Justia Drugs & Biotech Opinion Summaries

In 2001, BioEnterics obtained FDA approval for the Lap-Band, “designed to induce weight loss in severely obese patients by limiting food consumption" by creation of a small gastric pouch. The FDA indicated that the Lap-Band’s labeling must “specify the requirements that apply to the training of practitioners who may use the device” and required annual progress reports on a postapproval study. BioEnterics's brochure states that surgeons planning laparoscopic placement must have specific experience, participate in a training program authorized by BioEnterics, be observed by “qualified personnel” during their first placements, have the equipment and experience necessary to complete the procedure via laparotomy if required, and report on their personal experiences using the device. In 2003, plaintiff underwent a surgical procedure to implant a Lap-Band, which eventually eroded into her stomach and her liver; Lap-Band tubing became entangled with her small intestine. During surgery to remove the Lap-Band she suffered a massive hemorrhaging from her liver, causing her to experience profound hypotension and systemic shock, resulting in brain damage. More than nine years later, plaintiff filed suit. The court of appeal affirmed dismissal of her claim that the company failed to adequately train physicians in the use of the Lap-Band, as preempted by federal law. View "Glennen v. Allergan, Inc." on Justia Law

Plaintiffs filed suit against Pfizer and others, alleging violations of federal securities laws because Pfizer made fraudulent misrepresentations and fraudulently omitted to disclose information regarding the safety of two of its drugs, Celebrex (celecoxib) and Bextra (valdecoxib). On appeal, plaintiffs argued that the district court abused its discretion in excluding the testimony of plaintiffs' expert regarding loss causation and damages. The court concluded that the district court abused its discretion by excluding the expert's testimony in its entirety; the district court erred in concluding that the expert needed to disaggregate the effects of Pfizer’s allegedly fraudulent conduct from Searle’s or Pharmacia’s, regardless of whether Pfizer is ultimately found liable for the latters’ statements; the testimony could have been helpful to the jury even without such disaggregation; as to the expert's adjustment to the price increases, the district court did not abuse its discretion in concluding that this change was not sufficiently reliable to be presented to a jury; the expert's error did not render the remainder of his testimony unreliable and the district court should have prevented him from testifying about the adjustment, but otherwise allowed him to present his findings on loss causation and damages; the district court erred in concluding, as a matter of law, that Pfizer had insufficient authority over certain Searle and Pharmacia statements as to have “made” them; but, however, the court's finding that the district court abused its discretion in excluding the expert's testimony does not turn on the question of Pfizer’s ultimate liability for these statements. Accordingly, the court vacated the district court's grant of summary judgment for Pfizer and remanded. View "In re Pfizer Inc. Securities Litigation" on Justia Law

GTG’s 179 patent claims methods of analyzing sequences of genomic deoxyribonucleic acid (DNA) for decoding genetic variations. The Federal Circuit affirmed dismissal of GTG’s infringement suit, finding certain claims ineligible for patenting under 35 U.S.C. 101. The court stated that GTG’s attempts to distinguish its position on the ground that the method of the claim is useful “have no basis in case law or in logic.” The claim ineligible for claiming unpatentable subject matter, not for lack of utility; even valuable contributions can fall short of statutory patentable subject matter. View "Genetic Techs. Ltd. v. Merial L.L.C." on Justia Law

Eilise was born in 1996 and had problems with gross motor skills and language development. After therapy, Eilise showed dramatic improvement. In 2001, Eilise received three vaccinations, including her second dose of the measles, mumps, and rubella vaccine. Five days later, Eilise’s brother witnessed her arching her back, thrusting her head back, rolling her eyes, and jerking. He did not know what was happening. Her parents, who did not witness the seizure, noted that Eilise was feverish and lethargic. Eilise had a grand mal seizure at school. She was taken to a hospital. She had another seizure there. Eilise’s MRI results were generally normal, but her EEG results were “consistent with a clinical diagnosis of epilepsy.” She continued to suffer seizures until she started a ketogenic diet. Her parents filed suit under the National Childhood Vaccine Injury Compensation Program, 42 U.S.C. 300aa, alleging that Eilise suffered from autism as a result of her vaccinations; they later amended to allege, instead, that Eilise suffered from a “seizure disorder and encephalopathy.” The Claims Court affirmed denial of her petition. The Federal Circuit vacated: in certain cases, a petitioner can prove a logical sequence of cause and effect between a vaccination and the injury with a physician’s opinion where the petitioner has proved that the vaccination can cause the injury and that the vaccination and injury have a close temporal proximity. View "Moriarty v. Sec'y of Health & Human Servs." on Justia Law

BBC, owner of the FLANAX trademark in Mexico, and its sister company, Bayer, filed suit against Belmora, owner of the FLANAX trademark in the United States, contending that Belmora used the FLANAX mark to deliberately deceive Mexican-American consumers into thinking they were purchasing BCC’s product. The court concluded that the Lanham Act’s, 15 U.S.C. 1125, plain language contains no unstated requirement that a section 43(a) plaintiff have used a U.S. trademark in U.S. commerce to bring a Lanham Act unfair competition claim; the Supreme Court’s guidance in Lexmark International, Inc. v. Static Control Components, Inc. does not allude to one, and the court's prior cases either only assumed or articulated as dicta that such a requirement existed; and therefore, the district court erred in imposing such a condition precedent upon Bayer’s claims. The court also concluded that BCC has adequately pled a section 43(a) false association claim for purposes of the zone of interests prong; BCC's allegations reflect the claim furthers the section 45 purpose of preventing the deceptive and misleading use of marks in commerce within the control of Congress; and BCC has also alleged injuries that are proximately caused by Belmora’s violations of the false association statute. Therefore, the court held that BCC has sufficiently pled a section 43(a) false association claim to survive Belmora’s Rule 12(b)(6) motion. Because these statements are linked to Belmora’s alleged deceptive use of the FLANAX mark, the court is satisfied that BCC’s false advertising claim, like its false association claim, comes within the Act’s zone of interests. The court inferred that the alleged advertisements contributed to the lost border sales pled by BCC, and that the claim also satisfies Lexmark’s proximate cause prong. Further, the court agreed with Bayer that the district court erred in overturning the TTAB’s section 14(3) decision because it read a use requirement into the section that is simply not there. Accordingly, the court vacated and remanded. View "Belmora LLC v. Bayer Consumer Care AG" on Justia Law

In consolidated cases, patent-holder plaintiffs market drugs and have patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication (Orange Book), 21 U.S.C. 355(b)(1). Mylan filed Abbreviated New Drug Applications (ANDA), 21 U.S.C. 355(j), seeking FDA approval to market generic versions of the drugs, certifying that the Orange Book patents are invalid or would not be infringed by the proposed drugs. The plaintiffs sued in Delaware under 35 U.S.C. 271(e)(2)(A). Mylan is incorporated in, and has its principal place of business in, West Virginia and submitted its ANDAs in Maryland; it intends to direct sales into Delaware, among other places, once it has FDA approval. Mylan sent notices to the plaintiffs in New York, Ireland, Delaware and Sweden. One plaintiff is incorporated in Delaware, the U.S. subsidiary of another has its principal place of business in Delaware. Both have sued others for infringement in Delaware. Each district court concluded that Delaware had sufficient contacts related to the subject of these cases to exercise specific personal jurisdiction over Mylan. The judges disagreed about whether Delaware could exercise general personal jurisdiction (independent of suit-related contacts) on the ground that Mylan consented to jurisdiction in registering to do business. Each declined to dismiss. The Federal Circuit affirmed on the issue of specific jurisdiction, declining to address general personal jurisdiction. View "Acorda Therapeutics, Inc. v. Mylan Pharma., Inc." on Justia Law

The People filed a complaint charging defendants with causing, aiding, and abetting the illegal delivery of marijuana. The trial court granted an injunction barring defendants from further developing or marketing their marijuana delivery app. At issue on appeal is whether Proposition D, L.A. Mun. Code, 45.19.6, which City voters enacted in 2013 to regulate medical marijuana businesses, generally prohibits the delivery of marijuana by vehicles. The court concluded that the City established a likelihood of proving defendants’ app caused, aided, or abetted the violation of Proposition D because, outside of the narrow exception for designated primary caregivers, it prohibits the vehicular delivery of medical marijuana to qualified participants, identification card holders, or primary caregivers in the City. Further, defendants’ opposition to the City’s unfair competition allegations necessarily fails because the City has demonstrated a likelihood of success on its claim that defendants facilitated a violation of Proposition D. In this case, defendants made no showing at all concerning the balance of hardships, much less that the balance tipped sharply in their favor. Accordingly, the court affirmed the trial court's judgment. View "People v. Nestdrop, LLC" on Justia Law

Plaintiffs filed suit under federal securities laws and state blue sky laws, alleging that Sanofi made materially false or misleading statements regarding its breakthrough drug, Lemtrada, designed to treat multiple sclerosis. The district court granted defendants' motion to dismiss for failure to state a claim. The court agreed with the district court's reasoning and holding. The court writes principally to examine the impact of the Supreme Court’s decision in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, decided after the district court rendered its decision. Given the sophistication of the investors here, the FDA’s public preference for double‐blind studies, and the absence of a conflict between defendants’ statements and the FDA’s comments, the court concluded that no reasonable investor would have been misled by defendants’ optimistic statements regarding the approval and launch of Lemtrada. Issuers must be forthright with their investors, but securities law does not impose on them an obligation to disclose every piece of information in their possession. As Omnicare instructs, issuers need not disclose a piece of information merely because it cuts against their projections. Accordingly, the court affirmed the judgment. View "In re Sanofi Sec. Litig." on Justia Law

The underlying coverage dispute arose from the supplying of a defective ingredient for incorporation into Wisconsin Pharmacal Company (Pharmacal) probiotic supplement tablets. Pharmacal brought this action against Jeneil Biotech, Inc. and Nebraska Cultures of California, Inc. (the Insureds) and the Netherlands Insurance Company and Evanston Insurance Company (the Insurers), alleging numerous tort and contract claims. The Insurers moved for summary judgment, arguing that their respective insurance policies did not cover any damages that arose out of the causes of action against the Insureds. The circuit court granted the Insurers’ motions for summary judgment, determining that the facts of this case did not trigger the Insurers’ duties to defend. The court of appeals reversed, concluding that the policies provided coverage. The Supreme Court reversed, holding that there was no “property damage” caused by an “occurrence” in this case, and even if there were, certain exclusions in both policies applied to negate coverage. View "Wis. Pharmacal Co., LLC v. Neb. Cultures of Cal., Inc." on Justia Law

Warner Chilcott, a brand-name drug manufacturer that owns the patent covering Loestrin 24 Fe, and Watson Pharmaceuticals, Inc., which sought to introduce a generic version of Loestrin 24, entered into a settlement agreement wherein Watson agreed to delay entry of its generic version of Loestrin 24 in exchange for favorable side deals. Thereafter, Lupin Pharmaceuticals, Inc. announced that it would introduce a generic version of Loestrin 24. Warner and Lupin settled on terms similar to those between Warner and Watson. Two putative classes of plaintiffs brought antitrust claims that the settlement agreements were violations of the Sherman Act and constituted illegal restrains on trade under FTC v. Actavis. At issue in this case was whether such settlement agreements are subject to federal antitrust scrutiny where they do not involve reverse payments in pure cash form. The district court dismissed, concluding that Actavis applies only to monetary reverse payments and that Plaintiffs had alleged the existence of non-cash reverse payments only. The First Circuit vacated and remanded, holding that the district court erred in determining that non-monetary reverse payments do not fall under the scope of Actavis. Remanded. View "In re Loestrin 24 FE Antitrust Litig." on Justia Law