Plaintiff’s Brief in Opposition to Defendants Motion to Dismiss

Summary: In this product liability case, Heygood, Orr & Pearson represented the family of a man who died while using a pharmaceutical product called a fentanyl patch.  After the case was filed, the defense filed a motion to dismiss.  The below brief was our firm’s response to the motion to dismiss.  The motion to dismiss was defeated with the exception of a couple of insignificant claims.

IN THE UNITED STATES DISTRICT COURT FOR THE
DISTRICT OF NEBRASKA
ROBERT HOUSTON, as Personal
Representative of the ESTATE
OF RHONDA HOUSTON,

Plaintiff,

vs.

MYLAN, INC., MYLAN
PHARMACEUTICALS, INC., and MYLAN
TECHNOLOGIES, INC.,

Defendants.

Case No. 8:09-cv-00306

PLAINTIFF’S BRIEF IN OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS

PRELIMINARY STATEMENT

Defendants Mylan, Inc., Mylan Pharmaceuticals, Inc., and Mylan Technologies, Inc. (the “Drug Companies”) seek dismissal of Plaintiff Robert Houston’s complaint pursuant to Rule 12(b)(6). (See Dkts. 18-19.) The Drug Companies do not contend that Robert has failed to plead the legal elements of his claims or that his claims are defective under Nebraska law. Instead, the Drug Companies complain that Robert does not provide the factual specificity that they desire. This argument is without merit because, as Robert’s complaint sufficiently describes the factual allegations that support each cause of action, his complaint complies with the Federal Rules of Civil Procedure.

As pleaded in his complaint, Robert’s causes of action each flow from a fairly simple set of facts. Robert’s wife, Rhonda, was prescribed a fentanyl patch for pain relief. That patch was designed, manufactured, marketed, and sold by the Drug Companies. The Drug Companies represented that the patch was designed and manufactured to give Rhonda a therapeutic level of fentanyl—an extremely powerful narcotic that is more than 80 times stronger than morphine. Instead, despite proper use, Rhonda received a lethal dose of fentanyl from the Drug Companies’ patch. As described more thoroughly in this response, this basic set of facts supports Robert’s claims of strict products liability, negligence, and fraudulent misrepresentation. Accordingly, Robert’s claims should not be dismissed; his complaint provides the notice required by Federal Rule of Civil Procedure 8. (See infra, pages 3 to 10.)

This same basic set of facts has been pleaded against the Drug Companies in numerous other cases where patients have died after receiving fatal doses of fentanyl from their prescribed Mylan patches. In most of those cases, the Drug Companies have simply answered the substantially similar complaints. In the few instances in which the Drug Companies have challenged the complaints as insufficient, courts have unanimously held that the factual allegations are sufficient as a matter of law. The majority of these cases are federal cases and, in all of the federal cases, the answer was filed or the motion to dismiss was ruled on after the U.S. Supreme Court’s decision in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). (See, infra, pages 10 to 12.) Indeed, the Drug Companies have engaged in discovery in this matter by entering a discovery agreement, serving documents, and serving cross-notices for depositions.

Alternatively, should this Court conclude that Robert’s factual allegations are deficient, Robert seeks leave to amend his complaint and plead additional factual allegations consistent with the Court’s order. (See, infra, page 13.)

FACTUAL BACKGROUND

The Drug Companies design, manufacture, market, and sell fentanyl patches to treat chronic pain. (Compl. ¶¶ 6-7 (Dkt. 1).) A patch is applied by the patient and delivers fentanyl through the skin. (Compl. ¶ 8.) The Drug Companies design, manufacture, market, and sell the patches with the intent that the patches will release a certain amount of fentanyl into a patient at a certain rate, and thus produce a certain concentration of fentanyl in the patient’s blood. (Compl. ¶ 8.) If the patch works as intended and is properly used by the patient, the patient should not receive a harmful dose. (Compl. ¶ 8.)

Rhonda’s physician prescribed her 50 mcg fentanyl patches for her pain. (Compl. ¶ 6.) Rhonda filled that prescription at a local pharmacy, and she did not abuse or misuse the patch. (Compl. ¶¶ 6, 8.) When Rhonda died on September 10, 2007, she was wearing one of the prescribed patches. (Compl. ¶ 6.) At the time of her death, Rhonda had a fatal concentration of fentanyl in her blood. (Compl. ¶ 10.) The cause of death listed on her death certificate is “drug toxicity.” (Compl. ¶ 10.)

Prior to Rhonda’s death, numerous patients had received lethal doses of fentanyl while using the patches as prescribed. (Compl. ¶ 9.) The Drug Companies knew or should have known of these deaths because (1) wrongful death lawsuits had been filed against them; (2) they had received information about fentanyl overdoses from the FDA’s adverse event reporting system and from the World Health Organization; and (3) information about patient overdoses from Mylan fentanyl patches was available from medical examiners. (Compl. ¶ 9.)

ARGUMENT AND AUTHORITIES

A. The Drug Companies are not entitled to detailed factual pleading.

Glossing over the factual allegations in Robert’s complaint, the Drug Companies assert that they are entitled to more detailed, specific, factual allegations under Twombly and Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009). But “a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations.” Twombly, 550 U.S. at 555. Indeed, “Federal Rule of Civil Procedure 8(a)(2) requires only ‘a short and plain statement of the claim showing that the pleader is entitled to relief,’ in order to ‘give the defendant . . . fair notice of what the . . . claim is and the grounds upon which it rests.’” Id. at 555 (citations omitted). All that is required of this short plain statement is that the “[f]actual allegations must be enough to raise a right to relief above the speculative level.” Id. at 570; see also Iqbal, 129 S. Ct. at 1950 (noting that the complaint must move from “conceivable to plausible”). For the reasons discussed below, the Drug Companies’ motion to dismiss is fatally flawed because it ignores all of the factual allegations in the complaint and, instead, focuses on only the legal allegations. (See, e.g., Dkt. 19 at 8-9.) When the complaint is read as a whole, it is clear that Robert’s complaint is more than sufficient to satisfy the Federal Rules of Civil Procedure.

1. Robert has sufficiently pleaded his manufacturing-defect claim.

The Drug Companies ignore Robert’s numerous factual allegations when arguing that he has not sufficiently pleaded his manufacturing-defect claim (Dkt. 19 at 9):

  • Rhonda was properly wearing a prescribed 50 mcg patch designed by the Drug Companies when she died (Compl. ¶¶ 6-7);
  • Although a properly manufactured patch “will not [provide] a harmful dose of fentanyl,” (Compl. ¶ 8), Rhonda died with an elevated fentanyl concentration in her blood, and the medical examiner’s report lists her death as “drug toxicity” (Compl. ¶ 10);
  • Rhonda was not aware of the patch’s defective condition, and the patch reached her without substantial change to its condition (Compl. ¶¶ 14-15);
  • The patch was unreasonably dangerous because “it gave [Rhonda] a much higher dose of fentanyl than a properly functioning patch should have given her” (Compl. ¶ 13); and
  • The patch “was defective because it malfunctioned and did not perform as intended and designed.” (Compl. ¶ 15.)

These pleaded facts give the Drug Companies more than sufficient notice of Robert’s manufacturing-defect claim, especially when they concede that “[t]here is no question that Plaintiff’s complaint . . . encompasses in its language Nebraska’s consumer expectations test.” (Dkt. 19 at 8.)

Although the Drug Companies argue that Robert has not pleaded “facts establishing how the Patch differed from the plans and specifications,” he has no duty to do so. (Dkt. 19 at 9.) The Eighth Circuit has held that a plaintiff has no duty to plead or prove a specific defect under Nebraska’s strict-products-liability law. See Shuck v. CNH Am., LLC, 498 F.3d 868, 877 (8th Cir. 2007); see also Genetti v. Caterpillar, Inc., 621 N.W.2d 529, 542 (Neb. 2001) (“[A] precise or specific defect does not need to be proved in order to find a product defective.”)). Similarly, the Nebraska Court of Appeals has approvingly cited Restatement (Third) of Torts, Products Liability Section 3 for the proposition that “it may be inferred that the harm sustained by the plaintiff was caused by a product defect existing at the time of sale or distribution, without proof of a specific defect.” Urbach v. Indus. Chem. Lab., No. A-96-368, 1997 Neb. App. LEXIS 134, *23 (Neb. Ct. App. Sept. 9, 1997). Thus, the Drug Companies’ complaint that Robert has not pleaded facts that he has no duty to prove is of no moment.

Simply put, Robert pleads sufficient circumstantial facts to demonstrate that the Drug Companies’ patch was defective and caused Rhonda’s death. Id.

2. Robert has sufficiently pleaded his failure-to-warn claim.

The Drug Companies allege that Robert’s complaint allegedly contains insufficient allegations regarding (a) the nature of the inadequacy of the warnings, (b) why the Drug Companies should have known that the warnings were inadequate, and (c) whether the lack of sufficient warnings caused Rhonda’s death. (See Dkt. 19 at 10-11). The Drug Companies’ argument focuses solely on paragraph 19 of Robert’s complaint and improperly ignores Robert’s factual allegations. When viewed as a whole, Robert’s complaint provides a significant factual basis for his failure-to-warn claim.

a. The complaint contains sufficient allegations that the patch was defective because it contained inadequate warnings that a patient could receive a fatal fentanyl overdose while properly using the patch.

Contrary to the Drug Companies’ argument, Robert has plead ample facts supporting his allegation that the patch was defective because, among other things, it was marketed and sold with inadequate warnings about the risk that the patch could cause (and had caused) fatal fentanyl overdoses even when used properly:

  • The Drug Companies design, manufacture, market, and sell the patch with the intention that it will release a certain amount of fentanyl into a patient at a certain rate, and thus produce a certain level of fentanyl in the blood of the patient. If a Patch functions as intended and it is properly used by the patient, the patient should not receive a harmful dose of fentanyl. (Compl. ¶ 8);
  • Prior to the time Rhonda’s patch was manufactured and distributed, numerous patients received lethal doses of fentanyl while using the patch as prescribed (Compl. ¶ 9);
  • The patch is unsafe for its intended or reasonably foreseeable use because it can and does cause lethal levels of fentanyl in patients (Compl. ¶ 9);
  • The patch was in a defective condition at the time it was designed, manufactured, sold, and/or marketed by the Drug Companies at the time it left their possession because it was defectively manufactured, defectively designed, and contained insufficient warnings concerning its risks (Compl. ¶ 13);
  • The patch was unreasonably dangerous and thus defective because, among other things, it gave Rhonda a much higher dose of fentanyl than a properly functioning patch should have given her (Compl. ¶ 13);
  • The Drug Companies failed to warn Rhonda or her doctor of the dangerous condition of the patch (defined in the fact section of the complaint as the risk of a fatal fentanyl overdose from the patch) or the facts that made it dangerous (Compl. ¶ 17);
  • The Drug Companies failed to provide the FDA with information or data relevant to the safety of the patch (which is relevant to the warnings issue because the FDA often requires drug companies to strengthen their warnings because of adverse events ) (Compl. ¶ 25d);
  • The Drug Companies failed to conduct adequate testing and post-marketing surveillance to determine the safety of the patch (which is relevant to the warnings issue because drug companies have a duty to strengthen their warnings based on post-marketing surveillance) (Compl. ¶¶ 25d, 25m);
  • The Drug Companies misrepresented that the patch was safe for use (Compl. ¶ 25j);
  • The Drug Companies failed to list death as an adverse event (Compl. ¶ 25n);
  • The Drug Companies marketed the patch for unsafe uses (Compl. ¶ 25p); and
  • The Drug Companies failed to communicate to the FDA, Rhonda, physicians, distributors, pharmacists, and/or the general public, that proper use of the patch could cause serious injury and/or death (Compl. ¶ 30).

Collectively, these allegations make it abundantly clear that Robert is alleging that the patch was defective because it provided inadequate warnings to Rhonda’s prescribing doctor about the following risks: (1) that the patch could give patients a fatal fentanyl level instead of the therapeutic level listed in the package insert; (2) death is a potential adverse event; and (3) prior to the time Rhonda’s patch was manufactured and sold, numerous patients had received fatal fentanyl overdoses while properly using the patch.

b. The complaint contains sufficient allegations that the Drug Companies knew or should have known that patients could receive fatal fentanyl overdoses while properly using the patch.

The Drug Companies’ assertion that the complaint contains insufficient allegations that they knew or should have known about the dangerous condition of the patch ignores numerous factual allegations about their knowledge. The complaint alleges that the Drug Companies knew or should have known that the patch was defective because numerous patients had received lethal doses of fentanyl while using the patch as prescribed and that the drug companies received reports of these adverse events:

  • Prior to the time Rhonda’s patch was manufactured and distributed, numerous patients received lethal doses of fentanyl while using the Patch as prescribed;
  • The Drug Companies knew or should have known that patients were receiving lethal fentanyl doses from proper use of the patch because of wrongful death lawsuits filed against them; and
  • The Drug Companies knew or should have known that patients were receiving lethal fentanyl doses from proper use of the patch because they had received information about patient overdoses from the FDA’s adverse event reporting system and the World Health Organization, and information was publicly available from medical examiners about patient overdoses from Mylan patches.

(Compl. ¶ 9.) The complaint also fairly alleges that, if the Drug Companies did not know about the dangerous condition of the patch, their lack of knowledge is due to their negligence:

  • The Drug Companies failed to obtain easily accessible information or data relevant to the safety of the patch (Compl. ¶ 25e);
  • The Drug Companies failed to perform sufficient testing of the patch to confirm or ensure it was safe for its intended use (Compl. ¶ 25f);
  • The Drug Companies failed to conduct adequate testing and post-marketing surveillance to determine the safety of the patch (Compl. ¶ 25i);
  • The Drug Companies conducted inadequate and/or insufficient research into the safety of the product prior to sale (Compl. ¶ 25l); and
  • The Drug Companies conducted inadequate and/or insufficient monitoring or research regarding adverse events (Compl. ¶ 25m).

Collectively, these allegations provide sufficient factual support for Robert’s allegation that the Drug Companies failed to warn of risks that were known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time the patch was manufactured and distributed. (Compl. ¶ 17.)

c. The complaint sufficiently alleges that the Drug Companies’ failure to warn was a proximate cause of Rhonda’s death.

The Drug Companies assert that the complaint’s allegation that the Drug Companies’ “failure to warn was a proximate cause of Decedent’s death and the damages claimed herein” is “the very definition of a legal conclusion.” (Dkt. 19 at 11.) Their argument—which refers to no pharmaceutical failure-to-warn cases—is without merit. As a preliminary matter, proximate cause is a question of fact; an allegation that a defect was a proximate cause is a factual allegation. See Sharkey v. Bd. of Regents, 615 N.W.2d 889, 902 (Neb. 2000) (holding that “the proximate cause of [plaintiff’s] damages [is a] question[] of fact for the finder of fact”).

But, even assuming something more is required, the complaint contains other allegations regarding the causal connection between the Drug Companies’ inadequate warnings and Rhonda’s death:

  • The Drug Companies knew or should have known that patients were receiving lethal fentanyl doses from proper use of the patch (Compl. ¶ 9);
  • The Drug Companies failed to warn Decedent or her doctor of the dangerous condition of the patch or the facts that made it dangerous (Compl. ¶¶ 17, 25a);
  • The Drug Companies knew that the patch created a high risk of unreasonable, dangerous side effects, including that proper use of the patch can cause death, but they failed to communicate to the FDA, Decedent, physicians, distributors, pharmacists, and/or the general public, that proper use of the patch could cause serious injury and/or death (Compl. ¶ 25a); and
  • Rhonda and others, including, without limitation, Rhonda’s physician(s) and her pharmacist(s), justifiably relied on the Drug Companies’ misrepresentations (Compl. ¶ 31e).

These allegations are more than sufficient to demonstrate that Rhonda was prescribed fentanyl and died from a fentanyl overdose because the Drug Companies failed to provide adequate warnings that a fatal overdose from the proper use of a fentanyl patch could occur.

Therefore, Robert has sufficiently pleaded his failure-to-warn claim.

3. Robert has sufficiently pleaded his design-defect claim.

Although the Drug Companies do not specifically identify why Robert’s complaint is deficient as to his design-defect claim, Robert has sufficiently pleaded this claim. The complaint alleges:

  • Rhonda was properly wearing a prescribed patch designed by the Drug Companies when she died (Compl. ¶¶ 6-7);
  • a properly designed patch “will not [provide] a harmful dose of fentanyl” (Compl. ¶ 8);
  • Rhonda died with a lethal fentanyl concentration in her blood, and the medical examiner’s report lists her death as “drug toxicity” (Compl. ¶ 10);
  • Rhonda was not aware of the patch’s defective condition, and the patch reached her without substantial change to its condition (Compl. ¶¶ 14-15); and
  • because Rhonda received a fatal level of fentanyl, the patch “failed to perform as safely as an ordinary consumer would expect when used [in] an intended or reasonably foreseeable manner.” (Compl. ¶ 18.)

Moreover, despite the fact that “Nebraska no longer requires proof of an alternative design for a claimant to recover [for] defective design,” Kudlacek v. Fit S.p.A., 509 N.W.2d 603, 611 (Neb. 1994), Robert also alleges that a safer, alternative design was available. (Compl. ¶ 19.) Because Robert has plead numerous specific facts concerning his design-defect claim and because the Drug Companies concede that “[t]here is no question that Plaintiff’s complaint . . . encompasses in its language Nebraska’s consumer-expectations test,” the Drug Companies have no basis for arguing that “[n]othing in Plaintiff’s pleading is not wholly generic.” (Dkt. 19 at 8.) Robert has, accordingly, sufficiently pleaded his design-defect claim.

4. Robert has sufficiently pleaded his negligence claim.

The Drug Companies appear to argue that Robert’s complaint is speculative because it specifies the numerous ways in which the Drug Companies were negligent. But Robert has sufficiently pleaded his negligence claim. (Dkt. 19 at 12.) Robert alleges:

  • His wife, when she died, was properly wearing a prescribed fentanyl patch designed, manufactured, and distributed by the Drug Companies (Compl. ¶¶ 6-8);
  • Although a properly functioning and designed patch should not have delivered a fatal level of fentanyl, Rhonda died of drug toxicity (Compl. ¶¶ 8, 10);
  • Her death was proximately caused by the patches’ defective design, manufacture, or marketing (Compl. ¶¶ 13, 17); and
  • The Drug Companies—prior to Rhonda’s death—were aware that properly worn patches could cause death (Compl. ¶ 9).

After alleging these facts, he specified that the Drug Companies were negligent by, among other ways:

  • providing misleading and insufficient warnings regarding the patch to Rhonda or her prescribing doctor;
  • failing to use due care in designing and manufacturing the patch;
  • failing to use proper materials reasonably suited to the manufacture of the patch;
  • failing to provide to the FDA information or data relevant to the safety of the patch;
  • failing to perform sufficient testing of the patch to confirm or ensure it was safe for its intended use;
  • failing to conduct adequate testing and post-marketing surveillance to determine the safety of the Patch; and
  • failing to inspect and test the product.

(Compl. ¶ 25.) Based on the fact that Rhonda died from receiving a fatal fentanyl dose from a patch that was not intended to deliver a fatal dose of fentanyl, these specific factual and legal allegations are simply not speculative.

5. Robert has sufficiently pleaded his fraudulent misrepresentation claim.

Finally, Robert has pleaded sufficient facts to support his fraudulent misrepresentation claim. Federal Rule of Civil Procedure 9(b) requires a party to “state with particularity the circumstances constituting fraud or mistake. [K]nowledge and other conditions of a person’s mind may be alleged generally.” Although allegations of “who, what, when, where, and how” must be pleaded, “Rule 9(b) is deemed satisfied if the allegations are accompanied by a statement of facts on which the belief is founded.” Drobnak v. Andersen Corp., 561 F.3d 778, 783-84 (8th Cir. 2009). In other words, Robert merely has the burden of “plead[ing] the equivalent of the first paragraph of any newspaper story.” Drobnak, 561 F.3d at 784. Robert alleges that:

  • Who: the Drug Companies, their employees, agents, representatives, and distributors;
  • What: fraudulently misrepresented, by omission, that unreasonable side effects, such as death, could accompany proper use of the patch;
  • To Whom: to the FDA, Rhonda, her physicians, and pharmacists;
  • When: at the time that Rhonda was prescribed and died from the proper use of her fentanyl patch;
  • Where: in Nebraska, where Rhonda died; and
  • How: by failing to disclose the fact that patients were receiving lethal fentanyl doses from proper use of the patches, even through the Drug Companies were on notice through the FDA, the WTO, and medical examiners’ adverse event reports.

(Compl. ¶¶ 9, 10, 29-31.) Indeed, although Robert only has a duty to plead the Drug Companies’ state of mind generally, he has alleged specific facts demonstrating that they had knowledge from adverse event reports that proper use of their products caused death. See Fed. R. Civ. P. 9(b). Any additional or more specific facts remain “peculiarly within the opposing party’s knowledge.” Id. at 783. Robert’s complaint satisfies his burden of “plead[ing] the equivalent of the first paragraph of any newspaper story.” Drobnak, 561 F.3d at 784.

B. The Drug Companies’ actions in other similar cases and in this matter demonstrate that they have notice of the claims against them.

Even if there any doubt existed about the sufficiency of the complaint, the Drug Companies’ conduct in other lawsuits demonstrates that they have sufficient notice of the complaint against them. They have answered nearly identical complaints in similar lawsuits without arguing that the allegations are not plausible. Indeed, in the few actions in which they have challenged the sufficiency of the pleaded allegations based on Iqbal, Twombly, or a similar doctrine, the courts—including federal district courts—have uniformly rejected their contentions. Moreover, in this action, they have already begun discovery. The complaint in this action, the close sibling of the complaints in numerous prior actions, meets the requirements for notice pleading under the Federal Rules of Civil Procedure.

1. The Drug Companies have answered nearly identical complaints in other lawsuits.

For unexplained reasons, the Drug Companies are highly selective in deciding which complaints to challenge as insufficient. Heygood, Orr & Pearson, Robert’s counsel in this matter, represents other wrongful-death beneficiaries and administrators in lawsuits that allege that the Drug Companies’ defective patches delivered a fatal dose of fentanyl. Because the facts underlying all of the deaths from defective fentanyl patches are substantially similar, the complaints contain nearly identical allegations: although properly using a prescribed patch designed, manufactured, and marketed by the Drug Companies, a decedent died from a lethal fentanyl overdose from a defective patch. (Compare, e.g., Dkt. 1, with Compl., Woodcock v. Mylan, Inc., No. 2:09-cv-00507 (S.D. W. Va.) (Ex.2), Compl., Milos v. Mylan, Inc., No. 09-L-002891 (Cir. Ct. of Cook County, Ill.) (Ex. 3), and Compl., LaPaglia v. Mylan Inc., No. 1:08-cv-03025 (N.D. Ohio) (Ex. 4).) In almost all cases, the Drug Companies answered those complaints (many of which were filed in federal court) without challenging the sufficiency of the plaintiff’s factual pleading. The Drug Companies’ position that they are suddenly unable to answer these nearly identical allegations or that these nearly identical allegations are speculative and conclusory is simply not credible.

2. When the Drug Companies have asserted that nearly identical allegations in other cases are insufficient, courts have unanimously rejected their argument.

Courts have rejected the Drug Companies’ challenges to the sufficiency of nearly identical allegations in other fentanyl-death complaints. For instance, federal district courts have recently held that nearly identical allegations are sufficient (even under Twombly and Iqbal). See Woodcock v. Mylan, Inc., No. 2:09-cv-00507, 2009 U.S. Dist. LEXIS 95403, at *16-30 (S.D. W. Va. Oct. 14, 2009); Grange v. Mylan Labs., Inc., No. 1:07-cv-107, 2008 U.S. Dist. LEXIS 92460, at *6-7, 20-23 (D. Utah 2008). In fact, although Illinois courts require more detailed factual pleading than federal courts, see People ex rel. Madigan v. Tang, 805 N.E.2d 243, 286 (Ill. App. Ct. 2004), the Illinois courts have held that nearly identical allegations satisfy Illinois’ more demanding pleading requirements. (See Order, Milos v. Mylan, Inc., No. 09-L-002891 (Cir. Ct. of Cook County, Ill. Sept. 14, 2009) (Ex. 5); see also Chrzanowski v. Mylan, Inc., No. CAM-L-19-09 (Sup. Ct. of Camden County, N.J.) (denying motion to dismiss breach-of-warranty-claim for alleged lack of sufficiency) (Ex. 6).) Nevertheless, they ask this Court to review the allegations once more, without even attempting to distinguish this case from any of the other cases in which nearly identical allegations have been deemed sufficient.

3. The Drug Companies have already proceeded to discovery in this matter.

Despite the Drug Companies’ contention that the complaint fails to provide them with sufficient information to respond to the lawsuit, they have already engaged in discovery in this matter. Four days before filing their motion to dismiss, the Drug Companies served three cross-notices for depositions. (Exs. 7-9.) They have also entered into a global discovery agreement, which expressly included Robert’s lawsuit. (See Ex. 10 at 1 (referring to Exhibit E of the Global Agreement).) After engaging in discovery in this matter, the Drug Companies cannot now argue that they cannot “fairly defend claims without reasonable notice of the factual basis.” (Dkt. 19 at 2.) At any rate, their participation in on-going discovery allows them to ascertain the key facts that they allege have been omitted, such as “who prescribed the Houston Patch and for what reason, when Decedent was prescribed the Houston Patch, when she began using the Patch, and when she began experiencing an adverse reaction.” (Dkt. 19 at 2.)

C. Alternatively, if the Court grants the Drug Companies’ motion, Robert requests leave to amend his complaint to add additional factual allegations.

If this Court concludes that additional factual pleading is required, Robert respectfully requests leave to amend. Generally, leave to amend “should, as the rules require, be ‘freely given.’’” Foman v. Davis, 371 U.S. 178, 182 (1962). Therefore, absent “undue delay, bad faith or dilatory motive on the part of the movant, repeated failure to cure deficiencies by amendments previously allowed, undue prejudice to the opposing party by virtue of allowance of the amendment, [or] futility of amendment,” the moving party should be allowed to test his claim on the merits. Id. Furthermore, “dismissing a claim with prejudice for failure to comply with Rule 8(a) tends to undermine one of the policies of the Federal Rules of Civil Procedure: facilitating a decision on the merits rather than on pleading technicalities. Accordingly, dismissal with prejudice is an extreme sanction that must be examined carefully.” North Carolina v. McGuirt, 114 Fed. App’x 555, 567 (4th Cir. 2004). The only alleged defect of Robert’s complaint is that the Drug Companies need additional facts to put themselves on notice of his claims. Robert can add these additional facts if this Court finds that his current complaint fails to comply with Federal Rule of Civil Procedure 8.

CONCLUSION

For all of the foregoing reasons, Robert respectfully requests that this Court deny the Drug Companies’ Motion to Dismiss Pursuant to F.R.C.P. 12(b)(6). In the alternative, if the Court determines that Robert’s complaint does not meet the requirements of Federal Rule of Civil Procedure 8, Robert seeks leave to amend his complaint to provide additional factual allegations.

Respectfully Submitted,

James Craig Orr, Jr..

Michael Heygood

Eric D. Pearson

Charles W. Miller

HEYGOOD, ORR & PEARSON

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