When a defective product causes personal injuries or death, it is necessary to prove that:
- the product was in fact dangerous or defective; or
- the manufacturer had notice of the danger or a defect; and
- the product was the cause of plaintiff’s injury. (Ault v. International Harvester Co. (1974) 13 Cal.3d 113, 121-122).
Evidence of other similar incidents (OSI) and consumer or user complaints regarding a product are effective in convincing a jury that the manufacturer knew there was a problem or at a minimum was on notice of an issue involving its product.
Proof of hundreds of OSIs was the key in our winning a $79,860,000 jury verdict for a defective surgical stapler against Johnson & Johnson — the largest defective product verdict in California.
As a general rule it is not necessary to show the circumstances surrounding OSIs were identical, but only that they are similar and not too remote. (Elsworth v. Beech Aircraft Corp. (1984) 37 Cal.3d 540, 555; Genrich v. State of Calif. (1988) 202 Cal. App. 3d 221, 227-228).
Manufacturers always attempt to exclude OSIs and argue that only those that are “identical” can be admitted into evidence.
Fortunately the “similar condition” requirement is far less stringent for purposes of proving a manufacturer was on notice of a problem or a series of complaints.
When a prior accident is offered only to show the defendant had notice, “all that is required … is that the previous injury should be such as to attract the defendant’s attention to the dangerous situation…” (Hasson v. Ford Motor Co. (1982) 32 Cal.3d 388, 404 (internal quotes omitted); Elsworth v. Beech Aircraft Corp., supra, 37 Cal. 3d at 555—prior aircraft accidents involving faulty spin characteristics admissible to show notice of dangerous condition despite lack of similarity; Cal. Prac. Guide Civ. Trials & Ev. Ch. 8B-B).
The most thorough application of these rules is found in lawsuits involving defective medical devices, largely because of the keeping of detailed records by both manufacturers and the government and the fact that many devices are never subject to independent screening or appraisal by the FDA.
Many devices are allowed to be sold to hospitals, physicians and the public without FDA review as a result of a major loophole, known as grandfathering.
A device that is “grandfathered” is one that was sold before the FDA took control of medical products in 1976 under the Medical Device Amendments Act. At that time the devices grandfathered into the system were relatively harmless and were “temporarily” approved, unfortunately some devices that are necessary for life were approved for continued sale.
This major oversight has opened a loophole for thousands of other devices to be approved under what is known as 510(k) process which allows manufacturers to submit data for a new device showing that it is substantially equivalent to an existing or “predicate” device. This is a much easier path than getting approval under the FDA’s Premarket Approval Process which requires extensive scientific studies proving that the device was effective and safe.
No clinical trials are needed to establish the safety of a 510(k) “cleared” device.
The major fault of the 510(k)-clearing process is that any device that is legally marketed can be used as a predicate device even though never tested and a daisy chain of approvals cascades.
Identifying OSIs is the chief avenue in proving that a “grandchild” product is defective.
There is substantial case law authorizing the admissibility of reports of other incidents involving medical devices. Here are some examples from courts across the United States.
- Toole v. Baxter Healthcare Corp., 235 F.3d 1307, 1313 (11th Cir. 2000) (district court properly admitted 270 complaints relating to defendant’s silicone gel breast implant in plaintiff’s case to establish notice of the product’s defective nature)
- Hahn v. Sterling Drug, Inc., 805 F.2d 1480, 1483 (11th Cir. 1986) (evidence of similar incidents involving ingestion of defendant’s topical analgesic, including FDA report compiling statistics of other incidents, admissible for several purposes in product action)
- Kehm v. Procter & Gamble Mfg. Co., 724 F.2d 613, 625-26 (8th Cir. 1983) (other incidents involving defendant’s tampon admissible in products action for various purposes)
- Worsham v. A.H. Robins Co., 734 F.2d 676, 688-89 (11th Cir. 1984) (district court’s decision to allow testimony regarding similar injury-related lawsuits involving defendant’s intrauterine contraceptive device affirmed)
- Benedi v. McNeil-P.P.C., Inc., 66 F.3d 1378, 1385-86 (4th Cir. 1995) (district court properly admitted FDA Drug Experience Reports and summaries relating to defendant’s painkiller)
- Golod v. Hoffman La Roche, 964 F. Supp. 841 (S.D.N.Y. 1997) (Held: FDA Adverse Experience Reports and FDA computer printouts summarizing reports for defendant’s drugs relevant to notice, and not inadmissible as hearsay)
- Tyler v. Sterling Drug, Inc., 19 F.Supp.2d 1239, 1241 (N.D. Okla. 1998) (anecdotal reports of product injuries admissible for notice, failure to warn, and causation)
- Arrow, Int’l, Inc. v. Sparks, 98 S.W.3d 48, 53-54 (Ark. 2003) (trial court properly allowed evidence of 36 Medical Device Reports filed pursuant to FDA regulations regarding similar device malfunctions in wrongful death action)
- Mahaney ex rel. estate of Kyle v. Novartis Pharm. Corp., 835 F. Supp. 2d 299, 311-13 (W.D. Ky. 2011) (FDA Adverse Drug Experience Reports relevant to show notice and medical causation).
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