PHILLIPS v. BAXTER HEALTHCARE CORPORATION (1993)

Plaintiff and appellant Deborah Phillips appeals from a judgment following a jury trial in a product liability action, in favor of defendant and respondent Baxter Healthcare Corporation (“Baxter”).¹  Appellant's action arose from the rupture of silicone gel breast implants.   She contends that the trial court erred in excluding certain evidence and committed instructional error.   She also argues that the verdict is not supported by substantial evidence.   We affirm the judgment.

FACTS

We view the facts adduced at trial in the light most favorable to the judgment, giving a prevailing party the benefit of every reasonable inference, and resolving conflicts in support of the judgment.  (Sanchez-Corea v. Bank of America (1985) 38 Cal.3d 892, 906-907;  Crawford v. Southern Pacific Co. (1935) 3 Cal.2d 427, 429.)   These presumptions are given added support by a trial court's denial of a losing party's motion for new trial.  (Lerner v. Glickfield (1960) 187 Cal.App.2d 514, 526.)

Respondent is engaged in the manufacture of silicone breast implants.   In June 1978, appellant consulted Dr. Robert Rhodes regarding the possibility of mammoplasty.   She was told that the silicone gel implants used were “as sturdy as a football.”   Appellant elected to undergo the breast augmentation procedure in August 1978.   Dr. Rhodes used implants manufactured by respondent.²  Appellant subsequently suffered from capsular contracture in her right breast, a hardening of the breast caused by the formation of scar tissue.   In January 1979, appellant underwent an open capsulotomy performed by Dr. Rhodes.   He opened both right and left breasts, removed the implants, broke up the hardened capsule, and reinserted the implants.

In August 1984, appellant's gynecologist referred her to Dr. Glowacki.   Her right breast was firmer than the left.   He recommended, and later performed, a closed capsulotomy of the right breast.   In this procedure, the physician applies manual pressure to the exterior of the breast to break up the hardened tissue.   However, appellant subsequently re-experienced capsular contraction in the right breast.

During the summer of 1985, appellant was reading a book in her backyard.   She rolled over onto her stomach and felt a “popping” in her chest.   She thought her fibrous adhesions had broken, since her breasts were softer.   However, shortly thereafter, she noticed a bulge under her right arm and a streak of material under the skin running from her right breast to her waist.   It seemed to be a gelatinous substance.   Dr. Glowacki examined her and concluded that the right breast implant had ruptured.   He attempted to remove as much of the implant and loose gel as possible.   Appellant suffered immediate capsular contraction and an inflammatory reaction to the silicone in her tissues.   Dr. Glowacki removed the entire implant in November 1985.   In May 1986, he inserted a new implant.

Appellant elected surgery in September 1986 to re-position the implant in her left breast to achieve greater symmetry with the right breast.   When her left breast was opened, Dr. Glowacki discovered that the left implant had also ruptured.   After that surgery, appellant noticed that the lymph node under her right arm had hardened.   She later underwent an open capsulotomy on her right breast in February 1987.

PROCEDURAL BACKGROUND

On approximately June 19, 1986, appellant filed an action against respondent seeking damages for personal injury on theories of negligent manufacture, negligence, and breach of warranty arising from the implants which she had received in 1978.   Appellant conceded that the hardening of her breasts was a known risk of breast augmentation, but asserted that rupture of the breast implants was not.   In addition, she contended the implant was defective because the silicone used in the implant had a low viscosity, giving it a high rate of flow in the event of a rupture and making it more likely that the silicone would migrate outside of the breast.   Appellant contended that respondent breached its duty to warn of these problems.   Appellant alleged that further surgeries would be required and that she was at high risk for disease due to migrated silicone.

Trial commenced on June 11, 1991.   Respondent filed six motions in limine.   Of these, two concerned the exclusion of evidence of the 1991 Food and Drug Administration's (the “FDA”) regulation of silicone gel breast implants.   The trial court excluded evidence concerning FDA activities after 1978.

At trial, appellant presented testimony by Thomas Talcott, a materials engineer formerly employed at Dow Corning in the research and development of silicone breast prostheses.   Talcott left Dow Corning in 1976, because he believed that its relatively fluid silicone gel was dangerous.   He joined Heyer-Schulte as director of materials research and development.   According to Talcott, the medical community by 1978 was aware of animal studies demonstrating that silicone was phagocytized ³ to vital organs.   Talcott developed a flow test for silicone gel, by which he measured the amount of silicone which would extrude from a hole of given dimension in 30 minutes.   This test was later adopted by the American Society of Testing and Material (“ASTM”) as an industry standard.   The silicone in appellant's implants did not meet the standards developed from these tests.   Instead, respondent used a 15 second “slump test” which Talcott deemed inadequate.

Appellant also presented testimony from Dr. Rhodes, who contended that a rupture of a breast implant during a closed capsulotomy procedure would be instantly known to the physician.   He also testified that it was an accepted procedure to reuse an intact implant during an open capsulotomy.   He contended that the implant literature, which warned of “low tear strength,” referred to cuts by a scalpel.

Edmund Seder, vice-president for regulatory affairs and quality assurance at respondent, testified that the manufacturing process in 1979 (when he commenced his employment with respondent) was identical to that in place in 1978, when appellant's implants were made.   Prior to 1975, respondent made a lower-flow gel implant to prevent migration.   However, physicians requested a higher-flow implant because it had a more natural feel.   Beginning in 1975, respondent began to manufacture a higher-flow implant.   Industry standards for gel flow were promulgated by ASTM in 1981 and respondent began complying with those standards as early as 1976.   Although respondent used a 15-second “slump test” instead of the 30-minute industry standard test, the results of the two tests could be mathematically correlated to achieve the proper consistency of gel.   This was the procedure performed by respondent.   Each lot of silicone was also tested for viscosity.   According to Seder, the implant removed from appellant met industry standards, based on these established correlations.   He examined one of the ruptured breast implants and opined that it had been put at risk during appellant's open capsulotomy.

Three reasons supported the product insert warning against reuse.   First, the implant sometimes adheres to the hardened breast tissue.   Secondly, the implant may be injured by a scalpel or other sharp object.   Finally, the implant may become contaminated while out of the body.   Respondent offered free replacement implants to avoid reuse and to study and test implants after removal.   However, neither the viscosity nor the consistency of the silicone gel has an impact upon the possibility of rupture of the implant.

In 1975, respondent sent a “Dear Doctor” letter to physicians who had ordered implants.   The letter warned of 140 complaints about the products, including incidents of product rupture.   It also warned of gel migration and inflammatory response described in the medical literature.   In 1980, the product insert was modified to add a warning that “gel migration subsequent to rupture of a prosthesis may cause inflammation and silicone granuloma formation.”

Dr. Richard Escajeda, a plastic surgeon, also testified for the defense.   In his opinion, the product insert was adequate and meant that respondent could not guarantee the silicone gel would be contained in the breast capsule after rupture.   According to Dr. Escajeda, the closed capsulotomy performed on appellant probably ruptured the implant in that breast.   This procedure was popular in the medical community in the late 1970's.   The left implant probably ruptured due to trauma.   It is possible for an implant to rupture during closed capsulotomy without the physician becoming aware.   Dr. Escajeda did not reuse an implant after a closed capsulotomy.

Another plastic surgeon, Dr. Gary Brody, who had visited respondent's plant in the late 1970's testified that respondent's quality control and research was good.   Dr. Brody had performed between 500 and 1000 breast augmentations since 1964.   Earlier implants, which had a firmer consistency, felt less natural to the touch and had a higher rate of capsular contracture.   The medical profession and manufacturers worked together to achieve a balance between a more natural product and an acceptable risk of rupture or migration.   As a result, all implants were filled with a thinner gel.   The product insert, in his opinion, adequately warned the profession about rupture.

In 1978, Dr. Brody used the closed capsulotomy procedure because it was quick and effective.   However, the industry, including respondent, warned that it could not guarantee the integrity of the implant if a closed capsulotomy were performed.   In addition, respondent warned against reuse of the implant, although Dr. Brody acknowledged that he would reuse an implant if it were intact when removed.   In his opinion, appellant's implants ruptured because of force which stretched them beyond their limits, and not because the implants were defective.   Appellant experienced some migration of gel outside her capsules, but not outside the breast plane.   No gel was found in her lymph nodes or other part of her body.   He testified that the “streak” on appellant's abdomen was probably a vein, since it disappeared.   The lump under her arm was not likely to be related to silicone.   The asymmetry of her right breast was due to scar tissue.   According to Dr. Brody, there was no medical literature of substance in 1978 which demonstrated a causal connection between autoimmune disorder and exposure to silicone gel.   At that time there were large surveys which demonstrated no connection.

After only two hours of deliberations, the jury returned a defense verdict.   Appellant's motion for a new trial was denied and she timely appealed.

DISCUSSION

Evidentiary RulingsA. Post-1978 Scientific Evidence

Appellant contends that the trial court excluded any post-1978 scientific evidence regarding the problems associated with silicone breast implants.   Respondent maintains that the trial court ruling was restricted to the exclusion of evidence concerning regulatory activity by the FDA in 1991.   The record appears to support respondent's position.

Prior to the commencement of trial in this action, respondent moved in limine to exclude reference to 1991 regulations of the FDA requiring pre-market approval of breast implants.   Prior to that time, the FDA did not require manufacturers of breast implants to submit a pre-market approval application to the FDA, because breast implants were already on the market as of the effective date of the law requiring such pre-market submissions.  (Medical Device Act Amendments of 1976, Pub.L. No. 94-295.)   However, federal law permitted the FDA to require such submissions in the future.  (21 U.S.C., § 333 et seq.)   On April 10, 1991, the FDA announced that silicone breast implant manufacturers had 90 days within which to submit a pre-market approval application or withdraw their products from the market.  (21 C.F.R., § 878.)

In its written motion in limine, respondent argued that regulatory activities by the FDA in 1991 were irrelevant to events which occurred in 1978, the year in which appellant received her implants.   Respondent contended that the probative value of such information was outweighed by its time-consuming, prejudicial and confusing nature.  (Evid.Code, § 352.)   When this motion was granted, the trial court announced its ruling as follows:

“The third motion in limine [ ] to preclude evidence regarding activities by the FDA after 19 [sic ] or subsequent to 1978 is granted.” 4

During trial, the court sustained objections to evidence concerning the 1991 FDA action.   On appeal, appellant does not seem to contest these rulings pertaining to the 1991 FDA action.⁵  Rather, appellant complains that “the trial court erred in prohibiting [appellant from putting on evidence of scientific knowledge acquired or available to [respondent] after 1978.”   Appellant concedes that a cause of action for failure to warn must be assessed in light of the scientific and technological knowledge available or known at the time the product was sold.  (Anderson v. Owens-Corning Fiberglas Corp. (1991) 53 Cal.3d 987;  Rosburg v. Minnesota Mining & Mfg. Co. (1986) 181 Cal.App.3d 726.)

Nevertheless, appellant contends that the jury might have found useful post-1978 evidence concerning “the mechanism of injury.”   For example, evidence regarding implant failure or gel migration which might shed light on the question of causation, as well as recent epidemiological or medical studies on silicosis.   Appellant also maintains that duty to warn does not terminate with the sale of a product.  (See, e.g., Temple v. Velcro USA, Inc. (1983) 148 Cal.App.3d 1090, 1094.)

Fatal to appellant's argument is her complete failure to specifically identify the evidence which she sought to introduce at trial.   In her reply brief, appellant refers to an offer of proof regarding Talcott's post-1978 knowledge, about which the trial court would not allow him to testify.   Our review of the record reveals that this ruling was based on the premise that Talcott, a materials engineer employed at respondent until 1978, was competent to testify about his experiences at respondent as an employee, not as an expert.   Since he was not qualified as a medical or epidemiological expert, his review of the post-1978 literature was hearsay.   As a non-expert witness, he was not entitled to rely on hearsay or to offer opinion testimony in that area.

More importantly, although appellant, in her reply brief, makes specific references to her so-called offer of proof, she fails to note that her offer of proof was formally withdrawn.   The trial court allowed a recess to prepare the offer of proof as regards Talcott's testimony and convened outside the presence of the jury to hear the offer.   Appellant's counsel then stated, “Your honor, at this time [appellant] has decided to withdraw our offer of proof in that matter․”  Instead, appellant asked permission to reopen the direct testimony of Talcott, which permission was granted.   Appellant plainly waived the right to introduce additional testimony from Talcott.

Since appellant does not cite to any further examples of post-1978 testimony which were barred by the trial court, we conclude that no error occurred.⁶

B. The 1980 Product Insert

Appellant also argues the trial court erroneously failed to admit into evidence respondent's 1980 product insert.   That insert reads in pertinent part, “gel migration subsequent to a rupture of a prosthes[i]s may cause inflammation and silicone granuloma formation.”

Appellant conceded at trial that this insert would be barred under section 1151 of the Evidence Code as evidence of a subsequent remedial measure which is inadmissible to prove negligence.   Appellant argued, however, that since she had dismissed her negligence and warranty theories and was proceeding only upon a theory of strict liability, Evidence Code section 1151 did not apply.   While Evidence Code section 1151 may not preclude the admission of such evidence,⁷ our Supreme Court's opinion in Anderson v. Owens-Corning Fiberglas Corp., supra, 53 Cal.3d at page 1004 does.   That case concerned whether, in a strict liability “failure to warn” action, the defendant's ability to know of product dangers at the time of the manufacture was relevant.   The Anderson court concluded that “the fact that a manufacturer acted as a reasonably prudent manufacturer in deciding not to warn, while perhaps absolving the manufacturer of liability under the negligence theory, will not preclude liability under strict liability principles if the trier of fact concludes that, based on the information scientifically available to the manufacturer, the manufacturer's failure to warn rendered the product unsafe to its users.”  (Id. at p. 1003.)   A defendant may present evidence of “the state of the art, i.e., evidence that the particular risk was neither known nor knowable by the application of scientific knowledge available at the time of manufacture and/or distribution.”  (Id. at p. 1004.)

In the instant case, it is obvious that a product insert distributed by respondent in 1980-two years after appellant's mammoplasty-may not be relevant-without a substantial foundational showing-to the issue of respondent's actual knowledge of the risks associated with the product as of the date of manufacture and/or distribution, 1978.   We note that the trial court could properly have concluded appellant failed to demonstrate the information referenced in the 1980 insert was known or knowable to respondent in 1978.

Appellant, realizing the import of the Anderson decision, argues that she should have been allowed to introduce the product insert in order to impeach Seder, who testified that he did not recall that the 1978 product insert was ever modified.   The trial court sustained an Evidence Code section 352 objection to admission of the product insert.   This was well within the broad discretion of the trial court, which had to consider the prejudicial or confusing effect such information may have had on the jury, which was only to consider respondent's knowledge as of 1978, not 1980.   Moreover, to the extent this could conceivably be characterized as an abuse of discretion, appellant was not prejudiced by the exclusion.   The trial court allowed appellant to cross-examine Seder concerning the subject matter of the product insert.   For example, appellant elicited from Seder the admission that respondent knew of the possible complication of granuloma formation in 1976, but failed to mention it in its 1978 product insert.

In addition, other evidence in the record supported respondent's actual knowledge in 1978, such as the “Dear Doctor” letter dated August 23, 1976, which described the possible adverse side effect of inflammatory response to silicone.   Thus, were appellant to have been allowed to read from the 1980 product insert, the single sentence concerning silicone gel migration causing inflammation and silicone granuloma formation, the result in this case would not likely have been different.   The essential fact that respondent knew as of 1978 that silicone could migrate and cause inflammatory response was before the jury.   Thus, to the extent that the trial court erred in excluding the product insert, no prejudice resulted which would require reversal of the jury verdict.  (Finn v. G.D. Searle & Co. (1984) 35 Cal.3d 691, 703 [where information in subsequent product insert excluded from evidence was already presented to jury, no prejudice shown].)

Nor would the 1980 product insert be particularly effective at impeaching Seder, who had testified only that he did not “recall” that the 1978 product insert had been modified.

Thus, we conclude that the trial court did not abuse its discretion in excluding the 1980 product insert under section 352 of the Evidence Code and the Anderson and Finn decisions.

Instructional Error

A. Duty to Warn Consumer

Appellant contends the trial court erred in instructing the jury that respondent did not have a duty to warn appellant directly as to product use,⁸ rather than to warn her physician.⁹  Appellant concedes that the general rule is that where there is a “learned intermediary” and the end user lacks the requisite scientific and technical knowledge to evaluate the risks of the product, the manufacturer has no duty to warn the patient, “absent special circumstances.”  (Toole v. Richardson Merrell, Inc. (1967) 251 Cal.App.2d 689;  Charmichael v. Reitz (1971) 17 Cal.App.3d 958, 989.)

Appellant cites no authority to the effect that breast implants present such a “special circumstance.”   She argues that the recipient of breast implants may be treated by different physicians who are not aware of the brand of her implant and may erroneously recommend closed capsulotomy or reuse of the implants after open capsulotomy.   Thus, she argues, the patient should be armed with product warnings provided by the manufacturer.   We reject this contention.   First, appellant has not distinguished this case from any other pharmaceutical or medical device case in which the duty to warn runs only to the physician not to the patient.   Any patient may change physicians and encounter similar problems.   Nor, do we accept that breast augmentation patients are more actively involved in the use of the medical device than patients who “passively” ingest pharmaceuticals.   Those patients too are actively involved in following the physician's instructions and monitoring side effects and responses.

It seems obvious that it would be inappropriate for the manufacturer to warn the patient and then rely on the patient to deliver those warnings to the subsequent physician.   The physician is in the superior position to evaluate product risks and side effects, not the patient.   The licensed physician is, in effect, the consumer.  (Rosburg v. Minnesota Mining & Mfg. Co., supra, 181 Cal.App.3d at pp. 732-733.)

Moreover, the record reflects that appellant requested a strikingly similar instruction, BAJI No. 9.00.7.¹⁰  That instruction provides that the manufacturer must give appropriate warnings to the physician.   Thus, any prejudice which would flow from the instruction given in this case would be minimal, since appellant concedes the general rule is that the duty flows to the doctor, not the patient.   While BAJI No. 9.00.7 does not foreclose the possibility that in “special circumstances” the manufacturer must warn the patient, the instruction makes clear that the special circumstances exception to the general rule is a narrow one.   Reading BAJI No. 9.00.7 in place of the instruction at issue would not likely have produced a different result in this case.   An appellant may not complain of an erroneous instruction if she requested that instruction or one substantially similar to it.   Further, appellant's conduct in requesting a substantially similar instruction constitutes a waiver of any defect in the instruction given.  (Horseman's Benevolent and Protective Assn. v. Valley Racing Assn. (1992) 4 Cal.App.4th 1538, 1555.)

B. Instruction re Product Misuse

Appellant contends that the trial court erred in instructing the jury:

“A manufacturer is not liable for injuries related to the use of its product when the product was not used in a reasonably foreseeable manner.   In considering whether a product was used in a reasonably foreseeable manner, you may consider the manufacturer's instructions for the use of the product, as well as the manufacturer's warnings regarding the risk and complications attendant to the use of the product.”

The trial court rejected appellant's related instructions, which emphasized the manufacturer's duty to foresee “accidents” which may occur even when the product is used in the normal, intended manner, and its duty to design the product so as to minimize foreseeable risks of injury.¹¹

Appellant contends that the instruction given allows the manufacturer to define foreseeable use by its own instructions, rather than what is objectively known and anticipated from experience with the product.   Specifically, appellant maintains the instruction allowed respondent to argue to the jury that a closed capsulotomy procedure constitutes product misuse because of the warning against that procedure contained in the product insert.   It also allowed respondent to contend the reinsertion of appellant's implants following her open capsulotomies constituted product misuse given the instruction that the product was intended for single use only.   Appellant argues that, because reuse and closed capsulotomies were standard in the community, the product should have been designed to withstand such practices.

Appellant overstates the impact and meaning of the instruction given.   It merely informs the jury that in determining whether misuse has occurred, it may consider, inter alia, the manufacturer's instructions for use.   It does not allow manufacturer's to immunize themselves through cleverly drafted instructions against injury resulting from use of the product in a reasonably foreseeable fashion.   Among the questions for the jury was whether the alleged use was reasonably foreseeable in light of the manufacturer's warnings against such use.

In any event, no substantial prejudice could have resulted from the instruction since the record was replete with expert opinion evidence, from both appellant's and respondent's witnesses, that both closed capsulotomies and reinsertion were relatively common in the medical community.   Thus, to the extent that the instruction at issue, together with the manufacturer's warnings about closed capsulotomies and reuse of implants, suggests those procedures constitute “misuse,” that suggestion is counterbalanced by considerable evidence those procedures did not constitute misuse and were widely accepted in the community.   Thus, it is not reasonably probable that a result more favorable to appellant would have been reached in the absence of any purported instructional error.  (Mitchell v. Gonzales (1991) 54 Cal.3d 1041, 1054.)

C. Instruction re Duty to Compel Physicians to Heed Warnings

The trial court instructed the jury, at respondent's request:  “A manufacturer of prescription drugs and prescriptive products does not have a duty to compel the medical community to heed its warning in regard to prescriptive products.”

Appellant argues simply that the instruction was superfluous, since her case did not include the contention that respondent had a duty to compel her physicians to heed product warnings.   Assuming arguendo the instruction is superfluous,¹² we fail to see how any prejudice could have inured to appellant or that it is reasonably likely in the absence of such an instruction the jury would have reached a different result.

Substantial Evidence to Support the Verdict

Finally, appellant maintains that no substantial evidence supports the defense verdict on failure to warn.   As noted supra, for purposes of a substantial evidence review, we indulge every possible inference in favor of the judgment.   We need determine only whether any solid, credible evidence supports that judgment.

Essentially, appellant argues that, since Seder acknowledged respondent's knowledge of gel migration and silicone granuloma formation as early as 1976, no substantial evidence supports the conclusion that respondent did not have a duty to warn of these side effects in 1978.   Appellant fails to consider, however, the substantial expert opinion testimony offered, which supports the conclusion that respondent adequately warned physicians of the possibility of gel migration.   The record discloses ample evidence of this type, which is summarized above, and need not be repeated here.

Appellant also maintains respondent did not warn that normal activities, like rolling over, could result in rupture.   The record contains substantial evidence, however, that appellant's ruptures were caused by trauma, closed capsulation, or open capsulation, and not merely from the simple act of rolling over.

The record includes substantial evidence to support the conclusion that, given respondent's knowledge or ability to know in 1978, adequate warnings of gel migration and rupture were made by respondent.

DISPOSITION

The judgment is affirmed.   Appellant shall bear respondent's costs on appeal.

FOOTNOTES

1.   In 1985, Baxter assumed the assets and liabilities of American Hospital Supply Corporation, the parent of Heyer-Schulte Corporation, the manufacturer of appellant's breast implants.   Heyer-Schulte ceased manufacturing breast implants in March 1984.   Baxter defended appellant's claim and the parties stipulated that it was the only and proper defendant in the action.   For ease of reference, we use the term respondent to apply to Heyer-Schulte and Baxter.

2.   Those implants were accompanied by a manufacturer's insert which read, in relevant part:  “WARNINGS.   The silicone elastomer envelope of these products has a low tear strength and is thin to achieve desired prosthesis softness and mobility.   For these reasons, the envelope may be easily cut by a scalpel or rupture by excessive stresses, manipulation with blunt instruments, or penetration by a needle.   Gel prosthesis may be easily ruptured when still hot from the autoclave.   Care must be exercised during handling to prevent such events.  [¶] Heyer-Schulte cannot guarantee the structural integrity of its implant should the surgeon elect to treat capsule firmness by forceful external stress.  [¶] The gel interior of these products is vulcanized to retard the migration of gel should a rupture occur in the silicone envelope be ruptured, Heyer-Schulte cannot guarantee reliable gel containment, and the prosthesis should be replaced.”  (Bold in original.)

3.   In this process, silicone particles are picked up by cells and carried throughout the body, resulting in silicosis.

4.   We note that the only evidence implicated by this ruling was the 1991 FDA action.   Appellant did not seek to introduce evidence of any other post-1978 action by that agency.

5.   Recently, a federal court reversed a judgment in favor of a breast implant patient against respondent on the ground the 1991 FDA regulations were erroneously and prejudicially received into evidence.   (Toole v. McClintock (11th Cir.1992) 999 F.2d 1430, 1433-1435.)

6.   Moreover, the trial court did admit some evidence of post-1978 scientific information concerning silicone breast implants.   Thus, appellant's suggestion that all such information was barred does not appear to be supported by the record.

7.   See, e.g., Ault v. International Harvester Co. (1974) 13 Cal.3d 113 and Burke v. Almaden Vineyards, Inc. (1978) 86 Cal.App.3d 768.

8.   As distinguished from product side effects.

9.   The instruction in question reads as follows:  “In cases involving prescription drugs and medical devices, there is no duty to warn the patient herself about the potential dangers.   When adequate warning of potential dangers of the device has been given to a physician using the product, there is no duty on the manufacturer to insure that the warning reaches the doctor's patient for whom the device is utilized.”

10.   That instruction provides, in relevant part, “In the case of prescription drugs, such warning must be given to the physician.”   Appellant consented to modify the instruction to apply to prescription medical devices instead of drugs.

11.   Appellant requested the following instructions:  (1) “A manufacturer and seller of products, such as those involved in this case, are required to foresee that as an incident of normal use in the environment in which such products will be used, accidents may occur.   Because of this possibility, the manufacturer and seller of such products are required to design and manufacture such products so as to minimize foreseeable risks of injury”;  and (2) “The law requires that a manufacturer and seller of products, such as those involved in this case, must evaluate the accident potential of their product, and take such steps as may be reasonable and practicable to forestall particular accidental injuries and mitigate the seriousness of others.”

12.   Appellant maintains that the instruction is not supported by California law, but cites no authority for that proposition.   Respondent cites a federal decision as authority for the instruction.  (Swayze v. McNeill Laboratories, Inc. (5th Cir.1987) 807 F.2d 464, rehrg. denied 812 F.2d 1405.)

GREGNON, Associate Justice.

TURNER, P.J., and ARMSTRONG, J., concur.