Justia Drugs & Biotech Opinion Summaries

Plaintiff alleged various causes of action against the maker of the generic drug (Pliva), brand defendants, and others after she was injured by the prescription medication metoclopramide. On appeal, plaintiff challenged the district court's grant of summary judgment in favor of brand defendants and dismissal of her claims against Pliva. The court denied plaintiff's motion to supplement the record, finding no compelling reason to allow plaintiff to do so; the district court did not err in determining plaintiff's claims against brand defendants failed as a matter of law because she stipulated that she had not ingested a product manufactured by brand defendants; reversed the district court's dismissal of plaintiff's non-warning design defect and breach of implied warranty claims and remanded for further consideration; and because there was no causal link between Pliva's failure to incorporate the 2004 labeling change and plaintiff's injury, the district court's dismissal of that claim was not error. Accordingly, the court affirmed in part, reversed in part, and remanded for further proceedings.View "Bell v. Pfizer, et al." on Justia Law

Johnson, a Louisiana citizen, and Lucier, a Pennsylvania citizen, suffer from birth defects allegedly caused by their mothers’ use of thalidomide. They claim that newly-accessible evidence revealed that the defendant companies were aware of the drug’s risks while marketing it to pregnant women, and that they have been engaged in a 60-year cover-up to avoid liability. After defendants removed their suit for damages to federal court, the plaintiffs moved to remand the action to state court because four of the defendants are Pennsylvania citizens. The district court denied the motion. The Third Circuit affirmed, concluding that the district court correctly analyzed the citizenship of the companies, examining the principal place of business of one company and the fact that a limited liability company assumes the citizenship of its owner.View "Johnson v. SmithKline Beecham Corp." on Justia Law

Tolmar’s filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Differin® Gel, 0.3%, a topical medication containing 0.3% by weight adapalene approved for the treatment of acne. Galderma sued Tolmar, alleging that Tolmar’s ANDA product infringed its patents. The district court ruled against Tolmar, finding the Galderma patents not invalidity for obviousness under 35 U.S.C.103. The Federal Circuit reversed, after examining prior art. While the comparable tolerability of 0.1% and 0.3% adapalene was unexpected in view of the prior art, a skilled artisan would have expected that tripling the concentration of adapalene would have resulted in a clinically significant increase in side effects, so the result does not constitute an unexpected result that is probative of nonobviousness. The commercial success of Differin® is of “minimal probative value.” View "Galderma Labs, L.P. v. Tolmar, Inc." on Justia Law

The plaintiffs allege that they ingested metoclopramide, the generic equivalent of the prescription drug Reglan, and, as a result, developed a serious neurological disorder, tardive dyskinesia. The labeling for the drugs recommends short-term use for heartburn and acute and recurrent bloating: up to 12 weeks in adults for heartburn. Reglan and metoclopramide have not been shown to be either efficacious or safe for long-term treatment; the drugs affect the brain’s movement center, typically causing involuntary, repetitive movements. Overuse can result in symptoms including tardive dyskinesia, dystonia, and akathisia, Parkinsonism, and Reglan-induced tremors. Reglan and metoclopramide have also been associated with central nervous system disorders, depression with suicidal ideation, visual disturbances, and other problems. The plaintiffs sued both the generic and brand-name manufacturers, alleging various product-liability claims. The district court dismissed, finding the metoclopramide claims preempted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301-399f, and that the brand-name manufacturers are not liable because none of the plaintiffs ingested Reglan. The Sixth Circuit affirmed and denied the plaintiffs’ motion to certify a proposed question to the Tennessee Supreme Court. View "Speed v. Wyeth Pharm., Inc." on Justia Law

Volkman, an M.D. and a Ph.D. in pharmacology from University of Chicago, was board-certified in emergency medicine and a “diplomat” of the American Academy of Pain Management. Following lawsuits, he had no malpractice insurance and no job. Hired by Tri-State, a cash-only clinic with 18-20 patients per day, he was paid $5,000 to $5,500 per week. After a few months, pharmacies refused to fill his prescriptions, citing improper dosing. Volkman opened a dispensary in the clinic. The Ohio Board of Pharmacy issued a license, although a Glock was found in the safe where the drugs were stored. Follow-up inspections disclosed poorly maintained dispensary logs; that no licensed physician or pharmacist oversaw the actual dispensing process; and lax security of the drug safe. Patients returned unmarked and intermixed medication. The dispensary did a heavy business in oxycodone. A federal investigation revealed a chaotic environment. Cup filled with urine were scattered on the floor. The clinic lacked essential equipment. Pills were strewn throughout the premises. Months later, the owners fired Volkman, so he opened his own shop. Twelve of Volkman’s patients died. Volkman and the Tri-State owners were charged with conspiring to unlawfully distribute a controlled substance, 21 U.S.C. 841(a)(1); maintaining a drug-involved premises, 21 U.S.C. 856(a)(1); unlawful distribution of a controlled substance leading to death, 21 U.S.C. 841(a)(1) and 841(b)(1)(C), and possession of a firearm in furtherance of a drug-trafficking crime, 18 U.S.C. 24(c)(1) and (2). The owners accepted plea agreements and testified against Volkman, leading to his conviction on most counts, and a sentence of four consecutive terms of life imprisonment. The Sixth Circuit affirmed. View "United States v. Volkman" on Justia Law

OWW owns related patents directed to cushioning devices that fit over the residual stumps of amputated limbs to make the use of prosthetics more comfortable. Some of the patents have been asserted in patent infringement suits and many have been involved in reexamination proceedings before the Patent and Trademark Office. OWW sued Alps for infringement of the 237 patent, entitled “Gel and Cushioning Devices,” lists Kania as the sole inventor and has an application date of 1996. The district court issued its claim construction order. Alps subsequently initiated the first of two consecutive ex parte reexaminations of the 237 patent. After a stay was lifted, the district court granted summary judgment to Alps, finding certain claims invalid due to the collateral estoppel effect of parallel litigation and other claims invalid for obviousness. The district court also granted OWW summary judgment of no inequitable conduct. The Federal Circuit affirmed on the issues of collateral estoppel and obviousness, but reversed and remanded on the issue of inequitable conduct. Issues of material fact regarding whether OWW committed inequitable conduct during the reexamination proceedings by withholding information preclude summary judgment.View "Ohio Willow Wood Co. v. ALPS South, LLC" on Justia Law

IL-13 is a regulatory molecule called a cytokine. Cytokines interact with cytokine receptors located on target cells. Sanofi and Pfizer were conducting research, for therapeutic and diagnostic purposes, and each discovered and filed patent applications directed to the polynucleotide encoding the IL-13 protein binding chain. The patent is awarded to the first applicant to conceive and reduce to practice the invention represented by an interference count, in accordance with Patent and Trademark Office (PTO) rules. Sanofi had a December 6, 1995 priority date. Pfizer’s filing date was March 1, 1996; Pfizer bore the burden of proving a date of conception earlier than Sanofi’s date. Pfizer presented evidence that it had isolated and identified the desired cDNA before that date, but, due to sequencing errors, did not then have a completely accurate analysis of the entire nucleotide sequence. The PTO Board found that Pfizer had “the claimed polynucleotide in hand with some additional identifying information including at least a partial sequence,” and ruled that Pfizer “established conception and actual reduction to practice of a polynucleotide within the scope of count 3” before the Sanofi date. The Federal Circuit affirmed; possession and appreciation of the actual isolated DNA is dispositive for priority of conception for an interference count directed to isolated DNA.View "Sanofi-Aventis v. Pfizer, Inc." on Justia Law

The patent concerns blood glucose monitoring systems, used by individuals with diabetes. Such systems typically consist of an electrochemical meter and disposable test strips onto which the user places a drop of blood. The strip contains “working electrodes” or “reference electrodes,” that connect to the meter during operation. Each working electrode is coated with an enzyme and a mediator. The enzyme reacts with glucose in the blood sample, releasing electrons. The mediator then transfers those electrons to the working electrode, which is connected to the meter, which measures the resulting electric current to determine blood glucose level. Meters and test strips of this general design became available in the 1980s. LifeScan’s patent claims to improve earlier systems with a method of comparing measurements from separate working electrodes. Significant differences in the readings of the working electrodes indicate problems such as inadequate sample volume or manufacturing defects, and the readings are to be discarded. A reference electrode on the strip serves as a common reference for both working electrodes. LifeScan manufactures such a system, the “OneTouch Ultra” and claimed infringement by defendant. The district court found likely infringement and entered an injunction. The Federal Circuit reversed, finding that defendant established a patent exhaustion defense. View "Lifescan Scotland, Ltd. v. Shasta Tech., LLC" on Justia Law

Synthes filed suit, alleging that SK’s M6-C and M6-L intervertebral implants infringed claims of a Synthes patent that is directed to an “Intervertebral Implant,” a prosthetic device designed to replace a diseased or degenerated disc located between adjacent vertebrae of the human spine. The Synthes patent originated from a German language Patent Cooperation Treaty application filed in 2003. The asserted claims were added by amendment in 2008. A jury found that SK’s implants did not infringe the asserted claims and that the claims were invalid for lack of written description. The Federal Circuit affirmed both the finding of invalidity and the district court’s denial of SK’s request for attorneys’ fees.View "Synthes USA LLV v. Spinal Kintetics, Inc." on Justia Law

At age four months, Elias received a Diptheria-Tetanus-acellular-Pertussis (DTaP) vaccine. Elias developed a seizure disorder shortly afterwards. While a petition for compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. 300aa-1, was pending, Elias died as a result of his seizure disorder at the age of seven. A special master determined that the DTaP vaccine caused Elias’ epilepsy and resulting death. The Secretary of Health and Human Services and the estate agreed to a $250,000 death benefit plus $175,000 for actual pain and suffering and past unreimbursable expenses. The estate also sought future lost earnings under section 300aa-15(a)(3)(B). The special master determined that the estate was entitled to future lost earnings. Subject to the right to seek review, the Secretary proffered, and the estate accepted the sum of $659,955.61 as a measure of the lost earnings. The Claims Court affirmed the special master’s future lost earnings award. The Federal Circuit reversed, holding that an estate cannot recover lost future earnings under section 300aa-15(a)(3)(B) when the person injured by a vaccine dies before entry of a compensation judgment. View "Tembenis v. Sec'y of Health & Humans Servs." on Justia Law