Products Liability Law Daily Wrap Up, PREEMPTION—MEDICAL DEVICES—S.D. Miss.: Injured lens recipient’s claims preempted, time-barred, (Apr 29, 2015)

By Susan Lasser, J.D.

Claims by a cataract surgery patient who alleged injuries from a left eye replacement lens against the lens manufacturer were preempted by federal law, a federal district court in Mississippi ruled. The court also determined that even if her claims were not preempted, they were barred by the applicable statutes of limitations. Therefore, the patient’s second amended complaint was dismissed (Williams v. CIBA Vision Corp., April 27, 2015, Ozerden, H.).

Background. On October 15, 1999, Dovie J. Williams had cataract surgery on her eyes. During the surgery, she received a MemoryLens IOL/U940A, Lot S/N M381747 (M381747) replacement lens for her left eye, and a MemoryLens IOL/U940A, Lot S/N M402355 (M402355) replacement lens to her right eye. The lenses she received were manufactured by CIBA Vision Corporation (CIBA), and the MemoryLens IOL is a Class III device that was subject to premarket approval by the Food and Drug Administration (FDA). Premarket approval of an individual Class III medical device is specific to the individual device. The patient alleged in her complaint that although she was diligent in her follow-up with her treating physicians, she began to experience an assortment of problems with her left eye over the next couple of years. Specifically, she claimed that over the next few years following the surgery, she experienced inflammation, pain, infection, and the inability to see out of her left eye. She asserted that the “symptoms” she suffered prevented her from “living a normal life and severely restricted her activity,” and that she had to live with “pain, discomfort, and the restrictions of her sight” for twelve years. She did not claim any injury to her right eye as a result of receiving the M402355 replacement lens.

On or about April 12, 2012, Williams experienced a “stabbing pain in her left eye.” It was at this time that her treating physician indicated that the MemoryLens IOL may need to be replaced. About a year later, Williams underwent an extraction of the lens from her left eye. Diagnostic testing on the extracted MemoryLens “confirmed a foreign substance” on the extracted M381747. She filed suit on September 20, 2013; and her second amended complaint alleged that the injuries to her left eye were caused by a manufacturing defect in the MemoryLens IOL, which allegedly was caused by CIBA’s deviation from the manufacturing process pre-approved by the FDA. She specifically alleged that during the years 1999 through 2000, CIBA “deviated from the FDA pre-approved manufacturing process and mandated that the subject MemoryLens undergo a modified (buffered tumbling) manufacturing process.” She alleged that the modified process “allowed for biofilm formation within the lens causing opacification in a large majority of lenses,” which caused patients to suffer “severe side effects” and led to a voluntary recall of the MemoryLens IOL/U940A and U940B. She advanced claims for negligence, gross negligence, strict liability, breach of implied warranty, breach of express warranty, and negligent infliction of emotional distress.

CIBA moved to dismiss the second amended complaint, arguing that on the face of the pleading, Williams’ claims were barred by the applicable statutes of limitations and were preempted by federal law.

Express and implied preemption. In determining whether the patient’s claims were expressly preempted under the Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug and Cosmetic Act (FDCA), a court must determine (1) whether the federal government has established requirements pertaining to the device, and (2) whether the plaintiff’s common law claims are based on state requirements that are different from, or in addition to, the federal requirements and relate to safety and effectiveness, as set forth in 21 U.S.C. §360k(a). Because the MemoryLens IOL at issue received premarket approval, the first prong of the express preemption analysis was satisfied. For the second prong, the court had to determine whether Williams’ claims were based on state requirements that were “different from, or in addition to” the federal requirements. A manufacturer, however, is not protected from state tort liability when the claim is based on the manufacturer’s violation of applicable federal requirements. A parallel claim is one based on a damages remedy provided by state law for a manufacturer’s violation of the applicable federal requirements, provided that the state law does not impose additional or different duties than those imposed by the applicable federal requirements.

Implied preemption bars a plaintiff’s claims if the claims are based solely on a violation of federal law. Under the FDCA, the federal government, not private litigants, is authorized to file suit for noncompliance with the medical device provisions. For a plaintiff to avoid implied preemption, his or her claims must be premised on “state-law tort claims rather than any duties independently created” by the FDCA or FDA regulations. Thus, the court stated that to survive both express and implied preemption, a claim must be premised on conduct that (1) violated the FDCA and (2) would give rise to recovery under state law even in the absence of the FDCA.

Preemption of claims. The court held that the patient’s claims were preempted by federal law. All of her claims in the case were premised on “the unadorned conclusory allegation” that CIBA failed to follow the FDA’s preapproved manufacturing process. As such, she failed to articulate a parallel state law claim to survive federal preemption under both express preemption (21 U.S.C. §360k(a)) and implied preemption (21 U.S.C. §337(a)).

To overcome preemption, not only did she have to state a parallel claim, but she also had to do so with sufficient facts to support a legally cognizable claim for relief. To overcome dismissal on both express and implied preemption, her complaint had to state “the existence of a manufacturing defect caused by a violation of federal regulations and allegations connecting a defect in the manufacture of the specific device to [her] specific injury.” All of Williams’ claims regarding the design, manufacture, testing, advertising, warning, marketing, and sale of the MemoryLens IOL relied on her basic premise that CIBA (1) deviated from the FDA’s pre-approved manufacturing process; and thereafter (2) failed to warn of the possible adverse side effects caused by the new manufacturing process; (3) failed to conduct adequate testing of the new manufacturing process; (4) failed to provide adequate information to medical providers concerning the possible side effects of the new manufacturing process; (5) failed to warn consumers and medical providers of a known defect due to the new manufacturing process; and (6) failed to notify prescribing physicians that the product was defective. Essentially, her claims for damages asserted that CIBA deviated from the manufacturing process that had been pre-approved by the FDA for the MemoryLens IOL/U940A and that the alleged “modified (buffered tumbling) manufacturing process” caused adulterated lenses.

The court found that although Williams asserted the basic legal elements of a parallel claim—that CIBA deviated from the pre-approved manufacturing process which in turn caused a defect in the lens which in turn caused her injury—she failed to state facts to support the conclusory allegation that the alleged “buffered tumbling process” violated the pre-approved manufacturing process or any requirement specific to the MemoryLens IOL. Her “belief” that CIBA deviated from the pre-approved manufacturing process was unsupported by any fact specific to the MemoryLens IOL, the court said, noting that the U.S. Court of Appeals for the Fifth Circuit had affirmed the dismissal of a similar case. Therefore, because the patient failed to articulate a parallel state law claim, her claims were preempted, the court held.

Statute of limitations. The court additionally held that even if the patient’s claims were not preempted, her state law claims were barred by the applicable statutes of limitations under Mississippi law. The three-year statute of limitations for the patient’s negligence and strict liability claims (Mississippi Code Annotated §15-1-49) expired in 2002, and the six-year statute of limitations for her warranty claims (Mississippi Code Annotated §75-2-725) expired in 2005, both well before she filed suit on September 20, 2013. The court found her reliance on §15-1-49(2) for the proposition that she was entitled to the benefit of the discovery rule was misplaced because she did not suffer a latent injury, and the discovery rule under the statute is limited to latent injuries. Williams asserted that she suffered a latent injury and that she was not put on notice of an injury to her left eye until she felt the stabbing pain in her left eye and her doctor suggested the replacement of the MemoryLens IOL. The court noted, however, that the facts set forth in her second amended complaint reflected chronic ongoing medical complaints which began almost immediately following the implantation of the left eye replacement lens in 1999. The court further observed that the patient’s statement that she had suffered from pain and loss of vision in her left eye for twelve years prior to the lens extraction in April 2013, reflected that she experienced the pain and loss of vision in April 2001. As such, the court determined that since the left eye replacement lens was implanted in October 1999, the pain and loss of vision she had suffered occurred prior to the running of the three-year statute of limitations in 2002.

The court concluded that based on the record, the patient knew or should have discovered through reasonable diligence that the replacement lens caused the injury to her left eye well within both the three- and six-year statutes of limitations. The court further stated that the sharp pain she experienced in April 2012 did not establish a new cause of action; and it rejected her theory that she was required to have a medical opinion which causally linked her eye problems to the replacement lens before her cause of action could accrue. Based upon the facts contained on the face of the second amended complaint, the court determined that there was no question that Williams knew or reasonably should have known of her injury within three years following her October 1999 cataract surgery. Thus, the court dismissed her second amended complaint with prejudice.

The case is No. 1:13-cv-368-HSO-RHW.

Attorneys: Corban Gunn (Corban Gunn, PLLC) for Dovie J. Williams. Eric G. Lasker (Hollingsworth, LLP) and Mildred M. Morris (Watkins & Eager) for CIBA Vision Corp.

Companies: CIBA Vision Corp.

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