The JOBS Act in 2013: What’s really driving the IPO Market?

Congress passed the Jumpstart Our Business Act (JOBS Act) in April 2012 with the hope that it would accelerate the IPO market for emerging growth companies (EGCs), which would in turn create job growth and help revive the economy. Initially slow to deliver, the Act has inspired a great deal of speculation. Recent market trends, however, point to a clear upswing in IPO activity, with a significant increase in the second quarter of 2013.

According to data from IPO Watch, IPO listings jumped 82 percent (from 34 to 62) during the second quarter of 2013 compared to the first quarter of the year. Analysts say the increase has been bolstered by a growing number of growth-related industry sectors like biotech firms, which outpaced all other industry groups in the number of IPOs filed and the amount of capital raised in second quarter of 2013. Other leading industry sectors entering the IPO pipeline include financial services, technology and healthcare services. 

Activists pressure FDA for more generic drug regulation

Last month the U.S. Supreme Court set aside a 21 million jury verdict for a woman who was injured as a result of an adverse reaction to a generic drug, similar to common pain medication like ibuprofen. In Mutual Pharmaceutical Co. Inc. v. Bartlett, the court ruled that the consumer’s design defect claim against the company was pre-empted, since generic drugs must be designed the same way as their brand-name counterparts. The decision, the latest in a string of drug-regulatory cases helps to shield generic drug makers from personal injury litigation claims and signals another victory for the industry.

Two years ago, the court ruled in Pilva Inc. v. Mensing that generic drug manufacturers could not be held liable for failure to warn claims. In response, several Democratic

Do clinical trials work?

The gauze is starting to be removed from the world of clinical trials. As transparency increases, so too will the likelihood of legal liability for drug makers and other trial sponsors. A recent article in the New York Times demonstrates that this type of news has become mainstream. First, the news. Then the implications for risk management.

The NY Times story and others like it in the popular press give rise to greater knowledge that the data from clinical trials is imperfect inherently. For example, trial populations are seldom representative of those with the disease or condition. Participants are usually much younger than the average sufferer. It is just harder to recruit older participants who are less likely to desire participation in a speculative trial when their remaining life from a successful outcome is not as long as for younger persons. Further,

Two cases show why all employers should know about GINA

Do you know GINA as well as you should? That is a question all employers should be asking themselves. Recent activity by the EEOC has led many employers to assess their knowledge of the Genetic Information Nondiscrimination Act (GINA) or more importantly, their lack of knowledge regarding GINA.

GINA, which became effective in November 2009, prohibits the use of genetic information in employment decisions. According to the Act, genetic information includes information about an employee’s or prospective employees genetic tests, tests of family members and family medical history, including information about manifestations of a disease or disorder (i.e. cancer, diabetes or heart related illness) in an employee’s or prospective employee’s family members. GINA prohibits an employer from requiring

Concussions in student athletes: does your institution have a risk management strategy?

Within the past decade, hundreds of professional and student athletes have spoken out about the side effects of concussions, with many filing lawsuits against the athletic organizations that permitted them to play while sustaining those injuries. From headaches and memory loss to anxiety, depression and even suicide, the emerging science about the effects of head trauma and players’ own personal stories has propelled the issue to the forefront of news media and sparked public discussion debate on the topic.

The Centers for Disease Control Prevention estimates that student athletes suffer about 2 million brain injuries every year, and other studies suggest that nearly 15 percent of pro football players endure at least one mild brain injury during the season. The legal implications are serious for institutions involved in these types of cases, especially colleges and universities that may face financial loss and reputational harm. The guidelines and regulations for the care

Blurred deadlines of Obamacare implementation

The past 12 months The WGA Health Reform Consulting Team has been working with clients and prospects at breakneck speed, getting them ready and compliant for the 2014 employer mandates forced upon us by the new health care reform law. The confusing and often contradictory components of the regulations has made getting companies in to compliance a challenging and often frustrating exercise. WGA’s clients like many companies across the United States, have worked hard historically to be great corporate citizens in providing their employees a competitive and affordable healthcare program. However these same companies have been in the crosshairs of Obamacare, faced with inevitable penalties, taxes and compliance obligations under the Obamacare law; a law that penalizes companies for providing an affordable level of coverage for their employees and encourages dumping employees in to tax subsidized state programs or Exchanges.

Obamacare provisions set to hit small business hard

It is discouraging to realize that key provisions of the Affordable Care Act (ACA) that were supposed to integrate with the Massachusetts reform law instead threaten to accelerate the already burdensome cost of health insurance for small employers.  As a result, there is a third ACA-related bill being debated in the Commonwealth that would force Governor Deval Patrick and his administration to file a federal waiver to avoid the adverse effects of rating and rule changes to the Massachusetts merged market (1-50 employees).  The move could lead to some turmoil for the Obama Administration as the ACA seems to be forcing significant changes to a state law that they claimed acted as a model in Washington.

Specifically, the provisions in question are those around the ACA-required changes to rating factors which could have a substantial impact on premium costs for small businesses in the 1-50 marketplace