- Concordia, Par Pharmaceutical settle anti-competition charges -U.S. FTC (reuters.com)
Concordia Pharmaceuticals Inc and Par Pharmaceutical Inc have settled charges they unlawfully agreed not to compete in the sale of a generic version of Kapvay (clonidine), a drug used to treat attention deficit hyperactivity disorder,…Federal Trade Commission…alleged Concordia,…had agreed not to sell…drug in exchange for a share of Par's revenues…. settlement bars them from enforcing anticompetitive provisions of their agreement, including the profit-sharing provision..
- Planned Parenthood Seeks Injunction After Abortion Allegations (health.wusf.usf.edu)FL Planned Parenthood Inspections Find Violations (health.wusf.usf.edu)
Planned Parenthood fired back..against allegations that three Florida abortion clinics provided second-trimester abortions without proper licenses, seeking an emergency injunction against the state Agency for Health Care Administration "to protect women's access to safe, legal abortion."… grounds for the injunction,… AHCA was ignoring a 2006 agency rule, which defined the first trimester as "extending through the completion of 14 weeks of pregnancy…
- Journalist fights Amgen subpoena in Aranesp class action suit (fiercepharma.com)
It isn't too often that drugmakers and journalists go head to head in court. But as part of Amgen's latest legal battle, it's asking a federal judge to force a reporter to testify about an article he wrote that prompted a shareholder suit against the company and to spell out how he got information about an abandoned clinical trial…. shareholders claiming the company failed to disclose information about the study...
- Amarin wins injunction against FDA in free speech case (fiercepharma.com)Amarin case could unleash a flood of off-label promos (fiercepharmamarketing.com)
Amarin won what was being called a First Amendment free speech victory for drugmakers. It got a federal court to say the FDA cannot bar Amarin from discussing off-label use of its fish-oil drug Vascepa for a wider group of patients than it is approved for…not clear how big a victory the ruling will be given it came in a lawsuit Amarin brought against the FDA as a defensive move.
- Amgen pays $71 mln to settle Enbrel, Aranesp marketing case (reuters.com)
Amgen Inc has reached a $71 million settlement ...to resolve claims that the biotechnology company promoted its popular Enbrel and Aranesp drugs for uses not approved by the federal Food and Drug Administration… Amgen violated state consumer protection laws by marketing both drugs for off-label uses, through its promotion of Enbrel to treat mild plaque psoriasis and Aranesp to treat anemia caused by cancer.
- Health system cleared in data breach lawsuit (healthcareitnews.com)
An appellate court has cleared Advocate Medical Group of wrongdoing in a class action lawsuit alleging the organization failed to protect patient data following a massive HIPAA data breach… The fact that two plaintiffs to date (out of those four million) have received notification of fraudulent activity, i.e., have suffered actual injury arising…does not show that plaintiffs here face imminent,..impending, or a substantial risk of harm..
- EHRs can increase docs’ medical malpractice liability (fierceemr.com)
Electronic health records can increase a provider's malpractice exposure,… EHRs initially were envisioned to reduce medical errors, but surmises that hasn't yet occurred…EHRs are causing or contributing to malpractice problems… found to create new, unanticipated legal problems…are changing the nature of medical malpractice lawsuits.
- Computer glitches and design flaws, such as a restrictive drop down menu, which can cause medical errors
- The "transparency" of EHRs themselves, which makes it harder to hide mistakes or sloppy work habits
- The increased documentation requirements and resulting desire to use templates and other shortcuts, which can lead to discrepancies in the EHR
- The inability of EHRs to catch some errors, such as dosage mistakes
- Pharmacy Students Participate in Mock Trial Based on Real Error (pharmacytimes.com)
Considering that a pharmacist’s mistake may cost a patient’s life, one class at Auburn University’s Harrison School of Pharmacy prepares pharmacy students for the gravity of their actions…. Foundations of Pharmacy course for incoming students has included a mock trial… Begin imagining yourselves in the chair as the defendant in the case, a pharmacist who has practiced for some time [and who] made an error….
- NCPA Supports Arkansas Law, Decries Shameful PBM Corporation Lawsuit (ncpanet.org)
National Community Pharmacists Association,.. issued the following statement..to champion a generic drug pricing transparency law enacted in Arkansas and to condemn a lawsuit filed on behalf of pharmacy benefit manager corporations to attempt to overturn the common-sense law…bipartisan law to bring more transparency to the generic drug pricing and reimbursement process...
- CVS Accused Of Autodialed Ads In TCPA Suit (law360.com)
CVS Pharmacy Inc. sent thousands of autodialed calls and texts advertising its products to customers without their consent, violating the Telephone Consumer Protection Act, according to a putative class action filed Tuesday in Louisiana federal court.