Justia Drugs & Biotech Opinion Summaries

After Congress directed the FDA to establish a twelve-member Tobacco Products Scientific Advisory Committee to, among other things, report on the safety of menthol cigarettes, plaintiffs filed suit claiming that the FDA appointed to the Committee three members with pecuniary interests hostile to their products, in violation of relevant conflict-of-interests statutes and regulations, and that these appointments injured plaintiffs. Plaintiffs claim that the FDA’s appointments of these Committee members caused them three injuries: (1) an increased risk that the FDA will regulate menthol tobacco products adversely to plaintiffs’ interests; (2) access by the challenged Committee members to plaintiffs’ confidential information, with a probability of their using the information to plaintiffs’ detriment; and (3) the shaping of the menthol report to support the challenged members’ consulting and expert witness businesses, with injuries flowing both from the report itself and from its use as support for their expert testimony and consulting. The court concluded that plaintiffs' alleged injuries are too remote and uncertain. Because the alleged injuries are insufficiently imminent to confer standing, the court vacated the district court's grant of summary judgment for lack of jurisdiction and dissolved the district court's injunction barring the use of the menthol report and ordering the reconstitution of the Committee. View "R.J. Reynolds Tobacco Co. v. FDA" on Justia Law

The FDA opened an investigation and sent warning letters to 1-800-GET-THIN and a few surgery centers in California, stating that the FDA believed 1-800-GET-THIN’s LapBand advertising violated the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq., by not providing relevant risk information regarding the LapBand procedure. The district court subsequently granted the government’s ex parte motion to compel production of attorney-client documents. The court agreed with the Sixth Circuit and concluded that, while in camera review is not necessary to establish a prima facie case that the client was engaged in or planning a criminal or fraudulent scheme when it sought the advice of counsel to further the scheme, a district court must examine the individual documents themselves to determine that the specific attorney-client communications for which production is sought are sufficiently related to and were made in furtherance of the intended, or present, continuing illegality. Accordingly, the court vacated the order compelling production of all subpoenaed documents so the district court may examine the documents in camera to determine which specific documents contain communications in furtherance of the crime fraud exception to the attorney client privilege. View "United States v. Omidi" on Justia Law

Ethicon’s patent is directed to a surgical device used to staple, secure, and seal tissue that has been incised. As is commonly done during endoscopic procedures, a surgeon will insert the device into the patient and will pull a trigger to latch onto a desired tissue. Once attached, the surgeon will then pull another trigger, which causes a blade to move, cutting the desired tissue. Simultaneously, rows of staples on either side of the cutting blade are actuated against a staple forming surface, both securing and sealing the newly-cut tissue. The Patent Trial and Appeals Board granted inter partes review found all challenged claims invalid as obvious over the prior art. The Federal Circuit rejected an argument that the Board’s final decision is invalid because the same Board panel made both the decision to institute and the final decision and upheld the determination that the claims would have been obvious over prior art. View "Ethicon Endo-Surgery, Inc. v. Covidien, LP" on Justia Law

In 2005, Urbanski filed the 614 application, entitled “Protein and Fiber Hydrolysates” and is directed to a method of enzymatic hydrolysis of soy fiber, such that the product has a reduced water holding capacity suitable for use as food additives. The Patent Trial and Appeal Board affirmed the Examiner’s rejection of certain claims as unpatentable under 35 U.S.C. 103(a). The Federal Circuit affirmed, upholding the determination that the claims would have been obvious over cited references relating to enzymatic hydrolysis of dietary fibers, which are readily combinable. View "In re: Urbanski" on Justia Law

The Patent Trial and Appeal Board granted SAMSF’s motion to cancel certain claims prior to its review of SAMSF’s patents relating to administering the “natural” stereoisomer of 5-methyl-tetrahydrofolic acid (L-5-MTHF) and other vitamins to treat symptoms associated with folate deficiency, which causes health issues, including cardiovascular disease, neurological disorders, birth defects, and skeletal disorders. The Federal Circuit affirmed the Board’s conclusion of obviousness under 35 U.S.C. 103. The court prior rejected SAMSF’s arguments art taught away from its claimed use of a reduced folate to treat folate deficiency, and that objective indicia of non-obviousness further demonstrated the validity of its patents. Although the Board erred in its assessment of the evidence of licensing, its other factual findings were supported by substantial evidence. View "S. Ala. Med. Sci. Found. v. Gnosis, S.P.A." on Justia Law

At the request of Gnosis, the Patent Trial and Appeal Board instituted inter partes review of claims of Merck’s patent, which relates to methods of using folates to lower levels of homocysteine in the human body. Homocysteine is an amino acid that, when present in excessive quantities, can cause severe cardiovascular, ocular, neurological, and skeletal disorders. Merck filed a response and a motion to cancel claims 1–3, 5, 6, and 13, which the Board granted. The Board only reviewed the patentability of dependent claims 8, 9, 11, 12, 14, 15, and 19–22 and found them invalid for obviousness, 35 U.S.C. 103, in light of prior art. The Federal Circuit affirmed, finding that the Board’s factual findings to the contrary were supported by substantial evidence and rejecting Merck’s arguments that the prior art taught away from the claimed method and that objective indicia of non-obviousness further support the patentability of the claims. View "Merck & Cie v. Gnosis, S.P.A." on Justia Law

In 2004, Yates, 17 years old, was sexually active and was suffering from severe menstrual cramps. Smith, a licensed physician assistant, counseled Yates about various contraceptives, and the risks and benefits accompanying each. Yates admits that she was counseled concerning the risk of a stroke and clotting associated with ORTHO EVRA®. She decided to try Depo-Provera, which requires injections at three-month intervals. In 2005 she discontinued Depo-Provera due to weight gain and switched to the ORTHO EVRA® patch. Smith again discussed side effects. Yates admitted that she would have used ORTHO EVRA® even if she had read package warnings. Yates suffered a stroke while she was wearing her first weekly patch. A board-certified neurologist and neurophysiologist opined that Yates’s “use of the Ortho-Evra patch was the contributing cause of her stroke.” Smith’s suit was transferred for consolidated pretrial proceedings in connection with In re: Ortho Evra Products Liability Litigation. The district court dismissed her claims. The Sixth Circuit affirmed. The ORTHO EVRA® warnings in effect when Yates was prescribed the patch adequately warned her prescribing medical provider of the risk of stroke; there was no duty to directly warn Yates. The court rejected design defect, manufacturing defect, and negligence claims. View "Yates v. Ortho-McNeil-Janssen Pharma., Inc." on Justia Law

Plaintiff, a physician and airplane pilot, filed suit contending that LabCorp and other drug testing companies, engaged to administer a random drug test in accordance with federal regulations governing aviation safety, mishandled the test. The court reserved decision and certified the following questions to the New York Court of Appeals: whether drug testing regulations and guidelines promulgated by the FAA and DOT create a duty of care for drug testing laboratories and program administrators under New York negligence law; and whether a plaintiff may establish the reliance element of a fraud claim under New York law by showing that a third party relied on a defendantʹs false statements resulting in injury to the plaintiff. View "Pasternack v. Laboratory Corporation" on Justia Law

Verinata and Ariosa compete in the field of noninvasive prenatal diagnostics, including testing for fetal chromosomal abnormalities. Verinata owns the 430 patent, which describes methods of noninvasive prenatal testing for the presence of fetal chromosomal abnormalities, particularly “aneuploidy,” i.e., the presence of an abnormal number of copies of a chromosome. Ariosa petitioned the Patent Trial and Appeal Board for inter partes review and challenged the claims for obviousness under 35 U.S.C. 103. The Board concluded that Ariosa had not met its burden of proving that claims 1–18 and 19–30 would have been obvious.The Federal Circuit vacated and remanded because the Board’s language suggests it did not sufficiently consider a 2008 patent that discloses a method of determining fetal aneuploidy by isolating fetal cells, not cell-free DNA. View "Ariosa Diagnostics v. Verinata Health, Inc." on Justia Law

Plaintiffs, three health-benefit plans (HBPs), filed suit under the Racketeer Influenced and Corrupt Organizations Act (RICO), 18 U.S.C. 1961 et seq., and state laws, claiming that Aventis engaged in a pattern of mail fraud by failing to disclose the true risks of the antibiotic drug telithromycin, marketed as “Ketek.” The district court denied plaintiffs' motion to certify a class of all HBPs that paid for Ketek prescriptions on the theory that such HBPs were injured as a result of paying for Ketek prescriptions that would not have been written if Aventis had not concealed Ketek’s safety risks. The court concluded that UFCW Local 1776 v. Eli Lilly & Co. (Zyprexa) does not foreclose class certification for all RICO mail‐fraud claims brought against a drug manufacturer. However, the court concluded that Zyprexa’s reasoning applies to this case, and bars plaintiffs’ attempt to certify a class. While it may be possible for a class of plaintiffs to prove the causation element of a pharmaceutical fraud claim such as this one with generalized proof, plaintiffs have failed to offer such proof here. Therefore, class certification was correctly denied. The court's certification decision necessarily disposes of the summary judgment question as well: if plaintiffs’ RICO claims cannot be proved by generalized proof and plaintiffs have adduced no individualized proof, plaintiffs' claims cannot survive summary judgment. Further, the court agreed with the district court’s dismissal of the state‐law claims. Accordingly, the court affirmed the judgment. View "Sergeants Benevolent Ass'n v. Sanofi-Aventis US" on Justia Law