Preemption Update: The Legal Landscape since Reigel v. Medtronic, Inc., 128 S.Ct. 999 (2008) Wendy Fleishman Lieff Cabraser Heimann & Bernstein, LLP

Size: px
Start display at page:

Download "Preemption Update: The Legal Landscape since Reigel v. Medtronic, Inc., 128 S.Ct. 999 (2008) Wendy Fleishman Lieff Cabraser Heimann & Bernstein, LLP"

Transcription

1 Preemption Update: The Legal Landscape since Reigel v. Medtronic, Inc., 128 S.Ct. 999 (2008) Wendy Fleishman October 5,

2 I. The Medical Device Amendments Act The Medical Device Amendments of 1976 ( MDA ), 21 U.S.C. 360c et seq., to the Federal Food, Drug and Cosmetic Act ( FDCA ), 21 U.S.C. 301 et seq., contain an express preemption clause stating that: no [s]tate or political subdivision... may establish or continue in effect with respect to a device intended for human use any requirement -- (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. 21 U.S.C. 360k(a) (1976) ( 360k(a) ) (emphasis added). II. Legal Challenges After Riegel In the Second Circuit, there were two reported decisions at the District Court level in two medical device cases where the District Courts dismissed claims as preempted and applied the logic of Riegel: Horowitz v. Stryker Corp., 613 F.Supp.2d 271, 68 UCC Rep.Serv.2d 64, Prod.Liab.Rep. (CCH) P 18,192, E.D.N.Y., February 20, 2009 (NO. CIV.A.CV DGT) The District Court, Trager, J., held that: (1) recipient's negligence and recklessness, defective manufacturing, defective design, breaches of express and implied warranties, and failure to warn 2

3 claims were preempted by Medical Device Amendments (MDA) to Food, Drug and Cosmetic Act (FDCA), and (2) recipient's allegations failed to state violations of New York state General Business Law. Ilarraza v. Medtronic, Inc., 677 F.Supp.2d 582, E.D.N.Y., December 28, 2009 (NO. CV ) The Plaintiff brought a cause of action in her amended complaint for negligence per se against Medtronic in connection with a pain pump. The cause of action alleges that Medtronic failed to manufacture the Medication Pump in a reasonable and prudent manner, and in accord with federally prescribed Current Good Manufacturing Practices ( CGMP's ). The Amended Complaint goes on to list eleven federal regulations alleged to have been violated in the manufacture of the Medication Pump. The District Court recognized that the Supreme Court held open the potential for parallel claims: The Court went on to hold that the MDA preemption provision does not bar a state from imposing a dam-ages remedy for a claim premised on the violation of federal law. In such a lawsuit, the plaintiff would seek damages for the violation of federal, and not state lawduties that the Court referred to as parallel to FDA requirements. Riegel, 128 S.Ct. at Thus, the court left open a narrow class of state court actions that could seek damages for injuries alleged to have been caused by federally regulated medical devices. Such lawsuits can be referred to as parallel actions. See *586 In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F.Supp.2d 1147, 1152 (D.Minn.2009) (referring to narrow back door left open by Riegel ). The court turns to consider whether the Amended Complaint states such a claim. 677 F.Supp.2d 582, 586. Nonetheless, the District Court dismissed the action, on the grounds that the claims assserted by the plaintiff were only the broad statement of the federal manufacturing regulations, without specific violations asserted. The court wrote: The broad nature of the federal regulations relied upon also leads to the conclusion 3

4 that Plaintiff's claim cannot withstand the pleading requirements of Twombly. As noted, those standards require dismissal of complaints that do nothing more than engage ion a formulaic recitation of the elements of a cause of action... Twombly, 127 S.Ct. at Where, as here, the plaintiff has done nothing more that recite unsupported violations of general regulations, and fails to tie such allegations to the injuries alleged, the complaint is properly dismissed. Id. at 588. In the Third Circuit In Williams v. Cyberonics, Slip Copy, 2010 WL , (Not Selected for publication in the Federal Reporter), C.A.3 (Pa.), July 30, 2010 (NO ), users of medical device implanted into neck to stimulate nerves in order to treat depression brought action against device manufacturer, alleging strict liability for manufacturing defect, breach of warranty, fraudulent misrepresentation, and negligent misrepresentation. The United States District Court for the Eastern District of Pennsylvania, (Brody, J. 654 F.Supp.2d 301), granted manufacturer's motion for summary judgment, and users appealed. The U.S. Court of Appeals for the Third Circuit issued the ruling, saying the common law product liability for manufacturing defect and breach of warranty claims are preempted by the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act. The Third Circuit, however, said the device was given premarket approval after a rigorous review by the U.S. Food and Drug Administration as required by the MDA. The amendments, the Court said, were also specifically designed to preempt the claims advanced by the plaintiffs. The Court wrote: Appellants' allegations of strict products liability based on manufacturing defect and breach of warranty are pre-empted by the MDA. Generalized common law theories of liability, such as those advanced in appellants' complaint, are precisely the type of claims the MDA sought to preempt. See id. at 325 ( tort law, 4

5 applied by juries under a negligence or strict-liability standard, is pre-empted by the MDA); Horn, 376 F.3d at 173 ( [I]t is firmly established that a requirement under 360k(a) can include legal requirements that arise out of state common-law damages actions. ). Success on appellants' breach of warranty claims would require them to show that the VNS Therapy System device was unsafe or ineffective despite the PMA process, thereby interfering with the requirements already established by the MDA, which has preempted safety and effectiveness determinations for a device. 21 U.S.C. 360k(a); see Riegel, 552 U.S. at 325 (holding that state law that requires a manufacturer's devices to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme ). Appellants also advance a strict products liability claim for a manufacturing defect based on the malfunction theory, which allows the trier-of-fact to infer a defect from the fact that the device malfunctioned. See Bruesewitz v. Wyeth Inc., 561 F.3d 233, 255 (3d Cir.2009), cert. granted, --- U.S. ----, 130 S.Ct. 1734, 176 L.Ed.2d 211 (2010) (stating that the malfunction theory permits a plaintiff to base a products liability claim on circumstantial evidence of a manufacturing defect. ). Although it is alleged that the VNS Therapy System stopped working for the Williamses and malfunctioned for Knight, appellants fail to explain how the device deviated from the FDA requirements. See Riegel, 552 U.S. at 330 (holding that strict liability claims under 360k are not preempted if premised on a violation of FDA regulations ); Horn, 376 F.3d at 179 (rejecting plaintiff's manufacturing defect claim because she did not assert[ ] that [defendant] has in any way failed to conform with the FDA requirements prescribed by its 5

6 PMA-nor that it deviated from, or violated, any of the FDA's federal statutes or regulations ). Rather, appellants seek to ground Cyberonics' liability on requirements that go beyond those established by the MDA. Accordingly, appellants' claims are preempted. III. CONTRARY DECISIONS: A. Breach of Warranty Claims Should Not Be Preempted As part of the PreMarket Approval ( PMA ) process, a manufacturer is required to submit a label for the FDA s review. Under the FDA regulatory scheme, once a device has received premarket approval, a manufacturer generally must obtain FDA approval before making any changes in the labeling, or any other attribute that would affect the device s safety or effectiveness. The important exception to that regulatory scheme is that the MDA allows a Special PMA Supplement Changes Being Effected ( CBE Supplement ) under 21 C.F.R (d) (2008). A CBE Supplement permits a manufacturer to make [l]abeling changes that add or strengthen a contraindication, warning, precaution, or information about an adverse reaction for which there is reasonable evidence of a causal association prior to FDA approval. 21 C.F.R (d)(2)(i). A manufacturer is also allowed to make [l]abeling changes that delete misleading, false, or unsupported indications. 21 C.F.R (d)(2)(iii). If these changes are not objected to by the FDA, they become accepted as part of the label. This CBE system is nearly identical to the CBE system applicable to pharmaceutical products. In Wyeth v. Levine, 129 S. Ct. at 1196, the United States Supreme Court, conducted a detailed review of that system and found that state law claims premised on the same are not preempted: There is an FDA regulation that permits a manufacturer to make certain changes to its label before receiving the agency s approval. Among other things, this changes being effected (CBE) regulation provides that if a manufacturer is changing a label to add or strengthen a contraindication, warning, precaution, or adverse reaction or to add or strengthen an instruction about dosage and administration that is intended to increase the 6

7 safe use of the drug product, it may make the labeling change upon filing its supplemental application with the FDA; it need not wait for FDA approval (c)(6)(iii)(A), (C). Under both the MDA and the regulations applicable to pharmaceutical products, the manufacturer has a duty to update the label about adverse effects once there is a reasonable evidence of a causal association. 21 C.F.R (d)(2)(i). That obligation is made explicit in the FDA s Conditions of Approval. Those conditions state: A PMA supplement must be submitted when unanticipated adverse effects, increases in the incidence of anticipated adverse effects, or device failures necessitate a labeling, manufacturing, or device modification (emphasis added). Therefore, an argument can be made that the failure to warn and the failure to follow the express instructions of the FDA in its approval is a parallel claim. B. Manufacturing Defect Claims Should Not Be Preempted In Purcel v. Advanced Bionics, 2008 WL (N.D.Tex.2008), for example, the plaintiff successfully stated a parallel claim. There, it was alleged that a particular malfunction causing plaintiff's injury was the result of an unapproved supplier's modification of a component part of the regulated device. Purcel, 2008 WL *1. The pleading with respect to the modification in Purcel alleged that defendant violated a particular federal specification referring to the device at issue. Similarly, in Rollins v. St. Jude Medical, 583 F.Supp.2d 790 (W.D.La.2008), the plaintiff stated a parallel claim where he was able to point to the alleged violation of premarketing packing requirements applicable to the particular medical device at issue. See Rollins, 583 F.Supp.2d at In Hofts v. Howmedica Osteonics Corp., 597 F.Supp.2d 830 (S.D.In.2009), the patient sued the manufacturer of an artificial hip replacement device, asserting claims of strict liability for defective manufacture, negligent manufacture, breach of express warranty, breach of the implied warranty of fitness for a particular purpose, breach of the implied warranty of merchantability, and violations of the Indiana commercial fraud statute. The manufacturer moved to dismiss. The District Court, David F. Hamilton, Chief Judge, held that the patient's claims were 7

8 not preempted under the express preemption clause of the Medical Device Amendments of 1976 (MDA). Hofts' negligence and strict liability claims (Counts I and IV of his Amended Complaint) stem from his allegations that Howmedica defectively manufactured the Trident by violating the FDA's manufacturing requirements. The Court wrote: Here it is clear that Hofts bases his tort claims on his allegations that Howmedica failed to meet the FDA's requirements, not on allegations that Howmedica failed to depart from or exceed those requirements. A jury could find that Howmedica breached the duty of care it owed to Hofts by failing to adhere to the FDA's manufacturing requirements without imposing different or additional requirements. See Lohr, 518 U.S. at 495, 116 S.Ct Similarly, on Hofts' strict liability claim, a jury could find that Howmedica's deviation from the FDA's manufacturing requirements was unreasonably dangerous without imposing different or additional requirements. If supported by the evidence, these results would be entirely consistent with the legal presumption that the FDA got it right in setting those requirements. A jury verdict could simply enforce those same federal requirements. The only state law requirements implicit in Hofts' tort claims are thus identical or parallel to the FDA's federal requirements under Riegel, so that Hofts' state tort claims are not preempted under section 360k(a). 597 F.Supp.2d 830, 836. In addition, the Court found that Hofts express breach of warranty claims were also not preempted. C. Product Liability Claims involving a Medical Device that was Approved Pursuant to a 510(k) Should Not Be Preempted Riegel, and its progeny all address Class III medical devices that have been approved pursuant to the PMA process. 8

9 Medical Device Amendments (MDA) classify medical devices in three categories based on risk to public: devices that present no unreasonable risk of illness or injury are designated Class I and are subject only to minimal regulation by general controls; potentially more harmful devices are designated Class II and may be marketed without advance approval, but their manufacturers must comply with federal performance regulations known as special controls; and devices that either present potential unreasonable risk of illness or injury, or which are purported or represented to be for use in supporting or sustaining human life or for use which is of substantial importance in preventing impairment of human health, are designated Class III and must obtain premarket approval (PMA). Federal Food, Drug, and Cosmetic Act, 513(a)(1)(A, B, C), as amended, 21 U.S.C.A. 360c(a)(1)(A, B, C). Two important exceptions exist to premarket approval (PMA) requirement for Class III medical devices under Medical Device Amendments (MDA): first, grandfathering provision allows pre-1976 devices to remain on market without Food and Drug Administration (FDA) approval until such time as FDA initiates and completes requisite PMA, and second, to prevent manufacturers of grandfathered devices from monopolizing market while new devices clear PMA hurdle and to ensure that improvements to existing devices can be rapidly introduced into market, MDA also permits devices that are substantially equivalent to preexisting devices to avoid PMA process. Federal Food, Drug, and Cosmetic Act, 515(b)(1)(A, B), as amended, 21 U.S.C.A. 360e(b)(1)(A, B); 21 C.F.R (c)(1). While Class III medical devices which are substantially equivalent to devices already approved may be marketed under Medical Device Amendments (MDA) without rigorous premarket approval (PMA) review, such new devices, as well as all new Class I and Class II devices, are subject to limited form of review under which every manufacturer intending to market new device is required to submit premarket notification to Food and Drug Administration (FDA); if FDA concludes that the device is substantially equivalent to preexisting device, it can be marketed without further regulatory analysis. Federal Food, Drug, and Cosmetic Act, 510(k), as amended, 21 U.S.C.A. 360(k). Where a device has been approved pursuant to a 510(k) approval, there is no submission of detailed clinical studies and related scientific 9

10 analysis. Under Medtronic v. Lohr, 518 U.S. 470, 116 S.Ct (1996), the Supreme Court held that state law defective design claims asserted against manufacturer of pacemaker which was Class III device under Medical Device Amendments (MDA), and which was marketed as device substantially equivalent to devices already on market, were not preempted under MDA; Food and Drug Administration (FDA) in approving device based on substantial equivalency did not require pacemaker to take any particular form for any particular reason, and simply allowed pacemaker to be marketed without running gauntlet of premarket approval (PMA) process under MDA. Federal Food, Drug, and Cosmetic Act, 510(k), as amended, 21 U.S.C.A. 360(k)

Bender's Health Care Law Monthly September 1, 2011

Bender's Health Care Law Monthly September 1, 2011 Bender's Health Care Law Monthly September 1, 2011 SECTION: Vol. 2011; No. 9 Federal Pre-Emption Under The Food, Drug & Cosmetic Act From Medtronic, Inc. V. Lohr; Pliva, Inc. V. Mensing By Frederick R.

More information

) ) ) ) ) ) ) ) ) ) ) )

) ) ) ) ) ) ) ) ) ) ) ) Case :0-cv-00-RCC Document Filed /0/0 Page of 0 0 Richard Stengel, et al., vs. Medtronic, Inc. Plaintiffs, Defendant. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF ARIZONA No. CV 0--TUC-RCC ORDER

More information

Case 2:09-cv LKK-KJM Document 28 Filed 07/09/2009 Page 1 of 20

Case 2:09-cv LKK-KJM Document 28 Filed 07/09/2009 Page 1 of 20 Case :0-cv-00-LKK-KJM Document Filed 0/0/00 Page of 0 0 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF CALIFORNIA MARLENE PRUDHEL, RANDALL S. PRUDHEL, BRADLEY K. PRUDHEL, RYAN K. PRUDHEL, and

More information

Preemption in Nonprescription Drug Cases

Preemption in Nonprescription Drug Cases drug and medical device Over the Counter and Under the Radar By James F. Rogers, Julie A. Flaming and Jane T. Davis Preemption in Nonprescription Drug Cases Although it must be considered on a case-by-case

More information

Case 6:11-cv CEH-TBS Document 43 Filed 09/27/12 Page 1 of 13 PageID 355 UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA ORLANDO DIVISION

Case 6:11-cv CEH-TBS Document 43 Filed 09/27/12 Page 1 of 13 PageID 355 UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA ORLANDO DIVISION Case 6:11-cv-01444-CEH-TBS Document 43 Filed 09/27/12 Page 1 of 13 PageID 355 UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA ORLANDO DIVISION PEGGY MCCLELLAND as Personal Representative of the

More information

IN THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT

IN THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT Case: 14-40183 Document: 00512886600 Page: 1 Date Filed: 12/31/2014 IN THE UNITED STATES COURT OF APPEALS FOR THE FIFTH CIRCUIT RICARDO A. RODRIGUEZ, Plaintiff - Appellant Summary Calendar United States

More information

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF GEORGIA ATLANTA DIVISION : : : : : : : : : : : : ORDER

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF GEORGIA ATLANTA DIVISION : : : : : : : : : : : : ORDER Case 111-cv-04064-AT Document 25 Filed 06/15/12 Page 1 of 19 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF GEORGIA ATLANTA DIVISION SHERYL D. CLINE, Plaintiff, v. ADVANCED NEUROMODULATION

More information

Latham & Watkins Litigation Department

Latham & Watkins Litigation Department Number 522 July 18, 2006 Client Alert Latham & Watkins Litigation Department Second Circuit Finds State Common Law Claims Involving FDA Premarket Approved Medical Devices Preempted Riegel is a significant

More information

Supreme Court Bars State Common Law Claims Challenging Medical Devices with FDA Pre-Market Approval

Supreme Court Bars State Common Law Claims Challenging Medical Devices with FDA Pre-Market Approval report from washi ngton Supreme Court Bars State Common Law Claims Challenging Medical Devices with FDA Pre-Market Approval March 6, 2008 To view THE SUPREME COURT S DECISION IN riegel V. medtronic, Inc.

More information

CV (LDW) (ARL) Plaintiff Theresa Burkett ( Burkett ) brings this products liability action against

CV (LDW) (ARL) Plaintiff Theresa Burkett ( Burkett ) brings this products liability action against UNITED STATES DISTRICT COURT EASTERN DISTRICT OF NEW YORK --------------------------------------------------------X THERESA BURKETT, Plaintiff, MEMORANDUM AND ORDER -against- CV 12-4895 (LDW) (ARL) SMITH

More information

IN THE MISSOURI COURT OF APPEALS WESTERN DISTRICT

IN THE MISSOURI COURT OF APPEALS WESTERN DISTRICT IN THE MISSOURI COURT OF APPEALS WESTERN DISTRICT J.W., ) ) Appellant, ) ) v. ) ) BAYER CORP., ET AL., ) Opinion filed: December 5, 2017 ) Respondent. ) APPEAL FROM THE CIRCUIT COURT OF THE HONORABLE COUNTY,

More information

Federal Preemption in Class III Medical Device Cases By Donna B. DeVaney and Patrick Hamilton

Federal Preemption in Class III Medical Device Cases By Donna B. DeVaney and Patrick Hamilton Product Liability Federal Preemption in Class III Medical Device Cases By Donna B. DeVaney and Patrick Hamilton I. Introduction The Medical Device Amendments ( MDA ), 21 U.S.C. 360c et seq., to the Food,

More information

UNITED STATES COURT OF APPEALS. August Term, Argued: December 15, 2005 Decided: May 16, 2006) Docket No cv MEDTRONIC, INC.

UNITED STATES COURT OF APPEALS. August Term, Argued: December 15, 2005 Decided: May 16, 2006) Docket No cv MEDTRONIC, INC. UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT August Term, 2005 Argued: December 15, 2005 Decided: May 16, 2006) Docket No. 04-0412-cv CHARLES R. RIEGEL AND DONNA S. RIEGEL, v. MEDTRONIC, INC.,

More information

Recent Developments in Federal Preemption of Pharmaceutical Drug and Medical Device Product Liability Claims. Bryan G. Scott Elizabeth K.

Recent Developments in Federal Preemption of Pharmaceutical Drug and Medical Device Product Liability Claims. Bryan G. Scott Elizabeth K. Article originally published in 17 THE DEFENDER, Fall 2009, at 22 (publication of the North Carolina Association of Defense Attorneys). Recent Developments in Federal Preemption of Pharmaceutical Drug

More information

Glennen v. Allergan, Inc.

Glennen v. Allergan, Inc. Glennen v. Allergan, Inc. GINGER PIGOTT * AND KEVIN COLE ** WHY IT MADE THE LIST Prescription medical device manufacturers defending personal injury actions have a wide variety of legal defenses not available

More information

on significant health issues pertaining to their products, and of encouraging the

on significant health issues pertaining to their products, and of encouraging the Number 836 March 17, 2009 Client Alert Latham & Watkins Wyeth v. Levine and the Contours of Conflict Preemption Under the Federal Food, Drug, and Cosmetic Act The decision in Wyeth reinforces the importance

More information

178 S.W.3d 127, *; 2005 Tex. App. LEXIS 5135, ** LEXSEE

178 S.W.3d 127, *; 2005 Tex. App. LEXIS 5135, ** LEXSEE Page 1 LEXSEE KEITH BAKER, INDIVIDUALLY, AND IAN BAKER, INDIVIDUALLY AND AS INDEPENDENT EXECUTOR OF THE ESTATE OF JEAN BAKER, DECEASED, Appellants v. ST. JUDE MEDICAL, S.C., INC. AND ST. JUDE MEDICAL,

More information

CASE 0:12-cv PJS-JSM Document 88 Filed 06/18/13 Page 1 of 24 UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA

CASE 0:12-cv PJS-JSM Document 88 Filed 06/18/13 Page 1 of 24 UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA CASE 0:12-cv-01717-PJS-JSM Document 88 Filed 06/18/13 Page 1 of 24 UNITED STATES DISTRICT COURT DISTRICT OF MINNESOTA RICHARD J. PINSONNEAULT, Civil No: 12-1717 (PJS/JSM) v. Plaintiff, ST. JUDE MEDICAL,

More information

IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF OKLAHOMA

IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF OKLAHOMA Ý» ëæïîó½ªóððêíðóó ܱ½«³»² íé Ú»¼ ðîñðêñïí Ð ¹» ï ±º îè IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF OKLAHOMA PATRICIA CAPLINGER, ) ) Plaintiff, ) ) vs. ) Case No. CIV-12-630-M ) MEDTRONIC,

More information

MEMORANDUM OPINION. This civil action is before the Court on defendant Coloplast Corporation s motion

MEMORANDUM OPINION. This civil action is before the Court on defendant Coloplast Corporation s motion UNITED STATES DISTRICT COURT EASTERN DISTRICT OF TENNESSEE AT KNOXVILLE STANLEY ROGER SPIER, ) ) Plaintiff, ) ) v. ) No.: 3:14-CV-550-TAV-HBG ) COLOPLAST CORPORATION, ) ) Defendant. ) MEMORANDUM OPINION

More information

Federal preemption in the non-drug context after Wyeth v. Levine. by Michael X. Imbroscio. Covington & Burling LLP *

Federal preemption in the non-drug context after Wyeth v. Levine. by Michael X. Imbroscio. Covington & Burling LLP * Federal preemption in the non-drug context after Wyeth v. Levine by Michael X. Imbroscio Covington & Burling LLP * The Supreme Court s 6-3 decision in Wyeth v. Levine, 129 S.Ct. 1187 (2009), rejected implied

More information

Case: Document: Page: 1 Date Filed: 09/14/2017

Case: Document: Page: 1 Date Filed: 09/14/2017 Case: 16-3785 Document: 003112726677 Page: 1 Date Filed: 09/14/2017 U.S. Department of Justice Civil Division, Appellate Staff 950 Pennsylvania Ave. NW, Rm. 7259 Washington, DC 20530 Tel: (202) 616-5372

More information

DEFENDING OTHER PARTIES IN THE CHAIN OF DISTRIBUTION

DEFENDING OTHER PARTIES IN THE CHAIN OF DISTRIBUTION DEFENDING OTHER PARTIES IN THE CHAIN OF DISTRIBUTION Publication DEFENDING OTHER PARTIES IN THE CHAIN OF DISTRIBUTION July 16, 2009 On March 4, 2009, the United States Supreme Court issued its much anticipated

More information

Case 5:05-cv IMK-JSK Document 51 Filed 04/03/2007 Page 1 of 43

Case 5:05-cv IMK-JSK Document 51 Filed 04/03/2007 Page 1 of 43 Case 5:05-cv-00177-IMK-JSK Document 51 Filed 04/03/2007 Page 1 of 43 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF WEST VIRGINIA CLARKSBURG DIVISION STEVEN RATTAY, and SHARON RATTAY,

More information

Drug Preemption v. Medical Device Preemption: A Study in Contrast

Drug Preemption v. Medical Device Preemption: A Study in Contrast Journal of the Kansas Association for Justice u Product liability Drug Preemption v. Medical Device Preemption: A Study in Contrast By Leslie Overfelt and Patrick A. Hamilton Leslie Overfelt, is a staff

More information

Case 2:18-cv GAM Document 15 Filed 07/23/18 Page 1 of 12 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

Case 2:18-cv GAM Document 15 Filed 07/23/18 Page 1 of 12 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA Case 2:18-cv-01959-GAM Document 15 Filed 07/23/18 Page 1 of 12 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA HELEN McLAUGHLIN : CIVIL ACTION NO. 14-7315 : v. : : NO. 18-1144

More information

Product Safety & Liability Reporter

Product Safety & Liability Reporter Product Safety & Liability Reporter Reproduced with permission from Product Safety & Liability Reporter, 30 PSLR 840, 08/01/2011. Copyright 2011 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com

More information

Supreme Court of the United States

Supreme Court of the United States No. 12-1351 IN THE Supreme Court of the United States MEDTRONIC, INC., Petitioner, v. RICHARD STENGEL and MARY LOU STENGEL, Respondents. On Petition for a Writ of Certiorari To the United States Court

More information

In the Supreme Court of the United States

In the Supreme Court of the United States No. 12-1351 In the Supreme Court of the United States MEDTRONIC, INC., PETITIONER v. RICHARD STENGEL AND MARY LOU STENGEL ON PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR

More information

The Supreme Court's Bright Line Ruling in Riegel v. Medtronic, Inc. Gives Manufacturers of Defective Medical Devices Broad Immunity

The Supreme Court's Bright Line Ruling in Riegel v. Medtronic, Inc. Gives Manufacturers of Defective Medical Devices Broad Immunity Journal of the National Association of Administrative Law Judiciary Volume 29 Issue 2 Article 7 10-15-2009 The Supreme Court's Bright Line Ruling in Riegel v. Medtronic, Inc. Gives Manufacturers of Defective

More information

Case 0:15-cv BB Document 28 Entered on FLSD Docket 11/19/2015 Page 1 of 18 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA

Case 0:15-cv BB Document 28 Entered on FLSD Docket 11/19/2015 Page 1 of 18 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA Case 0:15-cv-61210-BB Document 28 Entered on FLSD Docket 11/19/2015 Page 1 of 18 JOSEPH T. MINK, v. Plaintiff, SMITH & NEPHEW, INC., a foreign corporation, Defendant. / UNITED STATES DISTRICT COURT SOUTHERN

More information

PREEMPTION AND THE PHYSICIAN PAYMENTS SUNSHINE ACT TOPICS. Overview of Preemption. Recent Developments. Consequences and Strategies

PREEMPTION AND THE PHYSICIAN PAYMENTS SUNSHINE ACT TOPICS. Overview of Preemption. Recent Developments. Consequences and Strategies PREEMPTION AND THE PHYSICIAN PAYMENTS SUNSHINE ACT Robert N. Weiner October 22, 2008 TOPICS Overview of Preemption Recent Developments Consequences and Strategies OVERVIEW OF PREEMPTION SUPREMACY CLAUSE

More information

TADC PRODUCTS LIABILITY NEWSLETTER

TADC PRODUCTS LIABILITY NEWSLETTER TADC PRODUCTS LIABILITY NEWSLETTER Selected Case Summaries Prepared Fall 2013 Editor: I. Summary Joseph S. Pevsner Thompson & Knight LLP Co-Editor: Janelle L. Davis Thompson & Knight LLP Contributing Editor:

More information

WASHINGTON LEGAL FOUNDATION

WASHINGTON LEGAL FOUNDATION Docket No. FDA-2016-D-2021 COMMENTS of WASHINGTON LEGAL FOUNDATION to the FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH & HUMAN SERVICES Concerning DRAFT GUIDANCE FOR INDUSTRY AND FDA STAFF: DECIDING

More information

No IN THE UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT. ALEXIS DEGELMANN, et al., ADVANCED MEDICAL OPTICS INC.,

No IN THE UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT. ALEXIS DEGELMANN, et al., ADVANCED MEDICAL OPTICS INC., Case: 10-15222 11/14/2011 ID: 7963092 DktEntry: 45-2 Page: 1 of 17 No. 10-15222 IN THE UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT ALEXIS DEGELMANN, et al., v. Plaintiffs-Appellants, ADVANCED

More information

IN THE UNITED STATES COURT OF APPEALS FOR THE ELEVENTH CIRCUIT. No LISA GOODLIN, Appellant, MEDTRONIC, INC., Appellee.

IN THE UNITED STATES COURT OF APPEALS FOR THE ELEVENTH CIRCUIT. No LISA GOODLIN, Appellant, MEDTRONIC, INC., Appellee. IN THE UNITED STATES COURT OF APPEALS FOR THE ELEVENTH CIRCUIT No. 97-5801 LISA GOODLIN, v. Appellant, MEDTRONIC, INC., Appellee. Appeal from the United States District Court for the Southern District

More information

SUPREME COURT OF THE UNITED STATES

SUPREME COURT OF THE UNITED STATES Cite as: 552 U. S. (2008) 1 NOTICE: This opinion is subject to formal revision before publication in the preliminary print of the United States Reports. Readers are requested to notify the Reporter of

More information

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION. v. No. 04 C 8104 MEMORANDUM OPINION

IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION. v. No. 04 C 8104 MEMORANDUM OPINION Case 1 :04-cv-08104 Document 54 Filed 05/09/2005 Page 1 of 8n 0' IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION GALE C. ZIKIS, individually and as administrator

More information

The Reverse Read and Heed Causation Presumption: A Presumption That Should Be Given Little Heed

The Reverse Read and Heed Causation Presumption: A Presumption That Should Be Given Little Heed b y J o h n Q. L e w i s, P e a r s o n N. B o w n a s, a n d M a t t h e w P. S i l v e r s t e n The Reverse Read and Heed Causation Presumption: A Presumption That Should Be Given Little Heed Failure-to-warn

More information

UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT

UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT FOR PUBLICATION UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT CHRISTINA MCCLELLAN, Plaintiff-Appellant, v. I-FLOW CORPORATION, a Delaware corporation; DJO, L.L.C., a Delaware corporation; DJO INCORPORATED,

More information

United States Court of Appeals

United States Court of Appeals In the United States Court of Appeals For the Seventh Circuit No. 13-1786 STEVEN KALLAL, Plaintiff-Appellant, v. CIBA VISION CORPORATION, INC., Defendant-Appellee. Appeal from the United States District

More information

pìéêéãé=`çìêí=çñ=íüé=råáíéç=pí~íéë=

pìéêéãé=`çìêí=çñ=íüé=råáíéç=pí~íéë= No. 13-1379 IN THE pìéêéãé=`çìêí=çñ=íüé=råáíéç=pí~íéë= ATHENA COSMETICS, INC., v. ALLERGAN, INC., Petitioner, Respondent. On Petition for a Writ of Certiorari to the United States Court of Appeals for

More information

pìéêéãé=`çìêí=çñ=íüé=råáíéç=pí~íéë=

pìéêéãé=`çìêí=çñ=íüé=råáíéç=pí~íéë= No. IN THE pìéêéãé=`çìêí=çñ=íüé=råáíéç=pí~íéë= MEDTRONIC, INC., v. Petitioner, RICHARD STENGEL AND MARY LOU STENGEL, Respondents. On Petition For A Writ Of Certiorari To The United States Court Of Appeals

More information

No IN THE UNITED STATES COURT OF APPEALS FOR THE EIGHTH CIRCUIT. v. MEDTRONIC, INC., et al.,

No IN THE UNITED STATES COURT OF APPEALS FOR THE EIGHTH CIRCUIT. v. MEDTRONIC, INC., et al., Appellate Case: 09-2290 Page: 1 Date Filed: 11/15/2010 Entry ID: 3724072 No. 09-2290 IN THE UNITED STATES COURT OF APPEALS FOR THE EIGHTH CIRCUIT IN RE MEDTRONIC, INC. SPRINT FIDELIS LEADS PRODUCTS LIABILITY

More information

New Federal Initiatives Project. Executive Order on Preemption

New Federal Initiatives Project. Executive Order on Preemption New Federal Initiatives Project Executive Order on Preemption By Jack Park* September 4, 2009 The Federalist Society for Law and Public Policy Studies www.fed-soc.org Executive Order on Preemption On May

More information

Case 2:14-cv JP Document 49 Filed 04/29/15 Page 1 of 63 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

Case 2:14-cv JP Document 49 Filed 04/29/15 Page 1 of 63 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA Case 214-cv-07315-JP Document 49 Filed 04/29/15 Page 1 of 63 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA HELEN MCLAUGHLIN, Plaintiff, v. BAYER, CORP., BAYER HEALTHCARE

More information

Case 2:15-cv GP Document 46 Filed 06/30/15 Page 1 of 3

Case 2:15-cv GP Document 46 Filed 06/30/15 Page 1 of 3 Case 215-cv-00384-GP Document 46 Filed 06/30/15 Page 1 of 3 Case 215-cv-00384-GP Document 46 Filed 06/30/15 Page 2 of 3 Case 215-cv-00384-GP Document 46 Filed 06/30/15 Page 3 of 3 Case 215-cv-00384-GP

More information

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF HAWAII ) ) ) ) ) ) ) ) ) ) ) ) I. INTRODUCTION

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF HAWAII ) ) ) ) ) ) ) ) ) ) ) ) I. INTRODUCTION Case 1:13-cv-00686-JMS-RLP Document 32 Filed 04/10/14 Page 1 of 44 PageID #: 984 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF HAWAII KARLA BEAVERS-GABRIEL, vs. Plaintiff, MEDTRONIC, INC. and

More information

The Federal Preemption Battle Has Just Begun

The Federal Preemption Battle Has Just Begun Portfolio Media, Inc. 648 Broadway, Suite 200 New York, NY 10012 www.law360.com Phone: +1 212 537 6331 Fax: +1 212 537 6371 customerservice@portfoliomedia.com The Federal Preemption Battle Has Just Begun

More information

2. Plaintiffs amended complaint is hereby dismissed with prejudice.

2. Plaintiffs amended complaint is hereby dismissed with prejudice. MID-L-002442-18 L 09/12/2018 12/24/2018 4:04:04 PM Pg Pg 1 of 1 2 of Trans 2 Trans ID: ID: LCV20182226629 LCV20181580346 Michael C. Zogby (NJ ID 030312002) Jessica L. Brennan (NJ ID 024232007) DRINKER

More information

THE STATE OF NEW HAMPSHIRE JUDICIAL BRANCH SUPERIOR COURT

THE STATE OF NEW HAMPSHIRE JUDICIAL BRANCH SUPERIOR COURT THE STATE OF NEW HAMPSHIRE JUDICIAL BRANCH SUPERIOR COURT Hillsborough Superior Court Southern District 30 Spring Street Nashua NH 03060 NOTICE OF DECISION DAVID FERRERA, ESQ NUTTER MCCLENNEN & FISH LLP

More information

Case 2:06-cv CJB-SS Document 29 Filed 01/12/2007 Page 1 of 6 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA VERSUS NO:

Case 2:06-cv CJB-SS Document 29 Filed 01/12/2007 Page 1 of 6 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA VERSUS NO: Case 2:06-cv-00585-CJB-SS Document 29 Filed 01/12/2007 Page 1 of 6 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA CLIFTON DREYFUS CIVIL ACTION VERSUS NO: 06-585 ADVANCED MEDICAL OPTICS, INC.

More information

Buckman Extended: Federal Preemption of State Fraud-on-the-FDA Statutes

Buckman Extended: Federal Preemption of State Fraud-on-the-FDA Statutes Seton Hall University erepository @ Seton Hall Law School Student Scholarship Seton Hall Law 5-1-2014 Buckman Extended: Federal Preemption of State Fraud-on-the-FDA Statutes Christine Anne Gaddis Follow

More information

2013 PA Super 215. Appellants No. 83 EDA 2012

2013 PA Super 215. Appellants No. 83 EDA 2012 2013 PA Super 215 IN RE: REGLAN/METOCLOPRAMIDE LITIGATION, IN THE SUPERIOR COURT OF PENNSYLVANIA APPEAL OF: MORTON GROVE PHARMACEUTICALS INC., AND WOCKHARDT USA, LLC, Appellants No. 83 EDA 2012 Appeal

More information

Case 2:14-cv PD Document 65 Filed 03/22/16 Page 1 of 54 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

Case 2:14-cv PD Document 65 Filed 03/22/16 Page 1 of 54 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA Case 2:14-cv-07317-PD Document 65 Filed 03/22/16 Page 1 of 54 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA HELEN McLAUGHLIN : CIVIL ACTION : v. : : BAYER CORPORATION, et

More information

UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK

UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK Case 7:16-cv-05774 Document 1 Filed 07/20/16 Page 1 of 27 UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK ANNAH MARIE GIDORA -against- Plaintiff, COMPLAINT AND DEMAND FOR JURY TRIAL

More information

Dobbs V. Wyeth: Are We There Yet, And At What Cost?

Dobbs V. Wyeth: Are We There Yet, And At What Cost? Portfolio Media. Inc. 860 Broadway, 6th Floor New York, NY 10003 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Dobbs V. Wyeth: Are We There Yet, And At What Cost?

More information

Case 3:16-cv Document 1 Filed 09/09/16 Page 1 of 41 PageID: 1 UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY TRENTON DIVISION

Case 3:16-cv Document 1 Filed 09/09/16 Page 1 of 41 PageID: 1 UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY TRENTON DIVISION Case 3:16-cv-05478 Document 1 Filed 09/09/16 Page 1 of 41 PageID: 1 UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY TRENTON DIVISION CRYSTAL ERVIN and LEE ERVIN, Civil Action No. Plaintiffs, JANSSEN

More information

Gile v. Optical Radiation Corporation, et al.

Gile v. Optical Radiation Corporation, et al. 1994 Decisions Opinions of the United States Court of Appeals for the Third Circuit 5-3-1994 Gile v. Optical Radiation Corporation, et al. Precedential or Non-Precedential: Docket 93-5555 Follow this and

More information

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA VERSUS NO: TEVA PHARMACEUTICALS USA, INC. ET AL.

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA VERSUS NO: TEVA PHARMACEUTICALS USA, INC. ET AL. DAVIS UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA CIVIL ACTION VERSUS NO: 13-6365 TEVA PHARMACEUTICALS USA, INC. ET AL. SECTION: "J" (4) ORDER AND REASONS Before the Court is a Motion for

More information

Case 3:17-cv Document 1 Filed 10/20/17 Page 1 of 40 PageID: 1 UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY

Case 3:17-cv Document 1 Filed 10/20/17 Page 1 of 40 PageID: 1 UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY Case 3:17-cv-08867 Document 1 Filed 10/20/17 Page 1 of 40 PageID: 1 UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY IN RE: INVOKANA (CANAGLIFLOZIN) PRODUCTS LIABLITY LITIGATION ROBIN PEPPER, Plaintiff,

More information

NO IN THE SUPREME COURT OF THE UNITE STATES. October Term, 2017 ALICE IVERS. Petitioner, WESTERLY PHARMACEUTICAL, INC. Respondent.

NO IN THE SUPREME COURT OF THE UNITE STATES. October Term, 2017 ALICE IVERS. Petitioner, WESTERLY PHARMACEUTICAL, INC. Respondent. NO. 17-230 IN THE SUPREME COURT OF THE UNITE STATES October Term, 2017 ALICE IVERS Petitioner, v. WESTERLY PHARMACEUTICAL, INC. Respondent. On Writ of Certiorari to the Twelfth Circuit Court of Appeals

More information

3:14-cv MGL Date Filed 10/23/14 Entry Number 24 Page 1 of 5

3:14-cv MGL Date Filed 10/23/14 Entry Number 24 Page 1 of 5 3:14-cv-01982-MGL Date Filed 10/23/14 Entry Number 24 Page 1 of 5 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF SOUTH CAROLINA COLUMBIA DIVISION Melinda K. Lindler, Plaintiff, vs. Civil Action

More information

Case 3:15-cv SMY-DGW Document 1 Filed 10/28/15 Page 1 of 46 Page ID #1

Case 3:15-cv SMY-DGW Document 1 Filed 10/28/15 Page 1 of 46 Page ID #1 Case 3:15-cv-01195-SMY-DGW Document 1 Filed 10/28/15 Page 1 of 46 Page ID #1 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF ILLINOIS EAST ST. LOUIS DIVISION Anthony R. Allen, ) ) Plaintiff,

More information

NEXT DECADE TO-DO: Enforce Preemption for Class II Devices with Special Controls. Luther T. Munford and Erin P. Lane

NEXT DECADE TO-DO: Enforce Preemption for Class II Devices with Special Controls. Luther T. Munford and Erin P. Lane NEXT DECADE TO-DO: Enforce Preemption for Class II Devices with Special Controls Luther T. Munford and Erin P. Lane 32 The common assumption is that FDA premarket approval of a Class III device is a necessary

More information

IN THE UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF ALABAMA SOUTHERN DIVISION

IN THE UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF ALABAMA SOUTHERN DIVISION Case Case 1:15-cv-00636-CB-C Document 1 Filed 1 Filed 12/15/15 Page Page 1 of 145 of 45 IN THE UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF ALABAMA SOUTHERN DIVISION Luana Jean Collie, ) ) CIVIL ACTION

More information

Case 4:18-cv JAS Document 1 Filed 03/01/18 Page 1 of 45 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF ARIZONA

Case 4:18-cv JAS Document 1 Filed 03/01/18 Page 1 of 45 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF ARIZONA Case 4:18-cv-00116-JAS Document 1 Filed 03/01/18 Page 1 of 45 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF ARIZONA KRISTI ANN LANE, ) ) PLAINTIFF, ) ) Civil Action No: vs. ) ) BOEHRINGER INGELHEIM

More information

Case 3:16-cv Document 1 Filed 07/25/16 Page 1 of 39 PageID: 1 UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY TRENTON DIVISION

Case 3:16-cv Document 1 Filed 07/25/16 Page 1 of 39 PageID: 1 UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY TRENTON DIVISION Case 3:16-cv-04484 Document 1 Filed 07/25/16 Page 1 of 39 PageID: 1 UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY TRENTON DIVISION SHERYL DESALIS, Civil Action No. Plaintiff, JANSSEN PHARMACEUTICALS,

More information

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF KENTUCKY SOUTHERN DIVISION (at London) ) ) ) ) ) ) ) ) ) ) *** *** *** ***

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF KENTUCKY SOUTHERN DIVISION (at London) ) ) ) ) ) ) ) ) ) ) *** *** *** *** UNITED STATES DISTRICT COURT EASTERN DISTRICT OF KENTUCKY SOUTHERN DIVISION (at London TASHA BAIRD, V. Plaintiff, BAYER HEALTHCARE PHARMACEUTICALS, INC., Defendant. Civil Action No. 6: 13-077-DCR MEMORANDUM

More information

Latest Developments in Federal Preemption. Submitted for. ACI Drug and Medical Device Conference. New York, New York.

Latest Developments in Federal Preemption. Submitted for. ACI Drug and Medical Device Conference. New York, New York. Latest Developments in Federal Preemption by Anand Agneshwar, 1 Michael Imbroscio, 2 and Lisa Martinez Wolmart 3 Submitted for ACI Drug and Medical Device Conference New York, New York December 2007 1

More information

Case 4:15-cv JSW Document 55 Filed 03/31/17 Page 1 of 6 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA

Case 4:15-cv JSW Document 55 Filed 03/31/17 Page 1 of 6 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA Case :-cv-0-jsw Document Filed 0// Page of UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA 0 TROY WALKER, Plaintiff, v. CONAGRA FOODS, INC., Defendant. Case No. -cv-0-jsw ORDER GRANTING MOTION

More information

- F.3d, 2009 WL , C.A.Fed. (Mass.), April 03, 2009 (NO )

- F.3d, 2009 WL , C.A.Fed. (Mass.), April 03, 2009 (NO ) CITE AS: 1 HASTINGS. SCI. AND TECH. L.J. 269 ARIAD PHARMACEUTICALS, INC. V. ELI LILLY AND COMPANY - F.3d, 2009 WL 877642, C.A.Fed. (Mass.), April 03, 2009 (NO. 2008-1248) I. STATEMENT OF THE FACTS Defendant-Appellant

More information

Case: 1:17-cv Document #: 33 Filed: 01/11/18 Page 1 of 21 PageID #:324

Case: 1:17-cv Document #: 33 Filed: 01/11/18 Page 1 of 21 PageID #:324 Case: 1:17-cv-05428 Document #: 33 Filed: 01/11/18 Page 1 of 21 PageID #:324 UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION CATHERINE GRAVITT and TRAVIS GRAVITT, Plaintiffs,

More information

Case: 1:09-cv Document #: 160 Filed: 01/28/13 Page 1 of 7 PageID #:1776

Case: 1:09-cv Document #: 160 Filed: 01/28/13 Page 1 of 7 PageID #:1776 Case: 1:09-cv-03346 Document #: 160 Filed: 01/28/13 Page 1 of 7 PageID #:1776 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION STEVEN KALLAL, Plaintiff, No. 09 C 3346 v. Judge

More information

Case 2:15-cv GEKP Document 107 Filed 02/21/17 Page 1 of 41 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

Case 2:15-cv GEKP Document 107 Filed 02/21/17 Page 1 of 41 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA Case 2:15-cv-00384-GEKP Document 107 Filed 02/21/17 Page 1 of 41 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA HELEN McLAUGHLIN : CIVIL ACTION : v. : : BAYER CORPORATION,

More information

Product Liability Update

Product Liability Update Product Liability Update In This Issue: May 2009 United States Supreme Court Holds State Law Failure-to-Warn Claims Involving Prescription Drugs Not Preempted by FDA Approval of Warnings Absent Clear Evidence

More information

MASTER DOCKET NO Ruby Ledbetter IN THE DISTRICT COURT OF. v. HARRIS COUNTY, T E X A S

MASTER DOCKET NO Ruby Ledbetter IN THE DISTRICT COURT OF. v. HARRIS COUNTY, T E X A S MASTER DOCKET NO. 2005-59499 Ruby Ledbetter IN THE DISTRICT COURT OF v. HARRIS COUNTY, T E X A S Merck & Co., Inc. 157 th JUDICIAL DISTRICT (Trial Court: 151st Dist. Court of Harris County, Cause No. 2005-58543)

More information

Case 2:12-cv Document 1 Filed 06/08/12 Page 1 of 11 PageID #: 1

Case 2:12-cv Document 1 Filed 06/08/12 Page 1 of 11 PageID #: 1 Case 2:12-cv-01935 Document 1 Filed 06/08/12 Page 1 of 11 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA CHARLESTON DIVISION Kimberly Durham and Morris Durham,

More information

Case 5:13-cv SMH-MLH Document 50 Filed 08/15/14 Page 1 of 12 PageID #: 260

Case 5:13-cv SMH-MLH Document 50 Filed 08/15/14 Page 1 of 12 PageID #: 260 Case 5:13-cv-03132-SMH-MLH Document 50 Filed 08/15/14 Page 1 of 12 PageID #: 260 UNITED STATES DISTRICT COURT WESTERN DISTRICT OF LOUISIANA SHREVEPORT DIVISION ANNIE V. KENNEDY CIVIL ACTION NO. 13-3132

More information

Case: 1:09-oe DAK Doc #: 118 Filed: 01/05/15 1 of 18. PageID #: 5762

Case: 1:09-oe DAK Doc #: 118 Filed: 01/05/15 1 of 18. PageID #: 5762 Case: 1:09-oe-40023-DAK Doc #: 118 Filed: 01/05/15 1 of 18. PageID #: 5762 IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF OHIO WESTERN DIVISION STEPHANIE YATES, -vs- ORTHO-MCNEIL PHARMACEUTICAL,

More information

Case 2:15-cv Document 1 Filed 12/14/15 Page 1 of 49 PageID 1 IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF TENNESSEE

Case 2:15-cv Document 1 Filed 12/14/15 Page 1 of 49 PageID 1 IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF TENNESSEE Case 2:15-cv-02799 Document 1 Filed 12/14/15 Page 1 of 49 PageID 1 IN THE UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF TENNESSEE Wardell Fleming, ) ) Plaintiff, ) ) vs. ) Case No. ) JANSSEN

More information

No IN THE UNITED STATES COURT OF APPEALS FOR THE TENTH CIRCUIT

No IN THE UNITED STATES COURT OF APPEALS FOR THE TENTH CIRCUIT Appellate Case: 16-4050 Document: 01019691148 Date Filed: 09/19/2016 Page: 1 No. 16-4050 IN THE UNITED STATES COURT OF APPEALS FOR THE TENTH CIRCUIT ALEXANDER CERVENY, VICTORIA CERVENY, AND CHARLES CERVENY

More information

Nos , , IN THE UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT

Nos , , IN THE UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT Case: 09-5460 Document: 006110791529 Filed: 11/16/2010 Page: 1 Nos. 09-5509, 09-5460, 09-5466 IN THE UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT DENNIS MORRIS, Plaintiff-Appellant, v. WYETH INC.,

More information

United States Court of Appeals

United States Court of Appeals United States Court of Appeals FOR THE EIGHTH CIRCUIT No. 08-3850 Gladys Mensing, * * Plaintiff - Appellant, * * v. * * Wyeth, Inc., doing business as Wyeth; * Pliva, Inc.; Teva Pharmaceuticals, * USA,

More information

Case 1:09-md KAM-SMG Document 159 Filed 01/30/12 Page 1 of 12 PageID #: 1349

Case 1:09-md KAM-SMG Document 159 Filed 01/30/12 Page 1 of 12 PageID #: 1349 Case 1:09-md-02120-KAM-SMG Document 159 Filed 01/30/12 Page 1 of 12 PageID #: 1349 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF NEW YORK ----------------------------------X In re: PAMIDRONATE PRODUCTS

More information

Case 2:13-cv Document 281 Filed 11/24/14 Page 1 of 9 PageID #: 20272

Case 2:13-cv Document 281 Filed 11/24/14 Page 1 of 9 PageID #: 20272 Case 2:13-cv-22473 Document 281 Filed 11/24/14 Page 1 of 9 PageID #: 20272 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA CHARLESTON DIVISION DIANNE M. BELLEW, Plaintiff,

More information

Don't Overlook Pleading Challenges In State Pharma Suits

Don't Overlook Pleading Challenges In State Pharma Suits Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Don't Overlook Pleading Challenges In State

More information

2:14-cv RMG Date Filed 02/25/14 Entry Number 1 Page 1 of 19 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLORADO

2:14-cv RMG Date Filed 02/25/14 Entry Number 1 Page 1 of 19 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLORADO 2:14-cv-01400-RMG Date Filed 02/25/14 Entry Number 1 Page 1 of 19 Civil Action No. WILMA DANIELS, Plaintiff, v. PFIZER, INC., Defendant. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLORADO

More information

2018 PA Super 158 OPINION BY PLATT, J.: FILED JUNE 08, Appellant, Joseph A. Caltagirone, appeals individually and as

2018 PA Super 158 OPINION BY PLATT, J.: FILED JUNE 08, Appellant, Joseph A. Caltagirone, appeals individually and as 2018 PA Super 158 JOSEPH A. CALTAGIRONE, AS ADMINISTRATOR AD PROSEQUENDUM FOR THE ESTATE OF JOSEPH F. CALTAGIRONE, DECEASED AND JOSEPH A. CALTAGIRONE, INDIVIDUALLY, IN THE SUPERIOR COURT OF PENNSYLVANIA

More information

Case 3:10-cv B Document 1 Filed 09/10/10 Page 1 of 6 PageID 1 UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS DALLAS DIVISION

Case 3:10-cv B Document 1 Filed 09/10/10 Page 1 of 6 PageID 1 UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS DALLAS DIVISION Case 3:10-cv-01787-B Document 1 Filed 09/10/10 Page 1 of 6 PageID 1 UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS DALLAS DIVISION JERRE FREY, individually, Plaintiff VS. Civil Action

More information

Post-Decision Diagnosis: Medical Device Preemption Alive and Mostly Well after Medtronic, Inc. v. Lohr

Post-Decision Diagnosis: Medical Device Preemption Alive and Mostly Well after Medtronic, Inc. v. Lohr Annals of Health Law Volume 6 Issue 1 1997 Article 10 1997 Post-Decision Diagnosis: Medical Device Preemption Alive and Mostly Well after Medtronic, Inc. v. Lohr Scott W. Sayler Shook, Hardy & Bacon L.L.P.

More information

Jury Trial Demanded. Bayer Pharmaceuticals Corporation, Bayer Healthcare Pharmaceuticals, Inc., Plaintiff,

Jury Trial Demanded. Bayer Pharmaceuticals Corporation, Bayer Healthcare Pharmaceuticals, Inc., Plaintiff, Case 2:13-cv-00450-JP Document 1 Filed 01/25/13 Page 1 of 22 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA Tricia Prendergast, Plaintiff, Civil Action No: V. COMPLAINT Bayer

More information

Will High Court Provide Clarity On 'Clear Evidence'?

Will High Court Provide Clarity On 'Clear Evidence'? Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Will High Court Provide Clarity On 'Clear

More information

Supreme Court of the United States

Supreme Court of the United States No. 06-179 IN THE Supreme Court of the United States DONNA S. RIEGEL, individually and as administrator of the estate of Charles R. Riegel, Petitioner, v. MEDTRONIC, INC., Respondent. On Writ Of Certiorari

More information

ANSWER A TO ESSAY QUESTION 5

ANSWER A TO ESSAY QUESTION 5 ANSWER A TO ESSAY QUESTION 5 Sally will bring products liability actions against Mfr. based on strict liability, negligence, intentional torts and warranty theories. Strict Products Liability A strict

More information

Case 1:06-cv JFK Document 111 Filed 10/27/10 Page 1 of 8

Case 1:06-cv JFK Document 111 Filed 10/27/10 Page 1 of 8 Case 1:06-cv-05513-JFK Document 111 Filed 10/27/10 Page 1 of 8 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK ----------------------------------------X IN RE: : FOSAMAX PRODUCTS LIABILITY LITIGATION

More information

Horn v. Thoratec Corp., A "Heartless" Decision: Why Pre-Market Approval Does Not Preempt All State Tort Claims Against Medical Device Manufacturers

Horn v. Thoratec Corp., A Heartless Decision: Why Pre-Market Approval Does Not Preempt All State Tort Claims Against Medical Device Manufacturers St. John's Law Review Volume 80 Issue 2 Volume 80, Spring 2006, Number 2 Article 8 February 2012 Horn v. Thoratec Corp., A "Heartless" Decision: Why Pre-Market Approval Does Not Preempt All State Tort

More information

IN THE COURT OF APPEALS OF TENNESSEE AT JACKSON April 2000 Session

IN THE COURT OF APPEALS OF TENNESSEE AT JACKSON April 2000 Session IN THE COURT OF APPEALS OF TENNESSEE AT JACKSON April 2000 Session GRETCHEN BISH, ET AL. v. SMITH & NEPHEW RICHARDS, INC., ET AL. EUGENE HAFFEY, ET AL. v. SOFAMOR DANEK GROUP, INC., ET AL. GRETCHEN BISH,

More information

Strict Liability and Product Liability PRODUCT LIABILITY WARRANTY LAW

Strict Liability and Product Liability PRODUCT LIABILITY WARRANTY LAW Strict Liability and Product Liability PRODUCT LIABILITY The legal liability of manufacturers, sellers, and lessors of goods to consumers, users and bystanders for physical harm or injuries or property

More information

COVERING THE COURT S ENTIRE DECEMBER

COVERING THE COURT S ENTIRE DECEMBER Issue No. 3 Volume No. 35 November 26, 2007 COVERING THE COURT S ENTIRE DECEMBER CALENDAR OF CASES, INCLUDING BOUMEDIENE ET AL. V. BUSH ET AL. AND AL ODAH ET AL. V. UNITED STATES ET AL. Detainees being

More information