Justia Drugs & Biotech Opinion Summaries

Plaintiff's doctor prescribed, for shoulder pain, sulindac, a non-steroid anti-inflammatory, under the brand-name Clinoril; her pharmacist dispensed generic sulindac. She developed a hypersensitivity reaction, toxic epidermal necrolysis, with which the outer skin layer on a patient's body has deteriorated, been burned off or turned into an open wound. Plaintiff spent 70 days at Massachusetts General Hospital, more than 50 in its burn unit, with 60-65 percent of her skin affected. Her "truly horrific" injuries include permanent near-blindness. Her claims against the manufacturer included breach of warranty, fraud, and negligence, and products liability claims: design defect, failure to warn, and manufacturing defect. By trial, the remaining theory of design defect was narrowed to a claim that sulindac's risks outweighed its benefits making it unreasonably dangerous to consumers, despite the FDA having never withdrawn its statutory "safe and effective" designation. A jury awarded $21.06 million in compensatory damages. The First Circuit affirmed, rejecting claims including that the district court misunderstood New Hampshire law on design defect claims; that such claims as to generic drugs are preempted under federal law; that causation was not proved; and that damages were excessive and required a new trial. .View "Bartlett v. Mut. Pharm. Co., Inc." on Justia Law

Defendants, two of three lawyers who represented several hundred Kentucky clients in a mass-tort action against the manufacturer of the defective diet drug "fen-phen," settled the case for $200 million, which entitled them under their retainer agreements to approximately $22 million each in attorney fees. By visiting clients and obtaining their signatures on "confidential settlements," for lesser amounts, the two actually disbursed slightly more than $45 million, less than 23 percent of the total settlement. The lawyers kept the remainder for themselves and associated counsel, transferring much of it from the escrow account to various other accounts, including out-of-state accounts. The scheme was discovered; the lawyers were disbarred and convicted of conspiracy to commit wire fraud, 18 U.S.C. 1343, 1349. One was sentenced to 240 months, the other to 300 months. They were ordered to pay more than $127 million in restitution. The Sixth Circuit affirmed, rejecting a variety of challenges to the sufficiency of the evidence and trial procedures. View "United States v. Cunningham" on Justia Law

Plaintiffs sought compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa, for injuries to their children allegedly caused by the Diptheria-Tetanus-acellular Pertussis vaccine. The children suffer a seizure disorder, known as Severe Myoclonic Epilepsy of Infancy. The same special master presided over both cases and determined that plaintiffs failed to show entitlement to compensation because evidence showed that a gene mutation present in both children was the sole cause of their injuries. The Court of Federal Claims affirmed. The Federal Circuit affirmed, noting considerable evidentiary support for the conclusion. View "Stone v. Sec'y of Health & Human Servs." on Justia Law

This case involved a type of patent litigation settlement known as a "pay for delay" or "reverse payment" agreement. In this type of settlement, a patent holder paid the allegedly infringing generic drug company to delay entering the market until a specified date, thereby protecting the patent monopoly against a judgment that the patent was invalid or would not be infringed by the generic competitor. This case began when the FTC filed a complaint in district court alleging that the reverse payment settlements between the holder of a drug patent and two generic manufacturers of the drug were unfair restraints on trade that violated federal antitrust laws. The court's precedent established the rule that, absent sham litigation or fraud in obtaining the patent, a reverse payment settlement was immune from antitrust attack so long as its anticompetitive effects fell within the scope of the exclusionary potential of the patent. The court rejected the FTC's claims to the contrary and affirmed the judgment. View "FTC v. Watson Pharmaceuticals, Inc., et al." on Justia Law

Plaintiffs are a dissident group, within a larger class of medical patient consumers in a case alleging fraud in overcharging for the medication Lupron. The patients, along with insurers and private health care providers, obtained a $150 million settlement agreement that was approved by the district court, of which $40 million was allocated to consumers. That agreement provided that if there were unclaimed monies from the $40 million consumer settlement pool after full recovery to consumer plaintiffs, all unclaimed funds would go into a cy pres fund to be distributed at the discretion of the trial judge. Dissident plaintiffs appealed distribution of the $11.4 million cy pres fund to the Dana Farber/Harvard Cancer Center and the Prostate Cancer Foundation for work on the treatment of the diseases for which Lupron is prescribed. They have already recovered more than 100% of their actual damages. The First Circuit affirmed. After expressing concern about distribution of such funds by judges and adding an audit requirement, the court noted the importance of avoiding windfalls for plaintiffs who have already been fully compensated. View "Rohn v. Dana Farber/Harvard Cancer Ctr." on Justia Law

Once the FDA has approved a brand manufacturer's drug, another company could seek permission to market a generic version pursuant to legislation known as the Hatch-Waxman Amendments. See Drug Price Competition and Patent Term Restoration Act of 1984, 98 Stat. 1585. The relevant statute at issue in this case provided that a generic company "may assert a counterclaim seeking an order requiring the [brand manufacturer] to correct or delete the patent information [it] submitted... under [two statutory subsections] on the ground that the patent does not claim... an approved method of using the drug." 117 Stat. 2452, 21 U.S.C. 355(j)(5)(C)(ii)(I). At issue in this case was whether Congress had authorized a generic company to challenge a use code's accuracy by bringing a counterclaim against the brand manufacturer in a patent infringement suit. The Court held that a generic manufacturer could employ this provision to force correction of a use code that inaccurately described the brand's patent as covering a particular method of using the drug in question. Therefore, the Court reversed the judgment of the Federal Circuit. View "Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S" on Justia Law

A drug manufacturer can obtain FDA permission to market a generic version of an approved drug by Abbreviated New Drug Application (ANDA), rather than full New Drug Application (NDA). It is an act of infringement to file an ANDA for a drug or use of the drug claimed in a patent, 35 U.S.C. 271(e)(2)(A). Every NDA must identify every patent that could reasonably be asserted in an infringement action, 21 U.S.C. 355(b)(1), for publication in the Orange Book. An ANDA for a generic drug must address each patent in the Orange Book that relates to that drug. For patents that will not expire prior to proposed marketing, the applicant can include a statement that the applicant is not seeking approval for the method of use claimed in the patent or can certify that the patent is invalid or will not be infringed. Bayer markets Yasmin, an oral contraceptive, approved by NDA in 2001. Defendants filed ANDAs to market generic versions and certified that three patents would not be infringed, arguing that their ANDAs related only to contraceptive use and not to claimed methods for treating hirsutism or acne or reducing water retention. The district court entered judgment of noninfringement. The Federal Circuit affirmed.View "Bayer Schering Pharma, AG v. Lupin, Ltd." on Justia Law

A brand-name company seeking FDA new drug approval must submit information about patents for which a claim of infringement could reasonably be asserted, 21 U.S.C. 355(b)(1), for publication in the Orange Book. A generic company may seek FDA approval using abbreviated new drug application (ANDA), including, for each patent in the Orange Book, certification that approval is not sought until the patent expires or paragraph IV certification that such patent is invalid or will not be infringed. If an ANDA contains only paragraph IV certifications, it may be approved unless the holder sues for patent infringement within 45 days. The first generic company to file an ANDA containing paragraph IV certification receives a 180-day exclusivity period from the date of its first commercial marketing. The period can be forfeited by failure to launch after final judgment of noninfringement or invalidity. An ANDA filer, not sued within 45 days, can seek declaratory judgment under 28 U.S.C. 2201. Plaintiffs obtained declaratory judgment that a generic pharmaceutical did not infringe defendant's patent. The Federal Circuit affirmed, rejecting a challenge to the district court’s jurisdiction, based on a covenant not to sue contained in an earlier settlement between the parties.View "Dey Pharma, LP v. Sunovion Pharm., Inc." on Justia Law

Plaintiffs are the owner of the patents, which cover a modified-release dosage form of skeletal muscle relaxants (793) and a method of relieving muscle spasms with the formulation disclosed in the 793 patent, and the exclusive licensee of the patents. The district court found the patents invalid as obvious, but enjoined defendants from launching their generic product, pending appeal. The Federal Circuit reversed. The district court failed to consider the lack of a known pharmacokinetic/pharmacodynamic relationship for the claimed drug formulation and, therefore, erred when it assessed the importance of the teachings of the prior art to the obviousness analysis. The court rejected defendants' alternate argument that the patents were invalid for failure to disclose the best mode (35 U.S.C. 112), stating that the evidence supported a finding that the patents enable one of ordinary skill in the art to practice the inventor's preferred dew points.View "In re Cyclobenzaprine Hydrochloride Extended Release Casule Patent Litigation" on Justia Law

Plaintiff's 561 and 512 pharmaceutical patents for "Taxotere" are related to administration of the chemotherapy cancer drug docetaxel (a successor to the cancer drug paclitaxel, covered by a now-expired patent). To stabilize the perfusion and delay precipitation, the cancer drugs are mixed with additives like surfactants and ethanol. Prior art used the surfactant Cremophor, but it was known to trigger serious allergic reactions. The 561 and 512 patents relate to using surfactants other than Cremophor and decreasing the amount of ethanol to reduce alcohol intoxication and anaphylactic effects in patients. After defendants applied for FDA approval to market generic versions of Taxotere, plaintiff claimed infringement, 35 U.S.C. 271(e). The district court found certain claims invalid for obviousness and that the patents were unenforceable for inequitable conduct. The Federal Circuit affirmed, concluding that withheld references to prior art were material View "Aventis Pharma S.A. v. Hospira, Inc." on Justia Law