US Pharm. 2013;38(12):43-45.

 

The time between an injury caused by a pharmaceutical mistake and the filing of a lawsuit by the injured party (plaintiff) against the perpetrators (defendants) is often crucial from both procedural and substantive perspectives. Evidence can become less reliable over time. An individual’s recall surrounding the event that caused the problem may not be as accurate. From a policy perspective, defendants should not have to look over their shoulder forever in expectation that they will be subject to litigation. The theory is that plaintiffs should have a finite time to bring forth their complaints. The old cliché, “Justice delayed is justice denied,” is applicable here. Statutes of limitations exist to prevent injustice.

In order to address these concerns, state legislators have enacted laws setting limits on when lawsuits have to be filed. These laws are often called statutes of limitations or statutes of repose. Once the statutory period has passed, a lawsuit is barred. It must be noted that there are often different events that can initiate the limitations period. When the injury occurred and when the plaintiff became aware of the injury are often two very different points in time and could easily trigger different dates for the limitation period to run. Further, there are often time limits that differ between “ordinary” negligence and negligence allegedly committed by a healthcare professional (known as malpractice in most jurisdictions).

Two recent cases help illustrate the difficulty in determining which date to use in deciding when the applicable statute of limitations time periods begin to run. Pay close attention to the dates of each occurrence.

Case #1: Unintentional Pregnancy

The plaintiffs, parents of a child born on June 2, 2012, sued a CVS pharmacy that dispensed the birth control pill Tri-Previfem to the mother in July and August 2011 in an allegedly defective package.1 The package was incorrectly rotated 180 degrees, causing a mismatch between the actual order of the pills and the sequence indicated on the package. This mismatch caused the mother to take placebo pills when she should have been taking the active pills. She and the child’s father claimed that the mother became pregnant unintentionally. For purposes of this discussion, assume that the child is healthy and living with her parents. The complaint was filed on June 18, 2013.

On September 15, 2011, the manufacturer of the birth control pills issued a recall. On September 26, 2011, CVS sent a letter to the mother-patient notifying her of the recall.

Complaint: The only allegation of wrongdoing against CVS was for negligence. The parents claim that CVS had a legal duty to notify patients of the recall and advise them that they should not rely on the pills to prevent pregnancy. They also claim that CVS was negligent in failing to notify them in a timely manner of the recall and that the 11-day period between the time CVS learned of the problem and when it sent out the notice letter was an unreasonable delay. According to the plaintiffs, this delay was a substantial factor in causing the mother to become pregnant.

Motion to Dismiss: CVS asked the court to dismiss the complaint against it, arguing that, under the California law applying to healthcare professionals, the statute of limita-tions runs 1 year from the date the plaintiffs could have discovered that the pregnancy had occurred, i.e., the date of conception or at least just a few months later when the mother found out that she was pregnant.2 The pharmacy argued that the statute of limitations expired on September 26, 2012, 6 months prior to the filing of the complaint.

The plaintiffs averred that the state’s 2-year statute of limitations for ordinary negligence should apply and that, therefore, their complaint was timely filed.3 They claimed that CVS had a legal duty to notify them of the recall and not to rely on the birth control pills to prevent pregnancy. The also claimed that CVS breached this duty by waiting 11 days between the date the pharmacy was put on notice of the recall and the date the pharmacy sent out the notice of the recall to the plaintiffs.

The plaintiffs asserted that CVS was not a “healthcare professional” and that CVS was acting as the mere conduit of the manufacturer when it sent out notice of the recall to the plaintiffs. They claimed that sending the notice does not require the skill and expertise of a pharmacist or any other healthcare professional. They also argued that, as a practical matter, pharmacists send out letters of recall because pharmacists are the only ones who have direct communication with patients.

Court Rulings: The court, faced with the defendant’s motion to dismiss, first addressed whether CVS is a healthcare professional. It noted that every “person” certified by the California Board of Pharmacy to engage in the practice of pharmacy must be licensed to do so. Because the statute requires healthcare professionals to be licensed and that CVS has such a license, it is a healthcare professional under the meaning of the statute.

Next, the court considered the question of whether the plaintiff’s case of action was for “professional negligence,” governed by the 1-year statute of limitations, or “ordinary negligence,” regulated by the 2-year statute of limitations. It noted that CVS was rendering professional services for which it was licensed when it notified the plaintiffs of the birth control pill recall. It stated that “pharmacy practice is a dynamic patient-oriented health service that applies a scientific body of knowledge to improve and promote patient health by means of appropriate drug use, drug-related therapy and communication for clinical and consultative purposes.”4 Thus, it concluded that notifying a patient of a drug’s defect is communication to “promote patient health” and that the purpose of CVS’s conduct if issuing the recall notice to the plaintiffs was to “deliver healthcare.” This means that the court applied the 1-year statute of limitations to govern this case.

Next, the court considered the more difficult question for purposes of applying the statute of limitations: What was the injury? The statute clearly states that “a plaintiff must commence an action no more than one year after the plaintiff discovered, or with reasonable diligence should have discovered the injury.”3

CVS argued that the injury was the conception. The plaintiffs claimed that the injury was the birth of the child. Citing various prior case law, the court determined that for the purposes of applying the statute of limitations to this case, the injury commencing the 1-year time limit is the date of conception, not birth. In other words, the court characterized the plaintiffs’ case of action as one for “wrongful pregnancy” as opposed to “wrongful birth.”5 Thus, the cause of action accrues at the time the parents became aware of the pregnancy, not at the time of the child’s birth.

In this case, the court said that the plaintiffs had presumptive, if not actual, knowledge of the pregnancy at least 1 year prior to the filing of the complaint. By May 23, 2012, the plaintiffs were already on notice that the birth control pills might not be effective at preventing pregnancy because they had received notice of the recall from CVS 6 months earlier. The physical symptoms of pregnancy further put the plaintiffs on notice of inquiry. The date of conception was no later than September 26, 2011. By May 23, 2012, the mother was at least 34 weeks into her pregnancy. If this was not obvious, the mother also could have taken a pregnancy test. Thus, the plaintiffs could have discovered through the use of reasonable diligence the pregnancy before May 23, 2012. Therefore, CVS’s motion to dismiss was granted.

Case #2: Drug Interactions

On November 11, 2008, a patient requested a prescription for simvastatin (Zocor) from his physician. On that same day, the defendant-physician approved and wrote a prescription for the drug. The next day, the doctor’s office called the prescription in to the pharmacy. The patient did not fill the prescription until 3 weeks later, on December 3, 2008. Shortly thereafter, on December 8, 2008, the patient was hospitalized with drug-induced rhabdomyolysis, purportedly caused by an inter-action of the simvastatin and another medication he was taking. The patient was released from the hospital on January 12, 2009. He died on February 21, 2010. The plaintiffs filed their medical malpractice and wrongful death lawsuit on December 1, 2011.6

The lower court ruled against the physician’s motion to dismiss on the grounds that the state’s applicable 3-year statute of limitations runs from the date of the prescribing of the drug.7 The New Mexico Court of Appeals reversed the lower court and granted the physician’s motion to dismiss, holding that the statute of limitations begins on the date the medication was prescribed.

The plaintiffs argued that the 3-year statute of repose did not begin to run until either: 1) the patient had been injured, or 2) the last day that the patient ingested the prescribed drug. The physician contended that the statute of repose began to run on either the date he wrote the prescription, on November 11, 2008, or, at the latest, the date his office called in the prescription to the pharmacy, which was the following day. Thus, the physician asserted that the complaint filed on December 1, 2011, was outside the 3-year limitations period provided under New Mexico’s Medical Malpractice Act.7

The court explained that the malpractice act is a statute of repose rather than a statute of limitation, the difference being that a limitation statute establishes the time, after a cause of action arises, within which a claim must be filed. A statute of limitations begins to run when the cause of action accrues, the accrual date usually being the date of discovery of the injury. A statute of repose terminates the right to any action after a specific time has elapsed, even though no injury has yet manifested itself. A statute of repose runs from a statutorily determined triggering event.

Analysis

Statutes that limit the time that a plaintiff has to file a lawsuit favor defendants. As these cases illustrate, failure to file a claim in a timely manner could result in dismissal of the complaint. Many states have limitation periods for professional negligence or malpractice that are significantly shorter than the time allowed for ordinary negligence. This protects professional defendants from having to wait long periods before they are sued. Pharmacists should take precautions against any legal claim for relief. At the very least, they should be comforted to know that plaintiffs cannot linger for very long after a mistake is made.

REFERENCES

1. Manion v. Vintage Pharmaceuticals, Slip Op No. 13-2996 EMC ND Cal, 2013 US Dist Lexis 1491543, October 16, 2013. http://docs.justia.com/cases/federal/district-courts/california/candce/3:2013cv02996/267676/53. Accessed November 13, 2013. The parents also sued the manufacturer of the defective packaging. That cause of action is not relevant to the current discussion.
2. Cal Code of Civ Proc §340.5.
3. Cal Code of Civ Proc §335.1.
4. Cal Bus and Prof Code §4050.
5. See, e.g., Troppi v. Scarf, 31 Mich pp 240: 187 NW2d 511 (1971).
6. Chavez v. Delgado, Slip Op No. 32,719, 2013 NM App Lexis 108, October 17, 2013. http://caselaw.findlaw.com/nm-court-of-appeals/1647449.html. Accessed November 14, 2013.
7. NMSA 1978 §§41-5-1 to -29 (as amended 2008).

To comment on this article, contact rdavidson@uspharmacist.com.