Seattle, WA: Patients who suffer from reglan neurological side effects, such as tardive dyskinesia, may be shocked to learn they took Reglan for far longer than they should have. The drug, used to treat acid reflux and heartburn, is meant to be taken for only three months. Reglan has potentially irreversible side effects that often show up after the patient has used the drug on a long-term basis.

Reglan lawsuits are now being filed by patients who say they were never warned about the risks of tardive dyskinesia or long-term use. Some patients say they took the drug for years.

In 2008, a patient named Shirley Brinkley filed a lawsuit against Wyeth, the maker of Reglan. Brinkley alleges that she was first prescribed Reglan in June, 1992 to treat motility of her stomach, and continued taking the medication until April, 2007.

According to Brinkley’s lawsuit, her doctors relied on information published in the package inserts and the Physician’s Desk Reference and were not aware that the information given could have been inaccurate or misleading.

Brinkley has been diagnosed with permanent and disabling neurological injury, including tardive dyskinesia. Her lawsuit alleges that the makers of Reglan failed to warn her and her physicians of the risks associated with Reglan, including the risk of unsafe doses. She further alleges that the defendants committed fraud by misrepresenting Reglan’s adverse effects.

Brinkley’s lawsuit seeks in excess of $600,000 in damages.

Other lawsuits have now also been filed against the makers of Reglan, alleging failure to adequately warn the public about the risks associated with the use of Reglan. Some of these lawsuits were filed by parents of children who were prescribed Reglan as infants and now suffer from movement disorders as a result.

For a free consultation, please contact our office at 440-639-1020

___________

Gladys Mensing,                                          *

Plaintiff – Appellant,                  *

          *

v.                                                       *

          *

Wyeth, Inc., doing business as Wyeth;                   *

Pliva, Inc.; Teva Pharmaceuticals,                 *

USA, Inc.; Alpharma, Inc., doing                 *

business as Alpharma Pharmaceuticals;         *

UDL Laboratories, Inc.; Actavis                   *

Elizabeth, LLC; Schwarz Pharma, Inc.;         *

Purepac Pharmaceutical Company, and         *

the following fictitious party defendants        *

(whether singular or plural, individual   * Appeal from the UnitedStates

or corporate): No. 1, that entity which           * District Court for the

originally obtained permission from the         * District of Minnesota.

U.S. Food and Drug Administration to          *

market the drug branded Reglan No. 2,         *

that entity which obtained permission            *

from the FDA to market the Reglan,              *

metoclopramide and/or metoclopramide        *

HCI ingested by Gladys Mensing No. 3,       *

that entity which originally                             *

manufactured and sold any Reglan                *

which was ultimately ingested by                   *

Gladys Mensing No. 4, that entity                 *

which originally manufactured and sold         *

any Reglan, metoclopramide and/or              *

metoclopramide HCI which was                   *

ultimately ingested by Gladys Mensing *

No. 5, that entity which marketed                  *

Reglan or generic metoclopramide                *

and/or metoclopramide HCI, jointly              *

and individually,                                           *

                                                                   *

          Defendants – Appellees.                      *

___________

Submitted: October 20, 2009

Filed: November 27, 2009

___________

Before WOLLMAN, MURPHY, and BYE, Circuit Judges.

___________

MURPHY, Circuit Judge.

Gladys Mensing brought this failure to warn and misrepresentation case against a number of manufacturers of Reglan and its generic form, alleging that the medication she had taken caused her to develop tardive dyskinesia, a severe neurological movement disorder. The manufacturers moved for summary judgment and dismissal. The district court dismissed her claims against the generic defendants on the basis of federal preemption and against the name brand manufacturers on the basis that she had not taken their products. Mensing appeals, and we affirm the judgment in favor of the name brand manufacturers but reverse as to the generic manufacturers.

I.

In March 2001 Gladys Mensing’s doctor prescribed Reglan to treat her diabetic gastro paresis, and her pharmacist filled her prescription with its generic bioequivalent, metoclopramide. Minn. Stat. § 151.21. After four years of ingesting metoclopramide, Mensing developed tardive dyskinesia. Mensing sued the manufacturers and/or distributors of generic metoclopramide (generic defendants). Mensing’s complaint

Case: 08-3850 Page: 2 Date Filed: 11/27/2009 Entry ID: 3609541

1Wyeth manufactured both Reglan and generic metoclopramide. It joined in the summary judgment motions of both the generic and name brand defendants.

includes a variety of claims, but she has not challenged the district court’s

characterization that “at the core” they all assert failure to warn. Mensing v. Wyeth, Inc., 562 F.Supp.2d 1056, 1058 (D.Minn. 2008). Mensing argues that despite mounting evidence that long term metoclopramide use carries a risk of tardive dyskinesia far greater than indicated on the label, no metoclopramide manufacturer took steps to change the label warnings. According to her allegations, metoclopramide manufacturers in fact promoted the drug for long term use. Although she never ingested the name brand drug, Mensing also sued the manufacturers of Reglan (name brand defendants) for fraud and negligent misrepresentation on the theory that her doctor relied on Reglan’s label when assessing the risks and proper use

of metoclopramide.

          All defendants filed motions to dismiss or for summary judgment. The district court granted the motions to dismiss by generic defendants Actavis Elizabeth and Pliva and motions for summary judgment by generic defendants Teva, Wyeth, and UDL Laboratories on the ground of federal preemption. The court concluded that Mensing’s failure to warn claims created an impermissible conflict with federal law because they would require generic manufacturers to deviate from the name brand drug label; they were therefore preempted. The court also granted summary judgment to name brand defendants Schwarz and Wyeth,1 holding that they owed Mensing no duty of care under Minnesota law because she never ingested their product.

          Grants of motions to dismiss and for summary judgment are subject to de novo review. We affirm a dismissal if, taking all the plaintiff’s allegations as true, they “state a claim to relief that is plausible on its face.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007). On review of summary judgment, we “view the evidence in the light most favorable to the nonmoving party” and affirm only when “there are no genuine issues of material fact[.]” Takele v. Mayo Clinic, 576 F.3d 834, 838 (8th

Cir. 2009) (quotations omitted).

II.

We first address the generic defendants’ argument that federal law preempts

state failure to warn claims against them. Since a purely legal issue of statutory interpretation is raised, the generic defendants’ motions for summary judgment and dismissal will be considered together.

A.

All prescription drugs require approval by the Food and Drug Administration (FDA) before they may be marketed. Manufacturers of new drugs submit a new drug application (NDA) to the FDA. 21 U.S.C. § 355(a)-(b). An NDA must include information about the drug’s safety and efficiency gleaned from clinical trials. Id. At §§ 355(b), (d). It must also propose a label reflecting appropriate use, warnings, precautions, and adverse reactions. 21 C.F.R. § 201.56.

          Recognizing a need to bring more affordable generic drugs to market as quickly as possible after the patents of name brand drugs expire, Congress passed the Drug Price Competition and Patent Term Restoration Act in 1984. This statute amended the Food, Drug, and Cosmetic Act (FDCA) and is therefore referred to as the Hatch-Waxman Amendments to the FDCA. The Hatch-Waxman Amendments provided an abbreviated new drug application (ANDA) procedure for generic manufacturers. 21 U.S.C. § 355(j). Generic manufacturers do not need to repeat the clinical trials conducted by name brand manufacturers. ANDA’s are approved based

on the initial safety profile of the name brand drug, as well as any postmarketing surveillance. See Bartlett v. Mutual Pharmaceutical Co., Inc., — F.Supp.2d —, No. 08-cv-358-JL, 2009 WL 3126305, at *2-*6 (D.N.H. Sept. 30, 2009) (detailingrequirements and history of ANDA procedure). As a result, ANDA applicants must show the FDA that their drug is essentially the same as the name brand drug and that their proposed label is in relevant part identical to the name brand drug label. 21

C.F.R. § 314.94(a)(8).

          Drug labels are subject to change. New risks may become apparent only after the drug has been used more widely and for longer periods. When a manufacturer has “reasonable evidence of an association of a serious hazard with a drug[,]” the drug’s label must be revised; “a causal relationship need not have been proved.” 21 C.F.R. § 201.57(e) (redesign Ted as 21 C.F.R. § 201.80(e) in 2006, after the conduct at issue here). Manufacturers cannot distribute a “misbranded” drug, 21 U.S.C. §§ 331(a)-(b),

including a drug whose “labeling is false or misleading in any particular.” Id. at §352(a). The FDA has several enforcement mechanisms to ensure that drugs with misleading labels are taken off the market. See, e.g., id. at § 333, 355(e).

There are several procedures in 21 C.F.R. § 314.70 by which a manufacturer

may supplement its application and propose changes to the drug or its label. “Major changes” require the FDA’s prior approval through a prior approval supplement. 21 C.F.R. § 314.70(b). Manufacturers may implement “moderate changes,” including changing a label to strengthen a warning based on newly acquired information, through a Changes Being Effected (CBE) supplement. 21 C.F.R. § 314.70(c)(6)(iii)(A)-(D). Manufacturers may implement CBE changes before the FDA formally approves them.

          The FDA approved Reglan in 1980. Manufacturers began seeking approval for generic versions of metoclopramide five years later. The generic metoclopramide labels have always been in relevant part the same as the Reglan label. The label warnings about tardive dyskinesia, and other similar but less severe extrapyramidal symptoms, did not change from 1985 through the time Mensing stopped ingesting the drug in 2005. Mensing alleges that despite mounting evidence that long term metoclopramide users were at a much greater risk of movement disorders than indicated by the drug’s label, no manufacturer took any step to enhance the warnings.2

Moreover, Mensing asserts that defendants promoted metoclopramide for long term use even though the FDA had approved the drug only for use up to 12 weeks.

          Acting on its own initiative pursuant to the Food and Drug Administration Amendments Act of 2007, Pub. L. No. 110-85, 121 Stat. 823 (FDAAA), the FDA ordered manufacturers of Reglan and generic metoclopramide on February 26, 2009 to add a boxed warning to their labels about the increased risks of tardive dyskinesia from long term metoclopramide usage.

B.

In considering a preemption defense we must be attuned to Congressional intent and the presumption against preemption. Wyeth v. Levine, 129 S.Ct. 1187, 1194-95 (2009) (quotation omitted) (courts must assume “that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.”). In Wyeth, the Supreme Court ruled that failure to warn claims against name brand manufacturers are not preempted by the FDCA. The Court noted the historic coexistence of state tort remedies and federal regulation of prescription drugs:

If Congress thought state-law suits posed an obstacle to its objectives, it

surely would have enacted an express pre-emption provision at some

point during the FDCA’s 70-year history. But despite its 1976 enactment

of an express pre-emption provision for medical devices, . . . Congress

has not enacted such a provision for prescription drugs. . . . Its silence on

the issue, coupled with its certain awareness of the prevalence of state

tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and

effectiveness. Id.

2Mensing notes that in July 2004 the FDA approved Schwarz’s request to add a sentence to the Reglan label: “Therapy should not exceed 12 weeks in duration.”

          The Hatch-Waxman Amendments are part of this 70 year history and they do not explicitly preempt suits against generic manufacturers. Congress could have crafted a preemption provision for generic drugs in its 1984 amendments, having done so for medical devices less than 10 years earlier. It chose not to do that. Seven in ten prescriptions filled in this country are now for generic drugs. Susan Okie, Multinational Medicines–Ensuring Drug Quality in an Era of Global Manufacturing, 361 New Eng. J. Med. 737, 738 (2009). After Wyeth, we must view with a questioning mind the generic defendants’ argument that Congress silently intended to grant the manufacturers of most prescription drugs blanket immunity from state tort

liability when they market inadequately labeled products.

          The generic defendants distinguish Wyeth on the ground that it concerned claims against brand name manufacturers, but the decision carries important implications for their situation as well. See, e.g., Wyeth, 129 S. Ct. at 1197-98 (“[I]t has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate[.]“). The district court did not have the teachings of Wyeth available when it rendered its decision, but courts which have subsequently considered this issue have almost uniformly ruled that tort claims against generic manufacturers are not preempted. See, e.g., Stacel v. Teva Pharmaceuticals, USA, 620 F.Supp.2d 899, 906-907 (N.D. Ill. 2009); Schrock v. Wyeth, 601 F.Supp.2d 1262, 1265-66 (W.D.Okla.2009). The Fourth Circuit reached the same conclusion much earlier in considering whether a plaintiff injured by a generic drug can hold a name brand manufacturer liable. Foster v. American Home Products Corp., 29 F.3d 165, 170 (4th Cir. 1994) (“The statutory scheme governing premarketing approval for drugs simply does not evidence Congressional intent to insulate generic drug manufacturers from liability for misrepresentations made regarding their products, or to otherwise alter state products liability law.”).

Even when a federal law does not expressly preempt state law claims, a court may find that Congress impliedly preempted such claims by “conflict” if  1)compliance with both federal and state law is impossible, or 2) the claims would” stand[] as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 372-73(2000) (quotation omitted). The district court concluded that each basis for conflict preemption was present. We disagree.

C.

The Supreme Court characterized “[i]mpossibility pre-emption [as] a

demanding defense.” Wyeth, 129 S.Ct. at 1199. To prevail on that defense, the  generic defendants must show that compliance with both federal law and the state laws Mensing seeks to enforce is not merely difficult, but “a physical impossibility.” Fid. Fed. Sav. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 153 (1982) (quotation omitted). The parties agree that generic labels must be substantively identical to the name brand label even after they enter the market. See, e.g., 21 C.F.R. § 314.150(b)(10) (FDA may withdraw approval of a generic drug if its label is “no longer consistent” with the name brand label); 57 Fed. Reg. at 17961, cmt. 39 (1992). Because of this requirement, the generic manufacturers argue they are prohibited from

implementing a unilateral label change without prior FDA approval through the CBE process. Yet, 21 C.F.R. § 314.97compels generic manufacturers to “comply with the requirements of §[] 314.70[.]” Section 314.70 includes the CBE process and the prior 3See supra sec. II-A for a discussion of these regulatory processes. If the defendants were correct that generic manufacturers can use the CBE process only to copy label changes initiated by the name brand manufacturer, it is curious that § 314.70(c) was never revised to distinguish between name brand and generic manufacturers.

4The district court relied heavily on two FDA statements that no longer carry

the same weight after Wyeth. In light of Wyeth, the FDA formally withdrew its amicus briefs in Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D.Pa. 2006); aff’d in part and rev’d in part, 521 F.3d 253 (3d Cir. 2008); vacated, 129 S.Ct. 1578 (2009). The other FDA statement appears in a footnote in the “Supplementary Information” section of a notice of proposed rule making for a regulation not pertaining to generic drugs. 73 Fed. Reg. 2848, 2849 n.1 (Jan. 16, 2008) (“CBE changes are not available for generic drugs.”). Even the defendants admit that generic manufacturers can use the CBE process, § 314.97, to copy an updated name brand label. See also Demahy v. Wyeth, Inc., 586 F.Supp.2d 642, 655 (E.D.La. 2008), appeal docketed, No. 08-

31204 (5th Cir. Dec. 16, 2008); Wyeth, 129 S.Ct. at 1201. approval supplement process.3 In this case we need not decide whether generic

manufacturers may unilaterally enhance a label warning through the CBE procedure4 because the generic defendants could have at least proposed a label change that the FDA could receive and impose uniformly on all metoclopramide manufacturers if approved. The regulatory framework makes clear that a generic manufacturer must take steps to warn its customers when it learns it may be marketing an unsafe drug. Generic manufacturers are subject to the requirement that their labeling “shall be

revised as soon as there is reasonable evidence of an association of a serious hazard with a drug[.]” 21 C.F.R. § 201.57(e). The generic defendants argue that they comply with this statute by simply ensuring that their labels match the name brand label. Mensing alleges that the Reglan manufacturers did nothing to strengthen the label despite reasonable evidence of the drug’s association with a serious hazard. In these circumstances,§ 201.57(e) does not permit generic manufacturers passively to accept the inadequacy of their drug’s label as they market and profit from it. See Wyeth, 129 S.Ct. at 1202 (“The FDA has limited resources to monitor the 11,000 drugs on the market[.] . . . [M]anufacturers, not the FDA, bear primary responsibility

for their drug labeling[.]“). The statute itself empowers the FDA to withdraw approval for a drug that is “misbranded” due to an insufficient label. 21 U.S.C. §§ 331(a)-(b),

352(a).

3See supra sec. II-A for a discussion of these regulatory processes. If the

defendants were correct that generic manufacturers can use the CBE process only to copy label changes initiated by the name brand manufacturer, it is curious that §314.70(c) was never revised to distinguish between name brand and generic manufacturers.

4The district court relied heavily on two FDA statements that no longer carry

the same weight after Wyeth. In light of Wyeth, the FDA formally withdrew its amicus briefs in Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D.Pa. 2006); aff’d in part and rev’d in part, 521 F.3d 253 (3d Cir. 2008); vacated, 129 S.Ct. 1578 (2009). The other FDA statement appears in a footnote in the “Supplementary Information” section of a notice of proposed rule making for a regulation not pertaining to generic drugs. 73 Fed. Reg. 2848, 2849 n.1 (Jan. 16, 2008) (“CBE changes are not available for generic drugs.”). Even the defendants admit that generic manufacturers can use the CBE process, § 314.97, to copy an updated name brand label. See also Demahy v. Wyeth, Inc., 586 F.Supp.2d 642, 655 (E.D.La. 2008), appeal docketed, No. 08 31204 (5th Cir. Dec. 16, 2008); Wyeth, 129 S.Ct. at 1201.

          Interpretive commentary outside the regulations supports the requirement that at a minimum a generic manufacturer should alert the agency to any new safety hazard associated with its product. In commentary published contemporaneously to the adoption of the Hatch-Waxman Amendments, the FDA stated: “After approval of an ANDA, if an ANDA holder [a generic manufacturer] believes that new safety information should be added, it should provide adequate supporting information to

FDA, and FDA will determine whether the labeling for the generic and listed drugs should be revised.” 57 Fed. Reg. 17950, 17961 cmt. 40 (Apr. 28, 1992)  (emphasis supplied).

          Further, 21 C.F.R. § 314.98 requires that generic manufacturers follow the same record keeping and reporting of adverse drug experiences post marketing that name brand manufacturers must undertake. In discussing this provision, the FDA noted that “ANDA applicants [must] submit a periodic report of adverse drug experiences even if the ANDA applicant has not received any adverse drug experience reports or initiated any labeling changes.” 57 Fed. Rep. 17950, 17965 cmt 53 (Apr. 28, 1992) (emphasis supplied). See also CDER, Guidance for Industry, Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications 1-3 (Dec. 2001) (describing ANDA amendments addressing “labeling deficiencies” as “minor amendments” that the FDA will attempt to review within 60 days

          Implicit in these comments is the FDA’s expectation that generic manufacturers will initiate label changes other than those made to mirror changes to the name brand label and that the agency will attempt to approve such proposals quickly. The availability of one particular procedure (the CBE process, on which the district court expended the majority of its discussion) is immaterial to the preemption analysis in light of this clear directive to generic manufacturers and the availability of the prior approval process.

          Because there is nothing in the FDCA or Hatch-Waxman Amendments that explicitly forbids them from proposing a label change through the prior approval process, the generic defendants cite regulatory language in § 314.70 to the effect that the prior approval procedure is for “major changes” while changes to enhance warnings are subject to the CBE procedure. Defendants’ reading of § 314.70 is too restrictive. The section they cite establishes various methods of proposing changes to approved drugs. The more significant the change, the more notice the FDA needs

prior to its implementation. The section repeatedly uses the nonrestrictive phrase “[t]hese changes include, but are not limited to” in order to describe the changes manufacturers can propose through each kind of supplement. §§ 314.70(b)(2), (c)(2), (d)(2). Section 314.70 does not evidence an FDA policy, let alone Congressional intent, to prevent generic manufacturers from proposing changes to a label’s warning through the prior approval process. Indeed, manufacturers are required touse the prior approval process for “labeling changes” (with a few exceptions including permissive use of the CBE process for warning enhancements, § 314.70(b)(2)(v)(A)).

In addition to proposing a label change, the generic manufacturers could have suggested that the FDA send out a warning letter to health care professionals. When the FDA first adopted its labeling regulations, well before the Hatch-Waxman Amendments, it stated that the requirements “do not prohibit a manufacturer . . . from warning health care professionals whenever possibly harmful adverse effects associated with the use of the drug are discovered.” 44 Fed. Reg. 37434, 37447 (June 26, 1979); see also CDER, Manual of Policies and Procedures (MAPP) 6020.10, NDAs: “Dear Health Care Professional” Letters (July 2, 2003) (guidance document

5Mensing argues that the generic defendants themselves could have warned

their customers of the risk of tardive dyskinesia through such letters. The letters are considered regulated labeling, 21 C.F.R. §§ 202.1(1)(1), (2), and under the FDAAA, the FDA sends the letters out on behalf of ANDA holders if it determines that such a letter is a necessary part of a risk evaluation and mitigation strategy. 21 U.S.C. § 355- 1(i)(2). Although the FDAAA was not in effect when Mensing took metoclopramide, it provides support for the defendants’ contention that Congress did not intend that generic manufacturers send out “Dear Healthcare Provider” letters uncoordinated with other manufacturers of the drug. to name brand manufacturers stating that the letters may be ordered by the FDA or

sent by manufacturers without FDA involvement).5 The generic defendants argue that they have no duty under the FDCA to propose stronger warnings, but the issue here is whether they have such a duty under state law. The question before this court is whether generic defendants can both fulfill

a state law duty to warn and comply with the FDCA. Does federal law forbid them from taking steps to warn their customers? The district court concluded that generic drug manufacturers “may seek to add safety information to a drug label” through the prior approval process or by requesting that the FDA send “Dear Health Care Professional” letters, but it remained uncertain what the FDA might have done had they proposed a label change. It therefore hesitated to impose liability based on speculation.

Subsequently, the Supreme Court made it clear in Wyeth that uncertainty about the FDA’s response to such measures makes federal preemption less likely. “[A]bsent clear evidence that the FDA would not have approved a change to [the drug's] label, we will not conclude that it was impossible for [the manufacturer] to comply with both federal and state requirements.” Wyeth, 129 S.Ct. at 1198; see also Grand River Enterprises Six Nations, Ltd. v. Beebe, 574 F.3d 929, 936 (8th Cir. 2009) (“[A] hypothetical or potential conflict is insufficient to warrant the pre-emption of the state statute.”), citing Rice v. Norman Williams Co., 458 U.S. 654, 659 (1982).6 To support

preemption the generic defendants must show the likelihood of FDA inaction. The record contains nothing, let alone “clear evidence,” to suggest the FDA would have rejected a labeling proposal from any of them. In fact, earlier this year the FDA mandated that metoclopramide manufacturers enhance the label’s warning of the risks of tardive dyskinesia. See Letter from Joyce Korvick, CDER (Feb. 26, 2009), available athttp://www.fda.gov/downloads/Drugs/DrugSafety/…/UCM111376.pdf.

____________

5Mensing argues that the generic defendants themselves could have warned

their customers of the risk of tardive dyskinesia through such letters. The letters are considered regulated labeling, 21 C.F.R. §§ 202.1(1)(1), (2), and under the FDAAA the FDA sends the letters out on behalf of ANDA holders if it determines that such a letter is a necessary part of a risk evaluation and mitigation strategy. 21 U.S.C. § 355- 1(i)(2). Although the FDAAA was not in effect when Mensing took metoclopramide, it provides support for the defendants’ contention that Congress did not intend that generic anufacturers send out “Dear Healthcare Provider” letters uncoordinated with there manufacturers of the drug.

          The generic defendants attempt to minimize the significance of Wyeth by ocusing on Justice Breyer’s one paragraph concurring opinion, in which he emphasized the majority’s point that an agency could preempt state law through lawful specific regulations[.]” Wyeth, 129 S.Ct. at 1204 (Breyer, J. concurring). The defendants cite no regulations specifically mandating preemption like those posed as examples in Wyeth, however. Id. at 1201, n.9. On the face of the regulations in effect, generic manufacturers must comply with the CBE procedure and maintain adequate warnings. 21 C.F.R. §§ 314.97, 201.57(e). As Judge William K. Sessions

   ______________

6The generic defendants argue that they would risk rescindment of their ANDA y implementing a unilateral label change through the CBE procedure without prior DA approval. 21 C.F.R. § 314.150(b)(10). FDA commentary to § 314.150 makes clear that the section’s purpose is to enforce the undisputed requirement that generic manufacturers change their label to match a name brand change. 57 Fed. Reg. 17950, 7970 cmt. 78 (Apr. 28, 1992). The issue of preemption does not rest on the availability of the CBE procedure, and hypothetical conflicts are not favored. in Wyeth, the Supreme Court found it “difficult to accept” that “the FDA would ring an enforcement action against a manufacturer for strengthening a warning pursuant to the CBE regulation.” Wyeth, 129 S.Ct. at 1197. The defendants have not cited a single instance in which the FDA even threatened an enforcement action against a generic manufacturer for unilaterally enhancing its label warnings.  eover, “[t]he FDCA does not provide that a drug is misbranded simply because the manufacturer has altered an FDA-approved label;” the misbranding provisions focus on the accuracy of the label’s substance, including the adequacy of its warnings. Id.; see also 21 U.S.C. §§ 355(e); id. at 352.

III has observed, Justice Breyer’s concurrence “does not come close to a hint that an

unofficial FDA interpretation at odds with the plain language of a regulation will have

preemptive effect.” Kellogg v. Wyeth, 612 F.Supp.2d 437, 442 (D.Vt. 2009)

(concluding that Wyeth undermines preemption claims of generic manufacturers).

The generic defendants were not compelled to market metoclopramide. If they realized their label was insufficient but did not believe they could even propose a label change, they could have simply stopped selling the product. Instead, they are alleged to have placed a drug with inadequate labeling on the market and profited from its sales. If Mensing’s injuries resulted from their failure to take steps to warn their customers sufficiently of the risks from taking their drugs, they may be held liable.

D.

          Even if compliance with state and federal law is not impossible, state claims could still be preempted if they would obstruct the purposes and objectives of federal law. The generic defendants argue that proposing a label change would necessitate expensive clinical studies, thwarting the goal of the Hatch-Waxman Amendments to bring low cost generic drugs to market quickly. Yet the FDA did not conduct its own studies when it mandated an enhanced warning for metoclopramide. It simply referenced studies published elsewhere. Requests for label changes must be supported

by scientific substantiation,7 but there is nothing to indicate that the information must be acquired through a manufacturer’s own clinical tests. As a matter of fact, the Supreme Court concluded in Wyeth that multiple reports of an adverse experience with a drug provided the scientific substantiation to justify a manufacturer’s request to change a label. Wyeth, 129 S.Ct. at 1197. Generic manufacturers are already required to collect and report adverse drug experiences with their products. 21 C.F.R.

___________

7Section 314.70(c)(6)(iii)(A) addresses CBE labeling changes to strengthen

warnings; the applicable version during the period when Mensing took metoclopramide did not specify an evidentiary standard.

§ 314.98, referencing 21 C.F.R. § 314. 80. Mensing alleges that if the generic

manufacturers had merely taken note of the accumulation of adverse drug experiences

reports and the published medical studies about metoclopramide, they would have had

sufficient substantiation to warrant a label change.

The obligation Mensing seeks to impose upon generic manufacturers does not

obstruct the purposes and objectives of the Hatch-Waxman Amendments in any way.

On the contrary, “[f]ailure-to-warn actions,” like Mensing’s, “lend force to the FDCA’s

premise that manufacturers, not the FDA, bear primary responsibility for their drug

labeling at all times.” Wyeth, 129 S.Ct. at 1202. The generic defendants argue that

the Hatch-Waxman Amendments supply the relevant statutory framework, rather than

the whole FDCA. Yet additions to the statute like the Hatch-Waxman Amendments

must be considered part and parcel of the FDCA. These amendments provided for

cheaper, expedited approval of generic drugs, not relief from the fundamental

requirement of the FDCA that all marketed drugs remain safe. Congress and the FDA

have long viewed state tort law as complementing, not obstructing, the goals of the

FDCA. Wyeth, 129 S.Ct. at 1199-1200 (Congress “determined that widely available

state rights of action provided appropriate relief for injured [drug] consumers” and that

“state-law remedies further consumer protection by motivating manufacturers . . . to

give adequate warnings.”); id. at 1197 (“[T]he statute contemplates that federal juries

will resolve most misbranding claims[.]“).

15-

§ 314.98, referencing 21 C.F.R. § 314. 80. Mensing alleges that if the generic

manufacturers had merely taken note of the accumulation of adverse drug experiences

reports and the published medical studies about metoclopramide, they would have had

sufficient substantiation to warrant a label change.

The obligation Mensing seeks to impose upon generic manufacturers does not

obstruct the purposes and objectives of the Hatch-Waxman Amendments in any way.

On the contrary, “[f]ailure-to-warn actions,” like Mensing’s, “lend force to the FDCA’s

premise that manufacturers, not the FDA, bear primary responsibility for their drug

labeling at all times.” Wyeth, 129 S.Ct. at 1202. The generic defendants argue that

the Hatch-Waxman Amendments supply the relevant statutory framework, rather than

the whole FDCA. Yet additions to the statute like the Hatch-Waxman Amendments

must be considered part and parcel of the FDCA. These amendments provided for

cheaper, expedited approval of generic drugs, not relief from the fundamental

requirement of the FDCA that all marketed drugs remain safe. Congress and the FDA

have long viewed state tort law as complementing, not obstructing, the goals of the

FDCA. Wyeth, 129 S.Ct. at 1199-1200 (Congress “determined that widely available

state rights of action provided appropriate relief for injured [drug] consumers” and that

“state-law remedies further consumer protection by motivating manufacturers . . . to

give adequate warnings.”); id. at 1197 (“[T]he statute contemplates that federal juries

will resolve most misbranding claims[.]“).

III.

          We turn next to Mensing’s claims against the name brand manufacturers.  Traditional products liability requires a plaintiff to show that she actually consumed the defendant’s product. See, e.g., Bixler by Bixler v. Avondale Mills, 405 N.W.2d 428 (Minn. App. 1987). Although she never ingested name brand Reglan, Mensing claims that the name brand manufacturers are liable for various common law torts including negligent representation and fraud for misrepresenting the risks of tardive dyskinesia associated with metoclopramide.

          Mensing’s theory was rejected in Foster. There, the plaintiffs argued that “because generic drugs are required by federal law to be equivalent to their name brand counterparts,” the name brand defendant should be responsible for representations or omissions on the generic manufacturer’s label. Foster, 29 F.3d at 169. The Fourth Circuit’s response was that the plaintiffs were reframing products liability claims which they could not prove. Id. at 168. Presuming that generic manufacturers were responsible for altering their own labels when post approval safety concerns arose, the court found no legal precedent to hold the name brand manufacturers liable for injuries caused by their competitors. Id. at 170. Subsequently, the overwhelming majority of courts considering this issue has reached the same conclusion.8

          The Minnesota Court of Appeals is one of these courts. In Flynn v. American Home Products Corp., 627 N.W.2d 342 (Minn. App. 2001), a plaintiff like Mensing sought to hold name brand manufacturers liable for the harm caused by ingesting a generic equivalent. The court declined to recognize the “fraud on the FDA” claim essentially based on the name brand defendant’s misrepresentations to the FDA about the drug’s safety, and it also rejected an alternative argument based on Minnesota tort law. Id. at 350-52. Mensing argues that, unlike the Flynn plaintiffs, she did allege that the name brand defendants’ representations “were relied upon by her physician

when issuing the prescription.” Id. at 349-50. Mensing cites only one court since Foster to have found such a factor determinative. Conte v. Wyeth, 85 Cal. Rptr. 3d 299 (Cal. Ct. App. 2008).

Whatever the merits of Conte under California law, the Flynn court concluded that “central” to a fraudulent misrepresentation claim under Minnesota law is “a suppression of facts which one party is under a legal or equitable obligation to communicate to the other, and which the other party is entitled to have communicated to him.” Flynn, 627 N.W.2d at 350 (quotations omitted). In other words, regardless of whether her doctor relied upon the Reglan label, Mensing must show that the name brand manufacturers owed her a duty of care. Duty is a threshold requirement for all of the tort claims Mensing asserts.9 See, e.g., Noble Systems Corp. v. Alorica Central,  LLC, 543 F.3d 978, 985 (8th Cir. 2008) (finding that under Minnesota law negligent misrepresentation requires the plaintiff to “prove some relationship that is sufficient to create a duty owed by the defendant to the plaintiff”).

Such a duty of care does not extend to all potential Reglan consumers.

“Minnesota common law . . . requires a stronger relationship and a direct

communication.” Flynn, 627 N.W.2d at 350. Since Mensing “did not purchase or use [the name brand defendants'] product, . . . there was no direct relationship between

___________

9Mensing’s attempt to characterize her fraud claim as a type requiring no proof of a duty of care is unavailing. A plaintiff claiming fraud in Minnesota must show that the defendant intended to induce another to act in reliance on its fraudulent statement. Specialized Tours, Inc. v. Hagen, 392 N.W.2d 520, 532 (Minn. 1986). Mensing’s relationship with the Reglan manufacturers is too attenuated, and she has cited no Minnesota case in which the court imposed liability for fraud on a defendant who did not intend to communicate with the plaintiff. The Reglan manufacturers intended to communicate with their customers, not the customers of their competitors them, let alone a fiduciary relationship that gave rise to a duty.” Id. at 350. Mensing focuses on the foresee ability of harm from the defendants’ action. Like the Fourth Circuit, we conclude that holding name brand manufacturers liable for harm caused by generic manufacturers “stretch[es] the concept of foresee ability too far.” Foster, 29 F.3d at 171. As for Mensing’s negligent misrepresentation claim, “the Minnesota Supreme Court has recognized negligent misrepresentation involving damages only

for pecuniary loss[.]” Flynn, 627 N.W.2d at 350, citing Smith v. Brutger Cos., 569 N.W.2d 408, 414 (Minn. 1997). We find it unlikely the Minnesota Supreme Court would extend the doctrine to misrepresentation involving the risk of physical harm in these circumstances. We conclude that under Minnesota law Mensing has not shown that the name brand manufacturers owed her a duty of care necessary to trigger liability.

IV.

          In sum, we conclude that Mensing has stated a viable claim against the generic metoclopramide manufacturers. Far from prohibiting them from taking steps to warn their customers of new safety hazards, federal law requires such action. For the reasons stated we reverse the judgment in favor of the generic manufacturers but affirm the judgment as to the name brand manufacturers.

____________________________

 The Social Security Administration pays disability benefits under two programs.

 Social Security pays benefits to people who cannot work because they have a medical condition that is expected to last at least one year or result in death. Federal law requires this very strict definition of disability. While some programs give money to people with partial disability or short-term disability, Social Security does not.

                               The Social Security Disability Insurance Benefits program (SSDI) authorized under Title II of the Social Security Act, provides benefits to disabled workers, dependents, and surviving spouses.

                               The Supplemental Security Income program (SSI), authorized under Title XVI of the Social Security Act, provides benefits to the disabled the aged whose income and resources fall below a certain level.

Requirements for Social Security Disability

Social Security will review your application to make sure you meet some basic requirements for disability benefits. They will check whether you worked enough years to qualify. Also, they will evaluate any current work activities. If you meet these requirements, they will send your application to the Ohio Disability Determination Services office.

This state agency completes the disability decision for SSA. Doctors and disability specialists in the state agency ask your doctors for information about your condition. They will consider all the facts in your case. They will use the medical evidence from your doctors and hospitals, clinics or institutions where you have been treated and all other information. They will ask your doctors:

• What your medical condition is;
• When your medical condition began;
• How your medical condition limits your activities;
• What the medical tests have shown; and
• What treatment you have received.

They also will ask the doctors for information about your ability to do work-related activities, such as walking, sitting, lifting, carrying and remembering instructions. Your doctors are not asked to decide if you are disabled.

The state agency staff may need more medical information before they can decide if you are disabled. If more information is not available from your current medical sources, the state agency may ask you to go for a special examination. We prefer to ask your own doctor, but sometimes the exam may have to be done by someone else. Social Security will pay for the exam and for some of the related travel costs.

The individual applying for SSDI or SSI benefits is required to meet one standard of disability. Under both programs, a person is disabled if they are unable to “engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment which:

                               can be expected to result in death, or

                               has lasted or can be expected to last for a continuous period of not less than 12 months”

To meet this definition, an SSDI or SSI applicant must have “physical or mental impairment[s] of such severity that they are not only unable to do their previous work but cannot, considering their age, education, and work experience, engage in any other type of substantial gainful work existing in the national economy.”

Disability is determined using a five-step sequential evaluation process conducted by the SSA. If, at any point, an applicant is found not to be disabled, the evaluation process terminates and the claim for disability insurance benefits is denied. Following are the five requirements in determining disability:

                               Substantial gainful activity. If the applicant is currently engaged in substantial gainful activity, there is no disability, regardless of medical condition, age, or work experience.

                               Severe impairment. If the applicant is not engaged in substantial gainful activity, the SSA determines whether the applicant has a severe impairment. An impairment is considered “severe” if it significantly limits a person’s physical or mental ability to do basic work activities. If there is a finding of severity, the evaluation proceeds to the third step.

                               Listing of impairments. If the applicant’s condition meets the requirements, or is the equivalent of a disability on the SSA’s Listing of Impairments, then the applicant is ruled disabled. If the applicant does not meet the requirements, the sequential evaluation process continues to the fourth step.

                               Past relevant work. A medical assessment is performed to determine whether the impairment prevents the applicant from performing his past relevant work. If the applicant is found to be able to perform past relevant work, the claim will be denied. If not, the evaluation process continues to the final step.

                               Other work. The SSA evaluates whether the applicant can perform other available work existing in significant numbers in the national economy. The evaluation considers the applicant’s residual functional capacity (what the applicant is able to do in a work setting despite the impairment), age, education, and past work experience. If an applicant cannot perform other work, they will be found disabled.

Disability Benefits

Once the disability evaluation requirements have been met and the disability has been proven, disability payments will begin after a five-month waiting period. Benefits are payable starting with the sixth month after the onset of the disability and continue through the second month after it ends. Benefits continue until the disability improves or the recipient returns to substantial work.

Termination/Reduction of Benefits

Disability benefits terminate when the disability recipient dies or reaches full retirement age. Benefits may be reduced to offset payments received from other government programs designed to replace lost earning capacity. Derivative benefits may be available to disabled spouses, widows or widowers, or children. In addition, the social security laws contain work incentive provisions allowing disability recipients to return to work for a trial work period, during which time they can test their ability to work without losing benefits.

Ongoing Evaluation

The SSA may conduct a continuing disability review on a periodic basis to determine whether the applicant is still eligible for disability benefits. The beneficiary is notified in writing of the impending review and its requirements. The beneficiary may be required to undergo a medical examination and may submit other relevant evidence for SSA consideration.

Appeals

Appealing unfavorable decisions by the SSA involves a three-step appeal procedure, after which a dissatisfied applicant or benefits recipient may sue in federal court. Each step concludes with written notification of the outcome and includes a 60-day period during which a claimant may file for further review. Following are the three steps of the appeal process:

1. Reconsideration. Is the first step in the appeals process.  A reconsideration is a  complete review by the SSA of its initial decision. A social security representative who was not involved in the original application or decision conducts the review. The representative will also consider any new evidence submitted by the claimant.
2. Hearing. An Administrative hearing is the second step of the appeals process.  Many times this is the first time an applicant has the opportunity to speak directly to a decision maker.   An administrative law judge conducts a hearing.
3. Appeals Council Review. The Appeals Council of the SSA does not review all hearing decisions. For decisions it does review, the Council will either render a decision or return it to the administrative law judge for further review.

A claimant who is dissatisfied with the final appeal decision may bring suit in federal court within 60 days of the decision.

 Please Contact us for a free evaluation of your case (440)-639-1020

In Ohio, there are three basic actions which involve the suspension or termination of a legal marriage: (i) divorce, (ii) dissolution and (iii) legal separation. A “divorce” action is, in essence, a lawsuit – a lawsuit where one spouse sues the other spouse seeking to end the marriage, divide up the marital property and determine child support/child custody issues.

A “dissolution” is not really a lawsuit (e.g. wife vs. husband). However, it is nevertheless a legal proceeding in the domestic relations court – a legal proceeding which seeks all of the same things as a divorce. In a dissolution, both the husband and the wife file the “petition” for dissolution together in the same document. Attached to this “petition for dissolution” is another document called a “separation agreement.” A separation agreement is a contract between the husband and wife which settles all of the issues relating to the termination of the marriage (i.e. the legal termination of the marriage, the division of the martial assets and the allocation of the child support/custody issues. When the husband and the wife file the petition for dissolution (with the attached separation agreement), the domestic relations court sets up a dissolution hearing in about 30 to 60 days. At that hearing, the domestic relations judge will ask both the husband and the wife if they still want to end their marriage, and will further ask if they both want the marriage termination to be controlled by the terms of the separation agreement they attached to the petition for dissolution. If the answer to both of those questions is yes, the judge will grant them a divorce and will transform the separation agreement into a final court order judgment decree.

A “legal separation” has all of the attributes of a divorce or dissolution. However, the spouse who files the legal separation action does not seek the termination of the marriage. Instead, that spouse seeks to live completely separate and apart from the other spouse, seeks to divide up the marital property and seeks to determine all child support/child custody issues – all without actually ending the marriage. A legal separation can be converted into a divorce action if one of the parties files a motion requesting such a conversion.
 

With an aching shoulder and sore hip, Michael Spratt figured he’d have to apply for disability benefits someday. He just didn’t think that day would come so soon.

The 57-year-old was laid off from his job unloading chemicals from tanker trucks at the Rollie Williams Paint Spot in Elkhart, Ind., in January. The work involved some heavy lifting, and Spratt said that over the past couple of years he couldn’t do it without assistance.

“Without the help, I couldn’t have worked. The company, they more or less put up with me, because I worked there for 20 years. But it got to the point where if I had to work by myself, I wouldn’t have been able to do it,” Spratt said.

With business slowing, Spratt found himself out of a job along with more than a dozen colleagues. He doesn’t fault his old bosses for letting him go.

“I look at it as a blessing, because I know’d the day was coming that I’m not going to be able to work anymore,” he said.

Now, along with millions of other Americans, he’s turning to the disability system for support, creating an unexpected surge in applications.

According to the Social Security Administration, which runs the two main federal disability programs, new claims for disability benefits rose nearly 17 percent nationwide in fiscal year 2009, to 3 million. Disability filings are projected to rise another 10 percent in fiscal 2010, to 3.3 million new claims.

These applicants aim to join the roughly 12 million Americans who received disability benefits at a total cost of $161 billion in fiscal year 2009, according to the latest figures from Social Security.

‘A big mess’
Advocates and officials say the rising claims are driven by two main factors: the aging of the baby boomer generation and the slumping economy.

“The average age of disability we see nationwide is 50, so the baby boomers have already reached their peak years of disability. That by itself has been driving up volume big-time over the past decade,” said Jim Allsup, founder and CEO of Allsup Inc., a national disability representation firm. “Then they just went into the stratosphere because of the recession.”

With so many new claims being filed, Allsup is worried that the Social Security system can’t handle them all.

“Basically, it’s a big mess,” he said.

Michael Astrue, commissioner of the Social Security Administration, understands the frustration of Allsup and others who help disability applicants navigate the system.

“If I were in their shoes, I’d be concerned too,” Astrue said, acknowledging that his organization doesn’t have the best track record when it comes to processing claims in a speedy and efficient manner. In some parts of the country, disability applicants can wait years before they get a final decision.

“Where we’re having the biggest problems are states that have a combination of two things: One, the economy is very bad; and two, the state has embraced furloughs,” Astrue said. “California, Wisconsin, Ohio are three of the states where we’re really struggling now.”

To help the most overloaded offices, Astrue has beefed up hiring and created special strike teams. There are also plans to open seven new hearings offices by the middle of next year. Still, he admits, it may be a while before the system reaches full capacity.

“Part of the difficulty is these are highly technical, difficult jobs,” Astrue said. “The people we hired over the summer won’t be fully trained and productive for the most part until next summer. So we’re still struggling and limping a bit.”

Never been busier
In economically hard-hit northern Indiana, a person with questions about the disability claims process need not look far for answers — the airwaves are peppered with advertisements from lawyers offering to help people apply for benefits.

Attorneys in the field say they’ve never been busier.

“Let’s say you worked at an RV factory for 20-25 years and you lose your job and you’re 50 or 55, it’s almost impossible to find another job,” Davis said. “Many people that age of course do have serious impairments — they are diabetic, they have heart disease, whatever their impairments might be.”

But Astrue, the Social Security commissioner, said many applicants who have held jobs recently may not wind up being approved, unless their medical problems are found to be truly serious.

“Certainly you would expect that we would have a much lower allowance rate for people in that category with recent work history, where the problem may really be economic rather than medical,” Astrue said.

‘Nobody going to hire me’
Not long after being laid-off from the Paint Spot, Spratt filed an application for disability benefits.

He said that his ailments, including a right shoulder on which he had multiple surgeries in the mid-1990s, won’t allow him to get another manual labor job. And with just a 9th grade education — Spratt says he went to work full-time at the age of 15 after his parents got in an accident — he’s not a prime candidate for retraining for an office job.

“Ain’t nobody going to hire me,” he said.

He said a recent visit to the doctor brought some bad news.

“I just went to the doctor and found out I need the right shoulder replaced and the hip,” he said, his voice breaking. “I can’t afford that.”

To deal with the discomfort, Spratt is on prescription painkillers.

“They just upped me. I’m supposed to take three Vicodin a day, but I don’t. I don’t like taking it.”

In mid-October, Spratt got word that his claim for benefits had been rejected, so he signed up with a lawyer and is working on an appeal, a common step in the claims process.

Spratt’s attorney, Robert Rosenfeld, said that until the recession hit, many employers retained people with disabilities by making certain allowances for them.

“If you’ve got somebody who is a marginal employee but is trained and can do what you need him or her to do, they’ll keep them, they’ll make accommodations, they’ll allow excessive absenteeism,” he said. “When you lose the orders, when you lose the business, when you don’t need the employees … you keep the folks who can work 40 to 50 hours a week at a full productive rate. And the folks who were marginal at best get dropped. These are folks who probably qualified for disability but they were working, because they are good solid hardworking folks.”

Twists and turns
In order to get federal disability benefits, claimants must show they are unable to work due to a medical condition that is expected to last at least one year or result in death, according to the Social Security Administration.

It’s a high bar that few applicants meet at the initial application stage, when nearly two-thirds of claims are rejected. Those that are approved tend to be obvious cases — a person in a coma or someone with terminal cancer, attorneys say.

The next step is a “request for reconsideration,” which involves a review of the initial decision. It takes, in general, a few months, and roughly 14 percent of those who seek a review get the original decision overturned, according to Social Security.

The third, and for many applicants the most significant step, involves an in-person hearing before a judge, who must verify the legitimacy of the claim and where new evidence can be introduced. Roughly 55 percent of applicants who push on to this stage see benefits granted.

“It’s the one and only time that an individual who is seeking benefits sits down with the person making the decision,” Rosenfeld said.

It’s also the stage where people who can least afford it hit the longest snags. Applicants who seek a hearing in Dayton, Ohio, face an average wait of 635 days, the worst in the country. Another Ohio city, Columbus, is just behind, with an average processing time of 629 days. The national average is 491 days.

Rosenfeld said this can spawn some tough conversations with clients.

“The good news is we are going to get a hearing, the bad news is it might not be for two years. They say, ‘Well how do I survive?’ I don’t have an answer,” Rosenfeld said.

While some claimants may have significant savings or a spouse who works, others, like Rosemarie Grimm of Goshen, Ind., survive by tapping every source of income they can find.

While waiting for her hearing date, which came earlier this year, Grimm, 50, pieced together an existence by relying on her live-in boyfriend’s disability benefits (he lost one of his arms in 1996, she says), their 8-year-old son’s disability benefit (because he was a dependent of her boyfriend, the boy’s father, he got a monthly check too), food stamps, the Salvation Army and Elkhart County social services.

“When things got tough, I had to rely on different organizations to help. They’re real good out here like that,” Grimm said.

Many ailments, many medications
Grimm, who used to work as a waitress and hostess, initially filed for disability benefits in April 2007, claiming a variety of ailments. Her application was rejected, but nearly two years later, a judge granted her benefits, citing the following conditions: depressive disorder, anxiety disorder, degenerative disc disease, stenosis of the lumbar spine, bilateral carpal tunnel syndrome, status post fracture, shortening of the left wrist, fibromyalgia, erosive esophagitis, and more.

To deal with her many maladies, Grimm said she takes 15 medications each morning.

“I have them all in a row. You just get used to it after a while,” she said.

While Grimm said it was tough to get by as she waited for a hearing date, she wound up being compensated in the form of “back pay,” or past due benefits. Social Security pays successful claimants from just after the estimated onset of their disability, not from the day they are finally approved.

In Grimm’s case, this added up to $51,000 — $35,000 for herself and another $16,000 for her son — based on her awarded benefit of $1,094 per month, she said.

“When I got the money I felt bad, because there are people out there that don’t have any jobs,” Grimm said. “I felt guilty.”

But Grimm said friends urged her to put away her shame and reward herself and her family for their many years of doing without. So she paid ahead the family’s rent and a life insurance policy, and then bought new furniture for their small house on a busy road in Goshen, including three flat-screen TVs and a Sony Playstation, she said.

The family also owns two cars now — a 1994 Buick Park Avenue and a 1997 Ford Windstar — whereas they had none before, Grimm said.

‘Fair amount of judgment’
Cases where an applicant claims a combination of maladies as opposed to a single debilitating illness or condition have become increasingly common, according to Commissioner Astrue.

“We see a lot more combination of impairment cases, where people are alleging a lot of different impairments and saying the accumulated impact of all those impairments equals disability,” Astrue said. “A lot of these cases now involve a fair amount of judgment. It’s sort of a difficult looking into the soul of a person and trying to figure out, given the unique combinations of impairment this person has and the person’s vocational record, can we reasonably expect this person to work.”

“When Congress originally conceptualized the … disability program, it was an early retirement program for workers,” Astrue said. Congress expanded Social Security to include disability benefits in 1956. “What they had in mind were generally blue-collar workers, maybe 50-62 who had hurt their back on the job or that kind of thing and couldn’t work.”

While Spratt, the former paint shop laborer, awaits the reconsideration of his disability claims rejection, he and his wife get by on his $390 a month in unemployment benefits and her income from a waitressing job she’s held for more than 30 years at Elkhart’s Bulldog Restaurant, he said. The Spratts joke that she’s been there so long she’s been through at least one name change at the restaurant and an ownership change.

Even with his aching shoulder and bad news from the doctor about his hip, Spratt isn’t overly confident that his disability claim will wind up being approved.

“I don’t know. They say a lot of people are filing for it, so they might just say, ‘Well, no, you don’t qualify,’” he said. “You give the government money every year. Yet when you need the money, they ain’t going to give it back to you.”

Jason White

Reglan (Metoclopramide) is used to treat Gastroesophageal  Reflux Disease (GERD), heartburn and acid reflux disease. Although most side effects are temporary, a side effect that allegedly can be permanent, is Tardive Dyskinesia.

Tardive Dyskinesia is characterized by repetitive, involuntary, purposeless movements such as grimacing, tongue protrusion, lip smacking, puckering and pursing, and rapid eye blinking. Rapid movements of the arms, legs, and trunk may also occur. Impaired movements of the fingers may appear as though the patient is playing an invisible guitar or piano.

The FDA has only approved Reglan for short term use (4 to 12 weeks), but approximately 30% of patients are being prescribed the medication for 12 months or longer, which can result in tardive dyskinesia.

Although the labeling mentions tardive dyskinesia as a possible side effect, it claims the occurance is rare. However, two studies have determined that 27 to 29 percent of long term users of Reglan come down with tardive dyskinesia.

Tardive is a horrible, devastating syndrome that can last a lifetime. It affects victims physically, mentally, socially, emotionally and vocationally. It can cause involuntary movements of the tongue, mouth, face, lips and even arms and legs.

Other serious Reglan side effects are Neuropleptic Malignant Syndrome (NMS), which is often fatal. Patients can develop NMS after only short exposure to a drug. NMS symptoms include high fever, sweating, unstable blood pressure, stupor, muscular rigidity and autonomic dysfunction. Symptons can appear within the first 2 weeks of taking a drug.

If you have taken Reglan for a long time, and have experienced the side effects of Tardive Dyskinesia or Neuropleptic Malignant Syndrome, please contact an attorney immediately to determing your rights to compensation.

Lawyers and Settlements 2009

Under Ohio law, a court can award visitation rights to a grandparent  during or after a domestic relations proceeding if the grandparent has aninterest in the welfare of the child and visitation is in the best interest of the child.  A court can also award visitation rights to a grandparent if a parentis deceased or the child’s mother was unmarried when the child was born. Before awarding grandparent visitation rights in Ohio, a court must considerall relevant factors, including all factors listed in statute. In 2000, the United States Supreme Court held that a Washington grandparent visitation statute was unconstitutional as applied in a particularcase because it infringed on the fundamental right of a parent to make decisions concerning the care, custody, and control of his or her child. However, a recent  Ohio Supreme Court case determined that this decisiondoes not apply to Ohio and held that the Ohio third-party visitation statutesare constitutional on their face.Grandparent visitation: when granted  Historically, grandparents had no legal right of access to their grandchild, and parents had complete authority to grant or deny the privilege of visitation.

 Ohio has authorized grandparent companionship or visitation rights by statutein three circumstances: (1) when married parents terminate their marriageor separate, (2) when a parent of a child is deceased, and (3) when the childis born to an unmarried woman. In such cases, a court may order reasonablevisitation if it is in the best interest of the child.

PREPARED BY: LAURA SCHNEIDER, LSC RESEARCH ASSOCIATE

REVIEWED BY: MICHAEL O’NEILL, LSC DIVISION CHIEF

A main objective of the Child Support Enforcement program is to make sure that child support payments are made regularly and in the correct amount. While many non-custodial parents are involved in their children’s lives and are willing to pay child support, lapses of payment do occur. When they do, a family’s budget can be quickly and seriously threatened, and the anxiety the custodial parent feels can easily disrupt the family’s life.

In addition to wage withholdings, Ohio law allows the CESA office to utilize other administrative enforcement techniques, which include but are not limited to:

Seizing State and Federal income tax returns Suspending driver’s, professional, and recreational licenses. Imposing liens on real or personal property with the proceeds of the sale being applied to the support debt
Seizing bank accounts Revoking the ability to obtain or renew a passport for out-of-the-country travel
Credit Reporting

Cases can also be referred to the Prosecutor’s Office for legal intervention when support payments are not being made. The non-custodial parent will be summoned to court to show why he or she should not be held in contempt for not paying support as ordered, and depending on the offense, can be sentenced to jail.

Frequently Asked Questions:

Q. Can a wage withholding be requested for my child support payments?

A. Yes. All support orders issued or modified must include a provision for wage withholding.

Q. Can past-due child support be taken from the State income tax refund?

A. Under Federal law, all States with State income tax must offset State income tax refunds for past-due support owed.

Q. Can Federal income tax refunds be offset the same way?

A. Yes, States can request an offset of Federal income tax refunds for past-due support.

Q. The children’s father lost his job and is collecting unemployment compensation. Can child support payments be deducted and sent to me?

A. Yes. Unemployment compensation, and other State and Federal benefits can be withheld for child support.

Q. My children are over 18 and don’t get child support any more, but there is still a $10,000 arrearage owed to me for support that was never paid. Will the CSED collect that money for me?

A. Yes, Child Support Enforcement office is required to collect the back support.

Lawyers at our Painesville firm, Patrice Denman Co. LPA, have been helping clients with divorce and child support proceedings for over 20 years. If you would like to speak with one of our attorneys, please contact our Painesville office for a free consultation.

• Who is Covered by SSDI?
• Definition of Disabled
• Benefits Available to the Injured

Disability Guide Topics

• Filing for Disability: Requirements
• Filing for SSDI: Medical Records
• Disability Claim Determination
• Collecting Disability Payments
• Why a Disability Claim Gets Denied
• Other Benefits and Disability for Children
• When to Talk to a Lawyer

President Roosevelt created the Social Security Act and the Social Security Administration during the Great Depression.  It was a plan to provide a guaranteed income to older workers when they reached age 65.

Eventually through various amendments, the program was expanded to provide benefits to disabled workers, workers dependents, and death benefits if a worker died prematurely.

Social Security Disability is cash benefits paid to workers who are ill or injured.  Unlike workers compensation, the illness or injured does not have to occur or be related to the workplace.  The benefits are paid to the worker based on the workers contribution paid through his or her wage deductions while employed.

Who Benefits from Social Security Disability?

There are four classes of persons who can benefit from Social Security Disability, they are:

Disabled Worker

The primary beneficiary under social security disability is the disabled worker who qualifies for benefits.

Spouse of Disabled Worker

The spouse of a disabled worker can be eligible for SSDI benefit if  he or she is over 62 years of age, or caring for a child under the age of 16 (there is no age requirement under this circumstance), or caring for a disabled child.  (there is no age requirement under this circumstance).

Disabled Child

Unmarried child (includes adopted child and in some instances stepchild and grandchild) over the age of 18:

• If they have a disability that started before the age of 22. 
• The disability must also meet the definition for disabled adult.

Child

Unmarried child (includes adopted child and in some instances stepchild and grandchild) must be under the age of 18 or under age 19 if attending elementary or secondary school full-time.

Social Security Administration’s (SSA) Definition of Disabled

Social Security defines disabled as being:

• Unable to engage in any substantial gainful activity because of physical or mental impairment
• You must be unable to work but also unable to do any other work based on your age, education, and work experience
• The impairments must be established by objective medical evidence

• The impairment must be expected to result in death or expected to last at least 12 months

Programs Available

Social Security Disability Insurance (SSDI)

Each worker pays into the social security system through the payroll taxes that are taken out of their pay check based on a formula.  Your employer also pays payroll taxes into the system.  Social Security is a form of insurance; it is not a government handout.  You must meet non-medical criteria and medical criteria to receive benefits under the disability portion of the social security program.

Supplemental Security Income (SSI)

SSI is a Federal income supplement program funded by general tax revenues (not Social Security taxes): It is designed to help aged, blind, and disabled people, who have little or no income.  It provides cash to meet basic needs for food, clothing, and shelter.  The maximum amount of SSI a person can receive from the federal government is the same nationwide. The amount of SSI benefits a person is entitled to is dependent upon their income and assets.  Some states supplement the amount given by the federal government.

Mary and Bill recently divorced. Their divorce decree stated that Bill would pay the balances on their three joint credit card accounts. Months later, after Bill neglected to pay off these accounts, all three creditors contacted Mary for payment. She referred them to the divorce decree, insisting that she was not responsible for the accounts. The creditors correctly stated that they were not parties to the decree and that Mary was still legally responsible for paying off the couple’s joint accounts. Mary later found out that the late payments appeared on her credit report.

If you’ve recently been through a divorce – or are contemplating one – you may want to look closely at issues involving credit. Understanding the different kinds of credit accounts opened during a marriage may help illuminate the potential benefits – and pitfalls – of each.

There are two types of credit accounts: individual and joint. You can permit authorized persons to use the account with either. When you apply for credit – whether a charge card or a mortgage loan – you’ll be asked to select one type.

Individual or Joint Account

Individual Account: Your income, assets, and credit history are considered by the creditor. Whether you are married or single, you alone are responsible for paying off the debt. The account will appear on your credit report, and may appear on the credit report of any “authorized” user. However, if you live in a community property state (Arizona, California, Idaho, Louisiana, Nevada, New Mexico, Texas, Washington, or Wisconsin), you and your spouse may be responsible for debts incurred during the marriage, and the individual debts of one spouse may appear on the credit report of the other.

Advantages/Disadvantages: If you’re not employed outside the home, work part-time, or have a low-paying job, it may be difficult to demonstrate a strong financial picture without your spouse’s income. But if you open an account in your name and are responsible, no one can negatively affect your credit record.

Joint Account: Your income, financial assets, and credit history – and your spouse’s – are considerations for a joint account. No matter who handles the household bills, you and your spouse are responsible for seeing that debts are paid. A creditor who reports the credit history of a joint account to credit bureaus must report it in both names (if the account was opened after June 1, 1977).

Advantages/Disadvantages: An application combining the financial resources of two people may present a stronger case to a creditor who is granting a loan or credit card. But because two people applied together for the credit, each is responsible for the debt. This is true even if a divorce decree assigns separate debt obligations to each spouse. Former spouses who run up bills and don’t pay them can hurt their ex-partner’s credit histories on jointly-held accounts.

Account “Users”

If you open an individual account, you may authorize another person to use it. If you name your spouse as the authorized user, a creditor who reports the credit history to a credit bureau must report it in your spouse’s name as well as in your’s (if the account was opened after June 1, 1977). A creditor also may report the credit history in the name of any other authorized user.

Advantages/Disadvantages: User accounts often are opened for convenience. They benefit people who might not qualify for credit on their own, such as students or homemakers. While these people may use the account, you – not they – are contractually liable for paying the debt.

If You Divorce

If you’re considering divorce or separation, pay special attention to the status of your credit accounts. If you maintain joint accounts during this time, it’s important to make regular payments so your credit record won’t suffer. As long as there’s an outstanding balance on a joint account, you and your spouse are responsible for it.

If you divorce, you may want to close joint accounts or accounts in which your former spouse was an authorized user. Or ask the creditor to convert these accounts to individual accounts.

By law, a creditor cannot close a joint account because of a change in marital status, but can do so at the request of either spouse. A creditor, however, does not have to change joint accounts to individual accounts. The creditor can require you to reapply for credit on an individual basis and then, based on your new application, extend or deny you credit. In the case of a mortgage or home equity loan, a lender is likely to require refinancing to remove a spouse from the obligation.

For More Information

The FTC works for the consumer to prevent fraudulent, deceptive, and unfair business practices in the marketplace and to provide information to help consumers spot, stop, and avoid them. To file a complaint or to get free information on consumer issues, visit ftc.gov or call toll-free, 1-877-FTC-HELP (1-877-382-4357); TTY: 1-866-653-4261. The FTC enters consumer complaints into the Consumer Sentinel Network, a secure online database and investigative tool used by hundreds of civil and criminal law enforcement agencies in the U.S. and abroad. 

At Patrice Denman Co. LPA we are have over 20 years of Family Law experience.  For a free consultation call us at 440-639-1020