The case stems from the death of Agapita Marroquin after she had taken the generic prescription drug amiodarone. Plaintiff Gilbert Marroquin, Mrs. Marroquin's husband, brings seven claims under California law against Defendants Pfizer, Inc. ("Pfizer") and Mylan Institutional, Inc. ("Mylan") for strict products liability, negligence
RULE 12(b)(6) FRAMEWORK
Under Federal Rule of Civil Procedure 12(b)(6), a claim may be dismissed because of the plaintiff's "failure to state a claim upon which relief can be granted." Fed. R. Civ. P. 12(b)(6). A dismissal under Rule 12(b)(6) may be based on the lack of a cognizable legal theory or on the absence of sufficient facts alleged under a cognizable legal theory. See Mollett v. Netflix, Inc.,
BACKGROUND
From the Complaint, on April 15, 2016,
Marroquin alleges that: (1) the amiodarone was defective at the time it left Defendants' control; (2) Defendants breached their duty of care regarding preparation, design, research, development, manufacture, inspection, labeling, market, promotion, and sale of amiodarone ; (3) Defendants' breached the warranty of suitability/fitness with respect to amiodarone ; (4) Defendants failed to adequately warn of amiodarone's potential risks; (5) Defendants intentionally or negligently misrepresented that amiodarone was safe, fit, and effective for human use; and (6) Defendants concealed the fact that amiodarone was not safe, fit, or effective for human use.
I. PFIZER'S MOTION
Defendant's Arguments
Pfizer argues that the FDA approved label for amiodarone /Cordarone clearly warns of the risks and dangers of developing pulmonary toxicity and that pulmonary toxicity was fatal 10% of the time. In fact, pulmonary toxicity is identified 15 times in the drug label. Each of FAC's claims depend on a finding that the warning label was inadequate. Because the warning label is clear and adequate, no recovery is possible. By operation of California's learned intermediary doctrine, this is true even if Mrs. Marroquin did not read any part of the warning label.
Alternatively, Pfizer argues that the FAC fails to meet any of the applicable pleading requirements. First, the FAC's claims of concealment and negligent and intentional misrepresentation fail to comply with Rule 9(b). The FAC lumps defendants together and makes only conclusory allegations that do not identify the who, what, when, where, and how of any "fraudulent" conduct. Second, the first cause of action for "strict products liability" does not differentiate between a design defect and a manufacturing defect. However, California law does not recognize a design defect claim with respect to pharmaceutical products, and the manufacturing defect claim does not explain how the manufacturing process deviated from the intended outcome. Third, because the FAC's negligence claim is congruent with first claim for products liability except for an added element of causation, the negligence claim fails for the same reasons as the products liability claim. Fourth, the failure to warn products liability claim fails because the FAC fails to identify any danger about which no warning was given, nor does the FAC allege that any failure to warn was the cause of Mrs. Marroquin's death. Fifth, the FAC fails to allege the terms of any warranty, or that Mrs. Marroquin or her physician relied on any terms of a warranty. Further, any implied warranty theory fails because Mrs. Marroquin relied on the skill and judgment of her physician. Finally, the request for punitive damages fails because no factual allegations suggest oppressive, fraudulent, or malicious conduct.
Plaintiff's Opposition
Marroquin argues that not all of his claims are based on a failure to warn, and,
Second, Marroquin states that he agrees that he must prove the four elements of negligence, plus the element that the product defect was due to defendants' negligence. However, the FAC does allege that Pfizer breach its duty to Ms. Marroquin, which caused her health. If the Court finds the allegations incomplete, additional facts may be alleged.
Third, the "exact terms" of a warranty do not need to be alleged. Although the FAC adequately alleges breaches of both express and implied warranties, additional allegations regarding Pfizer's advertising to the public that its product was safe, fit, and effective could be made.
Fourth, a strict liability failure to warn claim has been properly pled. The adequacy of a warning is generally a fact question, it is unknown whether the label proffered by Pfizer is the same label provided on the relevant batch of amiodarone that was administered in this case. These are fact questions that prevent dismissal at this stage.
Fifth, Marroquin agrees that additional allegations are necessary to allege a plausible intentional misrepresentation claim.
Sixth, there is a growing trend among the district courts within the Ninth Circuit that negligent misrepresentation claims need not comply with Rule 9(b). Because the FAC allegations that Pfizer misrepresented that Amiodarone was safe, fit, and effective, a plausible claim has been stated.
Seventh, Pfizer's arguments are not clear. The FAC alleges that Pfizer concealed that amiodarone was not safe, fit, or effective for human use and that it had a serious propensity to cause injury or death. These are sufficient facts.
Finally, the punitive damages claim is based only on the fifth and seventh claims for intentional misrepresentation and concealment. The specific facts alleged under those claims are sufficient to support punitive damages.
Discussion
Initially, Pfizer's argument that each of Marroquin's claims involves the adequacy of warnings is not persuasive. As discussed below, the FAC alleges a manufacturing defect claim. The adequacy of any warnings will not defeat a manufacturing defect claim against a drug manufacturer. See Brown v. Superior Ct.,
1. 1st Cause of Action - "Strict Products Liability"
The FAC does not expressly allege what type of products liability theory is intended. However, Marroquin's opposition references the CACI 1201 jury instruction, which sets the elements for a manufacturing defect claim. Given this clarification, the Court will read the first cause of action as limited to a manufacturing defect claim.
Here, the FAC alleges that the defendants manufactured amiodarone, the defendants knew that amiodarone"was defective at the time [it left defendants' control]," that Mrs. Marroquin took amiodarone over a period of several days, and shortly thereafter developed a lung condition that led to her death. See FAC ¶ 12-15. What is absent are any allegations that actually describe a manufacturing defect. Simply alleging that the amiodarone is "defective" is a bare legal conclusion that is insufficient for purposes of Iqbal. Because the FAC fails to identify or explain how the amiodarone either deviated from the manufacturer's intended result/design or how the amiodarone deviated from other seemingly identical "units" of amiodarone, no plausible claim is stated and dismissal is appropriate. Lucas,
2. Fourth Cause of Action - Strict Liability - Failure to Warn
Because a manufacturer generally has a duty to warn consumers about the hazards of its product, a product may be dangerous because it lacks adequate warnings or instructions. Webb v. Special Electric Co. Inc.,
Here, there are several problems with the fourth cause of action. First, the FAC alleges that there were potential risks known regarding the use of amiodarone, but Defendants "failed to adequately warn of the potential risks." FAC ¶¶ 37, 38. Given that Mrs. Marroquin developed a fatal lung condition from amiodarone, the Court will assume that the "potential risks" refer to the risks of developing various lung and respiratory problems, some of which may be fatal. However, there are no allegations that explain how or why the warnings provided were inadequate. There are several ways in which a warning may be inadequate. E.g. Stevens,
Second, the FAC alleges that Mrs. Marroquin died as a result of amiodarone. See FAC ¶ 42. However, for a failure to warn claim, the inadequate warning must be a substantial factor in causing harm. See Ramos,
Third, the FAC alleges that "ordinary consumers" would not have recognized the potential risks of the amiodarone. FAC ¶ 39. However, as indicated above, because amiodarone is a prescription drug, the duty to warn runs to physicians, not to patients. Use of the term "ordinary consumer," without reference to or recognition
Fourth, Pfizer has submitted a copy of the FDA approved Cordarone label for 2015 that was in effect at the time Mrs. Marroquin was administered amiodarone. See Doc. No. 19-2.
Cordarone is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity.
Cordarone has several potentially fatal toxicities, the most important of which is pulmonary toxicity (hypersensitivity pneumonitis /alveolar pneumonitis ) that has resulted in clinically manifest disease at rates as high as 10 to 17% in some series of patients with ventricular arrhythmias given doses around 400 mg/day, and as a abnormal diffusion capacity without symptoms in a much higher percentage of patients. Pulmonary toxicity has been fatal about 10% of the time.
Id. at p.6. The warning section also contains nearly two pages of warnings relating exclusively to "Pulmonary Toxicity." Under the "Adverse Reactions" section, the label states that the "most serious reactions are pulmonary toxicity ...." Id. at p.17. Finally, in the "Medication Guide" portion of the label, the first thing that patients are informed is that "Cordarone can cause serious side effects that can lead to death including: lung problems ...." Id. at p.22.
Citing Schwoerer , Marroquin states that the adequacy of a warning is generally a fact question. The Court agrees, but this does not mean that adequacy is always a question of fact for a jury. Marroquin does not actually address the adequacy of the warnings described above. As quoted above, the FDA label clearly states that Cordarone is approved to treat two serious heart conditions and it is a drug of last resort because of its potentially fatal toxicities. More than once, pulmonary toxicity is clearly and expressly identified as the most dangerous toxicity/potential side effect.
Marroquin states that it is unknown whether the label quoted above was the same label on the batch of amiodarone administered in this case, and that neither party can presently confirm the existence of the label. It is unclear precisely what Marroquin means by this argument. To the extent that Marroquin relies on his wife reading or receiving any warnings or labels, that is irrelevant. The duty to warn does not run to Mrs. Marroquin, it runs to her prescribing physician. See Carlin,
For these reasons, no plausible claim is stated and dismissal is appropriate.
3 Second Cause of Action - Negligence Products Liability
"[U]nder either a negligence or a strict liability theory of products liability, to recover from a manufacturer, a
Here, the FAC alleges that the Defendants did not comply with existing standards of care in their preparation, design, research, development, manufacture, inspection, labeling, marketing, promotion, and sale of amiodarone, including a duty to ensure that users would not suffer from unreasonable, dangerous, or untoward side effects. See FAC ¶ 21. However, the FAC fails to identify a product defect with the amiodarone. The same analysis regarding the deficiencies of the strict liability causes of action apply, at least to defects in warning and manufacture. If a manufacturing defect is at issue, Marroquin must explain how the amiodarone differed from Defendants' intended design or how it was different from other batches of amiodarone. If a warning defect is at issue, Marroquin must explain how the warning was inadequate, keeping in mind that the duty to warn runs to the physician and that the FDA approved label appears adequate. If a design defect is at issue, Marroquin must identify what aspect of amiodarone makes it defective.
4. Third Cause of Action - Breach of Warranty
"An implied warranty of fitness for a particular purpose arises only where (1) the purchaser at the time of contracting intends to use the goods for a particular purpose, (2) the seller at the time of contracting has reason to know of this particular purpose, (3) the buyer relies on the seller's skill or judgment to select or furnish goods suitable for the particular purpose, and (4) the seller at the time of contracting has reason to know that the buyer is relying on such skill and judgment." Keith v. Buchanan,
Here, the FAC essentially tracks the CACI 1232 instruction. However, the particular purpose for which Mrs. Marroquin obtained the amiodarone is not identified. To give adequate notice and to state a plausible claim for an implied warranty of fitness claim, the intended or particular purpose of the warranted product must be identified. Cf. American Suzuki Motor Corp. v. Superior Ct.,
Additionally, the duty to warn about a prescription drug run to the physician, and information conveyed for purposes of a breach of warranty claim, are viewed with respect to the prescribing physician. See Carlin,
Finally, to the extent that Mrs. Marroquin's reliance (as opposed to her physician's reliance) is relevant, the FAC alleges that Mrs. Marroquin relied on Defendants' skill and judgment regarding amiodarone and that Defendants had reason to know that Mrs. Marroquin was relying on their skill and judgment. See FAC ¶¶ 28, 29. Amiodarone is not an over the counter medication, it is a prescription drug. Without a prescription from a physician, Mrs. Marroquin would not have been administered amiodarone at Kaweah Delta Medical Center. The Court agrees with Pfizer that these facts create the reasonable inference that Mrs. Marroquin relied on the experience and skill of her physicians to administer amiodarone. The FAC does not describe the circumstances under which the amiodarone was prescribed, and there are no factual allegations that reasonably suggest that she did not rely on the judgment of her physicians. The factual allegations do not plausibly indicate that Mrs. Marroquin relied on anything other than her physician's judgment. Cf. Carlin,
For these reasons, no plausible claim is stated and dismissal is appropriate.
5. Fifth, Sixth, & Seventh Causes of Action - Intentional Misrepresentation
"The elements of a cause of action for intentional misrepresentation are (1) a misrepresentation, (2) with knowledge of its falsity, (3) with the intent
To plead fraud with the particularity required by Rule 9(b), a complaint "must identify the who, what, when, where, and how of the misconduct charged, as well as what is false or misleading about the purportedly fraudulent statement, and why it is false." Davidson v. Kimberly-Clark Corp.,
Here, the three claims are based on representations that amiodarone is "safe, fit, and effective for human use." See FAC ¶¶ 46, 56, 66. These claims allege that such a representation is false, or that the Defendants concealed the fact that amiodarone was not safe, fit, and effective, and that Mrs. Marroquin relied on Defendants' representations or Mrs. Marroquin was unaware of the concealed fact. See id. at ¶¶ 48, 50, 58, 60, 67.
Marroquin concedes that his claim for intentional misrepresentation does not meet the Rule 9(b)"who, what, when, where, and how" test. That concession should apply equally to his claims of negligent misrepresentation and concealment, as all three claims share the same deficiencies.
The FAC does identify the "what" of the misrepresentations, that amiodarone was "safe, fit, and effective." However, the Court has serious concerns over the plausibility of this allegation. Pfizer has presented documentation that Cordarone has been approved by the FDA as a drug of last resort for two types of serious heart arrhythmias since 1985. See Doc. No. 26-2. From the FDA approved warning label in 1985 to the current 2015 warning label, lung toxicity and the statistics regarding those who develop lung toxicity have been listed. Further, the World Health Organization has listed amiodarone in its List of Essential Medicines. See www.who.int/medicines/publications/essentialmedicines/EML2015_8-May-15.pdf.
Additionally, there are concerns with the element of reliance. Amiodarone would have been prescribed through Mrs. Marroquin's doctor. The factual allegations do not plausibly suggest that Mrs. Marroquin relied on anything other than her doctor's judgment and assessment that amiodarone was the proper medication for her at that time. If Mrs. Marroquin relied on her physician to prescribe the amiodarone while she was in the hospital, it is unclear how she could rely on any representations by Pfizer or Mylan.
For these reasons, dismissal of the fifth, sixth, and seventh causes of action is appropriate.
Punitive damages are "merely an additional remedy that [are] dependent on a viable cause of action for an underlying tort." 569 E. County Blvd. LLC v. Backcountry Against the Dump, Inc.,
7. Leave to Amend
Granting a party leave to amend is the general rule, even when a party does not expressly ask for leave to amend. See Ebner,
II. MYLAN'S MOTION
Defendant's Arguments
Mylan makes essentially the same arguments as Pfizer with respect to the adequacy of the FAC's allegations under Rules 8 and 9(b). Additionally, Mylan argues that the gist of the FAC is a failure to provide adequate warnings. However, application of PLIVA, Inc. v. Mensing ,
Plaintiff's Opposition
Marroquin argues that only the fourth cause of action alleges a failure to warn theory, thus, PLIVA and Mutual Pharm. have no application to the other six causes of action. Further, the FAC can be amended to include allegations that Mylan is "also or either" a distributor of amiodarone. Marroquin argues that courts have declined to extend the preemption doctrine to the distributors of a generic drug like amiodarone.
Discussion
1. Pleading Requirements
In terms of the requirements of Rule 8 and Rule 9(b), the analysis under Pfizer's motion applies equally to Mylan's motion. Therefore, for the same reasons described above, there are no plausible claims against Mylan and dismissal of all claims is appropriate.
2. Federal Preemption
Under federal law, generic prescription drug manufacturers may obtain FDA approval to market their generic prescription drugs by demonstrating that their drugs are equivalent to a previously authorized name-brand version of the drug in three aspects: chemical formulation (including route of administration, dosage, and strength), bioequivalency, and labeling.
a. Fourth Cause of Action
The FAC does not allege that Mylan violated the duty of sameness with respect to its warning label for amiodarone. Further, Marroquin's opposition does not suggest that the warning label for amiodarone is different from the label of Cordarone. Instead, Marroquin argues that preemption will not apply because he can allege that Mylan was a distributor and Bartlett and Mensing apply only to manufacturers. The Court is not convinced.
Marroquin is correct that some courts have noted a distinction between manufacturers and distributors for purposes of Bartlett and Mensing. However, context is key. The case cited by Marroquin, Hatherley v. Pfizer, Inc. ,
Outside of the context of fraudulent joinder and removal/remand, courts have extended Mensing to entities that merely distribute prescription drugs, be they generic prescription or brand-name prescription drugs. See In re Lipitor (Atorvastatin Calcium) Mktg., Sale s Practices & Pr o d. Liab. Litig .,
Therefore, Marroquin's request to add an allegation that Mylan was a distributor does not save the fourth cause of action. By application of Mensing , amendment of the fourth cause of action against Mylan will be denied as futile. See Garmon,
b. First Cause of Action
As discussed above, the Court reads the first cause of action as attempting to allege a manufacturing defect. A manufacturing defect has nothing to do with FDA required labels. Therefore, Mensing and "impossibility preemption" does not apply to the first cause of action.
c. Remaining Claims
Mensing has been applied to state law claims for negligence, breach of warranty,
However, as discussed above, because of the conclusory nature of the FAC's allegations, it is not clear that amendment would be futile. The Court will grant Marroquin leave to amend the FAC, but any amendment must contain sufficient factual allegations that demonstrate Mensing does not apply.
ORDER
Accordingly, IT IS HEREBY ORDERED that:
1. Pfizer's motion to dismiss (Doc. No. 19) and Mylan's motion to dismiss (Doc. No. 18) are GRANTED;
2. Plaintiff may file an amended complaint that is consistent with this order no later than twenty-one (21) days from service of this order;
3. Defendants shall file a response to Plaintiff's amended complaint within fourteen (14) days of service of the amended complaint; and
4. The failure of Plaintiff to file a timely amended complaint will result in the withdrawal of leave to amend and the closure of this case without further notice.
IT IS SO ORDERED.
Notes
Amiodarone is the generic name for the prescription drug Cordarone. The FDA approved Cordarone"as a drug of last resort for patients suffering from ventricular fibrillation and ventricular tachycardia, both life-threatening heartbeat irregularities." McDaniel v. Upsher-Smith Labs.,
There are three possible strict products liability theories: design defect, manufacturing defect, and warning defect. See Webb v. Special Electric Co. Inc.,
Marroquin does not object to consideration of the FDA approved Cordarone label, nor does Marroquin contend that the document submitted by Pfizer is inaccurate. Therefore, the Court finds that taking judicial notice of the FDA approved label for Cordarone is appropriate. See Fed. R. Evid. 201(b)(2) (court may take judicial notice of a fact that is not subject to reasonable dispute because it "can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned."); Chandler v. Janssen Pharms., Inc.,
By federal law, the warning label for amiodarone must be identical to the warning label for Cordarone. See PLIVA, Inc. v. Mensing,
It seems highly unlikely that the physician would have read a label materially different from the 2015 label. As part of Pfizer's reply, it submitted copies of the FDA approved Cordarone box label for the years 1985, 2010, 2011, and 2014. See Doc. Nos. 26-1 to 26-6. The Court takes judicial notice of these labels. See Fed. R. Evid. 201(b)(2).
Defendants cannot be liable under a strict liability design defect. See Brown,
Pfizer argues that it is unclear whether Marroquin is alleging a breach of express warranty or an implied warranty. The allegations track the essential elements of a claim for breach of the implied warranty of fitness for a particular purpose. Cf. FAC ¶¶ 27-33 with CACI § 1232. Therefore, the Court will only read the third cause of action as alleging a claim for breach of the implied warranty of fitness.
Marroquin argues that some courts within the Ninth Circuit are not applying Rule 9(b) to negligent misrepresentation claims. The Court will not follow these cases. The Ninth Circuit has held that all claims sounding in fraud or grounded in fraud must meet Rule 9(b)'s heightened pleading requirement. See Kearns v. Ford Motor Co.,
With respect to concealment, some courts have recognized that a plaintiff may not be able to plead a specific time and place, depending on the circumstances of the concealment. See Stewart v. Electrolux Home Prods.,
The Court takes judicial notice that amiodarone is listed on the World Health Organization's List of Essential Medicines, as shown by the cited web address above. See Fed. R. Evid. 201(b)(2).
At least one court has found that Carlin 's analysis regarding warranty claims also applies to fraud claims. See Buckley v. DJO Surgical,
The fourth cause of action (strict liability for failure to warn) against Mylan is dismissed with prejudice.