Drug & Device News

Pharmaceuticals: Common-Law Claims Allowed in PA

In a 47-page opinion, Pennsylvania's Supreme Court recently announced in Lance v. Wyeth that a right of action for defective drug design exists in the state, in addition to claims for manufacturing defects and inadequate warnings.

The Lance case was brought by the mother of a woman who died after taking the drug Redux, a diet pill manufactured by Wyeth Pharmaceuticals. The woman took the pills for just four months, in early 1997. Redux was taken off the market in September 1997. The suit alleges that the company was negligent in designing the drug, and in testing and marketing it. Wyeth sought dismissal of those claims, saying it had complied with federal regulations. It also asserted the defense of the learned intermediary doctrine: that the claimants did not have a case against it because the deceased's doctor had prescribed the medication. And the company tried to persuade the court that it was good policy to restrict the extent of liability drug manufacturers may face in product liability suits, in order to ensure the development and continued availability of beneficial drug products.

The court found that these arguments were not enough to forestall application of traditional civil liability to the company. Writing for the majority, Justice Thomas G. Saylor stated, “A subtext of Wyeth's positions … is that the likelihood that a pharmaceutical company would actually tender an essentially worthless and dangerous drug into commerce is so minimal, and the burden of responding to meritless claims so great, that it is not sound to preserve an avenue for redress even for legitimate claims.” He continued,' “We are asked to curtail an avenue of traditional, fault-based tort liability as an all-or-nothing proposition. Based on the presentation and record before us, however, we are unable to see with reasonable clarity the results of such decision and to say with reasonable certainty that the change will serve the best interest of society. … Accordingly, we are not in a position to make a responsible, substantive change in the law.”

Howard Bashman, one of the plaintiff's attorneys, says that the ruling may well affect other drug injury claims nationwide: “Not only does this confirm the existence of these claims in Pennsylvania law, but it may lay the groundwork in other states to consider the availability of claims like these.”

Risperdal Lawsuit Filings on the Rise

Lawsuit filings concerning the antipsychotic drug Risperdal ' which plaintiffs claim causes males to grow female breasts (gynecomastia) and increases the risk of pituitary tumors ' are still going strong.

Philadelphia Court of Common Pleas Judge Arnold L. New, supervising judge of the trial division's civil section and coordinating judge of the Complex Litigation Center, says that about 200 such cases are currently active, with Sheller P.C. serving as the principal plaintiffs' firm. Stephen Sheller, who founded the Sheller firm, says that the cases against Johnson & Johnson include failure-to-warn claims. “We have a group of cases coming into trial in July. Right now we're getting contacted by other attorneys referring to us. We have all the experts and documents,” Sheller said. He added that in the future, “we'll probably have at least a thousand cases.”

Food for Thought: Two Drug Names May Increase Potential for Error

In an article written by oncology nurse Theresa Brown for The New York Times, the author questions the advisability of our current drug-naming system, which often gives one medication both a brand-name and generic identification. Brown, Theresa, “One Drug, Two Names, Many Problems,” The New York Times, 12/1/13, available at http://nyti.ms/1khzgqv. She points out that, with two names, it is easy for practitioners to get confused and order the wrong medication for a patient, particularly in an emergency situation.'

Gastric Acid Reducing Medications May Cause Vitamin Deficiency

A study published in the Journal of the American Medical Association indicates that the long-term (more than two years) use of certain medications for reducing gastric acid may make a consumer more likely to have a vitamin B12 deficiency. Lam, Jameson R., et al., “Proton Pump Inhibitor and Histamine 2 Receptor Antagonist Use and Vitamin B12 Deficiency,” JAMA. 2013;310(22):2435-2442.doi:10.1001/jama.2013.280490.

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Pharmaceuticals: Common-Law Claims Allowed in PA

In a 47-page opinion, Pennsylvania's Supreme Court recently announced in Lance v. Wyeth that a right of action for defective drug design exists in the state, in addition to claims for manufacturing defects and inadequate warnings.

The Lance case was brought by the mother of a woman who died after taking the drug Redux, a diet pill manufactured by Wyeth Pharmaceuticals. The woman took the pills for just four months, in early 1997. Redux was taken off the market in September 1997. The suit alleges that the company was negligent in designing the drug, and in testing and marketing it. Wyeth sought dismissal of those claims, saying it had complied with federal regulations. It also asserted the defense of the learned intermediary doctrine: that the claimants did not have a case against it because the deceased's doctor had prescribed the medication. And the company tried to persuade the court that it was good policy to restrict the extent of liability drug manufacturers may face in product liability suits, in order to ensure the development and continued availability of beneficial drug products.

The court found that these arguments were not enough to forestall application of traditional civil liability to the company. Writing for the majority, Justice Thomas G. Saylor stated, “A subtext of Wyeth's positions … is that the likelihood that a pharmaceutical company would actually tender an essentially worthless and dangerous drug into commerce is so minimal, and the burden of responding to meritless claims so great, that it is not sound to preserve an avenue for redress even for legitimate claims.” He continued,' “We are asked to curtail an avenue of traditional, fault-based tort liability as an all-or-nothing proposition. Based on the presentation and record before us, however, we are unable to see with reasonable clarity the results of such decision and to say with reasonable certainty that the change will serve the best interest of society. … Accordingly, we are not in a position to make a responsible, substantive change in the law.”

Howard Bashman, one of the plaintiff's attorneys, says that the ruling may well affect other drug injury claims nationwide: “Not only does this confirm the existence of these claims in Pennsylvania law, but it may lay the groundwork in other states to consider the availability of claims like these.”

Risperdal Lawsuit Filings on the Rise

Lawsuit filings concerning the antipsychotic drug Risperdal ' which plaintiffs claim causes males to grow female breasts (gynecomastia) and increases the risk of pituitary tumors ' are still going strong.

Philadelphia Court of Common Pleas Judge Arnold L. New, supervising judge of the trial division's civil section and coordinating judge of the Complex Litigation Center, says that about 200 such cases are currently active, with Sheller P.C. serving as the principal plaintiffs' firm. Stephen Sheller, who founded the Sheller firm, says that the cases against Johnson & Johnson include failure-to-warn claims. “We have a group of cases coming into trial in July. Right now we're getting contacted by other attorneys referring to us. We have all the experts and documents,” Sheller said. He added that in the future, “we'll probably have at least a thousand cases.”

Food for Thought: Two Drug Names May Increase Potential for Error

In an article written by oncology nurse Theresa Brown for The New York Times, the author questions the advisability of our current drug-naming system, which often gives one medication both a brand-name and generic identification. Brown, Theresa, “One Drug, Two Names, Many Problems,” The New York Times, 12/1/13, available at http://nyti.ms/1khzgqv. She points out that, with two names, it is easy for practitioners to get confused and order the wrong medication for a patient, particularly in an emergency situation.'

Gastric Acid Reducing Medications May Cause Vitamin Deficiency

A study published in the Journal of the American Medical Association indicates that the long-term (more than two years) use of certain medications for reducing gastric acid may make a consumer more likely to have a vitamin B12 deficiency. Lam, Jameson R., et al., “Proton Pump Inhibitor and Histamine 2 Receptor Antagonist Use and Vitamin B12 Deficiency,” JAMA. 2013;310(22):2435-2442.doi:10.1001/jama.2013.280490.

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