William G. Bassler

This case was a patent infringement action under the Hatch-Waxman Act in which Daiichi Pharmaceutical sued Apotex for allegedly infringing U.S. Patent No. 5,401,741 on a topical ofloxacin solution for treating ear infections (otopathy) via Apotex's ANDA for a generic version of FLOXIN Otic. Apotex raised defenses including invalidity by anticipation or obviousness, unenforceability due to inequitable conduct, and noninfringement. Following a bench trial, the court found that the '741 patent was valid and enforceable, as Apotex failed to prove anticipation, obviousness, or deceptive intent by clear and convincing evidence, and held that Apotex's ANDA infringed the patent.

business & regulatoryhealthcare

The case concerned a petition by the NLRB Regional Director under Section 10(j) of the National Labor Relations Act seeking temporary injunctive relief against Evergreen America Corporation for alleged unfair labor practices during a union organizing drive by Local 1964. The Board claimed Evergreen interrogated employees about union sympathies, threatened reprisals such as plant closure or job loss, and granted wage increases, promotions, and other benefits to erode union support, causing the union to lose a July 2002 election despite having obtained majority authorization cards beforehand. An Administrative Law Judge found the union had attained majority status by June 2002 and that Evergreen committed multiple violations of Sections 8(a)(1) and (3) of the Act. The court exercised jurisdiction to consider temporary relief, including cease-and-desist and bargaining orders, while the Board’s administrative proceedings remained pending, based on the need to prevent irreparable harm to employee rights.

labor & employment

This case was a class action brought by a participant in an employer-sponsored health plan against PCS Health Systems, a pharmaceutical benefits management company, alleging that PCS breached fiduciary duties under ERISA by switching his prescribed drug to one that generated higher rebates and fees for PCS from drug manufacturers. The court granted summary judgment to PCS. The core reasoning was that PCS provided contracted services like claims processing, formulary management, and drug utilization review to the HMO Oxford but lacked discretionary authority or control over plan assets or administration sufficient to qualify as an ERISA fiduciary, with Oxford retaining decision-making power.

healthcarelabor & employmentbusiness & regulatory

This case involves a dispute over reinsurance coverage for Pfizer's liabilities arising from defective Shiley mechanical heart valves implanted in patients, which occasionally fractured and caused injury or death. The plaintiff, as liquidator of insurer Integrity, sued reinsurer General Accident for failing to pay amounts due under the reinsurance agreement, with the core issue being whether coverage under the policies was triggered by injury at the time of valve implantation or only upon actual fracture. The court addressed post-trial motions to exclude expert testimony from both sides regarding the timing and nature of bodily injury. It denied the defendant's motion to exclude Dr. Gilchrist's testimony, denied in part and granted in part the motion regarding Mr. Bado's testimony, and denied the plaintiff's motion to exclude Dr. Haft's testimony, primarily on grounds of relevance, reliability, and compliance with evidentiary rules for expert opinions. The court also determined that a Minnesota Supreme Court decision on similar insurance coverage did not compel a finding that injury occurred at implantation.

business & regulatorytorts & liabilityprocedure

This case involved an appeal by Ricardo and JoAnn DeRosa from a bankruptcy court order expunging their proofs of claim against Chiro Plus, Inc. and related consolidated debtors in a Chapter 7 proceeding. The debtors had hired the DeRosas under a verbal agreement to process and collect bills for medical services, with payment due only upon collection, but the trustee objected on grounds that the bills were deemed fraudulent by insurers, the claims' calculations were unclear, and supporting details were missing. The district court affirmed the bankruptcy court's decision, holding that while the DeRosas' initial filings created a presumptively valid claim, the trustee's evidence negated that presumption and the claimants failed to prove their claims' validity by a preponderance of the evidence. The court also rejected the argument that the prevention doctrine excused the collection condition, finding no evidence that the debtors' actions caused the nonpayment since the bills were independently fraudulent and uncollectible. The appeal was resolved under standards of review applying clear error to facts and de novo to legal conclusions.

procedurebusiness & regulatory

The case concerns Daiichi's lawsuit against Apotex for alleged willful infringement of U.S. Patent No. 5,401,741 under the Hatch-Waxman Act, after Apotex filed an ANDA seeking approval for a generic ofloxacin otic solution. The patent claims a method of topically administering ofloxacin in a carrier to treat otopathy, including otitis media and otitis externa, with the goal of avoiding ototoxicity and bacterial resistance risks associated with other antibiotics. The opinion addresses claim construction, reviewing the seven patent claims, the specification's description of ear anatomy and infection risks, FDA approval of Daiichi's FLOXIN Otic product, and the applicable legal standards for interpreting terms from the perspective of a person of ordinary skill in the art. Core reasoning centers on using the patent's intrinsic evidence, such as the claims and specification, to define the scope of the invention without extending to unmentioned side effects or additional drugs.

business & regulatoryproperty

In this bankruptcy adversary proceeding, G-I Holdings and its subsidiaries sought a declaratory judgment that the subsidiaries could not be held liable for asbestos-related claims against G-I under theories of successor liability or alter ego/piercing the corporate veil, while the Official Committee of Asbestos Claimants and individual defendants counterclaimed seeking declarations that would allow such liability. The plaintiffs moved to strike the defendants' jury demand. The court denied the motion, holding that the defendants were entitled to a jury trial under the Seventh Amendment on both counts. It reasoned that both successor liability and piercing the corporate veil claims are legal in nature, analogous to 18th-century common-law actions tried in courts of law rather than equity, and seek legal remedies involving factual determinations typically resolved by juries.

business & regulatoryproceduretorts & liability

In this bankruptcy case, debtor G-I Holdings and its subsidiaries sought a declaratory judgment that the subsidiaries were neither successors to G-I's asbestos liabilities nor alter egos of G-I. The Legal Representative for present and future asbestos claimants moved for judgment on the pleadings, arguing that the action could not bind future claimants and misused the representative's statutory role. The court granted the motion, holding that the declaratory judgment action was not statutorily authorized under 28 U.S.C. § 2201 or Bankruptcy Code § 524(g), would violate due process rights of unknown future claimants, and improperly sought to resolve successor liability issues outside the channeling injunction framework. The ruling emphasized that plaintiffs had not pursued class certification for future claimants and that judicial efficiency could not override these procedural protections.

business & regulatoryproceduretorts & liability

The case involved a challenge by Black Car Assistance Corp., a trade association of New York livery companies whose drivers transport passengers into New Jersey, against a New Jersey statute (N.J.S.A. § 39:3-19.6) that required out-of-state for-hire vehicles to pay a fee and display a permit or face fines and impoundment. The plaintiff sought to enjoin enforcement of the law, arguing federal preemption. The court granted the plaintiff's motion for summary judgment and permanently enjoined the state from enforcing the law against the association's members. The core reasoning was that the federal RIDE Act (49 U.S.C. § 14501(d)) expressly preempts state registration requirements for vehicles providing prearranged ground transportation that satisfy the Act's conditions, which the plaintiff's members met without dispute from the state.

business & regulatoryfederal power

In this case, 15 current and former inmates at East Jersey State Prison sued Correctional Medical Services, its employees, and New Jersey Department of Corrections officials, alleging deliberate indifference to their serious medical needs in violation of the Eighth Amendment, along with related state-law medical malpractice claims. The plaintiffs sought damages and injunctive relief based on alleged systemic failures in medication delivery, treatment access, and record-keeping after CMS took over prison medical services. On defendants' motions for summary judgment, the court granted the motions in full as to nine plaintiffs (Drinkard, Griggs, Hanna, Howard, Izquierdo, Kahliq, Lewis, Musto, and Saalahudin), dismissing their federal claims and pendent state claims without prejudice. As to the remaining six plaintiffs (Cancio, Castellano, Jackson, Muhammad, Perkins, and Ratti), the court granted the motions in part and denied them in part after examining each inmate's individual medical history, expert reports, and evidence of treatment delays or inadequacies. The decisions rested on whether the record showed genuine disputes of material fact regarding deliberate indifference under the applicable legal standards.

criminal lawcivil rightshealthcareprocedure

This case involved a Holocaust survivor suing German pharmaceutical companies Schering AG and Bayer AG for their alleged role in Nazi medical experiments on prisoners at Auschwitz, including forced sterilization injections, seeking damages and disclosure of the substances used. The plaintiff filed suit in 2003 under claims of violations of international law. The court dismissed the complaint, finding the claims nonjusticiable. It reasoned that an international agreement between the US and German governments had established the German Foundation 'Remembrance, Responsibility and the Future' to provide compensation and legal peace for such Nazi-era claims, and that the US executive branch had filed a Statement of Interest urging dismissal to honor that framework, placing the matter outside the scope of US judicial resolution.

civil rightsfederal powertorts & liability

In Sasson v. Sasson, an Israeli father filed a petition under the Hague Convention on the Civil Aspects of International Child Abduction and ICARA seeking the return of his daughter to Israel after the mother retained her in New Jersey. The district court held an evidentiary hearing and determined that the child's habitual residence had become the United States based on the family's October 2002 move, the parents' sale of Israeli property and assets, the establishment of a U.S. business and residence, and other actions indicating a settled purpose to remain. The court therefore denied the petition for return, concluding that any retention was not wrongful under the Convention. The decision leaves custody questions for resolution in U.S. courts.

family law

This case involves the U.S. government's enforcement action under the Federal Food, Drug, and Cosmetic Act against Lane Labs-USA and Andrew J. Lane for distributing products including Be-neFin, SkinAnswer, and MGN-3. Following a July 12, 2004 order requiring the defendants to sequester inventory and comply with various FDA-related obligations, the defendants moved to modify or stay portions of that order. The court denied the motion as to most challenged paragraphs, reserving only on the bond requirement under Federal Rule of Civil Procedure 62(d) pending further submissions. It granted partial modification to paragraph 11, allowing the defendants an opportunity to propose a reconditioning plan for the sequestered articles subject to FDA approval and written authorization, with unapproved items to be destroyed and all activities remaining under FDA supervision and cost reimbursement rules. The July 12 order otherwise remained in effect.

business & regulatoryhealthcare

The case involved the United States seeking to enjoin Lane Labs-USA, Inc. and Andrew Lane from distributing certain products marketed as treatments for diseases. The court granted summary judgment to the plaintiff, finding that BeneFin, MGN-3, and SkinAnswer were unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act. The court permanently enjoined the defendants from selling these or similar unapproved drugs without FDA approval and ordered them to pay restitution to purchasers and disgorge profits. The decision was based on the lack of approved new drug applications and inadequate labeling for the products' intended uses.

business & regulatoryhealthcare

The case involved the U.S. government, acting for the FDA, suing Lane Labs-USA, Inc. and its president Andrew Lane for violating the Federal Food, Drug, and Cosmetic Act by marketing three products—BeneFin (shark cartilage), MGN-3 (rice bran with Shiitake enzymes), and SkinAnswer (glycoalkaloid extract)—as treatments for cancer, skin cancer, and HIV/AIDS. The defendants argued the items were lawful dietary supplements under the Dietary Supplement Health and Education Act of 1994 and made no disease-treatment claims. The court granted the government's motion for summary judgment, issuing a permanent injunction barring future marketing of the products or similar items as drugs without FDA approval and requiring restitution and disgorgement of profits. The core reasoning was that extensive promotional materials by the company and its consultants made explicit disease-treatment representations, rendering the products unapproved new drugs and misbranded under the FDCA, and that the statute authorizes equitable remedies including injunctions and monetary relief to address such violations.

business & regulatoryhealthcare

The case involved the Medical Society of New Jersey seeking to prevent state officials from enforcing the New Jersey Health Care Consumer Information Act, which requires public disclosure of medical malpractice settlement data via the internet and a toll-free line, and from releasing related information to a newspaper under a state court order. The plaintiff argued that such disclosures would breach confidentiality provisions in existing settlement agreements and violate federal reporting laws like the Health Care Quality Improvement Act. The court denied the request for a preliminary injunction, rejected the motion to dismiss for lack of jurisdiction, and granted dismissal under Rule 12(b)(6) for failure to state a claim. The decision rested on the conclusion that the plaintiff's federal claims did not warrant injunctive relief or survive the motion to dismiss.

healthcarebusiness & regulatory

This case, part of a multi-district litigation docket involving Holocaust-era claims, concerns plaintiffs Martin G. Wortham and Barbara Principe suing German companies Karstadtquelle AG and Warenhaus Wertheim GmbH for alleged fraud and tortious conduct in 1951 related to the restitution of family business holdings seized under Nazi policies. The defendants moved to dismiss on multiple grounds, including lack of personal jurisdiction. The court granted the motion to dismiss solely on personal jurisdiction grounds after analyzing the defendants' lack of sufficient minimum contacts with the forum and the unreasonableness of exercising jurisdiction, without addressing defenses such as the political question doctrine, international comity, or the act of state doctrine. The court also denied the plaintiffs' request for a suggestion of remand to the transferor district.

civil rightsproceduretorts & liability

The case involved Simona Pipko filing suit against the CIA under the Freedom of Information Act and Privacy Act after the agency denied her request for any records it maintained about her, citing exemptions for classified information and intelligence sources and methods. The CIA had acknowledged the request, conducted a search, and upheld the denial on appeal. The district court granted the CIA's motion for summary judgment, holding that the agency's affidavits adequately described the withheld information and demonstrated a logical connection to the claimed exemptions without evidence of bad faith or inadequate search procedures.

federal powerprocedure

The case concerned a challenge by the New Jersey Environmental Federation, an environmental advocacy group that raises funds through door-to-door canvassing, to a Wayne Township ordinance requiring permits for non-profit solicitors seeking donations, limiting the duration of such activities, and exempting political campaigners from the permit requirement. The plaintiff moved for partial summary judgment on constitutional grounds and to amend its complaint to include additional damages. The court granted both motions. It reasoned that the ordinance's differential treatment of canvassers based on the content of their speech or purpose rendered it subject to heightened scrutiny, which it failed to satisfy as either a content-based restriction or a reasonable time, place, and manner regulation.

free speech

This case involved a personal injury action in which a jury awarded plaintiff Michael Mandile $550,000 and the Estate of Maria Mandile $100,000. The court addressed post-trial issues concerning reduction of the judgment under New Jersey's collateral source rule for social security disability benefits and the award of prejudgment interest on the verdicts. The court reduced the judgment by $30,556.40 for known 2002 benefits received by the plaintiff and granted a credit for prior contributions, but declined further offsets because future benefits were not shown to be certain and enforceable at the time of judgment. It awarded no prejudgment interest on Michael Mandile's verdict and awarded it on the estate's verdict while suspending accrual during the period of an administrative stay triggered by the defendant's bankruptcy filing, treating that interval as an exceptional circumstance under applicable precedent.

torts & liabilityprocedure