In re Valsartan, Losartan, & Irbesartan Prods. Liab. Litig.
| Decision Date | 03 February 2021 |
| Docket Number | MDL No. 2875 (RBK/KW) |
| Parties | IN RE VALSARTAN, LOSARTAN, AND IRBESARTAN PRODUCTS LIABILITY LITIGATION This Document Relates to All Actions. |
| Court | U.S. District Court — District of New Jersey |
MTD OPINION 5: Subsumption, Negligence, Negligence Per se, Medical Monitoring, Strict Liability of Pharmacies
Before this Court are the Defendants' Motions to Dismiss (Doc. No. 520, 522, 523) the three Master Complaints filed in this Multi-District Litigation ["MDL"] that involves the sale of a generic blood pressure medication found to be contaminated with probable human carcinogens. Since the MTDs seek dismissal of several claims for each set of plaintiffs, the Court is issuing a series of opinions to resolve the motions. Each opinion will be numbered with this opinion being the fifth in the series.
This OPINION 5 resolves defendants' arguments relating to subsumption of claims by various states' Products Liability Acts, and Rule 12(b)(6) pleading deficiencies for common law claims of negligence, negligence per se against all three categories of defendants as well as common law claims of strict liability claims against the Pharmacy Defendants. An ORDER 5 of this date accompanies this OPINION 5.
The COURT HAVING REVIEWED the parties' submissions (without a hearing in accordance with Rule 78.1 (b)) relating to these arguments, and for the reasons stated below, and for good cause shown, the Court rules as set forth in Conclusion 7.0 infra.
1.0 FACTS AND PROCEDURAL BACKGROUND
The Court having presented facts underlying this MDL in the previous four MTD opinions, this review is kept short. Moreover, the Court hereby incorporates herein the facts, procedural history, and background of the other four MTD opinions, especially to the extent necessary to explicated pleaded facts in the Master Opinions that particularly relate to subsumption and negligence claims.
This MDL involves the generic active pharmaceutical ingredient, Valsartan, and the finished drugs produced with it, collectively termed here valsartan-containing drugs or VCDs. VCDs are universally prescribed drugs to lower blood pressure and/or treat heart failure.
In the summer of 2018, the U.S. Federal Drug Administration ["FDA"] and several of its counterparts in Europe and Canada discovered that certain batches of generic Valsartan1 contained nitrosamines, known carcinogens, in amounts above what the FDA considered allowable, that is above 96 nanograms (ng) per day. The first nitrosamine contaminant found was N-nitrosodimethylamine ["NDMA"]. Within a few months, other nitrosamines, which included N-Nitrosodimethylamine ["NDEA"], were also found in batches of VCDs.
In August 2018, these governmental health administrations began recalling VCDs made with the active pharmaceutical ingredient produced by certain API Manufacturers located in China or India. These include Zhejiang Huahei Pharmaceuticals Ltd. and Aurobindo Pharmaceuticals. The contaminated API had gone into a finished pill made by Finished Manufacturers located in India and Israel, which include Teva Pharmaceuticals, Mylan Pharmaceuticals, and Torrent. Many of these Manufacturers also began issuing their own recalls of contaminated VCDs already in the drug supply chain. To be clear, almost all generic Valsartan sold in the U.S. had come from these API Manufacturers and Finished Manufacturers.
After the recalls began, FDA testing revealed the valsartan API manufactured by and for defendants had levels of NDMA of between 15,180 and 16,300 ng, much in excess of the FDA daily limit. Further, FDA testing revealed levels of NDEA was similarly well in excess of FDA limits.
VCDs were (and remain) a drug of choice in lowering high blood pressure. Since they were widely prescribed worldwide and in the United States, the recalls caused consternation during much of 2019 in the global medical community, including the American Medical Association, both as there developed a shortage of VCDs and as physicians moved their patients to some other drug perceived less effective in order to avoid potential contamination. Several months after the recalls, the FDA (and non-U.S. health administrations) posited the contaminants in the VCDs to be the result of changes the API Manufacturers had adopted in their manufacturing processes, particularly in the solvents used. Some API Manufacturers had adopted manufacturing changes as early as 2012, which means potentially contaminated API may have been present in much of the Valsartan drug supply sold in the U.S. for about 6 years.
By late August 2018, plaintiffs had begun filing personal injury individual complaints. By October 2018, individual plaintiffs and third-party payors who had paid for individual plaintiffs' prescriptions of the contaminated Valsartan, filed several class actions alleging economic losses. (Doc. No. 1). Consumers also filed a medical monitoring class action alleging "cellular damage, genetic harm, and/or an increased risk of developing cancer" as a result of exposure to the human carcinogens in the VCDs. Lastly, personal injury claims were filed on behalf of consumers who alleged they had developed cancer as a result of taking the contaminated VCDs.
On 14 February 2019, the Judicial Panel on Multi-District Litigation ["JPML"] consolidated all of the individual filings into this MDL, No. 2875. On 17 June 2019, three Master Complaints were filed with this Court: the Economic Loss Master Complaint ["ELMC"] at ECF Doc. 121., the Personal Injury Master Complaint ["PIMC"] at ECF Doc. 122; and the Medical Monitoring Master Complaint ["MMMC"] at ECF Doc. 123. Since then, this MDL has advanced significantly, both in terms of filings and in the management of the litigation through various discovery phases. Currently, with over 700 pending filings, the MDL is well into the discovery phase of intensive document production; and, depositions of individuals and under Rule 30(b)(6) are proceeding.
1.1 ECONOMIC LOSS MASTER COMPLAINT
Plaintiffs in this Master Complaint (ECF Doc. 121) include individual consumers who purchased the VCDs at issue as well as third party payors ["TPPs"] that paid or co-paid for the VCDs at issue that consumers ingested. TPPs are health care benefit providers, such as an employer's insurance company providing health care benefit to employees. Many of the TPPs providing such health care benefits have assigned their rights to recovery in this MDL to a select few entities, termed assignors, who now stand as plaintiffs here.
Since the VCDs at issue had been FDA-approved as a generic of an FDA-approved branded drug listed in the Orange Book, plaintiffs assert generally that defendants lied to the public when the VCDs at issue were sold and identified as an approved generic. That is, the contaminants made the VCDs at issue differ substantially from the FDA-approved generic.
Plaintiffs' claims include:
- Common Law Breach of express warranties by all defendants because inclusion of defendants' VCDs in the U.S. Orange Book serves as a warranty that the VCDs at issue constituted a generic drug that is bio-equivalent in every way to the patented drug.
- State Law Breach of implied warranties and of warranty for fitness of purpose by all, or all but the Pharmacy, defendants under the law of each state, the District of Columbia, and Puerto Rico.
- Breach of the Magnuson-Moss Warranty Act under 15 U.S.C. §2301 et seq. by all, or all but the Pharmacy, defendants.
- Fraud, intentional misrepresentation and/or negligent misrepresentation by all, or all but the Pharmacy, defendants by omitting to inform the public the VCDs at issue were not bio-equivalent to the branded, FDA-approved drug.
- Breach of State Consumer Statues for Unfair Competition or False Advertising in all fifty states and in the District of Columbia and Puerto Rico.
- Unjust Enrichment against all, or all but Pharmacy, defendants.
- Common law negligence against all, or all but Pharmacy, defendants for breaching their duty to exercise reasonable care to oversee the safety of the VCDs at issue and prevent injury to plaintiffs and for failing to comply with current Good Manufacturing Practice ["cGMP"] federal regulations.
- Common law negligence per se against all, or all but Pharmacy, defendants for failing to ensure that VCDs sold in the U.S. were therapeutically equivalent to the Orange Book entry and failing to act as reasonably prudent actors throughout the U.S. drug supply chain.
The plaintiffs in this Master Complaint include all those who pleaded in their individual actions that they had suffered personal injuries as a result of the use of the VCDs at issue as well as, where applicable, plaintiffs' spouses, children, parents, decedents, wards, and heirs as represented by plaintiffs' counsel. The plaintiffs plead many of the same claims as in the ELMC, but do NOT exclude the Pharmacy defendants.
The claims specific to the PIMC include:
- Strict liability/product liability-manufacturing defects for making a drug that was not bio-equivalent to the Orange Book entry or to the patented drug because of flawed, faulty, and non-compliant cGMPs, which created a foreseeable and unreasonable danger to those ingesting the VCDs at issue.
- Strict liability/product liability-failure to warn, to physicians that the VCDs at issue would cause harm.
- Strict liability/product liability-design defect, that the VCDs at issue failed to perform in a safe manner expected by an ordinary consumer and increased the risk of causing cancer.
- Wrongful Death, that certain plaintiffs died as a result of the injury causes by ingesting unreasonably harmful VCDs that defendants made and marketed throughout the U.S. drug supply.
- Survival Action, that decedent plaintiffs before death were caused injury, including loss of body function, disability, pain and suffering and loss of economy, as a result of ingesting unreasonably harmful...
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