Mariann HOPKINS, Plaintiff-Appellee, v. DOW CORNING CORPORATION, Defendant-Appellant
Docket: 92-16132
Court: Court of Appeals for the Ninth Circuit; August 26, 1994; Federal Appellate Court
Mariann Hopkins filed a lawsuit against Dow Corning Corporation for injuries related to breast implants from surgeries in 1977 and 1986. The jury found Dow liable, awarding Hopkins $840,000 in compensatory damages and $6.5 million in punitive damages. Dow appealed, arguing that the claims were barred by the statute of limitations, that the evidence of fraud was insufficient, and that the admission of expert testimony on causation was erroneous. Dow also contested the damage awards. The case was heard under diversity jurisdiction, and the Ninth Circuit affirmed the district court's ruling.
Key facts include Hopkins undergoing a bilateral mastectomy in 1976, during which she received silicone gel implants from Dow. Complications led to the removal and replacement of implants, and in 1979, Hopkins was diagnosed with mixed connective tissue disease (MCTD). In 1986, ruptured implants were discovered but were not linked to her disease until 1987, when she learned about a potential connection. Her physicians had not indicated any causal link until then. Hopkins filed her complaint in December 1988, alleging fraud and product liability.
The case was bifurcated to first address liability, with the trial beginning on October 29, 1991. Evidence revealed that Dow rushed the development of silicone gel implants, inadequately tested them, and ignored known health risks. A Mammary Task Force was formed to expedite the implants' market entry in under five months, disregarding concerns about potential gel leakage. Salesmen were instructed to wash and dry the implants improperly, leading to silicone leakage and a high rupture rate. Despite suggestions for improved design methods, Dow opted for cheaper and simpler processes. An incident during a televised augmentation surgery raised questions about Dow's quality standards. Furthermore, there was no long-term health impact research; the longest study lasted only 80 days and indicated an inflammatory response to the gel. Dow was aware of harmful effects, as evidenced by a study involving dogs, but it delayed releasing negative findings, misleadingly implying safety. The jury found Dow liable on all counts, including strict liability, breach of warranty, and fraud. In the subsequent damages trial, the jury awarded the plaintiff $840,000 in compensatory damages and $6.5 million in punitive damages. Dow's motions for a directed verdict and alternatives were denied, and Dow appealed. Additionally, Dow argued that the plaintiff's claims were barred by California’s one-year statute of limitations for personal injury claims, while the plaintiff countered that her claims were timely under the "delayed discovery" doctrine.
California Code of Civil Procedure Sec. 340(3) establishes a one-year statute of limitations for actions involving injury due to another's wrongful act or neglect, applicable to products liability and breach of warranty claims in this case. The common law rule states that a cause of action accrues on the date of injury, modified by California's discovery rule, which delays accrual until the plaintiff is aware of the injury and its negligent cause. The parties dispute when Hopkins became aware of her injury and its wrongful cause, affecting the timeliness of her lawsuit.
The district court ruled that Hopkins' suit was timely filed, a decision subject to de novo review, meaning the appellate court will reassess whether any genuine issues of material fact exist and if the district court applied the law correctly. Under the discovery rule, the statute of limitations starts when a plaintiff suspects or should suspect that wrongdoing caused her injury, without needing to know all specific facts of the claim. To apply the discovery rule, a plaintiff must demonstrate the time and manner of discovery and the inability to have discovered earlier despite reasonable diligence.
Hopkins adequately pled the necessary facts to invoke the discovery rule, asserting that prior to December 1, 1987, she had no reason to suspect that her silicone breast implants were linked to her medical condition. The district court granted Hopkins' summary judgment motion and denied Dow's, leading to Dow's appeal. If Hopkins' motion was properly granted, then Dow's denial follows logically, prompting a review of the order favoring Hopkins.
A party seeking summary judgment must demonstrate to the district court the basis for the motion and identify evidence from pleadings, depositions, interrogatories, admissions, or affidavits that show no genuine issue of material fact exists. A genuine dispute exists if a reasonable jury could rule for the nonmoving party. In this case, Hopkins acknowledges her burden to prove that her discovery of wrongdoing occurred within one year before filing her action. To succeed in her summary judgment motion, she must show that Dow did not provide sufficient evidence to contest the timing of her discovery.
Hopkins testified that she learned about a potential link between breast implants and autoimmune disease from her mother in December 1987 and consulted doctors about this connection, with no evidence suggesting they informed her of such a link. She had not previously encountered any media reports on the matter. Her complaint was filed on December 1, 1988, within one year of her alleged discovery.
Regarding delayed discovery, Hopkins indicated that upon discovering her implants had ruptured in February 1986, she had no cause for concern about potential injury or wrongdoing, believing Dow's Complaint Analysis Report indicated the implants were not defective. The report noted no abnormalities or evidence of manufacturing defects and did not reference any medical research linking silicone to her condition. Dow acknowledged that the report did not claim the implants were defectively designed or that ruptures could occur without cause.
The facts presented by Hopkins support her time of discovery and justify her delayed discovery claims. The court must determine if Dow provided adequate specific facts to establish a genuine issue of material fact regarding the discovery rule based on the evidence available at the time of the summary judgment motion.
Dow argues that the statute of limitations began in 1986 when Dr. Bollinger discovered the ruptured implants during surgery, claiming that Hopkins was responsible for investigating potential wrongdoing at that time. Hopkins seeks recovery for MCTD, alleging it was caused by the defective implants. Dow contends that Hopkins's request for laboratory analysis of the implants indicated her suspicion of wrongdoing, thus obligating her to investigate further. However, the conclusion reached is that Dow did not demonstrate specific facts showing that Hopkins suspected injury or wrongdoing when she first learned about the ruptured implants. Unlike plaintiffs in referenced cases who expressed clear suspicions of malpractice or injury, Hopkins’s inquiries were merely informational and did not indicate any suspicion of wrongdoing. The document notes that without substantial factual evidence, there is no triable issue regarding whether Hopkins knew or should have known of any injury or wrongdoing in February 1986. Moreover, unlike other cases where the plaintiffs’ injuries were clearly linked to device failures, Hopkins's situation did not present an obvious conclusion that the implants were the cause of her injury.
Hopkins' case differs significantly from the Dalkon Shield cases, as breast implants are not designed to prevent medical conditions, and there is no widely recognized connection between breast implants and Mixed Connective Tissue Disease (MCTD). Dow's assertion that Hopkins could have discovered a possible link through investigation is rejected, as her review of Dow's Complaint Analysis Report revealed no such connection. The report did not mention any medical research linking silicone to autoimmune diseases, and as a layperson, Hopkins was unlikely to find the limited articles and cases identified by Dow. The court noted that the information Dow had regarding immunological responses to silicone implants was not disclosed in the report, which misled Hopkins into believing the product was safe. Consequently, any investigation by Hopkins was hindered by Dow's actions, leading to the conclusion that she did not suspect any wrongdoing or injury until December 1987. The statute of limitations was thus tolled until that discovery, validating the district court's decision to grant summary judgment in favor of Hopkins. Additionally, Dow's challenge to the admissibility of expert witness testimony was denied, as the court found no abuse of discretion in allowing testimony on causation, which was necessary for Hopkins to meet her burden of proof regarding the implants' link to her injuries.
The trial judge must determine if proposed expert testimony meets the criteria of scientific knowledge that assists in resolving factual issues, per Rule 104(a) and Rule 702. Dow contends the district court erred by not conducting a formal hearing, but it is determined that such a hearing is not required; the court only needs to assess the qualifications of the proposed experts. Dow challenges the qualifications of Hopkins' experts: Dr. Lappe, a toxicologist, and Drs. Kossovsky and Vasey, both medical doctors. Dow argues Dr. Lappe lacks the credentials to establish a causal link between the implants and Hopkins' disease, while asserting that Kossovsky and Vasey, despite being qualified physicians, cannot testify about Hopkins’ condition as they did not examine her. The court finds that all three experts possess sufficient knowledge, skill, and experience to meet Rule 104(a) standards, validating the district court's decisions.
Additionally, Dow disputes the methodology of the experts, claiming it does not adhere to generally accepted scientific principles, referencing Daubert v. Merrell Dow Pharmaceuticals, which established that the Frye "general acceptance" test is no longer applicable under the Federal Rules of Evidence. The Supreme Court emphasized that expert testimony must be relevant and reliable, grounded in scientific methods rather than subjective belief or speculation. The inquiry should focus on the principles and methodology rather than the conclusions drawn. Consequently, expert testimony need not stem from widely accepted methodologies but must be scientifically grounded to assist the trier of fact. The record indicates that Hopkins' experts relied on scientific data and techniques typical in toxic causation assessments, with Dr. Lappe providing his opinion based on his toxicology expertise, analysis of medical records, and relevant studies on silicone's immunological effects.
Dr. Kossovsky, an expert for Hopkins, testified that his methodology dates back to 1976 and is based on his scientific studies, a preliminary epidemiological study of over 200 women, and his examination of Hopkins, which revealed silicone in her tissue and symptoms linked to silicone exposure. He also referenced corroborating animal studies. Dr. Vasey, a rheumatologist, based his opinion on medical records, clinical experience, preliminary epidemiological study results, and medical literature. The court found the reasoning and methodology of Hopkins' experts scientifically valid under Daubert standards, affirming that the district court did not abuse its discretion in admitting their testimony.
Regarding strict liability, Dow challenged the district court's refusal to grant a motion in limine that invoked comment k of the Restatement of Torts, which exempts manufacturers of prescription drugs from strict liability. Hopkins contended that comment k does not apply to this case, and the court agreed, stating that the exemption is not available to Dow. Comment k outlines that certain products, particularly drugs, cannot be made entirely safe and, if properly prepared with appropriate warnings, are not deemed defective or unreasonably dangerous. The California Supreme Court in Brown v. Superior Court established that the comment k exemption applies broadly to all prescription drugs, regardless of whether they are classified as "unavoidably dangerous." This ruling emphasizes public policy considerations for the development of pharmaceutical products aimed at alleviating suffering, asserting that manufacturers are not strictly liable for injuries from prescription drugs if they are properly prepared and adequately warned.
Dow argues that the California law exception for prescription drugs should apply to the implants in Hopkins' body, citing Hufft v. Horowitz, which extends this exception to implanted devices. However, the court concludes that the exception does not apply to this case, as the jury found the mammary implant was defectively designed, defectively manufactured, and that Dow failed to provide adequate warnings of known risks. These findings indicate that the criteria for the strict liability exemption were not satisfied, regardless of whether the exemption could be extended to implanted devices.
The jury awarded Hopkins $840,000 in compensatory damages and $6.5 million in punitive damages, which Dow contests as excessive. The compensatory damages were supported by expert testimony, showing $404,083 in lost earnings, $37,318 in past medical bills, and $31,600 in future medical expenses, totaling $473,001. Additionally, $366,999 was awarded for mental suffering. Dow provided no substantial evidence to demonstrate that these damages were excessive.
For punitive damages, the district court assesses whether the award aligns with state law and federal standards, with appellate review under an abuse-of-discretion standard. The trial court has the discretion to award punitive damages, and the jury's decision will not be overturned unless unsupported by evidence.
The Supreme Court outlines several key considerations for determining whether a punitive damages award is excessive or inadequate:
1. The relationship between the punitive damages and the harm caused or likely to occur from the defendant's conduct.
2. The degree of reprehensibility of the defendant's actions, including factors such as the duration of the conduct, awareness, concealment, and the frequency of similar past behavior.
3. The profitability of the wrongful conduct and the importance of eliminating that profit while imposing a loss on the defendant.
4. The defendant’s financial position.
5. The costs of litigation.
6. Any criminal sanctions imposed on the defendant, which may mitigate the punitive damages.
7. Other civil awards against the defendant for the same conduct, also considered for mitigation.
In the case of *Pacific Mut. Life Ins. Co. v. Haslip*, the Court emphasized that these standards provide a meaningful constraint on punitive damages discretion. In *TXO Production Corp. v. Alliance Resources Corp.*, the Court upheld a punitive damages award of $10 million, highlighting that such awards result from various qualitative factors unique to each case. The Court confirmed that while proportionality to actual damages is relevant, it is just one of many factors in the constitutional assessment of punitive damages.
Additionally, the trial evidence indicated that numerous Dow silicone gel breast implants had been implanted in women, exposing them to risks similar to those faced by the plaintiff, Hopkins.
Dow's actions in exposing numerous women to a painful disease and profiting from this conduct support the imposition of punitive damages. The company was aware of potential defects in its implants, recognized the necessity for long-term safety studies, and concealed critical information, including negative results from limited tests. Despite this knowledge, Dow continued marketing its implants as safe for several years. Given Dow's financial status and the profits derived from the implants, a $6.5 million punitive damages award is deemed reasonable based on precedent cases TXO and Haslip. The court upheld the jury's findings regarding punitive damages, affirming the district court's summary judgment on the statute of limitations, the admissibility of expert testimony related to the plaintiff's injuries, and the corresponding damages award. The summary judgment affects the trial's future course, distinguishing it from a denial, which allows for further evidence production. Dow's claims regarding the timeliness of Hopkins' allegations, aside from those involving fraud and negligent misrepresentation, were rejected. Lastly, the admissibility of expert testimony was governed by Federal Rules of Evidence, affirming the court's discretion in determining expert qualifications and evidence relevance.
