Drug Maker May Be Liable for Injuries From Generic Product

Monday, November 10, 2008

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Drug Maker May Be Liable for Injuries From Generic Product—Court

By SHERRI M. OKAMOTO, Staff Writer

A drug manufacturer may be liable for negligent misrepresentation even though it would not be liable in strict products liability because it did not manufacture or sell the product which harmed the consumer, the First District Court of Appeal held Friday.

Reversing San Francisco Superior Court Judge Robert L. Dondero’s grant of summary judgment in favor of Wyeth Inc., Div. Three ruled that the pharmaceutical company owed a duty of care in formulating its product warnings extended to patients who were injured by generic versions of Wyeth’s medications.

Wyeth manufactures and markets a medication containing metoclopramide, sold under the trade name Reglan, which is used to treat gastroesophagel reflux disease. Purepac Pharmaceutical Company, Teva Pharmaceutical USA Inc., and Pliva Inc. all manufacture generic versions of metoclopramide.

Neurological Disorder

Elizabeth Conte’s doctor, Robert Elsen, prescribed metoclopramide to Conte, and she took a generic form of the drug for a period of almost four years. Conte alleged that she developed tardive dyskinesia, a debilitating and incurable neurological disorder, as a result of having taken the medication for so long.

She claimed that the drug manufacturers knew or should have known that doctors tended to prescribe metoclopramide for periods of 12 months or longer, even though the medication is only approved for 12 weeks of use, because the drug’s labeling understated the risks of side-effects from extended use.

Her complaint asserted claims for fraud, fraud by concealment and negligent misrepresentation against Wyeth; and negligence, strict products liability, negligence per se, and breach of express and implied warranties against the generic drug manufacturers.

Conte’s causes of action were premised on misrepresentations in Wyeth’s labeling of Reglan and in a description on Reglan it provided for publication in the Physician’s Desk Reference, an annual publication compiling product information about pharmaceuticals.

Summary Judgment Motion

Purepac successfully moved for summary judgment on the ground that Conte’s claims were preempted by the federal Food, Drug and Cosmetic Act and its implementing regulations, and Pliva and Teva filed a joint motion for summary judgment on the same basis.

Wyeth moved for summary judgment arguing its product information had no causal relationship to Conte’s injuries and it owed her no duty of care.

Dondero granted Wyeth’s motion on both grounds, and granted the Pliva/Teva summary judgment motion on the ground that Conte’s state tort claims were preempted by federal law. The appellate court consolidated Conte’s appeals from the judgments.

Writing for the appellate court, Justice Peter J. Siggins, joined by Presiding Justice William R. McGuiness and Justice Stuart R. Pollak, reasoned that Conte had presented enough evidence to support a reasonable inference that Wyeth’s Reglan description was a causal factor in Elsen’s decision to prescribe the drug to Conte.

Deposition Testimony

Elsen’s deposition testimony was that he “probably” read Wyeth’s description of Reglan during his residency training. He also said that he generally refers to the Physicians Desk Reference in his clinical practice when he considers prescribing Reglan for his patients, and that he believed the information it contained was accurate.

“If it is established that Dr. Elsen relied on Wyeth’s product warnings when he prescribed metoclopramide and Conte’s long-term use of the medication led to her condition, a close link between Wyeth’s non-disclosure of its long-term effects and Conte’s condition is readily apparent,” Siggins wrote, concluding that the doctor’s testimony raised a triable question of fact sufficient to defeat summary judgment on the issue of causation.

As for the substantive issue of Conte’s claim against Wyeth, Siggins emphasized that Conte did not allege that Wyeth was strictly liable because the allegedly inadequate warnings rendered its product unreasonably dangerous, but rather claimed that Wyeth had failed to use due care when disseminating its product information.

“Negligence and strict products liability are separate and distinct bases for liability that do not automatically collapse into each other because the plaintiff might allege both when a product warning contributes to her injury,” Siggins wrote.

Justice’s Explanation

He explained that a defendant who authors and disseminates information about a product manufactured and sold by another may still be liable for negligent misrepresentation where the defendant should reasonably expect others to rely on that information and the product causes injury, even though the defendant would not be liable in strict products liability because it did not manufacture or sell the product.

Citing Palsgraf v. Long Island R.R.. Co. (1928) 248 N.Y. 339, Siggins said that Wyeth’s duty had to be examined in light of the foreseeability of physical harm to consumers.

Noting that pharmacists in California are statutorily authorized to fill prescriptions for name-brand drugs with their generic equivalents, Siggins reasoned it was “highly likely” that a prescription for Reglan written in reliance on Wyeth’s product information will be filled with generic metoclopramide.

Because the generic and name-brand versions of drugs are biologically identical, Siggins continued, it would be “eminently foreseeable that a physician might prescribe generic metoclopramide in reliance on Wyeth’s representations about Reglan,” and concluded that Wyeth should have perceived that there could be injurious reliance on its product information by a patient taking generic metoclopramide.

“As the foreseeable risk of physical harm runs to users of both name-brand and generic drugs, so too runs the duty of care, and Wyeth has not persuaded us that consideration of other factors requires a different conclusion,” Siggins wrote, acknowledging that such a conclusion was a departure from what the majority of courts which had addressed the issue have held.

But, Siggins cautioned if a prescribing physician not read or rely upon the allegedly inadequate warnings promulgated by a defendant about a product, there could be no proximate cause.

Because Conte conceded that the generic drug manufacturers did not disseminate any concerning their metoclopramide products aside from price lists and package inserts, and absent any evidence that Elsen relied on either price lists or package inserts for generic drug when prescribing metoclopramide to Conte, Siggins concluded Conte could not prove that the generic drug manufactures were responsible for her injury and summary judgment was appropriate as to those defendants.

Although Siggins declined to address the generic drug manufacturer’s preemption arguments, the Fifth District rejected the same arguments in McKenney v. Purepac Pharmaceutical Company, 167 Cal.App.4th 72.

The case is Conte v. Wyeth, Inc., 08 S.O.S. 6093.