A Medical Device Daily
VSP Vision Care (Rancho Cordova, California) and its legal team led by former U.S. Solicitor General Kenneth W. Starr today petitioned for a writ of certiorari with the Supreme Court of the United States.
The company reported retaining Starr last month (Medical Device Daily, July 17, 2008).
VSP wants to make a final plea to the Supreme Court to regain its federal tax-exempt status. As stated directly in the VSP Supreme Court petition filed today:
"This case presents a critically important, recurring question regarding the standards governing the tax-exempt status of nonprofit healthcare enterprises, particularly nonprofit health maintenance organizations (HMOs)," said Ken Starr, former U.S. Solicitor General.
"Without any change in statutory or regulatory law, and without any change in the operations of VSP, the IRS overturned its longstanding position, revoking VSP's tax exemption in 2002.
"The IRS's revocation of VSP's tax-exempt status, over 40 years after it was initially granted, represents an unauthorized departure from the established law of charitable trusts and from the specific judgment of the 1986 Congress," said VSP president /CEO Rob Lynch.
"The IRS's changed position - now condoned by the Ninth Circuit - makes it much more difficult for a nonprofit healthcare organization to qualify for an exemption under sections 501(c)(3) or 501(c)(4)," said Thomas Fessler, VSP's vice president and general counsel. "Despite the fact that the basic mission of these organizations is a charitable one - the promotion of health care - the IRS now requires something more in the way of community benefits' or public benefits' in order to qualify for an exemption."
VSP has provides low-income, uninsured children with free eyecare.
In other legalities:
The Securities and Exchange Commission reported that a final judgment by consent was entered by the U.S. District Court of the District of Massachusetts against Howard Richman, the former head of regulatory affairs of Biopure (Cambridge, Massachusetts) in a previously-filed action alleging misleading public statements about the company's efforts to obtain FDA approval for its primary product, Hemopure, a synthetic blood product.
The final judgment against Richman, age 56, of Houston, Texas entered on Aug. 6, 2008, permanently enjoins Richman from violating the antifraud and other provisions of the federal securities laws, permanently bars Richman from serving as an officer or director of any public company and orders him to pay a $150,000 civil penalty.
The commission's complaint, filed Sept. 14, 2005, alleges that, beginning in April 2003, Biopure received negative information from the FDA regarding its efforts to obtain FDA approval of its synthetic blood product Hemopure but failed to disclose the information, or falsely described it as positive developments. Specifically, the complaint alleges that in April 2003, the FDA placed a clinical hold barring Biopure from conducting clinical trials of Hemopure in trauma settings such as emergency rooms, because of safety concerns about Hemopure.
The complaint further alleges that, during the next eight months, Richman and other Biopure employees concealed the imposition of the clinical hold while making public statements about Biopure's plans to obtain approval for trauma uses of Hemopure. In addition, according to the complaint, in July 2003 the FDA informed Biopure that it had not approved Biopure's application for use of Hemopure in orthopedic surgery, and instead conveyed serious concerns about whether the materials Biopure had submitted in support of its application were reliable and questioning the safety of Hemopure.
The final judgment also permanently bars Richman from serving as an officer or director of any public company and imposes a civil penalty in the amount of $150,000.
Biopure and three others previously settled SEC charges concerning the same conduct (MDD, Feb. 23, 2007).
Candela (Wayland, Massachusetts) reported that the U.S. District Court for the Eastern District of Texas, Lufkin Division issued a Markman ruling on Aug. 6 in Candela's patent lawsuit against Palomar Medical Technologies (PMTI; Cambridge, Massachusetts).
In a Markman ruling, a district court hearing a patent infringement case interprets and rules on the scope and meaning of disputed patent claim language regarding the patents in suit. A Markman decision is often a significant factor in the progress and outcome of patent infringement litigation.
In the recently issued Markman Order, the court adopted interpretations that Candela believes are favorable to it on all claim terms that were in dispute in the litigation.
On Dec. 19, 2006, Candela filed a patent infringement complaint against PMTI in the U.S. District Court for the Eastern District of Texas, Lufkin Division, asserting that Palomar's Lux 1540, Lux DeepIR, Lux IR, Lux G, and Lux Y handpieces willfully infringe upon one or more of U.S. patents: 5,810,801, 6,659,999 and 6,120,497.
Candela distributes clinical solutions that enable physicians, surgeons, and personal care practitioners to treat selected cosmetic and medical conditions using lasers, aesthetic laser systems, and other advanced technologies.