LITIGATION BLOG

California Official Reports: Electronic Advance Sheet - Court Opinions For Tuesday, June 18, 2013

2013-06-18T19:32:12Z

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Index of new California opinions
Index of actions without opinion

Index of new California opinions:

1. City of Dana Point v. Cal. Coastal Comm'n, D060260, D060369, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 477 ^Shepardize, June 17, 2013, Opinion Filed

CORE TERMS: nuisance, ordinance, abatement, local coastal program, Coastal Act, local government, mandated, coastal development permit, abate, coastal ...

2. S. Cal. Edison Co. v. City of Victorville, E053938, E054740, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION TWO, 2013 Cal. App. LEXIS 478 ^Shepardize, June 17, 2013, Opinion Filed

CORE TERMS: cross-complaint, tariff, pole, public utility, street lights, intersection, luminaire, indemnity, placement, cause of action ...

3. Winn v. Pioneer Medical Group, Inc., B237712, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION EIGHT, 2013 Cal. App. LEXIS 412 ^Shepardize, May 24, 2013, Opinion Filed

CORE TERMS: elder, neglect, professional negligence, care provider, dependent adult, custodial, vascular, medical care, custodian, "reckless ...

4. People v. Scott, H037923, COURT OF APPEAL OF CALIFORNIA, SIXTH APPELLATE DISTRICT, 2013 Cal. App. LEXIS 407 ^Shepardize, May 23, 2013, Opinion Filed

CORE TERMS: sentence, Realignment Act, probation, sentenced, county jail, suspended, offenders, prison, sentencing, criminal justice ...

5. Ronay Family Limited Partnership v. Tweed, D062195, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 408 ^Shepardize, May 23, 2013, Opinion Filed, CERTIFIED FOR PARTIAL PUBLICATION** Pursuant to California Rules of Court, rule 8.1110, this opinion is certified for publication with the exception of part III.C.

CORE TERMS: arbitration, compel arbitration, customer, arbitration clause, party beneficiary, membership, FINRA Rule, arbitration agreement, promisee, broker ...

6. Heyen v. Safeway Inc., B237418, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION FOUR, 2013 Cal. App. LEXIS 409 ^Shepardize, May 23, 2013, Opinion Filed

CORE TERMS: exempt, nonexempt, manager, exemption, customer, spent, 'hourly, assistant manager, wage order, performing ...

7. People v. Pizarro, F057722, COURT OF APPEAL OF CALIFORNIA, FIFTH APPELLATE DISTRICT, 2013 Cal. App. LEXIS 402 ^Shepardize, May 21, 2013, Opinion Filed, As modified June 13, 2013., CERTIFIED FOR PARTIAL PUBLICATION** Pursuant to California Rules of Court, rules 8.1105(b) and 8.1110, only the Introduction; Procedural Summary; Facts; the following parts of the Discussion: I., II.A., II.E.1.a., II.E.1.e., II.E.1.f., II.E.2.a., II.E.2.f., heading of II.E.5., and II.E.5.f.; and the Disposition of this opinion are certified for publication., Modified and rehearing denied by People v. Pizarro, 2013 Cal. App. LEXIS 471 ^Shepardize (Cal. App. 5th Dist., June 13, 2013)

CORE TERMS: allele, juror, sequence, perpetrator, primer, extraneous, profile, misconduct, match, harmless ...

8. Bluford v. Safeway Inc., C066074, COURT OF APPEAL OF CALIFORNIA, THIRD APPELLATE DISTRICT, 2013 Cal. App. LEXIS 411 ^Shepardize, May 8, 2013, Opinion Filed, CERTIFIED FOR PARTIAL PUBLICATION** This opinion is certified for publication with the exception of parts III and IV of the Discussion., The Publication Status of this Document has been Changed by the Court from Unpublished to Published May 24, 2013.

CORE TERMS: rest periods, driver, meal, separately, certification, trip, piece-rate, hours worked, collective bargaining agreements, compensated ...

9. Target National Bank v. Rocha, Case No. 1-12-AP-001359, APPELLATE DIVISION, SUPERIOR COURT OF CALIFORNIA, SANTA CLARA COUNTY, 2013 Cal. App. LEXIS 410 ^Shepardize, April 29, 2013, Opinion Filed, The Publication Status of this Document has been Changed by the Court from Unpublished to Published May 16, 2013.

CORE TERMS: declaration, subpoena, cross-examination, attendance, mile, affiant, notice, attend, service of process, resident ...

Index of actions without opinion

No new actions since last update.

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Split U.S. Supreme Court Rules Attorneys May Not Use DMV Info To Solicit Clients

2013-06-17T22:03:43Z

WASHINGTON, D.C. - (Mealey's) Soliciting clients for a class action lawsuit is not a permissible attorney action covered by the Driver's Privacy Protection Act's litigation exception, a split U.S. Supreme Court ruled June 17 (Edward F. Maracich, et al. v. Michael Eugene Spears, et al., No. 12-25, U.S. Sup.). [lexis.com subscribers may access Supreme Court briefs for this case].

(Opinion available. Document #43-130621-007Z.)

"Attorneys are free to solicit plaintiffs through traditional and permitted advertising without obtaining personal information from a state DMV [Department of Motor Vehicles]. . . . In light of these and other alternatives, attorneys are not without the necessary means to aggregate a class of plaintiffs. What they may not do, however, is to acquire highly restricted personal information from state DMV records to send bulk solicitations without express consent from the targeted recipients," Justice Anthony M. Kennedy wrote for the majority.

Chief Justice John G. Roberts Jr. and Justices Clarence Thomas, Stephen G. Breyer and Samuel Anthony Alito Jr. joined in the majority opinion.

Freedom Of Information Request

On June 23, 2006, a South Carolina attorney submitted a state Freedom of Information Act request to the South Carolina DMV. The attorney was seeking to determine if charging illegal administrative fees was a common practice so that a lawsuit could be brought as a representative action under the South Carolina Regulation of Manufacturers, Distributors and Dealers Act (MDDA).

The attorney's letter requested information regarding "[p]rivate purchases of new or used automobiles in Spartanburg County during the week of May 1-7, 2006, including the name, address, and telephone number of the buyer, dealership where purchased, type of vehicle purchased, and the date of purchase." The South Carolina DMV provided the requested information.

On Aug. 24, 2006, the attorney and several others submitted a second FOIA request to the DMV seeking the information for car purchasers in five additional counties during the same week. The attorneys asserted that, like the first request, it was being made "in anticipation of litigation . . . pursuant to the exception in 18 USC §2721(b)(4)."

South Carolina Complaint

On Aug. 29, 2006, the attorneys filed a suit in South Carolina state court on behalf of four consumers who originally contacted them about the administrative fees. The case is referred to as the Herron suit. The Herron complaint named 51 dealers as defendants and invoked the MDDA's "group action" provision to assert claims "for the benefit of all South Carolina car buyers wh[o] paid administrative fees."

Some of the dealers moved to dismiss for lack of standing because none of the named plaintiffs purchased cars from them. On Oct. 26, 2006, while the motions to dismiss were pending, the attorneys submitted a new FOIA request to the South Carolina DMV. That request sought to locate additional car buyers who could serve as plaintiffs against the dealers who had moved to dismiss. On Oct. 31, 2006, the attorneys filed an amended complaint that added four named plaintiffs and increased the number of defendant dealers from 51 to 324. Once again, the defendant dealerships that had not engaged in any transactions with any of the eight named plaintiffs moved to dismiss for lack of standing.

Mass Mailing

On Jan. 3, 2007, using the information from the DMV, the attorneys sent a mass mailing to find car buyers to serve as additional plaintiffs in the litigation against the dealers.

Later in January, the attorneys filed three more FOIA requests with the DMV seeking personal information concerning people who had purchased cars from an additional 31 dealerships. The DMV granted all the requests.

The attorneys mailed additional rounds of letters to car buyers whose information had been disclosed by the DMV on Jan. 23, March 1, March 5 and May 8. In total, the attorneys sent letters to more than 34,000 car buyers in South Carolina.

In June 2007, the attorneys sought to amend their complaint to add 247 plaintiffs. The court denied leave to amend and held that the named plaintiffs had standing to sue only those dealerships from which they had purchased automobiles and any alleged co-conspirators.

In September 2007, the attorneys filed two new lawsuits on behalf of additional car buyers. Those cases were consolidated with the Herron suit. All claims against dealerships without a corresponding plaintiff-purchaser were dropped.

Privacy Violation

Three of the recipients of the attorneys' letter - Edward Maracich, Martha Weeks and John Tanner - filed a class complaint against the attorneys in 2009 in the U.S. District Court for the District of South Carolina. The plaintiffs alleged that the attorneys violated the Driver's Privacy Protection Act (DPPA) by obtaining, disclosing and using personal information from motor vehicle records for bulk solicitation without the express consent of petitioners and the other class members.

The attorneys moved to dismiss. The District Court held that the attorneys' use of the personal information was permitted under the DPPA's (b)(1) governmental-function exception. The Fourth Circuit U.S. Court of Appeals affirmed. However, the appellate panel held that the letters were "solicitations" within the meaning of the DPPA but that "solicitation is an accepted and expected element of, and is inextricably intertwined with, conduct satisfying the litigation exception under the DPPA, such solicitation is not actionable."

The letter recipients then petitioned the U.S. Supreme Court.

Dissenting Opinion

Disagreeing with the high court majority, Justice Ruth Bader Ginsburg opined that the lower courts were correct. "As the Fourth Circuit explained, respondents 'did what any good lawyer would have done.' 675 F. 3d 281, 298 (2012). This Court's holding, exposing respondents not only to astronomical liquidated damages, §2724(b)(1), but to criminal fines as well, §2723(a), is scarcely what Congress ordered in enacting the DPPA.

Respondent-lawyers obtained and used DMV information for 'investigation in anticipation of litigation' and for communications 'in connection with' a civil action. I would read that statutory language to permit use of DMV information tied to a specific, concrete proceeding, imminent or ongoing, with identified parties on both sides of the controversy. So read, §2721(b)(4) permitted the lawyers' conduct. Neither §2721(b)(12) nor any other provision of the DPPA warrants the massive liability this Court's judgment authorizes," she wrote.

Justices Antonin Scalia, Sonia Sotomayor and Elena Kagan joined in the dissenting opinion.

Counsel

Philip N. Elbert of Neal & Harwell in Nashville, Tenn., represents the petitioners. Paul D. Clement of Bancroft in Washington and M. Dawes Cooke Jr. of Charleston, S.C., represent the attorneys.

Arlene Fickler of Philadelphia filed an amicus curiae brief on behalf of the Electronic Frontier Foundation. Marc Rotenberg of the Electronic Privacy Information Center in Washington filed an amicus brief on behalf of the Electronic Privacy Information Center and 27 technical experts and legal scholars.

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High Court: Reverse-Payment Settlements Are Not Immune From Antitrust Scrutiny

2013-06-17T21:57:00Z

WASHINGTON, D.C. - (Mealey's) The U.S. Supreme Court on June 17 ruled 5-3 that reverse-payment settlements of patent litigation between the holder of a drug patent and potential generic manufacturers of the drug are not necessarily immunized from an antitrust challenge, even if the anti-competitive effects of the agreement fall within the scope of the exclusionary potential of the patent, and that reverse-payment settlements should be analyzed under the rule of reason (Federal Trade Commission v. Actavis, Inc., et al., No. 12-416, U.S. Sup.) (lexis.com subscribers may access Supreme Court briefs and the opinion for this case).

Justice Stephen G. Breyer, writing for the majority, said that the 11th Circuit U.S. Court of Appeals erred in dismissing the Federal Trade Commission's complaint against Solvay Pharmaceuticals Inc. and generic drugmakers Actavis Inc. (formerly known as Watson Pharmaceuticals Inc.), Paddock Holdings Inc. and Par Pharmaceutical Cos. Inc. The agreements at issue involve payments made by Solvay to the generic drugmakers to settle Solvay's patent infringement lawsuit in exchange for the generic manufacturers' agreement not to market generic versions of AndroGel, a topical gel that treats the symptoms of low testosterone, in the United States prior to 2015.

The majority declined to hold that reverse-payment settlement agreements are presumptively unlawful. Instead, the majority said that courts reviewing the agreements should apply the rule of reason, rather than a quick-look approach.

Justices Anthony M. Kennedy, Ruth Bader Ginsburg, Sonia Sotomayor and Elena Kagan joined in the majority opinion.

Chief Justice John G. Roberts Jr. filed a dissenting opinion, saying that patent law "provides an exception to antitrust law, and the scope of the patent - i.e., the rights conferred by the patent - forms the zone within which the patent holder may operate without facing antitrust liability." Justices Antonin Scalia and Clarence Thomas joined in the dissenting opinion.

Justice Samuel A. Alito Jr. took no part in the consideration or decision of the case.

FTC Complaint

The FTC alleged that Solvay was not likely to prevail in the infringement actions that it brought against the generic manufacturers and then settled and, therefore, that the reverse-payment settlements unlawfully protected or preserved a monopoly that likely was invalid in restraint of trade in violation of Federal Trade Commission Act Section 5(a).

The U.S. District Court for the Northern District of Georgia dismissed the FTC's complaint under Federal Rule of Civil Procedure 12(b)(6), finding that the FTC did "not allege that the settlements exceed the scope of the . . . patent."

On April 25, 2012, the 11th Circuit ruled that "'absent sham (patent) litigation or fraud in obtaining the patent, a reverse payment settlement is immune from antitrust attack so long as its anticompetitive effects fall within the scope of the exclusionary potential of the patent,' i.e., so long as the patentee does not obtain more protection from competition than would result from a successful infringement suit."

Because the generic manufacturers' promise not to enter the market expired before the patent's term ended, the 11th Circuit found the agreement legal and dismissed the FTC complaint.

Patent Law Policy

In reversing and ruling that the 11th Circuit should have allowed the FTC's lawsuit to proceed, the majority said that "it would be incongruous to determine antitrust legality by measuring the settlement's anticompetitive effects solely against patent law policy, rather than by measuring them against precompetitive antitrust policies as well." The majority noted that the patent might not be valid and might not be infringed.

Moreover, "this Court's precedents make clear that patent-related settlement agreements can sometimes violate the antitrust laws" and "the Court has struck down overly restrictive patent licensing agreements - irrespective of whether those agreements produced supra-patent-permitted revenues," the majority said.

The majority distinguished the reverse-payment settlement agreements at issue from traditional settlements, saying that "[i]n the traditional examples . . . , a party with a claim (or counterclaim) for damages receives a sum equal to or less than the value of its claim. In reverse patent settlements, in contrast, a party with no claim for damages . . . walks away with money simply so it will stay away from the patentee's market."

Antitrust Considerations

In concluding that the desirability of settlements should not immunize reverse-payment settlements from antitrust challenges, Justice Breyer said that such settlements have the "potential for genuine adverse effects on competition" because "payment in return for staying out of the market - simply keeps prices at patentee-set levels, potentially producing the full patent-related $500 million monopoly return while dividing that return between the challenged patentee and the patent challenger. The patentee and the challenger gain; the consumer loses."

"These anticompetitive consequences will at least sometimes prove unjustified," Justice Breyer said, adding that "where a reverse payment threatens to work unjustified anticompetitive harm, the patentee likely possesses the power to bring that harm about in practice."

The majority also concluded that "it is normally not necessary to litigate patent validity to answer the antitrust question. . . . [T]he size of the unexplained reverse payment can provide a workable surrogate for a patent's weakness, all without forcing a court to conduct a detailed exploration of the validity of the patent itself."

"[T]he fact that a large, unjustified reverse payment risks antitrust liability does not prevent litigating parties from settling their lawsuit. They may, as in other industries, settle in other ways, for example, by allowing the generic manufacturer to enter the patentee's market prior to the patent's expiration, without the patentee paying the challenger to stay out prior to that point," the majority said.

Not Presumptively Unlawful

However, the majority rejected the FTC's argument that reverse-payment settlement agreements are presumptively unlawful and subject to a quick-look approach.

"[T]he likelihood of a reverse payment bringing about anticompetitive effects depends upon its size, its scale in relation to the payor's anticipated future litigation costs, its independence from other services for which it might represent payment, and the lack of any other convincing justification. The existence and degree of any anticompetitive consequence may also vary as among industries," the majority said.

Therefore, such agreements are subject to a rule-of-reason analysis, the majority ruled.

Dissent

Dissenting, Chief Justice Roberts said that "under our precedent, this is a fairly straightforward case. Solvay paid a competitor to respect its patent - conduct which did not exceed the scope of its patent. No one alleges that there was sham litigation, or that Solvay's patent was obtained through fraud on the PTO [Patent and Trademark Office]. As in any settlement, Solvay gave its competitors something of value (money) and, in exchange, its competitors gave it something of value (dropping their legal claims). In doing so, they put an end to litigation that had been dragging on for three years. Ordinarily, we would think this a good thing."

"The majority's rule will discourage settlement of patent litigation," which is "particularly complex" and "particularly costly," the dissent said.

"[A]lthough the question posed by this case is fundamentally a question of patent law - i.e., whether Solvay's patent was valid and therefore permitted Solvay to pay competitors to honor the scope of its patent - the majority declares that such questions should henceforth be scrutinized by antitrust law's unruly rule of reason," the dissent said, also noting that antitrust law provides for treble damages.

"I fear the Court's attempt to limit its holding to the context of patent settlements under Hatch-Waxman will not long hold," the chief justice said.

Amici

Amicus curiae briefs in support of the FTC were filed by Knowledge Ecology International; Public Patent Foundation; Louisiana Wholesale Drug Co. Inc., CVS Pharmacy Inc., Rite Aid Corp., Walgreen Co., Eckerd Corp., The Kroger Co., Safeway Inc., Albertson's Inc., Hy-Vee Inc. and Maxi Drug Inc.; America's Health Insurance Plans; States of New York, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Illinois, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Mexico, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Vermont, Washington and Wyoming, the District of Columbia and the Commonwealth of Puerto Rico; 118 law, economic and business professors and the American Antitrust Institute; Apotex Inc.; AARP, American Medical Association, National Legislative Association for Prescription Drug Prices and U.S. Public Interest Research Groups; Rep. Henry A. Waxman; and National Association of Chain Drug Stores (NACDS).

Amicus briefs in support of the drug companies were filed by National Association of Manufacturers; generic manufacturers Upsher-Smith Laboratories Inc., Teva Pharmaceuticals USA Inc., Ranbaxy Pharmaceuticals Inc., Mylan Pharmaceuticals Inc. and Impax Laboratories Inc.; Enavail; Generic Pharmaceutical Association; Bayer AG and Bayer Corp.; Shire PLC; New York Intellectual Property Law Association; Merck & Co. Inc.; Pharmaceutical Research and Manufacturers of America; antitrust economists; law professors Gregory Dolin, Kent Bernard, Christopher Holman, Adam Mossoff, Emily Michiko Morris, Mark F. Schultz, Geoffrey A. Manne and Max Oppenheimer; American Intellectual Property Law Association Mediation and Negotiation Professionals; David W. Opderbeck and Erik Lillquist; health and economics professors; Washington Legal Foundation; and Intellectual Property Owners Association.

Counsel

The FTC is represented by Solicitor General Donald B. Verrilli Jr., Acting Assistant Attorney General Renata B. Hesse, Deputy Solicitor General Malcolm L. Stewart and Assistant to the Solicitor General Benjamin J. Horwich of the U.S. Department of Justice and Acting General Counsel David C. Shonka, Deputy General Counsel for Litigation John F. Daly, Deputy Chief Trial Counsel Michael B. Kades and Attorneys Mark S. Hegedus and Mark J. Woodward of the FTC. All are in Washington.

Actavis is represented by Clifford M. Sloan, Steven C. Sunshine and Julia K. York of Skadden, Arps, Slate, Meagher & Flom in Washington and David A. Buchen of Actavis in Parsippany, N.J. Solvay is represented by Jeffrey I. Weinberger, Stuart N. Senator and Adam R. Lawton of Munger, Tolles & Olson in Los Angeles and Rohit K. Skngla, Michelle T. Friedland and Michael J. Mongan of Munger Tolles in San Francisco. Par and Paddock are represented by Eric Grannon, J. Mark Gidley, Ryan M. Christian and David R. Courchaine of White & Case in Washington.

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U.S. Supreme Court Will Hear Bankruptcy Case Involving Charge On Debtor's Property

2013-06-17T21:51:32Z

WASHINGTON, D.C. - (Mealey's) The U.S. Supreme Court on June 17 granted certiorari in a case involving the question of whether a bankruptcy court has the power to levy a financial charge against a Chapter 7 debtor's residential property, which he has claimed falls under the homestead exemption, despite the suggestion of the U.S. solicitor general that the high court deny hearing the case (Stephen Law v. Alfred Siegel, No. 12-5196, U.S. Sup.) (lexis.com subscribers may access Supreme Court briefs for this case).

Bankruptcy Filed

In 2004, Stephen Law filed for Chapter 7 bankruptcy in the U.S. Bankruptcy Court for the Central District of California. He listed his home property value as $363,348 and sought a homestead exemption.

The Chapter 7 trustee, Alfred Siegel, did not object to the homestead exemption, but two years later, the trustee moved to surcharge Law's homestead exemption $75,000.

Law argued that he was not properly served in the process.

Lien

The trustee had argued that Law defrauded his creditors by filing a phony lien against his property to take value out of the property.

The Bankruptcy Court granted the trustee's surcharge, and Law appealed to the U.S. Bankruptcy Appellate Panel (BAP) for the Ninth Circuit. The BAP reversed the surcharge order, concluding that it was "not warranted."

The trustee appealed to the Ninth Circuit U.S. Court of Appeals, which reversed the BAP's ruling and determined that the surcharge was proper. Law appealed to the Supreme Court.

Surcharge

Law argues that the Supreme Court should reverse the Ninth Circuit's ruling and order the trustee to pay him the $75,000 surcharge pertaining to the homestead exemption.

Law maintains that the surcharge in question is not permitted against his property because it is protected by the homestead exemption.

The solicitor general had contended that the case should not be granted certiorari because it did not present the question on which courts of appeals are divided. Specifically, the solicitor general said the equitable surcharge at issue in the case at hand was independently supported by the Bankruptcy Court's inherent authority to sanction fraudulent and abusive litigation conduct.

Law is represented by Matthew Hellman of Jenner & Block in Washington. The trustee is represented by David Seror of Ezra Brutzkus Gubner in Woodland Hills, Calif. The solicitor general is represented by Solicitor General Donald B. Verrilli Jr., Acting Assistant Attorney General Stuart F. Delery, Deputy Solicitor General Malcolm L. Stewart, Assistant to the Solicitor General Sarah E. Harrington, Michael S. Raab and Anne Murphy of the U.S. Department of Justice. All are in Washington.

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California Official Reports: Electronic Advance Sheet - Court Opinions For Monday, June 17, 2013

2013-06-17T21:46:50Z

The Shepard's Link(TM) feature has created hyperlinks to www.lexis.com

Find a LexisNexis Sales Representative ▪ Browse Legal Bookstore ▪ Search Court Records ▪ Feedback

The CA e-Advance provides a business daily e-mail service to keep you updated and to provide online links to:

Index of new California opinions
Index of actions without opinion

Index of new California opinions:

1. County of Los Angeles v. Los Angeles County Employee Relations Com., S191944, SUPREME COURT OF CALIFORNIA, 2013 Cal. LEXIS 4692 ^Shepardize, May 30, 2013, Filed

CORE TERMS: disclosure, privacy, nonmember, notice, collective bargaining, privacy interest, bargain, presumptively, invasion, balancing ...

2. In re Boyette, S092356, SUPREME COURT OF CALIFORNIA, 2013 Cal. LEXIS 4693 ^Shepardize, May 30, 2013, Filed

CORE TERMS: juror, movie, referee, deliberation, prison, misconduct, watched, film's, biased, bias ...

3. People v. Rountree, S048543, SUPREME COURT OF CALIFORNIA, 2013 Cal. LEXIS 4424 ^Shepardize, May 23, 2013, Filed

CORE TERMS: juror's, shot, death penalty, murder, prospective juror, special circumstances, photographs, codefendant, change of venue, confession ...

4. Scott B. v. Bd. of Trs. High Sch. of Arts, G047177, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 475 ^Shepardize, June 14, 2013, Opinion Filed

CORE TERMS: knife, blade, weapon, expulsion, expelled, charter school, writ of mandate, evidentiary hearing, qualify, capricious ...

5. Donlen v. Ford Motor Co., C065722, COURT OF APPEAL OF CALIFORNIA, THIRD APPELLATE DISTRICT, 2013 Cal. App. LEXIS 474 ^Shepardize, June 14, 2013, Opinion Filed

CORE TERMS: repair, transmission, warranty, truck, new trial, non-warranty, limine, dealer, miles, technician ...

6. Series Agi W. Linn of Appian Group Investors De Llc v. Eves, A135832, COURT OF APPEAL OF CALIFORNIA, FIRST APPELLATE DISTRICT, DIVISION TWO, 2013 Cal. App. LEXIS 476 ^Shepardize, June 14, 2013, Opinion Filed

CORE TERMS: guaranty, attachment, declaration, enhancement, surety, italics, guarantor, lender, exempt, contractual ...

7. People v. Pizarro, F057722, COURT OF APPEAL OF CALIFORNIA, FIFTH APPELLATE DISTRICT, 2013 Cal. App. LEXIS 471 ^Shepardize, June 13, 2013, Opinion Filed

CORE TERMS: allelic, dropout, criminal cases, perpetrator's, sentence, presently, scientific community, scientific, reexamine, innocent ...

8. County of Siskiyou v. Superior Court, C067252, COURT OF APPEAL OF CALIFORNIA, THIRD APPELLATE DISTRICT, 2013 Cal. App. LEXIS 468 ^Shepardize, June 13, 2013, Opinion Filed

CORE TERMS: groundwater, concurrent jurisdiction, venue, river, decree, public trust doctrine, real property, interconnected, water rights, subject matter ...

9. Teva Pharmaceuticals. USA, Inc. v. Superior Court, G047134, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 470 ^Shepardize, June 13, 2013, Opinion Filed

CORE TERMS: label, generic, manufacturer, labeling, drug manufacturer, brand-name, warning, preemption, update, federal law ...

10. Association of Orange County Deputy Sheriffs v. County of Orange, G047167, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 472 ^Shepardize, June 12, 2013, Opinion Filed

CORE TERMS: investigative, interview, bargaining, working conditions, internal affairs, past practice, preinvestigative, scope of representation, meet-and-confer, misconduct ...

11. Sims v. Department of Corrections & Rehabilitation, A135290, COURT OF APPEAL OF CALIFORNIA, FIRST APPELLATE DISTRICT, DIVISION TWO, 2013 Cal. App. LEXIS 424 ^Shepardize, May 30, 2013, Opinion Filed

CORE TERMS: rulemaking, inmate, condemned, "clarity", lethal injection, protocol, lethal, Administrative Law, public participation, judicial review ...

12. American Way Cellular, Inc. v. Travelers Property Casualty Co. of America, B234188, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 425 ^Shepardize, May 30, 2013, Opinion Filed

CORE TERMS: insured, coverage, endorsement, sprinkler system, insurer, broker, causes of action, sprinkler, triable, declaratory relief ...

13. Estate of Bonzi, F065067, COURT OF APPEAL OF CALIFORNIA, FIFTH APPELLATE DISTRICT, 2013 Cal. App. LEXIS 427 ^Shepardize, May 30, 2013, Opinion Filed

CORE TERMS: landfill, remediation, closure, estoppel, probate, assurance, jointly, postclosure, executor, blocked account ...

14. In re Nadia G., B243392, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 428 ^Shepardize, May 30, 2013, Opinion Filed

CORE TERMS: nonminor, juvenile, dependency jurisdiction, social worker, termination, terminate, independent living, best interest, participating, transitional ...

15. Estate of Ben-Ali, A132979, COURT OF APPEAL OF CALIFORNIA, FIRST APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 422 ^Shepardize, May 29, 2013, Opinion Filed

CORE TERMS: signature, probate, subscribing witnesses', attestation clause, genuineness, testator, proponent, decedent, clear and convincing evidence, purported ...

16. Arei II Cases, A130447, COURT OF APPEAL OF CALIFORNIA, FIRST APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 423 ^Shepardize, May 29, 2013, Opinion Filed

CORE TERMS: causes of action, conspiracy, securities law, investor, materially, defraud, offering, demurrer, aiding and abetting, misrepresentation ...

17. Adir Internat., LLC v. Superior Court , B247117, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 421 ^Shepardize, May 29, 2013, Opinion Filed

CORE TERMS: levied, disbursed, writ of execution, levy, judgment creditor, notice of appeal, levying officer, appeal bond, extinguished, authority to order ...

18. People v. Loper, D062693, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 418 ^Shepardize, May 29, 2013, Opinion Filed

CORE TERMS: sentence, substantial rights, appealable, compassionate, right to request, prisoner's, secretary, prison's, Criminal Law, initiated ...

19. Maynard v. BTI Group, Inc., A136093, COURT OF APPEAL OF CALIFORNIA, FIRST APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 429 ^Shepardize, May 29, 2013, Opinion Filed

CORE TERMS: attorney fees, prevailing party, fee provisions, party prevailing, prevailing, prevailed, causes of action, contractual, prevail, attorney fees ...

20. In re T.V., D063023, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 473 ^Shepardize, May 29, 2013, Opinion Filed, The Publication Status of this Document has been Changed by the Court from Unpublished to Published June 14, 2013.

CORE TERMS: domestic violence, substantial risk, violence, juvenile, physical harm, social worker, custody, jurisdictional, abused, hit ...

21. People v. Hurtado, B246330, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 415 ^Shepardize, May 28, 2013, Opinion Filed

CORE TERMS: resentencing, sentence, substantial right, inmate, commitment offenses, appealable, offender, violent felony, degree burglary, vacate ...

22. National Football League v. Fireman's Fund Ins. Co., B245619, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION FIVE, 2013 Cal. App. LEXIS 414 ^Shepardize, May 28, 2013, Opinion Filed

CORE TERMS: resident, insurer, conveniens, coverage, choice of forum, burden of proof, strong presumption, nonresident, place of business, inconvenient" forum ...

23. In re Timothy N., D061891, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 403 ^Shepardize, May 22, 2013, Opinion Filed

CORE TERMS: probation, restitution, plea agreement, conditions of probation, "successfully completed, prosecutor's, misdemeanor, successful completion, "successfully complete, termination ...

24. Dow v. Lassen Irrigation Co., C068550, COURT OF APPEAL OF CALIFORNIA, THIRD APPELLATE DISTRICT, 2013 Cal. App. LEXIS 406 ^Shepardize, May 22, 2013, Opinion Filed

CORE TERMS: irrigation, river, decree, reservoir, diversion, "divert, storage, user, beneficial use, acre-feet ...

25. People v. Eid, G046129, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 404 ^Shepardize, May 22, 2013, Opinion Filed, As modified June 12, 2013., Modified and rehearing denied by People v. Eid, 2013 Cal. App. LEXIS 465 ^Shepardize (Cal. App. 4th Dist., June 12, 2013)

CORE TERMS: lesser, kidnapping, convicted, ransom, charged crimes, phone, false imprisonment, extortion, motel, lesser offense ...

26. Rybicki v. Carlson, B240211, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION FOUR, 2013 Cal. App. LEXIS 405 ^Shepardize, May 22, 2013, Opinion Filed

CORE TERMS: alcoholic beverages, alcohol, furnishing, common law rule, intoxicated person, proximate cause, intoxication, causes of action, civil liability, reinstate ...

27. Liberty National Enterprises v. Chicago Title Ins. Co., B234341, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION EIGHT, 2013 Cal. App. LEXIS 469 ^Shepardize, May 22, 2013, Opinion Filed, The Publication Status of this Document has been Changed by the Court from Unpublished to Published June 13, 2013.

CORE TERMS: coverage, duty to defend, insurer", insured, percent interest, insuring clause, partnership, quiet, encumbrance, sellers ...

28. Bombardier Recreational Products, Inc. v. Dow Chemical Canada ULC, C065603, COURT OF APPEAL OF CALIFORNIA, THIRD APPELLATE DISTRICT, 2013 Cal. App. LEXIS 399 ^Shepardize, May 21, 2013, Opinion Filed

CORE TERMS: minimum contacts, fuel tank, personal jurisdiction, forum state, purposefully, manufacturer, watercraft, manufactured, "purposeful, availment" ...

29. Schwartz v. Provident Life & Accident Ins. Co., A134706, COURT OF APPEAL OF CALIFORNIA, FIRST APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 400 ^Shepardize, May 21, 2013, Opinion Filed

CORE TERMS: insurer, policyholder, insured, premium, disability, coverage, unfair competition law, unfair competition, denied benefits, cause of action ...

30. North Coast Rivers Alliance v. Marin Municipal Water Dist. Bd. of Directors, A133821, A135626, COURT OF APPEAL OF CALIFORNIA, FIRST APPELLATE DISTRICT, DIVISION FOUR, 2013 Cal. App. LEXIS 401 ^Shepardize, May 21, 2013, Opinion Filed

CORE TERMS: tank, environmental, mitigation measures, emission, site, plant, impact report, fish", species, sampling ...

31. People v. Solis, No. B238099, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION SIX, 2013 Cal. App. LEXIS 467 ^Shepardize, May 15, 2013, Opinion Filed, The Publication Status of this Document has been Changed by the Court from Unpublished to Published June 13, 2013.

CORE TERMS: marijuana, cooperative, nonprofit, membership, reasonable doubt, guidelines, registered, vendor, patient, financial records ...

32. People v. Her, C069153, COURT OF APPEAL OF CALIFORNIA, THIRD APPELLATE DISTRICT, 2013 Cal. App. LEXIS 435 ^Shepardize, May 14, 2013, Opinion Filed, As modified June 12, 2013., CERTIFIED FOR PARTIAL PUBLICATION** Pursuant to California Rules of Court, rules 8.1105 and 8.1110, this opinion is certified for publication with the exception of parts II and III of the Discussion., The Publication Status of this Document has been Changed by the Court from Unpublished to Published May 29, 2013.Modified by People v. Zang Her, 2013 Cal. App. LEXIS 466 ^Shepardize (Cal. App. 3d Dist., June 12, 2013)

CORE TERMS: profile, contributor, partial, statistical analysis, bloodstain, mixture, pillow, allele", glove, mixed-source ...

33. People v. Smith, A135760, COURT OF APPEAL OF CALIFORNIA, FIRST APPELLATE DISTRICT, DIVISION FIVE, 2013 Cal. App. LEXIS 417 ^Shepardize, May 7, 2013, Opinion Filed, The Publication Status of this Document has been Changed by the Court from Unpublished to Published May 28, 2013.

CORE TERMS: sexually, frivolous, violent, predator, diagnosis, conditional release, unconditional, phase, paraphilia, mental disorder ...

34. Fuller v. First Franklin Financial Corp., C070452, COURT OF APPEAL OF CALIFORNIA, THIRD APPELLATE DISTRICT, 2013 Cal. App. LEXIS 419 ^Shepardize, May 1, 2013, Opinion Filed, The Publication Status of this Document has been Changed by the Court from Unpublished to Published May 29, 2013.

CORE TERMS: demurrer, broker--, limitations period, appraisal, cause of action, discovery, mortgage, fiduciary duty, notice, deceit ...

35. People v. Blackburn, H037207, COURT OF APPEAL OF CALIFORNIA, SIXTH APPELLATE DISTRICT, 2013 Cal. App. LEXIS 313 ^Shepardize, April 23, 2013, Opinion Filed

CORE TERMS: jury trial, waive, advisement, waived, personal waiver, exclusive control, mental disorder, best interests, mentally disordered, offender ...

Index of actions without opinion

No new actions since last update.

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Abbey Spanier LLP: California Appeals Court Reverses Its Previous Denial Of Class Certification In Light Of Brinker Decision

2013-06-14T21:27:21Z

Plaintiffs brought a class action on behalf of approximately 4,000 current and former employees of Boyd & Associates, Inc. which provides security guard services. Plaintiffs alleged that Boyd denied off-duty meal breaks and off-duty rest breaks and did not include certain reimbursements and an annual bonus payment in calculating the hourly rate of overtime pay. Plaintiffs proposed three subclasses: (1) the Meal Break Class, (2) the Rest Break Class, and (3) the Overtime Class. The appeals court initially issued an opinion affirming the denial of class certification of the Meal Break Class and the Rest Break Class and reversing the order denying certification of the Overtime Class. After the court issued its opinion, the California Supreme Court issued its landmark decision Brinker Restaurant Corp. v. Superior Court, 53 Cal. 4th 1004 (2012) [enhanced version available to lexis.com subscribers]. Upon reconsideration, the appellate court concluded that all three subclasses should be certified. The only class certification question in dispute before the appellate court was the predominance of common questions. The court concluded that in light of Brinker common issues of fact predominate in determining whether Boyd was liable for not providing off-duty meal breaks. The court explained that "Brinker teaches that we must focus on the policy itself and address the issue whether the legality of the policy can be resolved on a classwide basis." The court held that that plaintiffs' claim, that Boyd's meal policy is unlawful, is amendable to class treatment because "the evidence presented in connection with the motion for class certification established Boyd's on-duty meal break policy was uniformly and consistently applied to all security guard employees." The court reached a similar conclusion for the Rest Break Class and held that common issues predominate explaining that "the lawfulness of Boyd's lack of rest break policy and requirement that all security guard employees remain at their posts can be determined on a classwide basis." Finally, the court concluded that "whether the work uniform maintenance allowance and gasoline reimbursement must be included in calculating the overtime rate of pay can be decided on a classwide basis as a legal matter based on common proof" and that "[p]laintiffs also presented evidence that Boyd had uniform, companywide policies for determining entitlement to an annual bonus."

[lexis.com subscribers may read the enhanced opinion.]

Abbey Spanier, LLP, located in New York City, is a well-recognized national class action and complex litigation law firm.

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The Week In Securities Litigation: SEC Settles Going Private Transaction Fraud Action

2013-06-14T21:05:20Z

The Commission filed a settled action alleging fraud in connection with a going private transaction based on Exchange Act Section 13(e). The agency also brought its first action penalizing an exchange for regulatory filings this week.

The SEC also added a managing director of a New York brokerage firm as a defendant in its case centered on bribes paid to an official of an Argentine bank. The Manhattan U.S. Attorney's Office filed parallel criminal charges against the same person. In addition, the Commission filed another action against an investment adviser, this time centered on the theft of assets, and three new insider trading cases. One insider trading case involved tipping by a corporate executive; another tipping by the brother-in-law of a corporate director; and a third grew out of the expert network investigation.

Finally, the Commission lost another case in the D.C. Circuit. The Court remanded a FINRA panel decision, affirmed by the Commission, for failing to consider mitigating evidence before imposing a life-time industry bar. In the district courts the agency lost a statute of limitations ruling in the wake of Gabelli in an insider trading case. It did, however, prevail on a summary judgment motion centered on Morrison issues in its high profile market crisis action against a former Goldman Sachs employee.

Click here to read the entire post.

For more commentary on developing securities issues, visit SEC Actions, a blog by Thomas Gorman.

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California Official Reports: Electronic Advance Sheet - Court Opinions For Friday, June 14, 2013

2013-06-14T17:14:40Z

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Index of new California opinions
Index of actions without opinion

Index of new California opinions:

1. People v. Lopez, S073597, SUPREME COURT OF CALIFORNIA, 2013 Cal. LEXIS 4702 ^Shepardize, June 13, 2013, Filed

CORE TERMS: prosecutor, prospective jurors, murder, juror, gang, guilt, misconduct, shooting, killing, conversation ...

2. People v. Anzalone, S192536, SUPREME COURT OF CALIFORNIA, 2013 Cal. LEXIS 4700 ^Shepardize, June 12, 2013, Filed

CORE TERMS: juror, foreperson, clerk, recorded, verdict forms, discharged, unanimous, minutes, trial error, polled ...

3. People v. Delgado, S192704, SUPREME COURT OF CALIFORNIA, 2013 Cal. LEXIS 4701 ^Shepardize, June 12, 2013, Filed

CORE TERMS: kidnapping, robbery, asportation, driver, aider and abettor, aiding and abetting, backseat, driving, accomplice, personally ...

4. People v. Williams, S030553, SUPREME COURT OF CALIFORNIA, 2013 Cal. LEXIS 4004 ^Shepardize, May 6, 2013, Filed

CORE TERMS: prosecutor's, juror's, death penalty, death penalty, prospective jurors, demeanor, defense counsel, robbery, murder, accomplice ...

5. Pedeferri v. Seidner Enters., No. B233542, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 464 ^Shepardize, June 12, 2013, Opinion Filed

CORE TERMS: toxicologist's, sentence, replace, retrial, rested, carry-over, reasonable probability, apportionment of liability, unsupported, unimpaired ...

6. In re Marriage of Ficke, G046263, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 462 ^Shepardize, June 12, 2013, Opinion Filed

CORE TERMS: imputation, "custodial" parent, spousal support, child support, marriage, best interest, noncustodial parent's, spouse, spousal, rent ...

Index of actions without opinion

1. Natalini (Gabriel) v. Import Motors Inc., S209324, SUPREME COURT OF CALIFORNIA, 2013 Cal. LEXIS 3995 ^Shepardize, May 1, 2013, Filed

2. People v. Eid, G046129, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 465 ^Shepardize, June 12, 2013, Opinion Filed

3. Jenkins v. JPMorgan Chase Bank, N.A., G046121, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 463 ^Shepardize, June 12, 2013, Opinion Filed, Modification of opinion (___ Cal.App.4^th ___; ___ Cal.Rptr.3d ___).

4. People v. Her, C069153, COURT OF APPEAL OF CALIFORNIA, THIRD APPELLATE DISTRICT, 2013 Cal. App. LEXIS 466 ^Shepardize, June 12, 2013, Opinion Filed

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Florida Appeals Court Strikes Punitive Damages, Orders Remittitur On Others In Tobacco Case

2013-06-13T23:34:27Z

WEST PALM BEACH, Fla. - (Mealey's) A Florida appeals court conditionally struck $5 million in punitive damages from a tobacco wrongful death suit June 12 and directed a trial judge to grant remittitur on $15 million in survivors' consortium claims (Philip Morris USA Inc., et al. v. Sharon Putney, et al., Nos. 4D10-3606 and 4D10-5244, Fla. App., 4th Dist.; 2013 Fla. App. LEXIS 9279).

(Opinion available. Document #04-130619-035Z.)

The Fourth District Court of Appeal panel said that as in Philip Morris USA, Inc. v. Kayton (104 So. 3d 1145 [Fla. 4th DCA 2012]) [enhanced version available to lexis.com subscribers], the trial judge incorrectly struck the defendants' statute of repose defense based on the preclusive findings of Engle v. Liggett Group Inc. (945 So. 2d 1246 [Fla. 2006]) [enhanced version].

"Similar to Kayton, the entry of a partial summary judgment on the statute of repose defense deprived the Tobacco Companies of their right to defend on that issue and have the jury make the determination," the panel said. The punitive damages award, which was assessed at $2.5 million each against Philip Morris USA Inc. and R.J. Reynolds Tobacco Co. but not against defendant Lorillard Group LLC, was not excessive, the panel said, and will be reinstated if, on retrial, the plaintiffs prevail on the issue.

Consortium

The jury's award of $5 million to each of the late Margot Putney's three surviving children was excessive compared with other verdicts and given that the adult children did not live with or depend on their mother, the panel held. The trial court thus erred in failing to grant remittitur, the panel said.

The jury in the 17th Judicial Circuit Court for Broward County, Fla., with Judge Jeffrey E. Streitfeld presiding, returned a verdict for the plaintiffs on April 26, 2010, on negligence, strict liability and conspiracy to commit fraud by concealment (Nos. 07-36668 CV [19] and 08-80000 [19]). The jury found for the tobacco companies on the fraud-by-concealment claim. The jury apportioned responsibility for the decedent's death at 15 percent for Philip Morris, 30 percent for RJR and 20 percent for Liggett, with the remaining 35 percent for the decedent herself. With the appropriate reduction for proportionate responsibility, the plaintiffs would have received approximately $14.8 million had the verdict been upheld.

Judge Burton C. Conner wrote the opinion, in which Judges Carole Y. Taylor and Spencer D. Levine concurred.

Margot Putney began smoking in 1953 at age 15 and died in 1995 with a diagnosis of oat-cell/small-cell lung cancer caused by smoking. Daughter Sharon and sons Glen and Guy Putney brought claims asserting that their mother was a member of the Engle class and entitled to the preclusive findings established by the Florida Supreme Court.

Counsel

Philip Morris is represented by Gary L. Sasso of Carlton Fields in Tampa, Fla., and Stephen N. Zack and Andrew S. Brenner of Boies, Schiller & Flexner in Miami. R.J. Reynolds is represented by John P. Wiederhold of Wiederhold & Moses in West Palm Beach and Gregory G. Katsas of Jones Day in Washington, D.C. Liggett is represented by Karen H. Curtis and Craig Salner of Clarke Silverglate in Miami and Kelly Anne Luther of Kasowitz, Benson, Torres in Miami. The plaintiffs are represented by Lincoln J. Connolly of Rossman, Baumberger, Reboso, Spier & Connolly in Miami.

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Supreme Court Partly Reverses, Says Isolated DNA Not Patentable

2013-06-13T21:12:11Z

WASHINGTON, D.C. - (Mealey's) In a unanimous ruling June 13, the U.S. Supreme Court found that although complementary DNA, or "cDNA," is patent-eligible, isolated DNA is not (The Association for Molecular Pathology, et al. v. Myriad Genetics Inc., No. 12-398, U.S. Sup.). (lexis.com subscribers may access Supreme Court briefs and the opinion for this case).

The narrowly-tailored opinion authored by Justice Clarence Thomas partly reverses a July 2011 Federal Circuit U.S. Court of Appeals ruling in favor of respondent Myriad Genetics Inc., owner of several patents for diagnostic tests relating to mutations along the BRCA1 and BRCA2 genes.

"It is important to note what is not implicated by this decision," the court wrote.

"First, there are no method claims before this Court . . . . . Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. . . . We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material," the court added.

Scientific Advancement

BRCA1 and BRCA2 are two genes responsible for most cases of hereditary breast and ovarian cancer. Myriad has sued to stop competitors from offering genetic testing for the two genes and has sent numerous cease-and-desist letters to laboratories, universities and others. In 2009, several medical organizations and individuals - including lead petitioner the Association for Molecular Pathology, along with six patients diagnosed with or at risk of hereditary breast or ovarian cancer - filed a complaint in the U.S. District Court for the Southern District of New York against the U.S. Patent and Trademark Office (PTO), Myriad and the directors of the University of Utah Research Foundation.

The petitioners alleged that 15 claims from seven Myriad patents are invalid under Section 101 of the Patent Act because they cover products of nature, laws of nature and abstract ideas. They also alleged that the effect of the challenged patents is to preempt scientific inquiry and medical care to the detriment of patients' health and scientific advancement, in violation of both Article I, Section 8, clause 8, of the U.S. Constitution and the First Amendment. The petitioners and Myriad subsequently cross-moved for summary judgment, and the petitioners prevailed.

In granting the plaintiffs summary judgment, the court construed the term "isolated DNA" as "a segment of DNA nucleotides existing separate from other cellular components normally associated with native DNA, including proteins and other DNA sequences comprising the remainder of the genome." Accordingly, the court characterized the genes at issue as "products of nature" and deemed the patents invalid pursuant to Gottschalk v. Benson (409 U.S. 63, 67 [1972]) [an enhanced version of this opinion is available to lexis.com subscribers], Diamond v. Chakrabarty (447 U.S. at 309 [1980]) [enhanced version] and other cases. Myriad appealed to the Federal Circuit U.S. Court of Appeals, which in a divided July 2011 opinion, reversed, finding that the isolated DNA molecules as claimed do not exist in nature and are thus subject to patent protection. The Federal Circuit further found that the composition claims for the patents at issue that are limited to "complementary DNA," or cDNA, are patent eligible because cDNA is a synthesized genetic material that does not occur in nature but rather is the product of considerable human creativity.

Man-Made

The plaintiffs filed a petition for writ of certiorari with the Supreme Court, which granted the petition for the limited purpose of vacating and remanding in light of its ruling in Mayo Collaborative Services v. Prometheus Laboratories Inc. (No. 10-1150, U.S. Sup.) [enhanced version]. In another divided ruling, the Federal Circuit in August 2012 again reversed the District Court's ruling, reaffirming its earlier ruling upholding the challenged composition claims and one of the method claims. The Federal Circuit also found that isolated DNA molecules "are not found in nature" and are instead "obtained in the laboratory and are man-made, the product of human ingenuity."

The plaintiffs submitted a second petition for writ of certiorari to the high court, presenting three questions. On Nov. 30, the Supreme Court granted certiorari, limited to the first question presented: "Are human genes patentable?" Oral arguments were held April 15.

Chakrabarty Distinguished

Siding with the petitioners with regard to isolated DNA, the Supreme Court noted that the "location and order of the nucleotides existed in nature before Myriad found them." Furthermore, the respondent did not "create or alter" the genetic structure of native DNA. Uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13 is insufficient to render the genes patentable as new compositions of matter, according to the Supreme Court. Distinguishing the instant dispute from Chakrabarty, the court wrote "Myriad did not create anything."

"To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry," it added.

Chemical Changes

The Supreme Court was similarly unmoved by Myriad's claim at oral argument that by isolating DNA from the human genome, chemical bonds are severed and a non-naturally occurring molecule results. The respondent's argument is "simply not expressed in terms of chemical composition," nor does Myriad "rely in any way on the chemical changes that result from the isolation of a particular section of DNA" according to the ruling.

"Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad's patent claims on entire genes . . .by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a molecule would not be chemically identical to the molecule 'invented' by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule," the Supreme Court concluded.

Something New

Myriad prevailed with regard to cDNA, however, with the Supreme Court affirming the Federal Circuit's finding that creation of a cDNA sequence from messenger RNA results in an exons-only molecule that is not naturally occurring. To that end, the Supreme Court rejected the petitioners' contention that the nucleotide sequence of cDNA is dictated by nature, and not a lab technician. "That may be so," the court wrote, "but the lab technician unquestionably creates something new when cDNA is made."

"cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a 'product of nature' and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA," the Supreme Court added.

Counsel

The petitioners are represented by Christopher A. Hansen, Steven R. Shapiro, Sandra S. Park, Aden J. Fine and Lenora M. Lapidus of American Civil Liberties Union Foundation in New York and Daniel B. Ravicher and Sabrina Y. Hassan of Public Patent Foundation, Benjamin N. Cardozo School of Law in New York.

The respondents are represented by Gregory A. Castanias and Jennifer L. Swize of Jones Day in Washington; Brian M. Poissant and Laura A. Coruzzi of Jones Day in New York; Israel Sasha Mayergoyz and Dennis Murashko of Jones Day in Chicago; and Richard M. Marsh, Benjamin G. Jackson and Matthew S. Gordon of Myriad in Salt Lake City.

The United States is represented by Solicitor General Donald Verilli Jr. and Stuart F. Delery, Malcolm L. Stewart, Beth S. Brinkmann, Ginger D. Anders, Scott R. McIntosh, Mark R. Freeman and Melissa N. Patterson of the Department of Justice in Washington.

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California Official Reports: Electronic Advance Sheet - Court Opinions For Thursday, June 13, 2013

2013-06-13T20:53:04Z

The Shepard's Link(TM) feature has created hyperlinks to www.lexis.com

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The CA e-Advance provides a business daily e-mail service to keep you updated and to provide online links to:

Index of new California opinions
Index of actions without opinion

Index of new California opinions:

1. People v. Barnes, A135131, COURT OF APPEAL OF CALIFORNIA, FIRST APPELLATE DISTRICT, DIVISION TWO, 2013 Cal. App. LEXIS 459 ^Shepardize, June 11, 2013, Opinion Filed

CORE TERMS: phone, cell, technology, tracking, electronic, privacy, reasonable expectation of privacy, reliability, trespass, stolen ...

2. In re Cabrera, F059511, COURT OF APPEAL OF CALIFORNIA, FIFTH APPELLATE DISTRICT, 2013 Cal. App. LEXIS 460 ^Shepardize, June 11, 2013, Opinion Filed

CORE TERMS: gang, inmate's, drawing, validated, validation, affiliate, artist, gang members, prison gang, prison ...

3. State Farm Mutual Automobile Ins. Co. v. Huff, D062550, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 456 ^Shepardize, June 11, 2013, Opinion Filed

CORE TERMS: Hospital Lien Act, injured person, patient, settlement, burden of proof, medical services, tortfeasor, recovered, claimant, wrongful act ...

4. J.R. Marketing L.L.C. v. Hartford Casualty Ins. Co., A133750, COURT OF APPEAL OF CALIFORNIA, FIRST APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 455 ^Shepardize, May 17, 2013, Opinion Filed, The Publication Status of this Document has been Changed by the Court from Unpublished to Published June 11, 2013.

CORE TERMS: insurer, insured, reimbursement, cross-defendant, independent counsel, duty to defend, causes of action, demurrer, coverage, independent counsel ...

5. Schaefer v. Elder, C068229, COURT OF APPEAL OF CALIFORNIA, THIRD APPELLATE DISTRICT, 2013 Cal. App. LEXIS 461 ^Shepardize, May 16, 2013, Opinion Filed, The Publication Status of this Document has been Changed by the Court from Unpublished to Published June 12, 2013.

CORE TERMS: insured, insurer, independent counsel, independent contractors, conflict of interest, declaratory relief action, contractor's, reservation of rights, moving party, coverage ...

6. City of San Diego v. Boggess, D061715, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 458 ^Shepardize, May 15, 2013, Opinion Filed, The Publication Status of this Document has been Changed by the Court from Unpublished to Published June 11, 2013.

CORE TERMS: firearm, niece, weapon, gun, bear arms, endangering, detained, mentally, seized, likely to result ...

7. Do v. The Regents of the University of California, D061056, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 457 ^Shepardize, May 13, 2013, Opinion Filed, The Publication Status of this Document has been Changed by the Court from Unpublished to Published June 11, 2013.

CORE TERMS: quasi-judicial, hearing officer, intimidation, termination, administrative agency, substantial evidence, personnel, substantial evidence, supervisor, standard of review ...

8. Mendocino Community Health Clinic v. State Dept. of Health Care Services, C067826, COURT OF APPEAL OF CALIFORNIA, THIRD APPELLATE DISTRICT, 2013 Cal. App. LEXIS 350 ^Shepardize, May 2, 2013, Opinion Filed

CORE TERMS: utilization, clinic, psychology, outpatient clinic, health centers, services rendered, "federally, Medicaid Act, federal law, provider ...

9. Choate v. Celite Corp., B239160, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION SIX, 2013 Cal. App. LEXIS 349 ^Shepardize, May 2, 2013, Opinion Filed

CORE TERMS: collective bargaining agreement, vacation time, terminated, unmistakable, pro rata, vacation, statutory rights, waiting, preempted, willfully ...

10. Multani v. Witkin & Neal, B237295, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION SEVEN, 2013 Cal. App. LEXIS 347 ^Shepardize, May 1, 2013, Opinion Filed, As modified May 29, 2013., Modified and rehearing denied by Multani v. Witkin & Neal, 2013 Cal. App. LEXIS 434 ^Shepardize (Cal. App. 2d Dist., May 29, 2013)

CORE TERMS: notice, redemption, foreclosure, foreclosure sale, nonjudicial foreclosures, right of redemption, delinquent assessment, condominium, summary judgment, trustee sale ...

11. People v. Goolsby, E052297, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION TWO, 2013 Cal. App. LEXIS 340 ^Shepardize, April 30, 2013, Opinion Filed

CORE TERMS: arson, motor home, inhabited structure, lesser, inhabited, arson statute, jury's verdict, district attorney, mobilehome, matter of law ...

12. People v. Superior Court (Kaulick), B246632, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 341 ^Shepardize, April 30, 2013, Opinion Filed

CORE TERMS: sentence, resentencing, dangerousness, prisoner, notice, beyond a reasonable doubt, sentenced, sentencing, risk of danger, imprisonment ...

13. Duchrow v. Forrest, B233736, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 344 ^Shepardize, April 30, 2013, Opinion Filed

CORE TERMS: withdraw, contingency, attorney fees, amend, prior suit, hourly, quantum meruit, time spent, good cause, withdrawal ...

14. In re Marriage of Kahn, E054082, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION TWO, 2013 Cal. App. LEXIS 326 ^Shepardize, April 26, 2013, Opinion Filed, CERTIFIED FOR PARTIAL PUBLICATION** Pursuant to California Rules of Court, rules 8.1105(b) and 8.1110, this opinion is certified for publication with the exception of parts I, II, and III.

CORE TERMS: default, notice, marital, dissolution action, void, box, default judgment, fiduciary duty, dissolution, exceeded ...

15. Dep't of Corr. & Rehab. v. State Pers. Bd., D061653, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 325 ^Shepardize; 78 Cal. Comp. Cases 390, April 26, 2013, Opinion Filed

CORE TERMS: workers' compensation, criminal investigation, limitations period, peace officers, extrinsic, wrist, statutory language, lawmakers, vetoed, misconduct ...

16. Breceda v. Superior Court, B244574, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 321 ^Shepardize, April 25, 2013, Opinion Filed

CORE TERMS: trip, grand jury, district attorney, grand jury, meal, per diem, indictment, embezzlement, deputy, double ...

17. People v. Mortimer, H037530, COURT OF APPEAL OF CALIFORNIA, SIXTH APPELLATE DISTRICT, 2013 Cal. App. LEXIS 317 ^Shepardize, April 25, 2013, Opinion Filed

CORE TERMS: jury trial, personal waiver, waived, waive, statutory right, juvenile, advisement, offender--, advise, incompetent ...

18. People v. Fuquay, H037195, COURT OF APPEAL OF CALIFORNIA, SIXTH APPELLATE DISTRICT, 2013 Cal. App. LEXIS 318 ^Shepardize, April 25, 2013, Opinion Filed

CORE TERMS: jury trial, waive, advisement, waived, personal waiver, jury trial, statutory right, exclusive control, advise, incompetent ...

19. People v. Smith, D060317, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 285 ^Shepardize, April 15, 2013, Opinion Filed, CERTIFIED FOR PARTIAL PUBLICATION** Pursuant to California Rules of Court, rule 8.1110, this opinion is certified for publication with the exception of Discussion parts B. through H.

CORE TERMS: probable consequences, gang, gun, perpetrator", nontarget, killings, apartment, target offense, murder, confederate ...

20. Copenbarger v. Morris Cerullo World Evangelism, G046273, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION THREE, 2013 Cal. App. LEXIS 345 ^Shepardize, April 3, 2013, Opinion Filed, The Publication Status of this Document has been Changed by the Court from Unpublished to Published April 30, 2013.

CORE TERMS: notice, landlord, cause of action, unlawful detainer action, tenant, sublease, protected activity, repair, lawsuit, ground lease ...

21. Brown v. Mid-Century Ins. Co., B238357, COURT OF APPEAL OF CALIFORNIA, SECOND APPELLATE DISTRICT, DIVISION SEVEN, 2013 Cal. App. LEXIS 316 ^Shepardize, April 2, 2013, Opinion Filed, As modified Apr. 24, 2013., The Publication Status of this Document has been Changed by the Court from Unpublished to Published April 24, 2013.

CORE TERMS: pipe, coverage, sudden, leak, period of time, gradual, efficient proximate cause, water damage, hole, hot water ...

22. Heritage Pacific Financial, LLC v. Monroy, A135274, A136043, COURT OF APPEAL OF CALIFORNIA, FIRST APPELLATE DISTRICT, DIVISION TWO, 2013 Cal. App. LEXIS 323 ^Shepardize, March 29, 2013, Opinion Filed, The Publication Status of this Document has been Changed by the Court from Unpublished to Published April 25, 2013.

CORE TERMS: attorney fees, promissory note, tort claim, causes of action, assigned, consumer, Fair Debt Collection Practices Act, mortgage, borrower, notice ...

23. City of Monterey v. Carrnshimba, H036475, COURT OF APPEAL OF CALIFORNIA, SIXTH APPELLATE DISTRICT, 2013 Cal. App. LEXIS 328 ^Shepardize, March 27, 2013, Opinion Filed, The Publication Status of this Document has been Changed by the Court from Unpublished to Published April 25, 2013.

CORE TERMS: dispensary, marijuana, classification, ordinance, patient, moratorium, summary judgment, permitted uses, nuisance per se, business license ...

Index of actions without opinion

No new actions since last update.

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Recent SEC Charges Raise Liability Questions For Government Entities

2013-06-12T21:02:55Z

In two administrative enforcement actions last month, the SEC charged two municipalities - Harrisburg, Pa. and South Miami, Fla. - with securities fraud. These high-profile actions sounded alarm bells and raised concerns about possible securities violations involving other state and local governments. But while these two actions have grabbed a great deal of attention, the unfortunate fact is that allegations of securities law violations against local governments are nothing new. However, the recent problems do raise serious concerns for state and local government bond investors, which in turn raise concerns about what the liability implications may be for the government entities and their officials.

On May 6, 2013, in the first of the two most recent actions, the SEC instituted settled administrative proceedings against Harrisburg, charging the city with securities fraud for its "misleading public statements when its financial condition was deteriorating and financial information available to municipal bond investors was either incomplete or outdated." The SEC's press release describing the action and the city's entry into a consent cease and desist order details the misleadingly reassuring or incomplete statements the city provided at a time when its financial woes were well known to city officials.

The press release states that the Harrisburg action "marks the first time that the SEC has charged a municipality for misleading statements made outside of its securities disclosure documents." The agency's administrative order was accompanied by a separate report addressing the disclosure obligations of public officials and "their potential liability under the federal securities laws for public statements made in the secondary market for municipal securities."

Click here to read the entire post.

Read other items of interest from the world of directors & officers liability, with occasional commentary, at the D&O Diary, a blog by Kevin LaCroix.

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William A. Ruskin: No FIFRA Preemption, No Problem!

2013-06-12T19:58:12Z

By William A. Ruskin

In Gresser v. Dow Chemical Co., Ind. Ct. App., No 79A02-1111-CT-1014, 4/30/13 [enhanced version available to lexis.com subscribers], the plaintiffs in this toxic tort case alleged that their children developed a variety of illnesses after a purported exposure to Dursban TC in their home following a pesticide application by the co-defendant pesticide applicator.

Plaintiffs alleged that defendants Dow Chemical Company and Dow Agrosciences (collectively, "Dow") failed to use reasonable care to instruct about the use of the product; warn about its danger; and appropriately test the design of the product. Following discovery, both plaintiffs and Dow filed motions for summary judgment.

On April 13, 2013, the Indiana Court of Appeals reversed a trial court order granting Dow summary judgment on FIFRA preemption grounds, but granted Dow summary judgment on the basis of the rebuttable presumption in Indiana's product liability statute (the "IPLA") that a product is not defective if it complies with federal or Indiana standards or regulations. Thus, Dow obtained from the IPLA presumption relief that it could not obtain by preemption.

Ind. Code § 34-20-5-1 [enhanced version] provides a rebuttable presumption that a product which caused physical harm is not defective, and the manufacturer or seller of the product is not negligent, if before the sale by the manufacturer, the product "complied with applicable codes, standards, regulations, or specifications established, promulgated, or approved by the United States or by Indiana, or by an agency of the United States or Indiana."

In determining that Dow was entitled to the statutory presumption, the court held that Dursban TC's compliance with both FIFRA and Indiana law had a significant impact under IPLA's consumer expectation-based product liability regime because the risk of harm had been evaluated by agencies with the duty of monitoring the effects of Dursban TC. Furthermore, Dursban TC's labeling and warnings had been approved by experts.

On the basis of this ruling, the appellate court determined that the trial court correctly granted Dow summary judgment motion on plaintiffs' failure to warn claims

This decision is significant because Dow was able to obtain through the use of the statutory presumption the same end result that it would have obtained had the appellate court found that the plaintiff's claims were subject to preemption. Other states, including New Jersey, have similar provisions in their statutes in varying contexts. In New Jersey, the New Jersey Product Liability Act, N.J.S.A. 2A:58C-1 et seq., specifically provides an evidentiary presumption in the favor of drug manufacturers against failure-to-warn claims:

"If the warning or instruction given in connection with a drug or device or food additive has been approved or prescribed by the federal Food and Drug Administration under the Federal Food, Drug and Cosmetic Act, 52 Stat. 1040, 21 U.S.C. Sec. 301 et seq., ... rebuttable presumption shall arise that the warning or instruction is adequate."

Thus, product liability practitioners, in both the FDA and FIFRA contexts, should be mindful of the importance of developing evidence in discovery and at trial concerning the regulatory approval process and the evaluations performed by the agency of the appropriateness of the product warnings, directions for use, and of the product's safety and efficacy.

For more cutting edge commentary on developing issues, visit Toxic Tort Litigation Blog by William A. Ruskin of Epstein Becker & Green.

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California Official Reports: Electronic Advance Sheet - Court Opinions For Wednesday, June 12, 2013

2013-06-12T15:15:25Z

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The CA e-Advance provides a business daily e-mail service to keep you updated and to provide online links to:

Index of new California opinions
Index of actions without opinion

Index of new California opinions:

1. Julius Castle Restaurant Inc. v. Payne, A130955, A130957, and A131905, COURT OF APPEAL OF CALIFORNIA, FIRST APPELLATE DISTRICT, DIVISION ONE, 2013 Cal. App. LEXIS 453 ^Shepardize, June 10, 2013, Opinion Filed, CERTIFIED FOR PARTIAL PUBLICATION** Pursuant to California Rules of Court, rules 8.1105(b) and 8.1110, this opinion is certified for publication with the exception of parts III. through VII. of the Discussion.

CORE TERMS: restaurant, lease, parol evidence rule, repair, inducement, tenant, notice, fraudulent, sophisticated, induced ...

2. California Assn. of Professional Scientists v. Brown, C066948, C067288, C067461, COURT OF APPEAL OF CALIFORNIA, THIRD APPELLATE DISTRICT, 2013 Cal. App. LEXIS 387 ^Shepardize, May 16, 2013, Opinion Filed

CORE TERMS: expired, supersession, paid holidays, holiday, bargaining units, employee organizations, savings, premium, legislative history, declaratory relief ...

Index of actions without opinion

1. People v. Lewis, E055569, COURT OF APPEAL OF CALIFORNIA, FOURTH APPELLATE DISTRICT, DIVISION TWO, 2013 Cal. App. LEXIS 454 ^Shepardize, June 10, 2013, Opinion Filed, Modification of opinion (___Cal. App.4^th ___; ___ Cal.Rptr.3d ___), upon denial of rehearing.

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FDA Lifts All Restrictions On Plan B One-Step Contraceptive, Will Drop Appeal

2013-06-11T20:22:33Z

BROOKLYN, N.Y. - (Mealey's) The federal government on June 10 told a federal judge that it will make the one-pill Plan B One-Step emergency contraceptive available without age or point-of-sale restrictions and intends to voluntarily withdraw its appeal of the judge's order requiring the lifting of all restrictions (Annie Tummino, et al. v. Margaret Hamburg, et al., No. 12-763, E.D. N.Y., Annie Tummino, et al. v. Margaret Hamburg, et al., No. 13-1690, 2nd Cir).

(Letter available. Document #28-130620-003X. Citizen petition letter available. Document #28-130620-004X.)

In a letter to U.S. Judge Edward R. Korman of the Eastern District of New York, U.S. Attorney Loretta E. Lynch of the Eastern District said the U.S. Department of Health and Human Services and the Food and Drug Administration have complied with Judge Korman's April 10 judgment by granting a 2001 citizen petition by the Center for Reproductive Rights to make Plan B One-Step available over the counter and without age or point-of-sale restrictions.

The FDA had in April approved Plan B One-Step to be sold over-the-counter to women 15 years and older with proof of age and if sold in a store that has an on-site pharmacy.

"It is the government's understanding that this course of action fully complies with the Court's judgment in this action," Lynch said. "Once the Court confirms that the government's understanding is correct, the government will file with the Circuit Court [Second Circuit U.S. Court of Appeals] notice that it is voluntarily withdrawing its appeal in this matter."

Labeling Change Invited

Lynch said the FDA on June 10 invited the manufacturer of Plan B One-Step, Teva Branded Pharmaceutical Products R&D Inc., to promptly submit a supplemental new drug application (SNDA) with proposed labeling that will permit Plan B One-Step to be sold without a prescription and without age or point-of-sale restrictions. "Upon receipt of the SNDA, FDA will approve it without delay," Lynch said.

The U.S. attorney said that after the FDA receives and approves Teva's SNDA, it expects that sponsors of generic versions of Plan B One-Step will submit amendments to their abbreviated new drug applications.

Lynch also told Judge Korman that the FDA on June 10 issued a response to the 2001 citizen petition by outlining the steps the agency is seeking with respect to Plan B One-Step.

No Change For 2-Pill Version

However, Lynch said, "FDA will not at this time take steps to change the approval status of the two-pill Plan B or its generic equivalents." She said that although Judge Korman ordered the FDA to make levonorgestrel-based emergency contraceptives available without prescription or age or point-of-sale restrictions within 30 days of the order, the order also said that the FDA may determine whether any new labeling is reasonably necessary and that if the agency believes there is a significant difference between Plan B and Plan B One-Step, it may limit its over-the-counter approval of the one-pill product.

"FDA continues to believe, for the reasons that the government has previously explained in its briefs to the Court, that there are significant differences between Plan B and PBOS [Plan B One-Step] under FDA's regulations and the Food, Drug and Cosmetic Act," Lynch wrote.

The government's attorney also said Teva's Plan B One-Step application contained actual use data addressing the ability of adolescents to understand and follow directions for the drug. "[T]here are fewer data available regarding the actual use of Plan B as a non-prescription product by younger adolescents," she wrote.

"FDA therefore believes it is appropriate and consistent with this Court's order to comply by making only PBOS (and not the two-pill product) available OTC [over-the-counter] to younger adolescents."

Plan B Stance 'Unjustified'

Attached to Lynch's letter is the FDA's response to the 2001 citizen petition.

In a June 10 press release, Nancy Northrup, president and CEO of the Center for Reproductive Rights, praised the lifting of restrictions for Plan B One-Step but said the "the Obama Administration continues to unjustifiably deny the same wide availability for generic, more affordable brand of emergency contraception."

"We are pleased that women should soon be able to buy Plan B One-Step without the arbitrary restrictions that kept it locked behind the pharmacy counter when they needed it most urgently," Northrup said. "But we will continue to fight for fair treatment for women who want and need more affordable options."

Citizen Petition, Litigation

When the center and 60 other family planning and women's health organizations filed the citizen petition, only two-pill versions of levonorgestrel-based emergency contraception were available. When the FDA failed to act on the citizen petition, some of the petitioners sued.

Judge Korman found that the FDA's decisions were being politically influenced by the Bush administration and remanded the issue after the Obama administration came in. When the FDA instead made Plan B prescription for women under 17 and nonprescription but behind the counter for women over 17, the defendants reopened their case.

In April, Judge Korman found that the FDA acted in bad faith, noting that the FDA staff recommended lifting all restrictions for the emergency contraceptives but were overruled by Health and Human Services Secretary Kathleen Sebelius, who has no scientific background. Judge Korman ordered the FDA to immediately make all levonorgestrel-based emergency contraceptives available without restriction.

The FDA responded by approving Teva's application for Plan B One-Step and appealing Judge Korman's order. The judge stayed his order only as a courtesy to the Second Circuit, accusing the government of engaging in delay tactics.

Cost, Age Requirements Questioned

Judge Korman criticized the FDA's approval of Plan B One-Step as a "sweetheart" deal with Teva, which received limited exclusivity to market the drug and charged more than generic levonorgestrel-based contraceptives cost. The judge and the plaintiffs were also critical of the age restriction, saying many 15-year-olds and minority females may not have government-issued identification such as a driver's license.

Last week, the Second Circuit granted a stay as to Plan B One-Step but not as to Plan B.

The government is represented by Senior Counsel F. Franklin Amanat and Lynch of the U.S. Attorney's Office in Brooklyn, Stuart F. Delery, Beth S. Brinkmann, Mark B. Stern and Adam C. Jed of the U.S. Justice Department in Washington, D.C., and David J. Horowitz, Elizabeth H. Dickinson, Annamarie Kempic and Scott A. Kaplan of the U.S. Department of Health and Human Services in Washington.

The plaintiffs are represented by Kirsten Clanton of Southern Legal Counsel Inc. in Gainesville, Fla., Andrea Hope Costello and Mara Verheyden-Hilliard of the Partnership for Civil Justice Fund in Washington and Janet L. Crepps of the Center for Reproductive Rights in Simpsonville, S.C.

Intervenor Teva Women's Health is represented by Michael D. Shumsky of Kirkland & Ellis in Washington.

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