Generic Drug Manufacturers And Failure To Warn: What duty is there after Pliva v. Mensing?

The Supreme Court ruled on June 23, 2011, that generic drug manufacturers cannot be sued for a failure to warn under state tort law, as long as their labeling complies with the FDA mandated labeling for the innovator drug product. While the Court had previously declined to find that federal regulation and approval of drug labeling of an innovator drug preempted state tort law in Wyeth v. Levine, 555 US 555 (2009), the Court ruled 5-4 in Pliva that the comprehensive scheme for approval of generic drugs under the 1984 Hatch-Waxman amendments required generic manufacturers to use the same labeling as the innovator brand name product. Since the law and FDA regulations, as conceded by the Food and Drug Administration (FDA), preclude a generic company from obtaining approval of labeling different from the innovator brand name product, the Court held it was not possible for a generic manufacturer to comply with both federal and state law. As such, under the doctrine of impossibility, they ruled federal law was supreme and state tort laws on failure to warn were preempted. In so finding, they held that the issue of “impossibility” turns on whether the private party could independently do under federal law what state law requires of it. In this case, they held that generic manufacturers could only ask FDA to change labeling and could not do so without FDA approval, and thus could not act independently.

As stated by the Court:

The non obstante provision suggests that pre-emption analysis should not involve speculation about ways in which federal agency and third-party actions could potentially reconcile federal duties with conflicting state duties. When the “ordinary meaning” of federal law blocks a private party from independently accomplishing what state law requires, that party has established pre-emption.

The Court ruled at length upon the FDA’s interpretation of its authority. FDA conceded that a generic company could not obtain approval of a CBE-30 (Changes Being Effected in 30 day supplement) to add additional warning language to labeling, and that its only alternative if it chose to do so was to propose new warnings to the FDA if they believed they were necessary. At that point the Agency is to work with the brand name manufacturer “to create a new label”. The appellant manufacturers and FDA did not agree as to whether there was such a duty. The Court did not rule on that issue, since it found that pre-emption applies, even if there were such a duty.

Both the majority opinion conceded, and the dissent made a big point of, the fact that the result of the decision resulted in a situation where an individual’s right to seek relief for failure to warn turns on whether he/she took a generic or brand name of a product. As noted in the majority opinion:

We recognize that from the perspective of Mensing and Demahy, finding pre-emption here but not in Wyeth makes little sense. Had Mensing and Demahy taken Reglan, the brand-name drug prescribed by their doctors, Wyeth would control and their lawsuits would not be pre-empted. But because pharmacists, acting in full accord with state law, substituted generic metoclopramide instead, federal law pre-empts these lawsuits. See, e.g., Minn. Stat. §151.21 (2010) (describing when pharmacists may substitute generic drugs); La. Rev. Stat. Ann. §37:1241(A)(17) (West 2007) (same). We acknowledge the unfortunate hand that federal drug regulation has dealt Mensing, Demahy, and others similarly situated.
But “it is not this Court’s task to decide whether the statutory scheme established by Congress is unusual or even bizarre.” Cuomo v. Clearing House Assn., L.L.C., 557 U. S. ___, ___ (2009) (THOMAS, J., concurring in part and dissenting in part) (slip op., at 21) (internal quotation marks and brackets omitted). It is beyond dispute that the federal statutes and regulations that apply to brand name drug manufacturers are meaningfully different than those that apply to generic drug manufacturers. Indeed, it is the special, and different, regulation of generic drugs that allowed the generic drug market to expand, bringing more drugs more quickly and cheaply to the public. But different federal statutes and regulations may, as here, lead to different pre-emption results. We will not distort the Supremacy Clause in order to create similar preemption across a dissimilar statutory scheme. As always, Congress and the FDA retain the authority to change the law and regulations if they so desire.

Given this ruling, what duty do generic manufacturers have if they become aware of new information as to the safety of a drug? Generic drug manufacturers still have pharmacovigilance duties under 21 C.F.R. § 314.80, and may become aware of data that they believe requires a labeling change. While the Court did not rule there was a duty to take any action, the FDA made it clear in their briefing that there was an obligation to bring such information to their attention and request a label change. As stated by the Court:

According to the FDA, the Manufacturers could have proposed—indeed, were required to propose—stronger warning labels to the agency if they believed such warnings were needed. U. S. Brief 20; 57 Fed. Reg. 17961. If the FDA had agreed that a label change was necessary, it would have worked with the brand-name manufacturer to create a new label for both the brand-name and generic drug. Ibid.

The agency traces this duty to 21 U. S. C. §352(f)(2), which provides that a drug is “misbranded . . . [u]nless its labeling bears . . . adequate warnings against . . . unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users.” See U. S. Brief 12. By regulation, the FDA has interpreted that statute to require that “labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug.” 21 CFR §201.57(e).
According to the FDA, these requirements apply to generic drugs. As it explains, a “ ‘central premise of federal drug regulation is that the manufacturer bears responsibility for the content of its label at all times.’ ” U. S. Brief 12–13 (quoting Wyeth, 555 U. S., at 570–571). The FDA reconciles this duty to have adequate and accurate labeling with the duty of sameness in the following way:
Generic drug manufacturers that become aware of safety problems must ask the agency to work toward strengthening the label that applies to both the generic and brand name equivalent drug. U. S. Brief 20.

There are questions left open on this issue, including the lack of any clarity on whether this is indeed a statutory duty. If it is, what is the consequence if a generic manufacturer becomes aware of a safety issue with one of its product and does not act to bring the matter to FDA? In addition to the potential misbranding charges which FDA’s interpretation suggests, will the knowing failure to bring the matter to FDA result in liability under a negligence or other theory? Or is the only possible liability a potential violation of the Federal Food Drug and Cosmetic Act? (the Act) Would a plaintiff claiming a generic manufacturer did not pursue its duty to request a label change face the defense that there is no private right of action with regard to a generic manufacturer’s duty as outlined by FDA?

In addition, as discussed at same length in the dissent, what happens when the brand name product is discontinued as frequently occurs after generics enter the market? Who, if any one, may be exposed to failure to warn issue? If, as FDA frequently does, FDA lists the first generic as the Reference Listed Drug for purposes of bio-equivalence studies, does that “generic” manufacturer get put in the place of the brand name company in the analysis? While it may appear to be the last word on generic drug manufacturer labeling for failure to warn under state law, Pliva may not totally absolve generic drug manufacturers from product and other liability if they become aware of safety data and do not act to address the issue.


The Wisconsin Court of Appeals Upholds Dismissal of Medical Monitoring Claims

In Alsteen v. Wauleco, 2011 WL 2314988 (Wis. Ct. App. June 14, 2011), the Wisconsin Court of Appeals upheld the dismissal of numerous plaintiffs’ claims for medical monitoring, holding that the plaintiffs’ alleged increased risk of future harm was not an actual injury that would support an award of damages under Wisconsin law. Amber Alsteen and 69 other plaintiffs (collectively, “Alsteen”) alleged the defendants were liable for the release of a chemical preservative called “Penta” into a residential neighborhood in Wausau, Wisconsin from 1946 to 1986. While Alsteen did not suffer from any present adverse health effects due to the alleged contamination, she alleged that Penta exposure “significantly increased [her] risk of contracting cancer” and sought “future expenses related to medical monitoring.” The trial court dismissed Alsteen’s claims, finding that the alleged risk of future harm was insufficient to state a claim for actual injury, as required by Wisconsin law.

The Wisconsin Court of Appeals affirmed the dismissal of Alsteen’s claims. The court noted that Wisconsin law requires plaintiffs to prove an actual injury before they may recover in tort, and Alsteen did not allege any actual injury or damage. First, Alsteen’s allegation that she faces a significantly increased risk of cancer does not state an injury, because Wisconsin law holds that the “mere possibility of future harm” does not constitute actual injury. Second, the court held that mere exposure to a hazardous substance is not an actual injury, rejecting Alsteen’s reliance on cases involving needlesticks and the fear of HIV. The court explained that the needlestick cases involved actual injury (the needlestick) and different policy concerns than the possibility of environmental exposure to toxins, as “most people are exposed to a wide variety of environmental contaminants, including carcinogens, on a daily basis.” Finally, the court rejected Alsteen’s argument that her alleged future need for diagnostic examinations was an actionable injury. As the court explained, “Alsteen’s argument turns tort law on its head by using the remedy sought – compensation for future medical monitoring – to define the alleged injury.” Id.

By dismissing Alsteen’s claims, the Wisconsin Court of Appeals “recognize[d] that allowing a medical monitoring claim absent present injury would constitute a marked alteration in the common law.” Thus, the court preserved Wisconsin’s basic common law principle that a plaintiff must allege and prove an actual, present injury to recover in tort.

Amber Alsteen et. al. v. Wauleco, Inc. et al., 2011 WL 2314988, 2010AP1643 (Ct. App. June 14, 2011)

Stipulations Regarding Time Loss Compensation May Tie Employers’ Hands

Pursuant to state’s worker compensation statutes, injured workers can receive paid medical treatment and compensation for lost earnings, which is known as “time loss.” Employers often stipulate that a worker has suffered an injury on the job in order to streamline the process and ensure that the worker receives compensation as soon as possible. That stipulation may have a significant impact later if the worker and/or the employer decide to appeal the resulting time loss award.  In Chunyk & Conley/Quad-C v. Braw, 156 Wn. App. 246 (2010), such an employer stipulation resulted in the Court’s setting aside a jury verdict that a worker was not injured.

In Chunyk, the worker had fractured her right wrist while playing softball resulting in an arm cast, and while at work, she slipped carrying patient binders because of the pain in her wrist. Her right arm contracted at the elbow, her hand contracted into a claw, and her whole arm became sensitive. She was one armed, slow and awkward, in pain, mentally distracted and suffered memory loss. Washington Labor & Industries (“L&I”) determined that she had sustained an industrial injury when the patient binder struck her cast and the injury aggravated her pre-existing non-work related wrist fracture (i.e., the softball game injury). The employer, for whatever reason, stipulated that such on-the-job incident had caused the worker’s injuries. The worker then began working off the clock, sleeping at the job, and/or taking work home. Her supervisor reprimanded her for taking patient files to her house. Believing that the employer would eventually fire her, the worker quit.  She took a new administrative nursing job and experienced the same limitations. She was then fired. She then worked as a home companion for an elderly woman, providing home care services. Again, she was fired. At this point, she stopped working.

L&I determined that her industrial injury caused a “temporary total disability” so that she was entitled to time loss compensation for approximately four years. This time loss award included money for chronic pain and depression. Her initial employer challenged L&I’s earning capacity determination, asserting that the worker could in fact find a job (as she had done on two separate occasions after leaving the employer). At trial, several physicians testified that the worker’s chronic pain syndrome and depression were unrelated to the industrial injury and challenged L&I’s diagnosis of the extent of her claimed injuries. The worker had extensive family history problems, which were alternate explanations for her claimed depression. The jury agreed, overturned L&I’s determination, and found that the worker was not entitled to four years of time loss compensation.

The worker appealed and argued that, because the employer had previously stipulated her work injury caused these conditions, the employer should not have been allowed to contest the “time loss” award. The reviewing Court agreed and held that the judge engaged in reversible error by allowing the jury an opportunity to evaluate whether the workplace injury, in fact, caused her chronic pain and depression.

The takeaways from Chunyk are that employers should participate and contest any claim for workers’ compensation, and also not stipulate to causation. Delaying or failing to participate in the claim process and/or administrative review can lead to an accepted condition that will entitle the worker to time loss payments. Thus, a prudent employer will be on top of workers’ compensation claims and participate in the process to ensure fair and adequate handling of claims and to limit time loss payments. Another takeaway from Chunyk is that softball can be dangerous – both for the worker and the employer.

Governmental Immunity May Be the End to a Plaintiff’s Medical Malpractice Case

Those filing medical malpractice actions in Illinois may not know that public hospitals and medical professionals are afforded immunity from tort liability in many circumstances.  The Local Governmental and Governmental Employees Tort Immunity Act (hereinafter “the Act”) was enacted in Illinois as a means to protect local governmental agencies and public employees from liability for negligence committed during the exercise of their duties.  See 745 ILCS 10/1-101 et seq.  Article VI of the Illinois Tort Immunity Act specifically addresses certain immunities which apply to medical, hospital and public health activities.  However, it is important to note that there are instances where the Illinois courts have made distinctions as to when this immunity will apply.

Section 6-105 of the Act provides immunity for “injury caused by the failure to make a physical or mental examination, or to make an adequate physical or mental examination of any person for the purpose of determining whether such person has a disease or physical or mental condition that would constitute a hazard to the health or safety of himself or others.”  745 ILCS 10/6-105.  Of note, this immunity also applies to willful and wanton conduct.  In the case of Grandalski v. Lyons Township High School Dist. 204, the court held that a school district was immune for alleged negligence of a teacher and school nurse in providing medical care for a student.  711 N.E.2d 372 (1st Dist. 1999).  However, an Illinois court held that immunity did not apply to a school counselor’s failure to inform the mother of a student of that student’s suicide intentions. See Grant v. Board of Trustees of Valley View School District, 286 N.E.2d 705 (3rd Dist. 1997), appeal denied 684 N.E.2d 1335.   Interestingly, the immunity would have applied had the plaintiff alleged failure to examine or diagnose the student.

Section 6-106(a) of the Act provides immunity for injury caused by diagnosing or failing to diagnose a person afflicted with mental or physical illness or addiction.  In the matter of McQueen v. Shelby, 730 F.Supp. 1449 (C.D. Ill.1990), the court held that if a mental health organization was considered to be a public entity under the Act, the organization and its employees would be shielded from liability under the immunity afforded for failing to diagnose a jail inmate’s mental problems which led to the suicide of the inmate.  However, Section 6-106(c) provides that public employees who have undertaken to prescribe treatment for mental, physical or addiction are liable for an injury proximately caused by the employee’s negligence or wrongful acts.  745 ILCS 10/6-106(c).  Thus, the immunity from medical malpractice liability applies to public hospitals and employees if they fail to diagnose a condition present or fail to treat a patient.  However, once there is an undertaking to prescribe for a mental or physical illness, the immunity does not apply to negligent acts or omissions.

In the case of Hemminger v. Nehring, 2010 WL 1509345, No. 3-08-0751 (Ill. App. 3d Dist. Apr. 8, 2010), an Illinois medical malpractice claim involving a failure to diagnose cancer was barred by the Illinois Appellate Court under the Act.  Defendants in that matter were CGH Medical Center Auxiliary, d/b/a CGH Medical Center, a municipal entity, and a doctor and cytotechnician, employees of CGH.  The plaintiff’s complaint alleged that the defendant’s employee was negligent when she failed to correctly interpret the decedent’s Pap smear, which showed that the decedent had cervical cancer.  Plaintiff further argued that Pap smears are screening devices, and are not intended to diagnose cancer.  See Hemminger, 2010 WL 1509345 at *2.  The defendants filed motions for summary judgment and argued that they were immune from any liability or negligence under the Tort Immunity Act.  Plaintiff argued that immunity did not apply, as the complaint did not allege failure to make an adequate examination or failure to diagnose the cancer.  The trial court granted the defendants’ motions and plaintiff then appealed to the Illinois Appellate Court.  The Illinois Appellate Court upheld the trial court’s decision and ruled that the defendants were acting in the scope of their employment when reviewing plaintiff’s Pap smear and could not be held liable for any failure to diagnose the decedent’s cancer. The court found that the defendants performed a Pap smear to help diagnose the patient’s condition, clearly part of the diagnostic process and specifically the conduct that sections 6-105 and 6-106 of the Tort Immunity Act immunize.  See Hemminger, 2010 WL 1509345 at *6.

Clearly, the immunities afforded to certain hospitals and medical professionals in Illinois are a useful defense in many actions arising out of alleged medical malpractice.  In cases of medical malpractice where plaintiff’s theory of liability is often based upon a doctor’s failure to correctly diagnose the medical condition of the patient and thus failure to provide appropriate medical care to treat the patient, if the action involved a public hospital, clinic or doctor, the Illinois courts may well determine that no such cause of action exists.

Survey of Wrongful Death Verdicts for the Very Young and Very Old

Cook County verdict values for wrongful death cases involving the very young and very old show that there is still large exposure for the right case despite the decedent’s age.  Age has typically been a mitigating factor keeping down verdicts and settlements for cases involving the very young and elderly.  However, after undertaking a review of all verdict results for Cook County in the last five years, the data reveals some very large verdicts despite the age.

It is difficult to make sweeping conclusions from verdict reports alone especially in Cook County because there is such a wide variation from case to case, and of course, each case is dependent upon its own facts and the quality of the defense.  Additionally, it is important to note that the defense is still meritorious about two thirds more often than plaintiff at trial.  Even in Cook County it is still an up hill battle for any plaintiff.  There are also many, many reported settlements much lower than the values listed on the tables below.  However, of the cases that actually went to verdict in the last five years, it is clear there is still significant exposure in the cases that end up as a plaintiff verdict.  Below is a summary of the data for all wrongful death claims in a medical negligence case from 2005 to January, 2011, for children ages 0-9 and adults over the age of 80.

Wrongful Death Ages 0-9

Year Age Type of Case Verdict
2010 7 Days Failure to admit child from ER despite heart desaturations $4,000,000
2010 2 Failure to monitor during CT scan $3,662,221
2009 9 Failure to diagnose necrotizing blastomycosis $4,016,929
2009 Neonate,
14 days
Failure to diagnose HELLP syndrome in mother (severe pre-eclapsia) $6,171,119
2008 7 Inappropriate conscious sedation $3,000,000
2008 4 Failure to diagnose meningitis $7,000,000 (High/Low by doctor $985K – $1.8)
2007 0, Stillbirth Failure to admit and perform c-section secondary to placental abruption $1,651,166
2007 0, Stillbirth Failure to diagnose placental abruption $1,800,000
2006 2 Failure to advise mother of proper medication instructions $75,000

Of forty-two verdicts reviewed that matched our search criteria of wrongful death between 2005 and 2011 of a child under 9, thirty-three had a not guilty verdict.

Wrongful Death Ages 80+

Year Age Type of Case Verdict
2008 89 Failure to administer proper hypothyroidism medication $1,750,000
2007 84 Failure to monitor while eating/choked $500,000
2007 91 Fall at nursing home/head trauma $454,762
2007 88 Negligence related to off label use of
$75,000 (after 50% off
$150,000 due to contributory

Of thirteen verdicts reviewed that matched our search criteria of wrongful death between 2005-2011 of an elderly adult age 80 or older, nine were a not guilty verdict.

After review of these end of the spectrum wrongful death verdicts, it is encouraging to the defense that the majority of these verdicts were not guilty verdicts.  Also, many more were settled in a range well under $1 million dollars.  However, to dismiss a case as insignificant in value based upon the age of the decedent would be a mistake.  As shown above, hospitals and other health care providers still face significant damage exposure, despite the age of the decedent, in certain scenarios.  To best position our clients litigating these geriatric and pediatric cases, we make every effort to aggressively work up the cases from all angles and mount a reasoned defense supported by well qualified experts early in the litigation process.  We find this aggressive litigation strategy best positions us to be able to resolve the case in a reasonable range and to obtain a not guilty verdict should the case be tried.

A Peer Review Reminder to Take Caution with Documentation

Last month, the U.S. District Court for the Western District of Pennsylvania ruled that a handwritten nurse’s note was not protected by the peer review privilege. The court specifically denied peer review protection because the note was not part of the proceedings or record of a peer review committee, nor was it derived from a peer review committee’s evaluation or incident review. Instead, the court compared the note to an unprotected incident report or recording log. See Ellison v. Women & Children’s Hosp., W.D. Pa., No. 08-313 (12/10/10) at  Although this case was not decided under Wisconsin state law, the applicable peer review law is similar – reminding providers to take caution with documentation as it relates to peer review issues.