Dear Doctor letters were front and center in the just-tried case of Tietz v. Abbott Laboratories, Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more
In 2005, Karen Bartlett visited her doctor complaining of shoulder pain. Her doctor prescribed Sulindac, a nonsteroidal anti-inflammatory drug used to relieve pain and address symptoms of arthritis. Ms. Bartlett was dispensed...more
In the wake of the New England Compounding Center meningitis outbreak, the federal government has actively pushed for greater legislative oversight over compounding pharmacies. On April 26, 2013, the U.S. Senate Committee on...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Mayo Foundation for Medical Education and Research v. ARUP Laboratories, Inc. -
Infringement of U.S. Patent Nos....more
On April 17, 2013, the Office of Inspector General of the Department of Health and Human Services (“OIG”) released an Updated Provider Self-Disclosure Protocol (“SDP”). The Updated SDP replaces OIG’s original Provider...more
In This Issue:
- Firm News:
DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards
In This Bulletin:
- Just Moot It: Supreme Court in Already v. Nike Clarifies When a Covenant Not to Sue Can Kill a Declaratory Judgment Case
- Murky Waters: Post-Approval Regulatory Activities and the §...more
Yesterday, the Sixth Circuit issued its decision in Fulgenzi v. PLIVA, Inc., a case involving a state law claim for failure to warn against a generic drug manufacturer. Case No. 12-3504 (6th Cir. March 13, 2013). The court...more
Last week, Senator Al Franken (D-MN) was joined by Senators David Vitter (R-LA), Dick Durbin (D-IL), Jeanne Shaheen (D-NH), and Bernie Sanders (I-VT) in introducing S. 204, the "Fair and Immediate Release of Generic Drugs...more
Originally published in the Health Care Fraud Report, 17 HFRA 219, on 03/06/2013.
The final rule (the ‘‘Final Rule’’) implementing the Physician Payments Sunshine Act (‘‘Sunshine Act’’), published in the Federal...more
To accelerate GMP compliance by domestic pharmaceutical companies, the Chinese State Food and Drug Administration (“SFDA”) published a notice on February 22, 2013 (the “Notice”) clarifying the regulatory pathways for...more
On the first day of February, the Federal Circuit rejected Impax's efforts to get out from under a preliminary injunction in a case captioned In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation. ...more
In This Issue:
Novartis Pharmaceuticals Corp. v. Actavis LLC et al.; Precision Biosciences Inc. et al. v. Cellectis S.A. et al.; Bayer Pharma AG v. Warner Chilcott Co., LLC et al.; Promega Corp. et al. v. Life...more
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002...more
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released a final rule implementing the Physician Payment Sunshine Act (the “Act”). The Act requires certain manufacturers of covered drugs, devices, and...more
In This Issue:
Li Keqiang Comments from the 12th Plenary Meeting of the Medical Reform Leading Group (USCBC 2012-01-06) – January 6, 2013; MOH Announces Roadmap for Medical Reform (USCBC 2012-01-10) – January 10, 2013;...more
The Chinese Ministry of Health (“MOH”) published the long-awaited amendment of Good Supply Practices for Pharmaceuticals (the “Amended GSP”) on January 22, 2013, to be effective as of June 1, 2013.
After three rounds of...more
This promises to be an eventful year in securities and corporate governance litigation. A number of looming developments have the potential to change the landscape for many years to come. This is the first of two posts – or...more
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited final rule implementing the Federal Sunshine Law (42 U.S.C. 1320a-7h). (The rule was subsequently published in the Federal...more
If you watch the mega hit Breaking Bad, you know that the main characters Walter White (a former high school teacher) and his former student/sidekick punk Jesse Pinkman manufacture methamphetamine in part to pay for Walt’s...more
The Final Rule implementing the Physician Payment Sunshine Act was announced on February 1st and published in the Federal Register on February 8th. The Final Rule establishes procedures for drug and device manufacturers to...more
- This month several U.S. Senators introduced the Preserve Access to Affordable Generics Act. There is no similar bill pending in the U.S. House.
- The Act revives legislative efforts to wipe out the...more
On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug,...more
The Centers for Medicare and Medicaid Services (CMS) recently published the final rule implementing the Physician Payment Sunshine Act (Sunshine Act) that requires most manufacturers of drugs, devices, biologics or medical...more
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