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Hypertension and dyslipidemia are often insufficiently controlled in persons with type 2 diabetes (T2D) in Germany. In the current study we evaluated individual characteristics that are assumed to influence the adequate treatment and control of hypertension and dyslipidemia and aimed to identify the patient group with the most urgent need for improved health care.
The analysis was based on the DIAB-CORE project in which cross-sectional data from five regional population-based studies and one nationwide German study, conducted between 1997 and 2006, were pooled. We compared the frequencies of socio-economic and lifestyle factors along with comorbidities in hypertensive participants with or without the blood pressure target of<140/90mmHg. Similar studies were also performed in participants with dyslipidemia with and without the target of total cholesterol/HDL cholesterol ratio<5. Furthermore, we compared participants who received antihypertensive/lipid lowering treatment with those who were untreated. Univariable and multivariable logistic regression models were used to assess the odds of potentially influential factors.
We included 1287 participants with T2D of whom n=1048 had hypertension and n=636 had dyslipidemia. Uncontrolled blood pressure was associated with male sex, low body mass index (BMI), no history of myocardial infarction (MI) and study site. Uncontrolled blood lipid levels were associated with male sex, no history of MI and study site. The odds of receiving no pharmacotherapy for hypertension were significantly greater in men, younger participants, those with BMI<30kg/m2 and those without previous MI or stroke. Participants with dyslipidemia received lipid lowering medication less frequently if they were male and had not previously had an MI. The more recent studies HNR and CARLA had the greatest numbers of well controlled and treated participants.
In the DIAB-CORE study, the patient group with the greatest odds of uncontrolled co-morbidities and no pharmacotherapy was more likely comprised of younger men with low BMI and no history of cardiovascular disease.
Hypertension and dyslipidemia constitute major public health problems as they increase the risk of cardiovascular diseases (CVDs), especially in patients with concomitant type 2 diabetes (T2D) [1-4].
Nevertheless, several epidemiological studies indicate disappointing deficiencies in the detection and adequate treatment of hypertension and dyslipidemia in Germany with minimal improvement over the last decades [5-13]. About ten years ago, the South German site of the Monitoring Trends and Determinants in Cardiovascular Disease (MONICA) Study, the forerunner to the Cooperative Health Research in the Region of Augsburg (KORA) Study, revealed that the proportion of hypertensive participants with controlled hypertension<140/90mmHg was only 7% in men and 13% in women [6]. An earlier analysis of regional differences using data of the two population-based German studies KORA and SHIP (Study of Health in Pomerania) with participants aged 25-74years found that of all hypertensive participants, 8.4% in SHIP and 10.2% in KORA, were treated and well controlled. Recently, data of the German DIAB-CORE cooperation revealed that 64% of all participants with T2D and 49% of participants without T2D, aged 45-74years, had untreated or insufficiently treated hypertension [8]. Despite the increased awareness of physicians and the public regarding the beneficial effects of blood pressure control on cardiovascular outcomes such as myocardial infarction and stroke ( [5]), the data suggest that further barriers must exist that hinder optimal health care delivery.
To our knowledge, no population-based study in Germany has so far dealt with characteristics of patients with T2D and hypertension and/or dyslipidemia who are not sufficiently treated for these serious conditions. In our study, we describe demographic, socio-economic and lifestyle factors in DIAB-CORE participants with diabetes and concomitant hypertension or dyslipidemia and analyse the factors associated with insufficient disease control and absent pharmacotherapy. We therefore aim to identify the group of patients with the most urgent need for intensified care.
The DIAB-CORE Consortium consists of the following population-based studies (from north to south): the Study of Health in Pomerania (SHIP, Greifswald), the Dortmund Health Study (DHS, Dortmund), the Cardiovascular Disease, Living and Ageing (CARLA, Halle (Saale)) Study, the Heinz Nixdorf-Recall (HNR, Risk Factors, Evaluation of Coronary Calcification, and Lifestyle, Bochum, Essen, Mülheim a. d. Ruhr) Study, the Cooperative Health Research in the Region of Augsburg (KORA, Augsburg) Study, and the nationwide German National Health Interview and Examination Survey 1998 (GNHIES98), see Table 1.
All studies were conducted between 1997 and 2006 and used similar instruments, questionnaires and medical measurements to assess data. Detailed descriptions of study designs, samples and procedures are available elsewhere [14-20]. Ethical approval was obtained for each study. Primary study data of interest were pooled and frequencies compared.
Participants were classified in five age groups using five year intervals.
T2D was defined based on self-report or self-reported intake of oral anti-diabetic agents, insulin or a combination of both. Some studies lacked information on diabetes type. Thus, in order to exclude participants who probably had Type 1 diabetes, self-reported age at diagnosis of diabetes was used, and only those patients with an age at diagnosis of>30years were included in the T2D group.
Hypertension was defined using the mean of the second and third blood pressure measurements (the first and second measurements in DHS) conducted at the study centres with systolic blood pressure ≥140 and/or diastolic blood pressure ≥90mmHg, or intake of anti-hypertensive medication in participants with physician's diagnosis of hypertension ("awareness"). Participants with hypertension were categorized into one of the following four subgroups: (1) aware (with physician' diagnosis) and controlled treated to target levels of<140/90mmHg, (2) aware and treated, but not reaching target blood pressure values of<140/90mmHg, i.e. uncontrolled treated, (3) aware, but not treated, (4) unaware of hypertension. Thus, "awareness" of hypertension applied to participants in categories 1, 2 and 3, "treatment" applied to those in categories 1 and 2 and "control" to those in category 1.
Total cholesterol, high-density lipoprotein (HDL) cholesterol and low-density lipoprotein (LDL) cholesterol levels were measured from random blood samples. Dyslipidemia was defined analogously to hypertension using information on lipid-lowering medication intake, self-reported information on physician's diagnosis and a total cholesterol to HDL cholesterol ratio (TC/HDL) of>= 5 [21,22].
Self-reported data on myocardial infarction and stroke ("Did you ever have a myocardial infarction/stroke, diagnosed by a physician?") was assessed identically in all studies.
All study participants were asked to bring original packaging of their medications used during the last seven days to the examination. The variable "anti-hypertensive medication" included any prescription of medication belonging to the ATC subgroups C02 (antihypertensives), C03 (diuretics), C04 (peripheral vasodilators), C07 (beta blocking agents), C08 (calcium channel blockers) and C09 (agents reacting on the renin-angiotensin system).
Medications of the ATC subgroup C10 (lipid modifying agents) were included in the variable "lipid-lowering medication".
The BMI (kg/m2) was calculated using standardized weight and height measurements.
Two categories (current vs. ex- and never smoker) were defined to differentiate risk types. A current smoker reported smoking at least one cigarette per day. Persons who had reported that they had smoked at least one cigarette per day in the past but who quit smoking at least one year ago were defined as ex-smokers. Never-smokers were defined as those persons who had never smoked or smoked only occasionally (< 1 cigarette day).
In all studies, physical activity was assessed by self-report only. A threshold of less than 1h of physical activity per week was determined for a high risk lifestyle. Assessment of activity was restricted to all kinds of exercise training but did not comprise low level exercise such as stepping stairs or walking, as this type of exercise was not assessed in all studies.
In all studies, the participants were asked for their highest level of school qualification obtained. We classified educational level as a dichotomous variable contrasting low with medium or high level. According to the German school system, low educational level includes participants with up to 9years of schooling. Medium educational level is equivalent to 10years of schooling and high educational level to 12 or 13years of schooling, which is required to enter a university.
Information on monthly net household income as well as on household size was obtained from interviews. As the ages of household members were not available consistently across all studies, it was not possible to calculate the equivalent income according to the OECD equivalence scale. That is why the equivalent income was calculated according to the Luxembourg Income Study (income/household size) [23]. Pooling of income data was conducted by a regional approach, calculating the median income for each of the study centers separately. This approach allowed us to take into account overall income differences between the regions. For each study, we differentiated three income groups (<60% of the study-specific median income, ≥60% up to 150%, >150%) and pooled these groups across the six studies.
The pooled data set included 1,287 participants with T2D aged 45 to 74years. In the nationwide survey GNHIES98, 3% non-German citizens were included, KORA, SHIP and CARLA focused on participants of German nationality, and the other studies collected information on birthplace only. Two-stage cluster sampling or stratified random sampling were used. Overall response ranged between 56 and 69%.
The hypertension sub-analysis included 1,048 hypertensive participants. N=17 participants were excluded due to missing information on: study blood pressure measurement (n=3), physician's diagnosis of hypertension (n=3), and/or medication intake (n=14).
The dyslipidemia sub-analysis included 636 participants with dyslipidemia according to the definition specified above. N=126 participants had to be excluded due to missing information on laboratory measurements (n=32), physician's diagnosis of dyslipidemia (n=90, all participants of DHS and 3 of HNR), and/or medication intake (n=14). N=16 participants were not included in either one of the two sub-analyses.
T2D participants with hypertension, with or without the blood pressure target of<140/90mmHg, and T2D participants with dyslipidemia with or without the target of total cholesterol/HDL cholesterol<5, as well as T2D participants with or without treatment were compared with respect to their lifestyle factors, cardiovascular burden, clinical measurements and medications. Continuous variables were characterized by means and standard deviations (SD), categorical variables were described as percentages. Differences between groups were calculated using t-tests and Wilcoxon tests (continuous variables) or chi-square tests and univariable logistic regression models (categorical variables). At first, univariable logistic regression models were programmed to identify factors associated with blood pressure, lipid ratio or medication intake. In a second step, variables found to be significantly associated with the respective outcome were included in multivariable models to examine adjusted effects.
The goodness-of-fit of adjusted models was assessed by the c-value, and the Hosmer-Lemeshow test. The c-value describes the area under the ROC-curve, ranging from 0.5 (random correlations) to 1.0 (perfect fit). In epidemiologic studies, values between 0.6 and 0.8 are usually regarded as satisfactory. The Hosmer-Lemeshow test compares observed and predicted values with each other. If there is no significant difference (at the significance level of 0.05) the model is characterized as being appropriate.
A two-sided alpha level of 0.05 was chosen as criterion for statistical significance. All analyses were carried out using SAS, version 9.2 (SAS Institute Inc., Cary, NC, USA).
Of 1,287 T2D participants aged 45-74years, n=1,048 (82.5%) had hypertension and n=636 (54.8%) had dyslipidemia. N=530 (41.2%) had both conditions and were included in both sub-analyses.
The frequency of hypertension in persons with T2D differed slightly between studies, ranging from 78.5% in HNR to 89.6% in CARLA. Likewise, the number of participants with dyslipidemia ranged from 48.6% in CARLA to 59.6% in GNHIES98. The mean age was 63.1years (Std. 7.2years), and was very similar across all studies (Table 1). In total, 45.1% of participants were female, ranging from 40.0% in HNR to 49.8% in GNHIES98. Within the group of hypertensive participants, 46.3% were female, among participants with dyslipidemia, 43.1% were female.
Of 1,048 participants with T2D and hypertension, n=240 (22.9%) had controlled blood pressure of<140/90mmHg, and n=808 (77.1%) were uncontrolled. Dyslipidemia was treated to TC/HDL ratio<5 in 143 (22.5%) of 636 T2D participants and uncontrolled dyslipidemia was observed in 493 (77.5%) T2D participants (Figure 1).
Frequencies of associated variables, stratified by participants with and without controlled hypertension and with and without controlled dyslipidemia, respectively, are shown in Table 2. Frequencies of participant characteristics, stratified by those treated for hypertension or dyslipidemia, respectively, and those not treated for these diseases are shown in Table 3.
Systolic blood pressure (SBP) increased with age in participants with T2D, while diastolic blood pressure (DBP) decreased. Both measurements were consistently lower in women of all age groups than in their male counterparts (mean SBP in women: 149.8mmHg (SD 20.8) vs. 154.4mmHg (20.6) in men, mean DBP 83.2 (11.1) and 86.6 (11.2) in women and men, respectively) (Figure 2). Whilst men were more often free from hypertension (19.3% vs. 15.2%), women were significantly more often diagnosed and well controlled if affected: 25.0% of all women had controlled hypertension, compared to 13.9% in men, 43.5% were treated but did not achieve goal levels (compared to 38.8% in men), 5.9% were not treated even though they had a physician's diagnosis of hypertension (compared to 7.3% in men), and 10.3% had unknown hypertension (compared to 20.6% in men) (see Figure 3).
Total cholesterol and HDL-cholesterol were higher in women than in men (232.2mg/dl (SD 48.8) vs. 216.4mg/dl (48.0) and 53.9 (16.6) vs. 46.3 (14.0)) – albeit, 48.7% of women and 35.1% of men had less than 50 or less than 40mg/dl HDL respectively. However, the TC/HDL ratio was lower in women (4.7 (1.7) vs. 5.0 (1.7)).
More women than men were not affected with dyslipidemia as defined by a TC/HDL ratio<5 (47.5% vs. 43.4%), 14.9% were treated and well-controlled (vs. 10.2% in men), 7.9% were treated but did not reach goal values (compared to 6.7% in men), 16.3% were not treated despite of a physician's diagnosis (compared to 17.8% in men) and 13.4% had unknown dyslipidemia (compared to 21.9% in men) (see Figure 3).
Univariable logistic regression models yielded significant associations of uncontrolled hypertension with sex (OR for men: 2.01, 95% CI 1.50-2.69), BMI<30 (OR=1.89, 95% CI 1.40-2.55), and study. Age in five groups was not significantly associated but displayed a steady tendency towards having the greatest odds in the second oldest group (65-69years) compared to the youngest group (45-54years). With GNHIES98 as the reference study, HNR had the smallest odds of uncontrolled hypertension (OR=0.32, 95% CI 0.20-0.50), followed by CARLA (OR=0.47, 95% CI 0.28-0.79) and KORA (OR=0.52, 95% CI 0.30-0.91). Multivariable analysis with these significant variables (i.e. sex, BMI and study) showed consistent results as well as the associated factor 'no previous MI' which reached statistical significance (OR=1.70, 95% CI 1.06-2.70). A model including only sex, BMI and study had a c-value of 0.68 and a non-significant Hosmer-Lemeshow test (p=0.78).
Uncontrolled dyslipidemia was significantly associated with sex (OR for men: 1.82, 95% CI 1.25-2.65), no previous MI (OR=2.22, 95% CI 1.37-3.59) and study (OR for CARLA: 0.24, 95% CI 0.13-0.46 and HNR 0.41, 95% CI 0.23-0.74, GNHIES98 as reference). Again, age was not significantly associated, but showed some tendency, albeit in the other direction, with the youngest age group displaying the greatest odds of uncontrolled dyslipidemia (70-74years as reference). Multivariable analysis with sex, MI, and study generated consistent odds. A model including only these variables had a c-value of 0.69 and a non-significant Hosmer-Lemeshow test result (p=0.96). Smoking, physical activity, educational level and income were not significantly associated with either control of hypertension or dyslipidemia (Table 4).
Using univariable regression models, we found significant odds of non-use of anti-hypertensive medication in younger study participants (OR for 45-54years: 2.54, 95% CI 1.54-4.20, OR for 55-59years: 2.15, 95% CI 1.31-3.53, 70-74years as reference), males (OR=2.11, 95% CI 1.54-2.87), current smokers (OR: 1.80, 95% CI 1.22-2.64) and participants with BMI<30 (OR=2.06, 95% CI 1.52-2.79). Moreover, no previous MI (OR=3.75, 95% CI 1.79-7.82), no previous stroke (OR=3.12, 95% CI 1.42-6.88) and study (OR for CARLA: 0.42, 95% CI 0.24-0.71, OR for HNR: 0.60, 95% CI 0.40-0.92, GNHIES98 as reference) were significantly associated with untreated hypertension. In multivariable models adjusted for age, sex, BMI, MI, stroke, and study, the odds remained significant, except for smoking. A model including only these significant variables was characterized by a c-value of 0.71 and a non-significant Hosmer-Lemeshow test result (p=0.46).
Non-use of lipid lowering medication in participants with dyslipidemia was univariably associated with male sex (OR=1.75, 95% CI 1.27-2.43) and no MI (OR=3.16, 95% CI 1.99-5.01). Multivariable analysis adjusted for these two variables yielded additionally significant odds for no concomitant hypertension (OR=1.71, 95% CI 1.06-2.78), physical inactivity (OR=1.49, 95% CI 1.03-2.17) and the CARLA study (OR=0.56, 95% CI 0.32-0.98). A model including only sex and MI had a c-value of 0.64 and a non-significant Hosmer-Lemeshow test (p=0.62). Neither education nor income were associated with treatment of hypertension or dyslipidemia (Table 5).
Uncontrolled blood pressure in T2D participants with (diagnosed or unrecognized) hypertension was associated with male sex, BMI<30kg/m2, no previous MI, and study site. Similarly, uncontrolled blood lipid levels in T2D participants with dyslipidemia (diagnosed or unrecognized) were more frequent in men, those who had not suffered MI and attendees of the older DIAB-CORE studies.
Lack of treatment for hypertension was related to younger age, male sex, smoking, BMI<30, no history of MI or stroke, and study site. Male T2D participants without concomitant hypertension and who had not suffered MI had significantly greater odds of untreated dyslipidemia than other participants in DIAB-CORE.
Socioeconomic features such as educational level and income were not significantly associated with either disease control or pharmacotherapy; lifestyle factors were only associated in some models.
On the one hand, the results of our analyses indicate that the vast majority of patients with T2D in Germany are not adequately treated for hypertension and/or dyslipidemia, even though these conditions have been found to considerably increase the risk of co-morbidities and complications such as MI, stroke, nephropathy and retinopathy.
On the other hand, we confirmed the presumption that patients with additional risk factors, such as advanced age, previous MI, previous stroke or obesity are treated more often for hypertension and dyslipidemia and (apart from those with older age) more frequently achieve adequate blood pressure and lipid target levels. The difference between female and male participants was pronounced and consistent over all sub-analyses.
The essential strength of our study is the large population-based sample drawn from the general German population, aged 45 to 74years, and the fact that both, laboratory measurements and information on medication intake were available.
Differences in the frequencies of hypertension and dyslipidemia between studies were probably due to the relatively small numbers of affected participants within the individual studies and analyses. Due to the pooling process, only similarly collected and coded data of all six studies could be used and the least common denominator had to be found. Therefore, the definition of diabetes was based on self-report of physician's diagnosis and treatment with anti-diabetic agents rather than on clinical diagnosis and medical records. Blood pressure was calculated using the mean of the second and third measurements in all studies except for DHS, where only two measurements were performed and used to calculate the mean.
Moreover, measurements of blood pressure and lipids based on a single testing opportunity provide evidence for the respective condition, but are not equal to a clinical diagnosis with repeated measurements. We cannot exclude cases of 'white coat hypertension', i.e. elevated blood pressure caused by the excitement of the unfamiliar situation.
Due to compliance issues, women might have reported their medication intake more reliably than men, thus pharmacotherapy in men could have been underestimated and consequently, sex-specific differences overestimated in these analyses.
Patient-centered studies in Germany and other countries have so far examined awareness, treatment, control and factors associated with insufficient control of co-morbidities in patients with and without diabetes. A systematic review by McLean et al. from 2008, which included 26 studies from different countries with 66,833 diabetes patients with co-morbid hypertension, concluded that 83% (range 32-100%) of patients were treated, yet only about 29% (range 5-59%) had their blood pressure controlled to<140/90mmHg. The proportions of treatment to control were similar and thus equally insufficient between studies and countries. Unfortunately, the authors did not report person-related factors associated with disease control [24].
There are very few studies that have reported factors associated with cardiovascular disease control in patients with diabetes, as opposed to adults in general, irrespective of diabetes status. However, a number of recent studies that focused on gender differences [25-30] found that female patients with diabetes had a worse cardiovascular risk profile and were less controlled compared to their male counterparts. Our study confirmed these results in part; women in DIAB-CORE had higher total cholesterol values than men. However, since HDL-cholesterol values were also higher, the TC/HDL ratio was lower and thus more beneficial in women. In all studies [25-30], blood pressure was higher in women, especially in patients with cardiovascular disease. Although this sex difference was abrogated in some analyses after adjustment for associated variables [27,28]. There was either no sex difference in the amount of antihypertensive and lipid-lowering medication, or women took more medication, which is in agreement with our study. Furthermore, our results indicate that men are about twice as often unaware of their hypertension and dyslipidemia as women, which is well in line with known gender differences concerning health behaviour. Especially in the age group of about 30 to 60years, men use health care services less than women and tend to undervalue health care and health behaviour [31,32]. Several authors hypothesize that societally dominant 'traditional masculinity' leads men to adopt beliefs and behaviours that increase health risks and support the ideal of the 'bulletproof superhero' who would be embarrassed to check his cholesterol level [33-35].
Findings on the influence of age on hypertension control are controversial (e.g. [36,37]). An explanation for less control with simultaneously intensified treatment, as seen in our study, might be that resistant hypertension occurs more often in older persons [38]. Accordingly, this association was not detected for dyslipidemia. A cross-sectional study in Sweden examined the assumption that the excess cardiovascular risk of persons with diabetes compared to persons without diabetes decreases with increasing age. However, the authors found that the burden of CVD risk factors clustered over the entire life span with increasing glucometabolic disturbance, especially in older women. Likewise, self-rated health decreased with increasing cardio-metabolic risk and age. The authors suggest that a decreased burden of risk in older patients with diabetes might be due to a survival bias [39].
In our study obese participants (BMI≥30kg/m2) received medication more frequently and were more often well treated for hypertension, although they were more often affected with hypertension than leaner individuals (data not shown). A Swedish population-based study in hypertensive 60-year-old persons with and without diabetes by Carlsson et al. found an inverse, direct association of high waist circumference with uncontrolled hypertension [40]. The same seems to be true for patients in primary care irrespective of diabetes status [41]. Bramlage et al. found that the odds of good blood pressure control in diagnosed and treated individuals was significantly smaller in overweight and obese primary care patients than in patients with normal weight. Using data of physician diagnosed hypertensive DIAB-CORE participants without diabetes (n=5012), we found that 29.2% of those with BMI<25 had controlled hypertension (41.2% were uncontrolled and 29.6% untreated) compared to 28.6% of those with BMI≥30 (50.9% uncontrolled and 20.5% untreated). These results indicate that obese people may be more difficult to treat and obtain goal blood pressure than lean persons; however, they appear to be more aware of their disease. The same seems to be true for a comparison of hypertensive people with and without T2D. Those with T2D are more often treated and well-controlled, much more often treated but not controlled, half as often untreated and half as often unrecognized, irrespective of BMI group (data not shown) than those without T2D. All in all, obese individuals do more often present with a blood pressure≥140/90mmHg, irrespective of treatment. Thus, people with additional risk factors (such as obesity and diabetes) may be more aware of their blood pressure and more often treated but at the same time, they are more difficult to effectively treat.
We expected to find a significant negative association of high socio-economic status with uncontrolled co-morbidities, however no significant associations were observed with any socio-economic characteristics and the outcome variables. This might, in the case of school education, be due to the unequal frequencies of low (about 80%) vs. high and middle status, which owns to the high mean age of the study population (63years) and the fact that older people mostly attended junior high school only. In the previously mentioned Swedish study, lack of health care due to low income was independently associated with uncontrolled hypertension in men (OR=2.71, 95% CI 1.09-6.78) but not in women. In contrast, living in an apartment instead of a house (as an indicator of lower socio-economic status) remained a significantly protective factor in an adjusted model in women (OR=0.55, 95%CI 0.35-0.85). The authors stated that the finding was puzzling and offered no explanation [40].
Carlsson et al. confirmed that previous cardiovascular disease or coronary heart disease has a protective effect on uncontrolled hypertension, probably because of more intense treatment, better medication adherence and/or symptom relief of angina pectoris [40].
There are a number of possible influences on uncontrolled hypertension and dyslipidemia that we could not consider. For example, the Swedish study by Carlsson et al. included data on nutrition and found that daily intake of fruit had an independent, protective effect in men but not in women [40].
Steckelings, 2004 et al. [5] used data from primary care patients, irrespective of diabetes status (the HYDRA Study: Hypertension and Diabetes Screening and Awareness Study), to describe possible determinants of unsatisfactory hypertension control in Germany. Less than 30% of treated and 19% of all patients, treated or untreated, had controlled blood pressure <140/90mmHg. The frequency of diagnosis was particularly low in young people, probably due to insufficient blood pressure screening. The authors found that physicians used outdated guidelines and based treatment on diastolic pressure. The great majority of participants (94%) stated that they knew that hypertension is an important risk factor for serious diseases, and most of them (63%) occasionally measured their own blood pressure. However, the physicians participating in the study often misclassified their patients as 'well controlled' even though they had BP measurements≥140/90mmHg.
According to a review by Düsing et al. 2006 [42], more complex, hindering factors could also be insufficient education and motivation provided to the patient by physicians, patients' reluctance to change lifestyle factors or commence/modify drug treatment, lack of awareness of the risks associated with hypertension, and poor compliance. The latter is a complex and thoroughly explored concept and challenge (e.g. [43]). Apparently, many people with hypertension do not seem to recognize high blood pressure as a progressive chronic illness, but rather misinterpret it as a risk factor in a gamble with a potentially positive outcome [44,45].
Finally, the sex of the attending physician has been shown to play a role in the quality of risk factor control in patients with hypertension and dyslipidemia. In a cross-sectional study by Journath et al., diabetic men and women achieved goals for blood pressure control, and men achieved goals for cholesterol control more often if they were treated by female physicians [46]. Likewise, a German study including 51,053 diabetes patients treated by 3,096 physicians concluded that female physicians achieved a better quality of care than their male counterparts, especially in risk management important for future disease prognosis [47].
Interestingly, there appears to be an intriguing difference in hypertension prevalence and control, irrespective of diabetes status, between Europe and the United States/Canada that has not been appreciated and examined sufficiently. Wolf-Maier et al. [48,49] compared sample surveys conducted in the 1990s in Germany, Finland, Sweden, England, Spain, Italy, Canada, and the United States and found that even though mean BMI was very similar across these countries, the prevalence of hypertension, defined as blood pressure>140/90mmHg or intake of anti-hypertensive medication, differed remarkably. The European average was 44.2% compared with 27.6% in North America. Germany had the highest prevalence with 55.3% [48]. Treatment and control of hypertensive participants within the individual studies was also significantly better in the United States than in Europe with 7.8% hypertension control in the population (29.9% in treated hypertensive participants) in Germany compared to 28.6% (54.5% in treated hypertensives) in the United States [49].
In order to improve awareness, creative new approaches have been successfully implemented in the United States, e.g. by addressing the issue and counseling black men during a visit at a barbershop [50]. Such innovative ideas might also work in Germany – possibly for younger men with diabetes and no previous cardiovascular complications.
In the DIAB-CORE study, participants with diabetes who were at the greatest odds of uncontrolled co-morbidities and no pharmacotherapy were male, younger, had lower BMI and no history of cardiovascular disease. Although the general risk profile appears relatively low, preventative efforts should not overlook, but specifically consider this group of patients.
ATC: Anatomical Therapeutic Chemical Classification System; BMI: Body mass index; BP: Blood pressure; CARLA: Cardiovascular Disease Living and Ageing Study; CVD: Cardiovascular disease; DHS: Dortmund Health Study; DMP: Disease management program; GNHIES98: German National Health Interview and Examination Survey; HDL: High-density lipoprotein; KORA: Cooperative Health Research in the Region of Augsburg Study; LDL: Low-density lipoprotein; OAD: Oral anti-diabetic medication; HNR: Heinz Nixdorf-Recall Risk Factors Evaluation of Coronary Calcification and Lifestyle Study; SD: Standard deviation; SHIP: Study of Health in Pomerania; T2D: Type 2 diabetes; TC: Total cholesterol.
The authors declare that they have no competing interests.
I-MR performed the statistical analyses and wrote the manuscript. CM and WM worked on pooling of the data, contributed to the discussion and reviewed/edited the manuscript. AM contributed to the discussion and reviewed/edited the manuscript. TT and WR worked on pooling of the data and reviewed/edited the manuscript. SS, HV, AK, K-HG, KB, GM, UE, HN, SM and SA contributed data and reviewed/edited the manuscript. All authors read and approved the final manuscript.
We thank the investigative groups of all individual studies, the study staffs and all study participants.
This work was supported by 'Kompetenznetz Diabetes mellitus (Competence Network for Diabetes mellitus)' funded by the Federal Ministry of Education and Research (FKZ 01GI0814-0816/-0855-0858).
The KORA research platform (KORA, Cooperative Health Research in the Region of Augsburg) was initiated and financed by the Helmholtz Zentrum München – German Research Center for Environmental Health, which is funded by the German Federal Ministry of Education and Research and by the State of Bavaria.
The CARLA study was funded by a grant from the Deutsche Forschungsgemeinschaft as part of the Collaborative Research Center 598 'Heart failure in the elderly – cellular mechanisms and therapy' at the Medical Faculty of the Martin-Luther-University Halle-Wittenberg, by a grant from the Wilhelm-Roux Programme of the Martin-Luther-University Halle-Wittenberg, by the Ministry of Education and Cultural Affairs of Saxony-Anhalt and by the Federal Employment Office.
SHIP is part of the Community Medicine Research net ( http://www.community-medicine.de) at the University of Greifswald, Germany. Funding was provided by grants from the German Federal Ministry of Education and Research (BMBF, grant 01ZZ0403), the Ministry for Education, Research and Cultural Affairs and the Ministry for Social Affairs of the Federal State of Mecklenburg–West Pomerania.
The collection of socio-demographic and clinical data in the Dortmund Health Study (DHS) was supported by the German Migraine & Headache Society (DMKG) and by unrestricted grants in equal shares from Astra Zeneca, Berlin Chemie, Boots Healthcare, Glaxo-Smith-Kline, McNeil Pharma (formerly Woelm Pharma), MSD Sharp & Dohme and Pfizer to the University of Muenster.
The German National Health Interview and Examination Survey (GNHIES98) was funded by the German Ministry of Health.
The Heinz Nixdorf Recall Study (HNR) was supported by institutional funding (German Diabetes Centre) of the German Ministry of Health and by the Ministry of Science of North-Rhine Westphalia. It was further funded by the German Ministry of Education and Research as part of the Diabetes Competence Network. We thank the Heinz Nixdorf Foundation (Chairman: Dr jur. G. Schmidt) for the generous support of the Heinz Nixdorf Recall Study. The study is also supported by the German Ministry of Education and Science.
PubMed Central Canada is a service of the Canadian Institutes of Health Research (CIHR) working in partnership with the National Research Council's national science library in cooperation with the National Center for Biotechnology Information at the U.S. National Library of Medicine(NCBI/NLM). It includes content provided to the PubMed Central International archive by participating publishers.


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September 10, 2012
VIRGIL SMITH, INDIVIDUALLY, AND ADAM SMITH, THROUGH HIS LEGAL GUARDIAN, VIRGIL SMITH, PLAINTIFFS,v.PHOENIX SEATING SYSTEMS, LLC, D/B/A FALCON/LEBAC SYSTEMS, AND APRIA HEALTHCARE GROUP, INC., DEFENDANTS.
Pending before the Court are the defendants' motions for summary judgment pursuant to FEDERAL RULE OF CIVIL PROCEDURE 56 (Docs. 113, 114).
Defendant Phoenix Seating Systems, LLC (Phoenix), requests summary judgment as to plaintiffs' strict liability claims, Counts I and II (Doc. 114), while defendant Apria Healthcare Group, Inc. (Apria), requests summary judgment as to plaintiffs' negligence claims, Counts III and IV (Doc. 113). As plaintiffs have responded to defendants' requested relief (Doc. 122), these motions are ripe for judicial resolution. For the following reasons, the Court DENIES Phoenix's motion (Doc. 114) and GRANTS Apria's motion (Doc. 113).
The instant litigation arises from mental and physical injuries Adam Smith (Adam) and Virgil Smith (Virgil) incurred beginning on or before August 7, 2007, allegedly resulting from polyurethanes contained in Adam's custom-made wheelchair's armrests (See Doc. 54-1). Defendants' relationship to Adam's Gel Ovations Model 312G armrests (312G) forms the crux of the instant motions. Apria is a seller of medical equipment and devices, including the custom-made wheelchair at issue (See Doc. 113-2, pp. 31-32). Phoenix is a supplier of specialty wheelchairs and wheelchair components (Doc. 114-1, pp. 7-9). Phoenix advertises and distributes products it designs and manufactures, as well as products other entities design and manufacture (Doc. 122-3, p. 3). Specifically, it served as the original conceptual designer and marketer of the 312G (Doc. 113-7, p. 10).
Adam's custom-made wheelchair resulted from a consultation he had with an Apria seating specialist, Dennis Layton (Layton), in early 2007. Layton came to plaintiffs' home to perform an evaluation (Doc. 113-2, pp. 11-12). As a result of the evaluation, plaintiffs selected a variety of wheelchair components for Adam's wheelchair and discussed the 312G (Doc. 113-2, p. 35). Apria assembled the wheelchair and Layton delivered it to plaintiffs on March 30, 2007 (Doc. 114-7). At that time, the 312G armrests were not present (Doc. 113-2, pp. 49-50). On April 23, 2007, Layton met with plaintiffs and ordered the 312Gs for Adam's wheelchair, which plaintiffs received on June 21, 2007 (Doc. 113-2, p. 56; Doc. 114-9). Phoenix sold the 312Gs at issue to Apria (Doc. 54-1, p. 2; Doc. 122-3, p. 4).
Virgil testified at his deposition that the 312Gs arrived in a large box. Inside the box was a large, sealed plastic baggy containing the 312Gs. Virgil called Layton to discuss the 312Gs' installation. Virgil then opened the baggy and stated he was "engulfed" by an "overpowering" odor (Doc. 113-9, p. 41). He then placed the 312Gs in the garage to "air out" for approximately seven days, as he did not feel comfortable immediately placing them on Adam's wheelchair due to the odor. As the odor allegedly did not dissipate, Virgil placed them on the outdoor patio for approximately three to four days (Doc. 113-9, p. 43). At that point, as he felt the odor had sufficiently diminished, Virgil placed them on Adam's chair (Doc. 113-9, p. 44).
Adam had used the 312Gs for approximately seven to ten days when his nurse Lois Frailey (Frailey) noticed fluid-filled blisters forming on Adam's arms on August 7. 2007. Thus, Virgil, Melody Smith (Melody), Virgil's wife and Adam's mother, and Frailey took Adam to the emergency room where he received treatment (Doc. 113-9, p. 53).
Virgil testified that initial testing of the 312Gs indicated a heightened level of Mercury (Doc. 113-9, p. 70). Virgil also states that certain tests conducted at the direction of Dr. Rauckman, a toxicologist, indicated that the 312Gs' cover contained Cyanate (Doc. 113-9, p. 76).
Thus, plaintiffs filed the instant action in this Court on July 28, 2009, on the basis of diversity (Doc. 1). Plaintiffs' amended complaint alleges two counts of strict liability against Phoenix. Specifically, plaintiffs state that at the time the 312G left the possession and control of Phoenix it was, "in a defective and unreasonably dangerous condition" and that:
a. It contained polyurethanes which, when originally manufactured, sustained only partial polymerization of amines and isocynates, and an excess of the catalyst mercury;
b. The armrest was completely devoid of labeling;
c. The armrest contained no warnings of any kind, including a warning of the potential health risks posed by the materials used to manufacture the armrest.
(Doc. 54-1, pp. 3-4).
Plaintiffs' Counts III and IV allege claims of negligence against Apria. Plaintiffs state Apria,
a. Negligently and carelessly failed to inform plaintiff, the purchaser, that the product was improperly designed and/or manufactured in that the product contained polyurethanes which, when manufactured, sustained only partial polymerization of amines and isocynates, and an excess of the catalyst mercury;
b. Negligently and carelessly failed to inform the purchaser that the product was completely devoid of labeling;
c. Negligently and carelessly failed to inform the purchaser that the product contained no warnings of any kind, including no warning of potential health risks posed by the materials used to manufacture the armrest;
d. Negligently and carelessly failed to inform the purchaser that there were potential health risks posed by the materials used to manufacture the armrest.
(Doc. 54-1, p. 6).
Thus, as a result of these allegations, plaintiffs allege they have, "sustained prolonged exposure to a toxic chemical combination, suffering dermal lesions externally, as well as severe kidney, liver, and pulmonary damage." Additionally, plaintiffs allege, "permanent pain, mental anguish, disability and disfigurement," an accrual of large sums of medically-related expenses, permanent prevention from attending to their usual affairs and duties, and seek lost wages and income (See Doc. 54-1).
On June 2, 2010, Phoenix filed a third party complaint for contribution and indemnity against Taiwanese corporation, Velo Enterprise Co., Ltd. (Velo), as the manufacturer of the 312Gs, and Taiwanese corporation, Rattox Corporation (Rattox), as supplier (See Doc. 54). Velo answered the third party complaint on August 18, 2010, admitting, "it was a manufacturer of [the 312G]," and that, "it sold [312Gs] to [Rattox]" (Doc. 64, pp. 3, 4). Rattox admitted that it purchased 312Gs from Velo and sold them to Phoenix (Doc. 64, pp. 5, 6). Thereafter, Phoenix requested an admission from Velo that it, "manufactures [312Gs] using a proprietary gel bend." Velo objected to this request as vague (Doc. 114-5, p. 2). Velo admitted that Phoenix, "does not control the proprietary gel blend used by [Velo in its] manufacture of [312Gs]" (Doc. 114-5, p. 3).
As both defendants Phoenix and Apria seek an Order of this Court finding they are not liable for plaintiffs' injuries as a matter of law, they filed separate motions for summary judgment on February 22, 2012 (Docs. 113, 114). PhoeniX seeks summary judgment as to Counts I and II, plaintiffs' strict liability claims, as it argues it did not manufacture the 312G and had no knowledge or control over the proprietary gel used, and it had no duty to warn plaintiffs or label the 312G (Docs. 114, 115). Apria seeks summary judgment on Counts III and IV, plaintiffs' negligence claims against it.*fn1 Apria argues it is entitled to summary judgment pursuant to 735 ILCS 5/2-621, known as the "seller's exception" to products liability. Further, Apria states it had no duty to warn plaintiffs about the alleged risks of the 312G (Doc. 113). Plaintiffs naturally oppose defendants' legal assertions (Doc. 122).
Summary judgment is proper where the movant shows "there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." FED. R. CIV. P. 56(A); accord Celotex Corp. v. Catrett, 477 U.S. 317, 322-- 23 (1986). A genuine issue of triable fact exists only if, "the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Pugh v. City of Attica, Ind., 259 F.3d 619, 625 (7th Cir. 2001) (quoting Anderson Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)).
The movant bears the burden of establishing the absence of fact issues and entitlement to judgment as a matter of law. Santaella v. Metro. Life Ins. Co., 123 F.3d 456, 461 (7th Cir. 1997) (citing Celotex, 477 U.S. at 323). Once the moving party has set forth the basis for summary judgment, the burden then shifts to the nonmoving party who must go beyond mere allegations and offer specific facts showing that there is a genuine issue for trial. FED. R. CIV. P. 56(e); see Celotex, 477 U.S. at 323--24. The nonmoving party must offer more than "[c]onclusory allegations, unsupported by specific facts," to establish a genuine issue of material fact. Payne v. Pauley, 337 F.3d 767, 773 (7th Cir. 2003) (citing Lujan v. Nat'l Wildlife Fed'n, 497 U.S. 871, 888 (1990)).
A party will successfully oppose summary judgment only if it presents, "definite, competent evidence to rebut the motion." EEOC v. Sears, Roebuck & Co., 233 F.3d 432, 437 (7th Cir. 2000). The Court considers the record in the light most favorable to the nonmoving party, and draws all reasonable inferences in the non-movant's favor. Lesch v. Crown Cork & Seal Co., 282 F.3d 467, 471 (7th Cir. 2002). However, the Court accepts the nonmoving party's version of any disputed fact only if supported by relevant, admissible evidence. Bombard v. Fort Wayne Newspapers, Inc., 92 F.3d 560, 562 (7th Cir.1996).
This case is before the Court pursuant to diversity jurisdiction. Thus, the substantive law of Illinois controls the instant dispute, as the parties do not raise a conflict of law issue. See Erie R. Co. v. Tompkins, 304 U.S. 64 (1938); Fednav Int'l Ltd. v. Cont'l Ins. Co., 624 F.3d 834, 838 (7th Cir. 2010).
1. Phoenix's Motion for Summary Judgment on Counts I and II: Strict Liability
Under Illinois law, it is well-settled that recovery in a strict product liability action requires a plaintiff plead and prove that, "the injury complained of resulted from a condition of the product, that the condition was unreasonably dangerous, and that it existed at the time the product left the manufacturer's control." Mikolajczyk v. Ford Motor Co., 901 N.E.2d 329, 335 (Ill. 2008) (citing Sollami v. Eaton, 772 N.E.2d 215, 219 (Ill. 2002)). A court may find a product is unreasonably dangerous based on proof of any one of the following three conditions of the product: a physical defect, a design defect, or a failure of the manufacturer to warn of the danger or to instruct on the proper use of the product. Id. In Illinois, "in a products liability action, all persons in the distributive chain are liable for injuries resulting from a defective product, including suppliers, distributors, wholesalers[,] and retailers." Hammond v. North Am. Asbestos Corp., 454 N.E.2d 210, 216 (Ill. 1983).
The Illinois Supreme Court has adopted section 402A of the Restatement (Second) of Torts, observing that a product is "unreasonably dangerous" due to a defect in either manufacturing or design when it is, "'dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics.'" Mikolajczyk, 901 N.E.2d at 335-36 (quoting Lamkin v. Towner, 563 N.E.2d 449, 458 (Ill. 1990)); Restatement (Second) of Torts § 402A, Comment i, at 352 (1965).
In theory, a toxic reaction to a product resulting from the presence of a toxin or poison in the product might render it defective or unreasonably dangerous. See Adelman-Tremblay v. Jewel Co., Inc., 859 F.2d 517, 522 (7th Cir. 1988) (citing § 402A, Comment h) (defective condition may arise "from harmful ingredients, not characteristic of the product itself . . . [and] from foreign objects contained in the product")).
However, a consumer who suffers an allergic reaction to a product without any identifiable defect may not generally invoke strict liable to recover from a manufacturer or seller. Id. (emphasis added) (citing Annotation, Products Liability: Strict Liability in Tort Where Injury Results From Allergenic (Side-Effect) Reaction to Product, 53 A.L.R.3d 298, § 3 (1973) ("[A] product, faultlessly manufactured and containing no impurities, is not rendered defective per se, within meaning of the doctrine of strict liability in tort, by the mere fact that it causes injury to certain individuals who, because of hypersensitivity or other peculiarity of makeup, suffer an allergenic or idiosyncratic reaction when exposed thereto.")); see also Presbrey v. Gillette Co., 435 N.E.2d 513, 519-20 (Ill. App. 1982) (Concerning allergic reactions to products, "[t]he unusual susceptibility of the consumer is generally recognized as a complete defense where the manufacturer did not know or had no reason to know that a very few users of his product might be injured," as, "[t]he proximate cause of injury is attributed to the idiosyncrasy or allergy of the plaintiff and not to a failure to warn of a defect in the product.").
Phoenix argues it is not liable as a matter of law for plaintiffs' strict liability claims, as it did not manufacture the 312G and had no knowledge or control over the proprietary gel used in the 312G's manufacture, it had no duty to warn of a risk that is remotely possible to the unknown few in the population, and there is no duty to label wheelchair armrests.
a. Phoenix's Status as Manufacturer
Phoenix first argues that although it, "originally conceptualized the general design of a gel filled armrest, Phoenix did not participate in the manufacture of the 312G, nor did Phoenix have any control over or access to the polymerization process or the components used in the polymerization process" (Doc. 114-2, pp. 10, 45-46, 133-137). Further, Phoenix reiterates that it was not aware of the exact components used in Velo's proprietary gel blend (Doc. 114-2, p. 46). Accordingly, Phoenix argues it had no control over the polymerization process and no control over the components and chemicals used in that process.
Plaintiffs respond by citing the Federal Food, Drug, and Cosmetic Act's (FDCA) various definitions of manufacturer. See 21 C.F.R. §§ 806.2(g)(1),(2), 807.3(d)(2), 820.3(o). Plaintiffs state Phoenix would receive the 312Gs in large boxes from Rattox. To prepare the individual 312Gs for shipment to dealers such as Apria, Phoenix would place the individual 312Gs in plastic bags with screws for attachment, seal them, and then place them in another box for shipment (Doc. 122-1, pp. 26-31). Further, as the 312Gs were not labeled upon Phoenix's receipt, it would place a sticky label with the words 312G, the size of the arm rest, and possibly the name of Phoenix's website on the package before shipment (Doc. 122-1, p 36). Finally, plaintiffs note that Phoenix admits that it, "specif[ied] the use of a gel armpad, the size of the gel armpad and the location of drill holes on the underside of the armpad in order to allow the armpad to be fastened to wheelchairs" (Doc. 122-3, pp. 2-3). Thus, as Phoenix repackaged the 312Gs and initiated their specifications, plaintiffs argue they "manufactured" the 312G under the FDCA's definition.
Without commenting on whether Phoenix satisfies the FDCA's definition of manufacturer, the Court notes confusion as to the relevance of Phoenix's status as a manufacturer. As explained above, all parties to the distribution chain are liable for injuries resulting from a defective product. Phoenix admits that it sold the 312Gs at issue to Apria, which then sold them to the ultimate users; plaintiffs. Thus, Phoenix's status as a supplier of the 312Gs, as opposed to a manufacturer, does not warrant judgment as a matter of law in its favor as to the strict liability counts against it.
b. "Unreasonably Dangerous"
Phoenix argues it has a complete defense to plaintiffs' strict liability claims against it, as plaintiffs' injuries resulted from their idiosyncrasies or allergies and not from Phoenix's failure to warn. Phoenix relies on Presbrey as the basis of its assertion. Prespbrey, 435 N.E.2d at 522. In Presbrey, the Illinois Appellate Court reversed a grant of judgment in plaintiff's favor for his severe reaction after using defendant's anti-perspirant. The plaintiff charged negligence in failure to sufficiently test the product, to warn of inherent dangers and to list and warn of dangerous contents. Additionally, he brought breach of express warranty and products liability counts. In reversing the trial court's judgment, the court found the plaintiff's reaction "idiosyncratic," as he was unusually susceptible to injury caused by the use of the anti-perspirant. The court noted that a seller of a product is not liable to a consumer who suffers an allergic reaction, "if the product contains no defect or ingredient which would cause harm to the 'average' person." Id. at 519 (emphasis added) (citing Stanton v. Sears Roebuck & Co., 38 N.E.2d 801, 803 (Ill. App. 1942) (plaintiff bore burden of presenting evidence that dyes in dress contained any harmful or poisonous substance of any kind)). Thus, Presbrey reiterates that in the failure to warn context, "if the product does not threaten severe harm to the ordinary consumer, then it is reasonably fit for the purpose for which it is sold," as, "[t]he proximate cause of injury is attributed to the idiosyncrasy or allergy of the plaintiff and not to a failure to warn of a defect in the product." Id. at 520.
However, instantly, plaintiffs allege not only that Phoenix failed to warn of possible dangers associated with the 312Gs, but also that the 312Gs are defective. Cf. Adelman-Tremblay, 859 F.2d at 522 ("In the present case, although the plaintiff has not alleged any defect in the cyanoacrylate glue, she argues the defendants should be held strictly liable for failure to warn of the possibility of an adverse allergic reaction to the glue."); see also Friedman v. Merck & Co., 131 Cal.Rptr.2d 885, 893 (Cal. App. 2003) (compiling cases) ("There is significant authority to the effect that there is no duty to warn of the possibility of rare, idiosyncratic hypersensitive, or unusual reaction to an otherwise safe and useful product.").
Plaintiffs allege the 312G, "was physically defective and unreasonably dangerous because it contained several toxic compounds, due- at least in part- to the polyurethanes being only partially polymerized while being mixed." Plaintiffs offer a report of Dr. Elmer Rauckman, a toxicologist, in support of this assertion (Doc. 122-4). Dr. Rauckman states that Chemir Analytical Laboratories conducted two sets of tests on the 312Gs. First, an analysis of the gel which filled the armrest. Second, an analysis of the surface material covering the gel. Dr. Rauckman states that the analysis of the surface material demonstrated, "the presence of Mercury, isopherone diisocynate, triehtylene diamine, and various other free amines." He goes on to state, "Mercury's toxicity is well established affecting multiple organs, isopherone dissocynate is among the most potent of sensitizers and the free amines are corrosive to the skin at high concentrations or in the pure state." Thus, in Dr. Rauckman's opinion, "the simultaneous exposure to these three agents was the cause of the kidney damage, dermal lesions, and respiratory tract symptoms experienced by [Virgil and Adam] and indirectly resulted in the hepatotoxicity (liver) experienced by Adam." Dr. Rauckman opines, "there was a problem with the formulation of the urethane batch employed in [the] manufacture of the polyurethanes used in this product, resulting in only a partial polymerization and an excess of catalyst and unreacted monomers" (Doc. 122-4, p. 2).
Phoenix offers the opinion of Dr. Michael E. Mullins who opines that the, "compounds found in the polyurethane foam armrests does not indicate or prove an acute or sub-acute toxic exposure." He further opines, "the only health effect which can be attributed to the arm rests is the appearance of a skin rash on Adam's forearms" (Doc. 114-13, p. 2). Thus, Phoenix relies on Dr. Mullins' report, in addition to the existence of Adam's and Virgil's numerous medical conditions and ailments (Docs. 114-10, 114-13), as holding plaintiffs are "unusually susceptible" consumers to which Phoenix had no duty to warn. Further, Phoenix points to its lack of specific knowledge as to the exact chemical make-up of the 312G, as holding it had no duty to warn.
As explained above, plaintiffs do not merely allege Phoenix had a duty to warn, but also that the 312G was defectively designed and/or manufactured. It is clearly disputed between the parties whether the proximate cause of plaintiffs' alleged injuries was a defect in the manufacture and/or design of the 312G, or an unusual susceptibility of plaintiffs. In considering the record in the light most favorable to plaintiffs and drawing all reasonable inferences in their favor, the Court finds there are genuine disputes of material fact which preclude judgment as a matter of law in Phoenix's favor at this time. Lesch, 282 F.3d at 471.
c. FDCA Requirements
Finally, although Phoenix does not directly raise the issue and cites no case law in support of its position, Phoenix impliedly argues that plaintiffs' claims are preempted by the express preemption provision of the Medical Device Amendments (MDA) to the FDCA, 21 U.S.C. § 360c et seq., which preempts products liability claims in the case of medical devices approved by the Food and Drug Administration's (FDA's) pre-market approval (PMA) process. The MDA authorizes the FDA to regulate the safety and effectiveness of medical devices. The MDA's express preemption clause states,
[N]o State or political subdivision may establish or continue in effect with respect to a device intended for human use any requirement-(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
21 U.S.C. § 360k(a).
In 1996, the Supreme Court held that lawsuits brought under state law against medical device manufacturers who submit "premarket notification" to the Food and Drug Administration are not preempted by 21 U.S.C. § 360k(a) when liability is premised on theories that the device was defective and unreasonably dangerous and that the manufacturer failed to use reasonable case in the device's design, manufacture, assembly, and sale.
Hofts v. Howmedia Osteonics Corp., 597 F. Supp. 2d 830, 832 (S.D. Ind. 2009) (Hamilton, J.) (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 481, 494-95 (1996)). Additionally, in 2008, the Supreme Court held that lawsuits brought under state law against medical device manufacturers who obtain federal PMA are preempted by Section 360k(a) of the MDA when liability is premised on violations of state law requirements that are "in addition to or different from" federal requirements regulating devices. Id. (citing Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)).
Thus, it is necessary to discuss the different between "notification" to the FDA and the PMA process. Under the MDA, there are three classes for medical devices depending on the risks associated with the device. Class I devices are those for which general controls, such as labeling requirements, "are sufficient to provide reasonable assurance of [their] safety and effectiveness." 21 U.S.C. § 360c(a)(1)(A)(i). They include such things as "elastic bandages and examination gloves" and are "subject to the lowest level of oversight." Riegel, 552 U.S. at 316. Class II devices are subject to heightened oversight mechanisms, such as "performance standards [and] postmarket surveillance," 21 U.S.C. § 360c(a)(1)(B). Class III devices are the highest class, as they present a potentially unreasonable risk of injuring patients or they are used to sustain life. See 21 U.S.C. § 360c(a)(1)(C). There are two ways for a Class III device to be approved for market: the Section 510(k) process or the PMA process. The Section 510(k) review process is not "specific to the device in question [representing] . . . entirely generic concerns about device regulation generally." Riegel, 522 U.S. at 322 (citing Lohr, 518 U.S. at 501). Thus, as no specific federal requirements are imposed on Class III medical devices approved under Section 501(k), state law claims against such devices are generally not preempted under the MDA.
However, as the PMA process is the most rigorous review process, applicable to only a small percentage of Class III medical devices, the MDA's preemption applies to state law claims that are different from, or in addition to, the federal requirements, as such medical devices undergo specific federal safety review. See id. at 323.
Instantly, the parties dispute whether the 312G is a "wheelchair accessory" under 21 C.F.R. § 890.3910 and thus "exempt from the current good manufacturing practice requirements of the quality system regulation in part 820," or as plaintiffs argue, a "wheelchair component" under 21 C.F.R. § 890.3920 and thus not exempt from the current good manufacturing practice requirements. Most importantly, the Court notes that regardless of the 312Gs label, both "wheelchair accessories" and "wheelchair components" are Class I devices. As explained above, Class I devices are subject only to general controls. See 21 U.S.C. § 360c(a)(1)(A). As such, Phoenix has not presented, nor has the Court independently found, a persuasive argument for finding the MDA preempts plaintiffs' claims. See Nat'l. Bank of Commerce of El Dorado v. Kimberly-Clark Corp., 38 F.3d 988, 997 (8th Cir. 1994) ("[T]he FDA would not preempt any and all tort actions against manufacturers of, say, crutches or tongue depressors simply by placing those items in class I."). Thus, on the basis of the limited record before the Court, the Court cannot hold that the MDA preempts plaintiffs' claims.
Finally, concerning whether the 312G is an "accessory" or a "component," the Court notes that Phoenix has repeatedly referred to the 312G as an "armrest" throughout its instant motion. 21 C.F.R. § 890.3920 specifically lists "[a]rmrests" as "wheelchair components." However, as Phoenix has not offered a persuasive reason for finding either 21 C.F.R. § 890.3910 or 21 C.F.R. § 890.3920 are exempt from the general labeling requirements of the MDA, the Court does not find it necessary to determine whether the 312G is a "component" or "accessory" at this time. Thus, for the above stated reasons, Phoenix's motion for summary judgment is DENIED (Doc. 114).
2. Apria's Motion for Summary Judgment on Counts III and IV: Negligence
Apria argues it is entitled to summary judgment on both negligence counts against it, as it has met the requirements of 735 ILCS 5/2-621, the "seller's exception" to product liability. Further, Apria alleges plaintiffs have not demonstrated it had a legal duty to warn plaintiffs.
a. 735 ILCS 5/2-621
Apria first alleges the negligence claims against it require dismissal under Illinois' "seller's exception" to product liability actions. See 735 ILCS 5/2-621. Surprisingly, Apria fails to mention that this Court has already held that Section 2-621 does not apply to the negligence claims against Apria (Doc. 39). To reiterate the reasoning for the Court's previous ruling, prior to 1995, Section 2-621 applied only to actions in strict liability; plaintiffs who brought actions against a non-manufacturer defendant under a negligence theory were not subject to dismissal under Section 2-621. Link by Link v. Venture Stores, Inc., 677 N.E.2d 486, 989 (Ill. App. 1997). However, in 1995, Public Act 89-7 amended Section 2-621, to provide that it applied to "any theory or doctrine." Importantly, the Illinois Supreme Court in Best v. Taylor Machine Works, found "core provisions" of Public Act 89-7 unconstitutional and voided the entire act on the principle of inseverability. 689 N.E.2d 1057 (1997). Therefore, the version of Section 2-621 that was in effect prior to the 1995 amendment is currently applicable. Murphy v. Mancari's Chrysler Plymouth, Inc., 887 N.E.2d 569, 572 n. 2 (Ill. App. 2008).
In arguing that the negligence claims against it require dismissal under Section 2-621, Apria erroneously relies on Ungaro v. Rosalco, Inc., 948 F. Supp. 783, 784 (N.D. Ill. 1996) (Kocoras, J.), which held the "seller's exception" applied to strict liability and negligence actions. As Ungaro predated Best by a year, it applied the amended version of Section 2-621, which is no longer good law. The Court sincerely hopes Apria's reliance on such unreliable precedent demonstrates a lack of research, not its intent to deceive. Regardless, the Court reaffirms its previous ruling in finding that Section 2-621 does not apply to plaintiffs' negligence claims against Apria.
b. Negligent Failure to Warn
Although neither party addresses the general law applicable to the instant dispute, under Illinois law, a product liability action asserting a claim based on negligence falls within the framework of common law negligence. See Calles v. Scripto-Tokai Corp., 864 N.E.2d 249, 263 (Ill. 2007) (citing Flaugher v. Sears, Roebuck & Co., 378 N.E.2d 337 (1978)). Thus, a plaintiff must establish the existence of a duty of care owed by the defendant, a breach of that duty, an injury that was proximately caused by that breach, and damages. Id. (citing Ward v. K mart Corp., 554 N.E.2d 223 (1990)). The key distinction between a negligence and strict liability claim is the concept of fault, as a defendant's fault, in addition to the condition of the product, is at issue in a negligence claim. Id. (citations omitted). Therefore, it is not enough to show the product is defective or not reasonably safe; the plaintiff must also show that the defendant knew, or in the exercise of ordinary care should have known, of that unsafe condition. Brobbery v. Enter. Leasing Co. of Chicago, 935 N.E.2d 1084, 1093 (Ill. App. 2010); see Gray v. Nat'l Restorations Sys., Inc., 820 N.E.2d 943, 956 (Ill. App. 2004) ("A duty to warn exists when there is unequal knowledge and the defendant, possessed with such knowledge, knows or should know that harm might occur if no warning is given.").
Relevantly, Section 388 of the Restatement (Second) of Torts delineates a duty to warn of known defects under negligence principles for suppliers of chattels providing: § 388 Chattel Known to Be Dangerous for Intended Use
One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel with the consent of the other or to be endangered by its probable use, for physical harm caused by the use of the chattel in the manner for which and by a person for whose use it is supplied, if the supplier
(a) knows or has reason to know that the chattel is or is likely to be dangerous for the use for which it is supplied, and
(b) has no reason to believe that those for whose use the chattel is supplied will realize its dangerous condition, and
(c) fails to exercise reasonable care to inform them of its dangerous condition or of the facts which make it likely to be dangerous. Restatement (Second) of Torts § 388, at 300--01.
Instantly, Apria argues it did not have a duty to warn plaintiffs of the 312Gs' allegedly defective manufacture and/or design. First, similarly to Phoenix, Apria argues the 312gs are "wheelchair accessories" under 21 C.F.R. § 890.3910, not "wheelchair components" under 21 C.F.R. § 890.3920. Thus, Apria was not required under the MDA to label the 312Gs. Plaintiffs' two-page response, which is completely devoid of relevant case law or specifically applicable statutory provisions on the subject, merely states, "Apria had a duty to label" under the FDCA. Again, without commenting as to whether the 312G is an "accessory" or "component," the Court notes that Apria has also failed to demonstrate that either Section 890.3910 or Section 890.3920 are exempt from the general labeling requirements of the MDA.
Regardless, assuming the general labeling requirements of the MDA apply to the 312G, plaintiffs have failed to demonstrate how such requirements are capable of imposing a common law duty to warn upon Apria, let alone a breach of said duty. Plaintiffs do not provide the Court with the MDA provisions which it argues demonstrate such duty and/or breach, nor has the Court's independent review sufficiently revealed said provisions. Thus, the Court cannot hold that the MDA provides evidence of Apria's alleged common law duty to warn.
Next, most relevant to the instant dispute, Apria argues it did know, nor have reason to know, of the alleged defect. Apria alleges it did not manufacture the 312G, take any part in its design, have knowledge concerning the specific materials contained in the 312G, or have knowledge of complaints similar to plaintiffs' instant grievances. In support, it offers Layton's deposition in which he testified Apria does not manufacture any of the wheelchair components it sells (See Doc. 113-2, p. 32). He further stated Apria did not have any knowledge concerning the 312Gs, "manufacturing ingredients or processes" (Doc. 113-2, p. 42). Instantly, Apria, or more specifically, Layton, did not even place the 312Gs on the subject wheelchair; Virgil did (Doc. 113-9, p. 44). Further, when asked, "[d]id you have any concern in your mind that there might be a problem with [the 312Gs]?" Layton stated, "I did not have any concern . . . to my knowledge, there have been no other reactions similar to Adam's" (Doc. 113-2, pp. 71-72). Additionally, Tami Morris (Morris), an Apria operations manager during the relevant time period who dealt with the instant dispute, testified she had no recollection of similar complaints (Doc. 113-3, pp. 65, 107). Morris further testified that had there been similar complaints, they would have been brought to her attention (Doc. 113-3, p. 99).
As to Apria's dealings with the 312Gs upon their arrival from Phoenix, Layton was asked, "[w]hat is your understanding as to what if anything Apria would have done relative to these armpads between the time that they were received from [Phoenix] and the time they were tendered to UPS for delivery?" Layton stated, "[t]he box would have been opened to ensure that the quantities were correct and the box would have been resealed and taken to the shipping department" (Doc. 113-2, pp. 77-78).
As plaintiffs' response does not address Apria's argument concerning its lack of knowledge, plaintiffs do not dispute such allegations. Moreover, plaintiffs' complaint does not allege Apria had any role in the 312gs' design or manufacture, or knowledge of the 312Gs' alleged defective design or manufacture (See Doc. 54-1). Similarly, plaintiffs have not instantly offered evidence demonstrating Apria was involved in the 312Gs' manufacture or design, or that other complaints or reactions to the 312G have ever been reported. Thus, on the basis of the record before the Court, plaintiffs have failed to demonstrate Apria possessed superior knowledge and consequently had a duty to warn about the alleged dangers associated with the 312G. See Gray, 820 N.E.2d at 957.
Further, plaintiffs seem to argue Apria's offer to split the costs of testing with Phoenix demonstrates Apria undertook a duty to warn plaintiffs. However, to the extent plaintiffs' allege this voluntary undertaking gave rise to a duty to warn, this argument must fail. Apria agreed to split the cost of testing after the alleged injuries took place. Thus, their alleged breach in violation of this duty could not have caused the injuries in dispute. See Vancura v. Katris, 939 N.E.2d 328 (Ill. 2010) ("[p]ursuant to the voluntary undertaking theory of liability, one who gratuitously or for consideration renders services to another is subject to liability for bodily harm caused to the other by one's failure to exercise due care."). Accordingly, plaintiffs have not offered evidence sufficient to demonstrate genuine issues of material fact exist as to plaintiffs' Counts III and IV for negligence. Thus, Apria's motion for summary judgment is GRANTED (Doc. 113).*fn2
For the above-stated reasons, defendant Phoenix's motion for summary judgment is DENIED (Doc. 114). Defendant Apria's motion for summary judgment is GRANTED (Doc. 113). Accordingly, plaintiffs' Counts III and IV for negligence are dismissed with prejudice.
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Noord-Salina Housewarming Gift Baskets
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You can send Housewarming Gift Baskets to Bonaire in the following cities.
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3 bedroom house for sale 85 Sunset Road, Mangakakahi 3015
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3 bedroom house for sale 11a Grayson Avenue, Mangakakahi 3015
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