Tsavaris v. Pfizer, Inc.

Citations: 154 F. Supp. 3d 1327; 2016 U.S. Dist. LEXIS 1680; 2016 WL 80221Docket: Case No. 1:15-cv-21826-KMM

Court: District Court, S.D. Florida; January 6, 2016; Federal District Court

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The Court granted Breckenridge Pharmaceutical, Inc.'s motion for judgment on the pleadings and Novo Nordisk Inc.'s motion to dismiss in a case brought by Plaintiff Maggie Tsavaris against multiple pharmaceutical companies, including both defendants, for claims related to Hormone Therapy Replacement (HRT) drugs that allegedly caused her breast cancer. Tsavaris specifically named Novo Nordisk for its brand HRT drug Activella and Breckenridge for the generic version, estradiol/norethindrone acetate. The Plaintiff alleged strict products liability due to defective design, negligence, and negligent misrepresentation against both defendants, as well as a failure to warn claim against Novo Nordisk. Additionally, other manufacturers, Pfizer, Inc. and Wyeth LLC, were included for similar claims regarding their HRT drug Prempro. The Plaintiff sought compensatory and punitive damages, attorney fees, and a recall of the drugs.

The medical history outlined indicates that during menopause, Tsavaris experienced severe symptoms for which her physician prescribed HRT, including Prempro. Despite family history of breast cancer, her physician downplayed the associated risks. After initially discontinuing Prempro, Tsavaris resumed it briefly before ultimately stopping all HRT drugs from July 2005 until August 2008. The complaint details her physician's advice regarding the risks of HRT, including breast cancer, which Tsavaris contends were misrepresented.

On September 17, 2008, Plaintiff was prescribed Activella (1.0mg/0.5mg), manufactured by Novo Nordisk, but was dispensed the generic version, estradiol/norethindrone acetate (1.0mg/0.5mg), produced by Breckenridge. Despite being prescribed Activella, Plaintiff only took the generic version. Dr. Schwartzbard, who prescribed the drug, indicated that breast cancer risks were minimal compared to the benefits of hormone replacement therapy (HRT). From December 2009 to February 2010, Plaintiff did not take any HRT drugs but resumed with the generic Activella in March 2010, continuing through May 2013. On January 31, 2012, her prescription was adjusted to a lower strength. On May 15, 2013, she was diagnosed with invasive ductal carcinoma, hormone receptor positive, and was advised to stop HRT immediately. Testing indicated that her cancer type requires hormones for growth. Plaintiff asserts that she lacked the endogenous hormones to support the cancer's growth prior to taking HRT, claiming that the exogenous hormones from the drugs led to her cancer development. She filed suit on May 14, 2015, alleging that the defendants’ HRT drugs caused her breast cancer and that they were aware of the associated risks. Breckenridge seeks judgment on the pleadings, arguing that Plaintiff's claims are preempted by federal law and fail to meet pleading standards, particularly contending that federal law restricts them from altering the generic drug's composition or labeling. Plaintiff counters that her claims are not failure to warn claims and emphasizes potential actions Breckenridge could have taken prior to FDA approval to enhance drug safety.

Federal Rule of Civil Procedure 12(c) allows a party to move for judgment on the pleadings after the pleadings are closed, provided it does not delay trial. Such a motion is appropriate when there are no material facts in dispute and the moving party is entitled to judgment as a matter of law. If the defendant files this motion, it follows the same standard as a motion to dismiss for failure to state a claim, meaning all facts alleged by the non-moving party are accepted as true and viewed favorably. If a material dispute of fact is found in the pleadings, the motion must be denied.

The document also outlines the legal background regarding federal pharmaceutical regulations, emphasizing the strict approval process for drug manufacturers under the Federal Food, Drug, and Cosmetic Act (FDCA). Manufacturers must obtain FDA approval before marketing drugs, demonstrating safety, effectiveness, and accurate labeling, which requires extensive clinical testing. This process applied uniformly to both brand name and generic drugs until the enactment of the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Amendments) in 1984, which streamlined the approval process for generic drugs. Now, generic manufacturers can be approved with less stringent testing if they can prove their drugs are chemically and biologically equivalent to existing brand name drugs and that their labeling matches that of the brand name counterpart.

Brand name manufacturers are accountable for the accuracy of their drug labels, while generic manufacturers must ensure their labels match those of the brand name drugs and cannot make unilateral changes. Once a drug is approved, neither brand nor generic manufacturers can alter the formulation significantly. The Hatch-Waxman Amendments facilitate the development of generic drugs at lower costs by eliminating the need for duplicate clinical trials, helping to make medications more affordable.

However, these amendments also lead to preemption of certain claims against generic manufacturers. In *Pliva v. Mensing*, the Supreme Court ruled that a state failure to warn claim could not proceed because federal law required generic manufacturers to use the same labeling as their brand-name counterparts, creating a conflict with state law. Similarly, in *Mutual Pharmaceutical Co. v. Bartlett*, the Court found that New Hampshire’s design defect claim was preempted because it effectively forced the generic manufacturer to alter the drug’s labeling, which federal law prohibits. Thus, both cases establish that federal law can preempt state law claims against generic drug manufacturers when compliance with both is impossible.

In Guarino v. Wyeth, 719 F.3d 1245 (11th Cir. 2013), the Eleventh Circuit upheld a summary judgment favoring Teva Pharmaceuticals regarding claims of negligence, strict liability, breach of warranty, misrepresentation, and fraud related to the generic drug metoclopramide. The plaintiff contended that her negligence claim, asserting a 'failure to communicate' a label change to medical providers, should not be preempted. However, the court determined that all claims were based on an 'allegedly inadequate warning,' thus preempted by federal law. The court specifically noted that recharacterizing the claims did not change their fundamental nature regarding Teva's failure to warn about the drug's risks.

Subsequently, the court addressed Breckenridge’s Motion for Judgment on the Pleadings. It found that federal law preempted the plaintiff's claims against Breckenridge for strict products liability, negligence, and negligent misrepresentation because they were based on failure to warn and defective design. The plaintiff argued that Breckenridge's generic drug was 'not reasonably safe' and had 'unreasonably dangerous design defects.' However, referencing Bartlett, the court highlighted that federal law prohibits imposing a duty on generic manufacturers to redesign a drug or alter its warnings. 

The plaintiff attempted to argue that Breckenridge could have acted differently before FDA approval, asserting that they could not establish the impossibility of redesign prior to marketing. Nonetheless, the court clarified that a generic drug must be chemically and bioequivalently identical to its brand-name counterpart, and any design alteration would necessitate a new drug approval process, contravening the objectives of the Hatch-Waxman Amendments aimed at fostering the generic drug market. Therefore, the court granted Breckenridge’s motion, affirming that the defective design claim was preempted.

Plaintiff's reliance on Trahan v. Sandoz, Inc. is deemed misguided as it centered on the packaging defects of methotrexate, specifically involving glass vials that led to contamination. Sandoz's defense highlighted that as a generic drug manufacturer, it could not alter the packaging without FDA approval, which the plaintiff conceded. The court determined that Trahan's focus was on packaging, unlike the current case which concerns the drug's composition. Consequently, Plaintiff's design defect claim is preempted by federal law, as Breckenridge, the generic manufacturer, could not legally modify the drug's composition.

Plaintiff's negligence claim asserts Breckenridge breached its duty of care by failing to conduct adequate pre-clinical testing and by not warning about the risks of breast cancer associated with its hormone replacement therapy (HRT) drugs. However, these allegations also fall under federal preemption, as federal law restricts the ability of generic manufacturers to alter drug warnings or designs. For a valid state tort negligence claim, Plaintiff must show Breckenridge breached its duty and could have acted within federal law to fulfill that duty. Given that any action to warn or change the drug would violate federal law, Plaintiff's negligence claim also fails. Claims based on a generic manufacturer's failure to warn are consistently ruled as preempted by federal law, as established in relevant case law.

Breckenridge is accused of breaching its duty of reasonable care by failing to conduct adequate pre-clinical testing and by not properly designing, manufacturing, and distributing its HRT drugs. The plaintiff's assertion hinges on the claim that Breckenridge did not design a safe drug. However, the court notes that, per Supreme Court precedent in Bartlett, claims against generic manufacturers for defective design are preempted if they impose a duty to redesign a drug. Moreover, claims regarding inadequate pre-clinical testing and the discovery of latent hazards also fall under this preemption, as federal regulations limit what actions Breckenridge could have taken even if it had identified hazards. Testing obligations are considered part of a manufacturer's duty to design reasonably safe products, and thus are subsumed within the defective design claims. Comparatively, in the cited Trahan case, the court found that claims regarding inadequate testing were not preempted because the defective design claims were allowed to proceed. However, in this instance, since Breckenridge's defective design claims are preempted, so are the allegations about inadequate testing and failure to discover hazards.

Additionally, the plaintiff's negligent misrepresentation claim is similarly preempted. The plaintiff alleges that Breckenridge misrepresented the risks associated with its drugs, which led to her developing breast cancer. However, this claim essentially mirrors a failure to warn allegation, which is also preempted, regardless of how the plaintiff articulates it.

Plaintiff's claim is based on a state law duty not to deceive, alleging that Breckenridge failed to warn about increased breast cancer risks associated with its drug. This mirrors the failed communication claim previously rejected in Bartlett. The Court reiterates that prior arguments regarding Breckenridge's potential actions before FDA approval have already been dismissed. Consequently, Breckenridge’s Motion for Judgment on the Pleadings is granted.

Regarding Novo Nordisk’s Motion to Dismiss, the Court finds that the claims against Novo Nordisk are equally unmeritorious. As Plaintiff did not consume any hormone replacement therapy (HRT) drugs from Novo Nordisk, liability is not established. The Court emphasizes that a motion to dismiss tests the complaint's sufficiency without addressing the case's merits. For a claim to survive, it must present factual matter that supports a plausible entitlement to relief. Under Florida law, a brand-name manufacturer cannot be held liable for injuries to consumers who only used the generic version of a drug, a position upheld by all Florida courts that have examined the issue. This principle aligns with a national consensus across various courts, reinforcing that brand-name manufacturers are not liable for injuries related to generic drug use.

Courts across Florida and other jurisdictions have consistently ruled that consumers cannot pursue claims for negligence, fraud, strict liability, misrepresentation, or breach of warranty against brand-name pharmaceutical manufacturers if they only ingested generic versions of the drugs. Even though brand-name manufacturers are responsible for the labeling of generics and physicians rely on these labels for prescriptions, liability does not extend to consumers who did not take the brand-name products. The argument that regulatory structures make it foreseeable for physicians and patients to rely on brand-name labels has been largely rejected, with only a few outlier cases, such as Kellogg v. Wyeth and Conte v. Wyeth, cited by the plaintiff to support their claims against Novo Nordisk. However, these cases are not binding and contradict the prevailing majority view. The Eleventh Circuit has explicitly ruled that Florida law does not allow recovery from brand-name manufacturers like Novo Nordisk when consumers only took generics. The case of Bennett v. Forest Laboratories, cited by the plaintiff, is distinguishable because the plaintiff in that case directly ingested a drug manufactured by Forest Laboratories, unlike the situation here with Novo Nordisk and the generic version of Activella. As a result, the court grants Novo Nordisk's motion to dismiss with prejudice, and also grants judgment on the pleadings for Breckenridge Pharmaceutical, Inc. The court will address the motion to dismiss by the Wyeth Defendants separately.

Menopause is characterized by a significant decrease in the production of hormones such as progesterone and estrogens, leading to various physical symptoms, including mood swings, hot flashes, loss of bone density, depression, irritability, night sweats, vaginal dryness, and forgetfulness. These symptoms can vary in severity among women. In Florida and most states, pharmacists are required to substitute generic drugs for brand-name prescriptions unless specified otherwise by the physician or patient. The Eleventh Circuit indicated that even if the plaintiff's claims against Teva were not federally preempted, they would still fail due to the learned intermediary doctrine. The argument concerning this doctrine, raised by the Wyeth Defendants, will be addressed in a later order, while Novo Nordisk and Breckenridge did not raise it. Novo Nordisk applied for FDA approval of Activella on November 7, 1997, which was granted on November 19, 1998, for treating symptoms related to menopause. Novo Nordisk took over U.S. marketing for Activella in 2003 and deployed sales representatives in 2004. Breckenridge received approval for its generic versions of Activella in 2008 and 2011. The excerpt references the Bartlett case, where the Supreme Court rejected the notion that a generic manufacturer could avoid liability by ceasing to sell a drug in order to comply with both federal and state law. This reasoning suggests that it would not be viable for the court to rule that Breckenridge could meet its state law obligations by stopping the sale of the generic Activella.

Plaintiff's negligence claim against Breckenridge is challenged on two grounds: first, Breckenridge contends that the claim is inadequately pled under the Twombly/Iqbal standard, as the Amended Complaint does not specify how Breckenridge failed in its duty of care regarding the testing, design, manufacturing, and distribution of its generic version of Activel-la. Second, Breckenridge argues the absence of allegations regarding specific concealments and the lack of a direct connection between its alleged breach and Plaintiff's breast cancer. However, the Court's grant of Breckenridge's motion for judgment on the pleadings makes these arguments moot. Additionally, Breckenridge claims that the negligent misrepresentation allegation lacks sufficient factual support, but this, too, is rendered moot by the Court's ruling. Furthermore, Breckenridge's request to dismiss the Plaintiff's punitive damages claim is also moot. Plaintiff's efforts to differentiate this case from Guarino are deemed insufficient.