Richard Shaling v. BIOMET, INC.

Indiana Court of Appeals·Decided March 11, 2025·No. 24A-CT-00516·Published

Opinion

IN THE

Court of Appeals of Indiana Richard Shaling, FILED Appellant-Plaintiff Mar 11 2025, 8:47 am

CLERK

Indiana Supreme Court

v. Court of Appeals and Tax Court

Biomet, Inc., et al.,

Appellees-Defendants

March 11, 2025

Court of Appeals Case No.

24A-CT-516

Appeal from the St. Joseph Circuit Court The Honorable John E. Broden, Judge Trial Court Cause No.

71C01-1906-CT-216

Opinion by Chief Judge Altice Judges Vaidik and Scheele concur.

Altice, Chief Judge.

Case Summary [1] Richard Shaling appeals the grant of summary judgment in favor of Biomet,

Inc., Biomet Orthopedics, LLC, Biomet U.S. Reconstruction, LLC, and Biomet Manufacturing LLC (collectively, Biomet), arguing that the trial court should have applied Alabama law to his products liability claims against Biomet, and that the trial court erred in determining that his action is time-barred under the Indiana Products Liability Act’s (IPLA) statute of repose, Ind. Code § 34-20-3- 1. Specifically, Shaling contends that Alabama law should govern his action because he provided Biomet with sufficient notice of his intent to assert the applicability of its laws. Shaling further maintains that Indiana’s statute of repose did not bar his claims because that statute does not apply in products liability actions where, as here, an injury was caused by a disease that might have been contracted from prolonged exposure to an inherently dangerous foreign substance. Shaling further claims that his action was timely because he sued Biomet within two years after his cause of action had accrued.

[2] We affirm.

Facts and Procedural History [3] On February 20, 2001, Shaling—while living in Alabama—underwent total hip

replacement surgery 1 in Birmingham, Alabama, wherein Dr. Timothy Cool

1 The designated evidence reveals a discrepancy regarding the date of the surgery. Shaling’s complaint alleges that the surgery was performed on February 20, 2001, whereas the designated evidence asserts that it

Court of Appeals of Indiana | Opinion 24A-CT-516 | March 11, 2025 Page 2 of 16 implanted a metal-on-metal system (M2 System) in Shaling’s left hip. Biomet, whose principal place of business is in Warsaw, Indiana, manufactured, engineered, and designed the M2 System. Shaling’s surgery replaced metal hardware that had been implanted in his hip following a serious motorcycle accident in 1984.

[4] In August 2014, Shaling was diagnosed with leukemia, and in early 2015, testing revealed elevated metal ion levels in his blood. Shaling began conducting his own online research to determine whether metal-on-metal hips caused the ions and could have caused his leukemia.

[5] On January 29, 2015, Shaling visited his primary care physician, Dr. Jeremy Smith, shared several articles with him about metal ion levels, and discussed whether the M2 System might have produced his illness. Following their conversation, Dr. Smith ordered various tests for Shaling, and it was discovered that Shaling’s ion levels remained elevated. At the time, Shaling was not experiencing pain or suffering mobility problems. Dr. Smith determined that the elevated levels had not reached a dangerous point, and he did not recommend any further action.

[6] In March 2015, Shaling consulted with Dr. Cool about the elevated ions and whether he might require surgery to replace the M2 System. Dr. Cool did not

was performed on December 20, 2001. As the discrepancy does not affect the issues on appeal, we reference February 20, 2001 as the date of the surgery.

Court of Appeals of Indiana | Opinion 24A-CT-516 | March 11, 2025 Page 3 of 16 see an immediate need for additional surgery, and he could not predict whether the elevated levels might cause future problems. Dr. Cool, however, ordered Shaling to undergo MRI and CT scans. Shaling’s medical records indicated that the CT scan findings, dated June 16, 2015, were “worrisome for particle disease.” Appellant’s Appendix Vol. 3 at 104.

[7] After a follow-up appointment with Dr. Smith on July 28, 2015, medical records indicated that Shaling had consulted with Dr. Cool about replacing or resurfacing his left hip. Shaling, however, asserted that there was “no talk” about additional surgeries, and that Dr. Cool assured him it was not time to replace the hip, regardless of the elevated levels. Id. at 200.

[8] From early February 2016 through February 2017, additional blood tests showed that Shaling’s ion levels had fluctuated from a minor elevation to a “cobalt toxicity” level. Id. at 208. Dr. Cool was concerned that the M2 System had likely caused the metal ion release. At a follow up appointment with Dr. Cool on July 14, 2017, Shaling was experiencing hip pain. At some point thereafter, Dr. Cool told Shaling—without further explanation—that they “needed to get that hip out.” Id. at 215, 217. Dr. Cool ruled out infection and loosening of the prosthetic as causes of Shaling’s elevated ion levels.

[9] Shaling underwent revision surgery on August 15, 2017, in Alabama, where it was determined that the M2 System had failed. Dr. Cool used a different cobalt chromium head in the surgery and left some of the metal components in Shaling’s body. Following the surgery, Shaling’s ion levels drastically decreased. Dr. Cool concluded that the M2 System had “poisoned Shaling from the inside,” because the implant was “shedding cobalt.” Appellant’s Appendix Vol. 3 at 347, 356.

[10] Following the revision surgery, Shaling’s levels eventually returned to normal. Shaling, however, began to experience intense pain, paralysis and numbness in his left leg, and he needed a crutch to walk. Shaling underwent an additional surgery because his sciatic nerve was encased in scar tissue from the prior hip surgeries. Shaling ultimately suffered a serious infection and is now permanently disabled.

[11] On June 10, 2019, Shaling filed a products liability complaint against Biomet, seeking compensatory and punitive damages. Shaling alleged that Biomet had “fast tracked” the M2 System—before the Federal Drug Administration had approved it—by claiming that the device was substantially equivalent to other products that had already been cleared for sale. Appellant’s Appendix Vol. 2 at 32-33. Shaling further asserted that Biomet misled him and the public regarding the safety of its products, that the M2 System was defectively designed and unreasonably dangerous, and that Biomet failed to provide reasonably complete and accurate information to Shaling and the orthopedic community about the M2 System.

[12] On May 7, 2023, the trial court entered an order setting the matter for a two- week jury trial to begin on June 3, 2024. Thereafter, on October 31, 2023, Biomet filed a motion for summary judgment, arguing that Shaling’s claims were time-barred under the IPLA’s two-year statute of limitations and the statute of repose. Biomet maintained that because Shaling was implanted with the M2 System more than 18 years before filing his complaint, the statute of repose barred his action. Biomet also asserted that Shaling’s case was independently barred by the two-year statute of limitations because Shaling knew—no later than June 2015—of his elevated metal ion levels in his blood, that the M2 System was the cause of the elevated levels, and that he would require revision surgery to remove the M2 System. Thus, Biomet argued that Shaling was required to file his complaint prior to June 2017.

[13] In opposing Biomet’s motion for summary judgment, Shaling argued that there were genuine issues of material fact as to when he suffered his injury. Shaling maintained that he did not sustain injury until July 2017, and the injury was documented on August 11, 2017. Shaling also argued—for the first time—that Alabama law should govern the action because the two surgeries were performed there. Shaling maintained that while Alabama’s two-year statute of limitations is similar to Indiana’s, there is no statute of repose in Alabama that would bar his claims.

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