Laurie Ann Humberd v. Sav-On Drugs, et al.
Case No: 18CV02449
Hearing Date: Tue Sep 24, 2019 9:30

Nature of Proceedings: Demurrer to First Amended Complaint

Demurrer

Attorneys:

Plaintiff: represents self

For Defendant Dr. Reddy’s Laboratories: Thomas R. Watson, et al. (Gordon & Rees – San Diego); John Ipsaro (Ulmer & Beme – Cincinnati, OH)

Ruling: The Court sustains defendant Dr. Reddy’s Laboratories, Inc.’s demurrer to the first and second causes of action in plaintiff Laurie Ann Humberd’s first amended complaint, without leave to amend.

Background

After the Court sustained the demurrer of defendants Jackson and Engberg Medical Corporation, dba Jackson Medical Group, Inc. (“Jackson”), and Nancy Warner, NP (“Warner”), to plaintiff’s complaint, plaintiff Laurie Ann Humberd filed her first amended complaint (“FAC”) for negligence, strict liability, and battery. Plaintiff asserts the negligence and strict liability causes of action against, among others, defendant Dr. Reddy’s Laboratories, Inc. (“Reddy’s”).

As relevant here, plaintiff alleges: On May 17, 2016, Jackson and Warner prescribed and gave plaintiff the drug Ciprofloxacin (“Cipro”), manufactured and distributed by defendant Reddy’s. Warner and Jackson instructed plaintiff to take the medication on a regular basis and did not advise her that Cipro could cause her major debilitating, dangerous, and life-threatening injuries and symptoms. [FAC ¶12] After taking Cipro, plaintiff suffered pain, massive headaches, nausea, potential or actual aortic aneurysms and nerve damage, neurological complications and issues, walking and standing difficulties, bladder control issues, insomnia, upper body sweating, left arm and hand tremors, hand shaking issues, and constant fatigue. [FAC ¶13] Reddy’s was at all times fully aware of the wrongful, unlawful, and tortious acts towards plaintiff, and ratified, approved, and otherwise consented to same. [¶8] Defendants failed to warn plaintiff of the complications, dangers, injuries, and symptoms which could or would arise from using Cipro. [¶¶16, 20]

Demurrer:

Defendant Reddy’s demurs to the first and second causes of action in the FAC on the ground that plaintiff has failed to state facts sufficient to constitute the cause of action. Plaintiff opposes the demurrer.

Plaintiff filed her opposition on September 11, which was timely. However, there is no proof of service of the opposition. Counsel for Reddy’s says he sent plaintiff an email on September 13 requesting a copy of her opposition. Plaintiff emailed a copy on September 16, which arrived late that afternoon at counsel’s office. He received an overnight delivery of the opposition on September 17, the day a reply was due. Incredibly, Reddy’s managed to file a timely reply. The Court will address the opposition as it is well addressed in the reply.

1. Demurrer Standards: The court’s only task in ruling on a demurrer is to determine whether the complaint states a cause of action. Moore v. Regents of University of California, 51 Cal.3d 120, 125 (1990). The court treats “the demurrer as admitting all material facts properly pleaded, but not contentions, deductions or conclusions of fact or law”; considers “matters which may be judicially noticed”; and gives “the complaint a reasonable interpretation, reading it as a whole and its parts in their context.” Evans v. City of Berkeley, 38 Cal.4th 1, 6 (2006) [internal quotation marks and citations omitted].

2. Judicial Notice: Reddy’s argument relies on its status as a manufacturer of generic ciprofloxacin. This fact does not appear in the complaint. Reddy’s asks the Court to take judicial notice of the “National Drug Code Directory” from a FDA website https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm. Entries for Reddy’s show an application number beginning with “ANDA.” The FDA approves a generic drug pursuant to an abbreviated new drug application, for which the acronym is “ANDA.” In re Testosterone Replacement Therapy Prod. Liab. Litig. Coordinated Pretrial Proceedings, 142 F.Supp.3d 747, 748 (N.D. Ill. 2015).

The court may take judicial notice of “Official acts of the legislative, executive, and judicial departments of the United States and of any state of the United States” and “Facts and propositions that are not reasonably subject to dispute and are capable of immediate and accurate determination by resort to sources of reasonably indisputable accuracy.” Evid. Code § 452(c), (h).

“‘Official acts include records, reports and orders of administrative agencies.’” Ordlock v. Franchise Tax Bd., 38 Cal.4th 897, 912 (2006) [citation omitted]. While the report may be a public record of which the court could take judicial notice, the report must still be properly authenticated. People v. Medina, 51 Cal.3d 870, 890 (1990).

Governmental websites have a self-authenticating feature, with addresses such as “fda.gov” or “dir.ca.gov.” Courts take judicial notice of certain facts not reasonably subject to dispute on government websites. E.g., Placerville Historic Pres. League v. Judicial Council of California, 16 Cal.App.5th 187, 191 (2017) (El Dorado County website); Barri v. Workers’ Comp. Appeals Bd., 28 Cal.App.5th 428, 437 (2018) (judicial notice of the most recent version of the Department of Industrial Relation’s website listing liens subject to a Labor Code § 4615 stay—http://www.dir.ca.gov/fraud_prevention/).

Plaintiff does not oppose the request for judicial notice. The Court will take judicial notice that Reddy’s is a manufacturer of generic ciprofloxacin.

3. Federal Preemption: Reddy’s bases its demurrer on federal preemption. The ciprofloxacin Reddy’s sells is a generic drug. Federal Drug Administration (“FDA”) regulations require generic drug manufacturers to use the same labeling as the approved brand-name drug. “[G]eneric drug manufacturers have an ongoing federal duty of ‘sameness.’” PLIVA, Inc. v. Mensing, 564 U.S. 604, 612-613 (2011). If generic drug manufacturers independently change their labels to satisfy state-law duty to adequately and safely label their products, they would violate federal law. Id. at 618. Thus, state law tort claims based on inadequate warning labels of generic drugs are pre-empted. Id. at 624.

The causes of action for negligence and strict liability rely on the lack of adequate warnings regarding Reddy’s generic ciprofloxacin. Under U.S. Supreme Court jurisprudence, the claims are preempted.

Plaintiff argues that ciprofloxacin should be taken off the market because of its dangerous side effects. She also argues that Reddy’s is an active conspirator with the brand manufacturer to defraud the public and governmental organizations. She does not allege this in the complaint. Her argument reemphasizes the theory stated in the complaint, when she says: “Dr. Reddy, through its silence and reliance on the labeling of the Brand manufacture (sic), cannot break the law to comply with the law.” [Opposition 4:20-21]

Plaintiff refers to “Dr. Reddy’s record of deception with the FDA.” [Opposition 5:8-9] She attaches several pages of information downloaded from YouTube, various new organizations, Wikipedia, and something called “FiercePharma.” She does not ask the Court to take judicial notice of these items, nor could the Court. “Simply because information is on the Internet does not mean that it is not reasonably subject to dispute.” Huitt v. Southern California Gas Co., 188 Cal.App.4th 1586, 1605 n10 (2010). The truth of the contents of information on a website is not a proper matter for judicial notice, only the fact that the information and website were published. All One God Faith, Inc. v. Organic & Sustainable Industry Standards, Inc., 183 Cal.App.4th 1186, 1198 n10 (2010). Internet information or a “web posting” is clearly objectionable hearsay. Knapp v. Doherty, 123 Cal.App.4th 76, 101-102 (2004); United States v. Jackson, 208 F.3d 633 (7th Cir. 2000).

Nor is information on the Internet necessarily credible. “The Internet contains, or more accurately is connected to and thus capable of conveying, a large and growing part of all of the recordable information in existence. Some of this information is as reliable as any traditional source of information. But some of it would be almost universally considered not only unreliable but extravagantly untrue. If this technology provides the means to store and convey every truth any human has ever articulated, it also has the capability of ‘publishing’ every misconception, error, delusion, or outright lie anyone has ever set down.” People v. Franzen, 210 Cal.App.4th 1193, 1212 (2012).

There are three very brief references to the FDA website dealing with deviations from manufacturing practice and objectionable conditions. But those have nothing to do with plaintiff’s theory of her case.

The Court sustains defendant Dr. Reddy’s Laboratories’s demurrer to the first and second causes of action in plaintiff Laurie Ann Humberd’s first amended complaint.

4. Leave to Amend: Plaintiff asks for leave to add an additional defendant—the unnamed “Brand Manufacturer” of ciprofloxacin and to include fraud and other unspecified causes of action.

“If there is a reasonable possibility that the defect in a complaint can be cured by amendment, it is an abuse of discretion to sustain a demurrer without leave to amend. [Citation.] The burden is on the plaintiff, however, to demonstrate the manner in which the complaint might be amended. [Citation.]” Hendy v. Losse, 54 Cal.3d 723, 742 (1991). “It is not up to the judge to figure that out.” Lee v. Los Angeles County Metropolitan Transportation Authority, 107 Cal.App.4th 848, 854 (2003).

The plaintiff has the burden “to show what facts he or she could plead to cure the existing defects in the complaint.” McClain v. Octagon Plaza, LLC, 159 Cal.App.4th 784, 792 (2008). “The assertion of an abstract right to amend does not satisfy this burden. The plaintiff must clearly and specifically set forth the ‘applicable substantive law’ and the legal basis for amendment, i.e., the elements of the cause of action and authority for it. Further, the plaintiff must set forth factual allegations that sufficiently state all required elements of that cause of action. Allegations must be factual and specific, not vague or conclusionary.” Rossberg v. Bank of Am., N.A., 219 Cal.App.4th 1481, 1491 (2013) [internal quotations and citations omitted]. “To meet this burden, a plaintiff must submit a proposed amended complaint or, on appeal, enumerate the facts and demonstrate how those facts establish a cause of action.” Cantu v. Resolution Trust Corp., 4 Cal.App.4th 857, 890 (1992).

Other than her legal conclusion, plaintiff offers no facts of a conspiracy involving Reddy’s and an unnamed brand-name manufacturer. She suggests a fraud upon the FDA and the public. But, as the U.S. Supreme Court indicated, a change in labeling of the drug is a matter exclusively between the FDA and the brand-name manufacturer. PLIVA, Inc. v. Mensing, supra, 564 U.S. at 620-621. Any communication with the public is through that label. Again, as to Reddy’s, the argument is derailed by preemption.

Plaintiff makes several references to fraud in her opposition. She does not suggest facts that she might plead supporting a claim of fraud. A party must plead fraud specifically; general and conclusory allegations do not suffice. Lazar v. Superior Court, 12 Cal.4th 631, 645 (1996). “This particularity requirement necessitates pleading facts which show how, when, where, to whom, and by what means the representations were tendered.” Id. “The requirement of specificity in a fraud action against a corporation requires the plaintiff to allege the names of the persons who made the allegedly fraudulent representations, their authority to speak, to whom they spoke, what they said or wrote, and when it was said or written.” Tarmann v. State Farm Mut. Auto. Ins. Co., 2 Cal.App.4th 153, 157 (1991).

A court’s order sustaining a demurrer to a pleading with leave to amend, “must be construed as permission to the pleader to amend the cause of action which he pleaded in the pleading to which the demurrer has been sustained.” People ex rel. Department of Public Works v. Clausen, 248 Cal.App.2d 770, 785 (1967). “It gives the pleader an opportunity to cure the defects in the particular causes of action to which the demurrer was sustained, but that is all.” Community Water Coalition v. Santa Cruz County Local Agency Formation Com., 200 Cal.App.4th 1317, 1329 (2011). Plaintiff’s request to assert a cause of action against an unspecified new defendant is beyond the scope of leave to amend upon sustaining a demurrer. That would require a separate motion.

The Court sustains the demurrer without leave to amend.