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Court: Brand Name Drug Makers Can be Liable for Generic Labels

The top court in Massachusetts ruled recently that consumers can sue brand name drug manufacturers over injuries caused by generic versions of their drugs/ treatments made by other companies. 

This ruling – and a growing number like it – are important in product liability law following the 2011 U.S. Supreme Court ruling in Pliva v. Mensing, which held generic drug makers couldn’t be liable for failure to warn about a dangerous drug because those companies are required to use the exact same safety label as the brand name version. Generic drugs account for about 80 percent of all prescription medications distributed in the U.S. Pliva created a quagmire for consumers because generic manufacturers denied responsibility for creating the labels, but then brand name drug makers were successfully arguing they shouldn’t be liable for drugs they didn’t make or sell. Another 5-4 ruling by the highest court in Mutual Pharmaceutical Co. v. Bartlett reaffirmed this. Plaintiff suffered horrific injuries after taking a generic version of a pain medication and sought to sue generic drug makers for defective design. As then-Justice Samuel Alito remarked in the majority opinion, “Sympathy for the respondent does not relieve us of the responsibility of following the law.”

What the recent case, Rafferty v. Merck & Co. Inc., helps establish is that drug makers can still be held accountable when those medications harm consumers. Although this was an out-of-state case, our Orlando personal injury attorneys recognize that this is a ruling to which many state high courts will likely turn when facing similar issues.

In this particular case, the Massachusetts Supreme Judicial Court was careful to law out some background:

The federal Food, Drug and Cosmetic Act disallows manufacturers to market drugs across state lines without FDA approval, and any manufacturer that wants to market a new brand-name drug must submit an application showing the drug is effective and safe. As part of the application, the manufacturer also has to show the proposed warning label is accurate and adequate. It’s a long process, one that was ultimately shortened in 1984 for generic drug makers, so long as they indicated their generic drug was equivalent to an approved brand name drug with the same active ingredients, administration, dosage and strength.

Plaintiff’s claim stemmed from his treatment of a benign enlarged prostate with a drug called finasteride, a generic of the drug Proscar. Plaintiff then experienced a number of side effects, including sexual dysfunction. Ultimately, he stopped taking the drug and was eventually diagnosed with hypogonadism (low testosterone) and androgen deficiency – both reportedly caused by the finasteride. He is undergoing treatment which may continue indefinitely.

The label on the generic drug plaintiff took warned of potential side effects from sexual dysfunction, but indicated such effects would resolve after use was discontinued. The generic label conformed to the brand name drug’s label, as required by federal law.

Plaintiff alleged that by the time he started taking the drug, numerous reports had already emerged suggesting those side effects could persist even after discontinued use. Brand name manufacturer had also updated its label in certain international markets by that time to reflect a warning about long-term sexual dysfunction.

He sued the brand name manufacturer for failure to warn. As expected, brand name manufacturer filed a motion to dismiss, arguing defendant owed no duty of care to plaintiff because it did not make the product that reportedly caused plaintiff’s injuries. Trial court agreed and dismissed, reasoning “liability generally follows control.”

In its reversal, the MSJC ruled that while usually the duty to warn is limited to the manufacturer of the product and plaintiffs couldn’t reasonably be expected to rely on warnings for another product to apply to the one they used. This case, however, presents an exception to the pattern. Because generic drugs require use of the same labels as brand name drugs, it is reasonable for consumers to rely on warnings crafted for the brand name of the generic drug they’re taking. Imposing a duty on brand name manufacturers to generic drug consumers would result in greater financial incentive to revise their warnings to prevent failure to warn lawsuits. Absent this, the court noted, neither generic nor brand name manufacture would have incentive to maintain safe labels for the majority of prescription drugs being distributed.

In weighing these and other considerations, the MSJC concluded that public policy is not served if generic drug consumers have no remedy for the failure of a brand name manufacturer’s failure to warn in cases where such failure exceeds ordinary negligence and rises to the level of recklessness. Reckless disregard for the safety of others is generally understood in common law to mean an act or intentional failure to act when it is his or her duty to do so, knowing or having reason to know the conduct creates an unreasonable risk of harm and such risk is substantially greater than that which is necessary to make the conduct negligent.

Product liability is complex litigation and requires an experienced defective product attorney on your side to help you navigate these complicated issues.

Call Freeman Injury Law — 1-800-561-7777 for a free appointment to discuss your rights. Now serving Orlando, West Palm Beach, Port St. Lucie and Fort Lauderdale.

Additional Resources:

Rafferty v. Merck & Co., Inc., March 16, 2018, Massachusetts Supreme Judicial Court

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South Florida Sees Increase in Deaths Involving Plastic Surgery, Jan. 12, 2018, Florida Product Liability Attorney Blog

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