491 F.Supp.3d 87
D. Maryland2020Background
- Plaintiff Charlotte Morris received a Biomet M2a Magnum metal-on-metal right total hip implant in Feb. 2008; she did not participate in device selection and relied on her surgeon, Dr. Jacobs.
- By 2011 she developed a pseudotumor and toxic cobalt/chromium levels; Dr. Jacobs performed revision surgery in Nov. 2011 and observed marked metallosis and tissue damage.
- Plaintiff thereafter suffered recurrent dislocations and multiple infections requiring additional revisions and ongoing treatment; she sued Biomet alleging design defect, failure to warn, negligence, fraudulent concealment, breach of implied and express warranties, and punitive damages.
- Biomet moved to exclude Plaintiff’s expert (Dr. John I. Waldrop) and for summary judgment on all claims; Dr. Waldrop proposed to testify about general metal-on-metal failure patterns, specific causation for the first revision, later harms, and reasonableness of billed charges.
- The Court admitted Dr. Waldrop’s general metal-on-metal observations and his specific-causation opinion for the first revision, but excluded his opinions tying later dislocations/infections to the original device and his testimony on medical-billing reasonableness.
- On summary judgment the Court denied judgment as to design-defect liability for injuries tied to the first revision, but granted summary judgment to Biomet on failure-to-warn, fraudulent concealment, implied and express warranty claims, punitive damages, and attorney’s fees; design-defect claims based on harms after the first revision were dismissed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of Dr. Waldrop’s general metal-on-metal opinions | Waldrop’s experience permits general observations to aid causation | Opinions not sufficiently particularized to Biomet device; unreliable on later harms and billing | Court admits general observations and specific-causation for first revision; excludes opinions on later harms and medical-billing reasonableness |
| Reliability of Waldrop’s differential diagnosis for first revision | He performed standard differential diagnosis based on records, surgery findings, experience | Methodology insufficient to rule out alternatives | Admissible for causation of first revision (reliable); not admissible for post-revision harms (speculative) |
| Design-defect causation | Biomet’s metal-on-metal design caused metallosis leading to first revision and injury | No reliable expert linkage between design and injuries | Genuine dispute survives re: design defect for first revision; summary judgment for Biomet as to harms after first revision |
| Failure to warn / Learned intermediary | Warnings were inadequate about metallosis/pseudotumors and prevalence | Duty runs to physician; Dr. Jacobs knew of metal-on-metal risks and relied on independent literature, so warnings would not have changed outcome | Summary judgment for Biomet: plaintiff cannot show physician would have relied on different warnings |
| Fraudulent concealment | Biomet misrepresented safety/survivorship and downplayed risks to physicians | No evidence Morris or Dr. Jacobs relied on Biomet’s statements in choosing the device | Summary judgment for Biomet for lack of reliance/particularity |
| Breach of implied warranty | Device was unmerchantable/unsuitable; notice provided by filing suit | UCC requires timely notice to seller; suit is not adequate notice | Summary judgment for Biomet: plaintiff failed to give required pre-suit notice |
| Breach of express warranty | Biomet marketed device as "pain-free" and omitted risks in IFU | No affirmative warranty to Plaintiff; omissions are not express warranties; Plaintiff never relied on any express claim | Summary judgment for Biomet: no evidence an express warranty formed the basis of the bargain |
| Punitive damages | Biomet acted with knowledge/intent to conceal defects | No clear-and-convincing evidence of actual malice or deliberate disregard | Summary judgment for Biomet: punitive damages dismissed |
| Attorney’s fees | Seeks fees if successful | No contractual or statutory basis; American Rule applies | Summary judgment for Biomet: fees denied |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (expert testimony must be reliable and relevant)
- Westberry v. Gislaved Gummi AB, 178 F.3d 257 (4th Cir. 1999) (Rule 702 liberal admission but gatekeeping needed)
- Cooper v. Smith & Nephew, 259 F.3d 194 (4th Cir. 2001) (differential diagnosis standard for medical causation)
- Celotex Corp. v. Catrett, 477 U.S. 317 (summary judgment burden-shifting)
- Anderson v. Liberty Lobby, 477 U.S. 242 (summary judgment: credibility and reasonable inferences governed)
- Owens-Illinois, Inc. v. Zenobia, 325 Md. 420 (Md. 1992) (punitive damages standard: actual malice required)
- Gourdine v. Crews, 405 Md. 722 (Md. 2008) (failure-to-warn requires duty, breach, causation, damages)
- Rite Aid Corp. v. Levy-Gray, 391 Md. 608 (Md. 2006) (formation and timing of express warranties)
- In re Wright Med. Tech. Inc., 127 F. Supp. 3d 1306 (N.D. Ga. 2015) (admitting similar expert testimony in hip-implant litigation)