ObamaCares Killer Device Tax

ObamaCare’s Killer Device Tax (WSJ) Much of the political conversation in Washington these days concerns innovation, job creation and competitiveness. But talk is cheap, and elected officials must enact policies that enhance economic activity and job creation. The medical device industry is an example of Washington doing exactly the opposite. Medical device manufacturing is one of [...]

New Hampshire May Soon Be Outlawing PODs

New Hampshire Outlawing PODs? (Walter Eisner @ OTW) The New Hampshire House of Representatives recently passed legislation to prohibit health care practitioner self-referrals for medical devices. Larry Biegelsen, senior analyst at Wells Fargo wrote on April 10, that he understands the bill was intended to outlaw physician-owned distributors (PODs) and is expected to pass the state’s [...]

Biomet Pays Feds to Enter Into DPA for Bribery Charges in Argentina, Brazil and China

Biomet Pays to Defer Bribery Prosecution (Walter Eisner @ OTW) The U.S. Department of Justice’s Criminal Division (DOJ) announced on March 26, that Biomet Inc. has entered into a deferred prosecution agreement (DPA) with the government to, “resolve improper payments by the company and its subsidiaries in violation of the Foreign Corrupt Practices Act (FCPA). Biomet [...]

Scorecard – DOJ Versus Orthopedic Companies

Biomet March 26, 2012 – entered into a DPA to resolve improper payments by the company and its subsidiaries in violation of the Foreign Corrupt Practices Act, paid $22M to avoid prosecution March 30, 2009 – expiration of DPA Sept 27, 2007 – agreed to DPA for 18 months and agreed to pay a civil settlement amount [...]

Anti-Kickback Charges Against Exactech Dropped

Anti-kickback Charges Against Exactech Dropped (Walter Eisner @ OTW) Exactech, Inc.’s Deferred Prosecution Agreement (DPA) with the U.S. Attorney’s Office in New Jersey has expired. With this expiration, all charges filed against the company in 2010 for conspiring to commit violations of the Federal Anti-kickback Statute have been dropped. The company remains under a Corporate Integrity [...]

Symmetry Medical Resolves 5-Year SEC Investigation

     Symmetry Medical Resolves SEC Investigation (press release) Symmetry Medical Inc., a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, today announced that it reached a settlement concluding an investigation resulting from the previously-reported informal inquiry that has been conducted by the U.S. Securities and [...]

Stryker Pays $15M Fine in a DOJ Settlement After Unapproved OP-1 Clinical Study

         Stryker Reaches Settlement with the U.S. Attorney’s Office (press release) Kalamazoo, Michigan – January 18, 2012 – Stryker Corporation (NYSE:SYK) announced today that Stryker Biotech has reached a settlement with the U.S. Attorney’s Office for the District of Massachusetts.  As part of the settlement, Stryker has agreed to plead to one misdemeanor [...]

New Bill Would Require Companies to Monitoring of 510(k) Implants Systems

     Bill Would Require More Monitoring of Implants (NY Times) Amid growing problems with artificial hips and other medical implants, bipartisan legislation was introduced in the Senate on Wednesday that would force manufacturers to track the performance of such products after they were approved for sale. The bill would allow the Food and Drug Administration [...]

Exactech Extends Deferred Prosecution Agreement With US Attorneys Office

    Exactech Announces Agreement with U.S. Attorney’s Office (press release) GAINESVILLE, Fla.–(BUSINESS WIRE)– Exactech, Inc. (Nasdaq: EXAC - News), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today that it agreed to enter into an amendment to its Deferred Prosecution Agreement (DPA) with the United States Attorney’s [...]

Strykers Reaction to the Upcoming Medical Device Tax

     Beyond The Medical Device Tax   (Worcester Business Journal) Last month, when Michigan medical device maker Stryker Corp., which has operations in Hopkinton, announced plans to reduce its worldwide workforce by 5 percent, it didn’t take long for observers to connect the cuts to a federal tax on medical device makers scheduled to take [...]

Did Medtronic Sell an Unsafe Product?

           Did Medtronic sell an unsafe product? (Star Tribune – Business) Under fire, the company looks to a top researcher to answer questions about its big seller Infuse. For Dr. Harlan Krumholz, numbers tell stories. The pioneering Yale University cardiologist’s medical sleuthing — called “outcomes research” — involves studying how sick people [...]

What Are the Changes in Surgeon Payments After the DOJ Settlement Are Done?

         Post-DOJ Settlement, Researchers Note Changes in Payment Patterns (written by Lauren Uzdienski @ HealthPointCapital) A new study published in the Archives of Internal Medicine sought to analyze changes in payments to orthopedic surgeons following five orthopedic manufacturers’ 2007 settlement with the DOJ. What they found between 2007 and today was a decrease in the number [...]

TranS1 Received a Subpoena Under the Federal Healthcare Fraud and False Claims Statutes

    Feds subpoena TranS1 in fraud probe (MassDevice) TranS1 Subpoenaed. No Accusations Made (written by Walter Eisner @ OTW) TranS1, Inc. has received a subpoena from the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS). The subpoena was issued under the authority of the federal healthcare fraud and false [...]

House Democrats Request Hearings on Metal-on-Metal Hips… Caused “Significant Harm to Human health”

      House Democrats Request Hearings on Metal-on-Metal (written by Lauren Uzdienzki @ HealthPointCapital) Democrats from the House Energy and Commerce Committee have asked Republican leaders to hold hearings on metal-on-metal hips and brain stents. In a letter, Democrats said these devices have caused “significant harm to human health”. Bloomberg writes that the FDA has received more [...]

Medtronic’S New CEO –> US Should “absolutely” Adopt the EU Regulatory System

  MDT’s Ishrak: U.S. Should “Absolutely” Adopt EU Regulatory System (written by Lauren Uzdienski @ HealthPointCapital) In comments to the Financial Times, Medtronic CEO Omar Ishrak criticized the FDA for a slow regulatory process that limits patient access to care. In the EU, “the response time is quicker, the clinical trial cycle is quicker, and maybe some of [...]

Wright Medical’S Compliance Officer Resigns Before the Conclusion of the Deferred Prosecution Agreement

  Wright Medical Compliance Officer Resigns (written by Walter Eisner @ OTW) Lisa L. Michels resigned as Vice President and Chief Compliance Officer of Wright Medical Group Inc., on August 16. The resignation was effective immediately. In an 8-K filing with the Securities Exchange Commission on August 22, the company stated that Ms. Michels is eligible [...]

FDA Needs Better Recall Monitoring, Says GAO

US FDA needs better recall monitoring, says GAO (Reuters) Congressional auditors have faulted U.S. health regulators for failing to track unsafe medical devices after they are recalled, opening the door to further risks to patients.  The Government Accountability Office (GAO) found 21 high-risk recalls between 2005 and 2009 where companies were unable to correct or [...]

Senators Investigating Medtronic for Links Between Surgeons Consulting Fees and Infuse Usage

  The Senate letter to Medtronic – June 21, 2011 Senators Look Into Medtronic, Doctors (WSJ Blog) The Senate Finance Committee is investigating whether surgeons who received large sums of money from medical-device giant Medtronic Inc. for consulting and other work failed to note complications associated with a Medtronic bone-growth protein that has become widely used in [...]

Medical-Device Venture Capitalists Go to Washington

Medical-Device Venture Capitalists Go To Washington (WSJ Blog) Health care-focused venture capitalists have long been telling anyone on Capitol Hill who will listen that problems at the Food and Drug Administration are stifling innovation and deal flow, as they say the agency is inconsistent and vague on the rules for approving new medical technologies.

5 Senators Start Investigation Into the Legality of Physician-Owned Distributorships (PODs)

Senators Request Probe of Surgeons (Wall Street Journal) Five U.S. senators asked the Inspector General of the Department of Health and Human Services to open an investigation into physician-owned distributorships, middleman entities that allow surgeons to profit from the medical devices they use on their patients, to determine whether they are legal. U.S. Senate Looking [...]

keep looking »

May 18, 2012

  • Newsletter Signup

  • Orthopedic Recruiting

    Now Hiring: Product Development Engineer - Memphis, TN

     

  • Editor – Tiger Buford

     


  •  

  • most popular this week

  • Monthly Articles

  • RSS Orthopedics This Week

  • RSS MedPageToday

  • Support OrthoStreams

  • Book of the Month