Court: District Court, E.D. Missouri; April 28, 2014; Federal District Court
Plaintiff Lois Annette Anastasi filed a Complaint against Defendants Wright Medical Technology, Inc. and Wright Medical Group, Inc. on January 13, 2014, alleging injuries from their medical devices, specifically the Wright Medical Hip Implant and Conserve Cup. The Complaint includes eight counts: strict liability (design defect), strict liability (manufacturing defect), strict liability (failure to warn), negligence, negligent misrepresentation, fraudulent misrepresentation, breach of express warranty, and breach of implied warranty. Defendants moved to dismiss Counts I, VI, VII, and VIII on March 14, 2014. The Plaintiff conceded to the dismissal of Counts VII and VIII, leading the Court to dismiss these counts entirely and focus its analysis on Counts I and VI.
The legal standard for evaluating a motion to dismiss under Rule 12(b)(6) requires the complaint to present sufficient factual matter to establish a plausible claim for relief. A claim is plausible when it allows the court to reasonably infer the defendant’s liability based on the alleged facts. Only the facts within the complaint and attached materials are typically considered, and the court must favorably interpret the complaint for the plaintiff. However, if the allegations lack essential elements for recovery, the claim will be dismissed. Conclusory statements and legal conclusions disguised as factual allegations do not meet the necessary standard.
Defendants were involved in the design, manufacturing, and distribution of the metal-on-metal Wright Hip Implant, including the Conserve Cup. The hip joint consists of the femoral head and acetabulum, and a total hip replacement typically includes four components: femoral stem, femoral head, liner, and acetabular shell. Unlike conventional implants that use a plastic acetabular cup, the Wright Conserve Cup uses metal for both the femoral ball and acetabular cup, resulting in direct metal-to-metal contact.
On January 11, 2012, Plaintiff underwent a right total hip replacement surgery at St. David’s Georgetown Hospital, where various Wright Medical components were implanted. These components were not altered before implantation. Following the surgery, Plaintiff experienced significant pain, metallosis-related infection, and loosening of the implant. On May 1, 2013, the implant was removed in a subsequent surgery.
Due to the defective design of the Wright Conserve Cup, many patients, including Plaintiff, required revision surgeries shortly after implantation. Additionally, the design was inadequately tested by Defendants and had not received FDA approval for safety or effectiveness for its intended use.
The Conserve Cup is classified as a Class III medical device, which includes devices critical for sustaining human life or significantly preventing health impairment, and that may pose unreasonable risks. Under the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetics Act of 1938, Class III devices must receive premarket approval from the FDA, necessitating a comprehensive clinical investigation and submission of detailed application materials. This includes safety and effectiveness studies, device specifications, manufacturing descriptions, and labeling samples. The FDA grants approval only if it finds reasonable assurance of the device's safety and effectiveness, balancing health benefits against potential risks.
Devices marketed before the MDA's effective date (May 28, 1976) are "grandfathered" and exempt from premarket approval. Additionally, devices launched post-MDA may avoid rigorous testing if deemed "substantially equivalent" to a grandfathered device, utilizing the "510(k) process." This requires manufacturers to notify the FDA of their intent to market the new device, demonstrating its equivalence to existing products, thereby allowing for expedited approval.
Defendants marketed the Wright Medical Hip Implant, including the Conserve Cup, without conducting clinical trials by claiming its design was substantially equivalent to existing hip products. Consequently, they obtained FDA approval through the 510(k) process, which only indicates equivalence to another product and does not confirm the device's safety and effectiveness for patient use.
Defendants’ Wright Medical Hip Implant and Conserve Cup are classified as adulterated under section 510(h) of 21 U.S.C. 351 due to failure to meet performance standards, causing severe injuries to patients, and necessitating painful revision surgeries that are often unsuccessful. The devices are also deemed misbranded as they inflict serious harm when used according to their labeling. The implantation leads to the release of toxic metal ions into patients' tissues and blood, causing metallosis, tissue death, and tumor growth. This friction wear, particularly during the early "wear in" period, exacerbates the release of harmful particles, resulting in inflammation, pain, infection, tissue death, bone loss, and potential tumor formation.
The design of the Wright Medical Hip Implant complicates proper surgical placement, even for skilled surgeons. It is noted that only about 5% of Class III medical device failures are reported to the FDA, which has still received numerous adverse event reports linking the implants to serious injuries, including metallosis, premature failure, and heavy metal toxicity. Consequently, leading orthopedic surgeons have largely ceased utilizing metal-on-metal hip implants due to high failure rates and associated complications.
In a press release dated August 25, 2005, Wright Medical Group announced the launch of its A-Class Advanced Metal designed to reduce wear debris and enhance the durability of its BFH® hip technology. This new metal aims to minimize wear and the release of metal ions, significantly improving the performance of Wright’s hip systems compared to conventional models.
Defendants have been aware since 2006 that the Wright Medical Hip Implant, particularly the Conserve Cup, is prone to early failure due to metal debris, leading to significant pain, debilitation, and the necessity for revision surgeries, which carry risks of complications and death. In May 2011, the FDA mandated that manufacturers of metal-on-metal hip implants conduct post-marketing safety studies due to concerns over heavy metal poisoning. Despite this knowledge, Defendants did not inform consumers, including the Plaintiff, about the risks of metallosis and increased failure rates associated with their implants. Instead, they took steps to obscure this information while marketing the implants as safe and effective.
From March 2006, Defendants promoted the Wright Medical Hip Implant and Conserve Cup as superior to metal-on-polyethylene implants, asserting that their metal-on-metal design would generate fewer wear particles. Their marketing claimed that wear-related issues persisted in modern hip replacements and emphasized the benefits of their design, suggesting minimal wear debris compared to other implant types. These misleading representations led the Plaintiff and her physicians to believe that the implants would have a lifespan exceeding the typical 15 to 20 years of conventional implants. Defendants' advertisements and communications to healthcare professionals, the FDA, and the public asserted that their products were safe and effective, aiming to induce purchases and usage of the Wright Medical Hip Implant and Conserve Cup.
Representations made by the Defendants concerning the Wright Medical Hip Implants were found to be false, leading the Plaintiff, who relied on these representations through her surgeon, to purchase the implant. The Defendants actively concealed information regarding defects and risks associated with the hip implant, delaying the discovery of issues that caused the Plaintiff pain and disability. Had the Plaintiff been aware of the potential for early failure and the associated risks of serious injury and complications, she would not have proceeded with the purchase.
The Plaintiff is a resident of Texas, where the relevant events took place, and both parties agree that Texas law governs this case. The Defendants have moved to dismiss Counts I and VI of the Plaintiff's Complaint under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim. In particular, the Defendants argue that Count I, alleging strict liability for design defect, should be dismissed based on Comment k to Section 402A of the Restatement (Second) of Torts, which addresses "unavoidably unsafe products." This comment states that certain products, particularly in the medical field, cannot be made safe for their intended use and, if properly prepared and accompanied by appropriate warnings, are not considered defective. Although Texas courts have not applied Comment k to medical devices, the Defendants argue that the rationale has been adopted by courts nationwide, asserting that holding them strictly liable for design defects would undermine public policy favoring medical advancements.
Plaintiff argues that Defendants' challenge focuses not on the sufficiency of her strict-liability, design-defect claim but on the legal inapplicability of Comment k to the hip implant components. She highlights the absence of Texas precedent applying Comment k to medical devices and contends that Comment k serves as an affirmative defense, requiring Defendants to prove the product was unavoidably unsafe at the time of manufacture and distribution. Plaintiff asserts that FDA approval processes differ significantly between prescription drugs and medical devices, specifically referencing the limited review associated with the Section 510(k) approval for Class III devices. She maintains that this approval does not provide a legal basis to classify the product as unavoidably unsafe at the pleading stage, emphasizing the lack of Texas law to support such a finding.
In diversity jurisdiction cases, federal courts must apply the law that the highest state court would likely follow. Texas recognizes strict products liability under Section 402A of the Restatement (Second) of Torts, and while Texas courts have exempted prescription drugs from strict liability based on Comment k, there is no clear precedent regarding medical devices. The Court accepts Plaintiff’s allegations as true, finding sufficient factual matter to support her strict-liability-design-defect claim, which requires proof of defectiveness, existence at the time of sale, unreasonably dangerous nature, injury to the plaintiff, and proximate cause. The Court concludes that Defendants’ reliance on Comment k in their Motion to Dismiss is premature.
Section 402A establishes liability for sellers or manufacturers of products that are sold in a "defective condition unreasonably dangerous" to consumers who suffer physical harm. The analysis for design defect claims involves determining whether the product is "unreasonably dangerous per se," which assesses the product's utility against its potential harmful effects. If the product is not deemed "unreasonably dangerous per se," the inquiry shifts to whether it was marketed with insufficient safeguards, thereby becoming "unreasonably dangerous as marketed." Comment k applies if the first prong is not met, indicating that a prescription drug is unreasonably dangerous in design if it lacks appropriate directions and warnings. The determination of "unreasonably dangerous" involves evidence weighing, making it inappropriate to apply Comment k in a motion to dismiss. Consequently, the Court will deny the Defendants' motion to dismiss the strict liability design defect claim.
In Count VI, the Defendants challenge the fraudulent misrepresentation claim, arguing it fails to meet the heightened pleading standard under Federal Rule of Civil Procedure 9(b). They assert that the allegations are vague, lacking specific details regarding the misrepresentations, including who made them and when. Rule 9(b) requires precise identification of the "who, what, when, where, and how" of the fraud. Under Texas law, fraud elements include a false material representation made with knowledge of its falsity, intent for reliance, actual reliance by the other party, and resulting injury. The fraud allegations are based on an "intermediary theory," where misrepresentations made to physicians, who then communicated them to the Plaintiff, can impose liability. Count VI claims that Defendants knew the Wright Medical Hip Implant and Conserve Cup were defective and posed an unreasonably high risk of injury when used as directed.
Count VI alleges that Defendants were aware of complaints regarding their implant device but continued to market it without warnings about the high risks of serious injury, prioritizing profits over public safety. The Complaint states that Defendants made false claims about the device’s safety and efficacy through various marketing channels directed at healthcare professionals, the FDA, and the public. It is claimed that these misrepresentations were intentional, aimed at suppressing safety concerns that could hinder sales and were designed to deceive both the Plaintiff and her physicians. As a result, the Plaintiff suffered personal injuries and other damages due to her reliance on Defendants' misleading information.
The Complaint asserts that all elements of fraud are met, including that Defendants marketed the device despite knowing it was defective and posed significant risks. Plaintiff seeks to amend her allegations if the Court finds them insufficient. The Court has decided to allow Plaintiff to replead her fraud claim (Count VI) and has ruled that Counts VII and VIII are dismissed with prejudice. The Plaintiff is required to file her amended complaint within 30 days. Additionally, the excerpt touches on FDA regulations requiring medical device manufacturers to report device classifications to ensure safety before marketing new products.
