Under the federal Food, Drug and Cosmetic Act, a drug is classified either as a branded drug (a drug whose composition is novel) or as a generic drug (a drug designed to be a copy of a branded drug). Manufacturers of the latter are currently immune from most products liability lawsuits. But this near-immunity may soon come to an end. The U.S. Food and Drug Administration proposed a rule to change federal law in a manner that purports to expose generic-drug manufacturers to personal injury liability. Indicative of the complexities of the proposal and importance of the issues, more than 100 comments were submitted in response. Yet questions remain as to whether the FDA’s proposal would do more harm than good and if an alternative to the FDA’s approach should be adopted.
The modern era of drug regulation began in 1984, when Congress passed the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch–Waxman Amendments to the FDCA. At that time, Congress had two goals: to provide incentives for the invention of new drugs and to lower the prices for patients to obtain existing drugs. In furtherance of these goals, Congress provided branded-drug manufacturers with greater patent protections to reward innovation and generic-drug manufacturers with a streamlined approval process to decrease the costs of market entry.
To obtain the FDA’s approval to market a branded drug, the drug’s sponsor must prove through the new drug application, or NDA, process that the drug’s active pharmaceutical ingredient is safe and effective for a particular indication. To do so, NDA sponsors must conduct extensive clinical trials and formulate warnings to apprise physicians of the side effects identified during those trials. The costs associated with the NDA process are staggering. Forbes has estimated that it costs approximately $5 billion to bring a branded drug to market. Read More
Recently, the Pennsylvania Supreme Court stayed the Montgomery County District Attorney from acting on a grand jury presentment accusing Attorney General Kathleen Kane of perjury and other offenses in connection with the disclosure of an investigation to a Philadelphia newspaper. The Pennsylvania Supreme Court ordered that the Montgomery County District Attorney could not file charges against Attorney General Kane, as set forth in the grand jury presentment, until the Supreme Court decides the legality of the appointment of the special prosecutor, Thomas Carluccio, by Court of Common Pleas Judge William Carpenter.
Not only does this matter address critical legal questions, the outcome will have a significant impact on the Commonwealth of Pennsylvania for months — if not years — to come. Absent a legislative grant of authority, is it constitutionally permissible for a judicial branch member to impanel a grand jury and authorize a special Prosecutor to investigate a high ranking official of the executive branch? If the Supreme Court rules for Attorney General Kane, will the legislative branch quickly enact a Special Prosecutor Law?
Judge Carpenter appointed Mr. Carluccio as Special Prosecutor to investigate allegations that Attorney General Kane’s office disclosed details about the secret investigation of J. Whyatt Mondesire, a former president of the Philadelphia chapter of the NAACP. Kane has acknowledged disclosing information to The Philadelphia Daily News last year about a 2009 investigation by her Republican predecessor into Mr. Mondesire’s financial activities, but Attorney General Kane has denied breaking any laws. Attorney General Kane has stated repeatedly that she had not been aware that the information might have included documents presented to a grand jury as part of the Mondesire investigation. The grand jury concluded that Attorney General Kane disclosed information to the news media in violation of grand jury secrecy laws.
The question before the Pennsylvania Supreme Court is whether a member of the judiciary has the legal authority to appoint a Special Prosecutor to convene and conduct a grand jury to investigate the Attorney General of the Commonwealth. Read More
The U.S. Supreme Court in Hana Financial, Inc. v. Hana Bank et al., resolved a circuit split with respect to the “tacking” doctrine in trademark law, holding that it is for the jury to decide whether a party is entitled to tack the use of previous marks to establish priority.
Trademark law provides that a party who first uses a mark in commerce has “priority” over other users of the same or confusingly similar marks. Tacking permits a trademark user to make modifications to their mark over time without losing priority if the modified mark creates the same, continued commercial impression so that consumers consider both marks as the same mark. This allows brand owners to update the mark over time without losing the priority date of the original mark. For example, in Hana Financial, the prior user established priority in their HANA BANK mark by tacking the use of two previously used marks, HANA OVERSEAS KOREAN CLUB and HANA WORLD CENTER.
The Court held that the issue of tacking should be a jury determination because the doctrine focuses on the impression a mark creates on the ordinary consumer. The Court reasoned that the “ordinary consumer” is similar to other factual determinations made by juries, such as the “reasonable man” or the “average person.”
As a result, the ability to have these matters addressed early in litigation is reduced, possibly leading to increased litigation costs. Read More
The U.S. Supreme Court continues to tackle labor and employment issues. Employers must be ready to react as the decisions roll out.
Young v. UPS, No. 12-1226
Issue: Whether the Pregnancy Discrimination Act, 42 U.S.C. § 2000e(k) (“PDA”), requires an employer to provide work accommodations to pregnant employees who are “similar in their ability or inability to work.” Young claims UPS violated the PDA by improperly denying her light-duty work requested due to a doctor-recommended lifting restriction during her pregnancy. Young was not given the same light-duty accommodation as non-pregnant employees with similar limitations. The 4th Circuit found that UPS’ refusal to accommodate pregnancy was not discrimination, since Young did not prove UPS’s policies were intended to discriminate against pregnant women or resulted in different treatment. Although the PDA requires pregnant workers to be treated the same as others who are “similar in their ability or inability to work,” UPS has argued that this does not require special treatment for pregnant workers.
Mach Mining v. EEOC, No. 13-1019
Issue: Whether and to what extent a court may enforce the Equal Employment Opportunity Commission’s (“EEOC”) mandatory duty to conciliate discrimination claims before filing suit. The EEOC sued Mach Mining under Title VII, asserting it engaged in systemic hiring discrimination against women, but Mach Mining sought dismissal, arguing that the EEOC did not first engage in statutorily-mandated good faith conciliation efforts before filing suit. The 7thCircuit held that the EEOC’s conciliation efforts were not subject to review by the courts, however, other federal courts have held the EEOC’s conciliation process is subject to court review, but the type and level of scrutiny varies between the circuits. The Supreme Court’s decision regarding statutory interpretation of Title VII’s requirements will affect whether failure to engage in the conciliation process is available as an affirmative defense to employers and the decision may define just how aggressive the EEOC will conduct itself during the conciliation process. Read More
The Supreme Court has shifted the balance of power in patent cases back to the district courts. On January 20, 2015, the United States Supreme Court held that a district court’s determination of subsidiary facts underpinning claim construction in patent cases is entitled to deference on review. The case, Teva Pharmaceuticals, USA, Inc. v. Sandoz, Inc., has the potential to significantly enhance a district court’s control over the claim construction process by limiting the scope of the Federal Circuit’s appellate review.
Prior to the Teva decision, the Federal Circuit had applied a de novo standard of review to all aspects of a district court’s claim construction, including its findings of fact with respect to evidentiary issues. This allowed the Federal Circuit to overrule the district court’s resolution of inherently factual issues such as credibility of witnesses and extrinsic evidence concerning the meaning of technical words and phrases even where there was no indication that the district court had committed error.
In light of the Supreme Court’s ruling in Teva, the Federal Circuit must now show deference to the district court’s determination of subsidiary facts unless the district court has committed “clear error.” The Supreme Court’s rationale for applying the clearly erroneous standard was an adherence to Federal Rule of Civil Procedure 52(a) in patent cases as well as the fact that a trial court is better equipped to evaluate factual issues given its familiarity with the evidence, witnesses, and parties. Accordingly, where a factual dispute exists, a district court will resolve the dispute and then interpret the patent claim in light of the facts as it has found them. Therefore, although the district court’s ultimate decision with respect to claim construction remains a question of law subject to de novo review, its findings of fact now must be upheld absent clear error. Read More
Marc S. Raspanti will speak at the American Conference Institute 2nd Annual False Claims and Qui Tam Enforcement seminar on “How Relator Counsel Validate and Investigate a Claim Before the Complaint is Filed.”
Related Information:
Additional Information Read More
PHILADELPHIA, PA – Marc S. Raspanti, a name partner in the law firm of Pietragallo Gordon Alfano Bosick & Raspanti, LLP, will present at the 2nd Advanced Forum on False Claims & Qui Tam Enforcement for the American Conference Institute on January 21st, 2015 in New York, New York.
Mr. Raspanti will speak on the panel “How Relator’s Counsel Validate and Investigate a Claim Before The Complaint is Filed?” The panel will discuss key aspects of federal and state False Claims Acts, the qui tam provisions, and the manner in which seasoned counsel evaluate qui tam cases before filing.
Mr. Raspanti has been recognized as one of the most successful, skilled, and experienced qui tam attorneys in the United States. Since 1989, Mr. Raspanti has litigated many of the most complex and important cases in the history of the federal False Claims Act. He has served as lead counsel for whistleblowers in false claims cases that have resulted in over $2 billion in recoveries for federal and state taxpayers. He focuses his practice on federal and state qui tam litigation, white collar criminal defense, criminal and civil health care fraud defense, internal corporate investigations, professional licensing litigation, and complex civil litigation.
In 2012, Mr. Raspanti was elected as a Fellow of the American College of Trial Lawyers, an organization devoted to recognizing outstanding civil and criminal trial lawyers in the United States and Canada. LexisNexis® Martindale-Hubbell® also recognizes Mr. Raspanti as an AV® Preeminent™ rated attorney, the highest such rating available to any individual lawyer in both legal ability and ethical standards.
Mr. Raspanti received his B.A. from Villanova University and his J.D. from Temple University School of Law. He frequently speaks, writes, lectures, and comments on white collar, qui tam, and health care fraud issues throughout the country. Read More
Articles in This Issue:
1. Designing the Defense: Cyber Risk for Construction Professionals and How to PRepare for the Inevitable Breaches
2. Safety First for Workers – Security First for Data
3. CGL Coverage for Construction Defects? – Yes or No Often Depends on a Border Crossing
4. Construction Professionals Beware: As the Commonwealth Crumbles, Statutory Caps on Damages Remain Strong
5. Can I Recover Damages from a Utility for Mismarking Underground Facilities?
6. Pennsylvania Public Utility Can Use Eminent Domain to Biild Gase Pipeline on Private Property
Related Information:
winter_2014_edition_of_the_construction_legal_edge.pdf Read More
PHILADELPHIA, PA – On behalf of their client Michael Epp, the law firms Morgan Verkamp LLC (Cincinnati) and Pietragallo Gordon Alfano Bosick & Raspanti, LLP (Philadelphia) note the settlement of claims initiated by Mr. Epp alleging fraud on the part of Supreme Foodservice, the “prime vendor” of food and related items to the Department of Defense and coalition troops in Afghanistan from 2005 until at least 2009.
Under agreements finalized today between Supreme Foodservice GmBH, Justice Department lawyers in Washington, D.C. and Philadelphia, and Mr. Epp, Supreme will pay the United States $101,000,000 in damages under the False Claims Act. Supreme Foodservice GmBH and related entities have entered guilty pleas to charges of major fraud, conspiracy to commit major fraud, and wire fraud. The criminal plea agreements require payment of $288,300,000 in fines and restitution, making the total recovery on the prime vendor contract $389,300.000. The allegations are detailed in a criminal Information filed this morning in U.S. District Court in Philadelphia.
“We believe this is the largest fraud recovery against any contractor relating to the Afghanistan and Iraq wars, the largest recovery in a military procurement case initiated by a qui tam whistleblower, and one of the largest fraud recoveries against any defense contractor,” said Frederick Morgan, one of Mr. Epp’s attorneys. “That the defendants pled guilty to major fraud is testament to the tenacity of the federal prosecutors and the strength of the evidence.”
Mr. Epp’s civil complaint, brought in March 2010 under the qui tam provisions of the United States Civil False Claims Act, alleges in part that Supreme Foodservice used a shell corporation to inflate the cost to the government of produce served to the troops; illegally increased the cost of bottled water by misrepresenting acquisition costs; and obtained kickbacks from vendors disguised as “prompt payment” discounts. Read More
