Justia Drugs & Biotech Opinion Summaries

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

Cubist Pharmaceuticals owns five follow-on patents that relate to the antibiotic daptomycin, which it sells under the name Cubicin. Hospira sought authorization to sell a generic version of Cubist’s daptomycin product, which led Cubist to file suit charging Hospira with patent infringement (Hatch-Waxman Act, 21 U.S.C. 355 and 35 U.S.C. 156 and 271(e)(2). The district court held, and the Federal Circuit affirmed, that some of the asserted claims of four of Cubist’s patents were invalid for anticipation and all the asserted claims of those patents sdfd invalid for obviousness. As for the fifth patent, the court held the two asserted claims not invalid and ruled that Hospira’s proposed products infringed those claims. View "Cubist Pharma., Inc. v. Hospira, Inc." on Justia Law

Enoxaparin, an anticoagulant that helps prevent blood clots, was approved for U.S. marketing in 1993 under the name Lovenox. In 2010, Momentaed market a generic version of enoxaparin. Momenta is also the assignee of the 886 patent, directed to a process used to ensure each batch of generic enoxaparin meets quality standards. Teva, another generic manufacturer, sought to enter the enoxaparin market. It does not manufacture enoxaparin, but sources it from an Italian company that manufactures, analyzes, tests, packages, and labels Teva’s generic version of enoxaparin. Momenta sued Teva for infringement, asserting that it intended to market in the U.S. an enoxaparin product that was manufactured using a process covered by the 886 patent. The court found Teva’s conduct did not infringe because it fell within the safe harbor in 35 U.S.C. 271(e)(1); it is not infringement for a party to use a patented invention “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.” The court also rejected Momenta’s contention that Teva’s U.S. sales constitute infringement under section 271(g), which prohibits selling within the U.S. a product which is made by a process patented in the U.S. The Federal Circuit affirmed as to noninfringement under 271(g), but vacated the “safe harbor” determination. View "Momenta Pharma, Inc. v. Teva Pharma. USA, Inc." on Justia Law

Irritable bowel syndrome (IBS) is a condition defined and diagnosed by its constellation of symptoms. A patient’s symptoms define the type of IBS with which a patient is diagnosed. Prometheus sued, alleging infringement of the 770 patent, which claims a method of treatment for IBS-D utilizing alosetron (brand name Lotronex), and has a priority date of 1997. The The district court found the claims invalid as obvious over the prior art or, in the alternative, invalid on grounds of obviousness-type double patenting over the now-expired 800 patent (issued in 1994). The Federal Circuit affirmed, finding the claims of the 770 patent invalid as obvious over the 800 patent and other prior art. View "Prometheus Labs, Inc. v. Roxane Labs., Inc." on Justia Law

The State of Mississippi brought a civil action against generic pharmaceutical provider Sandoz, Inc., alleging that Sandoz impermissibly exploited Mississippi’s Medicaid reimbursement program by routinely and exponentially reporting fictitious “Average Wholesale Prices,” a key data factor in the federally supervised formula used by the Mississippi Division of Medicaid to reimburse pharmacies serviced by Sandoz. The trial court, sitting as fact-finder, found Sandoz in violation of the Mississippi Consumer Protection Act and liable for common-law fraud. Sandoz appealed, and the State cross-appealed. On a deferential standard of review, the Supreme Court affirmed the trial court in full. View "Sandoz, Inc. v. Mississippi" on Justia Law

Whether a third-party payer (TPP) will cover the cost of a member’s prescription depends on whether that drug is listed in the TPP’s formulary. Pharmacy Benefit Managers prepare TPPs’ formularies of drugs approved for use by TPP members by analyzing research regarding a drug’s cost effectiveness, safety and efficacy. In 1999, the FDA approved Avandia as a prescription for type II diabetes. TPPs included Avandia in their formularies and covered Avandia prescriptions at a favorable rate. GSK downplayed concerns about Avandia’s heart-related side effects. In 2010, the FDA restricted access to Avandia in response to increasing evidence of its cardiovascular risks. TPPs (union health and welfare funds) sued GSK on behalf of themselves and similarly situated TPPs. asserting that GSK’s failure to disclose Avandia’s significant heart-related risks violated the Racketeer Influenced and Corrupt Organizations Act based on predicate acts of mail fraud, wire fraud, tampering with witnesses, and use of interstate facilities to conduct unlawful activity. They also claimed unjust enrichment and violations of the Pennsylvania Unfair Trade Practices and Consumer Protection Law and other states’ consumer protection laws. The Third Circuit affirmed the district court’s finding that the TPPs adequately alleged the elements of standing. View "In Re: Avandia Mktg.,Sales Practices & Prod. Liab." on Justia Law

Leucovorin is a compound used to ameliorate the toxic effects of methotrexate, a chemotherapy treatment; to treat folate deficiency; and to enhance the efficacy of a 5-fluorouracil cancer treatment. Spectrum, the exclusive licensee of the 829 patent, holds the approved New Drug Application for a levoleucovorin formulation, and listed the patent as claiming the drug product in the Food and Drug Administration publication, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), and markets Fusilev®. Sandoz submitted an Abbreviated New Drug Application (ANDA) in 2011, seeking FDA approval for a drug product that will be imported in the form of single-use vials with 175 mg or 250 mg of levoleucovorin, indicated for methotrexate rescue at doses of 7.5–75 mg per dose. Its ANDA contained a certification that the 829 patent was invalid or would not be infringed by the ANDA product, 21 U.S.C. 355(j)(2)(A)(vii)(IV). After receiving notice of that certification, Spectrum filed suit. The district court found certain claims invalid as obvious and others not infringed. The Federal Circuit affirmed, rejecting Spectrum’s argument that an aggregation of Sandoz’s approved product—that is, the total amount of levoleucovorin drug product to be imported—would infringe the claims. View "Spectrum Pharma., Inc. v. Sandoz Inc." on Justia Law