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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Brand-Name Drug Manufacturer can be Liable for Harm Caused by its Generic Version

Posted in Preemption

We are pleased with a recent order issued by a Federal District Judge in Illinois, which found that, under Illinois law, a brand-name manufacturer owes a duty to consumers of generic versions of its drugs.

The plaintiff in the case is a woman whose husband committed suicide after taking a medication called, paroxetine, which is manufactured by Mylan, Inc. Paroxetine is the generic version of the brand-name drug, Paxil, which is owned and manufactured by GlaxoSmithKline (“GSK”). The plaintiff brought a wrongful death action against both GSK and Mylan. Among other claims, the plaintiff brought negligence claims against both defendants.

The plaintiff’s husband’s doctor wrote him a prescription for Paxil to treat work-related anxiety. However, his prescription was ultimately filled with the generic version, paroxetine. Six days after beginning to take paroxetine, the husband purposefully leaped in front of a train to his death. Blood tests taken with his biopsy were positive for paroxetine.

According to the complaint, the plaintiff and her husband were financially secure, owned their home outright, and had no pressing debts. What caused such a drastic change in the husband’s mind that he would take his own life within six days? He took paroxetine. Besides work-related stress, it seems that, up until the time the husband took paroxetine, he enjoyed tranquility in his life, and never showed any signs of suicide whatsoever.

The paroxetine label in existence at the time of the husband’s death did not warn of the medication’s association with increased risk of suicidal behavior in adults. Instead, the label specifically stated the exact opposite—that no risk of suicide existed beyond the age of 24. However, the plaintiff asserts that the defendant companies had concrete knowledge that paroxetine use carried a substantial risk of suicidal behavior in adults above the age of 24, and yet promoted the medication as safe and effective.

The issue is whether either of the defendant companies can be held liable for damages caused by the medication that resulted in the plaintiff’s husband’s fatality. Here lies the difficult “catch” for the plaintiff in the case at hand, and other similarly situated plaintiffs: GSK argues that because it did not manufacture the actual pill that the husband ingested, it cannot be held responsible, and is entitled to judgment as a matter of law. Mylan, on the other hand, too, argues that it cannot be held liable, because federal law preempts claims against manufacturers of generic versions of brand-name drugs.

Although absurd, Mylan is correct. Due to a ruling by the United States Supreme Court, if you are harmed by a generic version of a brand-name drug, you cannot sue the manufacturer of the generic version. This is because, under federal law, the generic drug’s design and warning label must be identical to that of the name-brand version of the drug. As the Supreme Court recently summarized:

“First, the proposed generic drug must be chemically equivalent to the approved brand-name drug: it must have the same “active ingredient” or “active ingredients,” “route of administration,” “dosage form,” and “strength” as its brand-name counterpart.  21 U.S.C. §§ 355(j)(2)(A)(ii) and (iii).  Second, a proposed generic must be “bioequivalent” to an approved brand-name drug.  § 355(j)(2)(A)(iv). That is, it must have the same “rate and extent of absorption” as the brand-name drug. § 355(j)(8)(B).  Third, the generic drug manufacturer must show that “the labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug.” § 355(j)(2)(A)(v). Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S.Ct. 2466, 2471 (2013).

In accordance with the above ruling, the Illinois Federal Judge in the case at hand had no choice but to grant Mylan’s motion to dismiss, concluding that, “with respect to any alleged defects in connection with a generic drug’s warning label, a generic manufacturer’s hands are simply tied.” With regard to Mylan, the generic manufacturer, federal law simply preempted the plaintiff’s claims. As a result, the plaintiff’s only hope for any sort of compensation hinged on whether the court found that GSK, the brand-name manufacturer, was somehow liable.

Fortunately—and a bit creatively—the court found that, under Illinois law, a brand-name manufacturer owes a duty to consumers of generic versions of its drugs, and thereby denied GSK’s motion for summary judgment with regard to the plaintiff’s negligence claims.

In order to constitute a common law negligence claim, a plaintiff must allege facts establishing (1) a duty of care owed by the defendant to the plaintiff; (2) a breach of that duty; and (3) an  injury (4) proximately caused by the breach. Simpkins v. CSX Transportation, Inc., 965 N.E.2d 1092, 1096 (Ill. 2012). The court found that GSK did indeed owe a duty of care to the plaintiff and her husband, stating:

“[I]t is well understood that any generic manufacturer would be required by law to use GSK’s design and warning label, and that any defects later discovered could only be  cured by GSK.  Under such circumstances, it was entirely foreseeable that negligence on the part of GSK with respect to paroxetine’s design and warning label could result in injury to a consumer ingesting a subsequent generic version of the drug. Continuing with the duty inquiry described above, and again construing all facts and drawing all reasonable inferences in Plaintiff’s favor, GSK has not shown why the likelihood of injury was so remote as to undo GSK’s duty of care.  The principal distinction GSK insists upon – that Mr. Dolin did not ingest a product that GSK manufactured – does not lessen the likelihood that GSK’s allegedly tortious conduct would lead to Plaintiff’s injury. Under the regulatory scheme created by the Hatch-Waxman Act, whether a consumer ingests the name-brand or generic version of a given drug is immaterial as to the likelihood that negligence in the design or warning label of that drug will cause injury.”

As the patent holder, GSK was responsible for paroxetine’s design and warning label. Under the Hatch-Waxman Act, only GSK was legally permitted to cure any warning label defects. We applaud the court for finding that a brand-name manufacturer owes a duty to a patient who fills his or her prescriptions with the generic equivalent of the medication. The plaintiff in this case raised a genuine issue of material fact as to whether GSK, through negligent conduct, breached this duty, proximately causing her injuries.

It is our firm’s stance that a patient should be able to recover for injuries obtained as a result of taking an unsafe medication—whether the medication is the brand-name version or a generic equivalent. We hope that other courts will follow the Illinois Federal court’s example and ensure that plaintiffs harmed by generic versions of medications have an avenue by which to be compensated.