Proposed FDA Rule Strips Court Protection From Generic Drugs

A new rule proposed by federal drug regulators could address the current problem with generic drug warnings, which allow manufacturers of generic medications to escape liability even when they sell medications that contain known side effects that are not adequately disclosed on the warning label.  

Currently, federal regulations require that generic drug manufacturers provide the exact same label warnings as the brand name version of the drug they are copying. This applies even when the brand name version is no longer sold and when the generic manufacturer learns about new side effects that may cause consumers to suffer serious or even life-threatening injuries.

Following a 2011 Supreme Court ruling in Pliva v. Mensing, generic drug makers have used this limitation on their ability to update warning labels as a defense in product liability lawsuits brought by consumers who suffer injuries as a result of problems associated with the medication that were not disclosed by the manufacturer.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

Known as federal pre-emption, generic drug makers have successfully had thousands of lawsuits dismissed arguing that state-law failure to warn lawsuits are pre-empted by the current federal regulations that require they carry the same warnings as the brand name equivalents.

However, on Wednesday, the FDA proposed a new rule, which would allow generic drug manufacturers to update their labels with new warnings, even when the brand name is no longer on the market.

The proposed rule changes regulations for new drug applications, abbreviated new drug applications and biologics license applications. It lays out the means and requirements for generic drug manufacturers to update the labels on their drugs.

Proposed Rule Follows Another Blow to Consumer Protection

The proposal comes just days after the Supreme Court stripped a $21 million court victory from a woman who was blinded and burned across two-thirds of her body by generic sulindac. The case involved a lawsuit filed by Karen Bartlett against Mutual Pharmaceutical, the manufacturer of the generic version of Clinoril.

Bartlett had argued that Mutual Pharmaceutical should not be protected from her lawsuit, because the medication was defectively designed and the drug maker could have chosen not to sell the medication at all. Although a lower appeals court allowed the verdict to stand, the U.S. Supreme Court overturned the verdict and further narrowed the recourses available to people injured by generic drugs.

As in the 2011 ruling in Pliva v. Mensing, the ruling was split down ideological lines, with the majority conservative judges pushing for protection of manufacturers, and liberal judges dissenting in favor of protecting consumers.

Even before the latest ruling, a number of lawmakers and consumer protection groups called for the FDA to step up and author new regulations that would resolve the problem.

In August 2011, the prominent consumer advocacy group Public Citizen filed a petition with the FDA calling for the agency to amend the federal regulations that limit generic drug makers’ ability to update warning labels. The group indicated that the outdated regulations prevent consumers from learning about many known risks associated with generic drugs and has become a shield for pharmaceutical companies against product liability lawsuits.

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Uber Driver Sexual Assaults and Misconduct Reports Must Be Disclosed in Lawsuit Discovery
Uber Driver Sexual Assaults and Misconduct Reports Must Be Disclosed in Lawsuit Discovery (Posted today)

A federal magistrate judge is forcing Uber to hand over potentially hundreds of thousands of incident files involving reports of passengers who suffered sexual misconduct or sexual assault at the hands of the rideshare service's drivers.

Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits
Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits (Posted yesterday)

Abbott Laboratories is considering removing Similac infant formula products designed for preterm babies from the market, as it faces hundreds of lawsuits claiming the products increase the risk of necrotizing enterocolitis, which puts newborns at a high risk of permanent injuries and death.

Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL
Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL (Posted 2 days ago)

A federal judge has ordered parties involved in Suboxone dental decay lawsuits to submit proposals for exchanging information that will guide the selection of representative bellwether claims for early test trials.