United States District Court, E.D. California
ORDER GRANTING IN PART AND DENYING IN PART DEFENDANT'S MOTION TO DISMISS.
LAWRENCE J. O'NEILL, District Judge.
Before the Court in the above-styled and numbered cause of action is Defendant Bayer Healthcare Pharmaceuticals, Inc.'s ("Defendant" or "Bayer") Motion to Dismiss, filed November 25, 2014 (Doc. 9). Plaintiff Kareama Patterson's ("Plaintiff" or "Patterson") filed her Opposition on January 12, 2015 (Doc. 12), and Bayer filed a reply on January 16, 2015 (Docs. 13 & 15). The matters are appropriate for resolution without oral argument. See Local Rule 230(g). Having considered the record in this case, the parties' briefing, and the relevant law, the Court will grant in part and deny in part Bayer's motion.
This suit is a product liability case stemming from Patterson's use of the intrauterine contraceptive device ("IUD") known as "Mirena." See Complaint ("Compl.") ¶ 13, Doc. 1. Mirena is made by Defendant, a Delaware corporation, which is in the business of designing, testing, manufacturing, marketing, and distributing prescription drugs and women's healthcare products, including Mirena. Id. ¶¶ 2, 6, 8. Inserted into the uterus by a healthcare provider during an office visit, the Mirena IUD is a T-shaped polyethylene frame with a steroid reservoir of 52mg of the synthetic progestogen levonorgestrel, a prescription medication used as a contraceptive released directly into the uterus at the rate of 20 µg/day. Id. ¶ 13, 17. The federal Food and Drug Administration ("FDA") approved Defendant's New Drug Application for Mirena in December 2000. Id. ¶ 14, 15.
Patterson, a 34 year old woman and California resident, had a Mirena IUD inserted by her healthcare practitioner according to the manufacturer's instructions and without complication. Id. ¶¶ 1, 74, 75. Bayer provides a "Patient Information Booklet" ("Booklet") to physicians to be given to patients at the time of Mirena insertion. Id. ¶ 28. When her healthcare provided placed her Mirena IUD, Patterson received Bayer's Booklet, which she read and relied upon when deciding to use Mirena. Id. ¶¶ 76, 78. The Booklet does not mention pseudotumor cerebri ("PTC"), also known as idiopathic intracranial hypertension ("IIH, " or together, "PTC/IIH"). Id. ¶ 29, 80. In deciding whether to use and prescribe Mirena, Patterson and her healthcare practitioners relied on Bayer's representations about Mirena in its package insert, the Patient Information Booklet, or information otherwise disseminated by Bayer. Id. ¶ 77.
Subsequent to her Mirena placement, Patterson began experiencing severe headaches and vision problems, including blurred vision. Id. ¶ 79. She was ultimately diagnosed with PTC/IIH. Id. ¶ 80. Patterson also suffered other injuries related to her Mirena IUD and PTC/IIH. Id. ¶ 81. Eventually, she had her Mirena IUD removed by a healthcare practitioner. Id. ¶ 82.
Neither Mirena's label nor Bayer's Patient Information Booklet mention PTC/IIH, despite the known link between levonorgestrel and PTC/IIH. Id. ¶¶ 27-29. Patterson includes in her Complaint a reference to the "Mirena Label, " as of August 7, 2013. Id. ¶ 20. The Mirena package labeling: (1) recommends that Mirena be used in women who have had at least one child, id. ¶ 20; (2) recommends that Mirena be placed at least six weeks post-partum, id. ¶ 21; indicates that Mirena should be used with caution in patients who have "[m]igraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia, " id. ¶ 22; indicates that removal of Mirena should be considered if patients develop for the first time "[m]igraine, focal migraines with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia, " id. ¶ 23. Upon information and belief, Patterson alleges that the Mirena label indications are specifically designed to caution healthcare providers about a possible increased risk of transient cerebral ischemia or stroke with Mirena use. id. ¶ 25. Patterson alleges that Mirena's label does not accurately or sufficiently warn patients and understates the risks of certain medical conditions or injuries associated with use of Mirena, including non-stroke neurological conditions such as PTC/IIH. Id. ¶¶ 1, 26-29, 68.
PTC/IIH is a condition that develops in the skull when a person's cerebrospinal fluid becomes elevated, causing increased pressure. Id. ¶ 31. Fluid builds up in the skull and is not released and absorbed at the proper rate. Id. Pseudotumor cerebri, or PTC, derives its name from the fact that the condition acts like a tumor, but is not actually a tumor. Id. Patients with PTC/IIH typically develop symptoms of severe migraines or migraine-like headaches with blurred vision, diplopia (double vision), temporary blindness, blind spots, or other visual deficiencies. Id. ¶ 32. Visual problems and symptoms are a result of increased pressure on the optic nerve. Id. Patients with PTC/IIH often develop papilledema, or optic disc swelling due to increased intracranial pressure. Id. PTC/IIH patients may also develop a "whooshing" or ringing in the ear, clinically called tinnitus. Id. ¶ 33. PTC/IIH is frequently diagnosed after a lumbar puncture or spinal tap is performed, which allows a physician to evaluate the level of cerebrospinal fluid in the skull. Id. ¶ 34. When patients present with symptoms of PTC/IIH, they often first undergo an MRI, CT scan, and/or other diagnostic radiology tests to rule out an actual tumor or blood clot in the brain. Id. Normal intracranial pressure is considered between 5 and 15 millimeters of mercury (mmHg). Id. ¶ 37. Pressure above the 15mmHg range may lead to a diagnosis of PTC/IIC. Id. Failure to correctly diagnose and treat PTC/IIH may lead to permanent vision loss and even blindness. Id. ¶ 38. There is currently no treatment to reverse permanent injury to the optic nerves caused by increased intracranial pressure. Id. ¶ 39. PTC/IIH treatment focuses on halting visual loss that has already occurred. Id. Though it may take years before normal pressure is maintained, PTC is considered reversible in some patients, and irreversible in others. Id. ¶ 40. PTC/IIH may also recur throughout a patient's lifetime. Id. ¶ 41. Treatment for PTC/IIH may include weight loss, frequent lumbar punctures (which may provide some immediate relief, but does not cure the condition), or medication. Id. ¶ 36, 42. PTC/IIH patients are frequently prescribed the medicine Acetazolamine (Diamox), which has its own set of adverse reactions. Id. ¶ 42. In severe cases, therapeutic shunting, which involves surgical insertion of a tube to help drain cerebrospinal fluid from the lower back or from the skull, is recommended. Id. ¶ 44.
Estimates are that approximately 1-2 people per 100, 000 in the United States have PTC or IIH, although reports suggest that the prevalence of the disorder is increasing. Id. ¶ 50. In 1994, a study found that in females between the ages of 15-44, IIH occurred at a rate of approximately 3.3 per 100, 000 per year. Id. Patterson alleges upon information and belief that women who use levonorgestrel-containing products, like Mirena, more commonly develop PTC/IIH, and that the synthetic hormone released by Mirena - levonorgestrel - causes or contributes to the development of PTC/IIH, increases the risk of developing PTC/IIH, and/or worsens or exacerbates PTC/IIH. Id. ¶¶ 51, 52. Also, because Mirena is known to cause rapid weight gain in women, the risk of developing PTC/IIH is even greater with Mirena use. Id. ¶ 53.
Patterson alleges that issues with other levonorgestrel-related products illustrate that Bayer knew or should have known of the link between such products and PTC/IIH. Id. ¶¶ 54-66. Norplant, another levonorgestrel-releasing implant, became available in the United States in 1991, after its manufacturer obtained FDA approval in December 1990. Id. ¶ 54. Norplant was developed by the Population Council and distributed in the United States by Wyeth-Ayerst Laboratories ("Wyeth"), as the "Norplant System" (or "Norplant"). Id. Norplant consisted of a set of six small silicone capsules, each containing 36 mg of levonorgestrel, which together were implanted subdermally in the upper arm as contraception, and effective for five years. Id. ¶ 55. Norplant released levonorgestrel at an estimated 86 µg/day initially, falling after nine months to 50 µg/day, and by 18 months post-implantation to about 35 µg/day, ultimately dropping to about 30 µg/day. Id.
In February 1993, Wyeth submitted a supplemental new drug application to the FDA for the Norplant System, requesting the addition of "idiopathic intracranial hypertension" (also known as PTC/IIH) and other modifications to the "PRECAUTIONS" section of the Norplant physician labeling. Id. ¶ 56. The supplemental NDA also requested other modifications to the physician labeling and the patient package insert. Id. Wyeth requested expedited review of its supplemental NDA. Id. In March 1993, the FDA approved the supplemental NDA, including the proposed addition of warning regarding PTC/IIH to the Norplant System. Id. ¶ 57. The new labeling addition included under the "PRECAUTIONS" section stated:
Idiopathic intracranial hypertension (pseudotumor cerebri, benign intracranial hypertension) is a disorder of unknown etiology which is seen most commonly in obese females of reproductive age. There have been reports of idiopathic intracranial hypertension in NORPLANT SYSTEM users. A cardinal sign of idiopathic intracranial hypertension is papilledema; early symptoms may include headache (associated with a change in frequency, pattern, severity, or persistence; of particular importance are those headaches that are unremitting in nature) and visual disturbances. Patients with these symptoms should be screened for papilledema and, if present, the patient should be referred to a neurologist for further diagnosis and care. NORPLANT SYSTEM should be removed from patients experiencing this disorder.
Id. ¶ 58. A warning for PTC/IIH was also added to the patient package insert and stated:
Idiopathic intracranial hypertension (pseudotumor cerebri, benign intracranial hypertension) - An increase in intracranial pressure has been reported in NORPLANT SYSTEM users. Symptoms may include headache (associated with a change in the frequency, pattern, severity, or persistence, of particular importance are those headaches that do not stop) and visual disturbances. Contact your physician or health-care provider if you experience these symptoms. While a causal relationship is unclear, your health-care provider may recommend that the NORPLANT SYSTEM be removed.
Id. ¶ 59.
By 1995, the New England Journal of Medicine reported findings of women with PTC or IIH where levonorgestrel may have contributed to the onset of the condition. Id. ¶ 60. The authors concluded that until more information became available, patients should be screened for symptoms and the implants should be removed in patients who show increased intracranial pressure. Id. Additional studies concluded the same and noted that PTC/IIH had been reported in Norplant users. Id. ¶ 61.
By 2001, Norplant's label included an entry under the "Warnings" section for "Idiopathic Intracranial Hypertension" that stated:
Idiopathic intracranial hypertension (pseudotumor cerebri, benign intracranial hypertension) is a disorder of unknown etiology which is seen most commonly in obese females of reproductive age. There have been reports of idiopathic intracranial hypertension in NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM users. A cardinal sign of idiopathic intracranial hypertension is papilledema; early symptoms may include headache (associated with a change in frequency, pattern, severity, or persistence; of particular importance are those headaches that are unremitting in nature) and visual disturbances. Patients with these symptoms, particularly obese patients or those with recent weight gain, should be screened for papilledema and, if present, the patient should be referred to a neurologist for further diagnosis and care. NORPLANT (levonorgestrel implants (unavailable in us)) SYSTEM should be removed from patients experiencing this disorder.
Id. The "Warning" section of the package label for Jadelle or "Norplant II" (a two-rod version of a levonorgestrel-releasing implant), also contained similar language. Id. ¶ 62. The labels for both Jadelle and Norplant II included warning of PTC/IIH specifically informing patients of the disorder. Id. ¶ 64. Jadelle was approved in the United States in 1996 for up to five years' use, although it has never been marketed in the United States. Id. ¶ 63. Jadelle is contraindicated in patients with a history of IIH. Id.
By the mid-1990s, tens of thousands of lawsuits were filed claiming injuries due to Norplant. Id. ¶ 65. In 1996, the FDA received a "Citizen's Petition before the Food and Drug Administration requesting withdrawal for sale of Norplant." Id. The petition claimed a number of adverse events were related to Norplant use, including PTC/IIH. Id. In June 2002, Wyeth pulled Norplant off the market. Id.
Despite the existence of "a wide body of information available to Defendant regarding the connection between levonorgestrel and PTC/IIH, Mirena's label lacks any warning regarding PTC or IIH." Id. ¶ 66. Upon information and belief, Patterson alleges that because Mirena's label is devoid of any warnings about PTC or IIH, once a patient's healthcare provider rules out transient cerebral ischemia or stroke as a cause of symptoms of migraine and/or asymmetrical visual loss, the healthcare provider will not typically know or advise a patient with PTC to remove Mirena, which causes or contributes to the development and/or progression of PTC/IIH. Id. ¶ 67. Bayer has a history of overstating the efficacy of Mirena, while understating the potential safety concerns. Id. ¶ 68. Bayer knew or should have known that Mirena, and specifically, the synthetic progestin levonorgestrel, causes and/or contributes to the development of PTC/IIH, a severe and possibly irreversible brain condition. Id. ¶ 101. Despite over a ...