Slater v. Biomet, Inc.

Citations: 244 F. Supp. 3d 803; 2017 WL 1133623; 2017 U.S. Dist. LEXIS 43897Docket: Cause No. 3:14-cv-1055 RLM-MGG

Court: District Court, N.D. Indiana; March 26, 2017; Federal District Court

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Kimberly Slater filed a lawsuit against Biomet for damages related to her Biomet M2a Magnum hip implant's alleged failure. Biomet sought summary judgment on the grounds that Slater's claims were time-barred, proposing a universal bar date of February 10, 2011, when they claimed all plaintiffs should have been on constructive notice of potential claims. The judge rejected Biomet's bar date and analysis concerning Slater’s products liability and negligence claims.

Summary judgment is deemed appropriate when there are no genuine material facts in dispute, and the court must view evidence favorably for the non-moving party, which in this case is Slater. Biomet, as the moving party, must provide evidence showing the absence of material fact disputes. If Biomet meets this burden, Slater must then present admissible evidence that could support her case at trial. The court emphasizes that it is not its responsibility to find evidence for Slater; she must identify and present it herself.

Biomet argued that by the proposed bar date, sufficient public information was available to alert plaintiffs to potential claims related to the implant. They asserted that if an injury occurred on or before this date, the statute of limitations would start then; injuries after the date would trigger the statute upon the date of injury. Biomet cited various sources, including the device's Instructions for Use, medical journal articles, press reports, and FDA information, to support their claim that reasonable plaintiffs should have been put on notice by this date.

Biomet’s metal-on-metal hip implants come with Instructions for Use that highlight risks such as exposure to metal debris, osteolysis, metal hypersensitivity, and increased metal ion levels. Medical literature from 2010, including an editorial in the Journal of Arthroplasty, expressed concerns about these implants. Biomet asserts that early 2010 news reports regarding metal debris risks informed plaintiffs about potential claims, particularly following DePuy's recall of two ASR implants in August 2010 and subsequent coverage. Additionally, the FDA launched websites by February 10, 2011, warning the public about the possible health risks associated with these implants, advising patients to consult physicians if they experienced symptoms. Biomet argues that this cumulative information reasonably notified individuals about the connection between its device and potential injuries from metal exposure by the specified date. The discussion references three district court rulings, including In re Avandia, where publicity about a drug's adverse effects was deemed sufficient to notify injured individuals of potential liability, supported by various studies, statements from medical organizations, FDA actions, and extensive media coverage.

Evidence indicated a significant decline in Avandia prescriptions and sales, with a 45% drop in prescriptions and a 54% drop in sales by the proposed bar date, reflecting the awareness of physicians, patients, and attorneys about the drug's risks. In the Vioxx MDL, Judge Fallon established a bar date based on several factors, including a medical study linking Vioxx to cardiovascular events, extensive media coverage, a newly approved warning label, the initiation of a class action, and the drug's market withdrawal, which was notably publicized. The court determined that the media's reporting was adequate to alert plaintiffs to a potential connection between their injuries and Vioxx use.

Similarly, in the Zyprexa litigation, Judge Weinstein found grounds for a bar date when the FDA required a new warning label, leading medical associations issued risk statements, and the manufacturer sent out letters to physicians about these changes. In contrast, Biomet failed to establish a comparable level of notice to potential plaintiffs regarding its product risks. Biomet did not distribute risk alerts similar to those in the Avandia and Zyprexa cases, nor did it generate significant media coverage about its products. Additionally, unlike the other cases, no leading medical associations issued statements about Biomet's products. Biomet also did not adequately demonstrate how a reasonable plaintiff could interpret the Instructions for Use directed at surgeons, which contained complex and ambiguous language regarding potential risks, thus failing to provide clear notice of potential claims.

In two of the three cases, a class action or Multi-District Litigation (MDL) was initiated, leading to significant publicity and attorney advertisements. The Biomet MDL was established more than a year after Biomet proposed a bar date. Despite the states' discovery rules, Biomet failed to demonstrate that available information would have constructively notified all plaintiffs of a potential claim by February 10, 2011. Biomet's internal knowledge cannot be presumed to inform reasonable plaintiffs, who were not targeted with risk notifications and are unlikely to have actively sought information from medical journals or the FDA website. Without substantial media coverage regarding product withdrawals or label changes, Biomet did not prove that a reasonable plaintiff would have been aware of a potential claim. Consequently, the request to set a February 10, 2011, bar date was denied.

Ms. Slater received a Biomet M2a Magnum implant in March 2007 and experienced hip pain several months later, leading to four revision surgeries between 2008 and 2009. During these surgeries, issues such as fluid accumulation, metallosis, and metal debris were uncovered. Ms. Slater was unaware of the implant's metal-on-metal nature or its manufacturer until 2013. After contacting an attorney regarding a malpractice claim in 2009, she was informed that she had no case against her surgeon, with no mention of Biomet. She sought legal assistance again in 2013 after seeing a television ad and filed a claim on April 13, 2014.

Regarding the choice of law, cases filed directly in the MDL court apply the law of the state where the case originated. In this instance, North Carolina law applies, as the implant was prescribed, purchased, and implanted there. Under North Carolina law, personal injury claims must be filed within three years of the claim's accrual, defined as when bodily harm or property damage becomes apparent. The court must determine what Ms. Slater needed to know for the limitations period to commence. Generally, a plaintiff's awareness of a problem is sufficient to trigger the limitations period, though medical claims may involve more complexity regarding the source of harm, complicating the determination of when the limitations period should start.

Revision surgery shortly after a hip implant may indicate medical malpractice, device issues, unavoidable infection, or other unforeseen treatment risks. In medical malpractice cases, the statute of limitations begins when both the injury and its cause are discovered or should have been discovered. If the injury and cause are known but wrongdoing is not, the limitations period starts when the plaintiff discovers or should have discovered the wrongdoing. In the Black case, a plaintiff learned years later that a simpler treatment existed, which indicated her doctor's negligence, thus triggering the limitations period.

In Ms. Slater's situation, although she was aware of issues by her fourth revision surgery, this knowledge alone did not necessarily indicate wrongdoing, particularly since she was unaware of metallosis. Her realization that the implant itself might have failed only occurred later, spurred by an attorney advertisement. This raises a material fact issue regarding when Ms. Slater knew or should have known about the alleged failure, preventing a summary judgment in favor of Biomet on the product liability and negligence claims.

Conversely, Ms. Slater's breach of warranty claims, which follow a four-year limitations period starting from the delivery of the implant in March 2007, are time-barred, as she filed after this period. The possibility of a discovery rule for breach of warranty claims exists but requires evidence of a warranty extending to future performance, which was not presented. Consequently, Biomet's motion is granted for these claims.

Ms. Slater also alleges a violation of the North Carolina Unfair and Deceptive Trade Practices Act (UDTPA), which requires actions to be filed within four years of the cause of action accruing. While the statute recognizes the discovery rule for fraud or misrepresentation claims, Ms. Slater did not base her argument on these grounds, instead asserting a claim for the sale of a defective product. Biomet contends the cause of action accrued at the time of the sale, a position Ms. Slater did not counter. Therefore, Biomet's motion is granted regarding the UDTPA claim.

The court has granted Biomet’s motion for summary judgment regarding Ms. Slater’s breach of warranty and statutory claims (Counts III-V), but denied the motion concerning her products liability and negligence claims (Counts I-II). Cited references include various studies and articles related to the implications of metal-on-metal bearings in hip arthroplasty, including concerns about cobalt and chromium ion release. Ms. Slater contends that Biomet waived its statute of limitations defenses by failing to file a timely response, referencing relevant legal standards and case law regarding the discovery of injury in medical malpractice claims. Additionally, a stay on case-specific responsive pleading deadlines was previously granted, which remains in effect as the parties have not reached an agreement regarding the obligations of the Settlement Agreement; therefore, Biomet did not waive any affirmative defense by not filing an answer.