Justia Drugs & Biotech Opinion Summaries

Figueroa received the flu vaccine in 2008. Within 20 days, he developed numbness in his face, impaired speech, and weakness. He was diagnosed with Guillain-Barré Syndrome, a sometimes fatal nervous system disorder. Because GBS is not listed on the Vaccine Injury Table, 42 U.S.C. 300aa-14(a), it requires proof of causation, although flu vaccine GBS cases have been compensated under the National Childhood Vaccine Injury Act. Figueroa had 36 months from the onset of symptoms to file a petition under the Act (until November, 2011), but, in 2010, he died of pancreatic cancer. His widow timely sought compensation for the vaccine-related neurological injuries suffered prior to his death. A special master dismissed, reasoning that because Figueroa had died of pancreatic cancer, a non-vaccine-related cause, Ms. Figueroa lacked standing to seek injury compensation. The Court of Federal Claims affirmed. The Federal Circuit reversed, interpreting a section that provides: “any person who has sustained a vaccine-related injury, the legal representative of such person if such person is a minor or is disabled, or the legal representative of any person who died as the result of the administration of a vaccine ... may ... file a petition for compensation,” 42 U.S.C. 300aa-11(b)(1)(A) View "Figueroa v. Sec'y of Health & Human Servs." on Justia Law

Plaintiff and others sought and received LASIK eye surgery with a Nidek EC-5000 Excimer Laser System ("Laser") to correct farsightedness. Plaintiff, on behalf of himself and a class of similarly situated individuals, claimed that, had they known that the FDA had not approved the Laser for this use, they would not have consented to the surgeries. The court held that the complaint did not state a claim under the California Protection of Human Subjects in Medical Experimentation Act, Cal. Health & Saf. Code 24171 et seq., because the surgeries were not "medical experiments" subject to the protection of the Act. Plaintiff did not have standing to sue for injunctive relief under the California Consumers Legal Remedies Act (CLRA), Cal. Civ. Code 1750 et seq., and his other substantive claim was preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq. Plaintiff's common-law fraud by omission claim was expressly preempted by the preemption provision in the Medical Device Amendments. Even if it were not, it was impliedly preempted because it amounted to an attempt to privately enforce the FDCA. Accordingly, the court affirmed the dismissal of the complaint. View "Perez, et al v. Nidek Co., Ltd., et al" on Justia Law

This case stemmed from Cytori's application to the FDA to market two new medical devices, the Celution 700 and the StemSource 900. Two devices that use adipose tissue as a source of stem cells that could later be used in lab analysis or, potentially, in regenerative medicine. The FDA concluded that the Celution and the StemSource were not substantially similar to devices on the market that extract stem cells from blood or bone marrow. Thus, the FDA ruled that Cytori must go through an extensive premarket approval process for new medical devices, rather than go through the streamlined premarket notification process for new devices that would be substantially equivalent to another device already on the market. Cytori appealed. As a preliminary matter, the court concluded that it was the proper forum for direct review of the FDA's substantial equivalence determination. On the merits, the court concluded that the FDA reasonably concluded and reasonably explained, for purposes of the Administrative Procedures Act, 5 U.S.C. 500 et seq., that the Celution and StemSource did not meet either the "intended use" requirement or the "technological characteristics" requirement for a substantial equivalence determination. View "Cytori Therapeutics, Inc. v. FDA" on Justia Law

Fulgenzi was prescribed the generic drug metoclopramide (FDA approved in 1980), sold originally under the brand name Reglan, a drug approved for short-term treatment of patients suffering from gastroesophageal reflux disease. In her suit, claiming failure to adequately warn of risks, she alleged that taking the drug caused her to develop tardive dyskinesia, an often-irreversible neurological disorder that causes involuntary movements, especially of the lower face. In 2009, the Supreme Court held that with respect to branded drug manufacturers, state failure-to-warn suits were not preempted by the federal Food Drug and Cosmetic Act , 21 U.S.C. 301. In 2011 the Court held that such suits could not go forward against generic drug manufacturers, as it is impossible to comply simultaneously with their state duty to adequately warn and their federal duty of sameness (federal law requires generic drug labels to be the same as their branded counterpart). The district court dismissed. The Sixth Circuit reversed, noting that after the branded-drug manufacturer of metoclopramide strengthened warnings on its label, the generic manufacturer failed to update its label as required by federal law, rendering compliance with both federal and state duties no longer impossible. View "Fulgenzi v. PLIVA, Inc." on Justia Law

Between 1994 and 1997 Wyeth’s predecessor sold fenfluramine and dexfenfluramine, prescription weight loss drugs. After the drugs were linked to valvular heart disease and an FDA public health advisory, Wyeth withdrew the drugs from the market in 1997. Thousands of individuals filed suit; the cases were consolidated. In 1999, Wyeth entered into a Settlement Agreement; in 2000, the court certified the class, approved the Agreement, and retained jurisdiction. The Agreement enjoins class members from suing Wyeth for diet drug-related injuries, but allows class members to sue Wyeth if they can demonstrate that they developed PPH (a condition that deprives the lungs of oxygen) at a specified level through the use of the diet drugs. In 2011, Cauthen sued, alleging that she developed PPH. She produced a pulmonary consultation prepared by Fortin, a cardiologist. Because Cauthen’s report showed that lung capacity of less than 60 percent of predicted at rest, Wyeth sought to enjoin the state court lawsuit for failing to satisfy the precondition provided by the Agreement. Dr. Fortin asserted that comparing individual lung capacity with average capacity of persons having a similar demographic profile is not determinative in diagnosing PPH. The district court enjoined the suit. The Third Circuit affirmed. View "In Re: Diet Drugs Prod. Liab. Litig." on Justia Law

The DEA, under the authority of the Controlled Substances Act of 1970, 21 U.S.C. 812(b)(1)(B), classified marijuana as a Schedule I drug, the most restricted drug classification under the Act. Petitioners challenged the DEA's denial of its petition to initiate proceedings to reschedule marijuana as a Schedule III, IV, or V drug. The principal issue on appeal was whether the DEA's decision was arbitrary and capricious. First, the court denied the Government's jurisdictional challenge because the court found that at least one of the named petitioners had standing to challenge the agency's action. On the merits, the court held that the DEA's denial of the rescheduling petition survived review under the deferential arbitrary and capricious standard where the petition asked the DEA to reclassify marijuana, which, under the terms of the Act, required a "currently accepted medical use." A "currently accepted medical use" required, inter alia, "adequate and well-controlled studies proving efficacy." The court deferred to the agency's interpretation of these regulations and found that substantial evidence supported the agency's determination that such studies did not exist. Accordingly, the court denied the petition for review. View "Americans for Safe Access, et al v. DEA" 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

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

Plaintiffs appealed the district court's grant of summary judgment in favor of Merck in their diversity action alleging wrongful death. Plaintiffs' son died after being administered a Measles, Mumps, and Rubella vaccine manufactured by Merck. On appeal, plaintiffs contended that the district court erred in applying the standards of the National Childhood Vaccine Injury Act, 42 U.S.C. 300aa-22, to their individual claims for damages. Having concluded that Section 22 of the Act generally applied to limit tort liability in a parent's claim for individual injuries, the court determined that plaintiffs' suit was a "civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine" and thus limited by the Act. Accordingly, the court affirmed the judgment. View "Holmes, et al. v. Merck & Co., Inc." on Justia Law