Insights

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Dec 13, 2013 | Antitrust: European Commission Fines Johnson & Johnson and Novartis over $22 Million for Delaying Market Entry of Generic Painkiller Fentanyl

Not only was a fine imposed, but the companies were also reprimanded for their behaviour. Commission Vice-President Joaquín Almunia, in charge of competition policy, said, "J&J paid Novartis to delay the entry of a generic painkiller. The two compani...

Dec 4, 2013 | FDA Quickly Leverages its Jurisdiction over Compounding Pharmacies

Within one week of President Obama’s signing a law that will give the U.S. Food and Drug Administration (FDA) partial jurisdiction over compounding pharmacies, the FDA has taken important action that will effectively change how the industry is regula...

Nov 27, 2013 | Be Wary of Improper Inducements from Laboratories: False Claims Act Settlement Agreement with Bostwick Laboratories, Inc.

In sum, the settlement agreement in Bostwick is simply further evidence that the government will aggressively enforce and monitor laboratory and physician practices that encourage or contribute to overutilization. Therefore, a failure to establish an...

Nov 27, 2013 | Steubenville Superintendent and Others Indicted

These incidents make it clear that every public school district must have in place protocols and guidelines to be followed when any information is obtained related to the possible abuse of a minor (regardless of where the minor attends school). In th...

Nov 19, 2013 | U.S. Senate Approves the Drug Quality and Security Act

On November 18, 2013, the U.S. Senate, by voice vote, passed the Drug Quality and Security Act ( the “Act”) (H.R. 3204), marking the culmination of a nearly decade-long effort by many in the drug and pharmacy industry to clarify and strengthen both t...

Nov 19, 2013 | FDA to Initiate Limited Regulation of Compounding Pharmacies

At the beginning of 2013, FDA initiated an aggressive schedule of inspections of compounding pharmacies involved in the production or repackaging of large volumes of drugs. Almost immediately, FDA identified two compounding pharmacies producing taint...

Nov 18, 2013 | Expanded Antitrust Whistleblower Protections Pass in the U.S. Senate

The language of the bill, as approved in the Senate, provides that, “no employer may discharge, demote, suspend, threaten, harass, or in any other manner discriminate against a covered individual in the terms and conditions of employment” because of...

Nov 15, 2013 | Banks Face Huge Costs in the Event of a Data Breach

Cyber insurance, along with appropriate property casualty coverage for physical damage exposure to equipment, data and media, a comprehensive financial institution bond and director and officer (D&O) liability coverage, when combined, offer financial...

Nov 13, 2013 | Expanded HIPAA Privacy Rules Impose Requirements on Non-Healthcare Businesses in Possession of Medical Records

The Omnibus Rule greatly expands the number of organizations directly responsible for compliance with HIPAA privacy regulations. The requirements of the Omnibus Rule make BAs liable for failure to secure Protected Health Information (PHI), a rule tha...

Nov 12, 2013 | FDA Removes Trans Fats From GRAS List

The agency has opened a 60-day comment period on this preliminary determination to collect additional data and to gain input on the time potentially needed for food manufacturers to reformulate products that currently contain artificial trans fat sho...

Nov 11, 2013 | Roetzel Appellate Specialist Doug Leak Obtains Favorable Supreme Court Decision for Physician-Client Establishing Precedents for Defense of Medical Negligence Lawsuits

After extensive briefing and oral arguments by Doug Leak, the Ohio Supreme Court agreed with the position taken by Mr. Leak on behalf of the physician. In its decision, the Ohio Supreme Court set forth three holdings that will be invaluable to the de...

Nov 7, 2013 | Illinois State Police Release Sample Sign to Ban Concealed Weapons on Private Property

On July 9, 2013, Illinois passed the Firearm Concealed Carry Act (FCCA), becoming the 50th state to permit the concealed carry of firearms. The FCCA permits Illinois residents and non-residents who meet specified qualifications to apply for a licen...

Nov 4, 2013 | Deadline for Mandatory Employee Training on OSHA's Revised Hazard Communication Standard is Rapidly Approaching

...the standard requires employers to train their workers on the label elements and the SDS format by December 1, 2013. Training on label elements must include information on the type of data the employee would expect to see on the new labels, how an...

Nov 1, 2013 | DOJ Announces Record $34 Million Settlement in Immigration and Employment Eligibility Verifications Case

On October 30, 2013, the Indian company Infosys (INFY), a publicly traded company, reached a record $34 million settlement with the Department of Justice (DOJ), to settle "allegations of systemic visa fraud and abuse of immigration processes." T...

Oct 28, 2013 | FDIC Issues Warning to Bank Directors and Officers on Exclusionary Terms in Liability Policies

Earlier this month, the Federal Deposit Insurance Corporation (FDIC) issued Financial Institution Letter 47-2013. In the advisory, the FDIC sought to warn the officers and directors of its supervised banks of a recent increase in exclusionary terms o...

Oct 24, 2013 | Payments for Lavish Vacations Results in $48 Million FCPA Settlement for Diebold, Inc.

After the SEC entered into the agreement with Diebold, Inc., Scott W. Friestad, an Associate Director in the SEC’s Division of Enforcement, reinforced that, “A bribe is a bribe, whether it’s a stack of cash or an all-expense-paid trip to Europe.” Mr....

Oct 22, 2013 | Landmark Decision Clarifies Illinois Mortgage Foreclosure Law

Roetzel attorney Mark D. Belongia has secured a significant Illinois Appellate Court victory for client First American Bank. The landmark decision clarifies the Illinois Mortgage Foreclosure Law and defines the options available to banks against mort...

Oct 15, 2013 | The New Lee County Abandoned Property Registration Program Ordinance - How it Affects Lenders

On September 24, 2013, the Lee County Board of County Commissioners adopted the “Lee County Abandoned Property Registration Program Ordinance” with its stated purpose being to limit and reduce the deterioration of property and the protection of neigh...

Oct 10, 2013 | Banks are Increasingly Becoming Targets of Americans with Disabilities Act ATM Class Action Lawsuits

Just recently, however, ATMs have become the focus of law firms that specialize in representing disabled individuals. Certain law firms have filed hundreds of almost identical ADA ATM class action lawsuits in federal court since March 2012. Some of t...

Oct 8, 2013 | Community Bank Pays $8.2 Million Penalty for Money Laundering Violations

Saddle River Valley Bank (SRVB), a two-branch New Jersey community bank whose assets were acquired by Center Bancorp Inc. in 2012, has agreed to pay $8.2 million to settle claims that it violated anti-money laundering laws. U.S. Attorney Paul Fi...

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