Williams v. CIBA Vision Corp.

Citations: 100 F. Supp. 3d 585; 2015 U.S. Dist. LEXIS 56532; 2015 WL 1903429Docket: Civil No. 1:13-cv-368-HSO-RHW

Court: District Court, S.D. Mississippi; April 27, 2015; Federal District Court

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The court granted Defendant CIBA Vision Corporation's Motion to Dismiss the Second Amended Complaint filed by Plaintiff Dovie J. Williams in a products liability case concerning injuries to her left eye. Williams alleged she suffered complications, including inflammation and pain, after receiving the MemoryLens IOL during cataract surgery in 1999. Despite diligent follow-up care, her condition worsened, leading to a painful extraction of the lens in 2013, which revealed a foreign substance. Williams claimed the injuries were due to a manufacturing defect linked to CIBA Vision's deviation from FDA-approved manufacturing processes, which allegedly allowed biofilm formation and resulted in severe side effects, prompting a recall. The procedural history details multiple amendments and motions, culminating in this dismissal.

On January 21, 2014, the Plaintiff filed a Motion for Leave to File a Second Amended Complaint, which was granted on September 15, 2014, with the Defendant's motion to dismiss deemed moot. The Plaintiff submitted her Second Amended Complaint on October 8, 2014, asserting state law claims including negligence, gross negligence, strict liability, breach of implied and express warranty, and negligent infliction of emotional distress. On October 27, 2014, the Defendant moved to dismiss the Second Amended Complaint, claiming the claims were barred by statutes of limitations and preempted by federal law. The Plaintiff responded on November 10, 2014, and the Defendant replied on November 20, 2014.

When evaluating a motion to dismiss under Rule 12(b)(6), courts must determine if the complaint presents sufficient factual matter to establish a plausible claim for relief, accepting all well-pleaded facts as true while disregarding legal conclusions. Dismissal based on statutes of limitations is appropriate if the pleadings indicate the action is time-barred without any basis for tolling. Courts generally confine their analysis to the pleadings but may consider documents referred to within them. If extrinsic materials are presented and not excluded, the motion must be treated as one for summary judgment.

The Defendant argues that the Plaintiff's claims are both time-barred and preempted by federal law. The Court agrees that the claims are time-barred but will also examine whether the Plaintiff has adequately alleged any parallel state law claim that could survive federal preemption, specifically under 21 U.S.C. § 360k(a) (express preemption) and 21 U.S.C. § 337(a) (implied preemption).

Plaintiff acknowledges that her state law claims against Defendant regarding the MemoryLens IOL, a Class III medical device, are subject to federal preemption due to the device's premarket approval by the FDA. This preemption is based on the distinction that only claims which are 'parallel' to federal requirements, specifically those established during FDA premarket approval, are not preempted. For express preemption under the Medical Device Amendments of 1976 (MDA), a court must assess (1) whether federal requirements for the device exist and (2) whether the state claims diverge from these federal requirements. The MDA prohibits states from establishing requirements that differ from or add to federal standards relating to device safety and effectiveness. Since the MemoryLens IOL received premarket approval, the first prong of the express preemption analysis is satisfied. The second prong requires a determination of whether the claims are based on state requirements that are different from federal ones. If the claims arise from violations of federal standards, they may not be preempted, as parallel claims are allowed under state law. 

Implied preemption, on the other hand, prohibits claims that are solely based on violations of federal law, as enforcement of the FDCA and MDA is reserved for the Federal Government, with private litigants lacking the authority to initiate such actions.

To avoid implied preemption, the plaintiff's claims must be based on state-law tort claims rather than duties imposed by the FDCA or FDA regulations. To survive both express and implied preemption, the claims must demonstrate conduct that (i) violated the FDCA and (ii) would allow recovery under state law even without the FDCA. The Second Amended Complaint must articulate a parallel claim with sufficient factual support to be legally viable. Conclusory allegations and unwarranted factual inferences are not accepted when assessing a motion to dismiss. 

The plaintiff acknowledges that the MemoryLens IOL, U940A, received pre-market approval. To counter preemption and survive dismissal, the complaint must detail a manufacturing defect linked to a federal regulations violation, specifically connecting this defect to the plaintiff's injury. The plaintiff must specify how the defendant’s manufacturing process deviated from FDA approval to establish a truly parallel claim. 

The plaintiff's allegations include that the defendant deviated from the FDA-approved manufacturing process, failed to warn of adverse side effects, inadequately tested the new process, and did not inform medical providers about these issues. The core of the plaintiff's claims is that the defendant used a modified manufacturing process that resulted in defects leading to injury. Although the plaintiff asserts a parallel claim by stating that the defendant's deviation caused the defect and injury, the allegations regarding the "buffered tumbling process" lack factual support to substantiate that this process violated the pre-approved standards. The claims resemble those dismissed in a previous case, where the plaintiff's unsupported beliefs were insufficient for a viable claim.

The Fifth Circuit affirmed the dismissal of the plaintiffs' claims regarding a hip prosthesis, ruling that the allegations of a manufacturing defect were too vague and conclusory to meet legal standards. Specifically, the plaintiffs failed to detail how the manufacturing process deviated from FDA-approved protocols or identify specific federal requirements that would support an unpreempted parallel claim. The court emphasized that the plaintiffs did not provide sufficient particulars regarding the manufacturing defect, distinguishing the case from Bass v. Stryker Corp., where the plaintiff had presented concrete evidence of contamination and recall linked to his injury.

Furthermore, the court ruled that even if the claims were not preempted, they were barred by Mississippi's statutes of limitations. The three-year limit for negligence and strict liability claims expired in 2002, while the six-year limit for warranty claims expired in 2005, well before the plaintiff filed suit in 2013. The plaintiff's argument for the application of the discovery rule, which applies only to latent injuries, was rejected as she did not demonstrate that her injury was latent. The plaintiff claimed her injury was only recognized in April 2012, but the court determined that the discovery rule was inapplicable since there was no latent injury involved.

Chronic medical issues arose for the Plaintiff shortly after receiving a replacement lens in her left eye during cataract surgery in 1999, which included inflammation, pain, infection, and vision loss, impacting her daily life significantly. The Plaintiff reported suffering from these issues for twelve years prior to the lens extraction on April 9, 2013, indicating that pain and loss of vision began in April 2001. This timeline suggests that the Plaintiff was aware of her injuries before the expiration of the three-year statute of limitations in 2002. The court concluded that the Plaintiff should have discovered the lens's role in her injuries within the statutory periods. The sharp pain experienced in April 2012 did not create a new cause of action. Mississippi law adheres to the principle that a single tortious act leads to one cause of action, initiating the statute of limitations when the plaintiff becomes aware of the injury, rather than its cause.

The court rejected the Plaintiff's argument that a medical opinion linking her eye problems to the lens was necessary for her claims to accrue, clarifying that knowledge of the injury suffices. Absolute certainty or expert testimony is not needed for claims under Mississippi’s products liability statute. The determination of whether the statute of limitations is tolled by the discovery rule may sometimes be a factual issue for a jury, but can be resolved by the court if reasonable minds would reach the same conclusion. Based on the Second Amended Complaint's facts, it was evident that the Plaintiff knew or should have known of her injury within three years of the 1999 surgery, leading the court to find her claims barred by both the three- and six-year statutes of limitations. Consequently, the Plaintiff's claims were dismissed with prejudice, and CIBA Vision Corporation's Motion to Dismiss was granted.