Showing posts with label Court. Show all posts
Showing posts with label Court. Show all posts

Saturday, 16 November 2013

Legal News Podcast - New Hampshire Federal Court Dismisses Challenge to Obamacare - Standing Not A Fiction

A New Hampshire federal judge dismisses a challenge to the Health Care Act by a Medicare recipient, and, a $111 million interest award is issued in a Texas federal patent case. Hear these and other stories from LexisNexis® Mealey's Publications. Copyright© 2011 LexisNexis, a division of Reed Elsevier Inc. For the latest litigation news headlines, visit www.lexisnexis.com/mealeys or www.lexisnexis.com/community.

A New Hampshire judge overseeing what he said was possibly the first case brought by a Medicare recipient to challenge the Patient Protection and Affordable Care Act (PPACA), dismissed the lawsuit on March 30, saying the plaintiff lacked standing to bring the suit (Harold Peterson v. Barack Obama, et al., No. 10-170, D. N.H.). Harold Peterson sued President Barack Obama, the United States of America, the U.S. Congress, the U.S. Senate and the U.S. House of Representatives in the U.S. District Court for the District of New Hampshire, seeking declaratory judgment and injunctive relief. Peterson, a Medicare recipient, contended that the PPACA violated the Fifth, 10th and 14th Amendments and Article 1, Section 8, and Article 6 of the U.S. Constitution because the Constitution did not empower Congress to take over the health care business.

Although the PPACA and particularly the mandate raised interesting constitutional issues, Peterson did not have standing to litigate them, Judge Joseph N. Laplante said. Medicare coverage automatically satisfies the PPACA's individual mandate requirement, so Peterson wouldnot incur any financial burdens and wouldnot need to do anything to satisfy the mandate, Judge Laplante said.

The court rejected Peterson's unique arguement that standing was a 'Fiction'. "The Constitution limits the jurisdiction of federal courts to 'Cases' and 'Controversies.' Lujan v. Defenders of Wildlife, 504 U.S. 555, 559, 112 S. Ct. 2130, 119 L. Ed. 2d 351 (1992) (quoting U.S. Const. art. III, § 2, cl. 1). To satisfy the Constitution's 'case or controversy' requirement, a party seeking relief in federal court must show that he has suffered an actual injury, which is fairly traceable to the defendant's conduct and redressable by a favorable judicial decision. Coggeshall v. Mass. Bd. of Registration of Psychologists, 604 F.3d 658, 666 (1st Cir. 2010), citing Lujan, 504 U.S. at 560-61). That is commonly known as the doctrine of 'standing.' Peterson argues that 'standing is a fiction created by the courts' and that he need not satisfy any such requirement. But the Supreme Court has called the standing requirement 'essential and unchanging,' Lujan, 504 U.S. at 560, and this court must follow Supreme Court precedent."

Health Care and Medicine

Lexis.com subscribers can access the enhanced version of Peterson v. United States, 2011 U.S. Dist. LEXIS 34775 (D.N.H. 2011) decision with summary, headnotes, and Shepard's.

Lexis.com subscribers can access additional Heath Care Reform Resources, including our special Health Care Reform Special Alert. The two-volume Health Care Reform Special Alert publication may also be purchased at the Store.

Subscribers may access all of the Lexis.com Health Care Research Materials in one convenient location.

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LexisNexis® Legal News Podcast - Health Care Reform Takes a Hit - Court Rules Individual Mandate Violates Commerce Clause

A Pennsylvania federal judge finds the individual mandate in the Patient Protection and Affordable Care Act violates the Constitution, Goudy-Bachman v. United States HHS, 2011 U.S. Dist. LEXIS 102897 (M.D. Pa. Sept. 13, 2011), and, a California federal judge certifies a wage-and-hour class suing a refinery. Hear these and other stories from LexisNexis® Mealey'sTM Publications. Copyright© 2011 LexisNexis, a division of Reed Elsevier Inc. For the latest litigation news headlines, visit www.lexisnexis.com/mealeys or www.lexisnexis.com/community.

Lexis.com subscribers may also access the earlier decision of the court, and also the original complaint and initial motion to dismiss, in which the plaintiffs were found to have standing to challenge the PPACA in Goudy-Bachman v. United States HHS, 764 F. Supp. 2d 684 (M.D. Pa. 2011).

For more information about LexisNexis products and solutions, connect with us through our corporate site.


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Friday, 15 November 2013

LexisNexis® Legal News Podcast - Victory For Health Care Reform Is Appealed by Jerry Falwell's Liberty University To Supreme Court

Liberty University petitions the Supreme Court over dismissal of a health care reform case, and defendants in a Propofol infection case in Nevada are ordered to pay $162.5 million in punitive damages. Hear these and other stories from LexisNexis® Mealey's Publications. Copyright © 2011 LexisNexis, a division of Reed Elsevier Inc. For the latest litigation news headlines, visit www.lexisnexis.com/mealeys or www.lexisnexis.com/communities.

A Christian school on Oct. 10 filed a petition for certiorari with the U.S. Supreme Court, seeking review of a divided lower court decision that held that the Anti-Injunction Act (AIA) stripped the court of jurisdiction to hear a challenge to the Patient Protection and Affordable Care Act (PPACA) (Liberty University, et al. v. Timothy Geithner, et al., W.D. Va.).

On Nov. 30, the U.S. District Court for the Western District of Virginia, Liberty Univ., Inc. v. Geithner, 753 F. Supp. 2d 611 (W.D. Va. 2010), dismissed a challenge to the PPACA brought by Liberty University Inc., Martha A. Neal, Michele G. Wadell, Dr. David Stein, Pausanias Alexander, Mary T. Bendorf, Joanne V. Merrill, Kathy Byron and Jeff Helgeson against U.S. Treasury Secretary Timothy Geithner, Health and Human Services Secretary Kathleen Sebelius, Secretary of Labor Hilda L. Solis and U.S. Attorney General Eric Holder, finding that Congress acted within its constitutionally delegated powers under the commerce clause when it passed the employer and individual mandates contained in the PPACA.

In a divided opinion, Liberty Univ., Inc. v. Geithner, 2011 U.S. App. LEXIS 18618 (4th Cir. Va. Sept. 8, 2011), the majority of a Fourth Circuit U.S. Court of Appeals panel on Sept. 8 held that the AIA strips the court of jurisdiction to hear Liberty University's challenge to the PPACA and remanded the case with instructions to dismiss the case for lack of jurisdiction.  The dissenting judge said he would affirm the lower court's decision that Congress acted within its powers in passing the challenged provisions of the act.


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Cadwalader Clients & Friends Memo: Important Court Decision For No-Fault Insurers: Federal Court Rejects Limitation on State Farm v. Mallela

We are pleased to inform you that our firm has obtained a very favorable and significant decision for no-fault insurers on an important issue of first impression. Specifically, on January 7, 2013, in the case of Allstate Ins. Co. v. Elzanaty, the United States District Court for the Eastern District of New York (Honorable Arthur D. Spatt) rejected the defendants' attempt to limit the ability of insurers to seek affirmative recovery for fraud and the verification of compliance with licensing requirements from health care providers licensed pursuant to Article 28 of the New York Public Health Law ("Article 28 Facilities"). The decision is significant because it is the first time a court has extended the reach of State Farm v. Mallela to health care providers other than professional medical corporations.

As you may recall, in Mallela, the New York Court of Appeals ruled that, as of April 5, 2002, fraudulently-incorporated providers, or providers that were violating core licensing requirements, were not entitled to reimbursement under New York's no-fault system. Since that time, many providers have sought, in the context of litigating actions against insurers or defending againstaffirmative recovery actions brought by insurers, to limit the scope and effect of Mallela. In Elzanaty, Allstate's Complaint alleged claims of fraud and violations under the Racketeer Influenced and Corrupt Organizations ("RICO") Act, asserting that the defendants, certain Article 28 Facilities, were improperly licensed and formed as conduits for the defendants' fraudulent no-fault billing. In particular, the Complaint asserted that the defendants were not entitled to no-fault benefits because they had actively participated in fraudulent practices and were established and/or operated in violation of New York's Public Health Law and the rules and regulations promulgated thereunder.

The defendants sought to dismiss the Complaint on various grounds, essentially arguing that certain anti-fraud regulations and Mallela were not applicable to Article 28 Facilities because their formation and structure had already been approved by the State through the Article 28 establishment approval process and subsequent State overview of such facilities. Specifically, they argued that (i) the Court should abstain from exercising jurisdiction under the "Burford abstention" doctrine because a determination of the issue of whether the defendants were properly licensed would reverse the decision of the Department of Health to license those facilities, subvert the Department of Health's jurisdiction over licensing matters and undermine the comprehensive state regulatory process and (ii) the defendants were properly licensed through the Department of Health's establishment process and regulatory overview, and thus eligible to receive no-fault reimbursement.

Burford Abstention: The Court concluded that Burford abstention was not warranted because Allstate was not challenging the "Article 28 regulatory framework" or challenging the "State's authority with regard to licensing determinations." Rather, Allstate's challenge was to the defendants' fraudulent conduct and their ability to receive no-fault reimbursement. The Court explained that a determination with respect to the providers' fraudulent conduct would not disrupt the State's purpose in establishing a coherent public policy with respect to licensing and would not disrupt New York's regulatory scheme.

Licensure: The Court concluded that Allstate properly pleaded its fraud and RICO claims. The Court framed the issue as whether Allstate could "claim that a medical facility did not comply with N.Y. DOH's Article 28 licensing requirements under the auspices of fraud, when the N.Y. DOH has previously confirmed its compliance." The Court answered this question in the affirmative, relying largely on the Mallela decision. The Court explained that Mallela stands for the proposition that an insurer may bring an action for fraud or unjust enrichment, based on fraudulent incorporation, to recover no-fault payments made to fraudulently incorporated providers. Although the defendants in Mallela were licensed as medical corporations and not Article 28 Facilities, the Court found this difference to be "irrelevant." Relying on the operative regulation, 11 N.Y.C.R.R. § 65-3.16(a)(12), the Court concluded that any provider of health services -- a medical corporation, Article 28 Facilities, or otherwise -- was not eligible for reimbursement under the Insurance Law if it failed to meet any New York State or local licensing requirements. In emphasizing this point, the Court expounded that any attempt to limit Mallela only to fraudulent activity of medical corporations, as opposed to other types of health service providers, would "be in direct conflict with the New York Court of Appeals advice that insurers may 'look behind the face of licensing documents to identify willful and material failure to abide by state and local law.'"

*     *     *     *

This decision constitutes the first judicial ruling addressing the scope of available relief under Mallela against health service providers other than professional medical corporations. The decision is critical to no-fault insurers because entities that have attempted to shield their fraudulent activity through professional corporations will have no incentive to shift such fraudulent conduct to an Article 28 structure. This decision helps provide insurers with another tool to fight the proliferation of no-fault fraud.

If you have any questions concerning the decision, or require assistance in no-fault or other health care/insurance issues generally, please do not hesitate to contact an attorney from the Health Care and Not-for-Profit Group at Cadwalader.

William J. Natbony        +1 212 504 6351            bill.natbony@cwt.com

Jared L. Facher             +1 212 504 6494            jared.facher@cwt.com

For more information about LexisNexis products and solutions, connect with us through our corporate site.


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Tuesday, 25 June 2013

Supreme Court Nixes State Suits Against Generics

By David Pittman, Washington Correspondent, MedPage Today

WASHINGTON -- Makers of generic drugs cannot be sued under state law for side effects of their products, the Supreme Court ruled Monday, angering patients' rights advocates.

In a 5-4 decision, the justices overturned a multimillion dollar award to a woman who suffered damages from a generic medication, noting that federal law prohibits drugmakers from making changes in their warning labels without the approval of the FDA.

The case, Mutual Pharmaceutical v. Bartlett, involves a woman who, in 2004, was prescribed Clinoril, the brand name for the nonsteroidal anti-inflammatory drug sulindac. The pharmacist dispensed the generic version manufactured by Mutual. The woman developed an acute case of epidermal necrolysis and sued Mutual seeking damages for the severe disfigurement she developed. A jury awarded her $21 million, an award that was later upheld by a circuit court.

But the Supreme Court said the federal Food, Drug, and Cosmetic Act allows only the FDA to make labeling changes and supersedes state law -- including the one in New Hampshire where this case originated -- that tries to force drugmakers to make labeling or design changes when safety issues arise.

"Here, it is impossible for Mutual to comply with both its federal-law duty not to alter sulindac's label or composition and its state-law duty to either strengthen the warnings on sulindac's label or change sulindac's design," Justice Samuel Alito wrote for the majority.

The High Court said Monday the First Circuit Court of Appeals' ruling was flawed. The lower court said Mutual could have stopped selling sulindac if the drugmaker knew it was unsafe.

It was not until 2005 that the FDA ordered new labeling on all NSAIDs to include a warning for the condition.

The Generic Pharmaceutical Association, the Washington-based trade group of the generic-drug industry, hailed the decision, saying it reaffirms the FDA's authority to oversee the safety of drugs.

"When it comes to decisions on safety and approval of prescription medicine, the FDA is best equipped to make judgments that affect patients," Chief Executive Ralph Neas said in a statement. "The experts at FDA alone have the scientific knowledge, regulatory experience, and complete data to make these decisions."

Monday's decision frequently cited the 2011 case Pliva v. Mensing, which found that generic drugmakers were preempted in state failure-to-warn cases challenging the generics' safety because federal law prohibited changes to generic drug labels without changes to the branded drug's labeling.

"Generic-drug manufacturers' inability under current regulations to update the labeling of their products poses a threat to the safety of prescription drugs, creating unnecessary risks to patients," Michael Carome, MD, director of Public Citizen's Health Research Group, said in a statement.

The consumer advocacy group Public Citizen released a report Monday noting that many safety issues aren't recognized drugs until years after a drug receives FDA approval and are available in a generic form. According to the report, at least 53 drugs approved by the FDA more than 10 years ago have required new black box warnings in the past 5 years.

Public Citizen called on lawmakers and regulators to update post-marketing regulations to bring generics more in line with the safety requirements of their branded counterparts.

David Pittman

David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas, Chemical & Engineering News and most recently FDAnews.