Fisher v. Pelstring

• Decision Date: 11 January 2012
• Docket Number: Civil Action No. 4:09–cv–00252–TLW.
• Parties: William R. FISHER and Silbray N. Fisher, Plaintiffs, v. Mark F. PELSTRING, M.D., Wyeth, Inc., Schwarz Pharma, Inc., and PLIVA USA, Inc., Defendants.
• Court: U.S. District Court — District of South Carolina

817 F.Supp.2d 791

William R. FISHER and Silbray N. Fisher, Plaintiffs,

v.Mark F. PELSTRING, M.D., Wyeth, Inc., Schwarz Pharma, Inc., and PLIVA USA, Inc., Defendants.

Civil Action No. 4:09–cv–00252–TLW.

United States District Court, D. South Carolina, Florence Division.

Sept. 30, 2011.Order Granting Reconsideration in Part and Denying Reconsideration in Part Jan. 11, 2012.

Paul Jacob Cone, II, William Michael Gruenloh, Cone Gruenloh, Charleston, SC, Daniel J. McGlynn, Terrence Joseph Donahue, Jr., McGlynn Glisson and Mouton, Baton Rouge, LA, William Burton Curtis, Curtis Law Group, Dallas, TX, for Plaintiffs.

Lisa Arlene Thomas, John B. McCutcheon, Jr., Thompson and Henry, Conway, SC, for Defendants.

ORDER

TERRY L. WOOTEN, District Judge.

This action was removed to this Court from the Court of Common Pleas for Horry County, South Carolina on January 30, 2009. (Doc. # 1). The plaintiffs, William R. Fisher and Silbray N. Fisher (“plaintiffs”), who are husband and wife, allege William Fisher (“Mr. Fisher”) suffers from Tardive Dyskinesia caused by his long- term use of the prescription drug metoclopramide. They assert causes of action against his treating physician, Dr. Mark F. Pelstring, who prescribed metoclopramide to him. They also assert causes of action against Wyeth, Inc. and Schwarz, Inc., who they allege manufactured metoclopramide under the brand-name Reglan and in its generic form. On July 28, 2010, 2010 WL 2998474, this Court granted summary judgment to Wyeth and Schwarz and they were dismissed from this action. (Doc. # 89). In addition to Wyeth and Schwarz, the plaintiffs bring causes of action against PLIVA USA, Inc. (“PLIVA”), who they allege manufactured the generic metoclopramide ingested by Mr. Fisher.

Before the Court are several motions filed by the plaintiffs and PLIVA. On December 10, 2010, PLIVA filed a motion to dismiss based on federal preemption (Doc. # 104) and a motion for summary judgment (Doc. # 112). The plaintiffs filed responses to these motions (Docs. 130, 134), to which PLIVA submitted replies (Docs. 146, 147). On April 19, 2011, the plaintiffs filed a motion for partial summary judgment. (Doc. # 160). PLIVA filed a response to this motion (Doc. # 174), to which the plaintiffs submitted a reply (Doc. # 176). PLIVA also filed a surreply to the plaintiffs' reply (Doc. # 187), and the plaintiffs submitted a response to PLIVA's surreply (Doc. # 193). In light of the Supreme Court's decision in PLIVA, Inc. v. Mensing, ––– U.S. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011), where it considered the issue of federal preemption of state-law failure to warn claims involving generic drug manufacturers, this Court, on July 5, 2011, directed the plaintiffs and PLIVA to file supplemental briefing. (Doc. # 180). The parties submitted their supplemental briefs on July 25, 2011. (Docs. 182, 183).

Also before the Court are PLIVA's motions to exclude testimony of the following expert witnesses: Suzanne Parisian (Doc. # 106), Philip Seeman (Doc. # 108), and David Ross (Doc. # 110). Additionally, the plaintiffs have filed a motion to preclude Dr. Pelstring from offering any expert testimony or opinion (Doc. # 103) and motions to exclude testimony of the following expert witnesses: Raymond D. Harbison (Doc. # 157), Steven Lamm (Doc. # 158), and James Morrison (Doc. # 159).

The Court has considered the applicable law, arguments of counsel, and memoranda submitted. These motions are now ripe for disposition.

FACTS

The plaintiffs allege that Dr. Pelstring began prescribing metoclopramide to Mr. Fisher on about January 15, 2003 to treat symptoms of acid reflux disease. (Compl. ¶ 41). Dr. Pelstring allegedly continued to prescribe metoclopramide to Mr. Fisher until January 31, 2005. Id. The plaintiffs assert that Mr. Fisher's long-term use of metoclopramide caused him to develop Tardive Dyskinesia, which is an incurable neurological disorder that can cause involuntary and uncontrollable movements of the head, neck, face, arms, legs, and trunk in addition to grotesque facial grimacing and open-mouthed, uncontrollable tongue movements, tongue thrusting, tongue chewing, and other involuntary movements. (Compl. ¶¶ 32–33). In 2005, Dr. Pelstring referred Mr. Fisher to a neurologist, Dr. Michael McCaffrey, who examined Mr. Fisher on May 25, 2005. Id. ¶¶ 42–43. Although the plaintiffs assert in the complaint that during this examination Mr. Fisher was diagnosed with drug-induced Tardive Dyskinesia, id. ¶ 43, the plaintiffs now argue that this date is incorrect. Instead, they allege in their response to PLIVA's motion for summary judgment that Dr. McCaffrey diagnosed Tardive Dyskinesia on July 13, 2005, but later retracted this diagnosis and there was considerable confusion regarding Dr. McCaffrey's diagnosis. They assert that Mr. Fisher was first definitively diagnosed with Tardive Dyskinesia by Dr. David Ross on May 15, 2008.

Because the plaintiffs are asserting a medical malpractice claim against Dr. Pelstring and in accordance with South Carolina Code Annotated § 15–79–125, the plaintiffs filed a Notice of Intent to File Suit on May 22, 2008, in the Court of Common Pleas for Horry County, South Carolina before initiating this lawsuit. They initiated this lawsuit by filing their complaint in the same court on January 16, 2009. The lawsuit was then removed to this Court on January 30, 2009. (Doc. # 1). In addition to their medical malpractice claim against Dr. Pelstring, the plaintiffs assert causes of action for strict products liability based on warning defects, manufacturing defects, and design defects; breach of express warranty; breach of implied warranties; negligence; negligent misrepresentation; breach of undertaking a special duty; fraud and misrepresentation; constructive fraud; fraud by concealment; violation of the South Carolina Unfair Trade Practices Act; intentional infliction of emotional distress; and loss of consortium.

DISCUSSION

I. Motion to Dismiss Based on Federal Preemption

PLIVA argues in its motion to dismiss that federal law preempts the plaintiffs' state law claims. Federal law imposes complex drug labeling requirements, which involve proof by a manufacturer seeking federal approval to market a new drug that the drug is safe and effective and that the proposed label is accurate and adequate, a process which involves costly and lengthy clinical testing. PLIVA, Inc. v. Mensing, ––– U.S. ––––, 131 S.Ct. 2567, 2574, 180 L.Ed.2d 580 (2011) (“ Mensing ”). In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act, 98 Stat. 1585, commonly called the Hatch–Waxman Amendments. Id. This law allowed “generic drugs” to “gain FDA approval simply by showing equivalence to a reference listed drug that has already been approved by the FDA,” thereby allowing inexpensive development of generic drugs. Id. “A generic drug application must also ‘show that the [safety and efficacy] labeling proposed ... is the same as the labeling approved for the [brand-name] drug.’ ” Id. (quoting 21 U.S.C. § 355(j)(2)(A)(v)) (alterations and omission in original). Thus, “brand-name and generic drug manufacturers have different federal drug labeling duties.” Id. “A brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label.” Id. On the other hand, a generic drug manufacturer “is responsible for ensuring that its warning label is the same as the brand name's.” Id. At issue in the Supreme Court's decision in PLIVA, Inc. v. Mensing and also at issue in this case is “whether, and to what extent, generic drug manufacturers may change their labels after initial FDA approval.” Id.

The plaintiffs “contend that PLIVA failed to adequately warn consumers and physicians of a far greater risk of developing tardive dyskinesia than suggested by its product label, and that PLIVA breached its obligation to assess the risks associated with metoclopramide exposure.” Pl.'s Resp. to PLIVA's Mot. to Dismiss, p. 3 (Doc. # 134). PLIVA argues in its motion to dismiss that the plaintiffs' state law claims are preempted by federal law because they “place generic drug manufacturers in the untenable position of choosing between state and federal law. If a manufacturer complies with federal law governing generic drugs it can be held liable under state law for not using warnings different from the branded drug counterpart. If, to avoid liability under state law, a generic drug manufacturer changes the warnings, it will violate federal law, rendering its product misbranded.” Mem. in Support of PLIVA's Mot. to Dismiss, p. 2 (Doc. # 104, attach. 1). In response, the plaintiffs state they “do not contend that PLIVA should have unilaterally issued a new and different warning. Rather, [they] maintain that PLIVA should have notified the FDA of the risks associated with metoclopramide and requested that all manufacturers of metoclopramide/ Reglan be required to update its labels to properly reflect current medical knowledge.” Pl.'s Resp. to PLIVA's Mot. to Dismiss, p. 5 (Doc. # 134).

In Mensing, the Supreme Court ruled on this issue and held that impossibility preemption applies to state tort law claims based on generic drug manufacturers' failure to provide adequate warning labels for generic metoclopramide. Mensing, 131 S.Ct. at 2572. The Court largely accepted the reasoning advanced by PLIVA, namely that if manufacturers of metoclopramide independently seek to satisfy their state law duties by changing their labels, they violate federal law. Id. at 2577–78. Even assuming federal law imposes a duty on a generic drug manufacturer that becomes aware of safety problems to request a strengthened warning, the Court concluded preemption still applies, reasoning that “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.” Id. at 2576–77, 2579. The Court held that “when a party cannot satisfy...