Richard Shaling v. BIOMET, INC.

CourtIndiana Court of Appeals
DecidedMarch 11, 2025
Docket24A-CT-00516
StatusPublished

This text of Richard Shaling v. BIOMET, INC. (Richard Shaling v. BIOMET, INC.) is published on Counsel Stack Legal Research, covering Indiana Court of Appeals primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Richard Shaling v. BIOMET, INC., (Ind. Ct. App. 2025).

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.

Court of Appeals of Indiana | Opinion 24A-CT-516 | March 11, 2025 Page 1 of 16 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

Court of Appeals of Indiana | Opinion 24A-CT-516 | March 11, 2025 Page 4 of 16 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

Court of Appeals of Indiana | Opinion 24A-CT-516 | March 11, 2025 Page 5 of 16 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.

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