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Nature of Suit Code: 362
Nature of Suit: Medical Malpractice
Cause of Action: 

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United States Court of Appeals 

For the Seventh Circuit 

Chicago, Illinois 60604 

Argued January 26, 2016 

Decided February 3, 2016 

Before 

DIANE P. WOOD, Chief Judge 

WILLIAM J. BAUER, Circuit Judge 

RICHARD A. POSNER, Circuit Judge

No. 15-2411 

MICHAEL HOUSTON, 

 Plaintiff-Appellant, 

v. 

UNITED STATES OF AMERICA, et al., 

 Defendants-Appellees.

 Appeal from the United States District 

Court for the Northern District of Illinois, 

Eastern Division. 

No. 14 C 1042 

Jorge Alonso, 

 Judge.

ORDER 

Michael Houston is permanently disfigured as a result of a severe skin reaction 

called Stevens-Johnson Syndrome (SJS), which he developed after taking allopurinol, a 

prescription drug used to treat gout. Houston brought tort claims in state court against 

the federally funded health clinic where he was treated for gout, the physician’s assistant 

who prescribed allopurinol, and the drug manufacturer. The United States removed the 

case to federal court and substituted itself as the defendant in place of the federal 

healthcare providers, as the Federal Tort Claims Act provides. See 28 U.S.C. § 2679. The 

United States then moved to dismiss Houston’s claims against the United States for 

failing to exhaust his administrative remedies. See 28 U.S.C. § 2675(a). The drug 

manufacturer moved to dismiss, too, arguing that all of Houston’s state-tort claims 

NONPRECEDENTIAL DISPOSITION

To be cited only in accordance with Fed. R. App. P. 32.1 

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against it are preempted by federal drug regulations. The district court granted the 

defendants’ motions and dismissed the case with prejudice. Because the defects in 

Houston’s amended complaint cannot be cured, we affirm. 

 Houston visited the Komed Holman Health Center in July 2011 for pain in his 

right toe. James Pecard, a physician’s assistant, diagnosed Houston with gout and 

prescribed allopurinol. (Allopurinol is a generic form of Zyloprim and is used to treat 

gout by reducing uric acid in the body.) Pecard allegedly did not warn Houston that 

taking allopurinol risks SJS, blindness, and even death. One month later, Houston went 

to an emergency room because of severe eye pain, red eyes, and a small rash on his face. 

He was prescribed eye medication and sent home but returned two days later with 

persistent eye pain and a severe rash that had spread across his body. Houston was 

diagnosed with SJS and admitted to the intensive care burn unit, where doctors 

concluded that the allopurinol had triggered his SJS.1

Houston brought a complaint in Illinois court. He alleged medical malpractice 

claims against Pecard, the health clinic Komed and its parent company, and an unnamed 

doctor who allegedly failed to supervise Pecard (together, “the healthcare defendants”). 

 

1 According to the Mayo Clinic, SJS is a serious skin disorder. Stevens-Johnson 

Syndrome: Treatments and Drugs, MAYO CLINIC (Apr. 22, 2014), 

http://www.mayoclinic.org/diseases-conditions/stevens-johnson-syndrome/basics/treat

ment/con-20029623. If treated properly the syndrome can be eliminated within a few 

days of hospitalization, but severe cases may last several months. Id. SJS typically starts 

with flu or fever-like symptoms, and after a few days the skin begins to peel or blister, 

causing painful raw areas known as erosions that resemble severe hot water burns. 

Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis, NAT’L INSTS. OF HEALTH, 

http://ghr.nlm.nih.gov/condition/stevens-johnson-syndrome-toxic-epidermal-necrolysis 

(reviewed July 2015). Those erosions usually start on the face and chest and then spread 

to the rest of the body. Id. For most people SJS damages the mucous membranes, 

including the lining of the mouth and airways, making it difficult to breathe and 

swallow. Id. Painful blistering can also occur in the urinary tract and genitals. Id. SJS 

often affects eyes, as well, causing redness in the mucous membranes that protect the 

white parts of the eye, and damaging the cornea. Id. SJS is a potentially life-threatening 

disease, with one in ten cases resulting in death. Id. Long-term side effects may include 

changes in skin coloring, dry skin and mucous membranes, excess sweating, hair loss, 

abnormal growth or loss of fingernails and toenails, impaired taste, difficulty urinating, 

and genital abnormalities. Id.

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He also brought product-liability claims against the manufacturer of allopurinol, 

Qualitest Pharmaceuticals, for failing to warn about or better design the drug. He sought 

damages for mental and physical suffering associated with the skin disease. Houston 

states that he has incurred permanent physical injuries and disfigurement from SJS. 

 

The United States removed the case to federal court, see 28 U.S.C. § 2679, and 

substituted itself for the healthcare defendants. The government certified that “at the 

relevant times” Komed was a federally funded entity, Pecard acted “within the scope of 

his employment” at Komed, and the healthcare defendants are therefore federal 

employees under the Public Health Service Act, 42 U.S.C. § 233. See 28 U.S.C. § 2679(d). 

Under the FTCA, it continued, federal employees are immune from tort claims arising 

from conduct within the scope of their jobs; claims against them are deemed actions 

against the United States only. See 28 U.S.C. § 2679. 

Houston contested the government’s certification that Pecard acted within the 

scope of his employment. After the court allowed Houston limited discovery on that 

issue, Houston amended his complaint. He asserted that Pecard acted outside the scope 

of his job at Komed because he, “at all times relevant ... a physician’s assistant,” 

prescribed allopurinol without warning of its side effects or getting the signature of his 

supervising physician at Komed. Houston identified that supervising doctor as Syeda 

Shariff, adding that “at all times relevant” she worked at Komed. 

The defendants moved to dismiss. The United States argued that Houston did not 

allege facts supporting the claim that Pecard and Shariff were acting outside the scope of 

their employment and thus not covered by the FTCA. Houston’s claims, therefore, were 

against the United States and should be dismissed as unexhausted under the FTCA 

because he never filed an administrative claim. See 28 U.S.C. § 2675(a). Qualitest also 

moved to dismiss. It argued that under the Supreme Court’s recent decisions in Mutual 

Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013), and PLIVA, Inc. v. Mensing, 

131 S. Ct. 2567 (2011), all of Houston’s state-law claims are preempted by federal laws 

that regulate generic-drug manufacturers. 

 

The district court granted the motions. It agreed with Qualitest that the product 

liability claims are preempted. The court explained that federal drug regulations impose 

a duty of “sameness” on generic drug manufacturers to ensure that the generic versions 

of drugs have the same active ingredients, route of administration, dosage form, 

strength, and labeling as the brand name drug. See Bartlett, 133 S. Ct. at 2475; Mensing, 

131 S. Ct. at 2576. It would be impossible, the court reasoned, for the company to comply 

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with a state-law duty to change the label or design of allopurinol while complying with 

its federal duty to keep the label and design the same. The court also ruled that, because 

the acts attributed to the healthcare defendants occurred within the scope of federal 

employment, the claims against them were deemed against the United States and must 

be dismissed as unexhausted. 

 

The case ended there. Although the court did not enter the judgment on a 

separate document, Houston’s appeal is timely because he filed it within 150 days after 

the court’s final decision. See FED. R. CIV. P. 58(c)(2)(B); Brown v. Fifth Third Bank, 730 F.3d 

698, 699–700 (7th Cir. 2013). 

Turning first to the healthcare defendants, Houston argues that the district court 

erred in concluding that Pecard and Shariff acted within the scope of their employment; 

therefore it should not have deemed the claims against them to be against the United 

States and dismissed those claims as unexhausted. He relies on cases stating that a state 

employee is not shielded from tort liability under Illinois law if the employee’s duty to 

the plaintiff arises outside of the employment context. See, e.g., Currie v. Lao, 592 N.E.2d 

977, 980–81 (Ill. 1992); Janes v. Albergo, 626 N.E.2d 1127, 1133 (Ill. App. Ct. 1993). But the 

FTCA immunizes federal employees who act within the scope of their employment, 

regardless of the source of the employee’s duty to the plaintiff. See 28 U.S.C. § 2679(b)(1); 

Osborn v. Haley, 549 U.S. 225, 229 (2007). Pecard’s and Shariff’s duties to Houston may 

arise from the doctor–patient relationship rather than their employment with Komed. 

But they are nonetheless shielded from liability under the FTCA as long as they were 

acting within the scope of their employment at Komed. Id.

The question, then, is whether Houston has alleged facts to support his claim that 

Pecard and Shariff acted outside the scope of their employment. See Taboas v. Mlynczak, 

149 F.3d 576, 582 (7th Cir. 1998). Under Illinois law, which the parties agree governs, 

“[a]n employee’s action falls within the scope of employment if (a) it is of the kind he is 

employed to perform; (b) it occurs substantially within the authorized time and space 

limits; [and] (c) it is actuated, at least in part, by a purpose to serve the master.” Id.

(quoting Pyne v. Witmer, 543 N.E.2d 1304, 1308 (Ill. 1989)) (internal quotation marks 

omitted). When the court, as here, dismisses a complaint based on the government’s 

certification that its employees acted within the scope of employment, the plaintiff must 

point to facts suggesting that, based on this scope-of-employment formula, the 

certification is wrong. Taboas, 149 F.3d at 582. 

 

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Houston’s factual allegations suggest that Pecard and Shariff acted within the 

scope of their work. He alleges that “at all times” Pecard was a physician’s assistant at 

Komed. A physician’s assistant may prescribe drugs once a supervising physician has 

delegated that power to the assistant. See 720 ILCS 570/303.05(a)(1). Having received 

discovery on the matter, Houston needed to allege (if it was true) that no supervising 

physician at Komed delegated prescribing power to Pecard. But he has not. Likewise 

Houston also alleges that Shariff was “at all times” Pecard’s supervisor at Komed. But he 

does not allege that she (or Pecard) acted after work hours or offsite or that they were 

motivated by personal reasons rather than on behalf of the health center. Thus no factual 

allegations suggest that they acted outside the scope of their work. 

Houston offers two unavailing replies. First, he argues that, because Pecard 

negligently prescribed him allopurinol without warning him of possible side effects and 

Shariff negligently failed to supervise Pecard or sign the prescription, they exceeded 

their job authority. But an allegation of negligence is not enough to remove actions from 

the scope of employment. See Sellers v. Rudert, 918 N.E.2d 586, 591–92 (Ill. App. Ct. 2009). 

Second, Houston argues that Pecard and Shariff cannot be deemed federal employees 

because, as medical professionals, they exercise judgment. But the use of judgment is 

irrelevant to federal employment status. See, e.g., Arteaga v. United States, 711 F.3d 828, 

830–31, 835 (7th Cir. 2013); Alexander v. Mount Sinai Hosp. Med. Ctr., 484 F.3d 889, 891 (7th 

Cir. 2007). Therefore, because they acted as employees of Komed, the United States was 

the proper defendant under the FTCA. And because Houston does not dispute his 

failure to exhaust, the district court correctly dismissed the claims against the 

government. See 28 U.S.C. § 2675(a); McNeil v. United States, 508 U.S. 106, 113 (1993); 

Smoke Shop, LLC v. United States, 761 F.3d 779, 786–88 (7th Cir. 2014). 

As for his claims against Qualitest, Houston argues first that, once the United 

States was dismissed, those claims should have been remanded to state court because 

they do not fall within the district court’s original or supplemental jurisdiction. See 28 

U.S.C. § 1441(c). But the claims against Qualitest are part of the “same case or 

controversy” as the claims against the United States—that Houston developed SJS after 

taking allopurinol—and thus the claims fall within the court’s supplemental jurisdiction. 

McCoy v. Iberdola Renewables, Inc., 760 F.3d 674, 682–83 (7th Cir. 2014) (quoting United 

Mine Workers v. Gibbs, 383 U.S. 715, 725 (1966)); see 28 U.S.C. § 1367(a). Moreover, the 

parties are diverse (Houston is a citizen of Illinois and Qualitest is a citizen of Delaware 

and Alabama); and although Houston did not quantify his damages, based on the 

severity of SJS the amount in controversy likely exceeds $75,000. 

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Houston next argues that the district court wrongly dismissed his state-law 

claims against Qualitest as preempted by federal law. He is incorrect. Federal law 

imposes on Qualitest an “ongoing duty of sameness” to ensure that allopurinol’s 

chemical design and labeling are the same as its brand-name counterpart, Zyloprim. 

See 21 U.S.C. § 355(j)(2)(A)(ii)–(v); Mensing, 131 S. Ct. 2575. The duty preempts a 

state-law claim against a generic manufacturer if, as here, that claim would require the 

manufacturer to redesign its drug, change its labeling, or exit the market in order to 

avoid liability. See Bartlett, 133 S. Ct. at 2474–77; Mensing, 131 S. Ct. at 2578, 2581; see also 

Brinkley v. Pfizer, Inc., 772 F.3d 1133, 1139 (8th Cir. 2014); Drager v. PLIVA USA, Inc., 741 

F.3d 470, 476 (4th Cir. 2014). 

Houston offers three replies, none persuasive. First he argues that his state-law 

claims do not necessarily require Qualitest to change allopurinol’s design or label. But 

this argument is self-defeating because his suit alleges that under state law Qualitest 

should have labeled or designed the drug differently. Without a different label or design, 

the only way that Qualitest could avoid liability would be to exit (or never have entered) 

the generic market. But generic-drug makers benefit consumers when they bring 

FDA-approved drugs to market. For that reason, market exit is precisely the outcome 

that the duty of sameness and Mensing’s preemption principle are designed to prevent. 

Mensing, 131 S. Ct. at 2578. 

For the same reason, Houston’s claims for defective design, negligence, consumer 

fraud, battery, and breach of express and implied warranties are also preempted. 

See, e.g., Brinkley, 772 F.3d at 1140–41 (design-defect and implied-warranty claims); 

Johnson v. Teva Pharm. USA, Inc., 758 F.3d 605, 612–13 (5th Cir. 2014) (design-defect and 

express-warranty claims); Eckhardt v. Qualitest Pharm., Inc., 751 F.3d 674, 678–80 (5th Cir. 

2014) (same); In re Fosamax (Alendronate Sodium) Prods. Liab. Litig. (No. II), 751 F.3d 150, 

165 (3d Cir. 2014) (strict-liability design-defect claim); Drager, 741 F.3d at 476–79 (claims 

for negligence, design defect, breach of implied and express warranties, negligent 

misrepresentation and fraudulent concealment); Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 

378, 394–97 (6th Cir. 2013) (claims for breach of implied warranty, fraud and 

misrepresentation, and design defect); Schrock v. Wyeth, Inc., 727 F.3d 1273, 1286–89 (10th 

Cir. 2013) (claims for breach of express and implied warranties). 

Second, Houston argues that his claims should survive preemption under the 

Supreme Court’s decisions in Altria Group, Inc. v. Good, 555 U.S. 70 (2008), Bates v. Dow 

Agrosciences, LLC, 544 U.S. 431 (2005), and Cipollone v. Liggett Group, Inc., 505 U.S. 504 

(1992). But the claims in those cases, which accused cigarette and pesticide makers of 

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deceptive advertising, did not require manufacturers to violate any federal duty. 

See Altria Group, 555 U.S. at 87; Bates, 544 U.S. at 446, 452; Cipollone, 505 U.S. at 530–31. By 

contrast, Houston’s claims do. 

Third, Houston argues that Mensing and Bartlett do not apply here because his 

claims arose after the passage of the Food and Drug Administration Amendments Act of 

2007, Pub. L. No. 110-85, 121 Stat. 823 (2007). Those amendments, he explains, give the 

FDA authority to negotiate changes in drug labeling with generic-drug manufacturers. 

Although the Supreme Court reserved ruling on the effect of that legislation, Mensing, 

131 S. Ct. at 2574 n.1, the amendments still forbid a generic-drug maker from violating 

the duty of sameness without FDA permission. See generally Pub. L. No. 110-85, 121 Stat. 

823 (2007); see also Mensing, 131 S. Ct. at 2581 (“[W]hen a party cannot satisfy its state 

duties without the Federal Government’s special permission and assistance, which is 

dependent on the exercise of judgment by a federal agency, that party cannot 

independently satisfy those state duties for pre-emption purposes.”). And nothing in the 

amendments or other laws requires a manufacturer to seek that permission, the receipt of 

which would be speculative anyway. 

Two loose ends remain. Houston challenges the denial of his request to add 

claims against a new party, the manufacturer of the brand-name version of allopurinol, 

Zyloprim. This court has not addressed whether a consumer of a generic drug may sue 

the brand-name manufacturer, though others have. Compare Dolin v. Smithkline Beecham 

Corp., 62 F. Supp. 3d 705, 720–21 (N.D. Ill. 2014) (allowing generic consumer to pursue 

negligence claim against brand-name manufacturer), with Smith v. Wyeth, Inc., 657 F.3d 

420, 423–24 (6th Cir. 2011) (brand-name manufacturers owe no duty to generic 

consumers), and Foster v. Am. Home Prods. Corp., 29 F.3d 165, 170–71 (4th Cir. 1994). We 

need not takes sides. Even if Houston could otherwise pursue a claim against the 

brand-name manufacturer, the two-year statute of limitations for personal-injury claims 

in Illinois has already run, see 735 ILCS 5/13-202, and the brand-name manufacturer did 

not receive notice of this suit within the time that would allow any amendment to relate 

back to the date of the original complaint, see FED. R. CIV. P. 4(m), 15(c)(1)(C). 

Finally, Qualitest moved this court to take judicial notice of information on the 

FDA’s website. Qualitest says the information shows that the FDA approved allopurinol 

to treat gout, that allopurinol and Zyloprim have the same active ingredients, route of 

administration, dosage form and effect, and labeling, and that the labels for both 

products include the same warnings about SJS. This court may take judicial notice of any 

fact that “can be accurately and readily determined from sources whose accuracy cannot 

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reasonably be questioned,” FED. R. EVID. 201(b)(2), including public records, Henson v. 

CSC Credit Servs., 29 F.3d 280, 284 (7th Cir. 1994), and agency determinations, Fornalik v. 

Perryman, 223 F.3d 523, 529 (7th Cir. 2000). Although information on the FDA’s official 

website reflects the agency’s determinations, the information is unnecessary to resolve 

this appeal and thus the motion is DENIED. 

 

Therefore we AFFIRM the judgment of the district court. 

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