8, 2008

    GlaxoSmithKline (GSK) will pay $40 million to settle a class action lawsuit with 42,000 health...

Cephalon finalizes $425M false claims settlement

  • Pharma Compliance Alert, Issue 39, October 1, 2008

    Cephalon agreed to pay $425 million in civil and criminal penalties and entered into a corporate...

FDA warns five companies for incomplete or false advertising

  • Pharma Compliance Alert, Issue 39, October 1, 2008

    Shire, Johnson & Johnson, Novartis, Mallinckrodt, and Eli Lilly all received warning letters...

First Amendment not enough to dismiss off-label prosecution

  • Pharma Compliance Alert, Issue 39, October 1, 2008

    Eastern District of New York Judge Eric N. Vitaliano ruled the First Amendment’s free speech...

Internet promotion subject to FDA review

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 39, September 29, 2008

    Physicians and patients obtain most of their information about products online, said James M. Wood...

Trade shows present potential promotional pitfalls

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 38, September 22, 2008

    Clinical or medical personnel should be on hand at trade shows to provide information about...

Spectranetics under investigation

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 37, September 15, 2008

    The FDA and Immigration and Customs Enforcement executed a search warrant at Spectranetics...

Medtronic marketing investigated

  • Device Regulation Alert: Safety, Compliance and Reimbursement News, Issue 37, September 15, 2008

    Medtronic became the fourth major manufacturer investigated for improperly marketing its bile duct...

Documents unsealed in Lilly class action suit

  • Pharma Compliance Alert, Issue 36, September 10, 2008

    Eli Lilly may have a tougher time defending its marketing for its antipsychotic Zyprexa after a...

Idaho latest to sue Lilly because of Zyprexa

  • Pharma Compliance Alert, Issue 36, September 10, 2008

    Idaho became the latest state to sue Eli Lilly for the way it marketed its antipsychotic drug...

Journal ad for Bystolic misleading

  • Pharma Compliance Alert, Issue 36, September 10, 2008

    Forest Laboratories’ eight-page journal ad for Bystolic claims the drug is safer and more...

Amgen changes marketing practices for Aranesp

  • Pharma Compliance Alert, Issue 35, September 3, 2008

    Amgen will no longer offer rebates to oncology clinics for their use of the...

Stryker files suit against DOJ, OIG

  • Pharma Compliance Alert, Issue 35, September 3, 2008

    Stryker Corp. is suing the Department of Justice (DOJ) and Office of Inspector General (OIG) for...