Justia Drugs & Biotech Opinion Summaries

Congress enacted section 703 of the National Defense Authorization Act for Fiscal Year 2008, 10 U.S.C. 1074g(f), which subjected all prescriptions purchased at retail pharmacies by service members to the same price caps as drugs procured directly by the Department of Defense. Pursuant to this provision, the Secretary of Defense issued a regulation requiring pharmaceutical manufacturers to refund to the federal government the difference between the retail price and the price cap. The Coalition, a multi-industry interest group that represented pharmaceutical companies, filed suit challenging these actions. The court concluded that the Secretary reasonably interpreted section 703 to impose involuntary price caps and held that the statute itself imposed retroactive rebate liability on pharmaceutical manufacturers. View "Coalition For Common Sense in Government Procurement v. United States, et al" on Justia Law

Plaintiff appealed from the dismissal of wrongful death and survival actions she filed against her son's employer and two pharmaceutical companies. Plaintiff's son committed suicide using a gun provided by his employer while he was taking prescribed medication manufactured and distributed by the pharmaceutical companies. The court held that the district court did not err in ruling that plaintiff failed to state a claim of negligence against the employer when the district court invoked, sua sponte, District of Columbia law that suicide was an intervening and independent cause of death subject to limited exceptions that were inapplicable. The court declined to certify questions of negligence-liability to the D.C. Court of Appeals. The court also held that the district court did not err in ruling that the complaint failed to state a plausible claim of products liability against the pharmaceutical companies and in denying her leave to amend. View "Rollins v. Wackenhut Services, Inc., et al" on Justia Law

The 314 patent, a reissue of the 440 patent, covers the “statin” drug with the brand name Crestor®, which is approved for use in control of cholesterol and for treatment of atherosclerosis. The active ingredient of Crestor® is the calcium salt of a chemical compound whose common name is rosuvastatin, one of several statin products that lower cholesterol production in the liver by inhibiting the enzyme HMG-CoA reductase. Several generic producers initiated a challenge to the 314 patent by filing an Abbreviated New Drug Application (ANDA) accompanied by a Paragraph IV certification, 21 U.S.C. 355(j)(2)(A)(vii)(IV). An ANDA permits a generic producer to market a drug product based on the federal approval obtained by the original registrant. Submission of an ANDA constitutes a statutory act of infringement pursuant to 35 U.S.C. 271(e)(2)(A). If the challenge to the patent fails, the ANDA cannot be approved until expiration of the patent. The generic producers argued that the 314 patent was invalid on the ground of obviousness and improper reissue, and that the patent is unenforceable for inequitable conduct in the Patent and Trademark Office. The district court ruled that the patent is valid, enforceable, and infringed. The Federal Circuit affirmed. View "Astrazeneca UK, Ltd. v. Aurobindo Pharma, Ltd." on Justia Law

Defendant appealed from a conviction of conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor violation of 21 U.S.C. 331(a) and 333(a)(1). Defendant, a pharmaceutical sales representative, promoted the drug Xyrem for "off-label use." The court agreed with defendant that he was convicted for his speech -- for promoting an FDA-approved drug for off-label use -- in violation of his right of free speech under the First Amendment. The court limited its holding to FDA-approved drugs for which off-label use was not prohibited. Accordingly, the court vacated and remanded. View "United States v. Caronia" on Justia Law

Plaintiff sued OMJP and others for failing to warn adequately of the risk of tendon rupture in patients who, like plaintiff, were elderly and taking concomitant corticosteroids. A jury found OMJP primarily liable, awarding plaintiff compensatory and punitive damages. OMJP appealed the district court's denial of its motions for judgment as a matter of law (JMOL) and a new trial. The court held that the district court did not err in denying OMJP's motions for JMOL or a new trial based on the jury's award of compensatory damages where the district court found sufficient evidence of causation, reasoning that the jury finding was not against the preponderance of the evidence. The evidence was neither clear nor convincing, as a matter of law, that OMJP deliberately disregarded the safety of the users of Levaquin. Accordingly, the district court erred in denying JMOL for OMJP on punitive damages. View "Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc." on Justia Law

AdvancePCS is a prescription benefits manager for plans sponsored by employers, unions, and others and is retained to achieve savings by negotiating discounts from drug manufacturers, providing mail order service, contracting with retail pharmacies, and electronic processing and paying of claims. Plaintiffs are retail pharmacies that entered into agreements with AdvancePCS that include an agreed reimbursement rate and an arbitration clause. In 2003, plaintiffs filed suit, asserting that AdvancePCS engaged in an unlawful conspiracy with plan sponsors to restrain competition in violation of the Sherman Act, 15 U.S.C. 1; that AdvancePCS used the economic power of its sponsors to reduce the contractual amount it pays below levels prevailing in a competitive marketplace; and that the agreements impose other limitations. For almost a year, AdvancePCS litigated without mentioning arbitration. After denial of a motion to dismiss and reconsideration, AdvancePCS filed an answer with affirmative defenses, then sought to compel arbitration. The court granted the motion. Plaintiffs did not initiate arbitration, but sought dismiss pending appeal. A different judge vacated the order compelling arbitration. The Third Circuit remanded with directions to reinstate the order compelling arbitration. On remand, a third judge granted dismissal. The Third Circuit ruled in favor of plaintiffs, holding that AdvancePCS waived its right to arbitrate. View "In Re: Pharmacy Benefit Mgrs. Antitrust Litig." on Justia Law

The patent, issued in 1995, entitled “Valve Prosthesis for Implantation in the Body and a Catheter for Implanting Such Valve Prosthesis,” describes a prosthetic heart valve, mounted on a stent and implanted by catheter to avoid open heart surgery. The district court found the patent valid and infringed by and that the infringement was willful. The jury awarded damages of $72,645,555 in lost profits and $1,284,861 as a reasonable royalty. The district court entered judgment on the verdict, but declined to enhance damages for the willful infringement. The court also declined to issue an injunction against future infringement, apparently on defendant’s representation that, if enjoined, it would move its manufacturing operations to Mexico. The court also denied a request to modify the litigation-agreed protective order and to permit patent counsel and technical expert to participate in ongoing reexamination proceedings of the patent in suit and related patents. The Federal Circuit affirmed, but remanded reconsideration of the denial of an injunction in view of the representation of changed circumstances, and for reconsideration of the ruling on the protective order as applied to patents not in suit, to the extent that this issue has not become moot. View "Edwards Lifesciences AG v. Corevalve, Inc." on Justia Law

A chiropractor pleaded guilty to defrauding health insurers and to money laundering and was sentenced to 70 months (the bottom of the guidelines range) and to pay restitution of almost $2 million. At the guilty-plea hearing the judge asked the defendant whether he was “currently under the influence of any drugs, medicine, or alcohol,” and the defendant answered: “prescription medications.” He told the judge that he was taking medicines for “high anxiety, depression, adult attention hyperactivity disorder, and depression,” but stated that he was “thinking clearly.” He waived his right to appeal, but six weeks later moved to retract the plea, claiming that he had been taking psychotropic drugs, rendering his plea involuntary. The judge denied the motion because the defendant had presented no evidence that switching from Prozac to Lexapro could have the dramatic effects he claimed it had, and because at the plea hearing he had been alert and responsive and exhibited no signs of confusion. The Seventh Circuit affirmed.View "Unted States v. Hardimon" on Justia Law

Hibbard, then 41 years old and working as a teacher, received a flu vaccination in 2003. She claims that the flu vaccine caused her to develop a neurological disorder known as dysautonomia, a dysfunction of the autonomic nervous system and sought compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C.300aa-1 to 300aa-34. Following a two-day hearing, a special master found that Hibbard had failed to show that her dysautonomia resulted from autonomic neuropathy caused by the vaccine she received in 2003. The Court of Federal Claims upheld the decision. The Federal Circuit affirmed, finding substantial evidence to support the denial. View "Hibbard v. Sec'y Health & Human Servs." on Justia Law

In 2010-2011 several hundred plaintiffs filed 10 lawsuits in Illinois state courts against Abbott, for personal injuries they allege were caused by Depakote, a prescription. Plaintiffs moved the Supreme Court of Illinois to consolidate and transfer their cases to St. Clair County, pursuant to Illinois Supreme Court Rule 384; the Supreme Court has not ruled. Abbott removed each of the cases to federal court, asserting that the motion to consolidate brought the cases under the “mass action” provision of the Class Action Fairness Act, 28 U.S.C. 1332(d)(11)(B)(i), which allows the removal of any case where 100 or more people propose to try their claims jointly. Cases filed in St. Clair and Madison counties were removed to the Southern District of Illinois and cases filed in Cook County were removed to the Northern District; plaintiffs moved to remand in both courts. The Northern District denied plaintiffs’ motion to remand. The Seventh Circuit held that removal was proper, rejecting plaintiffs’ argument that they did not propose a joint trial because their motion to consolidate did not address how the trials of the various claims in the cases would be conducted, other than proposing that they all take place in St. Clair County.View "Abbott Labs., Inc. v. Alexander" on Justia Law