Subject: US Supreme Court

Supreme Court to Resolve Attorney-Client Privilege Split

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For the first time in 25 years, the U.S. Supreme Court is considering the scope of the attorney-client privilege in the case In re Grand Jury, No. 21-1397. The Court heard oral arguments earlier this week about when the attorney-client privilege protects communications involving both legal and nonlegal advice (dual-purpose communications).

In re Grand Jury

A grand jury subpoenaed documents from the petitioner, a tax law firm, related to a criminal investigation into the law firm’s client. In re Grand Jury, 23 F.4th 1088, 1090 (9th Cir. 2021). The law firm withheld documents that had dual-purpose communications based on the attorney-client privilege. After the government moved to compel, the district court used the “primary purpose test” to determine whether the dual-purpose communications were privileged. The court used the test to determine “whether the primary purpose of the communication [was] to give or receive legal advice, as opposed to business or tax advice.” Id. at 1091 (citation omitted). In the end, the district court ordered the law firm to produce documents to the government after redacting tax-related legal advice. When the law firm refused, the court held it in contempt, and the Ninth Circuit affirmed the contempt order.

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5 Major Drug and Device Developments of 2022

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As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702 updates that took place this year, which will carry over into 2023?), but provides a brief recap and assessment of five of the most interesting and consequential developments affecting drug and device law in 2022.

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Passengers on Litigation Tourism Train Get Review from Supreme Court

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The United States Supreme Court will soon consider whether the due process clause of the Fourteenth Amendment prohibits a state from requiring that a corporation consent to personal jurisdiction in order to conduct business there.

The question arises from a Pennsylvania Supreme Court case, Mallory v. Norfolk Southern Railroad Co., 266 A.3d 542 (Pa. 2021), which we wrote about here.  In Mallory, plaintiff Robert Mallory attempted to hold the Norfolk Southern Railway Co. liable for the colon cancer he allegedly developed after being exposed to chemicals during the two decades that he worked for the railroad in Virginia and Ohio.

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Another Brick in the Wall: The District Court Finds Preemption in Fosamax Case After Remand From the Supreme Court

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We have written before about the Supreme Court’s impossibility preemption decision, Merck Sharpe & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (Albrecht) (here, here, here, and here), highlighting some open questions and uncertainties that might come into play on remand. Albrecht held that impossibility preemption is a question of law for the court, not for the jury, “elaborated” on the “clear evidence” standard arising from Wyeth v. Levine, 555 U.S. 555 (2009) (Wyeth), and remanded to the Third Circuit for determination of the preemption issue. That court in turn remanded to the District of New Jersey and further directed the district court “to determine the effect of the FDA’s Complete Response Letter and other communications with Merck on the issue of whether the agency actions are sufficient” to find preemption.

We predicted that the decision on remand would be “interesting” and opined that the case for preemption was “strong.” We now have that decision, In re Fosamax (Alendronate Sodium) Prod. Liab. Litig., 2022 WL 855853 (D. N.J. Mar. 23, 2022) (Fosamax), and we were right on both counts.

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Pennsylvania Rejects Corporate Registration as Basis for Personal Jurisdiction

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A recent Pennsylvania Supreme Court opinion provides out-of-state corporations more protection from litigation tourists, bringing the state’s general personal jurisdiction rules in line with U.S. Supreme Court precedent. In Mallory v. Norfolk Southern Railway Co., a unanimous court invalidated part of Pennsylvania’s corporate registration statute, holding that corporations that are not incorporated and do not have a principal place of business in Pennsylvania cannot be subject to general personal jurisdiction simply because they have registered to conduct business in the Commonwealth.

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Circuits Split on CMS Vaccine Mandate, Highlighting “Great Significance” of Issue as It Heads to Supreme Court

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Three circuit court decisions issued in the past two weeks have considered the CMS vaccine mandate, bringing the issue – and similar vaccine mandate lawsuits – to the Supreme Court in the final weeks of the year. The CMS mandate generally requires that facilities certified to participate in Medicare or Medicaid ensure their staff are fully vaccinated against COVID unless the employee is exempt for medical or religious reasons. CMS issued the vaccine mandate on November 5, 2021. It went into effect immediately, with staff to be fully vaccinated by January 4, 2022.

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