Legal & Regulatory Features & News
Photo creation by RRY Publications LLC / Logo courtesy of CoAxia, Inc.
Walter Eisner • Tue, May 21st, 2013
Did the FDA kill CoAxia using the new de novo process? Despite reducing mortality rates in patients 2 to 1 over standard of care, the FDA pushed CoAxia into the new de novo process. In retrospect, it also killed the company. Attorney Mark DuVal, is warning clients to beware the de novo process lest it devours you.
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A Milwaukee spine surgeon has been indicted for lying to payers about minimally invasive spine procedures requiring nerve monitoring. Cully R. White, D.O. was charged with 13 counts of health care fraud by a federal grand jury in Milwaukee, Wisconsin.
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The drip, drip, drip of former Orthofix, Inc. employees convicted of cheating Medicare to sell bone growth stimulator devices continues. The U.S. Attorney’s Office announced that a former territory manager, pled guilty to health care fraud and paying kickbacks from 2005 through 2011 while selling Orthofix bone growth stimulators.
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Board certified surgeons and pain interventionists aren’t the only ones having a scope of practice argument over who is best qualified to treat patients. While some orthopedic surgeons assert that the government is limiting residency slots and could force medical school graduates into primary care, a study reported in the May 16, 2013 issue of…
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Imagine the massive effort required to spend a full day presenting evidence to the FDA orthopedic panel to prove your device is safe and effective. SpinalMotion, Inc. is doubling down and going for two days in July.
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DePuy Orthopaedics, Inc. actually had some good hip news on May 3, 2013, when the company announced FDA Pre-Market (PMA) Supplemental Approval for its Ceramax ceramic-on-ceramic hip system.
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Walter Eisner • Tue, May 7th, 2013
Image created by RRY Publications, LLC
New Jersey continues to be ground-zero for credentialing battles as the Association of American Physicians & Surgeons sues the American Board of Medical Specialties over the Board’s certification program. The complaint? Certification programs principally enrich private corporations at the expense of doctors. Really? We lift the veil.
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Walter Eisner • Tue, April 30th, 2013
Photo Creation by RRY Publications LLC / Source: Morguefile and wax115
What, exactly, is the scope of practice for interventional spine physicians? The new front line in this battle is New Jersey. The new poster child is Dr. Richard Kaul. This is a Runyon-esq melodrama punctuated with charges of greed, politics and restraint of trade against, among others, the former heads of NASS and the AMA.
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Five physicians, including a podiatrist and two hospital executives from Chicago-based Sacred Heart Hospital have been arrested for allegedly conspiring to pay and receive illegal kickbacks in exchange for the referral of patients insured by Medicare and Medicaid. Gary Shapiro, the U.S. Attorney for the Northern District of Illinois made the announcement on April 16,…
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Forty-four months ago, Intermountain Healthcare of Utah self-reported potential violations under the Stark Law to the government. On April 3, 2013, the Department of Justice and the Office of Inspector General of the Department of Health and Human Services (OIG) reached a $25.5 million settlement with the largest health system in the state. The system…
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Not guilty! DePuy Orthopaedics, Inc. announced on April 16, 2013 that a jury in Cook County Illinois returned a verdict in favor of the company in a product liability lawsuit over the company’s ASR metal-on-metal hip system. It’s the second jury to reach a decision. On March 8, 2013 the first jury in Los Angeles…
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Stryker Corporation announced on April 10, 2013 that the FDA has classified the voluntary recall of the company’s ShapeMatch Cutting Guides as a Class I Recall. A Class I Recall, according to the FDA, is a situation in which “there is a reasonable probability that the use of or exposure to a violative product will…
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The FDA wants you to invite them for a formal training visit to your research, clinical, manufacturing and health care facilities to observe firsthand how medical devices are designed, developed and utilized. They (promise/swear/cross-their-hearts-and-hope-to-die) that these visits are not a mechanism for the agency to inspect, assess, judge, or perform a regulatory function (i.e., compliance…
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Walter Eisner • Tue, April 9th, 2013
Image created by RRY Publications, LLC. Source: : Morguefile and Seemann
Ortho robot makers are at war in federal courts from coast to coast. Accusations of disloyalty, deceit, cheating and theft of trade secrets are flying as Stryker Corporation and MAKO Surgical Corp. try protect their hard earned turf. Who is the upstart that sparked such a conflagration?
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MAKO Surgical Corp. has won its court battle with Blue Belt Technologies, Inc. and former employee, Jeff Gellman. On April 4, 2013, MAKO announced that it had obtained an Order Granting Permanent Injunction keeping Blue Belt from employing Gellman and requiring the destruction of all proprietary MAKO business information in Blue Belt’s possession.
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Walter Eisner • Tue, April 2nd, 2013
Source: RRY Publications, LLC
The 81st Annual Meeting of the American Academy of Orthopaedic Surgeons took place in a background of a changing healthcare landscape where payers rule and value counts. Josh Jacobs, M.D., the Academy’s new leader has a plan. Oh yeah, there were also new knees, lots of them. Read on.
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The Office of Inspector General (OIG) fired a “Warning Shot” on March 26, 2013, for physician-owned distributors (PODs) that don’t follow appropriate investor guidelines. In a “Special Fraud Alert”, the OIG reiterates its longstanding position that it views PODs as “inherently suspect” under the anti-kickback statute.
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Walter Eisner • Tue, March 19th, 2013
Robert Booth, M.D., Arthur Bartolozzi, M.D., Richard Balderston, M.D., Philip Maurer, M.D., and David Nazarian, M.D.
You and your partners have agreed to sell your practice to a local hospital. Then you discover your partners changed the deal on you. So you decide to sue your former partners, including Gender Knee developer, Robert Booth, M.D. It’s a mess. Here’s what we know so far.
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The FDA sent NuVasive, Inc. a warning letter on March 12, 2013 related to labeling claims not cleared through any of the company’s Affix Spinous Process Plate system 510(k)s. The company announced the warning letter on March 18, 2013 and said the regulatory action came from an FDA inspection of the company’s San Diego, California…
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Stryker Corporation announced on March 12, 2013 that its Instruments division has received a warning letter from the FDA related to an FDA site visit made during a November 2012 inspection at its Portage, Michigan, location. The letter concerns quality system and cites Stryker for failing to notify the FDA of a product recall, and…
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Walter Eisner • Mon, March 11th, 2013
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The jury in the ASR metal-on-metal trial has reached a verdict and awards $8.3 million to the plaintiff. DePuy is guilty of designing a faulty device, but adequately warned patients and surgeons of the dangers. Read what the lawyers for the two sides told the jury in their closing arguments and how DePuy defended itself.
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The FDA Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee voted 12-9 on March 5, 2013, to recommend that the evidence did not support the use of calcitonin salmon nasal spray for the treatment of osteoporosis. The panel said there is little evidence they work and may actually…
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The jury in the DePuy Orthopaedic, Inc. ASR hip trial returned a mixed verdict on March 8, 2013, after a five week trial and has awarded Loren Kransky $8,338,000 in compensatory damages. Kransky’s lawyers had asked jurors for $338,000 in economic damages, $5 million in economic damages for pain and suffering, and up to $179…
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Walter Eisner • Tue, March 5th, 2013
Image created by RRY Publication, LLC. Source: Morguefile and mconnors
The DePuy ASR hip trial has reached the halfway point as plaintiff’s lawyers rest their case. Now the defense takes its turn. DePuy has taken its lumps, but maintains it did nothing wrong. Read the evidence the jury has heard and what it might mean to the other 10,000 cases pending against DePuy.
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If you own shares in a mutual fund that includes a company for whom you are a clinical investigator for an FDA-sponsored investigation, do you have to disclose that? Can a literature report be considered a covered clinical study? The FDA’s got the answers for you in a new guidance. The “Guidance for Clinical Investigators,…
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It’s not for an orthopedic medical device, but Medtronic, Inc. has received landmark FDA approval under new draft guidance to conduct an early feasibility study. The approval to study Medtronic’s Native Outflow Tract Transcatheder Pulmonary Valve (TPV), represent the first-ever FDA approval of an investigational device exemption (IDE). Investigational Device Exemption The intent of the…
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The FDA initiated an “urgent” Class 1 Medical Device Recall of DePuy Orthopaedic, Inc.’s LPS Diaphyseal Sleeve on February 15, 2013. The agency made the recall public on February 22, 2013. The sleeve is intended for use with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft…
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Walter Eisner • Tue, February 26th, 2013
Image created by RRY Publications, LLC. Source: Smallwon and Morguefile
When spine surgeon Andrew Cappuccino and NuVasive, Inc. had a messy breakup in 2011, it made big news in the small spine industry community. Cappuccino’s departure to Lanx, Inc., was followed by the defection of NuVasive sales reps. What happened? The lawsuits tell all.
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Walter Eisner • Thu, February 14th, 2013
Image created by RRY Publications, LLC. Sources: Wikimedia Commons, SSGT Tia Schroeder, USAF and Andrew Huth
In a time of great financial challenges for spine surgeons, the Laser Spine Institute had seemingly solved the riddle of bringing more patients in their doors and revenue in their coffers. Then came The Hulkster to question whether or not the institute delivers what it promises. We looked inside the lawsuit.
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Walter Eisner • Tue, February 5th, 2013
Image created by RRY Publications, LLC.
Orthopedics’ biggest trial is finally underway. The first witness has been called. The plaintiffs say that DePuy’s ASR metal-on-metal hip had a flawed design which the company knew about. The defendants have a strong counter argument. Bottom line: what did DePuy know and when did they know it?
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The FDA announced on January 23, 2013, that the agency would not appeal the landmark federal circuit court Caronia decision that the First Amendment protects truthful speech about the off-label use of FDA-approved products. Alfred Caronia was prosecuted and convicted of conspiring to introduce a misbranded drug into interstate commerce. He was caught on tape…
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