• J&J Settles Court Cases In Advance of Testimony by Former FDA Commissioner

    • 05 October 2012
    Even after stepping down from his position as head of the US Food and Drug Administration (FDA), former Commissioner David Kessler seems to be having a strong impact on the fortunes of some pharmaceutical companies. Kessler had been called on to testify on behalf of litigants in a series of trials set to be heard in a Pennsylvania court room the week of 8 October regarding Johnson & Johnson's marketing of its antipsychotic drug Risperdal (risperidone). Litigants have...
  • Reports: J&J Reaches Agreement to Settle Lawsuit Over 'Tsunami of Regulatory' Problems

    • 13 July 2012
    Life science manufacturing giant Johnson & Johnson has reportedly reached a tentative settlement agreement with a group of shareholders who had sued the company over allegations of chronically mismanaging its operations, leading to large-scale manufacturing problems and regulatory difficulties. The Associated Press reports the agreement came after J&J agreed to "big changes, including a new committee of independent board members to get reports about legal and q...
  • FDA: Bausch & Lomb Marketed Product Using Rejected Claims for Years

    A warning letter sent to Rochester, NY-based medical device manufacturer Bausch & Lomb, Inc by the US Food and Drug Administration (FDA) accuses the company of marketing its PureVision 2 contact lenses using an explicitly unapproved indication. In its 11 June 2012 letter, FDA explains Bausch submitted a supplement for the device-a tinted contact lens with an approved indication for extended wear -to the agency in 2010 seeking approval for a revised labeling stat...
  • MHRA, Researchers Warn of Metal-on-metal Hip Implant Risks

    In separate announcements, the Medicines and Healthcare products Regulatory Agency (MHRA) and a group of researchers have both raised troubling new questions about the failure rates of metal-on-metal (MoM) hip implants and how regulatory authorities can best respond. In a statement released 25 June, MHRA said it was advising surgeons to refrain from using a metal-on-metal hip implant product manufactured by Smith & Nephew after being made aware of postmarketing surve...
  • Reports: Johnson & Johnson to Pay $2.2 Billion to Settle Risperdal Marketing Probe

    Life science manufacturing giant Johnson & Johnson (J&J) is in the final stages of agreeing with federal prosecutors to pay an estimated $2.2 billion to settle charges of improperly marketing its blockbuster antipsychotic drug Risperdal, reports Bloomberg . The $2.2 billion sum would, in addition to settling Risperdal claims, also settle litigation regarding the marketing of J&J's schizophrenia drug Invega and congestive heart failure drug Natrecor, report...
  • J&J Announces Planned Cessation of Vaginal Mesh Sales

    Johnson & Johnson subsidiary Ethicon announced on 5 June 2012 it will cease sales of a controversial line of vaginal mesh implant products after being hit with a series of lawsuits alleging the products cause internal bleeding. Bloomberg Businessweek reports the company has requested approval from the US Food and Drug Administration (FDA) to end sales of the product within the next 120 days so consumers and doctors can find alternate suppliers or other treatment op...
  • Senators Launch Investigation Into 'Dubious Marketing Practices' of Pain Pill Manufacturers

    • 10 May 2012
    Explosive allegations have emerged from two prominent Senators regarding marketing tactics used by a number of pharmaceutical companies, including Purdue Pharma, Endo Pharmaceuticals and Johnson & Johnson, which are alleged to have engaged in "misinformation and dubious marketing practices." The Senators, Max Baucus (D-MT) and Charles Grassley (R-IA), charge the companies were involved in establishing "improper relationships between [the companies] and the organizati...
  • J&J Antibiotic Approved Via 'Animal Rule' Pathway

    • 30 April 2012
    After being backed by a US Food and Drug Administration (FDA) advisory committee , life sciences manufacturer Johnson & Johnson (J&J) has won FDA approval for Levaquin (levofloxacin), an antibiotic intended to treat pneumonic plague. The drug's approval is notable because it utilizes a rarely-used approval pathway known as the 'Animal Rule' pathway. The pathway allows sponsors of products intended to treat very dangerous or contagious conditions to forgo clinica...
  • J&J Earnings Drag as Regulatory Problems Accumulate

    Life sciences giant Johnson & Johnson (J&J) managed to increase first quarter profits by 12.5% despite a decrease in revenue of 0.2%, the company said in a statement. But the company's profits were sorely depressed by a series of regulatory issues, including recalls, shortages and legal battles, reports The Associated Press. Among J&J's many issues during Q1: The US Department of Justice rejected a settlement between the company and the US government ove...
  • Arkansas Slams J&J With $1.2 Billion Fine for Risperdal Marketing Tactics

    • 12 April 2012
    An Arkansas judge slammed Johnson & Johnson (J&J), the parent company of subsidiary Janssen Pharmaceuticals, with a $1.2 billion dollar fine after Janssen was found to have engaged in deceptive marketing practices for its drug Risperdal, reports The New York Times . Not only is the fine one of the largest monetary penalties ever levied upon a drug company, reports The Times , but it also opens the door for many subsequent lawsuits. "Most attorneys general can ...
  • NYTimes: J&J Privately Jettisoned Hip Implant Line After FDA Raised Questions

    Life science manufacturer Johnson & Johnson (J&J) worked to privately phase out a now-controversial metal-on-metal hip implant product in 2009 after the US Food and Drug Administration (FDA) contacted the company with concerns about levels of metal ions in patients' blood test, reports The New York Times . The report raises troubling questions about J&J's public response to FDA's nonapprovable letter, which stated FDA would not approve the device for sale ...
  • Bloomberg: J&J Sold Unapproved Medical Device for Years Prior to Approval

    Life sciences manufacturer Johnson & Johnson sold its now-controversial vaginal mesh implant for three years prior to being approved by the US Food and Drug Administration (FDA) in 2008, reports Bloomberg . The unauthorized sale of the Prolift vaginal mesh implant product, manufactured by Johnson & Johnson's Ethicon unit, could place the 510(k) approval pathway under additional scrutiny. The company marketed Prolift as early as 2005, reports Bloomberg , reason...